v062635
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
6-K
Report
of Foreign Private Issuer
Pursuant
to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of 1934
For
January 16, 2007
Commission
File Number: 000-51310
XTL
Biopharmaceuticals Ltd.
(Translation
of registrant's name into English)
750
Lexington Avenue, 20th
Floor
New
York, New York 10022
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under
cover Form 20-F or Form 40-F.
Form
20-F x
Form
40-F
o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1): o
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7): o
Indicate
by check mark whether by furnishing the information contained in this Form,
the
registrant is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes o
No
x
If
“Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-
N/A
XTL
Biopharmaceuticals Announces the In-Licensing of Bicifadine - A Late-Stage
Clinical Compound for the Treatment of Neuropathic Pain
NEW
YORK,
NEW YORK, 16 January 2007 - XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, LSE:
XTL,
TASE: 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® (approved for depression and neuropathic pain),
and Effexor® (approved only for depression). Both Cymbalta® and Effexor® 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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
| XTL BIOPHARMACEUTICALS LTD. | ||
| |
|
|
| Date: January 16, 2007 | By: | /s/ Ron Bentsur |
|
Ron Bentsur |
||
|
Chief
Executive Officer
|
||