FDA grants fast-track status for ViroPharma's maribavir to prevent cytomegalovirus infection

By E. Janene Geiss

Philadelphia, Feb. 7 - ViroPharma Inc. announced Tuesday that the Food and Drug Administration has granted fast-track designation for maribavir, an oral antiviral drug candidate for the prevention of cytomegalovirus infection in allogeneic bone marrow and solid organ transplant patients.

ViroPharma completed enrollment in a phase 2 study of maribavir in recipients of bone marrow transplant in November and expects to release the preliminary data from the trial by the end of the first quarter of 2006, according to a company news release.

"There is an unmet medical need for improved treatments for the prevention of cytomegalovirus infection and disease in transplant patients due to the limitations of current therapies, which include potential bone marrow and renal toxicities," Colin Broom, ViroPharma's chief scientific officer, said in the release.

An important feature of fast-track designation is that it emphasizes the critical nature of close, early communication between the FDA and the sponsor company with the goal of improving the efficiency of product development, officials said.

Fast-track designation may potentially expedite the review and accelerate approval of a drug that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition.

Maribavir is a potent and selective, orally bioavailable antiviral drug with a unique mechanism of action against cytomegalovirus and a favorable early clinical safety profile, officials said.

It is a potent member of a new class of drugs called benzimidazole ribosides. Unlike currently available anti-cytomegalovirus agents that inhibit cytomegalovirus DNA polymerase, maribavir inhibits viral DNA assembly and inhibits egress of viral capsids from the nucleus of infected cells, officials said.

Maribavir is active in vitro against strains of cytomegalovirus that are resistant to commonly used anti-cytomegalovirus drugs, officials said.

Cytomegalovirus is a member of the herpes virus group, which includes the viruses that cause chicken pox, mononucleosis, herpes labialis (cold sores) and genital herpes.

Like other herpesviruses, cytomegalovirus has the ability to remain dormant in the body for long periods of time. Human cytomegalovirus infection rates average between 50% and 85% of adults in the United States by 40 years of age, but in healthy adults causes little to no apparent illness. However, in immunocompromised individuals, cytomegalovirus can lead to serious disease or death.

Patients who are immunosuppressed following hematopoietic stem cell or solid organ transplantation are at high risk of cytomegalovirus infection, officials said.

In these patients, cytomegalovirus can lead to severe conditions such as pneumonitis or hepatitis or to complications such as acute or chronic rejection of a transplanted organ.

While currently available systemic anti-cytomegalovirus agents are effective against the virus, their use is limited by toxicities, most notably bone marrow suppression and renal impairment, officials said.

ViroPharma is an Exton, Pa., biopharmaceutical company that develops and commercializes products that address serious diseases treated by physician specialists and in hospital settings. The company focuses its drug development in viral diseases including cytomegalovirus and hepatitis C.

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