InterMune, Inc. Wins FDA Approval For Lung Drug At Center Of Roche Deal

Published: Oct 17, 2014

Roche Climbs Higher On InterMune Drug Approval

October 16, 2014

By Krystle Vermes, BioSpace.com Breaking News Staff

The U.S. Food and Drug Administration announced on this week that it had approved based InterMune, Inc. ’s lung drug Esbriet, also known as pirfenidone, for the treatment of idiopathic pulmonary fibrosis. InterMune Inc. was purchased by Roche back in August.

Shares of Roche were up slightly in Thursday trading on the news.

“Esbriet provides a new treatment option for patients with idiopathic pulmonary fibrosis, a serious, chronic lung disease,” said Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “We continue to help advance medication therapies by approving products that treat conditions that impact public health.”

Esbriet impacts multiple pathways that are thought to be involved in the scarring of lung tissue in patients with IPF. Its safety and effectiveness were established in three clinical trials of 1,247 patients. Poor forced vital capacity – the amount of air that can be exhaled from the lungs when taking the deepest breath possible – was improved in patients who received the drug.

The most common reported side effects of the drug were nausea, rash and abdominal pain. Esbriet is not being recommended to patients who have severe liver issues.

Roche Moves in on InterMune
Switzerland-based Roche and InterMune Inc. announced that they had reached a definitive merger agreement on Aug. 24 at a price of $74 per share in an all-cash transaction. The total value of the deal was estimated to be around $8.3 billion on a fully diluted basis. Roche was set to acquire all outstanding shares of InterMune common stock.

"We are very pleased that we reached this agreement with InterMune,” Severin Schwan, CEO of Roche, said at the time of the announcement. “Our offer provides significant value to InterMune's shareholders and this acquisition will complement Roche's strengths in pulmonary therapy. We look forward to welcoming InterMune employees into the Roche Group and to making a difference for patients with idiopathic pulmonary fibrosis, a devastating disease."

When the merger was announced, Roche claimed that it was planning a smooth transition for employees of InterMune. Furthermore, Roche planned to expand its drug portfolio with InterMune’s Esbriet.

“This merger recognizes the significant value created by our team's commitment, hard work and execution for more than a decade to develop and commercialize treatment options for IPF patients and their families,” stated InterMune's Chairman, CEO and President, Dan Welch, at the time of the announcement. “Roche shares our passion and commitment to the IPF community and to ensuring that pirfenidone is available as quickly as possible to patients in the United States, pending FDA approval.”

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