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.

Onyx Pharmaceuticals CEO Tony Coles headlines SF Business Times Biotech Forum — June 14

Onyx Pharmaceuticals CEO Tony Coles will headline the San Francisco Business Times' annual Biotech Forum.
The event begins with registration at 7:30 a.m. Thursday, June 14, at the Hilton San Francisco Union Square, 333 O'Farrell St.
Coles will be interviewed on stage by San Francisco Business Times biotech reporter Ron Leuty before joining a panel of Bay Area biotech industry experts. In addition to Coles, the panel will feature:
• Gideon Bollag, senior vice president for research, Plexxikon;
• Lissa Goldenstein, president and CEO, Auxogyn;
• Craig Muir, partner, Third Rock Ventures; and
• Glenn Oclassen, president and CEO, Transcept Pharmaceuticals.
Additionally, the event will feature presentations from three up-and-coming Bay Area life sciences companies -- Avalanche Biotechnologies, Organ-i and Neuraltus Pharmaceuticals -- about their businesses and the big scientific problems they are trying to solve.
Christie Smith, principal and West region life sciences leader at Deloitte Consulting LLP, will give opening remarks.

To order tickets for the event, call or email Jacquie Bischoff at 415-288-4972 or jbischoff@bizjournals.com. Tickets cost $70 per person or $750 for a table of 10.

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.

Slideshow: Best Bay Area life sciences CEOs of 2011

It’s the most wonderful time of the year — slow news days that translate into “10 Best …” stories and other such lists summarizing the previous 12 months or predicting what’s going to happen during the next 12.
So, here’s my list of the best life sciences CEOs in the Bay Area. It’s a purely subjective undertaking, heavily weighted toward CEOs who managed through all or part of a year of adversity.

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.

Transcept resubmits middle-of-the-night sleep drug to FDA

Transcept Pharmaceuticals Inc. resubmitted its middle-of-the-night sleep drug to federal regulators, two months after the drug was rejected, the company said Tuesday.
The Richmond company (NASDAQ: TSPT) earlier this month said that it planned to resubmit the drug, called Intermezzo, by the end of September. The Food and Drug Administration has said its review of the new application could take as little as two months.

Transcept to resubmit rejected sleep drug to FDA this month

Transcept Pharmaceuticals Inc. will resubmit its middle-of-the-night sleep drug for FDA approval this month, the company said Wednesday.
Following a meeting with the Food and Drug Administration, Richmond-based Transcept (NASDAQ: TSPT) said it will not undertake new studies of Intermezzo, its drug to help people who wake up in the middle of the night. The FDA rejected the drug in July, citing concerns that the lozenge would be used properly.

Sleep drug rejection leads Transcept to cut jobs

Transcept Pharmaceuticals Inc. , whose middle-of-the-night sleep drug was rejected by regulators last week for a second time, said late Friday that it would lay off 45 percent of its workforce.
The Richmond company (NASDAQ: TSPT) didn’t say exactly how many employees would lose their jobs, but based on previous headcounts reported by Transcept, about 14 people will lose their jobs from a workforce of 31.

FDA to reject middle-of-the-night sleep drug, Transcept says

Regulators are putting Transcept Pharmaceuticals ’ middle-of-the-night sleep drug to rest.
The Richmond company (NASDAQ: TSPT) said Tuesday that it expects the Food and Drug Administration to reject its tablet, called Intermezzo, for the second time in 21 months.
Transcept and the FDA met in a teleconference earlier Tuesday, the company said, during which the FDA had continued safety concerns about the drug.

Transcept awakens bid for sleeping pill approval