• Boehringer Ingelheim expands its strong position in lung cancer obtaining exclusive rights to HM61713 a 3rd generation EGFR targeting agent
• This new partnership will aim to achieve first market authorisation for HM61713 for patients with EGFR mutation-positive NSCLC by 2017 in the U.S.
• Expands Boehringer Ingelheim's broad commitment to cancer and specifically the development of innovative targeted therapies in lung cancer
Ingelheim, Germany and Seoul, Korea – Boehringer Ingelheim and Hanmi Pharmaceutical Co. Ltd today announced an exclusive license and collaboration agreement for the development and global commercialisation rights, except South Korea, China and Hong Kong, of HM61713, a novel 3rd generation EGFR targeted therapy for the treatment of EGFR mutation positive lung cancer. Under the terms of the agreement Hanmi will receive an initial payment of USD 50 million and is entitled to potential milestone payments of USD 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.
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 treatment options as we better understand the underlying drivers of this devastating disease. 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."
HM61713 is a novel 3rd generation, orally active, irreversible EGFR mutation selective tyrosine kinase inhibitor (TKI). At this year's ASCO Annual Meeting, interim results of the Phase I/II clinical trial were presented and showed strong efficacy signals, combined with a favourable safety profile.1 The compound is currently 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. Preparations have begun for a broader Phase III trial programme, to be initiated in 2016.
HM61713 is another important pillar in Boehringer Ingelheim's global lung cancer franchise which builds on two products, GIOTRIF®/GILOTRIF® (afatinib*) and VARGATEF® (nintedanib**), approved in various countries. With the inclusion of HM61713, Boehringer Ingelheim now has more than 10 compounds in clinical development in a wide variety of oncology indications, including immune oncology approaches like an mRNA based therapeutic vaccine under development in collaboration with CureVac.
Dr Jeewoong Son, Chief Medical Officer 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 in EGFR mutated disease. 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."
About Boehringer Ingelheim in Oncology
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.
In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.
For more information please visit www.boehringer-ingelheim.com
About Hanmi Pharmaceutical Co., Ltd.
Hanmi Pharmaceutical is a Korea-based global pharmaceutical company focused on the development and commercialization of new pharmaceutical products. The Company is fully integrated from R&D through manufacturing, marketing and sales with an established presence in Korea as well as China. The Company invests over 20 percent of its sales in R&D and has over 20 programs in clinical development in three main areas: 1) novel long-acting biologics based on the Company's LAPSCOVERY™ platform including weekly insulin, weekly to monthly GLP-1, and their combinations (Quantum Project) in diabetes and obesity; 2) novel targeted agents against cancer and autoimmune disorders; and 3) fixed-dose combination programs. More information on Hanmi is available atwww.hanmipharm.com
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
1 Park K. et al. Updated safety and efficacy results from phase I/II study of HM61713 in patients (pts) with EGFR mutation positive non-small cell lung cancer (NSCLC) who failed previous EGFR-tyrosine kinase inhibitor (TKI). J Clin Oncol May 2015; 33(Suppl.15): 8084.