Transcept, partner sue to protect new sleep drug from generic competitors

Transcept CEO Glenn Oclassen.

Four months after launching a middle-of-the-night sleep drug, Transcept Pharmaceuticals Inc. and partner Purdue Pharma are facing down generic competitors. Units of Actavis Group and Watson Laboratories filed abbreviated new drug applications with the Food and Drug Administration in July to sell generic versions of Intermezzo tablets, Richmond-based Transcept (NASDAQ: TSPT) said in a Tuesday filing with the Securities and Exchange Commission. Transcept and Purdue, which sells Intermezzo, on Aug. 23 filed a patent infringement suit against Actavis in U.S. District Court in New Jersey. They filed another suit Monday against Parsippany, N.J.-based Watson.

Transcept seeks $37M from stock offering

Transcept Pharmaceuticals Inc. would use some of the $37.6 million it hopes to net from a public stock offering to sell its FDA-approved middle-of-the-night sleep drug and to move forward with a drug for obsessive compulsive disorder. Transcept priced the offering of 4.5 million shares at $9 per share.

One-on-One with Transcept Pharma's Glenn Oclassen

It took two tries with federal regulators and a driving study in The Netherlands, but Transcept Pharmaceuticals Inc. is waking up plans for its middle-of-the-night sleep drug.
Transcept won’t be resting, though. In fact, 2012 is shaping up as an interesting year in terms of revenue growth (think royalties), hiring and acquisitions for the 18-employee company.
I talked to Transcept President and CEO Glenn Oclassen about Intermezzo, what the company gained and lost in the FDA approval process and its plans for next year.

Transcept could land $90M after Purdue opts for sleep drug

Purdue Pharma LP exercised its option for U.S. rights to the middle-of-the-night sleep drug Intermezzo, developed by Richmond’s Transcept Pharmaceuticals Inc.
Transcept (NASDAQ: TSPT), which lost $30 million in potential Purdue payments after the Food and Drug Administration twice rejected the drug, now could receive up to $90 million in milestone payments.
The FDA finally approved Intermezzo last month. Purdue had until Dec. 8 to exercise its option on the lozenge, which is designed to help people go back to sleep for up to four hours after waking up in the middle of the night.

FDA approves Transcept middle-of-the-night sleep drug Intermezzo

Transcept Pharmaceuticals Inc.’s middle-of-the-night sleep drug won approval Wednesday from the Food and Drug Administration.
Now it is up to Purdue Pharmaceuticals, the partner of Richmond-based Transcept (NASDAQ: TSPT), to say if it will commercialize the lozenge, called Intermezzo. Purdue has until Dec. 8 to notify Transcept of its decision.

Impax, Purdue Pharma in patent fight over painkiller OxyContin

Generic drug maker Impax Laboratories Inc. is challenging patents underpinning the blockbuster Purdue Pharma LP painkiller OxyContin.
Hayward-based Impax (NASDAQ: IPXL) said Monday that it filed an abbreviated new drug application, or ANDA, for a generic version of OxyContin in various controlled-release tablet doses. It sought so-called “Paragraph IV” certification, which claims that its drug does not infringe on patents or that those patents are unenforceable.
Stamford, Conn.-based Purdue, as well as Rhodes Technologies the University of Texas system’s board of regents and Grunenthal GbmH, filed suit Friday in the U.S. District Court for Southern New York, claiming that Impax’s generic oxycodone hydrochloride infringes on patents.