Boehringer Ingelheim Discontinues Faldaprevir, Halts HCV Drug Development

Boehringer Ingelheim has announced that it will discontinue development of its investigational hepatitis C virus (HCV) protease inhibitor faldaprevir, will withdraw pending approval requests, and will not proceed with further work in this area due to rapid changes in the hepatitis C treatment environment.

Faldaprevir (formerly BI 201335) worked well in combination with pegylated interferon and ribavirin in the STARTVerso trials. But people with hepatitis C are eager for interferon-free therapy, and several all-oral options are further along in the development pipeline.

While an interferon-free regimen of faldaprevir, the polymerase inhibitor deleobuvir (formerly BI 207127), and ribavirin performed well against genotype 1b HCV in Phase 2 and 3 trials, it was not as effective against harder-to-treat genotype 1a.

Earlier this year, Boehringer-Ingelheim announced that it would halt development of deleobuvir. With the discontinuation of faldaprevir, the company has decided to focus on other disease areas. Below is an edited excerpt from a company statement describing the decision.

Statement on Hepatitis C Drug Development

Ridgefield, CT -- June 20,2014 -- Boehringer Ingelheim has re-evaluated its strategy in hepatitis C (HCV), and as a result the company has decided not to move forward in this therapeutic area. The HCV treatment environment has significantly and rapidly evolved since the submission of the faldaprevir marketing applications to regulatory bodies around the world. There are now several new treatment options available for patients and additional all-oral options are expected to be approved in 2014. This decision was taken as there is no longer an unmet medical need for the faldaprevir interferon-based regimen that was the subject of the application.

Boehringer Ingelheim will withdraw all pending marketing applications for faldaprevir worldwide and is discontinuing further development.

Boehringer Ingelheim is committed to developing new treatments that provide high therapeutic value in areas where medical need exists. The company is focusing its efforts on numerous promising development projects in immunology, cardiovascular, respiratory, metabolic diseases, diseases of the central nervous system and oncology.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. 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 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.

For more information please visit www.us.boehringer-ingelheim.com.

6/27/14

Source

Boehringer-Ingelheim. Statement on Hepatitis C Drug Development. June 20, 2014.