Biotech targets Bayer growth hope Stivarga with IPR challenge

Bayer is counting on cancer med Stivarga to provide some serious growth going forward. But San Francisco’s Fustibal has other plans.

The biotech has filed a petition seeking an inter partes review of one of Bayer’s Stivarga patents with the U.S. Patent Trademark Office’s Patent Trial and Appeal Board (PTAB). The PTAB will now weigh whether to embark on that review. If it does, it could put the IP shield--which provides Stivarga exclusivity through February of 2031--in jeopardy.

Of course, there’s no guarantee the PTAB will go that route; as short-seller Kyle Bass has shown, getting a review initiated isn’t exactly a walk in the park. Bass, who has sought to use the IPR process to challenge the patents of companies whose stocks he’s shorting, has seen multiple review bids turned away by the PTAB.

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As he’s also shown, though, it’s possible to get the PTAB to reverse course with a second petition. Just look at Biogen ($BIIB) multiple sclerosis star Tecfidera: After the board denied Bass’ request for a review of the med last year, Bass scored a review this March with a follow-up petition.

Bayer, for one, is hoping to see the petition stopped dead in its tracks as soon as possible. The company has pegged Stivarga as one of 5 products that’ll drive the bulk of its growth going forward, and it’s made recent strides in expanding the med’s prospects. In May, the German drugmaker announced that the therapy--currently approved to treat metastatic colorectal cancer and metastatic gastrointestinal stromal tumors--had come up big in a trial of patients with unresectable liver cancer, which could represent a big new market opportunity.

And Stivarga may have to play an even bigger role going forward now that Adempas--another of Bayer’s Big 5 growth hopefuls--has run into some hurdles.  Earlier this year, the Leverkeusen-based pharma shut down a trial of the pulmonary arterial hypertension treatment in PAH patients with idiopathic interstitial pneumonias, scuttling hopes of a label expansion down the line.

- read Fustibal's release

Special Reports: The top 15 pharma companies by 2014 revenue - Bayer | The most influential people in biopharma today - 2016 - Kyle Bass - Hayman Capital

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