* European countries recall product after EU recommendation
* Acino says no health hazard exists
* Shares trade flat after slipping 2 pct
(Adds details, background)
ZURICH, April 13 (Reuters) - Swiss drugmaker Acino ACIN.S said its 2010 figures would be hit hard after various European countries recalled batches of its generic heart drug Plavix made at a factory in India.
“At this point in time, the value of goods subject to the recall is difficult to quantify. Acino will make a one-time provision for this in the current financial year,” the group said in a statement.
“Overall, this recall will have a significant negative impact on the 2010 result of Acino,” it said.
The decision by various European health authorities comes after Europe’s drugs watchdog recommended the recall in March because of a failure of good manufacturing practice (GMP) a factory in Visakhapatnam, India, where the active substance for the affected Acino product is produced. [ID:nLDE62O2HU]
Plavix, or clopidogrel, is sold as a brand by Sanofi-Aventis (SASY.PA) and Bristol-Myers Squibb (BMY.N), and is the world’s second biggest-selling medicine, with worldwide sales of more than $9 billion a year.
But the medicine is off patent in some European markets, where Acino is among companies supplying a cheaper generic version. Clopidogrel is the Swiss group’s top seller.
At 1025 GMT, shares in the group were trading near flat at 146 Swiss francs, recovering from an earlier slip of about 2 percent.
Acino said independent analyses had confirmed the quality of its clopidogrel, while inspecting regulatory authorities had also concluded the shortcomings found at the manufacturing site did not represent a health hazard.
“Acino explicitly points to the fact that the recall was ordered as a precautionary measure since, also in the opinion of the European Medicines Agency (EMA), no suspicion of a health hazard could be substantiated,” Acino said.
“As such, clopidogrel-containing medicines already supplied to patients can be used without restrictions,” the group added.
Acino also said Ratiopharm and Hexal, its marketing partners in its main market Germany, had decided to withdraw their clopidogrel-containing medicines using active ingredients from the Indian manufacturing site.
But both companies had been supplied with products containing an active ingredient from another source that is authorised across Europe.
Hexal and Sandoz are units of Novartis NOVN.VX, while Ratiopharm is an unlisted German drugmaker that was sold recently to Israeli generic drugs group Teva (TEVA.TA). [ID:nLDE62H25F] (Reporting by Katie Reid, editing by Will Waterman)