Shire Pharmaceuticals

Wayne, PA, United States

Shire Pharmaceuticals

Wayne, PA, United States
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Regenerative Medicine Market is estimated at $20.07 billion in 2015 and is projected to reach $101.3 billion by 2022 growing at a CAGR of 26.0% from 2015 to 2022Pune , India - April 24, 2017 /MarketersMedia/ — Regenerative Medicine Industry Description According to Stratistics MRC, the Regenerative Medicine Market is estimated at $20.07 billion in 2015 and is projected to reach $101.3 billion by 2022 growing at a CAGR of 26.0% from 2015 to 2022. Growing research applications, growing demand in tissue engineering, biomaterials and stem cell therapy systems are some of the factors driving the market growth. However, high cost associated with biomaterials will be a major factor to restrict the market growth. The stem cells application and advancements in nanotechnology will further drive the market over the forecast period. Gene therapies segment is expected to be the fastest emerging technology due to tremendous potential of gene therapy in minimizing immune rejections, which commonly occur after transplantations. Asia-Pacific would be the fastest growing region for regenerative medicine market. Europe and North America together accounted for over 3/4th of the market revenue and anticipated to be most profitable regional market. Some of the key players in the market include Shire Pharmaceuticals, Advanced Cell Technology, Inc, Genzyme, Athersys, Inc., Kinetic Concepts, Inc., NuVasive Inc., Stem cells, Inc., Cytori Therapeutics, Inc., Cytomedix Inc., Mesoblast Ltd. , Zimmer Holdings, Inc., Orthofix, DePuy Synthes Inc., Cell Medica and CryoLife. Request for Sample Report @ https://www.wiseguyreports.com/sample-request/456590-regenerative-medicine-global-market-outlook-2015-2022 Technologies Covered: • Small Molecules and Biologics • Gene Therapy • Cell Therapy Applications Covered: • Dermatology • Cardiovascular Disorders • Central Nervous System (CNS) • Orthopedic • Dental • Other applications o Autoimmune Diseases o Muscle Regeneration o Ocular Diseases o Internal organ regeneration Leave a Query @ https://www.wiseguyreports.com/enquiry/456590-regenerative-medicine-global-market-outlook-2015-2022 Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK o Spain o Rest of Europe • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements Buy now @ https://www.wiseguyreports.com/checkout?currency=one_user-USD&report_id=456590 Continued... Contact Us: Sales@Wiseguyreports.Com Ph: +1-646-845-9349 (US) Ph: +44 208 133 9349 (UK) Contact Info:Name: NORAH TRENTEmail: sales@wiseguyreports.comOrganization: WISE GUY RESEARCH CONSULTANTS PVT LTDAddress: Office No. 528, Amanora Chambers Magarpatta Road, Hadapsar Pune - 411028Phone: +91 841 198 5042Source URL: http://marketersmedia.com/regenerative-medicine-market-2017-global-share-trend-and-opportunities-forecast-to-2022/189453For more information, please visit https://www.wiseguyreports.com/sample-request/456590-regenerative-medicine-global-market-outlook-2015-2022Source: MarketersMediaRelease ID: 189453


