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News Article | February 22, 2017
Site: www.PR.com

SMi’s Paediatric Clinical Trials show returns to London for the 11th year on 20th-21st March 2017. London, United Kingdom, February 22, 2017 --( Through a series of interactive conference sessions, presentations and a workshop led by industry experts; the 2017 agenda will discuss current clinical trials, implementation, drug development, recruitment and retention, ethical issues and regulations. Key presentations not to be missed: - Bianca McDade, Director Regulatory Affairs, GSK - Tom Willgoss, Senior Outcomes Research Scientist, Patient-Centred Outcomes Research, Roche - Karl-Heinz Huemer, Scientific Committee Member and Expert, EMA, PDCO - Hernando Patino, Paediatric Drug Development Lead, Johnson & Johnson - Deborah Lee, VP Clinical Development, Insys Therapeutics - Andy Kenwright, Senior Statistical Scientist, Roche - Robert Kahn, Former Senior Safety Science Leader, Global Pediatric Oncology, Genentech Highlights for 2017: - Update from the EMA on the PDCO's 10 year review into paediatric investigation plans - Discuss clinical trial legislation in the EU and US - Review challenges in paediatric drug development for rare diseases - Optimise approaches to paediatric drug formulation to improve clinical success - Evaluate recruitment and retention - Discuss hot topic of data extrapolation In the lead up to the event SMi have released some pre-conference interviews with some of the speakers. For further insight into the topics being discussed at this year’s conference and an overall look into the paediatric trials field visit the download centre of the event website to access the 2017 speaker interview series. Interviews available to download include: Roche, Insys Therapeutics, Paediatric Research Consultancy, The Birmingham Children’s Hospital and Klausrose Consulting. Countries attending Paediatric Clinical Trials 2017 include: Australia, Austria, Belgium, Denmark, France, Germany, Netherlands, Spain, Switzerland, United Kingdom & USA. For those who are interested in attending register online at the event website www.paediatric-trials.co.uk/prcom Paediatric Clinical Trials 20-21 March 2017 Copthorne Tara Hotel, London, UK www.paediatric-trials.co.uk/prcom Sponsorship enquiries: Contact Alia Malick on: +44 (0) 20 7827 6168 or email amalick@smi-online.co.uk Group bookings: Contact Ameenah Begum on: +44 (0) 20 7827 6166 or email abegum@smi-online.co.uk About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk London, United Kingdom, February 22, 2017 --( PR.com )-- With just 4 weeks to go, registration will be closing soon for SMi’s Paediatric Clinical Trials 2017. The event will bring together Clinical Operations Leads and Heads of Clinical Trials to review the developments leading to the advancement of paediatric medicines.Through a series of interactive conference sessions, presentations and a workshop led by industry experts; the 2017 agenda will discuss current clinical trials, implementation, drug development, recruitment and retention, ethical issues and regulations.Key presentations not to be missed:- Bianca McDade, Director Regulatory Affairs, GSK- Tom Willgoss, Senior Outcomes Research Scientist, Patient-Centred Outcomes Research, Roche- Karl-Heinz Huemer, Scientific Committee Member and Expert, EMA, PDCO- Hernando Patino, Paediatric Drug Development Lead, Johnson & Johnson- Deborah Lee, VP Clinical Development, Insys Therapeutics- Andy Kenwright, Senior Statistical Scientist, Roche- Robert Kahn, Former Senior Safety Science Leader, Global Pediatric Oncology, GenentechHighlights for 2017:- Update from the EMA on the PDCO's 10 year review into paediatric investigation plans- Discuss clinical trial legislation in the EU and US- Review challenges in paediatric drug development for rare diseases- Optimise approaches to paediatric drug formulation to improve clinical success- Evaluate recruitment and retention- Discuss hot topic of data extrapolationIn the lead up to the event SMi have released some pre-conference interviews with some of the speakers. For further insight into the topics being discussed at this year’s conference and an overall look into the paediatric trials field visit the download centre of the event website to access the 2017 speaker interview series. Interviews available to download include: Roche, Insys Therapeutics, Paediatric Research Consultancy, The Birmingham Children’s Hospital and Klausrose Consulting.Countries attending Paediatric Clinical Trials 2017 include: Australia, Austria, Belgium, Denmark, France, Germany, Netherlands, Spain, Switzerland, United Kingdom & USA. For those who are interested in attending register online at the event website www.paediatric-trials.co.uk/prcomPaediatric Clinical Trials20-21 March 2017Copthorne Tara Hotel, London, UKwww.paediatric-trials.co.uk/prcomSponsorship enquiries: Contact Alia Malick on: +44 (0) 20 7827 6168 or email amalick@smi-online.co.ukGroup bookings: Contact Ameenah Begum on: +44 (0) 20 7827 6166 or email abegum@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group


ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF) today announced that for the first time, allergy immunotherapy is now recommended as a treatment option in the Global Initiative for Asthma (GINA) report: Global Strategy for Asthma Management and Prevention. This global strategy is a widely recognised practical resource developed to guide healthcare professionals and policy makers, and represents the latest clinical evidence and medical practice for the treatment and management of asthma. The strategy is updated annually based on review of recent scientific literature by an international panel of experts on the GINA Science Committee. The 2017 update, which includes new information regarding the use of allergy immunotherapy, has just been released and features the following addition to steps 3 and 4 of GINA's recommended stepwise treatment of asthma in adult house dust mite (HDM) sensitive patients: Consider adding SLIT (sublingual allergy immunotherapy) in adult HDM sensitive patients with allergic rhinitis who have exacerbations despite ICS (inhaled corticosteroids), provided FEV is > 70% of predicted lung function.[1] This change draws upon recently published results from ALK's Phase III clinical trial evaluating the treatment of HDM allergic asthma with the HDM SLIT-tablet, ACARIZAX® in The Journal of the American Medical Association (JAMA) [2] Henrik Jacobi, Executive Vice President of Research & Development at ALK, said: "We are extremely pleased to see the recognition of ACARIZAX® clinical evidence in the management of asthma. This confirms our long-held conviction that allergy immunotherapy has an important role to play in the treatment of allergic asthma, a belief confirmed by the unprecedented clinical development programme for ACARIZAX®, currently the only HDM SLIT-tablet indicated for use in patients with house dust mite allergic asthma that is not well controlled." House dust mite allergy and asthma often coexist. More than half of asthmatic patients have been reported to have house dust mite sensitisation. He continued: "ALK is committed to gathering further evidence to support the wider recognition of allergy immunotherapy as a treatment option for asthma, and to investigating the potential role for allergy immunotherapy in preventing the onset of asthma." Professor J. Christian Virchow, of the University of Rostock and lead author of the recently published paper in JAMA says: "This is very encouraging. I am pleased to see findings from this important trial translated into clinical guidelines. This underlines the importance of performing robust evidence based trials in allergy immunotherapy." ACARIZAX® is currently approved for the treatment in HDM allergic asthma in 12 European countries and Australia. ALK is a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment. ALK is a world leader in allergy immunotherapy - a treatment of the underlying cause of allergy. The company has approximately 2,300 employees, with subsidiaries, production facilities and distributors worldwide. ALK has entered into partnership agreements with Torii, Abbott, and Seqirus to commercialise sublingual allergy immunotherapy tablets in Japan, Russia, and South-East Asia, and Australia and New Zealand, respectively. The company is headquartered in Hørsholm, Denmark, and listed on Nasdaq Copenhagen. Find more information at http://www.alk.net. House dust mites (HDM) are the most common cause of allergy in the world. HDM allergy is estimated to affect around 90 million people in Europe, North America and Japan, and more than 100 million in China. It is estimated that one in 10 adults with allergic rhinitis are poorly controlled with current standard therapies. The condition appears early in life, is present all year round and patients face an elevated risk of developing asthma and other allergies. For some of these patients, the HDM SLIT-tablet is a relevant treatment option which can improve their quality of life and potentially modify the underlying cause of their disease. ALK's HDM SLIT-tablet is a treatment for house dust mite-induced allergic rhinitis (AR) with or without conjunctivitis and allergic asthma (AA) that is not well controlled by symptomatic medication. In Europe, where it is marketed as ACARIZAX®, the product has been approved in 14 countries for the treatment of AR, 12 of which also include the HDM AA indication. It is also approved in Japan for AR, where it is licensed by ALK to Torii and marketed under the trade name MITICURE[TM] and in Australia for HDM AR and AA, where it is licensed by ALK to Seqirus. The product is also being developed for a number of other markets around the world, including China, North America and countries in Southeast Asia. Altogether, clinical development activities for the HDM SLIT-tablet have involved more than 6,000 patients worldwide. In the 12 European countries where ACARIZAX® has been approved for HDM AR and AA, ACARIZAX® is indicated in adult patients (18-65 years) diagnosed by a clinical history and by a positive test for HDM sensitisation with at least one of the following conditions: Treating physicians should refer to full summary of product characteristics before considering ACARIZAX® for treatment in patients with house dust mite allergic asthma.[3] GINA was launched in 1993 in collaboration with the National Heart, Lung, and Blood Institute, National Institutes of Health, USA, and the World Health Organization. GINA's programme is determined and its strategies for asthma care are shaped by committees made up of leading asthma experts from around the world. The GINA Scientific Committee prepares updates to their reports and guidelines each year, which are made available on the GINA Website as they are completed. The Scientific Committee has developed a sophisticated set of procedures to review the world's literature with regards to asthma management and to update the GINA documents to reflect this state-of-the-art information.


