Addex and Merck & Co., Inc. Collaborate to Develop Drugs for
Parkinson's Disease
Collaboration Targets a Non-Dopaminergic Approach to Treating
Parkinson's Disease
Addex to Host Webcast and Conference Call Today at 5:00 pm CET (11:00
am EST)
Geneva, Switzerland - Allosteric modulation company Addex
Pharmaceuticals (SWX:ADXN) announced today that it has entered an
exclusive collaboration and license agreement with Merck & Co., Inc.
(through its affiliate Merck Sharp & Dohme Research Ltd) with the
goal of developing a new class of orally available drugs, initially
as candidates for the treatment of Parkinson's disease and
potentially other undisclosed indications. The partners will discover
and develop positive allosteric modulators (PAMs) targeting the
metabotropic glutamate receptor 4 (mGluR4). The deal includes lead
mGluR4 PAMs discovered by Addex.
"We are proud to have established this collaboration with Merck
because their researchers have helped to define the therapeutic
potential of targeting mGluR4 to treat Parkinson's disease," Vincent
Mutel, CEO of Addex, said. "This is another important validation of
our leadership in allosteric modulation."
"Addex has made exceptional progress in the area of mGlu receptor
allosteric modulation," said Darryle D. Schoepp, Ph.D., senior vice
president and franchise head, Neuroscience, at Merck Research
Laboratories. "This partnership is key to us jointly establishing a
leadership position in the promising area of mGluR4 receptor
modulation for Parkinson's disease. Merck scientists are excited to
work with Addex to extrapolate the full value of this novel mechanism
for a range of neuroscience disorders."
Parkinson's disease is a debilitating movement disorder. Current
treatments focus on dopamine-replacement strategies, however most
patients reach a stage where these treatments are no longer
effective. There can also be debilitating side effects with current
treatments and many patients limit doses so their symptoms are less
cumbersome. The recent success of surgical approaches suggests that
bypassing the dopamine system may provide a more effective treatment
strategy. It is believed that selective activation of mGluR4 is one
way to do this and could correct the circuitry that modulates motor
excitability. This has the potential to provide significant
palliative benefit in Parkinson's disease.
Under the terms of the agreement, Addex will receive $3 million
upfront and is eligible for up to $106.5 million in research,
development and regulatory milestones for the first product developed
for multiple indications. Additional milestones of up to $61 million
would be payable if a second and third product is developed. Addex is
eligible to receive undisclosed royalties on sales of any products
resulting from this collaboration.
Addex and Merck will collaborate on preclinical development. Merck
will be responsible for clinical development. Addex has an option to
co-promote in certain European Union countries and will participate
in the joint oversight committee for clinical development. Addex will
host a webcast & teleconference (see below).
Targeting glutamate receptors
Like dopamine and serotonin, glutamate is a key neurotransmitter in
the human brain, an important signaling molecule involved in control
of multiple brain functions ranging from motor control to mood.
Although marketed drugs modulate specific receptors involved in both
the dopaminergic and serotinergic systems, it has been difficult to
develop drugs that target specific G protein coupled receptors in the
glutamatergic system.
Merck has been a pioneer in research on mGlu receptors and the
metabotropic glutamatergic system for multiple indications. For
example, research by Merck scientists provided the first evidence
that mGluR4 activation has potential for treatment of Parkinson's
disease. However, a remaining challenge has been to make drug-like
molecules that activate mGluR4 in a specific fashion. Addex is a
pioneer in developing truly selective small molecule drug candidates
targeting glutamate receptors and has previously disclosed programs
targeting mGluR5 and mGluR2.
mGluR4 in Parkinson's disease
Published research* shows that mGluR4 activators, like those in
development at Addex, could work via two distinct mechanisms to
alleviate symptoms of Parkinson's disease and, potentially, even slow
the progression of the disease: 1) mGluR4 activation triggers a
compensatory mechanism that may spare or potentiate the use of
dopamine receptor activators; 2) mGluR4 activation may have a
neuroprotective effect that helps to preserve the brain's
dopaminergic neurons.