News Article | May 15, 2017
Site: globenewswire.com

-- Paolo Tombesi named as Chief Financial Officer -- -- Paul Streck, M.D., appointed as Chief Medical Officer -- -- Eugene Sullivan, M.D., assumes role of Chief Product Strategy Officer -- BRIDGEWATER, N.J., May 15, 2017 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced the appointment of Paolo Tombesi as Chief Financial Officer, effective June 1, 2017, and Paul Streck, M.D., as Chief Medical Officer, effective June 5, 2017. Additionally, Eugene Sullivan, M.D., has been appointed to the newly created role of Chief Product Strategy Officer. “These management changes will strengthen our already solid leadership team and add critical skills to our organization as we collectively advance the clinical development of our portfolio and prepare for the potential commercialization of liposomal amikacin for inhalation,” said Will Lewis, president and chief executive officer of Insmed. Mr. Tombesi brings over 20 years of experience in the biotechnology and pharmaceutical sector, most recently serving as Vice President and Chief Financial and Administrative Officer of Novartis Pharmaceuticals Corporation. In addition, Mr. Tombesi was also a member of Novartis’s Pharma Executive Committee, Commercial Leadership Team, Corporate Compliance Committee, Global Pharma Finance Leadership Team and Global Country CFO Team. He joined Novartis in 2006 as Head of Finance Region Europe, Oncology, and held several positions of increasing responsibility, including serving as Managing Director and CFO of Novartis Japan. Prior to joining Novartis, Mr. Tombesi held various financial positions with Bristol-Myers Squibb. His career began in consumer goods with Unilever NV and Johnson & Johnson. He holds a degree in business and managerial ecomonics from Rome’s La Sapienza University and a degree in accounting from Duca degli Abruzzi Roma. Dr. Streck joins Insmed with over 25 years of clinical development, management and leadership expertise. He most recently served as Vice President, Global Medical Specialty Franchise, Immuno-inflammation at GlaxoSmithKline where he was responsible for portfolio strategy, including drug launch, life cycle management, post-registration clinical strategy and health economics. Previously, he held various positions with functions ranging from clinical development to medical affairs to commercial with Shire Pharmaceuticals and AMGEN USA, Inc.  Dr. Streck also practiced in the Jefferson Health System at Thomas Jefferson University. He received his medical degree from Jefferson Medical College and was a resident in oral and maxillofacial surgery at Thomas Jefferson University Hospital. Dr. Streck also holds a doctorate of dental medicine from Temple University School of Denistry, a Masters of Business Administration from the Duke University Fuqua School of Business and board certification in oral and maxillofacial surgery from the American Board of Oral and Maxillofacial Surgery. Dr. Sullivan joined Insmed as Chief Medical and Scientific Officer in 2015, and has more than 20 years of experience with a focus on pulmonary and orphan diseases. Prior to joining Insmed, and in addition to other roles within the industry, Dr. Sullivan held several positions at the U.S. Food and Drug Administration. Dr. Sullivan’s extensive product strategy development experience uniquely qualifies him for the newly-created position as he will be tasked with overseeing the advancement of Insmed’s product pipeline. “Paolo’s extensive financial and commercial understanding of the pharmaceutical industry will assist us in addressing the challenges faced by rapidly growing, global businesses. Paul brings proven management and leadership skills that are critical to us as a multi-product development organization. Paul has played a crucial role in the clinical development, launch or commercial marketing of more than 25 medications across a broad range of indications, including rare and orphan diseases. In his new role, Gene will continue to rely on his broad clinical and regulatory background and will focus his directly relevant experience with the FDA and demonstrated product strategy expertise on the development of our ongoing portfolio strategy,” added Mr. Lewis. Insmed Incorporated is a global biopharmaceutical company focused on the unmet needs of patients with rare diseases. The company is advancing a global phase 3 clinical study of ARIKAYCE® (liposomal amikacin for inhalation) for adult patients with treatment refractorynontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC), which is a rare and often chronic infection that is capable of causing irreversible lung damage and can be fatal. There are currently no approved inhaled products specifically indicated for the treatment of refractory NTM lung disease caused by MAC in the United States or the European Union. Insmed's earlier-stage clinical pipeline includes INS1007, a novel oral reversible inhibitor of DPP1 with therapeutic potential in non-cystic fibrosis bronchiectasis, and INS1009, an inhaled nanoparticle formulation of a treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders, including pulmonary arterial hypertension. For more information, visit www.insmed.com. "Insmed" and "ARIKAYCE" are the company's trademarks. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners. This press release contains forward looking statements.  "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties.  Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. The forward-looking statements in this press release are based upon the company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such factors include, among others: uncertainties in the research and development of our existing product candidates, including due to delays in patient enrollment or failure of our preclinical studies or clinical trials to satisfy pre-established endpoints; failure to develop, or to license for development, additional product candidates, including a failure to attract experienced third party collaborators; failure to obtain, or delays in obtaining, regulatory approval from the United States Food and Drug Administration, the European Medicines Agency, and other regulatory authorities for our product candidates or their delivery devices, including due to insufficient clinical data or selection of endpoints that are not satisfactory to regulators; failure of third parties on which we are dependent to conduct our clinical trials and to manufacture sufficient quantities of our product candidates for clinical or commercial needs; failure to comply with license agreements that are critical for our product development, including our license agreements with PARI Pharma GmbH and AstraZeneca AB; lack of safety and efficacy of our product candidates; inaccuracies in our estimate of the size of the potential markets for our product candidates; failure to maintain regulatory approval for our product candidates, once received, due to a failure to satisfy post-approval regulatory requirements, such as the need for post-clinical trials; uncertainties in the rate and degree of market acceptance of product candidates, if approved; uncertainties in the timing, scope and rate of reimbursement for our product candidates; competitive developments affecting our product candidates; inaccurate estimates regarding our future capital requirements, including those necessary to fund milestone payments or royalties owed to third parties; inability to repay our existing indebtedness or to obtain additional financing when needed; failure to obtain, protect and enforce our patents and other intellectual property; inability to create an effective direct sales and marketing infrastructure or to partner with a third party that offers such an infrastructure for distribution of our product candidates; the cost and potential reputational damage resulting from litigation to which we are a party, including, without limitation, the class action lawsuit pending against us; failure to comply with the laws and regulations that impact our business; loss of key personnel; and changes in laws and regulations applicable to our business, including those related to pricing and reimbursement of our product candidates.  For additional information about the risks and uncertainties that may affect our business, please see the factors discussed in Item 1A, "Risk Factors," in the company's Annual Report on Form 10-K for the year ended December 31, 2016. The company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The company disclaims any obligation, except as specifically required by law and the rules of the Securities and Exchange Commission, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.


