Cephalon, Inc. (CEPH) recently received priority review from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for Nuvigil. The company had filed the sNDA in June 2009, seeking to expand Nuvigil’s label as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel. Priority review status means that a response from the agency will be out in six months instead of the usual 10-12 month review period. As such, a response from the FDA should be out by December 29, 2009. Nuvigil is Cephalon’s follow-on sleep franchise product which received FDA approval in June 2007 for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD). Cephalon launched Nuvigil in June 2009 and is promoting the product aggressively. The company has ...

Tender Offer for Taro Pharma Tarries Along India's largest generic drug company [web link to analysis of this market] by market cap, Sun Pharma (Bombay: 524715), and Israel-based Taro Pharma (TAROF) have one month to reach agreement on an outstanding tender offer of $7.75 per share by Sun Pharma to acquire its smaller rival or the Israel Supreme Court will decide on the case. In early 2007, Taro agreed to the deal as it was struggling to survive and Sun invested $60M as part of a private placement to resolve Taro's liquidity issues. However, in May of this year Taro cancelled Sun Pharma's takeover of the Company and in September a Tel Aviv District Court dismissed Taro's argument that ...

The accompanying table includes the Top 25 rated companies with market caps over $50M U.S. Dollar which are included in the ETF Innovators [ETFI] Indian Generic Drug Index as a major component in the Global Generic Drug Index. The index also includes three companies based outside of India – Akorn (AKRX), Caraco Pharma (CPD), and Taro Pharma (TAROF). Akorn has a joint venture with Strides Arcolab (Akorn-Strides, LLC) which is focused on the hospital market for generic injectables, dominated by Hospira (HSP) and APP Pharma, which was acquired by Fresenius Medical (FMS). Taro is involved in litigation with India's largest generic drug company by market cap, Sun Pharma, to fend off a tender offer which Taro claims undervalues the company since its has completed ...