PARIS (Reuters) - Sanofi SA has won U.S. approval for its multiple sclerosis (MS) pill Aubagio - one of the two treatments for the chronic disease that could return the French drugmaker to growth after several blockbuster drugs lost patent protection.
The drug is less effective than some rivals but has milder side effects and analysts say it could find favor among newly diagnosed patients. Around 35-40 percent of MS sufferers prefer to take no medication rather than face unwanted side effects.
Aubagio is expected to launch on the U.S. market in a few weeks, a spokeswoman for Sanofi unit Genzyme said.
The medicine will cost $45,000 for a year's treatment, making it cheaper than rivals and indicating Sanofi is ready for a commercial battle to win market share.
Novartis AG's Gilenya - the only other MS pill currently on the market - costs 28 percent more, while injectable treatments such as Biogen Idec Inc's Avonex and Teva Pharmaceutical Industries Ltd's Copaxone are 8 and 6.5 percent higher respectively.
Deutsche Bank analysts said the U.S. green light for Aubagio gave comfort that Sanofi could deliver new drugs from its late-stage pipeline but expectations for the medicine were not particularly high, given its modest efficacy.
Aubagio reduced the risk of MS relapses by about 30 percent in clinical tests, which is comparable to the efficacy of the older injectable drugs but less potent than either Gilenya, which showed a reduction of over 50 percent, or Biogen's experimental product BG-12.
Shares in Sanofi were 0.2 percent higher by 1220 GMT on Thursday, in line with a steady market for European drug stocks. Analysts said many investors had been anticipating U.S. approval for Aubagio in recent days.
$14 BILLION MARKET
Multiple sclerosis, which has no cure, affects 2.5 million people worldwide. It is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, paralysis and loss of vision.
Oral medicines like Aubagio offer a convenient and effective alternative to injections but Gilenya and BG-12 are widely expected to dominate the market that JPMorgan analysts see growing to $14 billion in 2015 from $9.6 billion last year.
Aubagio is likely to grab a relatively small chunk of this market, with worldwide sales expected to reach around $400 million in 2016, according to consensus forecasts compiled by Thomson Reuters Pharma.
Cheuvreux analyst Marcel Brand, who has a more optimistic forecast, predicts peak sales of Aubagio of 1.48 billion euros ($1.91 billion) by 2018. "Although Aubagio is not as effective on relapse rates as Gilenya, it's free of its longer-term side effects," he said.
Patients taking Gilenya have to be monitored because the drug causes the heart rate to slow down in the first hours after ingestion.
European regulators are expected to give their response to Aubagio in the first quarter of 2013.
In addition to Aubagio, Sanofi has filed for approval for MS injectable drug Lemtrada.
In a recent setback, however, the FDA asked Sanofi to refile its marketing application for Lemtrada. If it wins approval, the drug could be launched in 2013.
The most common side effects associated with Aubagio include increased levels of the enzyme alanine transaminase, which can indicate damage to the liver, as well as hair loss, diarrhea, influenza, nausea and numbness of the skin, Sanofi said.
The ongoing Aubagio clinical development program involves more than 5,000 patients in 36 countries. Some patients in extension trials have been treated for up to 10 years, the company said.
($1 = 0.7759 euros)
(Additional reporting by Tej Sapru, Sunayan Bhattacharjee and Ben Hirschler; Editing by Edwina Gibbs and Mark Potter)
Source: http://news.yahoo.com/sanofi-multiple-sclerosis-pill-gets-u-approval-030541796--finance.html
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