News Article | May 15, 2017
Site: globenewswire.com

-- Paolo Tombesi named as Chief Financial Officer -- -- Paul Streck, M.D., appointed as Chief Medical Officer -- -- Eugene Sullivan, M.D., assumes role of Chief Product Strategy Officer -- BRIDGEWATER, N.J., May 15, 2017 (GLOBE NEWSWIRE) -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced the appointment of Paolo Tombesi as Chief Financial Officer, effective June 1, 2017, and Paul Streck, M.D., as Chief Medical Officer, effective June 5, 2017. Additionally, Eugene Sullivan, M.D., has been appointed to the newly created role of Chief Product Strategy Officer. “These management changes will strengthen our already solid leadership team and add critical skills to our organization as we collectively advance the clinical development of our portfolio and prepare for the potential commercialization of liposomal amikacin for inhalation,” said Will Lewis, president and chief executive officer of Insmed. Mr. Tombesi brings over 20 years of experience in the biotechnology and pharmaceutical sector, most recently serving as Vice President and Chief Financial and Administrative Officer of Novartis Pharmaceuticals Corporation. In addition, Mr. Tombesi was also a member of Novartis’s Pharma Executive Committee, Commercial Leadership Team, Corporate Compliance Committee, Global Pharma Finance Leadership Team and Global Country CFO Team. He joined Novartis in 2006 as Head of Finance Region Europe, Oncology, and held several positions of increasing responsibility, including serving as Managing Director and CFO of Novartis Japan. Prior to joining Novartis, Mr. Tombesi held various financial positions with Bristol-Myers Squibb. His career began in consumer goods with Unilever NV and Johnson & Johnson. He holds a degree in business and managerial ecomonics from Rome’s La Sapienza University and a degree in accounting from Duca degli Abruzzi Roma. Dr. Streck joins Insmed with over 25 years of clinical development, management and leadership expertise. He most recently served as Vice President, Global Medical Specialty Franchise, Immuno-inflammation at GlaxoSmithKline where he was responsible for portfolio strategy, including drug launch, life cycle management, post-registration clinical strategy and health economics. Previously, he held various positions with functions ranging from clinical development to medical affairs to commercial with Shire Pharmaceuticals and AMGEN USA, Inc.  Dr. Streck also practiced in the Jefferson Health System at Thomas Jefferson University. He received his medical degree from Jefferson Medical College and was a resident in oral and maxillofacial surgery at Thomas Jefferson University Hospital. Dr. Streck also holds a doctorate of dental medicine from Temple University School of Denistry, a Masters of Business Administration from the Duke University Fuqua School of Business and board certification in oral and maxillofacial surgery from the American Board of Oral and Maxillofacial Surgery. Dr. Sullivan joined Insmed as Chief Medical and Scientific Officer in 2015, and has more than 20 years of experience with a focus on pulmonary and orphan diseases. Prior to joining Insmed, and in addition to other roles within the industry, Dr. Sullivan held several positions at the U.S. Food and Drug Administration. Dr. Sullivan’s extensive product strategy development experience uniquely qualifies him for the newly-created position as he will be tasked with overseeing the advancement of Insmed’s product pipeline. “Paolo’s extensive financial and commercial understanding of the pharmaceutical industry will assist us in addressing the challenges faced by rapidly growing, global businesses. Paul brings proven management and leadership skills that are critical to us as a multi-product development organization. Paul has played a crucial role in the clinical development, launch or commercial marketing of more than 25 medications across a broad range of indications, including rare and orphan diseases. In his new role, Gene will continue to rely on his broad clinical and regulatory background and will focus his directly relevant experience with the FDA and demonstrated product strategy expertise on the development of our ongoing portfolio strategy,” added Mr. Lewis. Insmed Incorporated is a global biopharmaceutical company focused on the unmet needs of patients with rare diseases. The company is advancing a global phase 3 clinical study of ARIKAYCE® (liposomal amikacin for inhalation) for adult patients with treatment refractorynontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC), which is a rare and often chronic infection that is capable of causing irreversible lung damage and can be fatal. There are currently no approved inhaled products specifically indicated for the treatment of refractory NTM lung disease caused by MAC in the United States or the European Union. Insmed's earlier-stage clinical pipeline includes INS1007, a novel oral reversible inhibitor of DPP1 with therapeutic potential in non-cystic fibrosis bronchiectasis, and INS1009, an inhaled nanoparticle formulation of a treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders, including pulmonary arterial hypertension. For more information, visit www.insmed.com. "Insmed" and "ARIKAYCE" are the company's trademarks. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners. This press release contains forward looking statements.  "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties.  Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. The forward-looking statements in this press release are based upon the company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such factors include, among others: uncertainties in the research and development of our existing product candidates, including due to delays in patient enrollment or failure of our preclinical studies or clinical trials to satisfy pre-established endpoints; failure to develop, or to license for development, additional product candidates, including a failure to attract experienced third party collaborators; failure to obtain, or delays in obtaining, regulatory approval from the United States Food and Drug Administration, the European Medicines Agency, and other regulatory authorities for our product candidates or their delivery devices, including due to insufficient clinical data or selection of endpoints that are not satisfactory to regulators; failure of third parties on which we are dependent to conduct our clinical trials and to manufacture sufficient quantities of our product candidates for clinical or commercial needs; failure to comply with license agreements that are critical for our product development, including our license agreements with PARI Pharma GmbH and AstraZeneca AB; lack of safety and efficacy of our product candidates; inaccuracies in our estimate of the size of the potential markets for our product candidates; failure to maintain regulatory approval for our product candidates, once received, due to a failure to satisfy post-approval regulatory requirements, such as the need for post-clinical trials; uncertainties in the rate and degree of market acceptance of product candidates, if approved; uncertainties in the timing, scope and rate of reimbursement for our product candidates; competitive developments affecting our product candidates; inaccurate estimates regarding our future capital requirements, including those necessary to fund milestone payments or royalties owed to third parties; inability to repay our existing indebtedness or to obtain additional financing when needed; failure to obtain, protect and enforce our patents and other intellectual property; inability to create an effective direct sales and marketing infrastructure or to partner with a third party that offers such an infrastructure for distribution of our product candidates; the cost and potential reputational damage resulting from litigation to which we are a party, including, without limitation, the class action lawsuit pending against us; failure to comply with the laws and regulations that impact our business; loss of key personnel; and changes in laws and regulations applicable to our business, including those related to pricing and reimbursement of our product candidates.  For additional information about the risks and uncertainties that may affect our business, please see the factors discussed in Item 1A, "Risk Factors," in the company's Annual Report on Form 10-K for the year ended December 31, 2016. The company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The company disclaims any obligation, except as specifically required by law and the rules of the Securities and Exchange Commission, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.


