DOV Pharmaceutical Announces Exclusive Agreement for the Development and Commercialization of Bicifadine
16 January 2007 - 11:51PM
PR Newswire (US)
SOMERSET, N.J., Jan. 16 /PRNewswire-FirstCall/ -- 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.
About Bicifadine 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. About DOV 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. Cautionary Note 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 to: * 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. DATASOURCE: DOV Pharmaceutical, Inc. CONTACT: DOV
Pharmaceutical, Inc. - Investor Relations and Corporate
Communications, +1-732-907-3600 Web site: http://www.dovpharm.com/
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