Threshold Inks Co-Promotion Agreement with Merck KGaA for Evofosfamide

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Threshold Pharmaceuticals said today it will co-promote its Phase III cancer compound evofosfamide (formerly TH-302) with Merck KGaA in the U.S.

The value of the co-promotion deal was not disclosed, though Threshold did say the deal would allow the company to reap up to half of the profits from the sale of the drug.

Threshold also said it has received to date upfront and milestone payments of $110 million from Merck KGaA under the companies’ license and co-development agreement stretching back to 2012. Threshold can receive additional potential milestone payments of up to $440 million.

The deal is subject to FDA approval of evofosfamide, a hypoxia-activated prodrug that is now the subject of two fully enrolled Phase III trials. One is assessing the compound in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (STS) (the TH-CR-406 trial).

In the other trial, evofosfamide is under study in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial).

Threshold said it expects to announce top-line data on the trials around the end of this year.

Both Phase III trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. The FDA and the European Commission have granted evofosfamide Orphan Drug designation for the treatment of STS and pancreatic cancer. The FDA has also granted Fast Track designation for evofosfamide for both STS and pancreatic cancer.

Evofosfamide is also being studied in a Phase II trial designed to support registration for the treatment of non-squamous non-small cell lung cancer, and in earlier-stage clinical trials of other solid tumors and blood cancers.

The new agreement gives Threshold the right to field at its own expense and oversee its own sales force for the compound that will work with Merck KGaA's U.S. sales force. Merck KGaA remains responsible for all other commercial and medical affairs functions associated with the launch and promotion of evofosfamide, Threshold said.

“Threshold is well positioned to integrate a commercial arm to its oncology discovery and development organization,” Threshold CEO Barry Selick, Ph.D., said in a statement. “The ability to co-promote and field a sales force represents one of two key options allowing Threshold to participate in the commercial phase of evofosfamide's lifecycle should it receive FDA approval.”








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