News Article | May 15, 2017
Site: globenewswire.com

Dr. Yaron Daniely to Step Down as Chief Executive Officer, Effective May 31, 2017 Dr. Daniely to Remain on Board of Directors and be Appointed Chairman TEL AVIV, Israel, May 15, 2017 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging pharmaceutical company focused on the development of new medications to treat significant unmet clinical needs, today announced that Dr. Yaron Daniely will be stepping down on May 31, 2017 as President and Chief Executive Officer to become the Chief Executive Officer of Yissum, the technology transfer company of the Hebrew University in Jerusalem, Israel. David Baker, currently Alcobra’s Chief Commercial Officer, will assume the position of interim CEO. Dr. Daniely will remain on the Board of Directors of Alcobra and will be actively involved in ensuring a seamless transition of duties and responsibilities.  The Company’s Board of Directors also announced that it has appointed Dr. Daniely as Chairman of the Board of Directors, effective June 1, 2017. “Dr. Daniely has been a driven and passionate leader for the company and we thank him for years of service as CEO and wish him all the best as CEO of Yissum.  We are grateful that he will continue to provide leadership as chairman of Alcobra and actively support the CEO transition,” said Howard B. Rosen, current Chairman of Alcobra. “Alcobra has significantly advanced a strategic alternatives process to review opportunities to create value for all of our shareholders.  Further, we have made substantial progress in reducing overall costs and expenses.  We look forward to updating shareholders on future developments.” “It has been an honor to lead Alcobra over the past seven years,” said Dr. Yaron Daniely. “I’m proud of what we’ve accomplished, and believe the company has made significant progress over the past few months to advance potential value creation.  I have full confidence in David and the rest of the management team and look forward to an ongoing role at the board level in shaping the future of Alcobra.” Mr. Baker said, “I am proud to succeed Dr. Daniely as Alcobra’s interim CEO. Yaron is an exceptional leader and mentor.  I look forward to working with the rest of Alcobra’s team to continue delivering on the company’s strategic objectives.” Alcobra continues its established process to explore options for creating shareholder value. The company is currently exploring strategic alternatives, which may include partnership or monetization opportunities for the company’s proprietary product candidates – MDX and/or ADAIR, as well as partnering, licensing, M&A opportunities or other transactions to further develop the company’s pipeline and drug- development capabilities for the benefit of increasing shareholder value. About David Baker Mr. Baker joined Alcobra in 2014 as Chief Commercial Officer. Prior to joining Alcobra, he worked at Shire Pharmaceuticals for 10 years, including as Vice President of Commercial Strategy and New Business in the Neuroscience Business Unit. In that role, Mr. Baker led the commercial assessment of neuroscience licensing opportunities, managed commercial efforts on pipeline CNS products, and led the long term strategic planning process. Previously, he served as Global General Manager for Shire’s Vyvanse® where he led the launch of Vyvanse and led global expansion efforts including successful establishment of a partnership in Japan and launches in Canada and Brazil. Prior to that, Mr. Baker served as Vice President of Marketing for all of Shire's ADHD products. From 1990 - 2004, Mr. Baker worked at Merck & Co., where he held positions of increasing responsibility in marketing, sales, market research, and business development. In addition to his knowledge and experience with CNS medications, Mr. Baker's expertise includes therapeutics for osteoporosis, migraine, and hyperlipidemia. He has been directly involved with the marketing of five medications with annual sales in excess of $1 billion each. Mr. Baker graduated Magna Cum Laude with a bachelor's degree in Economics and Computer Science from Duke University. He earned a Master of Business Administration in Marketing from Duke's Fuqua School of Business. About Alcobra Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of medications to treat significant unmet medical needs. For more information, please visit the company's website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference. Forward Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of the Company could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding updating shareholders on future developments, creating shareholder value and exploring strategic alternatives. The forward-looking statements contained or implied in this press release are subject to risks and uncertainties, including those discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2016, filed with the Securities and Exchange Commission (SEC) and in subsequent filings with the SEC. Except as otherwise required by law, the Company disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.


