GENEVA, SWITZERLAND--(Marketwire - August 25, 2010) -
Addex Pharmaceuticals / Addex Partner Completes ADX71149 Phase I Program
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the content of this announcement.
Geneva, Switzerland, 25 August 2010 - Allosteric modulation company
Addex
Pharmaceuticals Ltd (SWISS: ADXN) announced today that the Phase I studies
required
to commence Phase II testing of ADX71149 have been satisfactorily
completed.
Subject to regulatory authorizations, Phase IIa studies in
schizophrenia and
anxiety, are scheduled to start enrolling patients in the first quarter of
2011.
The Phase I program was conducted by Johnson & Johnson Pharmaceutical
Research
and Development (J&JPRD) on behalf of Ortho-McNeil-Janssen Pharmaceuticals,
Inc.
(OMJPI) and included more than five studies in normal human
volunteers,
including: single ascending dose; multiple ascending dose; food &
gender;
ketamine challenge (a model of psychosis); and anxiety challenge.
In 2005, Addex Pharmaceuticals announced it had entered an exclusive
worldwide
research collaboration and license agreement with OMJPI to discover,
develop and
commercialize novel allosteric compounds for the treatment of
anxiety,
depression, schizophrenia and Alzheimer's disease. The initial drug
discovery
research was conducted both at Addex and at J&JPRD. Under the terms
of the
agreement, OMJPI paid Addex a EUR3 million upfront fee and research funding
for 2
years. In addition, Addex is eligible for up to a total of EUR112 million
subject
to successful completion of development and regulatory milestones. In
addition,
Addex is eligible for low double-digit royalties on sales of ADX71149,
subject
to regulatory approval and successful commercial launch.
"ADX71149 is a truly innovative, potentially life changing drug
candidate for
patients suffering from schizophrenia, anxiety and possibly other
disorders,"
CEO Vincent Mutel said. "The Phase I program demonstrates that
ADX71149
tolerability and safety monitoring parameters were within acceptable
limits and
support continued study in patients."
ADX71149 is an mGluR2 positive allosteric modulator (PAM) being
developed by
OMJPI. Activation of mGluR2 is a clinically validated mechanism in
both
schizophrenia and anxiety.
Addex Pharmaceuticals (www.addexpharma.com) discovers and develops
allosteric
modulators for human health and is focused on validated therapeutic
targets for
diseases of the central nervous system, metabolic disorders and
inflammation.
Subject to regulatory approvals, Phase II clinical trials are expected to
start
soon in four indications for two lead products: ADX48621, an mGluR5
negative
allosteric modulator (NAM), in dystonia and Parkinson's disease levodopa-
induced
dyskinesia (PD-LID); and ADX71149, an mGluR2 positive allosteric
modulator
(PAM), in schizophrenia and anxiety. A third product, ADX71943, GABA-B
receptor
PAM with potential for chronic pain, is scheduled to enter Phase I
testing in
2011. In addition, Merck & Co., Inc. has licensed rights to two
preclinical
products: mGluR4 PAM for Parkinson's disease and mGluR5 PAM for
schizophrenia.
Additional preclinical discovery stage programs include: mGluR2 NAM, GLP1R
PAM,
IL1R1 NAM and TNFR1 NAM. Roche Venture Fund and SR-One, corporate venture
arm of
GlaxoSmithKline, are investors in Addex.
Chris Maggos
Investor Relations & Communications
Addex Pharmaceuticals
+41 22 884 15 11
chris.maggos@addexpharma.com
Disclaimer: The foregoing release may contain forward-looking statements
that
can be identified by terminology such as "not approvable",
"continue",
"believes", "believe", "will", "remained open to exploring", "would",
"could",
or similar expressions, or by express or implied discussions regarding
Addex
Pharmaceuticals Ltd, its business, the potential approval of its
products by
regulatory authorities, or regarding potential future revenues from
such
products. Such forward-looking statements reflect the current views of
Addex
Pharmaceuticals Ltd regarding future events, future economic
performance or
prospects, and, by their very nature, involve inherent risks and
uncertainties,
both general and specific, whether known or unknown, and/or any other
factor
that may materially differ from the plans, objectives, expectations,
estimates
and intentions expressed or implied in such forward-looking statements.
Such may
in particular cause actual results with allosteric modulators of mGluR2,
mGluR4,
mGluR5, mGluR7 or other therapeutic targets to be materially different
from any
future results, performance or achievements expressed or implied by
such
statements. There can be no guarantee that allosteric modulators of
mGluR2,
mGluR4, mGluR5, mGluR7 will be approved for sale in any market or
by any
regulatory authority. Nor can there be any guarantee that allosteric
modulators
of mGluR2, mGluR4, mGluR5, mGluR7 or other therapeutic targets will
achieve any
particular levels of revenue (if any) in the future. In particular,
management's
expectations regarding allosteric modulators of mGluR2, mGluR4, mGluR5,
mGluR7
or other therapeutic targets could be affected by, among other
things,
unexpected actions by our partners, unexpected regulatory actions or
delays or
government regulation generally; unexpected clinical trial results,
including
unexpected new clinical data and unexpected additional analysis of
existing
clinical data; competition in general; government, industry and general
public
pricing pressures; the company's ability to obtain or maintain patent or
other
proprietary intellectual property protection. Should one or more of these
risks
or uncertainties materialize, or should underlying assumptions prove
incorrect,
actual results may vary materially from those anticipated, believed,
estimated
or expected. Addex Pharmaceuticals Ltd is providing the information in
this
press release as of this date and does not undertake any obligation to
update
any forward-looking statements contained in this press release as a
result of
new information, future events or otherwise, except as may be
required by
applicable laws.
[HUG#1439952]
--- End of Message ---
Addex Pharmaceuticals
12, chemin des Aulx Plan-les-Ouates; Geneva Switzerland
ISIN: CH0029850754;
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