Posts Tagged ‘TSPT’

Transcept Pharmaceuticals Inc. (TSPT) nearly doubles on drug review

Thursday, September 15th, 2011

Transcept Pharmaceuticals Inc. (Nasdaq: TSPT) shares rose 93.7% to $6.47 a day after the drug developer said U.S. regulators might finish a new review of its sleep drug within two months. Volume for the stock exceeded 3.8 million, towering above a daily average of only 235,000.

A news release out Sept. 14 noted that the company, headquartered in Point Richmond, Calif., plans to resubmit to the U.S. Food and Drug Administration (FDA) its New Drug Application (NDA) seeking approval of Intermezzo® (zolpidem tartrate sublingual tablet) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

The plan to resubmit the Intermezzo® NDA results from a meeting today with the FDA during which the FDA generally agreed with a Transcept proposal to reduce the recommended Intermezzo® dose for women from 3.5 mg to 1.75 mg, and to keep the recommended Intermezzo® dose for men at 3.5 mg. The Transcept proposal also includes new instructions stating that Intermezzo® should only be taken if patients have at least four hours of bedtime remaining, and that patients should refrain from driving for at least one hour after arising and until five hours after dosing Intermezzo®.

In the same release, Transcept CEO Glenn A. Oclassen was quoted as saying “We are pleased that the FDA has expressed general agreement with our proposal to address the concerns expressed in the July 2011 Intermezzo® Complete Response Letter. We look forward to working with the FDA to complete the review of this important new treatment strategy for insomnia characterized by middle of the night awakening.”

Transcept is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience.

Transcept Pharmaceuticals Inc. (TSPT) – Buzz Stock of the Day

Monday, August 3rd, 2009

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Shares of Transcept Pharmaceuticals, Inc. (NASDAQ: TSPT) jumped $3.75 or 64.7 percent to $9.55 in morning trading on Monday, after the company announced a licensing deal for its insomnia treatment with Purdue Pharmaceuticals for up to $145 million, and royalty payments.

“This agreement is a transforming event for Transcept,” said Glenn A. Oclassen, President and CEO of Transcept Pharmaceuticals in a statement.

[–quote–]

Under the terms of the agreement, Purdue was granted the exclusive rights to sell Intermezzo in the U.S. and is able to negotiate for its approval in Mexico and Canada. Transcept Pharmaceuticals retains the rights to the drug in all other countries and has the option to co-promote Intermezzo to psychiatrists in the U.S.

The agreement states that Purdue will pay Transcept $25 million upfront, and up to $30 million more based on approval timing by the FDA. Additionally, Transcept could receive as much as $90 million more based on future benchmarks related to intellectual property and sales milestones.

The deal also includes royalties of greater than 10 percent and as much as about 25 percent for the Richmond, Calif.-based Transcept. If Transcept exercises the psychiatric co-promotion option, it will receive an additional double-digit royalty on those sales. Transcept can begin co-promotion as soon as one year after launch.

“We are excited to be working with Transcept towards the launch of this potential new entry into the prescription sleep aid market,” said Purdue’s President and CEO John H. Stewart. “This agreement is part of Purdue’s plan to diversify our product portfolio and broaden our commercial focus into therapeutic areas that complement our leadership position in pain.”

The active ingredient in Intermezzo is zolpidem, the same active ingredient in other insomnia sleep aids, such as Ambien. However, Intermezzo only has about one-third-to-one-quarter zolpidem as other insomnia treatments.

“We believe that Intermezzo has the potential to occupy an important position in the substantial worldwide market for prescription sleep aids, and that our U.S. partnership with Purdue is a key step toward the commercial success of Intermezzo.”