News Article | May 15, 2017
Site: globenewswire.com

Dr. Yaron Daniely to Step Down as Chief Executive Officer, Effective May 31, 2017 Dr. Daniely to Remain on Board of Directors and be Appointed Chairman TEL AVIV, Israel, May 15, 2017 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging pharmaceutical company focused on the development of new medications to treat significant unmet clinical needs, today announced that Dr. Yaron Daniely will be stepping down on May 31, 2017 as President and Chief Executive Officer to become the Chief Executive Officer of Yissum, the technology transfer company of the Hebrew University in Jerusalem, Israel. David Baker, currently Alcobra’s Chief Commercial Officer, will assume the position of interim CEO. Dr. Daniely will remain on the Board of Directors of Alcobra and will be actively involved in ensuring a seamless transition of duties and responsibilities.  The Company’s Board of Directors also announced that it has appointed Dr. Daniely as Chairman of the Board of Directors, effective June 1, 2017. “Dr. Daniely has been a driven and passionate leader for the company and we thank him for years of service as CEO and wish him all the best as CEO of Yissum.  We are grateful that he will continue to provide leadership as chairman of Alcobra and actively support the CEO transition,” said Howard B. Rosen, current Chairman of Alcobra. “Alcobra has significantly advanced a strategic alternatives process to review opportunities to create value for all of our shareholders.  Further, we have made substantial progress in reducing overall costs and expenses.  We look forward to updating shareholders on future developments.” “It has been an honor to lead Alcobra over the past seven years,” said Dr. Yaron Daniely. “I’m proud of what we’ve accomplished, and believe the company has made significant progress over the past few months to advance potential value creation.  I have full confidence in David and the rest of the management team and look forward to an ongoing role at the board level in shaping the future of Alcobra.” Mr. Baker said, “I am proud to succeed Dr. Daniely as Alcobra’s interim CEO. Yaron is an exceptional leader and mentor.  I look forward to working with the rest of Alcobra’s team to continue delivering on the company’s strategic objectives.” Alcobra continues its established process to explore options for creating shareholder value. The company is currently exploring strategic alternatives, which may include partnership or monetization opportunities for the company’s proprietary product candidates – MDX and/or ADAIR, as well as partnering, licensing, M&A opportunities or other transactions to further develop the company’s pipeline and drug- development capabilities for the benefit of increasing shareholder value. About David Baker Mr. Baker joined Alcobra in 2014 as Chief Commercial Officer. Prior to joining Alcobra, he worked at Shire Pharmaceuticals for 10 years, including as Vice President of Commercial Strategy and New Business in the Neuroscience Business Unit. In that role, Mr. Baker led the commercial assessment of neuroscience licensing opportunities, managed commercial efforts on pipeline CNS products, and led the long term strategic planning process. Previously, he served as Global General Manager for Shire’s Vyvanse® where he led the launch of Vyvanse and led global expansion efforts including successful establishment of a partnership in Japan and launches in Canada and Brazil. Prior to that, Mr. Baker served as Vice President of Marketing for all of Shire's ADHD products. From 1990 - 2004, Mr. Baker worked at Merck & Co., where he held positions of increasing responsibility in marketing, sales, market research, and business development. In addition to his knowledge and experience with CNS medications, Mr. Baker's expertise includes therapeutics for osteoporosis, migraine, and hyperlipidemia. He has been directly involved with the marketing of five medications with annual sales in excess of $1 billion each. Mr. Baker graduated Magna Cum Laude with a bachelor's degree in Economics and Computer Science from Duke University. He earned a Master of Business Administration in Marketing from Duke's Fuqua School of Business. About Alcobra Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of medications to treat significant unmet medical needs. For more information, please visit the company's website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference. Forward Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of the Company could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding updating shareholders on future developments, creating shareholder value and exploring strategic alternatives. The forward-looking statements contained or implied in this press release are subject to risks and uncertainties, including those discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2016, filed with the Securities and Exchange Commission (SEC) and in subsequent filings with the SEC. Except as otherwise required by law, the Company disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.