HORSHOLM, Denmark, Feb. 28, 2017 /PRNewswire/ -- ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF) today announced that for the first time, allergy immunotherapy is now recommended as a treatment option in the Global Initiative for Asthma (GINA) report: Global Strategy for Asthma Management and Prevention. This global strategy is a widely recognised practical resource developed to guide healthcare professionals and policy makers, and represents the latest clinical evidence and medical practice for the treatment and management of asthma. The strategy is updated annually based on review of recent scientific literature by an international panel of experts on the GINA Science Committee. The 2017 update, which includes new information regarding the use of allergy immunotherapy, has just been released and features the following addition to steps 3 and 4 of GINA's recommended stepwise treatment of asthma in adult house dust mite (HDM) sensitive patients: Consider adding SLIT (sublingual allergy immunotherapy) in adult HDM sensitive patients with allergic rhinitis who have exacerbations despite ICS (inhaled corticosteroids), provided FEV is > 70% of predicted lung function.[1] This change draws upon recently published results from ALK's Phase III clinical trial evaluating the treatment of HDM allergic asthma with the HDM SLIT-tablet, ACARIZAX® in The Journal of the American Medical Association (JAMA) [2] Henrik Jacobi, Executive Vice President of Research & Development at ALK, said: "We are extremely pleased to see the recognition of ACARIZAX® clinical evidence in the management of asthma. This confirms our long-held conviction that allergy immunotherapy has an important role to play in the treatment of allergic asthma, a belief confirmed by the unprecedented clinical development programme for ACARIZAX®, currently the only HDM SLIT-tablet indicated for use in patients with house dust mite allergic asthma that is not well controlled." House dust mite allergy and asthma often coexist. More than half of asthmatic patients have been reported to have house dust mite sensitisation. He continued: "ALK is committed to gathering further evidence to support the wider recognition of allergy immunotherapy as a treatment option for asthma, and to investigating the potential role for allergy immunotherapy in preventing the onset of asthma." Professor J. Christian Virchow, of the University of Rostock and lead author of the recently published paper in JAMA says: "This is very encouraging. I am pleased to see findings from this important trial translated into clinical guidelines. This underlines the importance of performing robust evidence based trials in allergy immunotherapy." ACARIZAX® is currently approved for the treatment in HDM allergic asthma in 12 European countries and Australia. ALK is a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment. ALK is a world leader in allergy immunotherapy - a treatment of the underlying cause of allergy. The company has approximately 2,300 employees, with subsidiaries, production facilities and distributors worldwide. ALK has entered into partnership agreements with Torii, Abbott, and Seqirus to commercialise sublingual allergy immunotherapy tablets in Japan, Russia, and South-East Asia, and Australia and New Zealand, respectively. The company is headquartered in Hørsholm, Denmark, and listed on Nasdaq Copenhagen. Find more information at http://www.alk.net. House dust mites (HDM) are the most common cause of allergy in the world. HDM allergy is estimated to affect around 90 million people in Europe, North America and Japan, and more than 100 million in China. It is estimated that one in 10 adults with allergic rhinitis are poorly controlled with current standard therapies. The condition appears early in life, is present all year round and patients face an elevated risk of developing asthma and other allergies. For some of these patients, the HDM SLIT-tablet is a relevant treatment option which can improve their quality of life and potentially modify the underlying cause of their disease. ALK's HDM SLIT-tablet is a treatment for house dust mite-induced allergic rhinitis (AR) with or without conjunctivitis and allergic asthma (AA) that is not well controlled by symptomatic medication. In Europe, where it is marketed as ACARIZAX®, the product has been approved in 14 countries for the treatment of AR, 12 of which also include the HDM AA indication. It is also approved in Japan for AR, where it is licensed by ALK to Torii and marketed under the trade name MITICURE[TM] and in Australia for HDM AR and AA, where it is licensed by ALK to Seqirus. The product is also being developed for a number of other markets around the world, including China, North America and countries in Southeast Asia. Altogether, clinical development activities for the HDM SLIT-tablet have involved more than 6,000 patients worldwide. In the 12 European countries where ACARIZAX® has been approved for HDM AR and AA, ACARIZAX® is indicated in adult patients (18-65 years) diagnosed by a clinical history and by a positive test for HDM sensitisation with at least one of the following conditions: Treating physicians should refer to full summary of product characteristics before considering ACARIZAX® for treatment in patients with house dust mite allergic asthma.[3] GINA was launched in 1993 in collaboration with the National Heart, Lung, and Blood Institute, National Institutes of Health, USA, and the World Health Organization. GINA's programme is determined and its strategies for asthma care are shaped by committees made up of leading asthma experts from around the world. The GINA Scientific Committee prepares updates to their reports and guidelines each year, which are made available on the GINA Website as they are completed. The Scientific Committee has developed a sophisticated set of procedures to review the world's literature with regards to asthma management and to update the GINA documents to reflect this state-of-the-art information.


ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that for the first time, allergy immunotherapy is now recommended as a treatment option in the Global Initiative for Asthma (GINA) report: Global Strategy for Asthma Management and Prevention. This global strategy is a widely recognised practical resource developed to guide healthcare professionals and policy makers, and represents the latest clinical evidence and medical practice for the treatment and management of asthma. The strategy is updated annually based on review of recent scientific literature by an international panel of experts on the GINA Science Committee. The 2017 update, which includes new information regarding the use of allergy immunotherapy, has just been released and features the following addition to steps 3 and 4 of GINA’s recommended stepwise treatment of asthma in adult house dust mite (HDM) sensitive patients: Consider adding SLIT (sublingual allergy immunotherapy) in adult HDM sensitive patients with allergic rhinitis who have exacerbations despite ICS (inhaled corticosteroids), provided FEV1 is > 70% of predicted lung function.1) This change draws upon recently published results from ALK’s Phase III clinical trial evaluating the treatment of HDM allergic asthma with the HDM SLIT-tablet, ACARIZAX® in The Journal of the American Medical Association (JAMA).2) Henrik Jacobi, Executive Vice President of Research & Development at ALK, said: “We are extremely pleased to see the recognition of ACARIZAX® clinical evidence in the management of asthma. This confirms our long-held conviction that allergy immunotherapy has an important role to play in the treatment of allergic asthma, a belief confirmed by the unprecedented clinical development programme for ACARIZAX®, currently the only HDM SLIT-tablet indicated for use in patients with house dust mite allergic asthma that is not well controlled.” House dust mite allergy and asthma often coexist. More than half of asthmatic patients have been reported to have house dust mite sensitisation. He continued: “ALK is committed to gathering further evidence to support the wider recognition of allergy immunotherapy as a treatment option for asthma, and to investigating the potential role for allergy immunotherapy in preventing the onset of asthma.” Professor J. Christian Virchow, of the University of Rostock and lead author of the recently published paper in JAMA says: “This is very encouraging. I am pleased to see findings from this important trial translated into clinical guidelines. This underlines the importance of performing robust evidence based trials in allergy immunotherapy.” ACARIZAX® is currently approved for the treatment in HDM allergic asthma in 12 European countries and Australia. For further information please contact: Media: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014 Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 About ALK ALK is a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment. ALK is a world leader in allergy immunotherapy – a treatment of the underlying cause of allergy. The company has approximately 2,300 employees, with subsidiaries, production facilities and distributors worldwide. ALK has entered into partnership agreements with Torii, Abbott, and Seqirus to commercialise sublingual allergy immunotherapy tablets in Japan, Russia, and South-East Asia, and Australia and New Zealand, respectively. The company is headquartered in Hørsholm, Denmark, and listed on Nasdaq Copenhagen. Find more information at www.alk.net. About house dust mite allergy and ACARIZAX®   House dust mites (HDM) are the most common cause of allergy in the world. HDM allergy is estimated to affect around 90 million people in Europe, North America and Japan, and more than 100 million in China. It is estimated that one in 10 adults with allergic rhinitis are poorly controlled with current standard therapies. The condition appears early in life, is present all year round and patients face an elevated risk of developing asthma and other allergies. For some of these patients, the HDM SLIT-tablet is a relevant treatment option which can improve their quality of life and potentially modify the underlying cause of their disease. ALK’s HDM SLIT-tablet is a treatment for house dust mite-induced allergic rhinitis (AR) with or without conjunctivitis and allergic asthma (AA) that is not well controlled by symptomatic medication. In Europe, where it is marketed as ACARIZAX®, the product has been approved in 14 countries for the treatment of AR, 12 of which also include the HDM AA indication. It is also approved in Japan for AR, where it is licensed by ALK to Torii and marketed under the trade name MITICURETM and in Australia for HDM AR and AA, where it is licensed by ALK to Seqirus. The product is also being developed for a number of other markets around the world, including China, North America and countries in Southeast Asia. Altogether, clinical development activities for the HDM SLIT-tablet have involved more than 6,000 patients worldwide. In the 12 European countries where ACARIZAX® has been approved for HDM AR and AA, ACARIZAX® is indicated in adult patients (18-65 years) diagnosed by a clinical history and by a positive test for HDM sensitisation with at least one of the following conditions: Treating physicians should refer to full summary of product characteristics before considering ACARIZAX® for treatment in patients with house dust mite allergic asthma.3) About GINA4) GINA was launched in 1993 in collaboration with the National Heart, Lung, and Blood Institute, National Institutes of Health, USA, and the World Health Organization. GINA’s programme is determined and its strategies for asthma care are shaped by committees made up of leading asthma experts from around the world. The GINA Scientific Committee prepares updates to their reports and guidelines each year, which are made available on the GINA Website as they are completed. The Scientific Committee has developed a sophisticated set of procedures to review the world’s literature with regards to asthma management and to update the GINA documents to reflect this state-of-the-art information.


ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that for the first time, allergy immunotherapy is now recommended as a treatment option in the Global Initiative for Asthma (GINA) report: Global Strategy for Asthma Management and Prevention. This global strategy is a widely recognised practical resource developed to guide healthcare professionals and policy makers, and represents the latest clinical evidence and medical practice for the treatment and management of asthma. The strategy is updated annually based on review of recent scientific literature by an international panel of experts on the GINA Science Committee. The 2017 update, which includes new information regarding the use of allergy immunotherapy, has just been released and features the following addition to steps 3 and 4 of GINA’s recommended stepwise treatment of asthma in adult house dust mite (HDM) sensitive patients: Consider adding SLIT (sublingual allergy immunotherapy) in adult HDM sensitive patients with allergic rhinitis who have exacerbations despite ICS (inhaled corticosteroids), provided FEV1 is > 70% of predicted lung function.1) This change draws upon recently published results from ALK’s Phase III clinical trial evaluating the treatment of HDM allergic asthma with the HDM SLIT-tablet, ACARIZAX® in The Journal of the American Medical Association (JAMA).2) Henrik Jacobi, Executive Vice President of Research & Development at ALK, said: “We are extremely pleased to see the recognition of ACARIZAX® clinical evidence in the management of asthma. This confirms our long-held conviction that allergy immunotherapy has an important role to play in the treatment of allergic asthma, a belief confirmed by the unprecedented clinical development programme for ACARIZAX®, currently the only HDM SLIT-tablet indicated for use in patients with house dust mite allergic asthma that is not well controlled.” House dust mite allergy and asthma often coexist. More than half of asthmatic patients have been reported to have house dust mite sensitisation. He continued: “ALK is committed to gathering further evidence to support the wider recognition of allergy immunotherapy as a treatment option for asthma, and to investigating the potential role for allergy immunotherapy in preventing the onset of asthma.” Professor J. Christian Virchow, of the University of Rostock and lead author of the recently published paper in JAMA says: “This is very encouraging. I am pleased to see findings from this important trial translated into clinical guidelines. This underlines the importance of performing robust evidence based trials in allergy immunotherapy.” ACARIZAX® is currently approved for the treatment in HDM allergic asthma in 12 European countries and Australia. For further information please contact: Media: Jeppe Ilkjær, tel. +45 7877 4532, mobile +45 3050 2014 Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525 About ALK ALK is a research-driven global pharmaceutical company focusing on allergy prevention, diagnosis and treatment. ALK is a world leader in allergy immunotherapy – a treatment of the underlying cause of allergy. The company has approximately 2,300 employees, with subsidiaries, production facilities and distributors worldwide. ALK has entered into partnership agreements with Torii, Abbott, and Seqirus to commercialise sublingual allergy immunotherapy tablets in Japan, Russia, and South-East Asia, and Australia and New Zealand, respectively. The company is headquartered in Hørsholm, Denmark, and listed on Nasdaq Copenhagen. Find more information at www.alk.net. About house dust mite allergy and ACARIZAX®   House dust mites (HDM) are the most common cause of allergy in the world. HDM allergy is estimated to affect around 90 million people in Europe, North America and Japan, and more than 100 million in China. It is estimated that one in 10 adults with allergic rhinitis are poorly controlled with current standard therapies. The condition appears early in life, is present all year round and patients face an elevated risk of developing asthma and other allergies. For some of these patients, the HDM SLIT-tablet is a relevant treatment option which can improve their quality of life and potentially modify the underlying cause of their disease. ALK’s HDM SLIT-tablet is a treatment for house dust mite-induced allergic rhinitis (AR) with or without conjunctivitis and allergic asthma (AA) that is not well controlled by symptomatic medication. In Europe, where it is marketed as ACARIZAX®, the product has been approved in 14 countries for the treatment of AR, 12 of which also include the HDM AA indication. It is also approved in Japan for AR, where it is licensed by ALK to Torii and marketed under the trade name MITICURETM and in Australia for HDM AR and AA, where it is licensed by ALK to Seqirus. The product is also being developed for a number of other markets around the world, including China, North America and countries in Southeast Asia. Altogether, clinical development activities for the HDM SLIT-tablet have involved more than 6,000 patients worldwide. In the 12 European countries where ACARIZAX® has been approved for HDM AR and AA, ACARIZAX® is indicated in adult patients (18-65 years) diagnosed by a clinical history and by a positive test for HDM sensitisation with at least one of the following conditions: Treating physicians should refer to full summary of product characteristics before considering ACARIZAX® for treatment in patients with house dust mite allergic asthma.3) About GINA4) GINA was launched in 1993 in collaboration with the National Heart, Lung, and Blood Institute, National Institutes of Health, USA, and the World Health Organization. GINA’s programme is determined and its strategies for asthma care are shaped by committees made up of leading asthma experts from around the world. The GINA Scientific Committee prepares updates to their reports and guidelines each year, which are made available on the GINA Website as they are completed. The Scientific Committee has developed a sophisticated set of procedures to review the world’s literature with regards to asthma management and to update the GINA documents to reflect this state-of-the-art information.


News Article | February 27, 2017
Site: globenewswire.com

Copenhagen, Denmark; February 27, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN) summons the Annual General Meeting on Tuesday, March 28, 2017 at 2:00 PM CEST at the Tivoli Hotel & Congress Center, Arni Magnussons Gade 2-4, DK-1577 Copenhagen V, Denmark. 1. Report by the Board of Directors on the Company’s activities during the past year. 2. Presentation and adoption of the audited Annual Report 2016 and resolution to discharge the Board of Directors and the Executive Management from liability. 3. Resolution on the distribution of profits as recorded in the adopted Annual Report. 4. Election of members of the Board of Directors. 6. Proposals from the Board of Directors: (a) Amendment of the general guidelines for incentive-based remuneration of the Board of Directors and the Executive Management. (b) Approval of remuneration to the Board of Directors for 2017. (c) Amendment of Article 5 of the Company's Articles of Association on authorization to issue warrants. (d) Insertion of a new Article 17 in the Company's Articles of Association on language of company announcements. 7. Authorization of the chairman of the General Meeting. It is proposed to take note of the report of the Board of Directors. It is proposed to adopt the audited Annual Report and to grant discharge to the Board of Directors and the Executive Management. It is proposed that the profit of DKK 1,331 million for the accounting year 2016 be carried forward by transfer to the accumulated deficit. Pursuant to Article 12 of the Company’s Articles of Association, the members of the Board of Directors are elected for periods of one year. The election period for Mats Pettersson, Dr. Anders Gersel Pedersen, Pernille Erenbjerg, Dr. Burton G. Malkiel and Dr. Paolo Paoletti expires at this General Meeting. The Board of Directors proposes to re-elect Mats Pettersson, Dr. Anders Gersel Pedersen, Pernille Erenbjerg and Dr. Paolo Paoletti for a one-year period. Dr. Burton G. Malkiel does not stand for re-election. The Board of Directors further proposes that Rolf Hoffman and Deirdre P. Connelly are elected as new members of the Board of Directors for a one year period so that the Board of Directors is composed of six members elected by the General Meeting. About Mats Pettersson, B.Sc. Swedish, 71, Male Board Chairman (Independent, elected by the General Meeting); Chairman of the Nominating and Corporate Governance Committee and member of the Audit Committee and the Compensation Committee. First elected 2013, current term expires 2017. Special Competences Extensive experience from international research-based biotech and pharmaceutical companies. Founder and CEO of SOBI AB. Responsible for several transforming Business Development deals and member of various executive management committees at Pharmacia. Current Board Positions Member: Magle Chemoswed AB. About Anders Gersel Pedersen, M.D., Ph.D. Danish, 65, Male Deputy Chairman (Non-independent, elected by the General Meeting); Chairman of the Compensation Committee and member of the Nominating and Corporate Governance Committee. First elected 2003, current term expires 2017. Special Competences Business and management experience in the pharmaceutical industry, including expertise in clinical research, development, regulatory affairs and product life cycle management. Current Position, Including Managerial Positions Executive Vice President, Research & Development at H. Lundbeck A/S. Current Board Positions Member: ALK-Abelló A/S. Deputy Chairman: Bavarian Nordic A/S. About Pernille Erenbjerg Danish, 49, Female Board member (Independent, elected by the General Meeting); Chairman of the Audit Committee and member of the Nominating and Corporate Governance Committee. First elected 2015, current term expires 2017. Special Competences Senior executive management and broad business experience from the telecoms industry. Comprehensive all round background within finance including extensive exposure to stock markets, equity and debt investors. Certified Public Accountant background. Responsible for major transformation processes in complex organizations including M&A. Current Position, Including Managerial Positions Group CEO and President of TDC A/S. Current Board Positions Member: DFDS A/S. Audit Committee Chairman: DFDS A/S. About Paolo Paoletti, M.D. Italian (USA citizenship), 66, Male Board member (Independent, elected by the General Meeting); Member of the Compensation Committee. First elected 2015, current term expires 2017. Special Competences Extensive experience in research, development and commercialization in the pharmaceutical industry. Successfully conducted submissions and approvals of new cancer drugs and new indications in the USA and in Europe. Responsible for seven new medicines for cancer patients during his 10 years at GlaxoSmithKline and one new cancer medicine during his time at Eli Lilly. Current Position, Including Managerial Positions Acting CEO at GammaDelta Therapeutics. Current Board Positions Chairman: PsiOxus Therapeutics Limited. Member: FORMA Therapeutics, Inc. and NuCana BioMed Limited. About Rolf Hoffmann German, 57, Male Independent Special Competencies Extensive international management experience with expertise in creating and optimizing commercial opportunities in global markets. Additional expertise in P&L management, governance and corporate integrity agreement management, compliance and organizational efficiency. Over 20 years’ experience in the international pharmaceutical and biotechnology industries at Eli Lilly and Company and Amgen, Inc. Current Position, including Managerial Positions Adjunct Professor of Strategy and Entrepreneurship at the University of North Carolina Business School. Current Board Positions: Member: STADA Arzneimittel AG and Trigemina, Inc. About Deirdre P. Connelly American, 55, Female Independent Special Competencies More than 30 years’ experience as a corporate leader and extensive experience in corporate governance as a board member. Comprehensive experience with business turnaround, corporate culture transformation, product launch, and talent development. Successfully directed the launch of more than 20 new pharmaceutical drugs. Former President, North America Pharmaceuticals for GlaxoSmithKline. Current Board Positions: Member: Macy’s Inc. and Lincoln National Corporation. If Deirdre P. Connelly is elected by the General Meeting, the Company’s goal of increasing the proportion of female directors to at least 25% of the directors elected by the General Meeting will be met. The Board of Directors proposes re-election of PricewaterhouseCoopers, Statsautoriseret Revisionspartnerselskab as the Company’s elected auditor in accordance with the Audit Committee's recommendation. The Audit Committee has not been influenced by third parties and has not been subject to any agreement with third parties, which limits the General Meeting’s choice to certain auditors or audit firms. The Board of Directors proposes to amend the Company's general guidelines for incentive-based remuneration for the Board of Directors and the Executive Management to specify that a new member of the Executive Management may receive a sign-on payment upon engagement subject to certain claw-back provisions. It is further proposed that, in exceptional cases, international, and in particular US based, members of the Executive Management, on an annual basis may be granted restricted stock units and/or warrants corresponding to a value (at the time of grant) of up to four (4) times the member's annual base salary, calculated before any pension contribution and bonus payment, in the year of grant. The value (at the time of grant) of the annual grant may, however, not exceed DKK 25 million. The motivation behind the proposed amendment is to ensure that a competitive compensation package can be offered to future, and in particular US based, members of the Executive Management. It is the Company’s belief that it is important