Lung Drug

 Boehringer's lung drug wins FDA 'breakthrough' tag

Boehringer Ingelheim 's treatment for a rare and deadly lung disease picked up the FDA's coveted breakthrough therapy designation, a mark that guarantees a speedy regulatory review and could help the company beat its nearest rival to market. The drug, dubbed nintedanib, is a therapy for idiopathic pulmonary fibrosis  (IPF), an often fatal disease that scars the lungs and stands in the way of oxygen absorption. In two Phase III studies on more than 1,000 patients, Boehringer's treatment reduced patients' annual rate of lung-function decline by 48% and 55%, compared to just 5% in the placebo arm. Nintedanib had already received the agency's promise of a priority review and a fast-track designation. Adding the breakthrough tag should only accelerate the drug's path to market and possibly help Boehringer beat out InterMune ($ITMN), which is seeking agency approval for a similar therapy. Pirfenidone, InterMune's competing IPF drug, endured an FDA rejection in 2010, but, thanks to some promising new Phase III data, the biotech has worked its way back into the agency's good graces. InterMune resubmitted the treatment in May and expects to win approval within 6 months, launching pirfenidone in the first quarter of 2015 if all goes according to plan. There are no FDA-approved treatments for IPF, which kills about 40,000 people a year, according to the Coalition for Pulmonary Fibrosis. InterMune's drug is already on the market in Europe, but, despite two years of momentum, it brought in just $70.2 million last year. The European Medicines Agency has agreed to an accelerated review of nintedanib, and Boehringer, with its commercial heft, should be able to compete if and when it launches nintedanib on the continent.Boehringer isn't disclosing its planned timeline for launching nintedanib, but Senior Vice President Sabine Luik said in a statement that the FDA's latest move should expedite the process. Analysts have said the U.S. market for IPF treatments could peak at north of $2 billion, but just which company will claim the largest share of it remains a contentious subject. InterMune's shares shot up in March after Boehringer revealed that nintedanib missed a secondary endpoint in one of its Phase III trials, but a May editorial in The New England Journal of Medicine heralded the drug's efficacy and potential as a new hope for IPF patients. Link:http://www.fiercebiotech.com/press-releases/boehringer-ingelheims-investigational-therapy-nintedanib-receives-fda-break?utm_medium=nl&utm_source=internal Boehringer Ingelheim's Investigational Therapy Nintedanib Receives FDA Breakthrough Therapy Designation RIDGEFIELD, Conn., July 16, 2014 -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy designation to nintedanib, an investigational therapy currently under FDA review for the treatment of people with idiopathic pulmonary fibrosis (IPF). The efficacy and safety of nintedanib in the treatment of IPF has not been established. "Boehringer Ingelheim is proud that the FDA has granted Breakthrough Therapy designation for nintedanib, which will help expedite its development and review as a potential treatment option for patients with IPF," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs at Boehringer Ingelheim Pharmaceuticals, Inc. "We are committed to working with the FDA during the NDA review of nintedanib for people living with this serious and life-threatening lung disease, for which there are currently no FDA-approved treatment options." The Breakthrough Therapy designation process was established by the FDA in 2012 and is intended to expedite the development and review of drugs for serious or life-threatening conditions, and preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. IPF is a serious and life-threatening lung disease that causes permanent scarring of the lungs, difficulty breathing and decreases the amount of oxygen the lungs can supply to the body. IPF affects as many as 132,000 Americans. There are currently no FDA-approved treatments. Results from two global Phase 3 studies (INPULSIS™-1 and INPULSIS™-2) evaluating the efficacy and safety of nintedanib in the treatment of IPF were presented at the American Thoracic Society (ATS) International Conference and published in the New England Journal of Medicine in May 2014. Nintedanib was granted Priority Review designation in June 2014, Fast Track designation in June 2013 and orphan drug status in June 2011. 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. Jennifer Forsyth Public Relations Phone: 203-791-5889 Email: Jennifer.Forsyth@Boehringer- Ingelheim.com