*Nature Reviews Neuroscience, Vol 6, Oct. 2005, pp 787-798
About Parkinson's disease
Parkinson's disease is a brain disorder. It occurs when certain
nerve cells (neurons) in a part of the brain called the substantia
nigra die or become impaired. Normally, these cells produce a
signaling molecule (neurotransmitter) known as dopamine. Among other
things, dopamine allows smooth, coordinated function of the body's
muscles and movement. When approximately 80 percent of the
dopamine-producing cells are damaged, the symptoms of Parkinson's
disease appear.
Parkinson's disease affects both men and women in almost equal
numbers. It shows no social, ethnic, economic or geographic
boundaries. In the United States, it is estimated that 60,000 new
cases are diagnosed each year, joining the 1.5 million Americans who
currently have Parkinson's disease. While the condition usually
develops after the age of 65, 15 percent of those diagnosed are under
50.
Most symptoms associated with Parkinson's disease, like tremor,
rigidity and slowness, are caused by a lack of dopamine. Marketed
medicines help to ease the symptoms of Parkinson's disease by either
replacing or mimicking dopamine. Currently, no marketed products
slow the disease progression. No marketed products work via
non-dopaminergic mechanisms.
About Addex
Addex Pharmaceuticals discovers and develops allosteric modulators,
an emerging class of small molecule therapeutic agents. Allosteric
modulation may offer more sophisticated ways to normalize biological
signaling compared to classical orthosteric agonist or antagonist
drugs. Allosteric, literally translated from its Greek roots, means:
other site. Thus, allosteric modulators bind receptors at sites that
are distinct from the binding sites of classical small molecule
"orthosteric" agonist and antagonist drugs.
The most advanced drug candidate, ADX10059, a negative allosteric
modulator (NAM) of metabotropic glutamate receptor 5 (mGluR5),
recently demonstrated clinically and statistically significant
efficacy in separate Phase IIa clinical trials in gastroesophageal
reflux disease (GERD) patients and migraine headache patients. Data
from another Phase IIa clinical trial of ADX10059 in acute anxiety
are due around the end of 2007.
The Addex discovery capability has previously been validated through
a collaboration with Ortho-McNeil, a Johnson & Johnson company. The
deal is limited to discovery and development of allosteric modulators
of metabotropic glutamate receptor 2 (mGluR2).
In May 2007, Addex completed an initial public offering on the SWX
Swiss Exchange, raising CHF137 million ($111 million / ¤83 million).
The IPO was the largest biotech IPO in Europe in three years.
Contacts
Chris Maggos
Head of IR & Communications
Addex Pharmaceuticals
+41 22 884 15 11
chris.maggos@addexpharma.com
Webcast & Conference call
Title: Addex and Merck & Co. mGluR4 Deal
The webcast and slides will be available at: www.addexpharma.com
Teleconference for investors and analysts:
Date: 3 December 2007
Time: 17:00 ~ 18:00 CET (11:00 am ~ 12:00 pm EST)
Dial-in numbers: +41 91 610 56 00 (Europe)
+44 207 107 0611 (UK)
+1 866 291 4166 (USA)
A replay and transcript will be made available in the investor
relations section of Addex' website.
Disclaimer
The foregoing release contains 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, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with
allosteric modulators of mGluR4, mGluR2 or mGluR5 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 mGluR4, mGluR2 or mGluR5 will be
approved for sale in any market or by any regulatory authority. Nor
can there be any guarantee that allosteric modulators of mGluR4,
mGluR2 or mGluR5 will achieve any particular levels of revenue (if
any) in the future. In particular, management's expectations
regarding allosteric modulators of mGluR4, mGluR2 or mGluR5 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 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.
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Addex Pharmaceuticals
12, chemin des Aulx Plan-les-Ouates, Geneva
Switzerland
ISIN: CH0029850754; Index: SLIFE, SPI, SPIEX, SSCI;
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