West Coast Editor
About a month after Idenix Pharmaceuticals Inc. and Novartis Pharmaceuticals Corp. made news by submitting a new drug application for telbivudine against chronic hepatitis B, Cangene Corp. won approval for its HepaGam B product that targets a different market - acute exposure to HBV.
Cangene's stock (TSE:CNJ) closed Tuesday at C$9.85 (US$8.62), up C$0.90, or 10.1 percent.
Specifically, the agency cleared the purified antibody HepaGam B for treatment of acute exposure to blood containing hepatitis B surface antigen (HbsAg), perinatal exposure of infants born to HbsAg-positive mothers, sexual exposure to HbsAg-positive persons and household exposure to persons with acute HBV infection.
Competitors in the space include BayHep B from Bayer AG, of Leverkusen, Germany, approved in 1977, and Nabi-HB, from Boca Raton, Fla.-based Nabi Pharmaceuticals Inc., approved in 1999.
John Langstaff, Toronto-based Cangene's president and CEO, told BioWorld Today that he expects HepaGam B to be priced "probably a little bit less than Nabi," as is Bayer's compound, though he declined to estimate the market size or provide other guidance.
Expected to launch within the next few months, HepaGam B is made by Cangene in Winnipeg, using a process similar to that of its other FDA-approved products WinRho SDF for immune thrombocytopenic purpura and vaccinia immune globulin, a purified antibody specific for Vaccinia (the virus used to make the smallpox vaccine).
HepaGam B will be distributed in the U.S. by the Toronto-based generic drug maker Apotex Corp. That firm is a member of the Apotex Group, Cangene's majority shareholder.
"It potentially can be used chronically in the prevention of re-infection of livers that have been transplanted," Langstaff said, adding that Cangene will pursue labeling to that effect. "Both us and Nabi will, I suspect," he said.
Meanwhile, the chronic-HBV market continues to heat up.
Cambridge, Mass.-based Idenix and Novartis submitted their new drug application for telbivudine during the summer, basing the filing primarily on one-year data from the GLOBE study, a two-year, Phase III trial under way to compare the compound with standard therapy lamivudine, which is marketed as Combivir by GlaxoSmithKline plc, of London. (See BioWorld Today, Aug. 1, 2005.)
The HBV space in which telbivudine would operate already is competitive. Other products include Hepsera (adefovir) and Viread (tenofovir), from Foster City, Calif.-based Gilead Sciences Inc., and Baraclude (entecavir), from Bristol-Myers Squibb Co., of New York.
John Lebbos, director of infectious diseases for Waltham, Mass.-based Decision Resources Inc., said analyst Aaron Woolsey is completing a report on the HBV landscape for the firm, due in the spring.
"There are a lot of products in late-stage development," he said. "It's a very exciting market and will be pretty dynamic coming up."
A recent survey showed that Hepsera prescriptions totaled 2,877 for the week ending Jan. 23 (compared with 2,723 in the prior week). Hepsera's share for HBV stood at 52.9 percent, with Baraclude taking 13.5 percent. GSK's Epivir (lamivudine, invented by BioChem Pharma Inc., of Laval, Quebec) took 33.5 percent of the market.