Healthcare Industry News: C. difficile
News Release - May 1, 2007
Robert G. Pietrusko Joins ViroPharma as Vice President of Global Regulatory Affairs and QualityEXTON, Pa., May 1 (HSMN NewsFeed) -- ViroPharma Incorporated (Nasdaq: VPHM ) announced today that Robert Pietrusko, Pharm. D. has joined the company and it's management team as vice president of global regulatory affairs and quality. Dr. Pietrusko will oversee the planning, implementation and optimization of ViroPharma's worldwide quality and regulatory strategies. His focus will be on helping to guide the development of ViroPharma's key pipeline opportunities, including maribavir, HCV-796, and NTCD; providing regulatory support for ViroPharma's physician education efforts in C. difficile-associated disease and assuring patient safety; providing additional leadership in quality assurance and compliance; and providing regulatory strategy and support for any additional compounds acquired by ViroPharma. He joins ViroPharma from his previous post as senior vice president of worldwide regulatory affairs for Millennium Pharmaceuticals, Inc.
"Now more than ever, it is essential that a biopharmaceutical company has a world class regulatory affairs strategy and capability enabling it to work closely with regulatory authorities in assuring patient safety and bringing important new drugs to market," commented Michel de Rosen, ViroPharma's chief executive officer. "In that regard, ViroPharma is fortunate to be able to attract someone of Bob's caliber, and I welcome him to the company."
Continued de Rosen, "Bob brings over two decades of pharmaceutical regulatory and quality knowledge - first at GlaxoSmithKline and most recently at Millennium - to ViroPharma's already strong management team, along with a wealth of product approval experience. He has played a significant role in the approval of 11 new products during his career to date, including Millennium's Velcade® (bortezomib) for multiple myeloma and GlaxoSmithKline's Havrix® (hepatitis A vaccine, inactivated) for prevention of Hepatitis A, and is one of the most knowledgeable regulatory professionals in anti-infectives and antivirals today. We expect this vast knowledge and regulatory experience to be instrumental to the regulatory success of our clinical compounds, and toward the achievement of our corporate growth goals."
At Millennium Pharmaceuticals, Dr. Pietrusko was most recently responsible for the global regulatory affairs function and strategy, where he has been instrumental in the approval of Millennium's products, including the accelerated approval and worldwide regulatory strategy for Velcade, a product approved in over 75 countries worldwide. Prior to Millennium, he spent 19 years at GlaxoSmithKline, culminating in his tenure as vice president and director, anti-infective and antiviral therapeutic areas, U.S. regulatory affairs, where he led the anti-infective and antiviral regulatory groups. During his tenure at GlaxoSmithKline, he was instrumental in approvals for products including Havrix, Augmentin® XR and ES (amoxicillin/clavulanate potassium) for bacterial sinusitis and community-acquired pneumonia, and Infanrix® (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed). Dr. Pietrusko has directed the submission of more than 20 NDAs, sNDAs and BLAs to the U.S. Food and Drug Administration (FDA) including antibiotics, anti-virals, vaccines, oncologics, cardiovascular products, pulmonary products and anti inflammatory compounds. He has been directly responsible for organizing and leading eight FDA Advisory Committee presentations. Dr. Pietrusko holds a Bachelor of Science degree in biology and a Bachelors of Pharmacy degree from Rutgers University, and a Doctor of Pharmacy degree from the Philadelphia College of Pharmacy and Science. Dr. Pietrusko is the author of 52 scientific publications.
Commented Dr. Pietrusko, "ViroPharma is at a point in its history where optimization and execution on its regulatory strategy is essential and needs to be integral with its clinical strategy. With the promise of its late stage pipeline for patients with serious diseases, the importance of its CDAD education and focus on patient safety and public health, and the decision to commercialize maribavir in Europe without a strategic partner, the company is poised for new levels of success. I am thrilled to join and contribute to the company at this exciting time."
About ViroPharma Incorporated
ViroPharma Incorporated is committed to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin® approved for oral administration for treatment of antibiotic- associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/Vancocin_pi_2007.htm). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the Company's website at www.viropharma.com.
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