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ViroPharma Incorporated Reports Second Quarter 2009 Financial Results
Date:7/29/2009

n statements in this press release contain forward-looking statements that involve a number of risks and uncertainties. Forward-looking statements provide our current expectations or forecasts of future events. Forward looking statements in this press release include our financial guidance for 2009, and statements regarding our clinical development programs, the effectiveness of our Vancocin and Cinryze sales efforts, our estimates of future tax rates, or our ability to execute a successful launch of Cinryze, our ability to conduct future studies with maribavir, and the timing and potential outcomes of the review of our regulatory submission related to an acute treatment indication for Cinryze.

We plan to remain vigorous in our opposition to 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. The FDA will convene a meeting of its Advisory Committee for Pharmaceutical Science and Clinical Pharmacology to discuss bioequivalence recommendations for oral vancomycin hydrochloride capsule drug products. The meeting is scheduled for August 4, 2009. We have submitted briefing materials to the Advisory Committee for its consideration on the issues presented by OGD's bioequivalence recommendation, and we expect to present these issues at the meeting. There can be no assurance that the FDA will agree with the positions stated in our Vancocin related submissions or that our efforts to oppose the FDA's December 2008 bioequivalence guidance for Vancocin will be successful. We cannot predict the timeframe in which the FDA will make a decision regarding either our citizen petition for Vancocin or the approval of generic versions of Vancocin. If we are unable to change the recommendation set forth by the FDA in December 2008, the threat of generic competition will be high. The entry of competing
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SOURCE ViroPharma Incorporated
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Related medicine news :

1. ViroPharma to Release 2009 Second Quarter Financial Results on July 29, 2009
2. ViroPharma Announces Appointment of Frank Baldino, Jr., Ph.D. to Board of Directors
3. ViroPharma Announces Meeting of FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology on Bioequivalence Recommendations for Oral Vancomycin Hydrochloride Products
4. ViroPharma to Present at Two May Healthcare Conferences
5. ViroPharma to Present at the Cowen & Company 29th Annual Healthcare Conference
6. ViroPharma to Host Investor Teach-In Educational Symposium on Hereditary Angioedema
7. ViroPharma to Release 2008 Fourth Quarter and Full Year Financial Results on February 24, 2009
8. ViroPharma Reports Results of Phase 3 Clinical Trial for Maribavir in Bone Marrow Transplant Patients
9. ViroPharma to Present at the 27th Annual J.P. Morgan Healthcare Conference
10. ViroPharma Provides Update on Vancocin(R)
11. ViroPharma Submits Supplemental Biologics License Application for Cinryze(TM) to Treat Acute Attacks of Hereditary Angioedema
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