By Mary Welch
BioChem Pharma Inc. presented a clinical update on Zeffix (lamivudine) showing seroconversion, an indication of long-term remission of the hepatitis B virus, increased from 38 percent after one year of treatment to 65 percent after three years.
The study on Zeffix - the only oral, once-daily treatment for chronic hepatitis B - was presented to doctors in Hong Kong.
In addition to the long-lasting clinical improvement after three years, the data also showed Zeffix could halt the progression of liver inflammation and even reverse the liver damage caused by the infection, allowing healthy liver tissue to regenerate.
"The general consensus around the office was that the results were good but could be better. They weren't very spectacular," said Kenneth Wahl, an analyst with Mehta Partners LLP in New York. "Sixty-five percent is certainly better than nothing but we're talking about a disease for which there's not a lot of other treatments."
Elise Wang, first vice president of PaineWebber Inc., in New York, believes the data are "an incrementally positive event for the company. While it's 65 percent, it was still a small patient population. We still think it's a good drug but something has to happen in its marketing before it takes off. We see near-term minimal sales until it reaches a broader market, like Asia, which takes time to grow. We don't see this as major news but it does support the profile. We're still cautious about sales estimates in the near term."
Jacques Lapointe, president and chief operating officer of BioChem Pharma, the drug's inventor, said partner Glaxo Wellcome plc was granted a permit to sell the drug in China, and the first shipment of drug is expected to arrive there next month. It will be sold as soon as it clears customs, he said. The price is being negotiated.
"We can only describe these results as outstanding and very significant," Lapointe said. "Sixty-five percent [of patients] don't have to continue taking the product because the body's immune system takes over."
The results presented involved three studies of 578 patients. Two studies compared Zeffix 100 mg a day to placebo; the third compared Zeffix 100 mg daily to interferon-alpha. Results show that only four out of 219, or 1.8 percent, of patients treated with Zeffix for 52 weeks progressed to cirrhosis, compared to 7.1 percent (seven out of 99) of placebo-treated patients and 9.5 percent (four out of 42) of interferon-alpha patients following a standard 16-week treatment program.
Zeffix is available in the Philippines, South Korea, Hong Kong, Thailand, Pakistan, Canada (as Heptovir), the U.S. (as Epivir-HBV) and Switzerland. It also is approved in China (as Heptodin), Indonesia, New Zealand, Australia, Argentina and Israel. The European Union's Committee for Proprietary Medicinal Products has recommended approval.
Hepatitis B is one of the most common infectious diseases in the world with more than 350 million people worldwide carrying the virus. Of those, up to 40 percent who become infected will die as a result of cirrhosis and liver cancer. Each year, up to 2 million people die from hepatitis B virus infection, making it the ninth leading cause of death.
The antiviral drug in a different formulation also is marketed as 3TC for HIV. A nucleoside analogue reverse transcriptase inhibitor, it reduces liver inflammation and enhances hepatitis B "e" antigen seroconversion. It directly interferes with viral replication, thus reducing the level of infection, which leads to reduced attack on the liver by the immune system.
BioChem Pharma, of Laval, Quebec, licensed lamivudine rights to Glaxo, of London, for most of the world.
BioChem Pharma's stock (NASDAQ:BCHE) closed Thursday at $21.50, up 25 cents.