News Article | May 15, 2017
Site: globenewswire.com

Dr. Yaron Daniely to Step Down as Chief Executive Officer, Effective May 31, 2017 Dr. Daniely to Remain on Board of Directors and be Appointed Chairman TEL AVIV, Israel, May 15, 2017 (GLOBE NEWSWIRE) -- Alcobra Ltd. (Nasdaq:ADHD), an emerging pharmaceutical company focused on the development of new medications to treat significant unmet clinical needs, today announced that Dr. Yaron Daniely will be stepping down on May 31, 2017 as President and Chief Executive Officer to become the Chief Executive Officer of Yissum, the technology transfer company of the Hebrew University in Jerusalem, Israel. David Baker, currently Alcobra’s Chief Commercial Officer, will assume the position of interim CEO. Dr. Daniely will remain on the Board of Directors of Alcobra and will be actively involved in ensuring a seamless transition of duties and responsibilities.  The Company’s Board of Directors also announced that it has appointed Dr. Daniely as Chairman of the Board of Directors, effective June 1, 2017. “Dr. Daniely has been a driven and passionate leader for the company and we thank him for years of service as CEO and wish him all the best as CEO of Yissum.  We are grateful that he will continue to provide leadership as chairman of Alcobra and actively support the CEO transition,” said Howard B. Rosen, current Chairman of Alcobra. “Alcobra has significantly advanced a strategic alternatives process to review opportunities to create value for all of our shareholders.  Further, we have made substantial progress in reducing overall costs and expenses.  We look forward to updating shareholders on future developments.” “It has been an honor to lead Alcobra over the past seven years,” said Dr. Yaron Daniely. “I’m proud of what we’ve accomplished, and believe the company has made significant progress over the past few months to advance potential value creation.  I have full confidence in David and the rest of the management team and look forward to an ongoing role at the board level in shaping the future of Alcobra.” Mr. Baker said, “I am proud to succeed Dr. Daniely as Alcobra’s interim CEO. Yaron is an exceptional leader and mentor.  I look forward to working with the rest of Alcobra’s team to continue delivering on the company’s strategic objectives.” Alcobra continues its established process to explore options for creating shareholder value. The company is currently exploring strategic alternatives, which may include partnership or monetization opportunities for the company’s proprietary product candidates – MDX and/or ADAIR, as well as partnering, licensing, M&A opportunities or other transactions to further develop the company’s pipeline and drug- development capabilities for the benefit of increasing shareholder value. About David Baker Mr. Baker joined Alcobra in 2014 as Chief Commercial Officer. Prior to joining Alcobra, he worked at Shire Pharmaceuticals for 10 years, including as Vice President of Commercial Strategy and New Business in the Neuroscience Business Unit. In that role, Mr. Baker led the commercial assessment of neuroscience licensing opportunities, managed commercial efforts on pipeline CNS products, and led the long term strategic planning process. Previously, he served as Global General Manager for Shire’s Vyvanse® where he led the launch of Vyvanse and led global expansion efforts including successful establishment of a partnership in Japan and launches in Canada and Brazil. Prior to that, Mr. Baker served as Vice President of Marketing for all of Shire's ADHD products. From 1990 - 2004, Mr. Baker worked at Merck & Co., where he held positions of increasing responsibility in marketing, sales, market research, and business development. In addition to his knowledge and experience with CNS medications, Mr. Baker's expertise includes therapeutics for osteoporosis, migraine, and hyperlipidemia. He has been directly involved with the marketing of five medications with annual sales in excess of $1 billion each. Mr. Baker graduated Magna Cum Laude with a bachelor's degree in Economics and Computer Science from Duke University. He earned a Master of Business Administration in Marketing from Duke's Fuqua School of Business. About Alcobra Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of medications to treat significant unmet medical needs. For more information, please visit the company's website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference. Forward Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of the Company could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding updating shareholders on future developments, creating shareholder value and exploring strategic alternatives. The forward-looking statements contained or implied in this press release are subject to risks and uncertainties, including those discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2016, filed with the Securities and Exchange Commission (SEC) and in subsequent filings with the SEC. Except as otherwise required by law, the Company disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.


