XTL Biopharmaceuticals Announces the In-Licensing of Bicifadine - A Late-Stage Clinical Compound for the Treatment of Neuropathi
January 16 2007 - 3:22AM
PR Newswire (US)
NEW YORK, January 16 /PRNewswire-FirstCall/ -- XTL
Biopharmaceuticals Ltd.
(NASDAQ:XTLBNASDAQ:LSE:NASDAQ:XTLNASDAQ:TASE:NASDAQ:XTL) announced
today that, through a wholly-owned subsidiary, it has signed an
agreement with DOV Pharmaceutical, Inc. (PS: DOVP.PK) to in-license
the worldwide rights for Bicifadine, a serotonin and norepinephrine
reuptake inhibitor (SNRI). XTL intends to develop Bicifadine for
the treatment of neuropathic pain - a chronic condition resulting
from damage to peripheral nerves. With 15 million people suffering
from neuropathic pain in the United States alone, and limited
treatment options available, neuropathic pain represents a
significant unmet medical need. According to Datamonitor, the
market for neuropathic pain drugs is expected to grow from $1.8
billion in 2005 to $5.5 billion by 2015. Bicifadine is a serotonin
and norepinephrine reuptake inhibitor (SNRI). Other members of the
SNRI class include Cymbalta(R) (approved for depression and
neuropathic pain), and Effexor(R) (approved only for depression).
Both Cymbalta(R) and Effexor(R) have been shown to be efficacious
in neuropathic pain. Activity on norepinephrine reuptake is thought
to be necessary for anti-depressants to be effective in neuropathic
pain. Compared to the currently approved SNRI's, Bicifadine has a
unique ratio of serotonin versus norepinephrine reuptake
inhibition, which is weighted toward norepinephrine reuptake
inhibition, providing a strong scientific rationale for using
Bicifadine for the treatment neuropathic pain indications.
Bicifadine has been tested extensively in over 15 clinical trials
involving over 3,000 patients, and has been shown to be safe and
generally well tolerated. Bicifadine was evaluated in various pain
indications, including two large, randomized clinical trials (n=750
and n=540) in patients suffering from acute (non-neuropathic) pain,
where Bicifadine demonstrated statistically significant efficacy.
Dr. Christine Sang, Director of Translational Pain Research at the
Brigham and Women's Hospital, Harvard Medical School, commented,
"Neuropathic pain continues to be an area of growing unmet medical
need, and I believe that Bicifadine represents an exciting
potential treatment option. Clinical data clearly support the role
of SNRI's for the treatment of neuropathic pain. Based on its
mechanism of action that includes a unique ratio of serotonin
versus norepinephrine reuptake inhibition, the demonstrated effect
of other SNRI's in this disease area, and the activity it has
demonstrated in acute pain studies, I have a high degree of
confidence that Bicifadine could be successfully developed as a
treatment for neuropathic pain." Ron Bentsur, XTL's Chief Executive
Officer, commented, "This is a very important event for XTL, as
this in-license transforms us immediately into a late-stage
development company. It is rare to come across an opportunity such
as Bicifadine, a drug candidate that addresses a multi-billion
dollar market, in a class with a proven mechanism of action, and
with an established safety profile and clear evidence of activity
in the treatment of pain." Mr. Bentsur added, "By re-directing the
development of Bicifadine away from the novel indications in acute
and chronic pain toward a proven area of efficacy of SNRI's in the
treatment of neuropathic pain, we believe we can be the second
approved SNRI for neuropathic pain, offering a differentiated
efficacy and possibly safety profile based on the drug's emphasis
on norepinephrine reuptake inhibition. We are excited to bring
Bicifadine on board as our lead compound." In accordance with the
terms of the license agreement, XTL will make an up-front payment
of $7.5 million in cash. In addition, XTL will make milestone
payments of up to $126.5 million, in cash and/or XTL ordinary
shares over the life of the license, of which up to $115 million
will be due upon or post approval of the product. XTL is also
obligated to pay royalties on net sales of the product to DOV. In
addition, the Company has committed to pay a transaction advisory
fee in the form of stock appreciation rights in the amount
equivalent to 3% of the Company's current fully diluted ordinary
shares, vesting after one year of the close of the transaction, and
7% of the Company's current fully diluted ordinary shares, vesting
following successful Phase 3 clinical trial results or the
acquisition of XTL. Payment of the stock appreciation rights by XTL
can be satisfied, at XTL's discretion, in cash and/or by issuance
of the Company's ordinary shares. ABOUT BICIFADINE Bicifadine is a
serotonin and norepinephrine reuptake inhibitor (SNRI) being
developed by XTL for the treatment of neuropathic pain. Bicifadine
was licensed by XTL from DOV Pharmaceutical, which originally
licensed it from Wyeth Pharmaceuticals. Four Phase 1 clinical
trials and 14 Phase 2 clinical trials involving more than 1,000
patients were conducted by Wyeth or DOV with an IR (immediate
release) formulation of Bicifadine. In five exploratory
double-blind, placebo-controlled Phase 2 clinical trials of the IR
formulation conducted by Wyeth, Bicifadine demonstrated a
statistically significant reduction in pain versus placebo, in some
cases with an outcome suggesting it might be comparable to or
better than positive controls such as codeine. In addition to these
trials with the IR formulation, eight Phase 1 clinical trials using
the SR (sustained release) formulation have been conducted, a
formulation that permits less frequent daily dosing, improves
tolerability and for which patents have been filed. It is intended
that the SR formulation will be used in future clinical development
and for commercial use In two additional and larger (n=750 and
n=540) single-dose, double-blind, placebo-controlled clinical
trials with Bicifadine in the treatment of moderate to severe
post-surgical acute dental pain, Bicifadine produced a highly
statistically significant, dose-related reduction in pain compared
to placebo, and which was comparable to a positive control arm
(codeine or Tramadol). Both trials demonstrated Bicifadine to be
safe and generally well-tolerated without producing any serious
adverse events. In a Phase 3 double-blind, placebo-controlled,
clinical trial (n=325) with Bicifadine in the treatment of moderate
to severe acute pain following bunionectomy surgery, statistically
significant increases in analgesia were measured as early as 30
minutes after administration and these effects were sustained for
the balance of the eight-hour measurement period. In this study,
Bicifadine was safe and generally well-tolerated. The complete
assessment of the analgesic action of Bicifadine under repeat
dosing conditions could not be fully elucidated due to the high
level of "rescue" analgesic medication used in both the placebo and
active drug groups. Due to the highly competitive nature of the
market for acute pain drugs, and the FDA requirement to complete
two repeat-dosing clinical trials in two different acute pain
indications, no further studies in acute pain are planned.
