DOV Pharmaceutical Announces Exclusive Agreement for the Development and Commercialization of Bicifadine
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- Published on Wednesday, 17 January 2007 02:00
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SOMERSET, NJ, USA | Jan 16, 2007 | DOV Pharmaceutical, Inc. (Pink Sheets: DOVP.PK) today announced an exclusive, worldwide license agreement with XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB) for the development and commercialization of DOV's novel drug candidate, bicifadine.
Under the terms of the agreement, DOV will receive an upfront payment of $6.5 million, of which $5.0 million will be paid to Wyeth as a result of the acceleration of a milestone payable from DOV to Wyeth pursuant to the parties' license agreement for bicifadine. Additionally, XTL will make a $1.0 million payment to DOV within 30 days upon successful transfer to XTL of the IND and certain program documentation. The total deal terms exceed $130.0 million, with escalating low double-digit royalties on annual net sales of bicifadine. XTL will fund future research, development, manufacturing and commercialization costs.
"Establishing this alliance with XTL is a critical step in our strategic plan outlined in October 2006. XTL is a motivated partner who has committed to the continued clinical development of bicifadine in the neuropathic pain area. This partnership will allow us to refocus our clinical development efforts on our triple reuptake inhibitor program, including the initiation of a Phase II study for DOV 21,947 in depression in the third quarter of 2007, and our discovery efforts on our GABAA receptor modulator and reuptake inhibitor programs" said Barbara Duncan, President and Chief Financial Officer of DOV.
Bicifadine has been shown to be effective in treating pain in three placebo-controlled efficacy trials in more than 1,600 patients with acute post-surgical pain. DOV also has conducted three substantial Phase III clinical trials of bicifadine in chronic low back pain and one early Phase II trial of bicifadine in osteoarthritis, all of which have provided DOV with a significant amount of data about the efficacy and safety of the drug. Bicifadine has demonstrated an attractive safety profile in short- and long-term safety studies involving more than 3,000 patients. Also, DOV has completed lifetime carcinogenicity studies in rats and mice with no meaningful signals of carcinogenicity detected after two years of testing, an outcome that DOV expects to be acceptable to the FDA.
DOV is a biopharmaceutical company focused on the discovery, acquisition and development of novel drug candidates for central nervous system disorders. The Company's product candidates address some of the largest pharmaceutical markets in the world including depression, pain and insomnia.
Statements in this press release that are not historical facts constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. You can also identify forward-looking statements by the following words: may, will, should, expect, intend, plan, anticipate, believe, estimate, predict, potential, continue or the negative of these terms or other comparable terminology. We caution you that forward-looking statements are inherently uncertain and are simply point-in-time estimates based on a combination of facts and factors currently known by us about which we cannot be certain or even relatively confident. Actual results or events will surely differ and may differ materially from our forward-looking statements as a result of many factors, some of which we may not be able to predict or may not be within our control. Such factors may also materially adversely affect our ability to achieve our objectives and to successfully develop and commercialize our product candidates, including our ability t
* complete negotiations with our bondholders regarding a consensual restructuring of our obligations under the debentures;
* successfully implement and satisfy all conditions to any such restructuring;
* raise substantial additional capital in order to repay the debentures;
* raise substantial additional capital in order to fund operations;
* obtain and maintain all necessary patents, licenses and other intellectual property rights;
* demonstrate the safety and efficacy of product candidates at each stage of development;
* meet our development schedule for our product candidates, including with respect to clinical trial initiation, enrollment and completion;
* meet applicable regulatory standards and receive required regulatory approvals on our anticipated time schedule or at all;
* meet or require our partners to meet obligations and achieve milestones under our license and other agreements;
* obtain and maintain collaborations as required with pharmaceutical partners;
* obtain substantial additional funds; and
* produce drug candidates in commercial quantities at reasonable costs and compete successfully against other products and companies.
You should also refer to the risks discussed in our filings with the Securities and Exchange Commission including those contained in our annual report on Form 10-K filed on March 15, 2006 and our quarterly report on Form 10-Q for the quarter ended September 30, 2006. We qualify all our forward-looking statements by these cautionary statements. Readers should not place undue reliance on our forward-looking statements. We do not undertake any obligation and do not intend to update any forward-looking statement.
SOURCE: DOV Pharmaceutical, Inc