By Jim Shrine
BioChem Pharma Inc.'s lamivudine, already an $800 million HIV treatment, won FDA approval Wednesday as a treatment for chronic hepatitis B.
The antiviral drug, marketed as 3TC in HIV uses, will be sold in the U.S. as Epivir-HBV for the hepatitis B indication. It is the first oral antiviral approved for the liver disease, and will be cheaper and have fewer side effects than the current standard treatment, alpha interferon injection.
The product was launched for HBV last week in Canada, and last month in the Philippines. The U.S. launch is expected by the end of the year, to be followed by rollouts in Pakistan and New Zealand, where the drug already has been approved. Applications are pending in more than 30 other countries, including some of the largest hepatitis markets -- China, South Korea and Taiwan.
"This is significant news," Elise Wang, an analyst at PaineWebber Inc., in New York, told BioWorld Today. "In our discussions with clinicians it is pretty clear lamivudine is regarded as a major new treatment for hepatitis B. Approval in the U.S. will serve as a catalyst in other countries, including China."
An estimated 350 million people worldwide are infected with the hepatitis B virus. About 25 to 30 percent of them are symptomatic, and could develop liver disease or cancer. About 1.2 million people in the U.S. and Canada have the virus, 30 percent of them chronic carriers, which make up the target population for Epivir-HBV.
"This drug has the potential to be a blockbuster, just given the size of the market," Wang said. "HBV is a much larger market than HIV. The challenge is in predicting what the market penetration will be. But we know it is an important product for Glaxo [Wellcome plc, of London], and Glaxo will be aggressive in marketing it."
Glaxo licensed the drug from BioChem Pharma, of Laval, Quebec, in 1990. The London firm has worldwide development, manufacturing and marketing rights (outside Canada) and pays BioChem Pharma royalties of 15 percent in the U.S. and 12 percent elsewhere, except in Canada, where BioChem has co-promotion rights. The drug for HBV is called Heptovir in Canada, Heptodin in China, and Zeffix in most of the rest of the world.
Annual Sales Of $200M Projected For New Indication
PaineWebber is predicting lamivudine sales for HBV of $200 million to $220 million in 1999. Vector Securities International Inc., of Deerfield, Ill., issued a report Wednesday, in which analyst John Sonnier estimated U.S. sales of $87 million next year. Sonnier said he is expecting approval in China soon.
Jacques Lapointe, president and chief operating officer at BioChem Pharma, told BioWorld Today that approval could come in China by the end of the year. He said applications are on track in South Korea and Taiwan and the drug could be approved there next year.
"The big question surrounding China is affordability in the private market and reimbursement in the public market," Lapointe said, adding that Glaxo is working "diligently" to gain approval and acceptance in the Chinese market.
Hepatitis B treatment with Epivir will entail a daily oral administration of 100 milligrams. Epivir will cost $3.41 per pill, or $1,245 per year, which is less than a quarter of the cost of alpha interferon.
"BioChem is and has been benefiting from the sales of 3TC the past few years," Lapointe said. "It has proven to be a blockbuster in the whole scheme of things. Lamivudine [for HBV] has similar potential. Time will tell whether or not it reaches that potential. It is very important for our future and our ability to expand activities and operations.
"It is quite well recognized the FDA is one of the more demanding agencies in the world," Lapointe added. "Getting approval by the FDA will be a strong vote of confidence for those evaluating it in other countries."
Drug Improves Liver Condition
The efficacy of lamivudine in treating HBV is well-established. The drug, a nucleoside analogue reverse transcriptase inhibitor, has been shown to reduce liver inflammation and enhance hepatitis B "e" antigen seroconversion, an indication of long-term remission of the disease. Two-year studies have shown lamivudine reverses progression of liver disease and improves the condition of the liver in a broad range of patients.
An FDA advisory panel, upon recommending approval of Epivir unanimously in October, expressed concerns about the durability of response and resistance. Panelists likened the state of therapy for HBV to the early days of HIV and said combination therapy eventually will become the norm. (See BioWorld Today, Oct. 8, 1998, p. 1.) *