Shire gears up to battle Allergan's Linzess with new constipation drug Motegrity

Takeda is set to gulp up Shire, whether disgruntled investors like the deal or not. But for those in the latter camp, the biotech’s latest approval may make it easier to swallow. 

The company has picked up an FDA blessing for Motegrity, which will take on rivals from Allergan and Synergy in the chronic idiopathic constipation market. Unlike its competitors, Motegrity works by stimulating muscle movement in the colon, Shire said.

“The approval of Motegrity marks a new day in the treatment of CIC,” Howard Mayer, M.D., Shire senior vice president and chief medical officer, said in a statement.

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Industry watchers had been expecting a go-ahead for the drug this week ahead of the FDA’s Dec. 21 decision deadline in light of a unanimous agency panel vote from October. An advisory committee voted 10-0 in favor of approval, signaling its satisfaction with Shire data showing the drug didn’t come along with the same cardiovascular safety risks as other products in its class of 5-HT4 treatments.

It’s a win both for Shire and for its soon-to-be parent Takeda, which snagged at least 88% of investor approval earlier this month for its $62 billion buyout of the Dublin drugmaker. Still, some holdouts had publicly disdained the deal, and the price raised some eyebrows along the way thanks to Shire’s trailing position in the hemophilia market.

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Motegrity, though, was one candidate Takeda held up in support of the deal. Another, now known as Takhzyro, nabbed its regulatory green light in August as a treatment for hereditary angioedema, and it’s gotten off to a flying start.

If Motegrity wants to follow suit, though, it’ll have to stare down Allergan’s Linzess, the longtime leader in the field. It’s a feat Synergy, maker of Trulance, hasn’t managed; its drug racked up just $11 million in third-quarter sales, compared with Linzess’ $205 million. Valeant, which recently placed a stalking horse bid to snatch Trulance out of bankruptcy, is hoping it can turn that performance around, but it’s facing its own competitive woes in the gastrointestinal space.