Biotech Mailbag: Study Boosts ImmunoGen

Unfortunately, Maxim was basically out of business, so the company merged with Epicept, a New Jersey drug firm, in 2005. Epicept ran with Ceplene in AML and after an initial rejection in Europe, regulators there finally approved the drug in October.

Epicept doesn't have a European commercial partner to sell Ceplene yet, so I'd wait to see if the company can land one, and at what price.

The Ceplene data in AML dates back to 2004 and doesn't make a very strong case for the drug's efficacy. That's because the phase III study treated AML patients with a combination of Ceplene and interleukin-2 making it unclear which drug, or the combination, was truly helping AML remain in remission longer.

It's partly for this reason that Maxim was never able to see FDA approval for Ceplene in AML, and why so far, neither has Epicept. It also helps explain Epicept's sub-$1 stock price.

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One more note: After my Onyx Pharmaceuticals (ONXX Quote) item in last week's Mailbag, I heard from the company's head of investor relations Julie Wood that the company, on the second-quarter conference call, raised sales guidance for Nexavar to a range of $660 million to $675 million. In my column, I had the current guidance at $600 million to $650 million, so my mistake.

The consensus Nexavar sales estimate for the third quarter remains in the $175 million range.