for the Company’s continued success that the Company in the future will be able to attract and retain members of the Executive Management from an international pool. It is moreover proposed to amend the general guidelines so that members of the Executive Management may be granted restricted stock units or a combination of restricted stock units and warrants. If members of the executive management are granted a combination of restricted stock units and warrants, the proportional value of the warrants may not exceed 50% of the total value (at the time of grant). It is further proposed to amend the general guidelines so that restricted stock units granted to a new member of the Board of Directors upon election may no longer exceed a value (at the time of grant) of four (4) times the fixed annual base fee. As a result hereof, the maximum value (at the time of grant) of restricted stock units that may be granted to members of the Board of Directors upon election will correspond to up to four (4) times the fixed annual base fee. It is moreover proposed that the proportional value (at the time of grant) of the restricted stock units that a member of the Board of Directors may be granted on an annual basis is lowered. As a result hereof, the maximum value (in DKK) of restricted stock units that may be granted to members of the Board of Directors on an annual basis will be lowered notwithstanding the increase in the basic fee for members of the Board of Directors proposed under item 6(b). Furthermore, it is proposed that the general guidelines are amended so that vesting of restricted stock units and warrants granted to members of the Executive Management may be subject to fulfilment of forward-looking performance criteria as determined by the Board of Directors. Vesting of restricted stock units granted to members of the Board of Directors shall, however, not be subject to forward-looking performance criteria. It is further proposed to amend the general guidelines so that warrants granted to members of the Executive Management vest three years after the date of the grant in accordance with the corporate governance recommendations. The Board of Directors will implement this through a subsequent general amendment of the Company's warrant program so that all warrants granted after the adoption of this proposal will vest three years after the grant date. The general guidelines have furthermore been subject to a general update and editorial changes with a view to make the general guidelines more reader-friendly. Going forward, the Company's general guidelines for incentive-based remuneration for the Board of Directors and the Executive Management will be included in the Company’s Remuneration Principles. The Board of Directors proposes that the basic fee for members of the Board of Directors is increased from DKK 375,000 to DKK 400,000, and that the deputy chairman receives two times the increased basic fee and that the chairman receives three times the increased basic fee. It is further proposed that the supplemental fee for membership of the board committees is increased from up to DKK 75,000 per membership to up to DKK 100,000 per membership, and that a committee chairman receives up to DKK 150,000. It is moreover proposed that the fee per committee meeting is increased from DKK 9,000 per committee meeting to DKK 10,000 per committee meeting. The Board of Directors plans to establish a Scientific Committee where the remuneration will be within the range of the proposed committee fees. Members of the Board of Directors will furthermore receive share-based instruments in the form of restricted stock units within the scope described and adopted in the Company’s general guidelines for incentive-based remuneration for the Board of Directors and the Executive Management. Re item 6 (c) on the agenda: The Board of Directors proposes that Article 5 of the Company's Articles of Association be amended so that the Board of Directors is authorised to issue an additional 500,000 warrants entitling the holder to subscribe for the Company's shares up to a nominal value of DKK 500,000. With this authorization to issue an additional 500,000 warrants, the potential dilution (including the outstanding warrants and the aggregate unused part of the existing authorization) is kept below 5% of the share capital. It is further proposed to amend Article 5 so that the Board of Directors is no longer entitled to issue warrants to members of the Board of Directors and consultants of the Company and its subsidiaries. This amendment will align the wording in Article 5 with the Company’s general guidelines for incentive-based remuneration for the Board of Directors and the Executive Management according to which members of the Board of Directors may only be granted restricted stock units. It is moreover proposed to amend Article 5 to specify that the Board of Directors’ authorizations entitle the Board of Directors to issue warrants to, among others, employees employed in the Company's directly and indirectly owned subsidiaries. This change is a result of Genmab B.V. having become a wholly-owned subsidiary of Genmab Holding B.V. The proposal means that Article 5 will read as follows: By decision of the General Meeting on April 25, 2012 the Board of Directors is authorized to issue on one or more occasions warrants to subscribe the Company’s shares up to a nominal value of DKK 250,000 and to make the related capital increases in cash up to a nominal value of DKK 250,000. The Board of Directors has issued 250,000 warrants and reissued 42,375 warrants under this authorization. This authorization shall remain in force for a period ending on April 25, 2017. Further, by decision of the General Meeting on April 17, 2013 the Board of Directors is authorized to issue on one or more occasions additional warrants to subscribe the Company’s shares up to a nominal value of DKK 600,000 and to make the related capital increases in cash up to a nominal value of DKK 600,000. The Board of Directors has issued 600,000 warrants and reissued 15,250 warrants under this authorization. This authorization shall remain in force for a period ending on April 17, 2018. Moreover, by decision of the General Meeting on April 9, 2014 the Board of Directors is authorized to issue on one or more occasions additional warrants to subscribe the Company’s shares up to a nominal value of DKK 500,000 and to make the related capital increases in cash up to a nominal value of DKK 500,000. The Board of Directors has issued 406,166 warrants and reissued 4,775 warrants under this authorization. This authorization shall remain in force for a period ending on April 9, 2019. Moreover, by decision of the General Meeting on March 28, 2017 the Board of Directors is authorized to issue on one or more occasions additional warrants to subscribe the Company’s shares up to a nominal value of DKK 500,000 and to make the related capital increases in cash up to a nominal value of DKK 500,000. This authorization shall remain in force for a period ending on March 28, 2022. The authorizations entitle the Board of Directors to issue warrants to the Company’s employees as well as employees of the Company’s directly and indirectly owned subsidiaries. Subject to the rules in force at any time, the Board of Directors may reuse or reissue lapsed non-exercised warrants, if any, provided that the reuse or reissue occurs under the same terms and within the time limitations set out in this authorization. Reuse is to be construed as the Board of Directors' entitlement to let another party enter into an existing agreement on warrants. Reissue is to be construed as the Board of Directors' option to reissue new warrants under the same authorization, if previously issued warrants have lapsed. The existing shareholders of the Company shall not have a right of pre-emption in connection with the issue of warrants based on these authorizations. One warrant shall give the right to subscribe one share with a nominal value of DKK 1 at a subscription price per share determined by the Board of Directors which, however, shall be no less than the market price per share of the Company’s shares at the time of issue. The exercise period for the issued warrants shall be determined by the Board of Directors. The Board of Directors is authorized to set out more detailed terms for the warrants that are to be issued based on these authorizations. The existing shareholders of the Company shall not have a right of pre-emption in connection with issue of shares on the basis of warrants. The shares that are issued through the exercise of warrants shall have the same rights as existing shares cf. these Articles of Association. The Board of Directors has exercised the above authorizations as stipulated in schedule A which is an integral part of these articles.” The Board of Directors proposes that a new Article 17 be inserted in the Articles of Association specifying that the Board of Directors may decide whether company announcements shall be prepared in English only. As a result, the present Articles 17, 18, 19 and 20 are renumbered to Articles 18, 19, 20 and 21. The new Article 17 will read as follows: Company announcements may be prepared in English only, if decided by the Board of Directors.” The Board of Directors proposes that the chairman of the General Meeting is authorized to register the resolutions passed by the General Meeting with the Danish Business Authority and to make such amendments and additions thereto or therein, including the Articles of Association of the Company, as the Danish Business Authority may require for registration. The proposals under item 6 (c) and 6 (d) of the agenda to amend the Articles of Association are required to be adopted by an affirmative vote of not less than 2/3 of the votes cast as well as of the voting share capital represented at the General Meeting. The Company's share capital amounts to DKK 60,350,056 divided into shares of DKK 1 each or any multiple hereof. Each share amount of DKK 1 shall entitle the shareholder to one vote. Pursuant to Section 99 of the Danish Companies Act, the following documents will be published on the Company’s website (www.genmab.com) no later than March 6, 2017: (1) the notice of the Annual General Meeting, (2) information on the total number of shares and votes issued by the Company on the date of the notice, (3) the agenda, (4) the complete proposals to be presented at the Annual General Meeting, (5) the Annual Report for 2016 and (6) forms needed to register for the Annual General Meeting and possible proxy voting and post voting. Registration Date: A shareholder’s right to participate in and vote at the Annual General Meeting is determined in proportion to the number of shares the shareholder owns on the registration date Tuesday March 21, 2017. Admission card: Admission cards may be requested no later than Friday March 24, 2017 by: Proxy vote: Shareholders who do not expect to be able to participate in the General Meeting may: Go to the Company’s website www.genmab.com or www.uk.vp.dk/agm to assign a proxy to the Board of Directors to vote in accordance with its recommendations, or assign a proxy indicating how you wish your votes to be cast by checking the boxes on the electronic proxy form. This must be done by 11:59 PM CET on Friday March 24, 2017. You may complete and sign the proxy form and return it by post to VP Investor Services A/S, Weidekampsgade 14, DK-2300 Copenhagen S, Denmark, or scan it and return it by e-mail to vpinvestor@vp.dk or by fax to +45 43 58 88 67 so that it is received by VP Investor Services A/S by 11:59 PM CET on Friday March 24, 2017. Postal vote: Shareholders who do not expect to be able to participate in the General Meeting may also vote by post: Go to the Company’s website www.genmab.com or www.uk.vp.dk/agm to vote by post. This must be done by 10:00 AM CEST on Monday March 27, 2017. You may complete and sign the postal voting form and return it by post to VP Investor Services A/S, Weidekampsgade 14, DK-2300 Copenhagen S, Denmark, or scan it and return it by e-mail to vpinvestor@vp.dk or by fax to +45 43 58 88 67 so that it is received by VP Investor Services A/S by 10:00 AM CEST on Monday March 27, 2017. Please note that you may either assign a proxy or vote by post, but not both. Any shareholder, to whom an admission card already has been issued, but who is prevented from attending the Annual General Meeting is kindly asked to notify the Company - preferably before Friday March 24, 2017. Right to ask questions: Prior to the General Meeting, the shareholders may ask the Company’s management in writing about matters of importance to the evaluation of the Annual Report 2016, the Company’s position or any of the other matters which are to be transacted at the General Meeting, or the Company’s relation to other companies in the Genmab Group. Shareholders’ questions must be sent by letter to Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications or by e-mail to r.gravesen@genmab.com. The question may be answered in writing by e.g. making the answer available on the Company’s website (www.genmab.com). The question may be neglected if the shareholder asking the question is not represented at the General Meeting. At the General Meeting, the shareholders may also ask the Company’s management about the above matters and may ask questions regarding the Annual Report 2016 to the auditor appointed by the General Meeting. About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.  Founded in 1999, the company has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications.  Daratumumab is in clinical development for additional multiple myeloma indications, other blood cancers, and solid tumors.  A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis.  Genmab also has a broad clinical and pre-clinical product pipeline.  Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector function enhanced antibodies.  The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies.  For more information visit www.genmab.com. Contact:           Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law. Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Biotech, Inc.


