On July 29, 2015 Hanmi Pharmaceutical Co. Ltd and Boehringer Ingelheim reported an exclusive license and collaboration agreement for the development and commercialisation rights, except South Korea, China and Hong Kong, of HM61713, a novel 3rd generation EGFR targeted therapy for the treatment of a specific type of lung cancer (Press release, Hanmi, JUL 29, 2015, View Source;hanmiEnglishNewsDtlSeq=123 [SID:1234508098]). Under the terms of the agreement Hanmi will receive an initial payment of USD50 million and is entitled to potential milestone payments of more than USD700 (600) million plus tiered double-digit royalties on future net sales. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, similar requirements outside the U.S., and other customary closing conditions.
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Jee Woong Son, Vice president, of Hanmi Pharmaceutical said, "We are excited at the potential this license agreement with Boehringer Ingelheim will bring to the successful development of HM61713 and the possibilities this will offer to lung cancer patients. Boehringer Ingelheim has significant expertise in the field of lung cancer, specifically with EGFR mutations, and with a strong pipeline which demonstrates long-term commitment to the successful development of lung cancer treatments, we are confident we have found the right partner to make the potential of HM61713 a reality."
HM61713 is a novel 3rd generation, orally active, irreversible EGFR mutation selective tyrosine kinase inhibitor (TKI). Currently in Phase II clinical development for patients with T790M mutation-positive non-small cell lung cancer (NSCLC) who have developed resistance to previous EGFR targeting agents. The interim results of the Phase I/II clinical trial presented at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting showed strong efficacy signals, combined with a favourable safety profile, leading to the preparation of a Phase III trial programme to be initiated in 2016.
Dr Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim said, "This exclusive license agreement with Hanmi Pharmaceutical is a significant step towards our vision of providing a wide-range of lung cancer treatments to patients in an area of significant unmet medical need. The in-licensing of a 3rd generation EGFR agent bolsters our existing lung cancer portfolio and reiterates our commitment towards innovation and tailored treatment options for patients."