PharmaEngine, Inc., is a biopharmaceutical company focuses on the development of new drugs for the treatment of cancer and Asian prevalent diseases, has signed an Amendment to its License Agreement of MM-398 (akaPEP02, nanoliposomal irinotecan injection, nal-IRI) with Merrimack Pharmaceuticals, Inc.
This week Merrimack announced an exclusive license and collaboration agreement with Baxter International Inc. for MM-398 outside of the United States and Taiwan.
PharmaEngine licensed the development, manufacturing and commercialization rights of PEP02 in Asia and Europe to Merrimack for US$220 million plus royalties and sublicense revenue in May 2011. In May 2014, the companies announced the successful completion of a global phase III study in patients with metastatic pancreatic cancer previously treated with gemcitabine – based therapy.
Under the amendment, PharmaEngine will receive an immediate payment of US$7 million and a guaranteed payment of US$5 million upon the acceptance of the MM - 398 New Drug Application by the US Food and Drug Administration (FDA) or no later than April 30, 2015. This payment was previously contingent on Merrimack receiving certain regulatory designations from the FDA for MM – 398.
Additionally, the amendment accelerates the reduction in the percentage of sublicense revenue to be received by PharmaEngine for future regulatory and approval milestones resulting in maximum sublicense revenue of US$39.5 million.
On the other hand, PharmaEngine is excluded from receiving sublicense revenue related to Merrimack’s upfront payment and up to US$150 million in development milestone payments from Baxter. The remaining US$200 million of regulatory and sales milestones , as well as the tiered royalties, remain unchanged.
In sum, PharmaEngine is eligible to receive up to a total of $251.5 million in the future, in addition to the license fees of US$15 million that were previously received under the Agreement.
“We are pleased that the amended terms facilitated Merrimack to close their deal with Baxter who expects to apply for regulatory approvals outside of the US beginning in 2015,” said Grace Yeh, Ph.D., president and chief executive officer. “This win-win partnership provided PharmaEngine with short term cash payments of $12 million; mid-term investment of additional clinical trials by the two partners; and long-term upside of market access by Baxter which has global presence in the healthcare industry.”