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News Article | February 16, 2017
Site: www.eurekalert.org

Throughout the past 15 years, Alliance for Cancer Gene Therapy (ACGT), the nation's only nonprofit dedicated exclusively to cell and gene therapies for cancer, has been an initial funder for early cancer cell, gene and immunotherapy research in North America. ACGT has provided nearly $27 million to cancer research and treatment. This year, ACGT is proud to announce two new scientists that are recipients of the ACGT Young Investigator Grants: Marco Gallo, PhD, of the University of Calgary and Greg Delgoffe, PhD, of the University of Pittsburgh. ACGT is supporting Dr. Gallo's research into the cellular anomalies in glioblastoma brain cancer and Dr. Delgoffe's research into metabolically reprogramming tumor-specific T cells for treating solid tumors including melanoma. Dr. Marco Gallo is an assistant professor of Physiology & Pharmacology and Biochemistry & Molecular Biology at the University of Calgary, Cummings School of Medicine in Alberta, Canada. Dr. Gallo's research focuses on the cellular anomalies in brain tumors, with a special emphasis on glioblastoma, the most common malignant brain tumor in adults with a survival rate of only 13 months. One of the reasons treatments are often ineffective is the Machiavellian cellular structure within the tumor. A small population of cancer cells, called cancer stem cells, successfully evade traditional therapies. Dr.Gallo's team has learned that cancer stem cells have regions of highly compacted DNA caused by low levels of a specific protein. His research is designed to alter the cancer-specific DNA architecture by introducing an engineered protein, which can be directed to any site in the human genome and will be used to unravel the tumor. Pre-clinical studies will permit an analysis of both immediate efficacy and lasting affect. Dr. Gallo earned a PhD in medical genetics at the University of British Columbia and a BS in molecular biology and biochemistry at Simon Fraser University, both in Canada. He has published six primary authorship papers since beginning his post-doctoral fellowship in 2010. "In essence, our technology will enable us to perform a new kind of gene therapy, by directly targeting DNA structure, which is the ultimate determinant of cancer stem cell behavior," said Dr. Marco Gallo, ACGT Young Investigator. Dr. Greg Delgoffe is an assistant professor of Immunology at the University of Pittsburgh School of Medicine and member of the Tumor Microenvironment Center at the University of Pittsburgh Cancer Institute (UPCI), partner with UPMC CancerCenter. Recent clinical successes have revealed that the immune system can be successfully harnessed to fight cancer. Various strategies are utilized, including enhancing a patient's 'natural' response to cancer as well as 'redirecting' a patient's immune cells, T cells, to the tumor using genetic engineering. T cell therapies have shown remarkable progress in the treatment of hematological malignancies but have yet to show dramatic success in solid tumors. Dr. Delgoffe's research focuses on how T cell metabolism might be bolstered through gene therapy to promote activity in the tumor microenvironment. Dr. Delgoffe's lab, building on basic observations that T cells are exquisitely sensitive to metabolic perturbations in their surroundings, has shown that in solid tumors, cancer cells evade immune responses in part by depriving the T cell of the ability to generate energy, and depleting the local environment of nutrients. Dr. Delgoffe's team will utilize genetic engineering to metabolically 'reprogram' tumor-specific T cells to fight cancer for an extended period of time. The goal is to generate super-soldier T cells that can be redirected to the tumor site, while bolstered metabolically to support long-term and durable responses. His research will explore the use of genetically modified T cells as a monotherapy against anti-PD1-resistant melanoma. His next goal will be to combine adoptive cell therapy with PD-1 blockade to learn if this combination is more effective. Dr. Delgoffe earned a PhD at Johns Hopkins University School of Medicine and a BS in Biomedical Sciences at Western Michigan University and has published several papers in the field of immune metabolism and tumor immunology. In 2015 he was selected as a Kimmel Scholar by the Sidney Kimmel Foundation for Cancer Research. "Our work has the potential to transform the way we reprogram therapeutic T cells, such that they have increased metabolic fitness and longevity to promoting durable and effective regression in cancer patients," noted Dr. Greg Delgoffe, ACGT Young Investigator. ACGT has a 15-year history of funding innovative cancer research. Drs. Gallo and Delgoffe represent ACGT's 51st and 52nd grant recipients, including 16 clinical translation grants. This is particularly exciting given ACGT's commitment to contributing 100 percent of donations directly to research. Additional breakthroughs carried out by ACGT grantees, like Dr. Carl June at the University of Pennsylvania and his work successfully treating leukemia through cancer gene therapy, have been touted in recent national documentaries aired on PBS and HBO. These trials are showing a 90 percent remission rate of children and adults with acute lymphoblastic leukemia after participating in a personalized cellular therapy trial. ACGT-funded work is also attracting increasing attention from the pharmaceutical industry, which is swiftly discovering the potential of cell and gene therapies. "ACGT has become a leader in funding early-stage breakthrough cancer cell, gene and immunotherapy research" said John Walter, CEO and president of ACGT. "ACGT's Young Investigator grants are an opportunity for talented young scientists to receive funding for research that might be overlooked by the NIH or other backers because it is deemed 'too early.' We at ACGT see this research in another light -- by backing Young Investigators, we can truly make an impact on how cancer is treated and hopefully play a part in making it a manageable disease." Established in 2001, ACGT is the nation's only non-profit dedicated exclusively to cell and gene therapy treatments for all types of cancer. One hundred percent of contributions go directly to research. ACGT has funded 52 grants in the U.S. and Canada since its founding in 2001 by Barbara Netter and her late husband Edward, to conduct and accelerate critically needed innovative research. Since its inception, ACGT has awarded 36 grants to Young Investigators and 16 grants to Clinical Investigators, totaling nearly $27 million in funding. ACGT is located at 96 Cummings Point Road, Stamford, Connecticut 06902; 203-358-5055. To learn more, visit acgtfoundation.org or join the ACGT community on Facebook, Twitter and YouTube at @acgtfoundation.


News Article | March 1, 2017
Site: globenewswire.com

NEW YORK, March 01, 2017 (GLOBE NEWSWIRE) -- Icahn Enterprises L.P. (NASDAQ:IEP) today announced that Icahn Capital LP, its wholly owned subsidiary, has hired Dr. Richard C. Mulligan as a Portfolio Manager. Dr. Mulligan will be focused on biotechnology investments for Icahn Partners LP and Icahn Partners Master Fund LP, the private investment funds comprising Icahn Enterprises’ Investment segment. "We are very pleased to have Richard join Icahn Capital given the depth and level of experience he brings as we look to enhance our focus on the biotechnology sector," said Carl C. Icahn, Chairman of Icahn Enterprises. Richard C. Mulligan is currently the Mallinckrodt Professor of Genetics, Emeritus, at Harvard Medical School, and Visiting Scientist at the Koch Institute for Integrative Cancer Research at MIT. Previously, Professor Mulligan was the Mallinckrodt Professor of Genetics at Harvard Medical School, and Director of the Harvard Gene Therapy Initiative, an integrated effort amongst basic science and clinical investigators at Harvard University and its Affiliated Hospitals directed towards the pre-clinical and clinical evaluation of novel gene-based therapies for inherited and acquired diseases. Professor Mulligan received his B.S. degree from Massachusetts Institute of Technology (MIT), and his Ph.D. from the Department of Biochemistry at Stanford University School of Medicine, where he studied under Nobel Laureate Paul Berg. After receiving postdoctoral training at the Center for Cancer Research at MIT with Nobel Laureates David Baltimore and Phillip Sharp, Professor Mulligan joined the MIT faculty and subsequently was appointed Professor of Molecular Biology and Member of the Whitehead Institute for Biomedical Research before moving to Harvard and Children’s Hospital in 1996. His honors include the MacArthur Foundation ‘Genius’ Prize, the Rhodes Memorial Award of the American Association for Cancer Research, the ASMB-Amgen Award, and the Nagai Foundation International Prize. Professor Mulligan is an internationally recognized pioneer in the development of new technologies for transferring genes into mammalian cells. A major interest in Professor Mulligan’s laboratory has been the development of genetically engineered animal viruses as gene transfer ‘vectors’. Scientists use the specialized tools created in his laboratory to unravel basic questions about human development and to devise new clinical ‘gene therapies’ for the treatment of both inherited diseases and acquired diseases. Professor Mulligan has been previously associated with a number of public biotechnology and pharmaceutical companies, either as a consultant or as a member of the company’s Board of Directors (BOD). These companies include: Dupont (consultant), Genetics Institute (consultant), Amgen (consultant), Somatix Therapy Corporation (founder, scientific advisory board (SAB), chief scientific officer (CSO), and member, BOD), Cell Genesys (SAB), Imclone (SAB, member, BOD, and member of Executive Committee of the Board), Cellectis (member, BOD, then private), Enzon (member, BOD), and, currently, Biogen (member, BOD). He has also served on the US National Institutes of Health Recombinant DNA Advisory Committee (RAC), which provides guidance to the NIH regarding experiments involving recombinant DNA, and on the FDA Biological Response Modifiers Advisory Committee (BRMAC), which advises the FDA on matters related to cell and gene therapies, including stem cell-based technologies. From 2013-2016, Professor Mulligan was Founding Partner and Senior Managing Director of Sarissa Capital Management LP. Icahn Enterprises L.P. (NASDAQ:IEP), a master limited partnership, is a diversified holding company engaged in ten primary business segments: Investment, Automotive, Energy, Railcar, Gaming, Metals, Mining, Food Packaging, Real Estate and Home Fashion.