News Article | February 27, 2017
Site: globenewswire.com

Copenhagen, Denmark; February 27, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN) summons the Annual General Meeting on Tuesday, March 28, 2017 at 2:00 PM CEST at the Tivoli Hotel & Congress Center, Arni Magnussons Gade 2-4, DK-1577 Copenhagen V, Denmark. 1. Report by the Board of Directors on the Company’s activities during the past year. 2. Presentation and adoption of the audited Annual Report 2016 and resolution to discharge the Board of Directors and the Executive Management from liability. 3. Resolution on the distribution of profits as recorded in the adopted Annual Report. 4. Election of members of the Board of Directors. 6. Proposals from the Board of Directors: (a) Amendment of the general guidelines for incentive-based remuneration of the Board of Directors and the Executive Management. (b) Approval of remuneration to the Board of Directors for 2017. (c) Amendment of Article 5 of the Company's Articles of Association on authorization to issue warrants. (d) Insertion of a new Article 17 in the Company's Articles of Association on language of company announcements. 7. Authorization of the chairman of the General Meeting. It is proposed to take note of the report of the Board of Directors. It is proposed to adopt the audited Annual Report and to grant discharge to the Board of Directors and the Executive Management. It is proposed that the profit of DKK 1,331 million for the accounting year 2016 be carried forward by transfer to the accumulated deficit. Pursuant to Article 12 of the Company’s Articles of Association, the members of the Board of Directors are elected for periods of one year. The election period for Mats Pettersson, Dr. Anders Gersel Pedersen, Pernille Erenbjerg, Dr. Burton G. Malkiel and Dr. Paolo Paoletti expires at this General Meeting. The Board of Directors proposes to re-elect Mats Pettersson, Dr. Anders Gersel Pedersen, Pernille Erenbjerg and Dr. Paolo Paoletti for a one-year period. Dr. Burton G. Malkiel does not stand for re-election. The Board of Directors further proposes that Rolf Hoffman and Deirdre P. Connelly are elected as new members of the Board of Directors for a one year period so that the Board of Directors is composed of six members elected by the General Meeting. About Mats Pettersson, B.Sc. Swedish, 71, Male Board Chairman (Independent, elected by the General Meeting); Chairman of the Nominating and Corporate Governance Committee and member of the Audit Committee and the Compensation Committee. First elected 2013, current term expires 2017. Special Competences Extensive experience from international research-based biotech and pharmaceutical companies. Founder and CEO of SOBI AB. Responsible for several transforming Business Development deals and member of various executive management committees at Pharmacia. Current Board Positions Member: Magle Chemoswed AB. About Anders Gersel Pedersen, M.D., Ph.D. Danish, 65, Male Deputy Chairman (Non-independent, elected by the General Meeting); Chairman of the Compensation Committee and member of the Nominating and Corporate Governance Committee. First elected 2003, current term expires 2017. Special Competences Business and management experience in the pharmaceutical industry, including expertise in clinical research, development, regulatory affairs and product life cycle management. Current Position, Including Managerial Positions Executive Vice President, Research & Development at H. Lundbeck A/S. Current Board Positions Member: ALK-Abelló A/S. Deputy Chairman: Bavarian Nordic A/S. About Pernille Erenbjerg Danish, 49, Female Board member (Independent, elected by the General Meeting); Chairman of the Audit Committee and member of the Nominating and Corporate Governance Committee. First elected 2015, current term expires 2017. Special Competences Senior executive management and broad business experience from the telecoms industry. Comprehensive all round background within finance including extensive exposure to stock markets, equity and debt investors. Certified Public Accountant background. Responsible for major transformation processes in complex organizations including M&A. Current Position, Including Managerial Positions Group CEO and President of TDC A/S. Current Board Positions Member: DFDS A/S. Audit Committee Chairman: DFDS A/S. About Paolo Paoletti, M.D. Italian (USA citizenship), 66, Male Board member (Independent, elected by the General Meeting); Member of the Compensation Committee. First elected 2015, current term expires 2017. Special Competences Extensive experience in research, development and commercialization in the pharmaceutical industry. Successfully conducted submissions and approvals of new cancer drugs and new indications in the USA and in Europe. Responsible for seven new medicines for cancer patients during his 10 years at GlaxoSmithKline and one new cancer medicine during his time at Eli Lilly. Current Position, Including Managerial Positions Acting CEO at GammaDelta Therapeutics. Current Board Positions Chairman: PsiOxus Therapeutics Limited. Member: FORMA Therapeutics, Inc. and NuCana BioMed Limited. About Rolf Hoffmann German, 57, Male Independent Special Competencies Extensive international management experience with expertise in creating and optimizing commercial opportunities in global markets. Additional expertise in P&L management, governance and corporate integrity agreement management, compliance and organizational efficiency. Over 20 years’ experience in the international pharmaceutical and biotechnology industries at Eli Lilly and Company and Amgen, Inc. Current Position, including Managerial Positions Adjunct Professor of Strategy and Entrepreneurship at the University of North Carolina Business School. Current Board Positions: Member: STADA Arzneimittel AG and Trigemina, Inc. About Deirdre P. Connelly American, 55, Female Independent Special Competencies More than 30 years’ experience as a corporate leader and extensive experience in corporate governance as a board member. Comprehensive experience with business turnaround, corporate culture transformation, product launch, and talent development. Successfully directed the launch of more than 20 new pharmaceutical drugs. Former President, North America Pharmaceuticals for GlaxoSmithKline. Current Board Positions: Member: Macy’s Inc. and Lincoln National Corporation. If Deirdre P. Connelly is elected by the General Meeting, the Company’s goal of increasing the proportion of female directors to at least 25% of the directors elected by the General Meeting will be met. The Board of Directors proposes re-election of PricewaterhouseCoopers, Statsautoriseret Revisionspartnerselskab as the Company’s elected auditor in accordance with the Audit Committee's recommendation. The Audit Committee has not been influenced by third parties and has not been subject to any agreement with third parties, which limits the General Meeting’s choice to certain auditors or audit firms. The Board of Directors proposes to amend the Company's general guidelines for incentive-based remuneration for the Board of Directors and the Executive Management to specify that a new member of the Executive Management may receive a sign-on payment upon engagement subject to certain claw-back provisions. It is further proposed that, in exceptional cases, international, and in particular US based, members of the Executive Management, on an annual basis may be granted restricted stock units and/or warrants corresponding to a value (at the time of grant) of up to four (4) times the member's annual base salary, calculated before any pension contribution and bonus payment, in the year of grant. The value (at the time of grant) of the annual grant may, however, not exceed DKK 25 million. The motivation behind the proposed amendment is to ensure that a competitive compensation package can be offered to future, and in particular US based, members of the Executive Management. It is the Company’s belief that it is important for the Company’s continued success that the Company in the future will be able to attract and retain members of the Executive Management from an international pool. It is moreover proposed to amend the general guidelines so that members of the Executive Management may be granted restricted stock units or a combination of restricted stock units and warrants. If members of the executive management are granted a combination of restricted stock units and warrants, the proportional value of the warrants may not exceed 50% of the total value (at the time of grant). It is further proposed to amend the general guidelines so that restricted stock units granted to a new member of the Board of Directors upon election may no longer exceed a value (at the time of grant) of four (4) times the fixed annual base fee. As a result hereof, the maximum value (at the time of grant) of restricted stock units that may be granted to members of the Board of Directors upon election will correspond to up to four (4) times the fixed annual base fee. It is moreover proposed that the proportional value (at the time of grant) of the restricted stock units that a member of the Board of Directors may be granted on an annual basis is lowered. As a result hereof, the maximum value (in DKK) of restricted stock units that may be granted to members of the Board of Directors on an annual basis will be lowered notwithstanding the increase in the basic fee for members of the Board of Directors proposed under item 6(b). Furthermore, it is proposed that the general guidelines are amended so that vesting of restricted stock units and warrants granted to members of the Executive Management may be subject to fulfilment of forward-looking performance criteria as determined by the Board of Directors. Vesting of restricted stock units granted to members of the Board of Directors shall, however, not be subject to forward-looking performance criteria. It is further proposed to amend the general guidelines so that warrants granted to members of the Executive Management vest three years after the date of the grant in accordance with the corporate governance recommendations. The Board of Directors will implement this through a subsequent general amendment of the Company's warrant program so that all warrants granted after the adoption of this proposal will vest three years after the grant date. The general guidelines have furthermore been subject to a general update and editorial changes with a view to make the general guidelines more reader-friendly. Going forward, the Company's general guidelines for incentive-based remuneration for the Board of Directors and the Executive Management will be included in the Company’s Remuneration Principles. The Board of Directors proposes that the basic fee for members of the Board of Directors is increased from DKK 375,000 to DKK 400,000, and that the deputy chairman receives two times the increased basic fee and that the chairman receives three times the increased basic fee. It is further proposed that the supplemental fee for membership of the board committees is increased