RAANANA, Israel, February 22, 2016 /PRNewswire/ --
XTL Biopharmaceuticals Ltd.
(NASDAQ: XTLB, TASE: XTLB.TA) ("XTL" or the
"Company"), a clinical-stage biopharmaceutical company developing
its lead product for the treatment of lupus, today announced that
the European Medicines Agency (EMA) has granted the Company Small
or Medium Sized Business Enterprise (SME) status in Europe. This comes in advance of XTL's global
Phase 2 trial of its lead compound hCDR1 for the treatment of
lupus, which is expected to commence in 2016 in markets including
the U.S. and Europe.
SME status offers biopharmaceutical companies numerous benefits
for medicinal products going through clinical testing and marketing
approval processes in Europe.
Incentives include: fee reductions and exemptions in pre- and
post-marketing authorization phases; administrative, procedural and
scientific advice, and eligibility for funding and grants.
"We believe SME status will benefit our hCDR1 clinical program
in Europe during our Phase 2 trial
and leading up to marketing registration. We look forward to a
continued productive relationship with the EMA," stated
Josh Levine, Chief Executive Officer
of XTL.
About hCDR1
hCDR1 is a novel compound with a unique mechanism of action and
with clinical data on over 400 patients in three clinical studies.
The drug has a favorable safety profile, is well tolerated by
patients and has demonstrated efficacy in at least one and possibly
more clinically meaningful endpoints. For more information please
see a peer reviewed article in Lupus Science and Medicine journal
(full article).
About Systemic Lupus Erythematosus (SLE)
Lupus is a chronic autoimmune disease involving many systems in
the human body, including joints, kidneys, central nervous system,
heart, hematological system and others. The biologic basis of the
disease is a defect in the immune (defense) system, leading to
production of self (auto) antibodies, attacking the normal organs
and causing irreversible damage. According to the Lupus Foundation
of America, at least 1.5 million Americans have the disease (more
than 5 million worldwide) with more than 16,000 new cases diagnosed
each year. The majority of patients are women of childbearing
years. There has been only one drug approved by the FDA in the last
50 years and recently two of the few drugs in advanced development
did not meet their primary endpoints in Phase 3 trials.
About XTL Biopharmaceuticals Ltd. (XTL)
XTL Biopharmaceuticals Ltd. is a clinical-stage biotech company
focused on the development of pharmaceutical products for the
treatment of autoimmune diseases including lupus. The Company's
lead drug candidate, hCDR1, is a world-class clinical asset for the
treatment of systemic lupus erythematosus (SLE). There currently is
no effective treatment on the market for SLE. hCDR1 has robust
clinical data in three clinical trials with 400 patients and over
200 preclinical studies with data published in more than 40 peer
reviewed scientific journals. Based on safety and efficacy data
shown in a completed Phase 2 study, the Company expects to initiate
a Phase 2 trial in 2016.
XTL is traded on the Nasdaq Capital Market (XTLB) and the Tel
Aviv Stock Exchange (XTLB.TA). XTL shares are included in the
following indices: Tel-Aviv Biomed, Tel-Aviv MidCap, and Tel-Aviv
Tech Index.
Cautionary Statement
This press release may contain forward-looking statements about
XTL's expectations, beliefs or intentions regarding, among other
things, its product development efforts, business, financial
condition, results of operations, strategies or prospects. In
addition, from time to time, XTL or its representatives have made
or may make forward-looking statements, orally or in writing.
Forward-looking statements can be identified by the use of
forward-looking words such as "believe," "expect," "intend,"
"plan," "may," "should" or "anticipate" or their negatives or other
variations of these words or other comparable words or by the fact
that these statements do not relate strictly to historical or
current matters. These forward-looking statements may be included
in, but are not limited to, various filings made by XTL with the
U.S. Securities and Exchange Commission, press releases or oral
statements made by or with the approval of one of XTL's authorized
executive officers. Forward-looking statements relate to
anticipated or expected events, activities, trends or results as of
the date they are made. Because forward-looking statements relate
to matters that have not yet occurred, these statements are
inherently subject to risks and uncertainties that could cause
XTL's actual results to differ materially from any future results
expressed or implied by the forward-looking statements. Many
factors could cause XTL's actual activities or results to differ
materially from the activities and results anticipated in such
forward-looking statements, including, but not limited to, the
factors summarized in XTL's filings with the SEC and in its
periodic filings with the TASE. In addition, XTL operates in an
industry sector where securities values are highly volatile and may
be influenced by economic and other factors beyond its control. XTL
does not undertake any obligation to publicly update these
forward-looking statements, whether as a result of new information,
future events or otherwise. Please see the risk factors associated
with an investment in our ADSs or ordinary shares which are
included in our Registration Statement on Form F-1 as filed with
the U.S. Securities and Exchange Commission on December 31, 2015.
For further information, please contact:
Investor Relations, XTL Biopharmaceuticals Ltd.
Tel: +972-9-955-7080
Email: ir@xtlbio.com
http://www.xtlbio.com
SOURCE XTL Biopharmaceuticals Ltd