News Article | March 1, 2017
Site: globenewswire.com

Notice is hereby given of the annual general meeting of H. Lundbeck A/S to be held on: The general meeting will be held at the offices of the Company at: In accordance with Article 8.1 of the Articles of Association, the agenda of the meeting is as follows: 7.1       Proposal from the Board of Directors to authorise the Board of Directors to allow the Company to acquire own shares. 7.2       Proposal from the Board of Directors to authorise the Chairman of the meeting to file for registration of the resolutions passed at the general meeting with the Danish Business Authority. The Board of Directors recommends that the report be adopted. The Board of Directors proposes that the annual report be approved. The Board of Directors proposes to distribute a dividend of 40% of the net profit for the accounting year 2016, corresponding to DKK 2.45 per share, or a total dividend of DKK 484 million. The Board of Directors of H. Lundbeck A/S should consist of persons who together possess the financial, pharmaceutical and international qualifications required for safeguarding the Company's and, thus, the shareholders' interests in the best manner possible having regard to the Company's other stakeholders. The Board of Directors' most important duties are to formulate Lundbeck's overall strategy, set specific objectives for the Company's Executive Management and ensure that the members of the Executive Management have the right qualifications. For a more detailed description of the qualifications required for members of the Board of Directors, please see the Company's website: www.lundbeck.comà About Us à Corporate Governance. Members of the Board of Directors elected by the general meeting are elected or re-elected every year, and therefore the term of office of the current members expires in connection with this annual general meeting. The Board of Directors proposes that the following members elected by the general meeting should be re-elected: Lars Rasmussen, Lene Skole, Lars Holmqvist and Jesper Ovesen. In addition, the Board of Directors proposes that Jeremy M. Levin is elected. Terrie Curran does not wish to stand for re-election. The Board of Directors expects to elect Lars Rasmussen as Chairman and elect Lene Skole as Deputy Chairman. The Board of Directors assesses that the candidates together possess the professional and international experience required for maintaining the Company's position as a leading global pharmaceutical company focusing on research and development in the field of brain disorders. The Board of Directors also considers the size of the Board appropriate taking into account the Company's needs and the aim of ensuring constructive debate and effective decision-making. Regard has been given to diversity in the selection of board candidates. The Recommendations on Corporate Governance recommend that at least half of a company's board members elected by the general meeting should be independent of the company. Lars Rasmussen, Jesper Ovesen and Jeremy M. Levin meet the criteria for independence. Lene Skole and Lars Holmqvist are considered to be non-independent board members due to their responsibilities in the Lundbeck Foundation. If the proposed candidates are elected to the Board of Directors, the Board will meet the recommendation for independence as defined by the Recommendations on Corporate Governance. The proposed board candidates have the following backgrounds: Lars Rasmussen, BSc Engineering and MBA, was born on 31 March 1959 and is a Danish citizen. He was nominated for election to Lundbeck's Board of Directors at the 2013 annual general meeting. He chairs Lundbeck’s Remuneration and Scientific Committees, and is member of Lundbeck's Audit Committee. Lars Rasmussen has considerable management experience in global med-tech. Lars Rasmussen was appointed as CEO of Coloplast A/S in 2008 and has been member of the company's executive management since 2001. In this period, he has been responsible for various functions in the group, including global sales, innovation and production. He has performed these duties from both Denmark and the USA. Lars Rasmussen's special qualifications for serving on Lundbeck's Board of Directors include his top management experience and knowledge of efficiency improvements and internationalisation. Lars Rasmussen is member of the Board of Directors of William Demant Holding A/S. Lene Skole, BCom Finance, was born on 28 April 1959 and is a Danish citizen. She was nominated for election to Lundbeck’s Board of Directors at the 2015 annual general meeting. She is member of Lundbeck's Remuneration and Scientific Committees. Lene Skole is CEO at the Lundbeck Foundation. Prior to joining the Lundbeck Foundation in 2014, Lene Skole was CFO at Coloplast A/S where she was a member of the company’s executive management since joining in 2005. Lene Skole’s responsibilities included finance, IT, HR, communication, strategy and M&A. Before 2005, Lene Skole held various positions in the AP Moller-Maersk group most recently as CFO of Maersk Company Ltd., London from 2000-2005. Lene Skole’s special qualifications for serving on Lundbeck’s Board of Directors include extensive knowledge and expertise within financing, strategy, business development and M&A as well as management experience from international companies including med-tech. Lene Skole is vice chairman of the Board of Directors of DONG Energy A/S, Falck A/S, ALK-Abelló A/S, and member of the Board of Directors of Tryg A/S and Tryg Forsikring A/S. Lars Holmqvist, MSc in business administration, was born on 4 September 1959 and is a Swedish citizen. He was nominated for election to Lundbeck’s Board of Directors at the 2015 annual general meeting. He is member of Lundbeck’s Audit Committee. Lars Holmqvist is senior advisor within healthcare at Bain Capital. He previously served as vice president responsible for sales and marketing at Pharmacia. In addition he has held management positions in several pharma and med-tech companies including Boston Scientific Corporation, Medtronic, Applied Biosystems Group, DAKO and Agilent Technologies. Lars Holmqvist’s special qualifications for serving on Lundbeck`s Board of Directors include his international management experience, his expertise in finance, and his sales and marketing experience from the global pharmaceutical, med-tech and life-science industry. Lars Holmqvist is member of the Board of Directors of the Lundbeck Foundation, ALK-Abelló A/S, Tecan AG and BPL Ltd. Jesper Ovesen, MSc in finance and state authorized public accountant, was born on 20 March 1957 and is a Danish citizen. He was nominated for election to Lundbeck’s Board of Directors at the 2015 annual general meeting and chairs Lundbeck’s Audit Committee. Jesper Ovesen most recently held the position of executive chairman of the Board of Directors of Nokia Siemens Networks BV. Prior to this, he served as CFO in TDC A/S, Lego A/S and Danske Bank A/S, and finance director at Novo Nordisk A/S. Jesper Ovesen’s special qualifications for serving on Lundbeck’s Board of Directors include his international management experience and his expertise in finance, accounting and international capital markets. Jesper Ovesen is vice chairman of the Board of Directors of Scandinaviska Enskilda Banken AB and member of the Board of Directors of Sunrise Communications Group AG and ConvaTec Group PLC. Jeremy M. Levin, BA Zoology, MA and DPhil in Molecular Biology and MB BChir Medicine and Surgery, was born on 9 September 1953 and is a British and US citizen. He is nominated for election to Lundbeck’s Board of Directors at the 2017 annual general meeting. Jeremy M. Levin has more than 25 years of experience in the global pharmaceuticals industry, leading companies and people to develop and commercialize medicines that address compelling medical needs worldwide. Since 2014, he has been CEO and chairman of Ovid Therapeutics, a New York-based neurology company focused on rare and orphan diseases of the brain. Previously, Jeremy M. Levin served as President & CEO of Teva Pharmaceuticals and before becoming CEO of Teva, he was a member of the Executive Committee of Bristol-Myers Squibb where he was globally responsible for overall strategy, alliances and business development. Prior to that, he was Global Head of Strategic Alliances at Novartis, where he established and managed strategic collaborations with multiple companies and research institutions around the world. Jeremy M. Levin’s special qualifications for serving on Lundbeck’s Board of Directors include a robust blend of clinical insight and experience, business development skills, corporate strategy and financial savvy. In addition he has substantial board experience. Jeremy M. Levin is member of the Board of Directors of BioCon in India, ZappRx and on the Board and Executive Committee of BIO, the Biotechnology Innovation Organization in the USA. It is proposed that the Board of Directors should receive the following remuneration for the current financial year: -     Ordinary members will receive a basic remuneration of DKK 350,000 (increased from DKK 300,000) -     The Chairman will receive three times the basic remuneration -     The Deputy Chairman will receive two times the basic remuneration -     Ordinary members of the Board Committees will receive DKK 200,000 in addition to the basic remuneration -     The committee chairmen will receive DKK 300,000 in addition to the basic remuneration In accordance with the recommendation submitted to the Board of Directors by the Audit Committee, the Board of Directors proposes that Deloitte Statsautoriseret Revisions-partnerselskab should be re-elected. The Audit Committee is free from influence by a third party and is not subject to a contract with a third party restricting the choice of the general meeting to certain categories or lists of statutory auditors or audit firms, as regards the appointment of a particular statutory auditor or audit firm to carry out the statutory audit of the Company. It is proposed to authorise the Board of Directors until the next annual general meeting to allow the Company to acquire own shares of a total nominal value of up to 10% of the share capital in accordance with applicable law. The purchase price for the relevant shares may not deviate by more than 10% from the price quoted on Nasdaq Copenhagen A/S at the time of the acquisition. The Board of Directors proposes to authorise the Chairman of the general meeting to make such amendments and additions to the resolutions passed by the general meeting and the application for registration with the Danish Business Authority that may be required by the Danish Business Authority in connection with the registration of the adopted amendments. All proposals on the agenda may be adopted by a simple majority of votes. H. Lundbeck A/S welcomes all shareholders who have obtained an admission card for themselves and for any adviser accompanying them at the general meeting. Please note that admission cards must be obtained prior to the general meeting in order to attend. Access to the general meeting is via the reception on Otilliavej 9, DK-2500 Valby. There is limited parking space available on Ottiliavej and Postgården. In accordance with Article 10.1 of the Articles of Association, admission cards will be provided to shareholders entitled to vote at the general meeting. Anyone who is registered as a shareholder in the register of shareholders on the date of registration, 23 March 2017, or who has made a request to such effect, including evidence of title to shares, that has reached the Company on that date, is entitled to vote at the general meeting (see Article 10.4 of the Articles of Association). Admission cards for the general meeting can be obtained up to and including 24 March 2017 at the Company's website www.lundbeck.com, from Computershare A/S, Kongevejen 418, DK-2840 Holte, tel. +45 4546 0999, or by returning the request form to Computershare A/S. As a new initiative admission cards will be sent out electronically via email to the email address specified in the investor portal upon registration. The admission card must be presented at the general meeting either electronically on a smartphone/tablet or printed. Shareholders who have ordered admission cards without specifying their email address can pick up the admission card at the entrance of the general meeting upon presentation of valid ID. Voting cards will be handed out at the entrance of the general meeting. The Company's nominal share capital is DKK 988,186,125 divided into shares of DKK 5 nominal value. Each share of DKK 5 carries one vote as provided by Article 10.6 of the Articles of Association. The following information and documents will be made available on the Company's website, www.lundbeck.com, on 1 March 2017: 1) The notice convening the general meeting; 2) the total number of shares and voting rights at the date of the notice; 3) all documents to be submitted to the general meeting, including the audited annual report; 4) the agenda and the full text of all proposals to be submitted to the general meeting; and 5) postal and proxy voting forms. All shareholders may ask questions in writing about the agenda and the documents to be used for the general meeting. Questions may be sent by post or by email to investor@lundbeck.com and will be answered prior to or at the general meeting. If you are prevented from attending the general meeting, the Board of Directors would be pleased to act as proxy to cast the votes attaching to your shares, in which case the proxy form, duly completed, dated and signed, must reach Computershare A/S, Kongevejen 418, DK-2840 Holte, by 24 March 2017. If you wish to appoint proxies other than to the Board of Directors, the form for appointing a third party as proxy can be used. The proxy forms are available on the Company's website, www.lundbeck.com. Proxies may also be appointed electronically on www.lundbeck.com on or before 24 March 2017 (please use custody account number and access code or the Danish NEMID). You may also vote by post by completing and signing the postal voting form and returning it to Computershare A/S, Kongevejen 418, DK-2840 Holte, so that it is received by 29 March 2017 at 12 noon. A postal voting form is available on the Company's website www.lundbeck.com, where votes may also be cast electronically. Also this year, Lundbeck offers simultaneous interpretation from Danish into English in the Auditorium. The general meeting will also be webcast live in Danish and English (can be replayed after the meeting). See the Company's website, www.lundbeck.com. If you have functional impairments which makes passage from the entrance to the Auditorium difficult you may request assistance from the staff upon arrival at the reception. H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are Alzheimer's disease, depression, Parkinson's disease and schizophrenia. Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, manufacturing, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have production facilities in Denmark, France and Italy. Lundbeck generated revenue of DKK 15.6 billion in 2016 (EUR 2.1 billion; USD 2.2 billion). For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck. The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses. Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.


