*Accutane been losing market share to generic alternatives
*Withdrawal unlikely to have any impact on earnings
(Adds background, generic company comments)
ZURICH, June 26 Swiss drugmaker Roche Holding
AG ROG.VX is no longer selling its acne drug Accutane as it
has reached the end of its life cycle and is losing ground to
generic alternatives, the company said on Friday.
Generics of the powerful medicine have been available since
2002 and now dominate the market, Roche said. Teva
Pharmaceutical Industries Ltd (TEVA.TA) and Mylan Inc (MYL.O)
said they will continue to sell generic versions.
"As always when you have generics around your market share
drops," Roche spokeswoman Martina Rupp said. "This was an
economical decision driven by falling market share." Accutane's
market share was between 4 and 5 percent.
Roche said the move was not done for safety or efficacy
reasons and was unlikely to have any impact on earnings.
The last date for distribution in the United States was
June 25. Accutane is now no longer available from Roche
directly but patients may still be able to get it from
pharmacies, she said.
Accutane, known generically as isotretinoin, has had a
controversial history since it began sale in 1982. While
powerful at clearing acne, the drug is linked to severe birth
defects if taken during pregnancy, so physicians and patients
must abide by a strict risk management program.
Accutane has also been suspected of other side effects,
such as causing depression and suicidal thinking.
The Swiss drugmaker noted on Friday it has been faced with
high costs from personal injury lawsuits that it continues to
defend against vigorously.
Roche shares rose 1.7 percent.
(Reporting by Katie Reid and Lewis Krauskopf in New York;
Editing by David Cowell and Richard Chang)