Bicifadine has been further evaluated in three Phase 3 trials in
Chronic Lower Back Pain (CLBP). The primary efficacy endpoint in
these trials was the change in pain severity rating score between
baseline and the end of dosing. In these trials, Bicifadine was
safe and generally well tolerated, but did not show a statistically
significant effect relative to placebo on the primary endpoint of
the study at any of the doses tested. XTL believes that the failure
of Bicifadine in the CLBP trials was a result of the inherent
heterogeneity of the studied patient population (i.e. the varying
causes of CLBP pain), uncontrolled physical activities in what is
largely an activity-dependent pain indication, and a high placebo
response. XTL believes that by re-directing the development of
Bicifadine away from the novel indications in acute and chronic
pain toward a proven area of efficacy of SNRI's in the treatment of
neuropathic pain, Bicifadine could be successfully developed to be
the second approved SNRI for neuropathic pain, offering a
differentiated efficacy and possibly safety profile based on the
drug's emphasis on norepinephrine reuptake inhibition. ABOUT XTL
BIOPHARMACEUTICALS LTD. XTL Biopharmaceuticals Ltd. ("XTL") is
engaged in the acquisition, development and commercialization of
therapeutics for the treatment of neuropathic pain and hepatitis C.
XTL is developing Bicifadine, a serotonin and norepinephrine
reuptake inhibitor, for the treatment of neuropathic pain. In
addition, XTL is developing XTL-2125 - a small molecule,
non-nucleoside inhibitor of the hepatitis C virus polymerase.
XTL-2125 is currently in a Phase 1 clinical trial in patients with
chronic hepatitis C. XTL is also developing XTL-6865 - a
combination of two monoclonal antibodies against the hepatitis C
virus - presently in Phase 1 clinical trials in patients with
chronic hepatitis C. XTL's hepatitis C pipeline also includes
several families of pre-clinical hepatitis C small molecule
inhibitors. XTL also has an active in-licensing and acquisition
program designed to identify and acquire additional drug
candidates. XTL is publicly traded on the NASDAQ, London, and
Tel-Aviv Stock Exchanges (NASDAQ:XTLB)(LSE:XTL)(TASE:XTL). Contact:
Ron Bentsur, Chief Executive Officer Tel: +1-(212)-531-5960
Cautionary Statement Some of the statements included in this press
release, particularly those anticipating future clinical and
business prospects for our clinical compound for neuropathic pain,
Bicifadine, operating strategies and similar matters, may be
forward-looking statements that involve a number of risks and
uncertainties. For those statements, we claim the protection of the
safe harbor for forward-looking statements contained in the Private
Securities Litigation Reform Act of 1995. Among the factors that
could cause our actual results to differ materially are the
following: our ability to successfully complete cost-effective
clinical trials for the drug candidates in our pipeline which would
affect our ability to continue to fund our operations with our
available cash reserves, our ability to meet anticipated
development timelines for the drug candidates in our pipeline due
to recruitment, clinical trial results, manufacturing capabilities
or other factors; and other risk factors identified from time to
time in our reports filed with the Securities and Exchange
Commission and the London Stock Exchange, including our annual
report on Form 20-F filed with the Securities and Exchange
Commission on May 25, 2006. Any forward-looking statements set
forth in this press release speak only as of the date of this press
release. We do not intend to update any of these forward-looking
statements to reflect events or circumstances that occur after the
date hereof. This press release and prior releases are available at
http://www.xtlbio.com/. The information in our website is not
incorporated by reference into this press release and is included
as an inactive textual reference only. DATASOURCE: XTL
Biopharmaceuticals Ltd CONTACT: Contact: Ron Bentsur, Chief
Executive Officer, Tel: +1-(212)-531-5960
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