News Article | March 1, 2017
Site: globenewswire.com

Notice is hereby given of the annual general meeting of H. Lundbeck A/S to be held on: The general meeting will be held at the offices of the Company at: In accordance with Article 8.1 of the Articles of Association, the agenda of the meeting is as follows: 7.1       Proposal from the Board of Directors to authorise the Board of Directors to allow the Company to acquire own shares. 7.2       Proposal from the Board of Directors to authorise the Chairman of the meeting to file for registration of the resolutions passed at the general meeting with the Danish Business Authority. The Board of Directors recommends that the report be adopted. The Board of Directors proposes that the annual report be approved. The Board of Directors proposes to distribute a dividend of 40% of the net profit for the accounting year 2016, corresponding to DKK 2.45 per share, or a total dividend of DKK 484 million. The Board of Directors of H. Lundbeck A/S should consist of persons who together possess the financial, pharmaceutical and international qualifications required for safeguarding the Company's and, thus, the shareholders' interests in the best manner possible having regard to the Company's other stakeholders. The Board of Directors' most important duties are to formulate Lundbeck's overall strategy, set specific objectives for the Company's Executive Management and ensure that the members of the Executive Management have the right qualifications. For a more detailed description of the qualifications required for members of the Board of Directors, please see the Company's website: www.lundbeck.comà About Us à Corporate Governance. Members of the Board of Directors elected by the general meeting are elected or re-elected every year, and therefore the term of office of the current members expires in connection with this annual general meeting. The Board of Directors proposes that the following members elected by the general meeting should be re-elected: Lars Rasmussen, Lene Skole, Lars Holmqvist and Jesper Ovesen. In addition, the Board of Directors proposes that Jeremy M. Levin is elected. Terrie Curran does not wish to stand for re-election. The Board of Directors expects to elect Lars Rasmussen as Chairman and elect Lene Skole as Deputy Chairman. The Board of Directors assesses that the candidates together possess the professional and international experience required for maintaining the Company's position as a leading global pharmaceutical company focusing on research and development in the field of brain disorders. The Board of Directors also considers the size of the Board appropriate taking into account the Company's needs and the aim of ensuring constructive debate and effective decision-making. Regard has been given to diversity in the selection of board candidates. The Recommendations on Corporate Governance recommend that at least half of a company's board members elected by the general meeting should be independent of the company. Lars Rasmussen, Jesper Ovesen and Jeremy M. Levin meet the criteria for independence. Lene Skole and Lars Holmqvist are considered to be non-independent board members due to their responsibilities in the Lundbeck Foundation. If the proposed candidates are elected to the Board of Directors, the Board will meet the recommendation for independence as defined by the Recommendations on Corporate Governance. The proposed board candidates have the following backgrounds: Lars Rasmussen, BSc Engineering and MBA, was born on 31 March 1959 and is a Danish citizen. He was nominated for election to Lundbeck's Board of Directors at the 2013 annual general meeting. He chairs Lundbeck’s Remuneration and Scientific Committees, and is member of Lundbeck's Audit Committee. Lars Rasmussen has considerable management experience in global med-tech. Lars Rasmussen was appointed as CEO of Coloplast A/S in 2008 and has been member of the company's executive management since 2001. In this period, he has been responsible for various functions in the group, including global sales, innovation and production. He has performed these duties from both Denmark and the USA. Lars Rasmussen's special qualifications for serving on Lundbeck's Board of Directors include his top management experience and knowledge of efficiency improvements and internationalisation. Lars Rasmussen is member of the Board of Directors of William Demant Holding A/S. Lene Skole, BCom Finance, was born on 28 April 1959 and is a Danish citizen. She was nominated for election to Lundbeck’s Board of Directors at the 2015 annual general meeting. She is member of Lundbeck's Remuneration and Scientific Committees. Lene Skole is CEO at the Lundbeck Foundation. Prior to joining the Lundbeck Foundation in 2014, Lene Skole was CFO at Coloplast A/S where she was a member of the company’s executive management since joining in 2005. Lene Skole’s responsibilities included finance, IT, HR, communication, strategy and M&A. Before 2005, Lene Skole held various positions in the AP Moller-Maersk group most recently as CFO of Maersk Company Ltd., London from 2000-2005. Lene Skole’s special qualifications for serving on Lundbeck’s Board of Directors include extensive knowledge and expertise within financing, strategy, business development and M&A as well as management experience from international companies including med-tech. Lene Skole is vice chairman of the Board of Directors of DONG Energy A/S, Falck A/S, ALK-Abelló A/S, and member of the Board of Directors of Tryg A/S and Tryg Forsikring A/S. Lars Holmqvist, MSc in business administration, was born on 4 September 1959 and is a Swedish citizen. He was nominated for election to Lundbeck’s Board of Directors at the 2015 annual general meeting. He is member of Lundbeck’s Audit Committee. Lars Holmqvist is senior advisor within healthcare at Bain Capital. He previously served as vice president responsible for sales and marketing at Pharmacia. In addition he has held management positions in several pharma and med-tech companies including Boston Scientific Corporation, Medtronic, Applied Biosystems Group, DAKO and Agilent Technologies. Lars Holmqvist’s special qualifications for serving on Lundbeck`s Board of Directors include his international management experience, his expertise in finance, and his sales and marketing experience from the global pharmaceutical, med-tech and life-science industry. Lars Holmqvist is member of the Board of Directors of the Lundbeck Foundation, ALK-Abelló A/S, Tecan AG and BPL Ltd. Jesper Ovesen, MSc in finance and state authorized public accountant, was born on 20 March 1957 and is a Danish citizen. He was nominated for election to Lundbeck’s Board of Directors at the 2015 annual general meeting and chairs Lundbeck’s Audit Committee. Jesper Ovesen most recently held the position of executive chairman of the Board of Directors of Nokia Siemens Networks BV. Prior to this, he served as CFO in TDC A/S, Lego A/S and Danske Bank A/S, and finance director at Novo Nordisk A/S. Jesper Ovesen’s special qualifications for serving on Lundbeck’s Board of Directors include his international management experience and his expertise in finance, accounting and international capital markets. Jesper Ovesen is vice chairman of the Board of Directors of Scandinaviska Enskilda Banken AB and member of the Board of Directors of Sunrise Communications Group AG and ConvaTec Group PLC. Jeremy M. Levin, BA Zoology, MA and DPhil in Molecular Biology and MB BChir Medicine and Surgery, was born on 9 September 1953 and is a British and US citizen. He is nominated for election to Lundbeck’s Board of Directors at the 2017 annual general meeting. Jeremy M. Levin has more