Alfacell Corp. licensed U.S. commercialization rights for the Phase III cancer drug Onconase (ranpirnase) to Strativa Pharmaceuticals in a deal worth up to $225 million.
Just $5 million will change hands up front, but both Alfacell and Strativa stand to gain much more if their gamble in choosing each other as partners pays off. Specifically, Alfacell could get $30 million for FDA approval of Onconase in unresectable malignant mesothelioma (UMM) and up to $190 million for milestones tied to Onconase sales as well as development and commercialization of the drug in additional indications. Alfacell also would receive double-digit royalties and retains a co-promotion option.
For Alfacell, the gamble lies in choosing Strativa, the recently-launched specialty pharmaceutical division of Par Pharmaceutical Cos. Inc. So far, Strativa markets just one product: Megace ES for anorexia, cachexia and unexplained weight loss in HIV patients. Although the company has deals in place for three additional late-stage products, all three are for HIV or cancer supportive care, and Onconase would be Strativa's first true oncology therapeutic.
Lawrence Kenyon, executive vice president and chief financial officer for Alfacell, told BioWorld Today that Onconase has been the subject of "bids from multiple companies for a number of years." Strativa was selected because it had the hunger of a start-up looking to build an oncology business focused on niche products, combined with the resources and infrastructure of Par Pharmaceuticals, he said.
For Strativa, the gamble lies in Onconase's somewhat checkered development history. The drug, a natural ribonuclease isolated from frog eggs, failed a Phase III trial in pancreatic cancer and its first Phase III trial in UMM.
In the pancreatic cancer trial, a preliminary analysis showed that Onconase plus tamoxifen failed to improve survival compared to 5-fluorouracil. Kenyon said part of the problem was an inability to recruit sufficiently healthy patients into the trial, and the pancreatic cancer program subsequently was discontinued. (See BioWorld Today, July 16, 1998.)
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