Boehringer Ingelheim enters into an exclusive license agreement with Hanmi Pharmaceutical to develop 3rd generation EGFR targeted therapy in lung cancer

- Boehringer Ingelheim expands its strong position in lung cancer by obtaining exclusive rights* to HM61713, a novel 3rd generation EGFR targeted therapy

- This new partnership will aim to achieve market authorization 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

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Boehringer Ingelheim Pharmaceuticals, Inc.

Jul 28, 2015, 08:00 ET

RIDGEFIELD, Conn. and SEOUL, Korea, July 28, 2015 /PRNewswire/ -- Boehringer Ingelheim and Hanmi Pharmaceutical Co., Ltd. today announced an exclusive license and collaboration agreement for the development and global commercialization 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. 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 favorable safety profile. 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 program 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. With Boehringer Ingelheim's strong pipeline demonstrating 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
Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research program to discover and develop innovative cancer treatments. Working in close collaboration with the international scientific community and a number of the world's leading cancer centers, Boehringer Ingelheim's commitment to oncology is underpinned by using advances in science to develop a range of targeted therapies for various solid tumors and hematological cancers. The current focus of late-stage research includes compounds in three areas: signal transduction inhibition, angiogenesis inhibition and cell-cycle kinase inhibition. The company is also evaluating a robust and growing pipeline of early-stage oncology compounds in areas including growth/survival signaling, immunotherapy and epigenetics.

For information about participating in a Boehringer Ingelheim clinical trial, please visit www.bicancertrials.com or call 1.866.725.7110.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with 146 affiliates and more than 47,000 employees. Since its founding in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel treatments for human and veterinary medicine.

Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and families. Our employees create and engage in programs that strengthen our communities. To learn more about how we make more health for more people, visit our Corporate Social Responsibility Report.

In 2014, Boehringer Ingelheim achieved net sales of about $16.96 billion dollars (13.3 billion euros). R&D expenditure corresponds to 19.9 percent of its net sales.

For more information please visit www.us.boehringer-ingelheim.com, or follow us on Twitter @BoehringerUS.

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 at www.hanmipharm.com.

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Boehringer Ingelheim Pharmaceuticals, Inc.
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Name: Paul Wynn
Phone: 203-798-4887
Email: [email protected]

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* Afatinib is approved in a number of markets, including the EU, Japan, Taiwan and Canada under the brand name GIOTRIF® and in the U.S. under the brand name GILOTRIF®.
** VARGATEF (nintedanib) is not approved for lung cancer in the U.S. but is currently being investigated in patients with various solid tumors.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.