MILAN, ITALY--(Marketwire - February 21, 2012) - Milan, Italy and Hasbrouck Heights, NJ, USA,
21 February 2012 - Recordati (BorsaItaliana: REC:MI) and Nymox
Pharmaceutical Corporation (NASDAQ: NYMX) announced
today the start of activities aimed to the preparation of a European
Phase III
clinical trial for NX-1207, following the successful completion of a
Scientific
Advice meeting with the European Medicines Agency (EMA). NX-1207, Nymox's
Phase
III investigational drug, is currently in clinical development in the
U.S. for
the treatment of benign prostatic hyperplasia (BPH). The pivotal
controlled
clinical trial will assess the efficacy and safety of a single TRUS-
guided
intraprostatic injection of NX-1207 in patients with lower urinary
tract
symptoms (LUTS) associated with BPH not adequately controlled by
medical
therapy.
A European licensing agreement for the development and commercialization
of NX-
1207 was signed on 16 December 2010 by Recordati and Nymox
Pharmaceutical
Corporation. Under the terms of the agreement Recordati received
exclusive
rights to develop and subsequently market and sell NX-1207 in Europe
including
Russia and the CIS, the Middle East, South Africa and the Maghreb area of
North
Africa.
NX-1207 is a novel patented drug developed by Nymox which is currently in
Phase
III trials. The drug is injected by a urologist in an office setting
directly
into the zone of the prostate where the enlargement occurs and involves
little
or no pain or discomfort. NX-1207 has successfully completed a series of
blinded
controlled multi-center U.S. clinical trials where a single dose of NX-
1207 has
been found to improve the signs and symptoms of BPH, with improvements
about
double those reported for currently approved BPH drugs, and without the
side
effects associated with those drugs, which can include sexual problems and
blood
pressure changes. Follow-up studies have shown evidence of long lasting
benefit
with a significant proportion of men reporting maintained improvement
in BPH
symptoms without other treatments for up to 7,5 years.
Two pivotal U.S. trials are currently ongoing at over 80 well-known
urology
investigative sites throughout the U.S. Accrual numbers have reached over
80%,
and steady progress has been made toward full enrollment.
Benign prostatic hyperplasia (BPH) or enlarged prostate is a common
affliction
of older men. The condition is associated with growth in prostate size
as men
age and can seriously impact the health and quality of life of older men.
It can
lead to acute urinary retention, incontinence, and other serious
consequences.
It is estimated that 50% of men in their 50's have pathological
signs of
prostatic hyperplasia; from 26% to 46% of men between the ages of 40 to 79
years
suffer from moderate to severe urinary problems and symptoms associated
with
BPH.
About Recordati
Recordati, established in 1926, is a European pharmaceutical group,
listed on
the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM,
ISIN IT
0003828271),with a total staff of over 2,800, dedicated to the
research,
development, manufacturing and marketing of pharmaceuticals. It has
headquarters
in Milan, Italy, operations in the main European countries, and a
growing
presence in the new markets of Central and Eastern Europe. A European
field
force of around 1,400 medical representatives promotes a wide
range of
innovative pharmaceuticals, both proprietary and under license, in a
number of
therapeutic areas including a specialized business dedicated to
treatments for
rare diseases. Recordati's current and growing coverage of the
European
pharmaceutical market makes it a partner of choice for new product licenses
from
companies which do not have European marketing organizations.
Recordati is
committed to the research and development of new drug entities
within the
cardiovascular and urogenital therapeutic areas and of treatments for
rare
diseases. Consolidated revenue for 2010 was EUR 728.1 million, operating
income
was EUR 154.8 million and net income was EUR 108.6 million. More
information about
Recordati is available atwww.recordati.com, email: inver@recordati.it.
About Nymox
Nymox is a biotechnology company engaged in the research and
development of
therapeutics and diagnostics, with a particular emphasis on products
targeted
for the unmet needs of the aging population. In addition to NX-1207 for
BPH,
Nymox has a number of drug development programs for oncology,
Alzheimer's
disease, E. coli food contamination, and other indications. The Company
offers
NicAlert® and TobacAlert® tests for measuring tobacco product
exposure, and has
developed AlzheimAlert®.
More information about Nymox is
available
at www.nymox.com email: info@nymox.com, or 800- 936-9669.
This press release contains certain "forward-looking statements" as
defined in
the United States Private Securities Litigation Reform Act of 1995 that
involve
a number of risks and uncertainties. There can be no assurance that
such
statements will prove to be accurate and the actual results and future
events
could differ materially from management's current expectations.
Development of
drug products involves substantial risks and actual results may
differ
materially from expectations. Such factors are detailed from time to
time in
Nymox's filings with the United States Securities and Exchange
Commission and
other regulatory authorities. All mentions and descriptions of
Recordati
products are intended solely as information on the general nature
of the
company's activities and are not intended to indicate the
advisability of
administering any product in any particular instance.
RECORDATI AND NYMOX ANNOUNCE THE START EUROP. PH. III CLIN. TRIAL:
http://hugin.info/143644/R/1587907/498177.pdf
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originality of the information contained therein.
Source: RECORDATI via Thomson Reuters ONE
[HUG#1587907]