Boehringer Ingelheim will partner with Hanmi Pharmaceutical to develop and commercialize HM61713, a third- generation treatment for EGFR mutation-positive lung cancer, in most of the world, the companies said today. 

The deal could generate as much as $730 million-plus for Hanmi, from which Boehringer Ingelheim has agreed to exclusively license rights to HM61713 in most of the world except South Korea, China, and Hong Kong.

HM61713 is an oral, irreversible EGFR mutation-selective tyrosine kinase inhibitor that has shown promise in interim Phase I/II results presented earlier this at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. HM61713 is now in Phase II clinical development for patients with non-small cell lung cancer (NSCLC) with T790M mutations who have developed resistance to previous EGFR targeting agents. A broader Phase III trial program is set to be launched in 2016.

Boehringer has agreed to pay Hanmi $50 million upfront and up to $680 million in payments tied to milestones, plus tiered double-digit royalties on future net sales.

The deal is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, similar requirements outside the U.S., and other customary closing conditions.

“The in-licensing of a 3rd generation EGFR agent bolsters our existing lung cancer portfolio and reiterates our commitment towards improving the lives of people with cancer through innovation and tailored treatment options,” Jörg Barth, M.D., corporate svp, therapy area head oncology with Boehringer Ingelheim, said in a statement.

Boehringer Ingelheim said HM61713 is a pillar of its global lung cancer franchise, anchored by Gilotrif®/ Giotrif® (afatinib), indicated for patients with distinct types of EGFR mutation-positive NSCLC; and Vargatef® (nintedanib), approved the E.U. in combination with docetaxel in adults with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumor histology after first-line chemotherapy.

Nintedanib capsules, marketed as OFEV®, are approved in the U.S. for idiopathic pulmonary fibrosis.

With HM61713, Boehringer Ingelheim said, the company now has more than 10 compounds in clinical development in a variety of oncology indications, including immune oncology approaches that include an mRNA-based therapeutic vaccine under development through an up-to-$600 million collaboration with CureVac launched last year.

“Boehringer Ingelheim’s strong pipeline demonstrates its long-term commitment to successful development of cancer treatments. We are confident we have found the right partner to make the potential of HM61713 a reality,” added Hanmi CMO Jeewoong Son, M.D., Ph.D.

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