Does Takeda have its solution for post-Actos malaise? Yes, the Japanese drugmaker has finally won FDA approval for its new diabetes franchise, which revolves around the active ingredient alogliptin. But the triumvurate of new DPP-4 inhibitors--including the straight alogliptin Nesina and two combination pills--face some formidable rivals.
Takeda badly needs Nesina and its kin to make up the ground lost to Actos generics, which have severely eroded sales. Until the drug's patent expired last August, Actos accounted for more than half of Takeda's U.S. revenues, and 18% of its overall sales. The drug brought in more than $16 billion in U.S. sales over its brand-name lifetime. Since Actos fell off patent, the company has been laying off workers and predicting a decline in profits through 2015.
But the three new products are latecomers to the DPP-4 market. Merck's ($MRK) Januvia group leads the class with $3 billion-plus in annual sales, so it's the most daunting rival. But there's also Onglyza, the Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN) drug, part of a stepped up joint venture between the two companies. That partnership aims to hit the streets hard in support of its now-broader range of diabetes products. And there's Galvus, the Novartis ($NVS) drug.
The approval was a long time coming. Takeda faced repeated delays from the FDA, as safety scares prompted the agency to raise the bar on diabetes treatments. GlaxoSmithKline's ($GSK) Avandia may be the most egregious example; the drug was pulled in Europe and severely restricted in the U.S. after links to heart attacks and other cardiovascular problems surfaced. But Actos, Avandia's only head-to-head competitor, came in for its own questions after studies suggested an increased risk of bladder cancer in Actos patients.
Now, however, Nesina is here. Takeda has to conduct some post-marketing safety studies, including a cardiovascular outcomes study. The combination drugs will be subject to label warnings, too. Kazano, which pairs alogliptin with the standard diabetes therapy metformin, will get a lactic acidosis warning. Oseni, a combination of alogliptin and Actos, gets a heart failure boxed warning.
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