InterMune, Inc., a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and fibrotic diseases, announced that Esbriet (pirfenidone) will be offered to patients in Germany beginning September 15, 2011. This will mark the first time Esbriet will be commercially available in Europe since it was approved by the European Commission in adults for the treatment of mild to moderate Idiopathic Pulmonary Fibrosis (IPF), a devastating and fatal lung disease.
“This first launch of Esbriet is an important occasion for patients in Germany and for InterMune,” said Dan Welch, chairman, chief executive officer and president of InterMune. “For the first time, German patients with IPF will have access to a medicine proven to reduce the decline in lung function, offering a treatment where none existed previously. Our team in Germany is well staffed and trained, and fully committed to making Esbriet available to all appropriate patients as rapidly as possible and our entire organization is actively preparing to launch Esbriet throughout Europe beginning in the first half of 2012.”
Esbriet (pirfenidone) is an orally active drug that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a key role in fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.
On February 28, 2011, the European Commission (EC) granted marketing authorization for Esbriet for the treatment of adults with mild to moderate IPF. The approval authorizes marketing of Esbriet in all 27 EU member states. Esbriet has since been approved for marketing in Norway and Iceland. It will soon be available in Germany on September 15, 2011 and is scheduled to be available in France, Italy and Spain during the first half of 2012, and in the United Kingdom during the third quarter of 2012.
Since 2008, Esbriet has been marketed in Japan as Pirespa by Shionogi & Co. Ltd.
InterMune is currently enrolling patients in a multinational Phase 3 clinical trial of pirfenidone in IPF (ASCEND), the results of which will supplement the existing Phase 3 clinical study data from InterMune's CAPACITY clinical trials to support the potential registration of pirfenidone to treat IPF patients in the United States. At this time pirfenidone is not approved for use in the United States.
IPF is a progressive, debilitating and ultimately fatal disease characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen. It is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20-40 percent, which makes IPF more rapidly lethal than many cancers, including breast, ovarian and colorectal. An estimated 30,000-35,000 new cases of IPF are diagnosed in Europe each year. Patients diagnosed with IPF are primarily between the ages of 40 and 80, with a median age of 63 years. The disease tends to affect slightly more men than women.