Roche to pay $8.3 billion for InterMune

Roche has swooped to acquire InterMune, the US biotech company behind the potential blockbuster treatment pirfenidone.

The Swiss pharma giant will pay $8.3 billion for the company, snatching it from under the noses of other companies interested in the acquisition, with Sanofi, GlaxoSmithKline and Actelion all said to have been bidders or potential bidders.

The takeover has come after a long period of turbulence for InterMune, based in Brisbane, California, which has struggled to break into profitability since it was established in 1998. Esbriet (pirfenidone), only the company’s second ever product, was launched in Europe and Canada in 2011 and 2012 respectively, but its board has now decided the time is right to sell.

Esbriet is the first ever treatment for idiopathic pulmonary fibrosis (IPF), an area of considerable unmet medical need, and one where a number of companies are set to launch new therapies.

The disease is a progressive scarring of the lungs that is almost always fatal, with a median survival of about three to five years.

But despite gaining approval in the EU and Canada, InterMune has not yet succeeded in securing FDA approval for its drug. The FDA rejected pirfenidone in 2010 because of doubts over its efficacy, a delay which has held the company back until now.

InterMune is poised to submit new trial data within the next few weeks, which should help it clinch the vital FDA approval.

Roche’s respiratory franchise

The deal makes good sense for Roche, as it markets to other specialist respiratory products – Pulmozyme and Xolair, and has other novel respiratory drugs diseases in its pipeline.

Roche says it plans a smooth transition of InterMune employees and operations into the Roche organisation, ensuring readiness for an expected launch of pirfenidone in the US by the end of 2014.

InterMune’s chairman, chief executive and president, Dan Welch, said: “This merger recognises the significant value created by our team’s commitment, hard work and execution for more than a decade to develop and commercialise treatment options for IPF patients and their families.

“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. Roche’s global resources and scale will not only facilitate and accelerate our ability to deliver pirfenidone to more patients around the world, but also to realise our joint vision to bring additional innovative therapies to patients with respiratory diseases.”

Data from the recently published phase III ASCEND trial showed that Esbriet significantly reduced disease progression in IPF patients. Specifically, results showed 16.5 percent of patients treated with the drug experienced at least a 10 percent decline in predicted forced vital capacity or death, versus 31.8 percent of placebo-treated patients.

The results of this study were part of the new drug application (NDA) resubmission that InterMune made in May 2014. The FDA awarded the drug the special breakthrough therapy designation in July, with the US regulator now set to give its ruling on 23 November.

A rival IPF treatment is now also closing in on InterMune’s drug – Boehringer Ingelheim’s nintedanib. Boehringer’s drug was also granted breakthrough status by the FDA in July, which means the drugs are now neck and neck in their race to market. Both drugs are tipped to achieve $1 billion in peak annual sales, but analysts are unsure if the two drugs can achieve higher sales.

The market is also likely to see further entrants, with Biogen Idec, Gilead, and Bristol-Myers Squibb all currently developing their own IPF treatments.

 

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The unmet needs of respiratory patients

 

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