ViroPharma

ViroPharma Incorporated, a pharmaceutical company, develops and sells drugs that address serious diseases treated by physician specialists and in hospital settings. The company focuses on product development activities on viral diseases, including those caused by cytomegalovirus (CMV) and hepatitis C virus (HCV) infections.

The company has strategic relationships with GlaxoSmithKline, Wyeth, Schering-Plough, and Sanofi-Aventis.

ViroPharma acquired 1,000,000 shares of Siga Technologies NASDAQ: SIGA, when Siga purchased ViroPharma's bio-defense compounds.

ViroPharma is a member of the NASDAQ Biotechnology Index and the S&P 600.

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History

ViroPharma Incorporated was founded in 1994 by Claude H. Nash (Chief Executive Officer), Mark A. McKinlay (Vice President, Research & Development), Marc S. Collett (Vice President, Discovery Research), Johanna A. Griffin (Vice President, Business Development), and Guy D. Diana (Vice President, Chemistry Research.)

None of the founders are still with the company.

Corporate Governance

• Michel de Rosen Chairman since September 2002, President and Chief Executive Officer since August 2000, Director since May 2000
• Paul A. Brooke Director since February 2001
• William D. Claypool Director since December 2003
• Michael R. Dougherty Director since January 2004
• Robert J. Glaser Director since August 1997
• John R. Leone Director since January 2006
• Howard H. Pien Director since 2006

Marketed Products

• Vancocin Pulvules HCl: licensed from Eli Lilly in 2004.^[1] Oral Vancocin is an antibiotic for treatment of staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis caused by Clostridium difficile.

Pipeline

Maribavir

Maribavir is an oral antiviral drug candidate licensed from GlaxoSmithKline in 2003 for the prevention and treatment of human cytomegalovirus disease in hematopoietic stem cell/bone marrow transplant patients.

In March 2006, the company announced that a Phase II study with maribavir demonstrated that prophylaxis with maribavir displays strong antiviral activity, as measured by statistically significant reduction in the rate of reactivation of CMV in recipients of hematopoietic stem cell/bone marrow transplants. In an intent-to-treat analysis of the first 100 days after the transplant, the number of subjects who required pre-emptive anti-CMV therapy was statistically significantly reduced (p-value = 0.051 to 0.001) in each of the maribavir groups compared to the placebo group (57% for placebo vs. 15%, 30%, and 15% for maribavir 100 mg twice daily, 400 mg daily, and 400 mg twice daily, respectively).

In February 2006, ViroPharma announced that the United States Food and Drug Administration (FDA) had granted the company Fast Track status for Maribavir. The Fast Track program is designed to facilitate the development, and expedite the review, of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

In September 2006, ViroPharma announced the start of a Phase III clinical study to evaluate the prophylactic use for the prevention of cytomegalovirus disease in recipients of allogeneic stem cell transplant patients.

HCV-796

A non-nucleoside polymerase inhibitor for the treatment of Hepatitis C, jointly developed with Wyeth.

In November 2005, ViroPharma announced preliminary results from a proof of concept study. In this study, HCV-796 demonstrated antiviral effects in adult patients with chronic hepatitis C infection. The patient cohort with the highest exposure to HCV-796 achieved a peak mean HCV viral load reduction of 1.4 log10, or 96%, on day four of a 14 day dosing period. HCV-796 was generally well tolerated, with a favorable pharmacokinetic profile and no dose-limiting toxicities.

In August 2006, the company released results of a Phase I study of HCV-796 in combination with pegylated interferon that demonstrated a 3.3 to 3.5 log10 decrease in viral load.

In August 2007, Phase II trials were discontinued due to safety concerns.^[2]

Pleconaril

Main article: Pleconaril

Oral pleconaril was ViroPharma's first compound, licensed from Sanofi in 1997. Pleconaril is active against viruses in the picornavirus family. ViroPharma's first indication was for enteroviral meningitis, but that indication was abandoned when the clinical trials did not demonstrate efficacy.

In 2001, ViroPharma submitted an New Drug Application of pleconaril to the FDA for the common cold.^[3] On 2002-03-19, the FDA Antiviral Advisory Committee recommended that the company had failed to show adequate safety, and the FDA subsequently issued a not-approvable letter.^[4] After the Advisory Committee meeting the stock price fell from 22 USD at the beginning of 2002 to an all time low of 0.87 USD on 2002-10-28. (The stock price recovered in 2005.)

In November 2003, ViroPharma licensed pleconaril to Schering-Plough, who are developing an intranasal formulation for the common cold and asthma exacerbations. (Schering-Plough Development Pipeline). In August 2006, Schering-Plough started a Phase II clinical trial.

FDA Advisory Committee Meeting for pleconaril in the common cold

• Briefing Information
• Slides
• Meeting Transcript

References

• The Long Road Ahead for ViroPharma Motley Fool 29 September 2006
• McDonald LC, Killgore GE, Thompson A, et al. 2005 Emergence of an epidemic, toxin gene variant strain of Clostridium difficile responsible for outbreaks in the United States between 2000 and 2004. N Engl J Med 353:2433-2441 [1]
• U.S. Centers for Disease Control and Prevention Report on Severe Clostridium difficile--Associated Disease in Populations Previously at Low Risk --- Four States, 2005 [2]
• Lu H, Thomas S. 2004. Maribavir (ViroPharma). Curr Opin Investig Drugs 5:898-906
• Fleischer R, Laessig K (2003). "Safety and efficacy evaluation of pleconaril for treatment of the common cold.". Clin. Infect. Dis. 37 (12): 1722. doi:10.1086/379830. PMID 14689362.
• Hayden FG, Herrington DT, Coats TL, Kim K, Cooper EC, Villano SA, Liu S, Hudson S, Pevear DC, Collett M, McKinlay M (2003). "Efficacy and safety of oral pleconaril for treatment of colds due to picornaviruses in adults: results of 2 double-blind, randomized, placebo-controlled trials.". Clin. Infect. Dis. 36 (12): 1523–32. PMID 12802751.

Maribavir

• Maribavir for Prevention of CMV After Stem Cell Transplants
• Prophylactic Use of Maribavir for the Prevention of CMV Disease in Stem Cell Transplant Recipients

Pleconaril

These studies are conducted by Schering-Plough

• Effects of Pleconaril Nasal Spray on Common Cold Symptoms and Asthma Exacerbations Following Rhinovirus Exposure

Other

• U.S. Centers for Disease Control and Prevention Information on Clostridium difficile infections
• Worldwide Patent Search in European Patent Office Database for ViroPharma
• List of Patents from United States Patent and Trademark Office for ViroPharma