Second-line use, crowded market won't keep Takeda's Entyvio from blockbuster run

Takeda is finally over the hump with its inflammatory bowel disease drug Entyvio after safety questions threatened its approval. And while the drug will take a backseat to a few of the market's heavyweights, some analysts say that won't stop it from hitting the blockbuster mark itself.

IBD is a crowded arena, and thanks to a few setbacks in clinical trials, Entyvio won't get a chance to compete as a first-line therapy. Instead, it's approved as a second-line treatment for Crohn's and ulcerative colitis, in line with the recommendations an advisory committee made last December.

But that won't stop it from carving out its place in the market--and making a run for the billion-dollar-sales club. As Deutsche Bank analyst Tim Race pointed out in a note to investors, the approved label doesn't restrict the drug to patients who have tried anti-TNF antibodies. Those are the big guns--AbbVie's ($ABBV) Humira, Amgen's ($AMGN) Enbrel, and Johnson & Johnson's ($JNJ) Remicade and follow-up Simponi--that help suppress the immune system and rake in some of the world's biggest sales. Entyvio can also follow use of corticosteroids, like Santarus' ($SNTS) Uceris.

All things considered, Race told FiercePharma he expects peak sales to hit ¥107 billion ($1.06 billion) in 2020, with sales split 80:20 between ulcerative colitis and Crohn's. And if it does, Entyvio could be contributing more than 10% to Takeda's core earnings in 2018, he wrote.

That's good news for the Japanese pharma, which has struggled to follow up one-time diabetes heavyweight Actos. Last year, the FDA approved Nesina along with a pair of combo drugs, once expected to bring in $2.53 billion in 2016. But now, the consensus peak forecast on the trio has sunk to $788 million, leaving the company in need of some help curbing the profit decline it expects through 2015.

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Special Report: New drug approvals of 2013 - Nesina