than 25 years of experience in the global pharmaceuticals industry, leading companies and people to develop and commercialize medicines that address compelling medical needs worldwide. Since 2014, he has been CEO and chairman of Ovid Therapeutics, a New York-based neurology company focused on rare and orphan diseases of the brain. Previously, Jeremy M. Levin served as President & CEO of Teva Pharmaceuticals and before becoming CEO of Teva, he was a member of the Executive Committee of Bristol-Myers Squibb where he was globally responsible for overall strategy, alliances and business development. Prior to that, he was Global Head of Strategic Alliances at Novartis, where he established and managed strategic collaborations with multiple companies and research institutions around the world. Jeremy M. Levin’s special qualifications for serving on Lundbeck’s Board of Directors include a robust blend of clinical insight and experience, business development skills, corporate strategy and financial savvy. In addition he has substantial board experience. Jeremy M. Levin is member of the Board of Directors of BioCon in India, ZappRx and on the Board and Executive Committee of BIO, the Biotechnology Innovation Organization in the USA. It is proposed that the Board of Directors should receive the following remuneration for the current financial year: -     Ordinary members will receive a basic remuneration of DKK 350,000 (increased from DKK 300,000) -     The Chairman will receive three times the basic remuneration -     The Deputy Chairman will receive two times the basic remuneration -     Ordinary members of the Board Committees will receive DKK 200,000 in addition to the basic remuneration -     The committee chairmen will receive DKK 300,000 in addition to the basic remuneration In accordance with the recommendation submitted to the Board of Directors by the Audit Committee, the Board of Directors proposes that Deloitte Statsautoriseret Revisions-partnerselskab should be re-elected. The Audit Committee is free from influence by a third party and is not subject to a contract with a third party restricting the choice of the general meeting to certain categories or lists of statutory auditors or audit firms, as regards the appointment of a particular statutory auditor or audit firm to carry out the statutory audit of the Company. It is proposed to authorise the Board of Directors until the next annual general meeting to allow the Company to acquire own shares of a total nominal value of up to 10% of the share capital in accordance with applicable law. The purchase price for the relevant shares may not deviate by more than 10% from the price quoted on Nasdaq Copenhagen A/S at the time of the acquisition. The Board of Directors proposes to authorise the Chairman of the general meeting to make such amendments and additions to the resolutions passed by the general meeting and the application for registration with the Danish Business Authority that may be required by the Danish Business Authority in connection with the registration of the adopted amendments. All proposals on the agenda may be adopted by a simple majority of votes. H. Lundbeck A/S welcomes all shareholders who have obtained an admission card for themselves and for any adviser accompanying them at the general meeting. Please note that admission cards must be obtained prior to the general meeting in order to attend. Access to the general meeting is via the reception on Otilliavej 9, DK-2500 Valby. There is limited parking space available on Ottiliavej and Postgården. In accordance with Article 10.1 of the Articles of Association, admission cards will be provided to shareholders entitled to vote at the general meeting. Anyone who is registered as a shareholder in the register of shareholders on the date of registration, 23 March 2017, or who has made a request to such effect, including evidence of title to shares, that has reached the Company on that date, is entitled to vote at the general meeting (see Article 10.4 of the Articles of Association). Admission cards for the general meeting can be obtained up to and including 24 March 2017 at the Company's website www.lundbeck.com, from Computershare A/S, Kongevejen 418, DK-2840 Holte, tel. +45 4546 0999, or by returning the request form to Computershare A/S. As a new initiative admission cards will be sent out electronically via email to the email address specified in the investor portal upon registration. The admission card must be presented at the general meeting either electronically on a smartphone/tablet or printed. Shareholders who have ordered admission cards without specifying their email address can pick up the admission card at the entrance of the general meeting upon presentation of valid ID. Voting cards will be handed out at the entrance of the general meeting. The Company's nominal share capital is DKK 988,186,125 divided into shares of DKK 5 nominal value. Each share of DKK 5 carries one vote as provided by Article 10.6 of the Articles of Association. The following information and documents will be made available on the Company's website, www.lundbeck.com, on 1 March 2017: 1) The notice convening the general meeting; 2) the total number of shares and voting rights at the date of the notice; 3) all documents to be submitted to the general meeting, including the audited annual report; 4) the agenda and the full text of all proposals to be submitted to the general meeting; and 5) postal and proxy voting forms. All shareholders may ask questions in writing about the agenda and the documents to be used for the general meeting. Questions may be sent by post or by email to investor@lundbeck.com and will be answered prior to or at the general meeting. If you are prevented from attending the general meeting, the Board of Directors would be pleased to act as proxy to cast the votes attaching to your shares, in which case the proxy form, duly completed, dated and signed, must reach Computershare A/S, Kongevejen 418, DK-2840 Holte, by 24 March 2017. If you wish to appoint proxies other than to the Board of Directors, the form for appointing a third party as proxy can be used. The proxy forms are available on the Company's website, www.lundbeck.com. Proxies may also be appointed electronically on www.lundbeck.com on or before 24 March 2017 (please use custody account number and access code or the Danish NEMID). You may also vote by post by completing and signing the postal voting form and returning it to Computershare A/S, Kongevejen 418, DK-2840 Holte, so that it is received by 29 March 2017 at 12 noon. A postal voting form is available on the Company's website www.lundbeck.com, where votes may also be cast electronically. Also this year, Lundbeck offers simultaneous interpretation from Danish into English in the Auditorium. The general meeting will also be webcast live in Danish and English (can be replayed after the meeting). See the Company's website, www.lundbeck.com. If you have functional impairments which makes passage from the entrance to the Auditorium difficult you may request assistance from the staff upon arrival at the reception. H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are Alzheimer's disease, depression, Parkinson's disease and schizophrenia. Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, manufacturing, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have production facilities in Denmark, France and Italy. Lundbeck generated revenue of DKK 15.6 billion in 2016 (EUR 2.1 billion; USD 2.2 billion). For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck. The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses. Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited.


