U.S. FDA Accepts NDA Filing for Boehringer Ingelheim's Investigational Nintedanib and Grants Priority Review Designation for the Treatment of Idiopathic Pulmonary Fibrosis

RIDGEFIELD, Conn., July 2, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the New Drug Application (NDA) for its investigational compound nintedanib has been accepted for filing by the U.S. Food & Drug Administration (FDA) and granted Priority Review designation. The application for nintedanib is currently under review for the treatment of people with idiopathic pulmonary fibrosis (IPF), a rare, progressive and fatal lung disease that affects as many as 132,000 Americans. There are currently no FDA-approved treatments for IPF. The efficacy and safety of nintedanib in the treatment of IPF has not been established.

"This is an exciting and important next step in the review of nintedanib for the treatment of IPF, which is a serious disease with a high unmet medical need," said Tunde Otulana, M.D., senior vice president, Clinical Development and Medical Affairs at Boehringer Ingelheim Pharmaceuticals, Inc. "If approved, nintedanib may offer a treatment option for people in the U.S. who are living with this progressive disease, and have no approved treatment options today. We look forward to continuing to work closely with the FDA during this review period."

The FDA grants Priority Review designation for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment of serious conditions when compared to standard applications.

The NDA package includes results from two global Phase 3 studies (INPULSIS™-1 and INPULSIS™-2) evaluating the efficacy and safety of nintedanib in the treatment of IPF. The INPULSIS™ studies were recently presented at the American Thoracic Society (ATS) International Conference and published in the New England Journal of Medicine.

In June 2011, nintedanib was granted orphan-drug designation in the U.S. Orphan-drug designation is a status given to a product intended for the treatment of a rare disease or condition. In June 2013, nintedanib was then granted fast track designation by the FDA. The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

About nintedanib

Nintedanib is an investigational small molecule tyrosine kinase inhibitor (TKI) in development by Boehringer Ingelheim for idiopathic pulmonary fibrosis (IPF). It targets growth factors, which have been shown to be potentially involved in pulmonary fibrosis – the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR).

About idiopathic pulmonary fibrosis

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, severely debilitating and ultimately fatal lung disease for which there are no FDA-approved treatment options in the U.S. Although lung transplantation has been shown to improve survival, the procedure is uncommon because of the limited availability of lungs for transplantation or people are either too ill or don't survive long enough to undergo the transplant. The incidence of IPF can vary considerably and there is some evidence that the population is increasing. IPF is characterized by progressive scarring of lung tissue and loss of lung function over time. Development of scarred tissue is called fibrosis. Over time, as the tissue thickens and stiffens with scarring, the lungs lose their ability to take in and transfer oxygen into the bloodstream, and vital organs do not get enough oxygen. As a result, individuals with IPF experience shortness of breath, cough and often have difficulty participating in everyday physical activities.

About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., 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 http://www.us.boehringer-ingelheim.com

Contact:

Boehringer Ingelheim
Pharmaceuticals, Inc.
Name: Jennifer Forsyth
Public Relations
Phone: 203-791-5889
Email: [email protected]

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.