Agreement related to late-stage candidate, Onconase, calls for $5 million upfront and $30 million upon FDA approval.

Alfacell and Strativa Pharmaceuticals entered into a license agreement valued at $225 million for the commercialization of Alfacell’s cancer drug in the U.S. Onconase is being evaluated as a treatment for unresectable malignant mesothelioma (UMM) in a Phase IIIb trial.

Alfacell will initially receive $5 million in cash and up to $30 million in cash upon FDA approval of Onconase for UMM. Additional milestone payments will be made pursuant to the achievement of development and regulatory milestones for other cancer indications as well as net sales milestones in cash plus nondilutive funding. In addition, Alfacell will receive double-digit royalties on net sales of Onconase.

Strativa will have exclusive marketing, sales, and distribution rights for the treatment of cancer in the U.S. and its territories. Alfacell is responsible for product manufacturing, clinical development, and obtaining regulatory approvals.
Alfacell retains all rights for non-U.S. jurisdictions where the company does not currently have partnerships. US Pharmacia holds the Eastern European rights, and Genesis Pharma has rights in Southeast Europe for Onconase. Alfacell also has the option to copromote Onconase in the future with support from Strativa.

If approved, Onconase will represent a first-in-class drug, according to Alfacell. It is natural protein isolated from the leopard frog based on RNase technology. The compound is also in mid-stage studies in non-small-cell lung, esophageal, and breast cancer.

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