Gilead and Boehringer Ingelheim Sign License Agreement for Novel HIV Non-Catalytic Integrase Inhibitors

Compounds Represent New Class of Antiretroviral

FOSTER CITY, Calif. & INGELHEIM, Germany--(BUSINESS WIRE)--Oct 5, 2011 - Gilead Sciences, Inc. (Nasdaq:GILD) and Boehringer Ingelheim today announced that the companies have entered into a licensing agreement, under which Boehringer Ingelheim has granted Gilead exclusive worldwide rights for the research, development and commercialization of its novel non-catalytic site integrase inhibitors (NCINIs) for HIV. This includes the lead compound BI 224436, which has been evaluated in a Phase 1a dose-escalation study to assess bioavailability and pharmacokinetics in healthy volunteers.

NCINIs target the key component of the HIV virus responsible for incorporation of the viral DNA into the human genome. NCINIs inhibit HIV integrase by binding to a novel site, distinct from the catalytic site used by the current class of integrase inhibitors, and therefore may possess a differentiated resistance profile from raltegravir or elvitegravir.

“We are very pleased to have established this licensing agreement. The Boehringer Ingelheim compounds complement our internal discovery programs and the efforts are aligned with our commitment to continue to innovate in the field of HIV,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “We are looking forward to progressing BI 224436 or other compounds further into clinical development.”

“Both companies' genuine interest in advancing research and development in virology is reflected by this collaboration's aim to address unmet patient needs,” said Prof. Dr. Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. “While Gilead will drive the integrase inhibitors in HIV into clinical development, we will focus our development efforts on further compounds of our virology pipeline, particularly our portfolio in hepatitis C.”

Under the terms of the agreement, Gilead will pay Boehringer Ingelheim an upfront payment. Boehringer Ingelheim could receive additional payments based upon the achievement of certain development, regulatory and commercial milestones, as well as royalties on future net sales.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific. For more information on Gilead, please visit www.gilead.com.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 42,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to be socially responsible including involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2010, Boehringer Ingelheim posted net sales of about 12.6 billion euro while spending almost 24% of net sales in its largest business segment, Prescription Medicines on research and development.

For further information, please visit www.boehringer-ingelheim.com.

Gilead Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements, including the risk related to the development of Boehringer Ingelheim's novel NCINIs for HIV, including BI 224436. There are also risks related to current and future clinical studies of BI 224436, including the possibility of unfavorable results and the need to modify or delay the studies or to perform additional trials. As a result, Boehringer Ingelheim's novel NCINIs for HIV, including BI 224436, may never be successfully commercialized. In addition, Gilead may make a strategic decision to discontinue development of Boehringer Ingelheim's novel NCINIs for HIV, including BI 224436. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2011, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Contact: Gilead
Susan Hubbard, 650-522-5715 (Investors)
Erin Rau, 650-522-5635 (Media)
or
Boehringer Ingelheim
Julia Meyer-Kleinmann, +49-6132-778271
Corporate Communications
press@boehringer-ingelheim.com

 

Posted: October 2011


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