Drug developer Sanofi-Aventis said Monday it will stop seeking regulatory approval for a stalled insomnia drug candidate and a prospective heart condition treatment.
In September, the company received a request from the Food and Drug Administration for more information on the chronic insomnia treatment eplivanserin. At the time, the agency asked for more detail on the drug candidate's risk profile. On Monday, the company said it will no longer seek approval of the drug in the U.S. or Europe, citing the need for significant further development and market constraints.
Sanofi-Aventis already makes the insomnia treatment Ambien, which recorded third-quarter U.S. sales of about $177.7 million, about the same as in the same period last year.
Meanwhile, the company is also pulling its application for idrabiotaparinux as a potential anticlot drug for patients suffering from abnormal heart rhythm.
"Considering recent therapeutic advances in this field, this compound does not appear able to bring significant improvement in the care of these patients," the company said.
Meanwhile, the company received a positive recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency for DuoPlavin. The drug is aimed at treating blood clots in patients with heart conditions who are also taking the anticlot drug clopidogrel and aspirin.
The European Medicines Agency normally follows the advice of its advisory committee.
Additionally, the Food and Drug Administration granted the potential prostate cancer treatment cabazitaxel fast track designation, allowing for a rolling review process. Sanofi-Aventis said it is in ongoing discussions regarding the drug's application with European regulators.
On Monday, Sanofi-Aventis also announced it will buy the U.S. health care company Chattem Inc. for about $1.9 billion in cash. Sanofi-Aventis said the deal would create the world's fifth-largest consumer health care company. Chattem, based in Chattanooga, Tenn., makes consumer health care products such as Gold Bond skin care creams and Icy Hot pain relief medicine.
U.S.-traded shares of Sanofi-Aventis, based in Paris, rose 18 cents to $39.29 in morning trading.