Less than two months after an advisory panel unanimously recommended approval of Gilead Sciences Inc.'s Hepsera (adefovir dipivoxil) for chronic hepatitis B, the FDA has given its expected nod and the company plans to ship the drug this week - with a price tag that was higher than some analysts had forecast.
"We've spoken to several advocates and they think the price is fair," said Erin Edgley, public affairs specialist with Foster City, Calif.-based Gilead, adding that physicians already have begun writing prescriptions and the company has set up an assistance program for patients not reimbursed by insurance for the drug.
Hepsera, the first nucleotide analogue to win approval for hepatitis B, has proven effective in patients resistant to lamivudine, including those wait-listed for a liver transplant or who already have had one.
The wholesale cost of once-daily Hepsera is $440 for 30 tablets, compared to about $150 per month for lamivudine, originally developed by Laval, Quebec-based BioChem Pharma Inc. and trade-named Epivir-HBV in the U.S.
Like Epivir-HBV, Hepsera is approved for the treatment of adult chronic hepatitis B patients with evidence of active viral replication and either persistently elevated serum aminotransferases or histologically active disease.
About 90 percent of hepatitis B patients recover from the disease in months, but a patient with elevated liver enzymes who hasn't shaken off the disease in six months is said to have chronic hepatitis B. About 5,000 people die in the United States each year from causes related to hepatitis B, and about 1,000 die of hepatitis B-related liver cancer.
Having a variety of available drugs is deemed important in the fight against the chronic form of the condition, since patients tend to develop resistance to treatment. Lamivudine resistance has been shown to range from as high as 32 percent at one year of treatment to about 67 percent after four years. Also available for hepatitis B is Intron A (interferon alpha-2b), from Schering-Plough Corp., of Madison, N.J.
"With interferons you have side effects and with lamivudine you have resistance, so from a competition standpoint, it's hard to say" which will be the primary contender with Hepsera, Edgley told BioWorld Today, although researchers have found Intron A works in a lower number of patients overall. Intron A and Epivir-HBV sometimes are used in combination as well.
Mutations that indicate a resistance to Hepsera did not show up during 48 weeks of pivotal studies with the drug, and the company is still collecting data by following 150 to 200 patients for five years.
Gilead will market Hepsera in the U.S. and Europe. The company's partner, London-based GlaxoSmithKline plc, will sell it in Asia and South America. In Europe, Gilead submitted a marketing authorization application in March, with approval expected in the second half of next year.
Gilead has five other products on the market, including Viread (tenofovir disoproxil fumarate) for HIV infection, which was approved in the U.S. in October 2001 and in Europe in February; AmBisome (liposomal amphotericin B); Tamiflu (oseltamivir phosphate) for influenza; Vistide (cidofovir) for cytomegalovirus retinitis in AIDS patients; and DaunoXome (liposomal daunorubicin) for AIDS-related Kaposi's sarcoma.
The company's stock (NASDAQ:GILD) fell 55 cents Monday, closing at $33.01, on a down day for the sector. The news was disclosed Friday after the market closed.