Stedesa PDUFA date extended 3 months to April 30, 2010 (NASDAQ:SEPR), (TYO:4506)

Stedesa (eslicarbazepine acetate) is a drug for adults who are suffering from epilepsy, which is a chronic and common neurological disorder that causes frequent seizures. This drug has been developed by Sepracor Inc. (NASDAQ:SEPR). On March 31, 2009, the company announced that it has submitted the new drug application (NDA) to get the approval of Food & Drug Administration to market Stedesa. According to the Prescription Drug User Fee Act, the United States of America’s toughest regulator FDA had to review the submitted NDA within 60 days from March 31. As a result, on June 1, 2009, Sepracor announced that the FDA had reviewed the NDA of Stedesa and found out the NDA contains sufficient information for allowing a thorough review, i.e. the NDA has been accepted for filing. Also, the FDA has given it a Prescription Drug User Fee Act date (also called Action date or PDUFA date). This is the date on which the Food & Drug Administration must respond to Sepracor’s application for marketing approval of Stedesa. According to Sepracor Inc., the new PDUFA date for Stedesa is April 30, 2010 which is an extension to the original PDUFA date of January 30, 2010.

After the acceptance of the NDA for filing, Adrian Adams, who is the Chief Executive Officer and President of Sepracor, said,

“We are very pleased to continue the advancement of STEDESA as a potential new adjunctive treatment for partial-onset epilepsy. STEDESA represents a significant and near-term opportunity for Sepracor, and the FDA acceptance of the NDA is yet another step forward in one of our near- and mid-term corporate objectives of expanding and advancing our pharmaceutical product pipeline.”

Inspired by the favorable response from the FDA in the United States of America, the company’s subsidiary in Canada, Sepracor Pharmaceuticals Inc. (SPI, previously known as Oryx Pharmaceuticals Inc.) submitted the New Drug Submission (NDS) application seeking approval for marketing Stedesa from the Therapeutic Products Doctorate (TPD) of Health Canada which is the Canadian equivalent of FDA.

While discussing the monumental movement made by Sepracor and its Canadian subsidiary, Adrian Adams said,

“This NDS is our first submission in Canada since our strategic acquisition of Oryx Pharmaceuticals in June of last year, and we are pleased to take this important step in what we hope to be the first of several submissions to Health Canada in the coming years. This advance follows our recent New Drug Application submission for Stedesa in the United States and is a manifestation of the value of the successful corporate development and licensing initiatives that Sepracor has executed to date.”

Things were looking so good for Sepracor, which is “a research-based pharmaceutical company dedicated to treating and preventing human disease by discovering, developing and commercializing innovative pharmaceutical products” and its epilepsy drug Stedesa that no one could have predicted the company’s announcement that came on September 3, 2009. The company disclosed that it was entering an agreement with Dainippon Sumitomo Pharma Co., Ltd. (TYO: 4506) (DNPUF.PK), “a top-ten listed pharmaceutical company based in Osaka, Japan”. The agreement would “allow DSP to acquire Sepracor for approximately $2.6 billion through a cash tender offer of $23.00 per share, followed by a merger to acquire all remaining outstanding Sepracor shares at the same price paid in the tender offer”. This meant the DSP was given the ownership of Sepracor’s fully integrated pharmaceutical infrastructure in both Canada and the USA. DSP now also own the huge number of pharmaceutical products, such as Stedesa, that are under Sepracor’s pipeline.