Sanofi-Aventis’ sleeping pill franchise has received a boost with the news that the US Food and Drug Administration has given its approval for Ambien(zolpidem) to be prescribed to children.
The granting of pediatric exclusivity covers both Ambien and Ambien CR, the controlled-release version of the drug; the French firm said that the decision was made on data that had been requested by the FDA in December 2005.
The decision means that patent protection for Ambien, which had been due to expire in October, will now be extended by six months at least, with Sanofi taking advantage of the 180-day exclusivity period.
Ambien is an important drug for the firm, given that third-quarter sales were 543 million euros, up 34% on the previous year. And also of benefit to the French drugmaker are the problems that potential rivals are having in
getting into the insomnia market. Neurocrine Biosciences recently said that its drug candidate indiplon, which is being developed with Pfizer, needs additional clinical testing before it can secure approval in the USA.
Sanofi analysts singing its praises
Meantime, analysts at Dresdner Kleinwort have been singing the praises of Sanofi , saying that investors are ignoring the good news coming out of the company and the stock is looking “very cheap.”
The broker added that Sanofi has unnoticed short and long-term value, given that 10 new drug filings are scheduled by 2008 and it claims that fears over reimbursement for the new obesity drug Acomplia (rimonabant) and the generic threat to antithrombotic Plavix (clopidogrel) are overdone. Dresdner Kleinwort noted that Plavix generic battle may now be settled by February,much earlier than expected, and reiterates its buy recommendation on the stock.