Marketed products Vancocin Pulvules HCl: licensed from
Eli Lilly in 2004. Oral Vancocin is an
antibiotic for treatment of
staphylococcal enterocolitis and
antibiotic associated
pseudomembranous colitis caused by
Clostridioides difficile.
Pipeline 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 February 2006, ViroPharma announced that the United States
Food and Drug Administration (FDA) had granted the company
fast track status for maribavir. 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). ViroPharma conducted a
Phase III clinical study to evaluate the
prophylactic use for the prevention of cytomegalovirus disease in recipients of
allogeneic stem cell transplant patients. In February 2009, ViroPharma announced that the Phase III study failed to achieve its goal, showing no significant difference between maribavir and a placebo in reducing the rate of CMV disease.
Failed products Oral pleconaril was ViroPharma's first compound, licensed from
Sanofi in 1995. 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 a New Drug Application of pleconaril to the FDA for the
common cold. 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. In November 2004, 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. ==References==