Transcept Insomnia Drug Fails to Win Approval
Transcept Pharmaceuticals Inc. (TSPT) said it failed to win U.S. clearance for the first drug specifically designed to help people get back to sleep after waking up in the middle of the night.
Transcept expects the Food and Drug Administration to issue a complete response letter asking for more information about the medicine, called Intermezzo, the Port Richmond, California-based company said yesterday in a statement. The treatment contains a low-dose of the active ingredient in Paris-based Sanofi’s sleeping pill Ambien and is given as a tablet that dissolves under the tongue.
Intermezzo is the first product for Transcept, a developer of neuroscience drugs. The company signed a licensing agreement with closely held Purdue Pharma LP in 2009. The product has been delayed since then because of the FDA concerns about dosing and safety, including whether patients’ driving ability is affected the next day.
“The FDA expressed continued concerns about the safety profile of Intermezzo” during a conference call yesterday, Transcept said in its statement. The company has “limited information about the full extent of the FDA concerns.”
The agency’s action date for a decision on the drug is tomorrow. The company said it would release further information and its plans for Intermezzo when it receives the FDA’s letter.
Transcept would get royalties of a percentage of U.S. sales from the mid-teens to mid-twenties under its agreement with Stamford, Connecticut-based Purdue, the maker of the pain pill OxyContin, according to Transcept’s annual report.
Sales Estimate
U.S. sales may reach $315 million in 2020, according to Christopher S. James, an analyst at McNicoll Lewis Vlak in New York. He recommended buying Transcept shares yesterday in a note to clients and predicted the stock will more than double to $20.
The company gained 35 cents, or 4.3 percent, to $8.59 at 4 p.m. New York time yesterday in Nasdaq Stock Market composite trading before its announcement. Transcept’s shares have fallen 22 percent this month, the biggest loss among 391 members of the Russell 3000 Health Care Index.
Intermezzo is designed to be absorbed rapidly by the body to help people get back to sleep quickly, while not knocking them out for as long as a typical sleeping pill would.
To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.
To contact the editor responsible for this story: Adriel Bettelheim at abettelheim@bloomberg.net.
Rate this Page