Biotechnology Events

Depomed, Inc.

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James A. Schoeneck, President and CEO, maintained guidance for the data read from the BREEZE-3 program. He stated, "As we said previously, we currently expect to have data from the BREEZE-3 pivotal trial report in fourth quarter of this year."
Source: Q2 2010 earnings conference call, 8/01/11.

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"With the approval and reacquisition of Gralise in the first quarter, Depomed is off to an excellent start in 2011. The results we achieved in the quarter position us well to launch the product later this year in a manner that optimizes the return to our shareholders," said James A. Schoeneck, Depomed's president and chief executive officer. "Our pipeline is promising, with menopausal hot flash product candidate Serada® completing Phase 3 enrollment in the first quarter and top-line results expected by the end of this year. We are pleased to add a potential revenue stream from Boehringer Ingelheim to our portfolio of technology collaborations that already includes Merck, Janssen and Covidien," Mr. Schoeneck added.
Source: press release, 5/5/11. http://investor.depomedinc.com/phoenix.zhtml?c=97276&p=irol-newsArticle&...

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Michael Sweeney, M.D., VP, R&D, gave guidance for BREEZE-III results. He stated, "We look forward to reporting BREEZE-III results in the fourth quarter of this year."
Source: Q4 2010 earnings conference call, 3/03/11.

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MENLO PARK, Calif., Mar 3, 2011 (GlobeNewswire via COMTEX) --

Depomed, Inc. (Nasdaq:DEPO) announced today that it has completed enrollment of Breeze 3, the company's pivotal Phase 3 clinical trial evaluating Serada(R) (extended release gabapentin tablets) for the non-hormonal treatment of menopausal hot flashes.
Source: press release, 3/03/11. http://investor.depomedinc.com/phoenix.zhtml?c=97276&p=irol-newsArticle&...

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MENLO PARK, Calif., Aug 11, 2010 (GlobeNewswire via COMTEX) -- Depomed, Inc. (Nasdaq:DEPO) announced today that it has
reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the
design and analysis of Breeze 3, a Phase 3 trial evaluating Serada(R) (extended release gabapentin tablets) for menopausal hot flashes.

Depomed is initiating Breeze 3 immediately as clinical sites are all on line with more than 200 patients in the screening
process already. Breeze 3 is expected to be completed by the end of the third quarter of 2011, with results to be reported in the fourth quarter.
Source: press release, 8/11/10. http://investor.depomedinc.com/phoenix.zhtml?c=97276&p=irol-newsArticle&...

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MENLO PARK, Calif., Jan 19, 2010 (BUSINESS WIRE) -- Depomed, Inc. (NASDAQ:DEPO) announced today it has received guidance
from the FDA in formal meeting minutes from a meeting held in December regarding SeradaTM, the company's extended release
gabapentin product candidate for the treatment of menopausal hot flashes. Based on guidance reflected in the meeting
minutes, Depomed plans to conduct a single additional pivotal Phase 3 trial evaluating Serada for the treatment of
menopausal hot flashes. The company expects to initiate the trial, which will be known as Breeze 3, by the end of April
2010 and to complete the trial by the end of the first quarter of 2011. The FDA has agreed to review the proposed Breeze 3 study protocol under the FDA's Special Protocol Assessment (SPA) process.

"We believe Serada continues to hold the potential to be the first non-hormonal treatment to address menopausal hot
flashes, a significant unmet need in women's health," said Michael Sweeney, M.D., Depomed's vice president, Research and
Development.
Source: press release, 1/19/10. http://investor.depomedinc.com/phoenix.zhtml?c=97276&p=irol-newsArticle&...

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BREEZE-3 - A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Gabapentin Extended Release (G-ER_ Tablets in the Treatment of Vasomotor Symptoms in Postmenopausal Women
Estimated Enrollment: 600
Study Start Date: August 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT01080300?term=depomed&phase=2&rank...

Mechanism of action: Serada™ is an investigational formulation of gabapentin, an FDA-approved immediate release pharmaceutical for the treatment of partial epilepsy and management of postherpetic neuralgia (PHN). Recently published studies suggest the potential application of gabapentin for the treatment of menopausal hot flashes. Based on these findings, the company has secured exclusive rights to develop and commercialize Serada™, an AcuForm™-enhanced formulation, for the treatment of menopausal hot flashes. Gabapentin is a small molecule that binds the α2δ subunit of the voltage-dependent N type calcium channel in the central nervous system.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2011-10-01 - 2011-12-31

Results:

Depomed Announces Top-Line Results From Serada(R) Phase 3 Trial BREEZE 3 in Menopausal Hot Flashes
Conference Call Today at 5:00 p.m. ET to Discuss Results

MENLO PARK, Calif., Oct 13, 2011 (GlobeNewswire via COMTEX) --

Depomed, Inc. (Nasdaq:DEPO) today announced top-line results from BREEZE 3, a Phase 3 trial evaluating the efficacy and safety of Serada(R) (extended-release gabapentin tablets) for menopausal hot flashes. Serada is a proprietary formulation of gabapentin using patented polymer technology that enables gradual release of the drug.
Source: press release, 10/13/11. http://investor.depomedinc.com/phoenix.zhtml?c=97276&p=irol-newsArticle&...