Date: 2015-07-29
Type of information: Licensing agreement
Compound: Olmutinib (BI 1482694; HM61713)
Company: Boehringer Ingelheim (Germany) Hanmi Pharmaceutical (South Korea)
Therapeutic area: Cancer - Oncology
Type agreement: licensing development commercialisation
Action mechanism: kinase inhibitor/tyrosine kinase inhibitor. BI 1482694 (HM61713) is a novel 3rd generation, orally active, irreversible EGFR mutation selective tyrosine kinase inhibitor (TKI) developed to specifically target tumours with T790M mutations. The T790M mutation is known as the most common resistance mechanism to develop in response to treatment with EGFR TKIs. It is found in approximately 50-60% of patients who previously received EGFR TKI therapy. There are currently no EGFR-directed therapies approved specifically for the treatment of this mutation, representing an area of great unmet need for these patients.
Disease: lung cancer
Details: * On July 29, 2015, Hanmi Pharmaceutical and Boehringer Ingelheim announced 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. HM61713 is 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 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.
Financial terms: Under the terms of the agreement Hanmi will receive an initial payment of $ 50 million and is entitled to potential milestone payments of $ 680 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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