EXTON, Pa., June 5 /PRNewswire-FirstCall/ -- ViroPharma Incorporated
(Nasdaq: VPHM) notes that FDA has published a notice of a meeting of its
Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to
be held on July 23, 2008. The Committee will address several issues at this
meeting, including a discussion of:
" ... presentations from the Office of Generic Drugs (OGD) on the
bioequivalence methods for locally acting drugs that treat
gastrointestinal (GI) conditions ... "
For over two years, ViroPharma has called for a deliberative public discussion that would include input from clinicians as well as biopharmaceutics and dissolution experts. Bioequivalence determinations for locally acting GI drugs, particularly drugs like Vancocin(R) that treat a serious and potentially life threatening disease, are complex. Clostridium difficile infection results in significant morbidity and mortality, and has developed into a national health issue. The risk to patients of a product that is not bioequivalent to Vancocin in this setting is high.
"While the notice does not specifically identify Vancocin, ViroPharma intends to take every opportunity to ensure the points we've raised through our submissions will be brought forward to this committee," commented Thomas F. Doyle, ViroPharma's vice president, strategic initiatives.
ViroPharma is encouraged that FDA is taking this first step to allow a critique of OGD's bioequivalence proposals. As the company noted in a letter that it sent to FDA earlier this year (newly available on the company's website at http://www.viropharma.com/OGDpetition/), bioequivalence for Vancocin is deserving of "at least the same level of process and scientific discussion it has previously afforded locally acting GI drugs used to treat far less serious disease where the consequence associated with getting it wrong do not pose as great a risk to patients."
About Clostridium difficile
One of the most serious problems facing the U.S. healthcare system today is hospital-acquired infections (HAIs). Clostridium difficile infection is one of the most common and devastating HAIs. The incidence of C. difficile observed in U.S. healthcare facilities more than doubled between 2000 and 2005; between 1999 and 2004, reported mortality rates from C. difficile in the U.S. more than quadrupled to 23.7 per million. Elderly patients exposed to antibiotics, long-term care patients, or those that have a serious underlying illness, are at greatest risk to contract the disease. Patients with this disease have GI tract conditions that are significantly different from those of a healthy individual due to infection. Typical symptoms include diarrhea, fever, nausea and abdominal pain and dehydration, though cases can lead to life threatening complications such as megacolon, peritonitis and perforation of the colon.
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R), 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/Products.aspx). ViroPharma currently focuses its drug development activities in diseases including cytomegalovirus (CMV) and Clostridium difficile. For more information on ViroPharma, visit the company's website at http://www.viropharma.com.
Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties, including the Company's plans to discuss Vancocin and the serious disease that Vancocin treats and that ViroPharma will ensure that the points in its Vancocin related submissions will be brought forward to this committee. There can be no assurance that the FDA will agree with the positions stated in ViroPharma's Vancocin related submissions or that ViroPharma's efforts to oppose the OGD's March 2006 recommendation to determine bioequivalence to Vancocin through in vitro dissolution testing will be successful. We cannot predict the timeframe in which the FDA will make a decision regarding either ViroPharma's citizen petition for Vancocin or the approval of generic versions of Vancocin. If we are unable to change the recommendation set forth by the OGD in March 2006, the threat of generic competition will be high. The entry of competing generic products will significantly affect our sales of Vancocin and our financial performance. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. These factors, and other factors, including, but not limited to those described in ViroPharma's annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission during 2008 could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.
|SOURCE ViroPharma Incorporated|
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