ViroPharma Incorporated (VPHM)

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ViroPharma Provides Update on Upcoming FDA Advisory Committee Meeting to Discuss Bioequivalence of Locally Acting Gastrointestinal Drugs
Tuesday July 8, 9:00 am ET

EXTON, Pa., July 8 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM - News) has been informed by U.S. Food and Drug Administration (FDA) that the July 23, 2008 meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology is not intended to discuss specifically ViroPharma's Vancocin® (vancomycin hydrochloride capsules) or any other drug products. Rather, FDA has informed ViroPharma that FDA's Office of Generic Drugs (OGD) will only present for the Committee's consideration issues of general applicability to all locally acting drugs that treat gastrointestinal (GI) conditions. FDA also informed ViroPharma that any resulting recommendations by the Committee will be similarly general in nature. Additionally, ViroPharma has been advised that it will be afforded no more time to speak at the meeting than is afforded to any other member of the public, consistent with the non-product specific focus of the meeting. ViroPharma understands that the time to be provided to any one speaker will be very limited.

Based on FDA's statements to ViroPharma regarding the purpose of this meeting, made by both Committee staff and FDA's Office of Chief Counsel, ViroPharma will not discuss Vancocin at this meeting. Given ViroPharma's experience in this area, and the limited time available to speakers at the meeting, ViroPharma today submitted a letter to the Committee to aid its consideration of the general issue of bioequivalence methods for locally acting GI drugs. Among other things, ViroPharma's letter notes important issues that must be addressed in this complex area of bioequivalence method development, and attaches for the Committee's review a letter sent to FDA last year by the Infectious Diseases Society of America (IDSA) expressing concerns of infectious disease experts. A copy of ViroPharma's letter and the attachment is now available on ViroPharma's website at http://www.viropharma.com/OGDpetition/.

FDA has indicated that ViroPharma can expect the opportunity for public input regarding bioequivalence methods for Vancocin, but has not yet committed to a next step. Commented Colin Broom, M.D., ViroPharma's vice president, chief scientific officer, "We are encouraged that FDA appears to be taking the first step toward a public process to consider the development of bioequivalence methods for locally acting drugs that treat gastrointestinal conditions. After the general discussion at the July 23rd Advisory Committee meeting, FDA should be better prepared to conduct a public process on bioequivalence methods for Vancocin specifically. ViroPharma is prepared to participate in that process when the time comes. We have long contended that changes in GI physiology observed in patients with Clostridium difficile infection make healthy gut bioequivalence models inapplicable to drugs, like Vancocin, which treat this condition."

ViroPharma has previously explained in various submissions to FDA that appropriate public process for development of bioequivalence methods specifically for Vancocin should include (1) public proposal of the method and the data FDA believes validate that method; (2) FDA receipt of and response to public comments on the proposed method; (3) consideration by the appropriate FDA Advisory Committees, including the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; and (4) final decision making on whether to adopt the method by neutral scientific and medical experts, not the FDA personnel who originally proposed the method. ViroPharma continues to believe that bioequivalence for Vancocin is deserving of at least the same level of process and scientific discussion that FDA has previously afforded locally acting GI drugs such as cholestyramine, mesalamine, and sucralfate that are used to treat far less serious diseases where the consequence associated with getting it wrong do not pose as great a risk to patients.

ViroPharma's filings detailing these requirements are available on ViroPharma's website at http://www.viropharma.com/OGDpetition/.