Healthcare Industry News:  metformin 

Biopharmaceuticals Generics Litigation

 News Release - December 20, 2006

Depomed Announces Sweeping Interim Victory in Litigation against Ivax

MENLO PARK, Calif.--(HSMN NewsFeed)--Depomed, Inc. (NASDAQ:DEPO ) today announced a favorable "Markman" decision by Judge Charles Breyer of the United States District Court for the Northern District of California in Depomed's patent infringement case against Ivax Corporation. Depomed sued Ivax for infringement of U.S. Patent Nos. 6,340,475 and 6,635,280 by Ivax's extended release metformin hydrochloride tablets. The patents are held by Depomed and relate to the company's AcuForm(TM) drug delivery technology. Depomed's Glumetza(TM) product is covered by these patents.

After comprehensive briefing and oral argument, Judge Breyer filed a Markman order rejecting all interpretations of the patent claims that Ivax had proposed in an effort to avoid a ruling of patent infringement. Instead, the District Court affirmed Depomed's understanding of the scope of the disputed patent claims, which are directed to novel compositions for controlled delivery of metformin and other highly soluble drugs. As a result of this ruling, the case is now scheduled to proceed through discovery and trial. In addition, Depomed is permitted to ask the District Court for a summary ruling that Ivax is infringing Depomed's patents without the need for trial.

"We are extremely pleased that the Court rejected Ivax's suggestion that our patents should be narrowly interpreted and are confident in our position going forward to trial," said John Fara, chairman, president and chief executive officer. "Importantly, we believe this ruling confirms the breadth of our intellectual property portfolio in this important technology."

Depomed is represented by Michael Plimack of Heller Ehrman, LLP.

About Depomed, Inc.

Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative AcuForm(TM) drug delivery technology to develop novel oral products and improved, extended release formulations of existing oral drugs. AcuForm-based products are designed to provide once daily administration and reduced side effects, improving patient convenience, compliance and pharmacokinetic profiles. ProQuin® XR (ciprofloxacin hydrochloride) extended-release tablets have been approved by the FDA for the once daily treatment of uncomplicated urinary tract infections and are currently being marketed in the United States. In addition, once daily Glumetza(TM) (metformin hydrochloride extended release tablets) has been approved for use in adults with type 2 diabetes and is currently being marketed in the United States and Canada. The company is conducting a Phase III trial in postherpetic neuralgia and has completed a Phase II trial in diabetic peripheral neuropathy with its product candidate, Gabapentin GR(TM). Additional information about Depomed may be found at its web site, www.depomedinc.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to our litigation against Ivax Corporation; our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; the timing of regulatory applications and product launches; and other risks detailed in the company's Securities and Exchange Commission filings, including the company's Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.


Source: Depomed

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