News Article | May 25, 2017
Site: globenewswire.com

SAINT-GENIS-POUILLY, France, May 25, 2017 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA or the Company), an international specialist in Molecular Nuclear Medicine (MNM), today announced that Christine Mikail, J.D. has joined the Company’s board of directors as an independent non-executive director. “Ms. Mikail brings both a broad legal skillset and substantial business development experience in the pharmaceutical industry,” stated Stefano Buono, Chief Executive Officer of AAA. “Her expertise in these areas will augment the current board composition, as we continue to build a global enterprise and advance the development and commercialization of our theragnostic pipeline.” “I am delighted to join AAA’s board of directors at such an exciting time in the Company’s development," said Ms. Mikail. “With the potential approval of lutetium Lu 177 dotatate (Lutathera®) on the horizon, and additional significant oncology assets entering clinical development, I look forward to supporting the Company’s continued growth by applying the same hands-on approach I have utilized throughout my career.” Christine Mikail has over fifteen years of experience managing and advising a number of public and private biotech and pharmaceutical companies focusing in the legal and business development functions. Ms. Mikail is the founder of DCA Advisory where she is currently advising several start-up and private biotech companies. She is also an Adjunct Professor at the Rutgers Business School in New Jersey. From March 2015, to March 2017, she was Chief Administrative Officer, Head of External Business Development and Alliance Management, and General Counsel at Axovant Sciences, Inc., where she helped raise $362 million in one the largest biotech Initial Public Offerings. Prior to this, Ms. Mikail served as Senior Vice President of Legal Affairs, General Counsel and Secretary at NPS Pharmaceuticals, Inc., where she was an integral part of the deal team that sold NPS Pharma to Shire Pharmaceuticals for $5.2 billion. AAA thanks Dr. Yvonne Greenstreet, who has completed her term as a board director, for her service and contributions to the Company’s development. During Dr. Greenstreet’s tenure, AAA completed a successful IPO, delivered positive Phase 3 study results for lutetium Lu 177 dotatate (Lutathera®), and successfully launched its first drug in the Unites States. Advanced Accelerator Applications is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine products. AAA’s lead investigational therapeutic candidate, lutetium Lu 177 dotatate (Lutathera®), is a novel MNM compound that AAA is currently developing for the treatment of neuroendocrine tumors, a significant unmet medical need. Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 21 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and more than 500 employees in 13 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, the U.S. and Canada). AAA reported sales of €109.3 million in 2016 (+23% vs. 2015). AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. For more information, please visit: www.adacap.com. Molecular Nuclear Medicine is a medical specialty using trace amounts of active substances, called radiopharmaceuticals, to create images of organs and lesions, and to treat various diseases, like cancer. The technique works by injecting targeted radiopharmaceuticals into the patient’s body that accumulate in the organs or lesions and reveal specific biochemical processes. MNM can be divided in two branches: Molecular Nuclear Diagnostics and Molecular Nuclear Therapy. Molecular nuclear diagnostics employs a variety of imaging devices and radiopharmaceuticals. PET (Positron Emission Tomography) and SPECT (Single Photon Emission Computed Tomography) are highly sensitive imaging technologies that enable physicians to diagnose different types of cancer, cardiovascular diseases, neurological disorders and other diseases in their early stages. Molecular nuclear therapy uses radioactive sources (radionuclides) to treat a range of tumor types. Using short-range particles, this therapy can target tumors with little effect on normal tissues. This press release contains forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements that appear in a number of places in this press release include the Company's current expectation regarding future events and various matters, including expected timing of filings with the FDA and EMA, approval dates, and expansion of NETSPOT®. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the timing of our submission of applications for regulatory approvals, EMA, FDA and other regulatory approvals for our product candidates, the occurrence of side effects or serious adverse events caused by or associated with our products and product candidates; our ability to procure adequate quantities of necessary supplies and raw materials for lutetium Lu 177 dotatate (Lutathera®) and other chemical compounds acceptable for use in our manufacturing processes from our suppliers; our ability to organize timely and safe delivery of our products or product candidates by third parties; any problems with the manufacture, quality or performance of our products or product candidates; the rate and degree of market acceptance and the clinical utility of lutetium Lu 177 dotatate (Lutathera®) and our other products or product candidates; our estimates regarding the market opportunity for lutetium Lu 177 dotatate (Lutathera®), our other product candidates and our existing products; our anticipation that we will generate higher sales as we diversify our products; our ability to implement our growth strategy including expansion in the U.S.; our ability to sustain and create additional sales, marketing and distribution capabilities; our intellectual property and licensing position; legislation or regulation in countries where we sell our products that affect product pricing, taxation, reimbursement, access or distribution channels; regulatory actions or litigation; and general economic, political, demographic and business conditions in Europe, the U.S. and elsewhere. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


