Boehringer Ingelheim Comments on June 18th FDA Advisory Committee Meeting

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Fri Jun 18, 2010 5:45pm EDT

For NON-US and NON-UK Media Only
INGELHEIM, Germany--(Business Wire)--
The Reproductive Health Drugs Advisory Committee met today to discuss the new
drug application (NDA) for flibanserin 100 mg as a treatment for Hypoactive
Sexual Desire Disorder (HSDD) in pre-menopausal women. The advisory committee
was convened by and makes recommendations to the U.S. Food and Drug
Administration (FDA). The FDA will consider the committee`s advice as part of
its final assessment of the NDA. 

The committee recognised the significant unmet medical need for women with HSDD
and the lack of approved treatments for this condition. Members of the committee
advised that additional data are necessary to further support the efficacy and
safety profile of flibanserin and recommended that clinical development of the
drug continue. 

"We are disappointed with the advisory committee`s recommendations and will work
with the FDA to address questions raised by the advisory committee," said
Christopher Corsico, M.D., M.P.H., U.S. medical director, Boehringer Ingelheim
Pharmaceuticals, Inc. "Our ongoing flibanserin clinical trial programme
demonstrates our continued commitment to women with HSDD." 

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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 142
affiliates in 50 countries and more than 41,500 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. 

In 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while
spending 21% of net sales in its largest business segment Prescription Medicines
on research and development. 

For more information please visit
www.boehringer-ingelheim.com/news/news_releases/press_releases/2010/19_june_2010.html

Boehringer Ingelheim GmbH
55216 Ingelheim/Germany
Corporate Division Communications
Julia Meyer-Kleinmann, +49 6132 77-8271
m-kleinmann@boehringer-ingelheim.com

Copyright Business Wire 2010

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