from up to DKK 75,000 per membership to up to DKK 100,000 per membership, and that a committee chairman receives up to DKK 150,000. It is moreover proposed that the fee per committee meeting is increased from DKK 9,000 per committee meeting to DKK 10,000 per committee meeting. The Board of Directors plans to establish a Scientific Committee where the remuneration will be within the range of the proposed committee fees. Members of the Board of Directors will furthermore receive share-based instruments in the form of restricted stock units within the scope described and adopted in the Company’s general guidelines for incentive-based remuneration for the Board of Directors and the Executive Management. Re item 6 (c) on the agenda: The Board of Directors proposes that Article 5 of the Company's Articles of Association be amended so that the Board of Directors is authorised to issue an additional 500,000 warrants entitling the holder to subscribe for the Company's shares up to a nominal value of DKK 500,000. With this authorization to issue an additional 500,000 warrants, the potential dilution (including the outstanding warrants and the aggregate unused part of the existing authorization) is kept below 5% of the share capital. It is further proposed to amend Article 5 so that the Board of Directors is no longer entitled to issue warrants to members of the Board of Directors and consultants of the Company and its subsidiaries. This amendment will align the wording in Article 5 with the Company’s general guidelines for incentive-based remuneration for the Board of Directors and the Executive Management according to which members of the Board of Directors may only be granted restricted stock units. It is moreover proposed to amend Article 5 to specify that the Board of Directors’ authorizations entitle the Board of Directors to issue warrants to, among others, employees employed in the Company's directly and indirectly owned subsidiaries. This change is a result of Genmab B.V. having become a wholly-owned subsidiary of Genmab Holding B.V. The proposal means that Article 5 will read as follows: By decision of the General Meeting on April 25, 2012 the Board of Directors is authorized to issue on one or more occasions warrants to subscribe the Company’s shares up to a nominal value of DKK 250,000 and to make the related capital increases in cash up to a nominal value of DKK 250,000. The Board of Directors has issued 250,000 warrants and reissued 42,375 warrants under this authorization. This authorization shall remain in force for a period ending on April 25, 2017. Further, by decision of the General Meeting on April 17, 2013 the Board of Directors is authorized to issue on one or more occasions additional warrants to subscribe the Company’s shares up to a nominal value of DKK 600,000 and to make the related capital increases in cash up to a nominal value of DKK 600,000. The Board of Directors has issued 600,000 warrants and reissued 15,250 warrants under this authorization. This authorization shall remain in force for a period ending on April 17, 2018. Moreover, by decision of the General Meeting on April 9, 2014 the Board of Directors is authorized to issue on one or more occasions additional warrants to subscribe the Company’s shares up to a nominal value of DKK 500,000 and to make the related capital increases in cash up to a nominal value of DKK 500,000. The Board of Directors has issued 406,166 warrants and reissued 4,775 warrants under this authorization. This authorization shall remain in force for a period ending on April 9, 2019. Moreover, by decision of the General Meeting on March 28, 2017 the Board of Directors is authorized to issue on one or more occasions additional warrants to subscribe the Company’s shares up to a nominal value of DKK 500,000 and to make the related capital increases in cash up to a nominal value of DKK 500,000. This authorization shall remain in force for a period ending on March 28, 2022. The authorizations entitle the Board of Directors to issue warrants to the Company’s employees as well as employees of the Company’s directly and indirectly owned subsidiaries. Subject to the rules in force at any time, the Board of Directors may reuse or reissue lapsed non-exercised warrants, if any, provided that the reuse or reissue occurs under the same terms and within the time limitations set out in this authorization. Reuse is to be construed as the Board of Directors' entitlement to let another party enter into an existing agreement on warrants. Reissue is to be construed as the Board of Directors' option to reissue new warrants under the same authorization, if previously issued warrants have lapsed. The existing shareholders of the Company shall not have a right of pre-emption in connection with the issue of warrants based on these authorizations. One warrant shall give the right to subscribe one share with a nominal value of DKK 1 at a subscription price per share determined by the Board of Directors which, however, shall be no less than the market price per share of the Company’s shares at the time of issue. The exercise period for the issued warrants shall be determined by the Board of Directors. The Board of Directors is authorized to set out more detailed terms for the warrants that are to be issued based on these authorizations. The existing shareholders of the Company shall not have a right of pre-emption in connection with issue of shares on the basis of warrants. The shares that are issued through the exercise of warrants shall have the same rights as existing shares cf. these Articles of Association. The Board of Directors has exercised the above authorizations as stipulated in schedule A which is an integral part of these articles.” The Board of Directors proposes that a new Article 17 be inserted in the Articles of Association specifying that the Board of Directors may decide whether company announcements shall be prepared in English only. As a result, the present Articles 17, 18, 19 and 20 are renumbered to Articles 18, 19, 20 and 21. The new Article 17 will read as follows: Company announcements may be prepared in English only, if decided by the Board of Directors.” The Board of Directors proposes that the chairman of the General Meeting is authorized to register the resolutions passed by the General Meeting with the Danish Business Authority and to make such amendments and additions thereto or therein, including the Articles of Association of the Company, as the Danish Business Authority may require for registration. The proposals under item 6 (c) and 6 (d) of the agenda to amend the Articles of Association are required to be adopted by an affirmative vote of not less than 2/3 of the votes cast as well as of the voting share capital represented at the General Meeting. The Company's share capital amounts to DKK 60,350,056 divided into shares of DKK 1 each or any multiple hereof. Each share amount of DKK 1 shall entitle the shareholder to one vote. Pursuant to Section 99 of the Danish Companies Act, the following documents will be published on the Company’s website (www.genmab.com) no later than March 6, 2017: (1) the notice of the Annual General Meeting, (2) information on the total number of shares and votes issued by the Company on the date of the notice, (3) the agenda, (4) the complete proposals to be presented at the Annual General Meeting, (5) the Annual Report for 2016 and (6) forms needed to register for the Annual General Meeting and possible proxy voting and post voting. Registration Date: A shareholder’s right to participate in and vote at the Annual General Meeting is determined in proportion to the number of shares the shareholder owns on the registration date Tuesday March 21, 2017. Admission card: Admission cards may be requested no later than Friday March 24, 2017 by: Proxy vote: Shareholders who do not expect to be able to participate in the General Meeting may: Go to the Company’s website www.genmab.com or www.uk.vp.dk/agm to assign a proxy to the Board of Directors to vote in accordance with its recommendations, or assign a proxy indicating how you wish your votes to be cast by checking the boxes on the electronic proxy form. This must be done by 11:59 PM CET on Friday March 24, 2017. You may complete and sign the proxy form and return it by post to VP Investor Services A/S, Weidekampsgade 14, DK-2300 Copenhagen S, Denmark, or scan it and return it by e-mail to vpinvestor@vp.dk or by fax to +45 43 58 88 67 so that it is received by VP Investor Services A/S by 11:59 PM CET on Friday March 24, 2017. Postal vote: Shareholders who do not expect to be able to participate in the General Meeting may also vote by post: Go to the Company’s website www.genmab.com or www.uk.vp.dk/agm to vote by post. This must be done by 10:00 AM CEST on Monday March 27, 2017. You may complete and sign the postal voting form and return it by post to VP Investor Services A/S, Weidekampsgade 14, DK-2300 Copenhagen S, Denmark, or scan it and return it by e-mail to vpinvestor@vp.dk or by fax to +45 43 58 88 67 so that it is received by VP Investor Services A/S by 10:00 AM CEST on Monday March 27, 2017. Please note that you may either assign a proxy or vote by post, but not both. Any shareholder, to whom an admission card already has been issued, but who is prevented from attending the Annual General Meeting is kindly asked to notify the Company - preferably before Friday March 24, 2017. Right to ask questions: Prior to the General Meeting, the shareholders may ask the Company’s management in writing about matters of importance to the evaluation of the Annual Report 2016, the Company’s position or any of the other matters which are to be transacted at the General Meeting, or the Company’s relation to other companies in the Genmab Group. Shareholders’ questions must be sent by letter to Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications or by e-mail to r.gravesen@genmab.com. The question may be answered in writing by e.g. making the answer available on the Company’s website (www.genmab.com). The question may be neglected if the shareholder asking the question is not represented at the General Meeting. At the General Meeting, the shareholders may also ask the Company’s management about the above matters and may ask questions regarding the Annual Report 2016 to the auditor appointed by the General Meeting. About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.  Founded in 1999, the company has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications.  Daratumumab is in clinical development for additional multiple myeloma indications, other blood cancers, and solid tumors.  A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis.  Genmab also has a broad clinical and pre-clinical product pipeline.  Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector function enhanced antibodies.  The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies.  For more information visit www.genmab.com. Contact:           Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law. Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Biotech, Inc.


