| XTL buys marketing rights
to painkiller - XTL will pay Dov Pharmaceutical $7.5 million
and a further $126.5 million subject to the meeting of certain
milestones for bicifadine XTL Biopharmaceuticals Ltd.
(Nasdaq:XTLB); LSE: XTL; TASE:XTL) has bought an exclusive,
worldwide license with Dov Pharmaceutical Inc. (Pink Sheets:
DOVP.PK) for the development and commercialization of Dov's
novel drug candidate, bicifadine, a treatment for acute post-surgical
pain. XTL will pay an up-front $7.5 million in cash and a
further $126.5 million in cash and shares subject to the meeting
of certain milestones, of which $115 million will only be
paid if and when the product is approved for marketing.
XTL will also Dov Pharmaceutical royalties on sales and a
consultancy fee amounting to 3 percent of the XTL's current
fully diluted ordinary shares, vesting after one year of the
close of the transaction, and 7 percent of the XTL's current
fully diluted ordinary shares, vesting following successful
Phase III clinical trial results or the acquisition of XTL.
XTL rose 23 percent on the TASE today following the announcement.
XTL plans to develop bicifadine for the treatment of neuropathic
pain -- a chronic condition resulting from damage to peripheral
nerves. The market for neuropathic pain drugs was $1.8 billion
in 2005. Dov Pharmaceutical acquired the drug from Wyeth ().
Both companies planned to register the drug for the treatment
of acute or chronic pain, both of which have huge, but extremely
competitive, markets. Wyeth and Dov conducted two successful
Phase I clinical trials (safety) and a Phase II clinical trial
(effectiveness) for post-surgical and back pain. The trials
showed bicifadine to have similar effectiveness as competing
treatments.
Statistically significant results were obtained in the Phase
III clinical trial for post-surgical pain, but the US Food
and Drug Administration (FDA) told Dov to conduct a further
effectiveness trial of bicifadine for treating chronic pain.
In view of the competitiveness in the market and the demand
for additional trials, Dov decided it was not worthwhile pursuing
licensing of the drug in this framework. Phase III trials
for chronic back pain yielded inconclusive results. The trials
cost tens of millions of dollars, which caused Dov's share
to plummet to give the company a current market cap of $7.7
million.
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