EXTON, Pa., Dec. 18 /PRNewswire-FirstCall/ -- ViroPharma Incorporated filed suit against the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) in Federal District Court for the District of Columbia under the Freedom of Information Act (FOIA). In its FOIA action, ViroPharma seeks the administrative record relating to FDA’s decision in March 2006 to change its long-standing interpretation of its regulations that required manufacturers of generic copies of Vancocin to show that the generic is bioequivalent to Vancocin through in vivo testing.
ViroPharma made its first request for the administrative record to FDA in March 2006. FDA acknowledged its receipt of ViroPharma’s FOIA request, but never otherwise responded to the request. In November 2007, ViroPharma appealed to HHS. Again, HHS acknowledged receipt of ViroPharma’s administrative appeal, but never otherwise responded to ViroPharma.
In a related action, ViroPharma submitted a FOIA request to FDA for the administrative record relating to FDA’s Vancocin bioequivalence guidance of December 15, 2008 that shifts away from a showing of “rapid” dissolution as originally proposed by FDA’s Office of Generic Drugs (OGD) in March 2006 to tests that require “comparable” dissolution and Q1/Q2 sameness with respect to inactive ingredients.
“First, in March 2006, we saw OGD abruptly change from clinical trials to a rapid dissolution test purportedly based on the Biopharmaceutics Classification System (BCS) in the absence of any published supporting Vancocin data,” commented Thomas F. Doyle, ViroPharma’s vice president, strategic initiatives. “On December 15, 2008, almost three years after OGD first provided to selected third parties the OGD’s conclusion that Vancocin is rapidly dissolving and thus eligible for a BCS-based biowaiver for in vivo studies, FDA finally released information indicating that it had completed a Vancocin dissolution study in February 2008 confirming that Vancocin is not rapidly dissolving. Faced with its own data that do not support OGD’s March 2006 bioequivalence approach, FDA was forced to modify its rationale yet again, and now proposes that a generic copy does not need to demonstrate rapid dissolution, and adds yet another standard, Q1/Q2 sameness, for which there are more questions than answers.”
Mr. Doyle continued, “OGD claimed in 2006 that it had the data to support a BCS biowaiver for Vancocin. However, FDA’s own 2008 Vancocin dissolution study suggests it did not. FDA now claims to have evaluated ‘the effect of inactive ingredients on the transport of vancomycin drug through the GI tract and/or the effectiveness of the drug at the site of action.’ We note that FDA finally made public Vancocin dissolution and solubility data on December 15th, but provided no data with respect to this evaluation of sameness of inactive ingredients in support of its proposal. We believe that the public has a right to evaluate those data, the standards and criteria that FDA intends to use to assess sameness, as well as whatever other information that might be found in the FDA’s records about Vancocin bioequivalence methods that has not been made available to date.”
C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower gastrointestinal tract where it may produce toxins which cause inflammation of the colon and diarrhea. Without proper treatment, the associated complications of the disease can be deadly. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and compromised immunity are conditions associated with increased risk of disease. According to the U.S. Centers for Disease Control and Prevention (CDC), there are an estimated 400,000 to 500,000 CA-CDAD and HA-CDAD cases annually based on 2004 data.
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) (vancomycin hydrochloride capsules, USP), 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, and Cinryze(TM) (C1 inhibitor (human)) for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema (HAE), also known as C1 inhibitor deficiency (for prescribing information on ViroPharma’s commercial products, please download the package inserts at http://www.viropharma.com/Products.aspx). ViroPharma currently focuses its drug development activities in diseases including cytomegalovirus (CMV), HAE and C. difficile.
ViroPharma routinely posts information, including press releases, which may be important to investors in the investor relations and media sections of our company’s web site, http://www.viropharma.com. The company encourages investors to consult these sections for more information on ViroPharma and our business.
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 continue to oppose vigorously any bioequivalence approach considered for use in approving generic formulations of Vancocin that does not require rigorous scientific methods to demonstrate safety and efficacy consistent with good medicine and science. 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 FDA’s proposed bioequivalence methods for Vancocin 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 FDA’s proposed bioequivalence methods for Vancocin, 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.
CONTACT: Media, Kristina M. Broadbelt, Assistant Director, PR & Advocacy,
+1-610-321-2358; Investors, Robert A. Doody Jr., Manager, Corporate
Communications, +1-610-321-6290, both of ViroPharma Incorporated
Web site: http://www.viropharma.com/
