Mixed appetite for Sanofi's new obesity pill
Tue Oct 31, 2006 2:00 PM GMT
By Caroline Jacobs and Ben Hirschler
PARIS/LONDON, Oct 31 (Reuters) - Sanofi-Aventis's <SASY.PA> new obesity pill Acomplia is selling well in Britain and Ireland.
In Germany, however, insurers have dismissed it as a "lifestyle" treatment and are refusing reimbursement.
The mixed response to the medicine, which switches off the same brain circuits that make people hungry when they smoke cannabis, highlights the challenge Sanofi faces in realising the drug's potential, according to industry analysts.
With timing of approval in the key U.S. marketplace still unclear, investors remain wary about a product Sanofi management has previously said could sell more than $3 billion a year.
So far, the drug has gone on sale in seven European markets plus Argentina and sales in the three months to Sept. 30 were 11 million euros ($14 million) -- mostly due to revenues in Britain, where it has been available on prescription since July.
Hanspeter Spek, head of pharmaceutical operations, told analysts on Tuesday that Acomplia's UK launch was comparable with the top six drug launches in Britain.
That puts take-up on a par with early sales of blockbusters such as GlaxoSmithKline's <GSK.L> asthma drug Seretide, AstraZeneca's <AZN.L> antiulcerant Nexium and Pfizer's <PFE.N> cholesterol pill Lipitor.
Julien Dormois, an analyst at investment firm Bryan Garnier, said the British launch was "really encouraging".
In Germany, however, where Acomplia was launched in September, uptake is threatened by a recommendation from state health insurers not to subsidise the medicine. Sanofi says it will appeal decision if it is ratified by the health ministry.
CONFLICTING VIEWS
Paul Diggle of Nomura Code Securities said there was a clear conflict in European government views. Acomplia will, for example, be reimbursed in Ireland without restriction. In Denmark, it is also reimbursable but only subject to prior authorisation in overweight patients with life-threatening obesity-related conditions.
Navid Malik of Collins Stewart believes reimbursement will remain an ongoing issue for Acomplia, given the relatively average weight loss seen in trials and a lack of clarity over further medical benefits.
Acomplia has been approved for use in Europe along with diet and exercise in treating obese patients or overweight people who also have diabetes or high cholesterol.
Paris-based Sanofi is positioning it as a medicine to reduce serious cardiovascular risks associated with excess abdominal fat, rather than as a weight-loss drug. It will present further data on its benefits to diabetics at a conference in December.
In the United States, the Food and Drug Administration is still discussing the product's approval with the company and Sanofi said it had submitted a full response to questions from the regulator on Oct. 26.
The U.S. market is expected to be make-or-break for Acomplia as a multibillion-dollar blockbuster, but just when the FDA will give its verdict remains unclear.
The timing of Sanofi's latest submission would imply an FDA action date either at the end of December or at the end of April, depending on whether the review is conducted under two-month or six-month rules.
David Beadle of UBS says a possible U.S. launch in mid-2007 now looks likely, though he is not ruling out further delays.
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