Healthcare Industry News: Biovail
News Release - February 12, 2007
Depomed and Biovail Sign License Agreement for AcuForm(TM) Drug Delivery TechnologyMENLO PARK, Calif. & TORONTO--(HSMN NewsFeed)--Depomed, Inc. (NASDAQ:DEPO ) and Biovail Corporation (NYSE:BVF ; TSX:BVF ) announced today that the companies have entered into an agreement that provides Biovail with access to Depomed's proprietary AcuForm(TM) drug delivery technology for the development of up to two Biovail products.
Under the terms of the agreement, Depomed has granted Biovail Laboratories International SRL, a subsidiary of Biovail, an option to license Depomed's AcuForm technology to develop and commercialize up to two pharmaceutical products. Biovail may select these products from an agreed-upon list of compounds at any time over the next 18 months. Depomed will have no development obligations under the agreement.
In return, Biovail has paid Depomed an upfront fee of $500,000, and is contingently obligated to pay Depomed additional fees related to the exercise of the license option, the initiation of the first Phase 3 trial for each product and upon receipt of U.S. regulatory approval for each product. The agreement also stipulates that Biovail make royalty payments to Depomed on net commercial sales of any product developed under the agreement.
"We are very pleased to have entered into this agreement with Biovail for our AcuForm technology, further validating the potential for its broad utility," said John Fara, Ph.D., Depomed's chairman, president and chief executive officer. "Given Biovail's in-depth familiarity with the AcuForm platform, we are confident that they have the know-how to develop additional products without any diversion of our resources from current projects."
Dr. Douglas Squires, chief executive officer of Biovail, said, "This agreement with Depomed is another example of Biovail leveraging strategic partners with complementary drug-delivery technologies to further deepen its drug-development pipeline."
In addition, Depomed and Biovail have amended their May 2002 Security Purchase Agreement to eliminate Biovail's Board observer rights and right of first negotiation related to any Depomed acquisition transactions.
"Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995
To the extent any statements made in this press release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and within the meaning of the "safe harbor" provisions of applicable Canadian securities legislation.
Although both Depomed and Biovail believe that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. Important factors that could cause actual results to differ materially from these expectations include risks and uncertainties related to licensing arrangements between Depomed and Biovail Laboratories; 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 each party's Securities and Exchange Commission filings, including -- in the case of Depomed -- their Annual Reports on Form 10-K and most recent Quarterly Reports on Form 10-Q and -- in the case of Biovail -- their most recent Annual Report on Form 20-F.
Depomed and Biovail caution that the foregoing list of important factors that may affect future results is not exhaustive. When relying on forward-looking statements to make decisions with respect to Depomed or Biovail, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Neither company undertakes any obligation to update or revise any forward-looking statement.
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 3 trial in postherpetic neuralgia and has completed a Phase 2 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.
About Biovail Corporation
Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies. For more information about Biovail, visit the Company's Web site at www.Biovail.com.
For further information about Biovail, please contact Nelson F. Isabel at 905-286-3000 or send inquiries to ir@Biovail.com.
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