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Boehringer Ingelheim. (9/30/16). "Press Release: Boehringer Ingelheim Returns Development and Commercial Rights of Olmutinib to Hanmi Pharmaceutical". Ingelheim.

Region Region ALL
Organisations Organisation Boehringer Ingelheim (Group)
  Organisation 2 Hanmi Pharmaceutical Co., Ltd. (KR)
Products Product olmutinib (BI 1482694 / HM61713)
  Product 2 clinical research
Index term Index term Boehringer–Hanmi: kinase inhibitor, 201507–201609 TERMINATED license to HM61713 ww excl KR + CN + HK with $50m upfront + $680m milestones + royalties
Person Person Barth, Jörg (Boehringer Ingelheim 201507 Corporate SVP Therapy Area Head Oncology)

> Decision is based on a re-evaluation of all available clinical data and recent advances made in the treatment of EGFR mutation-positive lung cancer

> Boehringer Ingelheim continues to expand its presence in oncology and lung cancer in particular, with increased investment in research and development, and collaborations

Boehringer Ingelheim announced that development and global commercialisation rights of olmutinib*, a third-generation EGFR targeted therapy, will be returned to Hanmi Pharmaceutical Co. Ltd.

The decision is based on a re-evaluation of all available clinical data on olmutinib and recent treatment advances made in the treatment of EGFR mutation-positive lung cancer. Boehringer Ingelheim will not initiate new clinical trials for this compound and will work closely with Hanmi Pharmaceutical to ensure a seamless transition of the responsibilities of the current olmutinib clinical development programme back to Hanmi Pharmaceutical.

Dr Jörg Barth, Corporate Senior Vice President, Therapeutic Area Head Oncology, Boehringer Ingelheim said, “We would like to thank Hanmi Pharmaceutical for their collaboration and commitment during our joint development of olmutinib. Partnering is a key pillar of our oncology strategy at all stages of research and development, in order to offer cancer treatments that fit the needs of patients, caregivers and healthcare professionals. Boehringer Ingelheim’s oncology pipeline is robust and transformative, with several compounds currently in clinical development and we strive for best-in-class, breakthrough cancer medications.”

Boehringer Ingelheim has successfully launched two products for the treatment of non-small cell lung cancer (NSCLC), afatinib** (Giotrif®) and nintedanib*** (Vargatef®), which have been widely adopted and established as important additions to current clinical practice. The company continues to increase its investment in research and development and a third of Boehringer Ingelheim’s human pharmaceutical pipeline, that is planned to enter Phase I clinical trials in the next 12 months, is in oncology.

Boehringer Ingelheim’s oncology pipeline is built on in-house scientific innovation as well as strong academic and industry collaborations. Two recent examples include a partnership with ViraTherapeutics to develop novel cancer treatments based on oncolytic viruses, with an option to acquire the company at a later time point. The other strategic collaboration is with Sarah Cannon Research Institute (SCRI) that brings together Boehringer Ingelheim’s extensive experience in cancer drug development and SCRI’s expertise in designing and executing clinical trials of investigational oncology drugs.

*Olmutinib (BI 1482694 / HM61713) is approved in South Korea for the treatment of EGFR T790M mutation-positive lung cancer. Olmutinib is not approved in other indications and jurisdictions.

**Afatinib is approved in more than 70 countries, including the EU, Japan, Taiwan and Canada under the brand name Giotrif®, in the US under the brand name Gilotrif® and in India under the brand name Xovoltib® for use in patients with distinct types of EGFR mutation-positive NSCLC. Afatinib is also approved in the EU, US and other markets for the treatment of patients with advanced SqCC of the lung whose disease has progressed (on or) after treatment with platinum-based chemotherapy. Afatinib is under regulatory review by health authorities in other countries worldwide. Registration conditions differ internationally, please refer to locally approved prescribing information.

*** Nintedanib is approved in the EU under the brand name VARGATEF® for use in combination with docetaxel in adult patients with locally advanced, metastatic or locally recurrent NSCLC of adenocarcinoma tumour histology after first-line chemotherapy. Nintedanib is under regulatory review by health authorities in other countries outside the EU. Nintedanib is not approved in other oncology indications.

Notes to editors

Intended audiences

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.

About Boehringer Ingelheim in oncology

Boehringer Ingelheim’s oncology research is driven by a passion to advance clinical practice and a determination to improve the lives of patients who are battling cancer. Through our own scientific innovation and partnerships, we are focused on discovering and providing novel best-in-class, breakthrough cancer medications that fit the needs of patients, caregivers and healthcare professionals. We have a clear strategy to become a leader in the field of lung cancer. Boehringer Ingelheim has successfully launched two products for NSCLC, which have been widely adopted and established as valuable additions to current clinical practice. Continuous insights and learnings from research and development are key parts of innovation and our way forward to advance clinical practice in lung cancer and other cancer types.

About Boehringer Ingelheim

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on 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 through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.

In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.

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Record changed: 2019-06-09


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