News Article | February 27, 2017
Site: globenewswire.com

Copenhagen, Denmark; February 27, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN) summons the Annual General Meeting on Tuesday, March 28, 2017 at 2:00 PM CEST at the Tivoli Hotel & Congress Center, Arni Magnussons Gade 2-4, DK-1577 Copenhagen V, Denmark. 1. Report by the Board of Directors on the Company’s activities during the past year. 2. Presentation and adoption of the audited Annual Report 2016 and resolution to discharge the Board of Directors and the Executive Management from liability. 3. Resolution on the distribution of profits as recorded in the adopted Annual Report. 4. Election of members of the Board of Directors. 6. Proposals from the Board of Directors: (a) Amendment of the general guidelines for incentive-based remuneration of the Board of Directors and the Executive Management. (b) Approval of remuneration to the Board of Directors for 2017. (c) Amendment of Article 5 of the Company's Articles of Association on authorization to issue warrants. (d) Insertion of a new Article 17 in the Company's Articles of Association on language of company announcements. 7. Authorization of the chairman of the General Meeting. It is proposed to take note of the report of the Board of Directors. It is proposed to adopt the audited Annual Report and to grant discharge to the Board of Directors and the Executive Management. It is proposed that the profit of DKK 1,331 million for the accounting year 2016 be carried forward by transfer to the accumulated deficit. Pursuant to Article 12 of the Company’s Articles of Association, the members of the Board of Directors are elected for periods of one year. The election period for Mats Pettersson, Dr. Anders Gersel Pedersen, Pernille Erenbjerg, Dr. Burton G. Malkiel and Dr. Paolo Paoletti expires at this General Meeting. The Board of Directors proposes to re-elect Mats Pettersson, Dr. Anders Gersel Pedersen, Pernille Erenbjerg and Dr. Paolo Paoletti for a one-year period. Dr. Burton G. Malkiel does not stand for re-election. The Board of Directors further proposes that Rolf Hoffman and Deirdre P. Connelly are elected as new members of the Board of Directors for a one year period so that the Board of Directors is composed of six members elected by the General Meeting. About Mats Pettersson, B.Sc. Swedish, 71, Male Board Chairman (Independent, elected by the General Meeting); Chairman of the Nominating and Corporate Governance Committee and member of the Audit Committee and the Compensation Committee. First elected 2013, current term expires 2017. Special Competences Extensive experience from international research-based biotech and pharmaceutical companies. Founder and CEO of SOBI AB. Responsible for several transforming Business Development deals and member of various executive management committees at Pharmacia. Current Board Positions Member: Magle Chemoswed AB. About Anders Gersel Pedersen, M.D., Ph.D. Danish, 65, Male Deputy Chairman (Non-independent, elected by the General Meeting); Chairman of the Compensation Committee and member of the Nominating and Corporate Governance Committee. First elected 2003, current term expires 2017. Special Competences Business and management experience in the pharmaceutical industry, including expertise in clinical research, development, regulatory affairs and product life cycle management. Current Position, Including Managerial Positions Executive Vice President, Research & Development at H. Lundbeck A/S. Current Board Positions Member: ALK-Abelló A/S. Deputy Chairman: Bavarian Nordic A/S. About Pernille Erenbjerg Danish, 49, Female Board member (Independent, elected by the General Meeting); Chairman of the Audit Committee and member of the Nominating and Corporate Governance Committee. First elected 2015, current term expires 2017. Special Competences Senior executive management and broad business experience from the telecoms industry. Comprehensive all round background within finance including extensive exposure to stock markets, equity and debt investors. Certified Public Accountant background. Responsible for major transformation processes in complex organizations including M&A. Current Position, Including Managerial Positions Group CEO and President of TDC A/S. Current Board Positions Member: DFDS A/S. Audit Committee Chairman: DFDS A/S. About Paolo Paoletti, M.D. Italian (USA citizenship), 66, Male Board member (Independent, elected by the General Meeting); Member of the Compensation Committee. First elected 2015, current term expires 2017. Special Competences Extensive experience in research, development and commercialization in the pharmaceutical industry. Successfully conducted submissions and approvals of new cancer drugs and new indications in the USA and in Europe. Responsible for seven new medicines for cancer patients during his 10 years at GlaxoSmithKline and one new cancer medicine during his time at Eli Lilly. Current Position, Including Managerial Positions Acting CEO at GammaDelta Therapeutics. Current Board Positions Chairman: PsiOxus Therapeutics Limited. Member: FORMA Therapeutics, Inc. and NuCana BioMed Limited. About Rolf Hoffmann German, 57, Male Independent Special Competencies Extensive international management experience with expertise in creating and optimizing commercial opportunities in global markets. Additional expertise in P&L management, governance and corporate integrity agreement management, compliance and organizational efficiency. Over 20 years’ experience in the international pharmaceutical and biotechnology industries at Eli Lilly and Company and Amgen, Inc. Current Position, including Managerial Positions Adjunct Professor of Strategy and Entrepreneurship at the University of North Carolina Business School. Current Board Positions: Member: STADA Arzneimittel AG and Trigemina, Inc. About Deirdre P. Connelly American, 55, Female Independent Special Competencies More than 30 years’ experience as a corporate leader and extensive experience in corporate governance as a board member. Comprehensive experience with business turnaround, corporate culture transformation, product launch, and talent development. Successfully directed the launch of more than 20 new pharmaceutical drugs. Former President, North America Pharmaceuticals for GlaxoSmithKline. Current Board Positions: Member: Macy’s Inc. and Lincoln National Corporation. If Deirdre P. Connelly is elected by the General Meeting, the Company’s goal of increasing the proportion of female directors to at least 25% of the directors elected by the General Meeting will be met. The Board of Directors proposes re-election of PricewaterhouseCoopers, Statsautoriseret Revisionspartnerselskab as the Company’s elected auditor in accordance with the Audit Committee's recommendation. The Audit Committee has not been influenced by third parties and has not been subject to any agreement with third parties, which limits the General Meeting’s choice to certain auditors or audit firms. The Board of Directors proposes to amend the Company's general guidelines for incentive-based remuneration for the Board of Directors and the Executive Management to specify that a new member of the Executive Management may receive a sign-on payment upon engagement subject to certain claw-back provisions. It is further proposed that, in exceptional cases, international, and in particular US based, members of the Executive Management, on an annual basis may be granted restricted stock units and/or warrants corresponding to a value (at the time of grant) of up to four (4) times the member's annual base salary, calculated before any pension contribution and bonus payment, in the year of grant. The value (at the time of grant) of the annual grant may, however, not exceed DKK 25 million. The motivation behind the proposed amendment is to ensure that a competitive compensation package can be offered to future, and in particular US based, members of the Executive Management. It is the Company’s belief that it is important for the Company’s continued success that the Company in the future will be able to attract and retain members of the Executive Management from an international pool. It is moreover proposed to amend the general guidelines so that members of the Executive Management may be granted restricted stock units or a combination of restricted stock units and warrants. If members of the executive management are granted a combination of restricted stock units and warrants, the proportional value of the warrants may not exceed 50% of the total value (at the time of grant). It is further proposed to amend the general guidelines so that restricted stock units granted to a new member of the Board of Directors upon election may no longer exceed a value (at the time of grant) of four (4) times the fixed annual base fee. As a result hereof, the maximum value (at the time of grant) of restricted stock units that may be granted to members of the Board of Directors upon election will correspond to up to four (4) times the fixed annual base fee. It is moreover proposed that the proportional value (at the time of grant) of the restricted stock units that a member of the Board of Directors may be granted on an annual basis is lowered. As a result hereof, the maximum value (in DKK) of restricted stock units that may be granted to members of the Board of Directors on an annual basis will be lowered notwithstanding the increase in the basic fee for members of the Board of Directors proposed under item 6(b). Furthermore, it is proposed that the general guidelines are amended so that vesting of restricted stock units and warrants granted to members of the Executive Management may be subject to fulfilment of forward-looking performance criteria as determined by the Board of Directors. Vesting of restricted stock units granted to members of the Board of Directors shall, however, not be subject to forward-looking performance criteria. It is further proposed to amend the general guidelines so that warrants granted to members of the Executive Management vest three years after the date of the grant in accordance with the corporate governance recommendations. The Board of Directors will implement this through a subsequent general amendment of the Company's warrant program so that all warrants granted after the adoption of this proposal will vest three years after the grant date. The general guidelines have furthermore been subject to a general update and editorial changes with a view to make the general guidelines more reader-friendly. Going forward, the Company's general guidelines for incentive-based remuneration for the Board of Directors and the Executive Management will be included in the Company’s Remuneration Principles. The Board of Directors proposes that the basic fee for members of the Board of Directors is increased from DKK 375,000 to DKK 400,000, and that the deputy chairman receives two times the increased basic fee and that the chairman receives three times the increased basic fee. It is further proposed that the supplemental fee for membership of the board committees is increased from up to DKK 75,000 per membership to up to DKK 100,000 per membership, and that a committee chairman receives up to DKK 150,000. It is moreover proposed that the fee per committee meeting is increased from DKK 9,000 per committee meeting to DKK 10,000 per committee meeting. The Board of Directors plans to establish a Scientific Committee where the remuneration will be within the range of the proposed committee fees. Members of the Board of Directors will furthermore receive share-based instruments in the form of restricted stock units within the scope described and adopted in the Company’s general guidelines for incentive-based remuneration for the Board of Directors and the Executive Management. Re item 6 (c) on the agenda: The Board of Directors proposes that Article 5 of the Company's Articles of Association be amended so that the Board of Directors is authorised to issue an additional 500,000 warrants entitling the holder to subscribe for the Company's shares up to a nominal value of DKK 500,000. With this authorization to issue an additional 500,000 warrants, the potential dilution (including the outstanding warrants and the aggregate unused part of the existing authorization) is kept below 5% of the share capital. It is further proposed to amend Article 5 so that the Board of Directors is no longer entitled to issue warrants to members of the Board of Directors and consultants of the Company and its subsidiaries. This amendment will align the wording in Article 5 with the Company’s general guidelines for incentive-based remuneration for the Board of Directors and the Executive Management according to which members of the Board of Directors may only be granted restricted stock units. It is moreover proposed to amend Article 5 to specify that the Board of Directors’ authorizations entitle the Board of Directors to issue warrants to, among others, employees employed in the Company's directly and indirectly owned subsidiaries. This change is a result of Genmab B.V. having become a wholly-owned subsidiary of Genmab Holding B.V. The proposal means that Article 5 will read as follows: By decision of the General Meeting on April 