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Eliquis and Ryzodeg feature among Japan's year-end approvals

Actonel and Neupro also given green light

Japan's regulatory authority cleared a new batch of products as 2012 drew to a close, including Bristol-Myers Squibb and Pfizer's blood thinner Eliquis; Novo Nordisk's once-daily basal insulin Ryzodeg; Takeda's once-monthly osteoporosis drug Actonel; and UCB and Otsuka's Parkinson's disease drug Neupro.

The Ministry of Health, Labour and Welfare (MHLW) cleared Eliquis (apixaban) for the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation, at around the same time as the anticoagulant was given a green light by the US FDA.

Eliquis has been tipped as a major new product for BMS and Pfizer and, despite a regulatory setback in 2011 when the FDA turned down an initial marketing application, is now approved in the three biggest pharma markets (the EU, US and Japan) as well as in Canada.

Eliquis is the third in a new generation of oral anticoagulants to reach the market after Boehringer Ingelheim's Pradaxa (dabigatran) and Johnson & Johnson/Bayer's Xarelto (rivaroxaban) but nevertheless is predicted to be a big seller, with Credit Suisse saying recently that peak sales could top $5bn.

Approval of combination product Ryzodeg (insulin degludec and insulin aspart) follows the registration of ultra-long-acting Tresiba (insulin degludec) as a monotherapy by Novo Nordisk in Japan (its first market) in September 2012.

Both Tresiba and Ryzodeg are considered critical new products for the Danish drugmaker as it tries to break into the long-acting basal insulin sector, which is currently dominated by Sanofi's Lantus (insulin glargine) product.

Analysts have predicted peak sales of $2bn to $4bn for the franchise, depending on whether Novo can convince doctors of the benefits of insulin degludec's long and predictable action and convenient once-daily dosing, and alleviate concerns about cardiovascular side effect.

Tresiba and Ryzodeg have been recommended for approval in the EU and US but a final decision on registration in these markets has yet to be made.

Takeda and partner Ajinomoto were also celebrating at the turn of the year after their once-monthly formulations of risedronate sodium hydrate - marketed respectively as Actonel and Benet - were approved for osteoporosis treatment by the MHLW.

In Japan, once-daily and once-weekly formulations of risedronate were launched in 2002 and 2007, respectively, but the country is playing catch-up with the once-monthly formulation. The depot version was first approved in 2008 and is already sold in a number of countries outside Japan.

Finally, Belgian drugmaker UCB and partner Otsuka received approval to market their transdermal patch product Neupro (rotigotine) for both the treatment of Parkinson's disease and for the symptomatic treatment of moderate-to-severe idiopathic restless legs syndrome in adults.

Otsuka has Japanese marketing rights for the patch, which delivers its dopamine agonist payload continuously over a 24-hour period. Neupro is now available in 35 countries and generated sales of around $125m in the first nine months of 2012.

2nd January 2013

From: Sales, Regulatory



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