News Article | February 23, 2017
Site: globenewswire.com

TEL-AVIV, Israel, Feb. 23, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today reported its financial results for the fourth quarter and full-year ended December 31, 2016. Revenues for the fourth quarter of 2016 were $0.1 million, compared to immaterial revenues for the fourth quarter of 2015. Research and Development Expenses for the fourth quarter of 2016 were $7.5 million, up 51% compared to the fourth quarter of 2015. The increase was mainly due to the ongoing Phase III and Phase II studies with BEKINDA® for gastroenteritis and IBS-D, respectively, the ongoing Phase III study with RHB-104 for Crohn’s disease and ongoing studies with YELIVA® for multiple indications. General, Administrative and Business Development Expenses for the fourth quarter of 2016 were $1.6 million, down 6.9% compared to the fourth quarter of 2015. The decrease was mainly due to a decrease in professional services. Operating Loss for the fourth quarter of 2016 was $9 million, up 33% compared to the fourth quarter of 2015. The increase was mainly due to an increase in research and development expenses, as detailed above. Financial Income, net for the fourth quarter of 2016 was $0.6 million, up 214%, compared to the fourth quarter of 2015. The increase was mainly due to a fair value gain on derivative financial instruments. Net Cash Used in Operating Activities for the fourth quarter of 2016 was $10.1 million, up 69% compared to the fourth quarter of 2015. The increase was mainly due to the increase in operating loss, as detailed above. Net Cash Provided by Investment Activities for the fourth quarter of 2016 was $21.3 million, up 206% compared to the fourth quarter of 2015. The increase was mainly due to maturity of bank deposits. Net Cash Provided by Financing Activities for the fourth quarter of 2016 was $35.9 million compared to an immaterial amount for the fourth quarter of 2015. The increase was mainly due to the December 2016 public offering. Revenues for 2016 were $0.1 million, compared to immaterial revenues in 2015. Research and Development Expenses for 2016 were $25.2 million, up 42% compared to 2015. The increase was mainly due to the ongoing Phase III MAP US study with RHB-104 for Crohn's disease, the ongoing Phase III and Phase II studies with BEKINDA® for gastroenteritis and IBS-D, respectively, and the ongoing studies with YELIVA® for multiple indications. General, Administrative and Business Development Expenses for 2016 were $5.4 million, up 31% compared to 2015. The increase was mainly due to an increase in professional services, compensation and other operating expenses. Operating Loss for 2016 was $30.5 million, up 39% compared to 2015. The increase was mainly due to an increase in research and development expenses, as detailed above. Financial Income, net for 2016 was $1.2 million, up 29% compared to 2015. The increase was mainly due to a fair value gain on derivative financial instruments. Net Cash Used in Operating Activities for 2016 was $28.2 million, up 59% compared to 2015. The increase was mainly due to an increase in operating loss, as detailed above. Net Cash Provided by Investment Activities for 2016 was $24.5 million, up 215% compared to 2015. The difference was mainly due to maturity of bank deposits. Net Cash Provided by Financing Activities for 2016 was $36 million, down 34% compared to 2015. The decrease resulted primarily from the two public offerings in February and July 2015 of the comparable period. Cash Balance3 as of December 31, 2016 was $66.3 million, an increase of $8.2 million compared to $58.1 million as of December 31, 2015 and an increase of $25.8 million compared to $40.5 million as of September 30, 2016. Micha Ben Chorin, RedHill’s CFO, said: “Our strong cash position of approximately $66 million at the end of 2016 should allow us to continue to execute our strategic plans for 2017. We are looking forward to an important year ahead, including the planned initiation of a confirmatory Phase III study with RHB-105 for H. pylori infection, a second independent DSMB meeting for the ongoing MAP US Phase III study with RHB-104 for Crohn’s disease, top-line results from the ongoing Phase III and Phase II studies with BEKINDA® for gastroenteritis and IBS-D, respectively, and commencement of our promotional activities in the U.S. with Donnatal®." The Company will host a conference call on Thursday, February 23, 2017, at 9:00 am EST to review the financial results and business highlights. To participate in the conference call, please dial the following numbers 5-10 minutes prior to the start of the call: United States: +1-877-280-1254; International: +1-646-254-3366; and Israel: +972-3-763-0145. The access code for the call is 4402478. The conference call will be broadcasted live and available for replay on the Company's website, http://ir.redhillbio.com/events.cfm, for 30 days. Please access the Company's website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software. RHB-105 - H. pylori bacterial infection (confirmatory Phase III) (QIDP status)         Following the announcement of the successful final results from a first Phase III clinical study with RHB-105 for the eradication of H. pylori infection (the ERADICATE Hp study) in March 2016, RedHill concluded two positive Type B meetings with the U.S. Food and Drug Administration (FDA) regarding RHB-105. The first meeting, announced in April 2016, confirmed the path to marketing approval of RHB-105 and the planned confirmatory Phase III study. A second Type B meeting, announced in November 2016, discussed the chemistry, manufacturing and controls (CMC) aspects of the RHB-105 Phase III development program towards filing the CMC package as part of the potential U.S. New Drug Application (NDA) to be submitted for RHB-105, subject to successful completion of the planned confirmatory Phase III study. The two-arm, randomized, double-blind, active comparator confirmatory Phase III study, comparing RHB-105 against a dual therapy amoxicillin and omeprazole regimen at equivalent doses, is planned to be initiated in the second quarter of 2017, subject to the successful completion of the ongoing supportive pharmacokinetic (PK) program and submission of the Clinical Study Report to the FDA. The confirmatory Phase III study is planned to enroll approximately 440 patients in up to 55 clinical sites in the U.S. In October 2016, RedHill provided an update on the RHB-104 Phase III Crohn’s disease development program, planned enhancements to the ongoing MAP US Phase III study and expected milestones, including an increase in the total number of patients planned to be enrolled in the MAP US study from 270 to 410, and the addition of an open-label extension study offering patients who complete 26 weeks of study participation and remain out of remission (Crohn’s disease active index (CDAI) >150) the opportunity to receive treatment with RHB-104 for a 52-week period. The open-label extension study is expected to be initiated in the coming weeks. Following a pre-planned review of safety data from its ongoing MAP US study by an independent Data and Safety Monitoring Board (DSMB), RedHill announced in December 2016 that it had received a unanimous recommendation to continue the MAP US study as planned. A second independent DSMB meeting of the MAP US study, expected in the second quarter of 2017, will include an interim efficacy analysis and will evaluate the option for an early stop for success for overwhelming efficacy, according to a pre-specified statistical significance threshold. Taking into account the increase in the total number of patients planned in the MAP US study, and assuming the MAP