Profile: ViroPharma Incorporated (VPHM.O)

ViroPharma Incorporated (Viropharma), incorporated in September 1994, is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases. As of December 31, 2008, the Company had two marketed products and three development programs. It markets and sells Vancocin HCl capsules, the oral capsule formulation of vancomycin hydrochloride, in the United States and its territories. During the year ended December 31, 2008, three wholesalers represented 94% of the total net product sales. ViroPharma has three development programs in its product pipeline. ViroPharma is developing two new product candidates, maribavir for the prevention and treatment of cytomegalovirus (CMV) disease and non-toxigenic strains of Clostridium difficile infection (NTCD) for the treatment and prevention of Clostridium difficile infection (CDI). On October 21, 2008, the Company acquired Lev Pharmaceuticals, Inc. (Lev), a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases.

Vancocin is a potent antibiotic approved by the United States Food and Drug Administration (FDA) to treat antibiotic-associated pseudomembranous colitis caused by CDI and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. The Company has three development programs; first program is for the acute treatment of hereditary angioedema (HAE), second clinical development program targets CMV with an initial focus on CMV disease in recipients of hematopoietic stem cell and solid organ transplants and third program is in preclinical development and targets the treatment and prevention of CDI utilizing the spore form of a NTCD.

Cinryze

The FDA granted approval for Cinryze in October 2008, for routine prophylaxis against attacks in adolescent and adult patients with HAE. HAE is a genetic disorder characterized by episodes of edema (swelling) in the extremities, face, abdomen, and airway passages. HAE is caused by a defective gene for C1 inhibitor (C1-INH). In December 2008, the Company submitted a supplemental Biologics Application (sBLA) for Cinryze as a treatment for acute attacks of HAE.

CMV Program

On February 9, 2009, the Company announced that its Phase III trial evaluating maribavir used as prophylaxis in allogeneic stem cell, or bone marrow, transplant (SCT) patients did not achieve its primary endpoint. The SCT study is a randomized, double-blind, placebo-controlled, multicenter pivotal Phase III study in 681 patients who have undergone allogeneic stem cell transplantation.

The Company has completed several Phase I clinical trials with maribavir to evaluate potential drug interactions, to evaluate the pharmacokinetics of maribavir in subjects with renal impairment and hepatic impairment, and to evaluate the relative bioavailability of different tablet formulations. The phase II clinical trials with maribavir for the prevention of CMV infections in allogeneic stem cell transplant patients which demonstrated that maribavir significantly reduced CMV reactivation in this population.

CDI Program

In February 2006, the Company entered into a licensing agreement to develop NTCD for the treatment and prevention of CDI. The concept behind this treatment approach aims to treat the disease with an effective product like Vancocin and eradicate the dangerous toxin-producing C. difficile which causes severe CDI. The treated patient could potentially then be dosed with oral NTCD to re-colonize the GI tract and prevent the pathogenic C. difficile bacteria from re-infecting the colon until normal GI flora returns and the patient is no longer susceptible to disease.