Healthcare Industry News: BioCryst Pharmaceuticals
News Release - August 8, 2007
BioCryst Appoints Elliott T. Berger, Ph.D., Senior Vice President of Regulatory AffairsBIRMINGHAM, Ala., Aug. 8 (HSMN NewsFeed) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX ) today announced that Elliott T. Berger, Ph.D., has joined the company's senior management team as Senior Vice President of Regulatory Affairs. Dr. Berger brings to BioCryst a long and successful track record in obtaining approval from the U.S. Food and Drug Administration (FDA) for numerous drugs.
"Dr. Berger brings distinguished regulatory affairs credentials to BioCryst at a key time when our pipeline is most promising," said Jon P. Stonehouse, Chief Executive Officer of BioCryst. "Elliott's breadth of experience in clinical development and regulatory affairs will be a valuable asset as we take our late-stage compounds through registration in the U.S."
Dr. Berger will play an integral role in BioCryst's planned clinical research programs for treatments for influenza, leukemia and lymphoma, autoimmune diseases and transplant rejection, and he will work in close collaboration with health authorities in the United States and other countries around the world.
Dr. Berger has more than 30 years of experience in the pharmaceutical industry, including over 25 years devoted to management of regulatory affairs supporting new drug and biologic development. Most recently he was Vice President, Regulatory Affairs and Quality Assurance, Head of Global Regulatory Strategy at EMD Pharmaceuticals, the North American subsidiary of Merck KGaA. Prior to EMD, Dr. Berger was a member of the Senior Executive Team at Astra Pharmaceuticals, most recently serving as Vice President, Regulatory Affairs. Before joining Astra, Dr. Berger held a variety of research positions at Merck Research Laboratories in West Point, Pennsylvania, most recently as Senior Director, Regulatory Liaison. Dr. Berger has submitted and managed over 10 New Drug Applications (NDAs) and numerous Investigational Drug Applications (INDs) in the areas of oncology, diabetes, cardiovascular disease, and neurology. Dr. Berger earned both his Ph.D. and MS degrees in Biometrics as well as his BA from Temple University.
BioCryst Pharmaceuticals, Inc. is a leader in the use of crystallography and structure-based drug design for the development of novel therapeutics to treat cancer, cardiovascular diseases, autoimmune diseases, and viral infections. The company is advancing multiple internal programs toward potential commercialization including Fodosine(TM) in oncology, BCX-4208 in transplantation and autoimmune diseases and peramivir in seasonal and life- threatening influenza. BioCryst has a worldwide partnership with Roche for the development and commercialization of BCX-4208, and is collaborating with Mundipharma for the development and commercialization of Fodosine(TM) in markets across Europe, Asia, Australia and certain neighboring countries. In January, 2007 the U.S. Department of Health and Human Services (DHHS) awarded a $102.6 million, four-year contract to BioCryst for advanced development of peramivir to treat seasonal and life-threatening influenza. In February 2007 BioCryst established a partnership with Shionogi & Co., to develop and commercialize peramivir in Japan. For more information about BioCryst, please visit the company's web site at http://www.biocryst.com.
This press release contains forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include that the Phase II clinical trials of peramivir may not be successful, that the Phase II trial of BCX-4208 for psoriasis may not be successfully completed, that development and commercialization of Fodosine(TM) in both T-ALL and CTCL may not be successful, that we may not resolve satisfactorily the particulate matter issue with the intravenous formulation of Fodosine(TM), that DHHS could reduce or eliminate funding for peramivir, that we or our licensees may not be able to enroll the required number of subjects in planned clinical trials of our product candidates and that such clinical trials may not be successfully completed, that BioCryst or its licensees may not commence as expected additional human clinical trials with our product candidates, that our product candidates may not receive required regulatory clearances from the FDA, that ongoing and future clinical trials may not have positive results, that we may not be able to complete successfully the Phase IIb trials for Fodosine(TM) that are currently planned to be pivotal, that we may not be able to commence the proposed Phase III trial for peramivir within the time frame we currently expect or at all, that we may not be able to announce preclinical developments for additional compounds by year-end 2007 as currently proposed, that we or our licensees may not be able to continue future development of our current and future development programs, that our development programs may never result in future product, license or royalty payments being received by BioCryst, that BioCryst may not reach favorable agreements with potential pharmaceutical and biotech partners for further development of its product candidates, that BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing or distribution of its products, the conditions to closing the private placement may not be satisfied, and that additional funding, if necessary, may not be available at all or on terms acceptable to BioCryst. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, current reports on Form 8-K which identify important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements.
Source: BioCryst Pharmaceuticals
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