US study is not stopped for success or inefficacy following the independent DSMB meeting in the second quarter of 2017, completion of recruitment is expected by the end of 2017. In December 2016, RedHill announced encouraging top-line final results of a Phase IIa, proof-of-concept clinical study, evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing remitting multiple sclerosis (the CEASE MS study). The top-line final results (48 weeks) were consistent with previously announced interim results, suggesting meaningful positive safety and clinical signals upon 24 weeks of treatment with RHB-104 as an add-on therapy, thereby supporting further clinical development. In January 2017, RedHill announced that RHB-104 had been granted Qualified Infectious Disease Product (QIDP) designation by the FDA for the treatment of nontuberculous mycobacteria (NTM) infections. RedHill plans to consult with the FDA regarding the RHB-104 development program for NTM infections. In February 2017, RedHill announced that the last patient enrolled in the randomized, double-blind, placebo-controlled Phase III clinical study with BEKINDA® 24 mg in the U.S. for acute gastroenteritis and gastritis (the GUARD study) had completed the treatment course and observation period for the primary endpoint evaluation. Top-line results are expected in the second quarter of 2017. A randomized, double-blind, placebo-controlled Phase II clinical study with BEKINDA® 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) is ongoing in the U.S. with top-line results expected in mid-2017. In June 2016, RedHill announced positive final results from a Phase I study with YELIVA® in patients with advanced solid tumors. The Phase I study, conducted at the Medical University of South Carolina Hollings Cancer Center, successfully met its primary and secondary endpoints, demonstrating that the drug is well-tolerated and can be safely administered to cancer patients at doses predicted to have therapeutic activity. In September 2016, RedHill announced a research collaboration with Stanford University School of Medicine for the evaluation of YELIVA®. The research collaboration is intended to complement RedHill’s planned Phase Ib clinical study to evaluate YELIVA® as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy. The Phase Ib study is planned to be initiated in mid-2017. In October 2016, RedHill announced the initiation of a Phase II clinical study with YELIVA® for advanced hepatocellular carcinoma at the Medical University of South Carolina. In December 2016, RedHill announced that the first patient was dosed in a Phase Ib/II study with YELIVA® for refractory or relapsed multiple myeloma, conducted at Duke University Medical Center. A Phase I/II clinical study evaluating YELIVA® in patients with refractory/relapsed diffuse large B-cell lymphoma is ongoing at the Louisiana State University Health Sciences Center and was recently amended to address overall recruitment prospects and to include Kaposi sarcoma patients in the study. A Phase II study to evaluate the efficacy of YELIVA® in patients with moderate to severe ulcerative colitis is planned to be initiated in the second half of 2017.    In 2016, RedHill and its co-development partner, IntelGenx Corp., entered into exclusive license agreements for the commercialization of RIZAPORT® oral thin-film for acute migraines with Grupo JUSTE S.A.Q.F (now Exeltis Healthcare, S.L.) for Spain and with Pharmatronic Co. for South Korea. Re-submission of the RIZAPORT® NDA to the FDA is expected in the third quarter of 2017. In January 2017, RedHill announced the signing of a new collaboration agreement with the Department of Molecular Biology and Genetics of Denmark-based Aarhus University for the evaluation of RedHill’s Phase II-stage oncology drug candidate, MESUPRON. The new research collaboration follows previous non-clinical studies conducted with Denmark’s Aarhus University and is designed to identify additional high affinity molecular targets of MESUPRON. Further evaluation of MESUPRON, together with Aarhus University, may allow for selection of appropriate sub-populations of patients toward demonstrating the activity of MESUPRON in planned clinical trials. RedHill is currently preparing a protocol for a Phase I/II study of the safety, efficacy and dose evaluation of MESUPRON in combination with chemotherapy in patients receiving adjuvant chemotherapy for resected pancreatic cancer. The Phase I/II study is expected to be initiated in the second half of 2017 in up to six sites in Germany. As part of RedHill’s strategic initiative to become a revenue-generating, gastrointestinal-focused, specialty pharmaceutical company with a commercial presence in the U.S., the Company entered in January 2017 into an exclusive co-promotion agreement with a subsidiary4 of Concordia International Corp., granting RedHill certain U.S. promotional rights for Donnatal®, a prescription oral drug used with other drugs in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel)5. RedHill expects to initiate promotion of Donnatal® in the coming months. In December 2016, RedHill closed an underwritten public offering and a registered direct offering of American Depositary Shares (ADSs) and warrants to purchase ADSs for aggregate net proceeds, after deducting underwriting discounts and commissions, placement agent fees and other offering expenses, of $35.9 million. Investors in the public offering included, among others, Sabby Management, LLC, DAFNA Capital Management, Rosalind Advisors, Inc., Koramic Holding, Lincoln Park Capital, and Nexthera Capital LP. About Donnatal®: Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal® slows the natural movements of the gut by relaxing the muscles in the stomach and intestines and acts on the brain to produce a calming effect. Donnatal® comes in two formulations: immediate release Donnatal® Tablets and immediate release Donnatal® Elixir, a fast acting liquid. Donnatal® is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal®. Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe. Further information, including prescribing information, can be found on www.donnatal.com. Please see the following website for important safety information about Donnatal®:           http://www.donnatal.com/professionals/important-safety-information/ About RedHill Biopharma Ltd.: RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill has a U.S. co-promotion agreement with Concordia for Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis. RedHill’s clinical-stage pipeline includes: (i) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102) - a once-daily oral pill formulation of ondansetron with an ongoing Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640) - a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered uPA inhibitor, targeting gastrointestinal and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in Germany in October 2015. More information about the Company is available at: www.redhillbio.com. This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully market Donnatal®, (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on February 25, 2016. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law. 1 All financial highlights are approximate and are rounded to the nearest hundreds of thousands. 2 All financial highlights are approximate and are rounded to the nearest hundreds of thousands. 5 Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) is a prescription drug, classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis.  For more information, please see the prescribing information: http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-Benefit-information-DTC-REV.-SE.pdf.


