Merck & Co and Portola agree $470 million deal for Phase II anticoagulant
This article was originally published in Scrip
Merck & Co has bought the exclusive rights to Portola Pharmaceuticals' investigational oral Factor Xa inhibitor betrixaban. Merck plans to commit up to $470 million to develop and commercialise the anticoagulant for stroke prevention in atrial fibrillation.
Merck will pay Portola $50 million upfront and up to $420 million in milestones, as well as double-digit royalties on worldwide sales. Merck will assume all development and commercialisation costs, although Portola may co-fund Phase III studies, in return for additional royalties, and co-promote the drug in the US.
The deal broadens Merck's cardiovascular portfolio into the oral anticoagulant market that has been dominated by warfarin since the 1950s. Credit Suisse responded positively to the deal as it gives Merck access into an important emerging class of therapeutics.
The analyst group values the market at $5 billion by 2015 and believes that betrixaban could achieve US revenues of $350 million by the same date. Atrial fibrillation affects about seven million people globally.
The product is likely to be the fourth new anticoagulant to market after Johnson & Johnson/Bayer's Xarelto (rivaroxaban), Boehringer Ingelheim's Pradaxa (dabigatran etexilate) and Bristol-Myers Squibb/Pfizer's apixaban. However, Credit Suisse believes that its advantages will ensure that it makes significant market share gains.
Betrixaban directly inhibits Factor Xa and overcomes the limitations of other anticoagulants with a longer half-life to allow once-daily dosing and a low peak-trough concentration ratio, which means that it does not require monitoring or dose adjustment.
The compound has less renal excretion than Xarelto and apixaban, and also has a longer half-life than all three products, Credit Suisse said. The Phase II dose-ranging EXPLORE-Xa trial in 500 patients is expected to be fully enrolled by year-end.
Merck could also exploit the compound's potential in other indications, such as the treatment or prevention of life-threatening blood clots in patients undergoing high risk orthopaedic and general surgery, as well as those with acute and chronic illnesses.
Credit Suisse said that the terms of the agreement appear reasonable compared with Portola's deal earlier this year with Novartis for the Phase II antiplatelet elinogrel. That agreement cost the Swiss firm $75 million upfront, $500 million in milestones and 100% of costs, although royalties were not disclosed (scripnews.com, February 12th, 2009).