Daiichi Sankyo gets EMA recommendation on clot buster

Japan's Daiichi Sankyo got some helpful news today as its works desperately to bring new revenue in the door ahead of next year's patent loss on its foundational product Benicar. The advisory group of the European Medicines Agency (EMA) recommended approval of Daiichi's new generation anticoagulant in Europe.

The EMA's Committee for Medicinal Products for Human Use (CHMP) gave a thumbs up for edoxaban, which Daiichi is marketing as Lixiana in Europe and Savaysa in the U.S. The drug won FDA approval in January, although with a black-box warning. CHMP recommended it be used to reduce stroke in patients with atrial fibrillation and treat deep vein thrombosis and pulmonary embolism,

An approval, which traditionally follows a recommendation by a couple of months, will help the drug generate some more revenue, but it lands in a market already dominated by competitors like Johnson & Johnson ($JNJ) and Bayer's Xarelto, the leader among the next-gen treatments, as well as Boehringer Ingelheim's Pradaxa and Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) Eliquis.

Estimates are the anticoagulant could bring in $220 million in sales for fiscal 2019, but that is roughly one-tenth of the revenue generated by cardio blockbuster Benicar. The drug's $2.6 billion haul last fiscal year accounted for 27% of Daiichi Sankyo's revenues. The company is making cost-cutting moves as well, and last month said it would whack 16% of its U.S. staff, with more cuts possibly coming. Analyst musings have been that Daiichi will not see growth for 5 years.

The company was able to improve its fortunes this month by disentangling itself from Ranbaxy Laboratories, the Indian generics maker that it bought in 2008 and whose regulatory problems sucked the value out of that play. Daiichi in March completed its $3.2 billion all-stock deal to sell Ranbaxy to India's Sun Pharmaceutical and then last week sold its 9% stake in Sun for about $3.6 billion. That might give the company some cash to make a small acquisition, a move some analysts have suggested could help.

- here's the EMA announcement

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