IRVINE, Calif., March 01, 2017 (GLOBE NEWSWIRE) -- CombiMatrix Corporation (NASDAQ:CBMX), a family health molecular diagnostics company specializing in DNA-based reproductive health and pediatric testing services, announces that Dirk van den Boom, Ph.D., has joined the Company’s Board of Directors, increasing Board membership to six.  “Dirk is a recognized leader in the development and commercialization of reproductive health diagnostics,” said R. Judd Jessup, Chairman of CombiMatrix.  “He brings a scientific perspective to the board along with a wealth of executive-level and strategic planning experience that will be invaluable as we build on our established position in this market.  Dirk also shares our passion for providing high-quality test results that assist physicians and their patients in family health and planning, making him an ideal fit for our Board.  We look forward to calling on Dirk’s expertise and guidance, and we are delighted to welcome him to our Company.” Dr. van den Boom most recently served as President, Chief Executive Officer and Director of publicly traded molecular diagnostics company Sequenom, Inc., prior to that company’s acquisition by Laboratory Corporation of America® (LabCorp®) in September 2016.  During his 18 year tenure at Sequenom, he held positions of increasing responsibility including Chief Scientific and Strategy Officer; Executive Vice President, Research and Development; Chief Technology Officer; and Senior Vice President of Research and Development.  Dr. van den Boom has co-authored more than 95 articles published in peer-reviewed journals and is inventor on more than 80 patents and patent applications. He received his Ph.D. in Biochemistry/Molecular Biology from the University of Hamburg. CombiMatrix Corporation provides best-in-class molecular diagnostic solutions and comprehensive clinical support to foster the highest quality in patient care. CombiMatrix specializes in pre-implantation genetic diagnostics and screening, prenatal diagnosis, miscarriage analysis and pediatric developmental disorders, offering DNA-based testing for the detection of genetic abnormalities beyond what can be identified through traditional methodologies. Our testing focuses on advanced technologies, including single nucleotide polymorphism chromosomal microarray analysis, next-generation sequencing, fluorescent in situ hybridization and high resolution karyotyping.  Additional information about CombiMatrix is available at www.combimatrix.com or by calling (800) 710-0624. Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations, speak only as of the date hereof and are subject to change. All statements, other than statements of historical fact included in this press release, are forward-looking statements. Forward-looking statements can often be identified by words such as "anticipates," “approximates,” "expects," "intends," "plans," "goal," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "could," "potential," "continue," "ongoing," similar expressions, and variations or negatives of these words and include, but are not limited to, statements regarding projected results of operations, including projected cash flow-positive operating results, management's future business, operational and strategic plans, recruiting efforts and test menu expansion. These forward-looking statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause our actual results to differ materially and adversely from those expressed in any forward-looking statement. The risks and uncertainties referred to above include, but are not limited to: our estimates of total market sizes for the tests that we offer; our ability to grow revenue and improve gross margin; delays in achieving cash flow-positive operating results; the risk that test volumes and reimbursements level off or decline; the risk that payors decide to not cover our tests or to reduce the amounts they are willing to pay for our tests; the risk that we will not be able to grow our business as quickly as we need to; the inability to raise capital; the loss of members of our sales force; our ability to successfully expand the base of our customers, add to the menu of our diagnostic tests, develop and introduce new tests and related reports, expand and improve our current suite of diagnostic services, optimize the reimbursements received for our molecular testing services, and increase operating margins by improving overall productivity and expanding sales volumes; our ability to successfully accelerate sales, steadily increase the size of our customer rosters in all of our genetic testing markets; our ability to attract and retain a qualified sales force in wider geographies; our ability to ramp production from our sales; rapid technological change in our markets; changes in demand for our future services; legislative, regulatory and competitive developments; general economic conditions; and various other factors. Further information on potential factors that could affect our financial results is included in our Annual Report on Form 10-K, Quarterly Reports of Form 10-Q, and in other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.


IRVINE, Calif., March 01, 2017 (GLOBE NEWSWIRE) -- CombiMatrix Corporation (NASDAQ:CBMX), a family health molecular diagnostics company specializing in DNA-based reproductive health and pediatric testing services, announces that Dirk van den Boom, Ph.D., has joined the Company’s Board of Directors, increasing Board membership to six.  “Dirk is a recognized leader in the development and commercialization of reproductive health diagnostics,” said R. Judd Jessup, Chairman of CombiMatrix.  “He brings a scientific perspective to the board along with a wealth of executive-level and strategic planning experience that will be invaluable as we build on our established position in this market.  Dirk also shares our passion for providing high-quality test results that assist physicians and their patients in family health and planning, making him an ideal fit for our Board.  We look forward to calling on Dirk’s expertise and guidance, and we are delighted to welcome him to our Company.” Dr. van den Boom most recently served as President, Chief Executive Officer and Director of publicly traded molecular diagnostics company Sequenom, Inc., prior to that company’s acquisition by Laboratory Corporation of America® (LabCorp®) in September 2016.  During his 18 year tenure at Sequenom, he held positions of increasing responsibility including Chief Scientific and Strategy Officer; Executive Vice President, Research and Development; Chief Technology Officer; and Senior Vice President of Research and Development.  Dr. van den Boom has co-authored more than 95 articles published in peer-reviewed journals and is inventor on more than 80 patents and patent applications. He received his Ph.D. in Biochemistry/Molecular Biology from the University of Hamburg. CombiMatrix Corporation provides best-in-class molecular diagnostic solutions and comprehensive clinical support to foster the highest quality in patient care. CombiMatrix specializes in pre-implantation genetic diagnostics and screening, prenatal diagnosis, miscarriage analysis and pediatric developmental disorders, offering DNA-based testing for the detection of genetic abnormalities beyond what can be identified through traditional methodologies. Our testing focuses on advanced technologies, including single nucleotide polymorphism chromosomal microarray analysis, next-generation sequencing, fluorescent in situ hybridization and high resolution karyotyping.  Additional information about CombiMatrix is available at www.combimatrix.com or by calling (800) 710-0624. Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995 This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations, speak only as of the date hereof and are subject to change. All statements, other than statements of historical fact included in this press release, are forward-looking statements. 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The risks and uncertainties referred to above include, but are not limited to: our estimates of total market sizes for the tests that we offer; our ability to grow revenue and improve gross margin; delays in achieving cash flow-positive operating results; the risk that test volumes and reimbursements level off or decline; the risk that payors decide to not cover our tests or to reduce the amounts they are willing to pay for our tests; the risk that we will not be able to grow our business as quickly as we need to; the inability to raise capital; the loss of members of our sales force; our ability to successfully expand the base of our customers, add to the menu of our diagnostic tests, develop and introduce new tests and related reports, expand and improve our current suite of diagnostic services, optimize the reimbursements received for our molecular testing services, and increase operating margins by improving overall productivity and expanding sales volumes; our ability to successfully accelerate sales, steadily increase the size of our customer rosters in all of our genetic testing markets; our ability to attract and retain a qualified sales force in wider geographies; our ability to ramp production from our sales; rapid technological change in our markets; changes in demand for our future services; legislative, regulatory and competitive developments; general economic conditions; and various other factors. 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News Article | February 21, 2017
Site: www.eurekalert.org

Monash University (Australia) and Cardiff University (UK) researchers have come a step further in understanding how the human immunodeficiency virus (HIV) evades the immune system. Declared a pandemic in 1987 by the World Health Organization, HIV infection has been responsible for 39 million deaths over the last 30 years. It remains one of the world's most significant public health challenges and thus a greater understanding of how HIV functions is urgently needed so that researchers can design better therapies to target this devastating pathogen. Published today in Nature Structural and Molecular Biology, the Monash-Cardiff team has made an important finding in understanding how HIV-I can evade the immune system. They demonstrated, in molecular detail, how mutations within HIV can lead to differing ways in which key immune molecules, termed the Major Histocompatibility Complex (MHC), display fragments of the virus and how this results in the HIV remaining "hidden" from the immune system. Principal author of the study, Dr Julian Vivian, said the team was yet to develop a complete understanding of how HIV outmanoeuvred our immune system. "This work uncovers a novel mechanism for HIV immune escape, which will be important to incorporate into future vaccine development and may have broader implications for immune recognition of MHC molecules," he said. The recent finding is part of a much larger international alliance between the two Universities, with the Systems Immunity Research Institute (SIURI) at Cardiff University and Monash Biomedicine Discovery Institute (BDI), having signed a Memorandum of Understanding. The five year mutual agreement recognises a number of highly productive joint projects already being conducted around inflammation and immunity, and provides a mechanism for enabling additional innovative projects and student exchange in the areas of protective immunity, metabolism, autoimmunity and cancer. A chief Investigator on the ARC CoE for Advanced Molecular Imaging, based at Monash BDI, Professor Jamie Rossjohn, said the find was exciting and unexpected. "These result were only possible because of the close collaborative ties between Monash and Cardiff researchers." Cardiff University Vice-Chancellor, Professor Colin Riordan, said the signing of the MoU called for a celebration. "Formalising this collaboration is another step forward in what will continue to be a highly successful exchange program and transfer of knowledge between the two countries for the benefit of all." Monash BDI Director, Professor John Carroll, said the research demonstrated the power of international collaboration. "We are bringing together excellence in molecular and systems level immunity in this partnership, and I know it will lead to many more great discoveries." The $39 million ARC-funded Imaging CoE develops and uses innovative imaging technologies to visualise the molecular interactions that underpin the immune system. Featuring an internationally renowned team of lead scientists across five major Australian Universities and academic and commercial partners globally, the Centre uses a truly multi scale and programmatic approach to imaging to deliver maximum impact. The Imaging CoE is headquartered at Monash University with four collaborating organisations - La Trobe University, the University of Melbourne, University of New South Wales and the University of Queensland. Committed to making the discoveries that will relieve the future burden of disease, the newly established Monash Biomedicine Discovery Institute at Monash University brings together more than 120 internationally-renowned research teams. Our researchers are supported by world-class technology and infrastructure, and partner with industry, clinicians and researchers internationally to enhance lives through discovery.


