By Brady Huggett
Cangene Corp. is in the hunt for its third marketed product, having filed a biologics license application with the FDA for its hyperimmune product for post-exposure prevention of hepatitis B.
¿We [filed] within a month or two of what we planned,¿ said John Langstaff, Cangene¿s president and CEO. ¿It was approximately what we hoped for.¿
Langstaff said the company expects to file for approval in Canada sometime in the upcoming month, and has scheduled meetings with regulatory authorities in Europe to discuss filing for approval in the European Union.
The hepatitis B product, as of now still unnamed, for post-exposure prevention has a small market ¿ the product won¿t reach blockbuster on this indication alone ¿ but Cangene, of Winnipeg, Ontario, believes overall the product can generate significant revenue.
¿The prophylaxis market is relatively small,¿ Langstaff said. ¿Maybe C$60 million (US$38.2 million) to C$70 million worldwide. But the market beyond that, such as liver transplants into hepatitis B patients, and solid organ transplants ¿ also we are seeing some hepatitis B in AIDS communities ¿ in general terms we think hepatitis B has a large potential. From our perspective, this is a great first step.¿
Langstaff said Cangene would hope for one-quarter to one-third of the prophylaxis market in the United States, perhaps more. The company will seek to market the product itself in some areas of the world and seek partners for others regions as the product is approved.
Cangene¿s two marketed products, WinRho SDF and VariZIG, also are hyperimmune products ¿ purified antibodies made from human plasma. Vaccines work to boost patients¿ own antibody production against certain afflictions. The idea behind hyperimmunes is to boost the patient¿s immune system immediately, without the time lag that occurs when the immune system builds itself up in response to a foreign body.
WinRho, used for hemolytic disease of the newborn and also immune thrombocytopenic purpura, should generate about C$20 million to C$30 million in sales this year, Langstaff said. Cangene and WinRho suffered through ¿some supply problems¿ at the end of 2000 and the beginning of 2001, Langstaff said, and the product is now beginning to regain its market share. Historically since 1995, he said, the product¿s sales have grown at about a 20 percent rate annually.
The product is marketed by Nabi, of Boca Raton, Fla., in the United States, and Cangene is searching for a European partner. A company called CSL, based in Australia, handles sales in New Zealand and Australia, but Cangene is responsible for the rest of the world, Langstaff said.
VariZIG, an antibody against the Varicella zoster virus that causes chicken pox, is approved in Canada. The total market worldwide is roughly C$15 million to C$20 million, Langstaff said, and Cangene figures to pull in about C$750,000 to C$1.5 million in Canada once the product gets the additional backing of the Canadian Blood Services.
Cangene has the rare distinction of being a biotechnology company in the black ¿ it posted net income of C$3.4 million at the end of its last reported quarter, April 30, and a C$8.2 million gain for the nine months ended on the same date. Founded in Mississauga, Ontario, in 1984, the company understands the importance of pushing candidates through its pipeline.
¿It¿s important for a small company like Cangene to continue to develop products we can both market ourselves and with other people.¿ Langstaff said. ¿It¿s a tremendous opportunity to get another product on the market. It¿s a good thing to get another product filed and hopefully it will go well.¿
Cangene¿s stock (TSE:CNJ) closed at C$5.65 Tuesday, unchanged.