Actavis : 180-day marketing exclusivity in the US for Zolpidem Tartrate extended-release tablets, USP 6,25mg CIV

19 OCT 2010 - Actavis has received approval from the FDA to market Zolpidem Tartrate Extended-Release Tablets, USP 6,25mg CIV in the United States. Distribution of the product has commenced.

As the first company to file an ANDA that contained a paragraph IV certification for Ambien® CR 6,25mg, Actavis has been awarded 180-day exclusivity to market this product.

Zolpidem Tartrate extended-release tablets 6,25mg, the generic equivalent of Ambien® CR 6,25mg by Sanofi-Aventis, had US sales of approximately USD129 million for the 12 months ending 30 June, 2010 (IMS Health data)... Actavis' Press Release -

Sanofi-aventis and Nichi-Iko Pharmaceutical : New Joint Venture for Generics in Japan

May 28, 2010 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Nichi-Iko Pharmaceutical Co., Ltd. (Nichi-Iko) (Osaka Stock Exchange and Nagoya Stock Exchange: NIK) announced that they have signed an agreement to establish a new joint venture, called sanofi-aventis Nichi-Iko K.K., in order to develop a generic business in Japan.
The new joint venture will be held at 51% by sanofi-aventis K.K. and at 49% by Nichi-Iko. In addition, sanofi-aventis will acquire 1,524,500 shares of Nichi-Iko, to be issued through a third-party allocation, and as a result will hold 4.66% of Nichi-Iko. Nichi-Iko is the leader and fastest growing generics company in Japan, with 2009 sales reaching 54.8 billion JPY - around 460 million Euros...

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...As a first step, the joint venture will take over the marketing and distribution rights in Japan for the antiinsomnia agent Amoban (zopiclone) from sanofi-aventis K.K. AmobanTM sales reached 5.1 billion Yen - or 43 million Euros* in 2009. Nichi-Iko will ensure the promotion and distribution of AmobanTM through its large network of pharmacies, wholesalers and medical institutions... [PDF] Sanofi-aventis' Press Release - [PDF, Japanese] Nichi-Iko Pharmaceutical's Press Release -

Sanofi-aventis : Ambien CR Improved Insomnia and Daily Functioning in Patients with Co-Morbid Major Depressive Disorder

June 10, 2008 - Sanofi-aventis announced today results from a new study that showed Ambien CR(R) (zolpidem tartrate extended-release) CIV tablets 12.5 mg provided significant improvement in sleep onset, sleep maintenance and total sleep time over 8 weeks in patients with co-morbid insomnia and major depressive disorder (MDD) who were administered a Selective Serotonin Reuptake Inhibitor (SSRI) for depression. Ambien CR also improved sleep-related next-day functioning measures. This data was presented at the SLEEP 2008 22nd Annual Meeting of the Associated Professional Sleep Societies (APSS)... [PDF] Sanofi-aventis' Press Release -

Sanofi-aventis : Positive results from GEMS, the third Phase III trial evaluating eplivanserin in sleep quality

April 30, 20008 - ... Eplivanserin : Sanofi-aventis announced today that the GEMS Phase III study shows that the 5-HT2A antagonist eplivanserin in development for the treatment of insomnia characterized by sleep maintenance difficulties/night- time awakenings significantly reduces WASO (Wake time After Sleep Onset) and the number of night-time awakenings reported by the patient at 6 and 12 weeks of treatment, versus placebo. An improvement of the quality of sleep was also observed in the study.

These results confirm those of the EPLILONG study (phase III study conducted in similar conditions), which also showed that eplivanserin significantly reduces WASO and the number of night-time awakenings reported by the patient at 6 and 12 weeks, versus placebo and improves the quality of sleep... [PDF] Sanofi-aventis' Press Release -