25, 2012 the Board of Directors is authorized to issue on one or more occasions warrants to subscribe the Company’s shares up to a nominal value of DKK 250,000 and to make the related capital increases in cash up to a nominal value of DKK 250,000. The Board of Directors has issued 250,000 warrants and reissued 42,375 warrants under this authorization. This authorization shall remain in force for a period ending on April 25, 2017. Further, by decision of the General Meeting on April 17, 2013 the Board of Directors is authorized to issue on one or more occasions additional warrants to subscribe the Company’s shares up to a nominal value of DKK 600,000 and to make the related capital increases in cash up to a nominal value of DKK 600,000. The Board of Directors has issued 600,000 warrants and reissued 15,250 warrants under this authorization. This authorization shall remain in force for a period ending on April 17, 2018. Moreover, by decision of the General Meeting on April 9, 2014 the Board of Directors is authorized to issue on one or more occasions additional warrants to subscribe the Company’s shares up to a nominal value of DKK 500,000 and to make the related capital increases in cash up to a nominal value of DKK 500,000. The Board of Directors has issued 406,166 warrants and reissued 4,775 warrants under this authorization. This authorization shall remain in force for a period ending on April 9, 2019. Moreover, by decision of the General Meeting on March 28, 2017 the Board of Directors is authorized to issue on one or more occasions additional warrants to subscribe the Company’s shares up to a nominal value of DKK 500,000 and to make the related capital increases in cash up to a nominal value of DKK 500,000. This authorization shall remain in force for a period ending on March 28, 2022. The authorizations entitle the Board of Directors to issue warrants to the Company’s employees as well as employees of the Company’s directly and indirectly owned subsidiaries. Subject to the rules in force at any time, the Board of Directors may reuse or reissue lapsed non-exercised warrants, if any, provided that the reuse or reissue occurs under the same terms and within the time limitations set out in this authorization. Reuse is to be construed as the Board of Directors' entitlement to let another party enter into an existing agreement on warrants. Reissue is to be construed as the Board of Directors' option to reissue new warrants under the same authorization, if previously issued warrants have lapsed. The existing shareholders of the Company shall not have a right of pre-emption in connection with the issue of warrants based on these authorizations. One warrant shall give the right to subscribe one share with a nominal value of DKK 1 at a subscription price per share determined by the Board of Directors which, however, shall be no less than the market price per share of the Company’s shares at the time of issue. The exercise period for the issued warrants shall be determined by the Board of Directors. The Board of Directors is authorized to set out more detailed terms for the warrants that are to be issued based on these authorizations. The existing shareholders of the Company shall not have a right of pre-emption in connection with issue of shares on the basis of warrants. The shares that are issued through the exercise of warrants shall have the same rights as existing shares cf. these Articles of Association. The Board of Directors has exercised the above authorizations as stipulated in schedule A which is an integral part of these articles.” The Board of Directors proposes that a new Article 17 be inserted in the Articles of Association specifying that the Board of Directors may decide whether company announcements shall be prepared in English only. As a result, the present Articles 17, 18, 19 and 20 are renumbered to Articles 18, 19, 20 and 21. The new Article 17 will read as follows: Company announcements may be prepared in English only, if decided by the Board of Directors.” The Board of Directors proposes that the chairman of the General Meeting is authorized to register the resolutions passed by the General Meeting with the Danish Business Authority and to make such amendments and additions thereto or therein, including the Articles of Association of the Company, as the Danish Business Authority may require for registration. The proposals under item 6 (c) and 6 (d) of the agenda to amend the Articles of Association are required to be adopted by an affirmative vote of not less than 2/3 of the votes cast as well as of the voting share capital represented at the General Meeting. The Company's share capital amounts to DKK 60,350,056 divided into shares of DKK 1 each or any multiple hereof. Each share amount of DKK 1 shall entitle the shareholder to one vote. Pursuant to Section 99 of the Danish Companies Act, the following documents will be published on the Company’s website (www.genmab.com) no later than March 6, 2017: (1) the notice of the Annual General Meeting, (2) information on the total number of shares and votes issued by the Company on the date of the notice, (3) the agenda, (4) the complete proposals to be presented at the Annual General Meeting, (5) the Annual Report for 2016 and (6) forms needed to register for the Annual General Meeting and possible proxy voting and post voting. Registration Date: A shareholder’s right to participate in and vote at the Annual General Meeting is determined in proportion to the number of shares the shareholder owns on the registration date Tuesday March 21, 2017. Admission card: Admission cards may be requested no later than Friday March 24, 2017 by: Proxy vote: Shareholders who do not expect to be able to participate in the General Meeting may: Go to the Company’s website www.genmab.com or www.uk.vp.dk/agm to assign a proxy to the Board of Directors to vote in accordance with its recommendations, or assign a proxy indicating how you wish your votes to be cast by checking the boxes on the electronic proxy form. This must be done by 11:59 PM CET on Friday March 24, 2017. You may complete and sign the proxy form and return it by post to VP Investor Services A/S, Weidekampsgade 14, DK-2300 Copenhagen S, Denmark, or scan it and return it by e-mail to vpinvestor@vp.dk or by fax to +45 43 58 88 67 so that it is received by VP Investor Services A/S by 11:59 PM CET on Friday March 24, 2017. Postal vote: Shareholders who do not expect to be able to participate in the General Meeting may also vote by post: Go to the Company’s website www.genmab.com or www.uk.vp.dk/agm to vote by post. This must be done by 10:00 AM CEST on Monday March 27, 2017. You may complete and sign the postal voting form and return it by post to VP Investor Services A/S, Weidekampsgade 14, DK-2300 Copenhagen S, Denmark, or scan it and return it by e-mail to vpinvestor@vp.dk or by fax to +45 43 58 88 67 so that it is received by VP Investor Services A/S by 10:00 AM CEST on Monday March 27, 2017. Please note that you may either assign a proxy or vote by post, but not both. Any shareholder, to whom an admission card already has been issued, but who is prevented from attending the Annual General Meeting is kindly asked to notify the Company - preferably before Friday March 24, 2017. Right to ask questions: Prior to the General Meeting, the shareholders may ask the Company’s management in writing about matters of importance to the evaluation of the Annual Report 2016, the Company’s position or any of the other matters which are to be transacted at the General Meeting, or the Company’s relation to other companies in the Genmab Group. Shareholders’ questions must be sent by letter to Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications or by e-mail to r.gravesen@genmab.com. The question may be answered in writing by e.g. making the answer available on the Company’s website (www.genmab.com). The question may be neglected if the shareholder asking the question is not represented at the General Meeting. At the General Meeting, the shareholders may also ask the Company’s management about the above matters and may ask questions regarding the Annual Report 2016 to the auditor appointed by the General Meeting. About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer.  Founded in 1999, the company has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications.  Daratumumab is in clinical development for additional multiple myeloma indications, other blood cancers, and solid tumors.  A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis.  Genmab also has a broad clinical and pre-clinical product pipeline.  Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector function enhanced antibodies.  The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies.  For more information visit www.genmab.com. Contact:           Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law. Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Biotech, Inc.


News Article | February 15, 2017
Site: www.eurekalert.org

Scientists know a great deal about blue whales off California, where the endangered species has been studied for decades. But they know far less about blue whales in the Northern Indian Ocean, where ships strike and kill some of the largest animals on Earth. Now a research team has found a way to translate their knowledge of blue whales off California and in the eastern tropical Pacific Ocean to the other side of the world, revealing those areas of the Northern Indian Ocean where whales are likely to be encountered. The team of scientists from NOAA Fisheries and the Sri Lankan Blue Whale Project published the findings in the journal Diversity and Distributions. The Scientific Committee of the International Whaling Commission included the results of the study when assessing a shift in busy shipping lanes off the south coast of Sri Lanka that will reduce the danger to whales in an important feeding area. "Small changes in shipping routes can be a very effective way to address a serious conservation issue with minimal inconvenience to the shipping industry, but rely on a good understanding of the relationship between whale distribution and habitat," said Russell Leaper, a member of the Scientific Committee. "This study makes an important contribution towards that understanding." To meet requirements of the U.S. Marine Mammal Protection Act, NOAA Fisheries regularly conducts marine mammal and ecosystem assessment surveys. Surveys off the U.S. West Coast and in the eastern tropical Pacific have shown that the upwelling of deep ocean water rich in nutrients supports dense patches of krill that blue whales feed on. This information has proven critical in addressing the emerging problem of ships striking blue whales, and has informed the management of ship traffic to and from the busy ports of Los Angeles and Long Beach to mitigate this problem. "We are fortunate in the United States to have some of the best marine mammal data sets in the world," said Jessica Redfern, a research scientist at NOAA Fisheries Southwest Fisheries Science Center in La Jolla, Calif., and lead author of the new study. "It was exciting to explore how we could use these data sets to aid conservation efforts in parts of the world where few data exist." The research developed computer models of blue whale habitat off the U.S. West Coast and in the eastern tropical Pacific, including upwelling and underwater topography that affects areas of krill concentration. The models then identified similar upwelling and feeding regions in the Northern Indian Ocean that are also likely to be important habitat for the endangered species. "The Sri Lankan Blue Whale Project has spear-headed efforts to draw attention to and mitigate the risk of ships striking blue whales in Sri Lankan waters. To best protect this species in this data-limited region, it is essential to adapt approaches developed in other parts of the world. Our collaboration achieves just that," said Asha de Vos, founder of the Sri Lankan Blue Whale Project and a coauthor on the study. The Northern Indian Ocean and its inhabitants have not been surveyed to the same extent as the eastern Pacific Ocean, and much of the information about whale distributions comes from Soviet whaling several decades ago. However, the model results matched up well with the limited information available, the scientists reported. The model suggests that the distribution of blue whales in the Northern Indian Ocean may shift seasonally, following their food as monsoon climate patterns alter the most productive habitat. The scientists concluded that research and monitoring is critical in the areas identified as blue whale habitat in the Northern Indian Ocean because many of these areas overlap with some of the busiest shipping routes in the world. "Marine mammals face threats from human activities in most of the world's oceans, but we lack the data needed to address these threats in many areas," Redfern said. "The data collected aboard our surveys allow us to predict species habitat in other parts of the world. Understanding species habitat allows us to address conservation problems that are often unexpected and critical to maintaining healthy populations."

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