News Article | May 25, 2017
Site: globenewswire.com

SAINT-GENIS-POUILLY, France, May 25, 2017 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA or the Company), an international specialist in Molecular Nuclear Medicine (MNM), today announced that Christine Mikail, J.D. has joined the Company’s board of directors as an independent non-executive director. “Ms. Mikail brings both a broad legal skillset and substantial business development experience in the pharmaceutical industry,” stated Stefano Buono, Chief Executive Officer of AAA. “Her expertise in these areas will augment the current board composition, as we continue to build a global enterprise and advance the development and commercialization of our theragnostic pipeline.” “I am delighted to join AAA’s board of directors at such an exciting time in the Company’s development," said Ms. Mikail. “With the potential approval of lutetium Lu 177 dotatate (Lutathera®) on the horizon, and additional significant oncology assets entering clinical development, I look forward to supporting the Company’s continued growth by applying the same hands-on approach I have utilized throughout my career.” Christine Mikail has over fifteen years of experience managing and advising a number of public and private biotech and pharmaceutical companies focusing in the legal and business development functions. Ms. Mikail is the founder of DCA Advisory where she is currently advising several start-up and private biotech companies. She is also an Adjunct Professor at the Rutgers Business School in New Jersey. From March 2015, to March 2017, she was Chief Administrative Officer, Head of External Business Development and Alliance Management, and General Counsel at Axovant Sciences, Inc., where she helped raise $362 million in one the largest biotech Initial Public Offerings. Prior to this, Ms. Mikail served as Senior Vice President of Legal Affairs, General Counsel and Secretary at NPS Pharmaceuticals, Inc., where she was an integral part of the deal team that sold NPS Pharma to Shire Pharmaceuticals for $5.2 billion. AAA thanks Dr. Yvonne Greenstreet, who has completed her term as a board director, for her service and contributions to the Company’s development. During Dr. Greenstreet’s tenure, AAA completed a successful IPO, delivered positive Phase 3 study results for lutetium Lu 177 dotatate (Lutathera®), and successfully launched its first drug in the Unites States. Advanced Accelerator Applications is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine products. AAA’s lead investigational therapeutic candidate, lutetium Lu 177 dotatate (Lutathera®), is a novel MNM compound that AAA is currently developing for the treatment of neuroendocrine tumors, a significant unmet medical need. Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 21 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and more than 500 employees in 13 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, the U.S. and Canada). AAA reported sales of €109.3 million in 2016 (+23% vs. 2015). AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. For more information, please visit: www.adacap.com. Molecular Nuclear Medicine is a medical specialty using trace amounts of active substances, called radiopharmaceuticals, to create images of organs and lesions, and to treat various diseases, like cancer. The technique works by injecting targeted radiopharmaceuticals into the patient’s body that accumulate in the organs or lesions and reveal specific biochemical processes. MNM can be divided in two branches: Molecular Nuclear Diagnostics and Molecular Nuclear Therapy. Molecular nuclear diagnostics employs a variety of imaging devices and radiopharmaceuticals. PET (Positron Emission Tomography) and SPECT (Single Photon Emission Computed Tomography) are highly sensitive imaging technologies that enable physicians to diagnose different types of cancer, cardiovascular diseases, neurological disorders and other diseases in their early stages. Molecular nuclear therapy uses radioactive sources (radionuclides) to treat a range of tumor types. Using short-range particles, this therapy can target tumors with little effect on normal tissues. This press release contains forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements that appear in a number of places in this press release include the Company's current expectation regarding future events and various matters, including expected timing of filings with the FDA and EMA, approval dates, and expansion of NETSPOT®. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the timing of our submission of applications for regulatory approvals, EMA, FDA and other regulatory approvals for our product candidates, the occurrence of side effects or serious adverse events caused by or associated with our products and product candidates; our ability to procure adequate quantities of necessary supplies and raw materials for lutetium Lu 177 dotatate (Lutathera®) and other chemical compounds acceptable for use in our manufacturing processes from our suppliers; our ability to organize timely and safe delivery of our products or product candidates by third parties; any problems with the manufacture, quality or performance of our products or product candidates; the rate and degree of market acceptance and the clinical utility of lutetium Lu 177 dotatate (Lutathera®) and our other products or product candidates; our estimates regarding the market opportunity for lutetium Lu 177 dotatate (Lutathera®), our other product candidates and our existing products; our anticipation that we will generate higher sales as we diversify our products; our ability to implement our growth strategy including expansion in the U.S.; our ability to sustain and create additional sales, marketing and distribution capabilities; our intellectual property and licensing position; legislation or regulation in countries where we sell our products that affect product pricing, taxation, reimbursement, access or distribution channels; regulatory actions or litigation; and general economic, political, demographic and business conditions in Europe, the U.S. and elsewhere. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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