News Article | February 21, 2017
Site: www.eurekalert.org

GRAND RAPIDS, Mich. (Feb. 21, 2017)--An international collaboration of life scientists, including experts at Van Andel Research Institute, has described in exquisite detail the critical first steps of DNA replication, which allows cells to divide and most advanced life, including human, to propagate. Results of the study are published in the journal Nature Structural and Molecular Biology and reveal that a ring-shaped protein called origin recognition complex (ORC) possesses a special alpha-helix, which slips into a groove on DNA and initiates a cascade of microscopic interactions that copy DNA. "This is a story of one ring that lords over another ring," says Huilin Li, Ph.D., a professor in Van Andel Research Institute's Center for Epigenetics and a senior author of the paper. "Biologists have known for many years that both ORC and helicase are ring-shaped structures essential in the initiation and execution of DNA replication, but until now we never understood exactly how the ORC ring loads the helicase ring onto DNA." The work also reveals that ORC, with the help of Cdc6 and Cdt1, loads the helicase core onto DNA via paired interactions of the so-called winged helix domains. The resulting 14-protein structure completes the loading of the first helicase ring and is now prepared to load the next ring. This process represents the inception of an immensely complex and elegant system that is constantly ongoing at tens of thousands of points on the DNA in many cells of the human body, and it all starts with ORCs. "We hope that by mapping this process, others will eventually convert this knowledge into new treatments for DNA replication-related conditions, including many cancers and rare disorders," says Li. At the outset, the six-protein ORCs assemble into a crescent, which envelops the DNA duplex. The ORCs then recruit a seventh protein, called Cdc6, to encircle DNA. Next, this ring threads the second ring, called minichromosome maintenance protein (Cdt1-bound Mcm2-7 hexamer), around DNA, which completes loading of the first Mcm2-7 hexamer. "It's like threading a pearl onto a string; but unlike a short piece of string, the DNA strand is incredibly long and so the bead cannot be threaded on at one end," says Christian Speck, a professor at Imperial College of London's Institute of Clinical Sciences, leader of the DNA Replication group at MRC London Institute of Medical Sciences and a senior author of the paper. "Instead, it must somehow be opened up, slotted around the strand, and closed again." The study was conducted on the DNA of Saccharomyces cerevisiae, better known as baker's yeast, because of its biological and genomic similarity to larger organisms, including mammals, at an average resolution of 3.9 Angströms (about 40 billionths of a meter), which is roughly the diameter of a single atom of sodium. Magnification of this scale is currently possible only with cryoelectron microscopy (cryo-EM), a revolutionary technology VARI continues to invest in through its recently established Cryo-EM Core. Imaging for this study was conducted at Howard Hughes Medical Institute's Janelia Research Campus and at Scripps Research Institute. Study authors are Zuanning Yuan, Lin Bai, Jingchuan Sun and Huilin Li, of Van Andel Research Institute; Alberto Riera, Marta Barbon and Christian Speck, all of Imperial College of London and MRC London Institute of Medical Sciences; Jingchuan Sun of University of Pennsylvania; Saikat Nandi and Bruce Stillman, both of Cold Spring Harbor Laboratory; Christos Spanos, Zhuo Angel Chen and Juri Rappsilber, all of University of Edinburgh. Rappsilber is also affiliated with Technische Universität Berlin. Sun is now affiliated with University of Pennsylvania. This work was funded by the U.S. National Institutes of Health (GM111472 and OD12272 to Huilin Li and GM45436 to Bruce Stillman), the Biotechnology and Biological Sciences Research Council UK (P56061 to Christian Speck), and the Wellcome Trust (Investigator Award P56628 to Speck, Senior Research Fellowship 103139 to Juri Rappsilber, a Centre core grant 092076 to Rappsilber, and an instrument grant 108504 to Rappsilber). Van Andel Institute (VAI) is an independent nonprofit biomedical research and science education organization committed to improving the health and enhancing the lives of current and future generations. Established by Jay and Betty Van Andel in 1996 in Grand Rapids, Michigan, VAI has grown into a premier research and educational institution that supports the work of more than 360 scientists, educators and staff. Van Andel Research Institute (VARI), VAI's research division, is dedicated to determining the epigenetic, genetic, molecular and cellular origins of cancer, Parkinson's and other diseases and translating those findings into effective therapies. The Institute's scientists work in onsite laboratories and participate in collaborative partnerships that span the globe. Learn more about Van Andel Institute or donate by visiting http://www. .


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

Sardinia sits at a crossroads in the Mediterranean Sea, the second largest island next to Sicily. Surrounded by sparkling turquoise waters, this Mediterranean jewel lies northwest of the toe of the Italian peninsula boot, about 350 kilometers due west of Rome. For evolutionary biologists, islands are often intriguing, geographically isolated pockets with unique populations that can be ripe for exploration. Now, in a new study appearing in the advanced online edition of Molecular Biology and Evolution an international team led by geneticist Anna Olivieri from the University of Pavia tackles a highly interesting question: what were the origins of the Sardinian population in the context of European prehistory and ancient human migrations? The authors analyzed 3,491 modern, whole mitochondrial DNA genomes from Sardinia (which are only passed down maternally). These were compared with 21 samples of ancient mitogenomes from the island, a large panel of non-Sardinian mitogenomes ---and even Ötzi (the nickname of Europe's oldest natural mummy, the 3,300 BCE-year old "Tyrolean Iceman") ---to better understand their origins. Their findings show Sardinia as an outlier in the general European genetic landscape. Almost 80 percent of modern Sardinian mitogenomes belong to branches that cannot be found anywhere else outside the island. Thus, they were defined as Sardinian-Specific Haplogroups (SSHs) that most likely arose in the island after its initial occupation. Almost all SSHs coalesce in the post-Nuragic, Nuragic and Neolithic-Copper Age periods. However, some rare SSHs display age estimates older than 7,800 years ago, the postulated archeologically-based starting time of the Neolithic in Sardinia. "Our analyses raise the possibility that several SSHs may have already been present on the island prior to the Neolithic," said prof. Francesco Cucca, from the Institute of Genetic and Biomedical Research (IRGB), at the CNR in Cagliari (Sardinia). The most plausible candidates would include haplogroups K1a2d and U5b1i1, which together comprise almost 3 percent of modern Sardinians, and possibly others. Such a scenario would not only support archaeological evidence of a Mesolithic occupation of Sardinia, but could also suggest a dual ancestral origin of its first inhabitants. K1a2d is of Late Paleolithic Near Eastern ancestry, whereas U5b1i1 harbours deep ancestral roots in Paleolithic Western Europe. This work provides evidence that contemporary Sardinians harbour a unique genetic heritage, as a result of their distinct history and relative isolation from the demographic upheavals of continental Europe. Anna Olivieri stresses: "It now seems plausible that human mobility, inter-communication and gene flow around the Mediterranean from Late Glacial times onwards may well have left signatures that survive to this day. Some of these signals are still retained in modern Sardinians." "Although in the past the stress has often been on the spread of the Neolithic, genetic studies too are beginning to emphasize the complexity and mosaic nature of human ancestry in the Mediterranean, and indeed in Europe more widely," concludes prof. Antonio Torroni, from the University of Pavia. "Future work on ancient DNA should be able to test directly to what extent this more complex model is supported by genetic evidence, and whether our predictions of Mesolithic ancestry in contemporary Sardinians can be sustained."

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