Boehringer Ingelheim Announces Nintedanib Expanded Access Program (EAP) for Patients with Idiopathic Pulmonary Fibrosis

RIDGEFIELD, Conn., June 24, 2014 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the company has initiated an open-label, U.S. multi-center expanded access program (EAP) for its investigational compound nintedanib, for people diagnosed with idiopathic pulmonary fibrosis (IPF) and who meet certain eligibility criteria. Nintedanib is an investigational therapy and has not been approved by the U.S. Food and Drug Administration (FDA). The safety and efficacy of nintedanib for the treatment of IPF have not been established. Healthcare professionals and patients can obtain details about participation in the nintedanib EAP by calling +1 866-438-8611. The program has also been posted on clinicaltrials.gov. 

The FDA allows companies in the late stages of drug development to provide patients with access to investigational drugs, such as nintedanib, in certain situations. Expanded access programs are intended for patients who may be ineligible for a clinical trial and who have serious or immediately life-threatening illnesses for which there are no comparable or satisfactory alternative treatment options.

“IPF is a rare and devastating disease with a very high mortality rate. There are currently no FDA-approved treatments and most patients die from their disease within three to five years of diagnosis,” said Tunde Otulana, M.D., senior vice president, Clinical Development and Medical Affairs at Boehringer Ingelheim. “Boehringer Ingelheim wants to make nintedanib, an investigational drug currently in development for the treatment of IPF, available to patients who are ineligible or unable to take part in our ongoing clinical trial program.”

About the Nintedanib EAP
The nintedanib EAP (clinical trial identifier NCT02171156) is an open-label, single-arm, multi-center trial for patients with IPF. As a single-arm trial, nintedanib will not be compared to any other IPF therapy. Enrollment criteria are available on clinicaltrials.gov and include patients with the following characteristics at first visit:

• Aged ≥40 years, male or female
• Confirmed diagnosis of IPF within five years based upon the most recent guidelines from the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS) and Latin American Thoracic Association (ALAT)
• Forced Vital Capacity (FVC) ≥ 50% predicted of normal
• Carbon monoxide diffusing capacity (DLCO) (corrected for Hb): 30%-79% predicted of normal

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 -- 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

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