Biotech Orphans Seek Homes

That's an issue for the U.S. Food and Drug Administration if or when it starts a review of BiovaxID. Still, a plenary session at the ASCO meeting is a high honor, so with investors buzzing about cancer vaccines in the wake of Dendreon's(DNDN) success, BiovaxID is worthy of further research.

Medarex

It's a bit unfair to group Medarex into this bio-orphan niche, if only because the company is much larger than the other two, and actually has a successful humanized antibody development business.

But Medarex has not yet successfully developed a drug on its own, and the biggest disappointment to date has been ipilimumab, a drug for skin cancer, which posted disappointing results from three pivotal trials in late 2007.

The failure of those three studies, coupled with the failure of a similar skin cancer drug being developed by Pfizer(PFE), put ipilimumab in Wall Street's penalty box. Both Medarex and its partner Bristol-Myers Squibb(BMY) insisted that ipilimumab wasn't done, but investors have been skeptical.

Perhaps perseverance is paying off. Medarex and Bristol-Myers continued to follow the patients treated with ipilimumab in those studies, and the results after two years show that between 30% and 42% of these skin cancer patients are still alive, according to data presented Sunday at the ASCO meeting.

Now, there were no control patients in any of these studies to make appropriate survival comparisons, but Medarex says that a search of the old melanoma studies covering about 2,000 patients shows that similar patients typically have about a 25% survival rate at one year.

For Medarex, this is encouraging news on ipilumumab and a big reason to look forward to later this year, when results are expected from another phase III study of ipilummab -- this one prospectively designed to assess the drug's ability to prolong survival in patients with newly treated melanoma.

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