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ViroPharma made its first request for the administrative record to FDA inMarch 2006. FDA acknowledged its receipt of ViroPharma's FOIA request, butnever otherwise responded to the request. In November 2007, ViroPharmaappealed to HHS. Again, HHS acknowledged receipt of ViroPharma'sadministrative appeal, but never otherwise responded to ViroPharma.
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In a related action, ViroPharma submitted a FOIA request to FDA for theadministrative record relating to FDA's Vancocin bioequivalence guidance ofDecember 15, 2008 that shifts away from a showing of "rapid" dissolution asoriginally proposed by FDA's Office of Generic Drugs (OGD) in March 2006 totests that require "comparable" dissolution and Q1/Q2 sameness with respect toinactive ingredients.
"First, in March 2006, we saw OGD abruptly change from clinical trials toa rapid dissolution test purportedly based on the BiopharmaceuticsClassification System (BCS) in the absence of any published supportingVancocin data," commented Thomas F. Doyle, ViroPharma's vice president,strategic initiatives. "On December 15, 2008, almost three years after OGDfirst provided to selected third parties the OGD's conclusion that Vancocin israpidly dissolving and thus eligible for a BCS-based biowaiver for in vivostudies, FDA finally released information indicating that it had completed aVancocin dissolution study in February 2008 confirming that Vancocin is notrapidly dissolving. Faced with its own data that do not support OGD's March2006 bioequivalence approach, FDA was forced to modify its rationale yetagain, and now proposes that a generic copy does not need to demonstrate rapiddissolution, and adds yet another standard, Q1/Q2 sameness, for which thereare more questions than answers."
Mr. Doyle continued, "OGD claimed in 2006 that it had the data to supporta BCS biowaiver for Vancocin. However, FDA's own 2008 Vancocin dissolutionstudy suggests it did not. FDA now claims to have evaluated 'the effect ofinactive ingredients on the transport of vancomycin drug through the GI tractand/or the effectiveness of the drug at the site of action.' We note that FDAfinally made public Vancocin dissolution and solubility data on December 15th,but provided no data with respect to this evaluation of sameness of inactiveingredients in support of its proposal. We believe that the public has aright to evaluate those data, the standards and criteria that FDA intends touse to assess sameness, as well as whatever other information that might befound in the FDA's records about Vancocin bioequivalence methods that has notbeen made available to date."
C. difficile is a bacterium, which under certain circumstances, typicallyafter antibiotic therapy, can colonize the lower gastrointestinal tract whereit may produce toxins which cause inflammation of the colon and diarrhea.Without proper treatment, the associated complications of the disease can bedeadly. Advanced age, gastrointestinal surgery/manipulation, long length ofstay in healthcare settings, a serious underlying illness and compromisedimmunity are conditions associated with increased risk of disease. Accordingto the U.S. Centers for Disease Control and Prevention (CDC), there are anestimated 400,000 to 500,000 CA-CDAD and HA-CDAD cases annually based on 2004data.
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated to thedevelopment and commercialization of products that address serious diseasestreated by physician specialists and in hospital settings. ViroPharmacommercializes Vancocin(R) (vancomycin hydrochloride capsules, USP), approvedfor oral administration for treatment of antibiotic-associatedpseudomembranous colitis caused by Clostridium difficile and enterocolitiscaused by Staphylococcus aureus, including methicillin-resistant strains, andCinryze(TM) (C1 inhibitor (human)) for routine prophylaxis against angioedemaattacks in adolescent and adult patients with hereditary angioedema (HAE),also known as C1 inhibitor deficiency (for prescribing information onViroPharma's commercial products, please download the package inserts athttp://www.viropharma.com/Products.aspx). ViroPharma currently focuses itsdrug development activities in diseases including cytomegalovirus (CMV), HAEand C. difficile.
ViroPharma routinely posts information, including press releases, whichmay be important to investors in the investor relations and media sections ofour company's web site, http://www.viropharma.com. The company encouragesinvestors to consult these sections for more information on ViroPharma and ourbusiness.
Certain statements in this press release may contain forward-lookingstatements that involve a number of risks and uncertainties, including theCompany's plans to continue to oppose vigorously any bioequivalence approachconsidered for use in approving generic formulations of Vancocin that does notrequire rigorous scientific methods to demonstrate safety and efficacyconsistent with good medicine and science. There can be no assurance that theFDA will agree with the positions stated in ViroPharma's Vancocin relatedsubmissions or that ViroPharma's efforts to oppose the FDA's proposedbioequivalence methods for Vancocin will be successful. We cannot predict thetimeframe in which the FDA will make a decision regarding either ViroPharma'scitizen petition for Vancocin or the approval of generic versions of Vancocin.If we are unable to change the FDA's proposed bioequivalence methods forVancocin, the threat of generic competition will be high. The entry ofcompeting generic products will significantly affect our sales of Vancocin andour financial performance. Our actual results could differ materially fromthose results expressed in, or implied by, these forward-looking statements.These factors, and other factors, including, but not limited to thosedescribed in ViroPharma's annual report on Form 10-K and quarterly reports onForm 10-Q filed with the Securities and Exchange Commission during 2008, couldcause future results to differ materially from the expectations expressed inthis press release. The forward-looking statements contained in this pressrelease may become outdated over time. ViroPharma does not assume anyresponsibility for updating any forward-looking statements.
SOURCE ViroPharma Incorporated
