FDA approves two new IPF drugs

Over the past year or so, InterMune and Boehringer Ingelheim have waged fierce struggles in the development of new drugs for idiopathic pulmonary fibrosis (IPF) and hope that their respective drugs will win the FDA approval. Previously, InterMune had a slight advantage over the PDUFA target date. But now, the FDA has also approved two companies' IPF drugs. In seizing the market, the two sides once again stand on an equal starting line.

InterMune's IPF drug is Esbriet (bifidone), Boehringer Ingelheim's IPF drug is Ofev (nintedanib). Both IPF drugs have received FDA status, priority review, orphan drugs, and breakthroughs. Therapeutic recognition, in terms of review, is also the beneficiary of these rapid review procedures. Previously, the FDA has designated Esbriet and Ofev's target drug user billing method (PDUFA) target dates of November 23, 2014 and January 2, 2015 respectively, but now, the FDA has approved both drugs in advance and at the same time.

Prior to this, the FDA had not approved any drugs for the treatment of IPF. Idiopathic pulmonary fibrosis (IPF) is a rare lung disease. According to the CPF data, there are 40000 IPF deaths each year. Analysts expect that the annual sales of the IPF drug market will exceed $2 billion. Now that the drugs of the two companies have been approved for listing at the same time, it is not too easy to say which company can capture a larger market share. Moreover, from the perspective of efficacy, in the key phase III trials, both drugs significantly improved lung function compared to placebo; in terms of safety, both drugs were contraindicated in patients with liver problems.

Now, how to seize more market share will depend on the commercialization of the two companies. However, InterMune employs less than 400 people, and it can't beat Boehringer on its own. However, in August of this year, Roche signed an agreement to acquire InterMune for a $8.3 billion premium of 38%. The deal was largely due to Roche's potential for Esbriet. While Roche has a large sales force, it appears that the deal is quite sensible.

The FDA approved two kinds of drugs at the same time. This move is very beneficial to Boehringer. It directly cuts off the initial listing advantages expected by InterMune and Roche. However, the FDA's move was a bittersweet taste for InterMune, because as early as 2010, the FDA had refused to approve the listing of Esbriet. InterMune later submitted new phase III data before winning the FDA's heartfelt conviction.