Geneva,
Switzerland, 3 January 2008 - Allosteric modulation company Addex
Pharmaceuticals (Swiss:ADXN.SW - News) announced today that it has
entered an exclusive worldwide license agreement with Merck & Co.,
Inc. ("Merck") to develop ADX63365, an orally available drug candidate
for the potential treatment of schizophrenia and other undisclosed
indications. Allosteric modulators are an emerging new class of
therapeutic agents. ADX63365, currently in preclinical development, is
a positive allosteric modulator (PAM) that targets the metabotropic
glutamate receptor 5 (mGluR5), which is believed to be important as a
target for the treatment of schizophrenia and other conditions. The
deal also includes mGluR5 PAM backup compounds discovered by Addex.
Under the terms of the agreement, Addex will receive $22 million
upfront and is eligible for up to $455 million in research,
development, regulatory and sales milestones for the first product
developed for two indications and up to $225 million in additional
development, regulatory and sales milestones for a second product
developed in two indications. Addex is eligible to receive royalties on
sales of any products resulting from this collaboration. In addition,
Addex has an option to co-promote in certain European Union countries
and will participate in the joint oversight committee for further
development that will be led by Merck.
Addex will host a webcast & teleconference later today (see below).
"We are thrilled to establish a second deal with Merck to
develop this groundbreaking new approach for patients suffering from
schizophrenia and other important diseases," Vincent Mutel, CEO of
Addex, said. "This deal confirms that Addex can successfully leverage
its technology to produce drug candidates that can have broad benefit
for human health."
"Merck scientists were the first to identify the potential for
targeting mGluR5 to treat schizophrenia," said Darryle D. Schoepp,
Ph.D., senior vice president and franchise head, Neuroscience, at Merck
Research Laboratories. "Through this second collaboration with Addex we
have now gained access to a promising drug candidate targeting this
receptor that potentially allows us to address an area of high medical
importance where current therapies are clearly inadequate."
On 3 December 2007, Addex announced a separate collaboration
with an affiliate of Merck, Merck Sharp & Dohme Research Ltd, to
discover and develop PAMs targeting mGluR4 for the treatment of
Parkinson's disease and other undisclosed indications.
"We now expect 2008 full year cash burn to be in the range of
CHF 25-30 million," Tim Dyer, CFO of Addex said, giving initial
guidance for 2008.
Targeting Glutamate Receptors
Like dopamine and serotonin, glutamate is a key signaling
molecule (neurotransmitter) in the human brain involved in control of
multiple brain functions including, mood, memory and motor control.
Although marketed antipsychotic 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 (GPCR) in the glutamatergic system.
About mGluR5 in Schizophrenia
Preclinical research* shows that activation of mGluR5 using
positive allosteric modulators can act as an antipsychotic and reverse
cognitive dysfunction of schizophrenia. As a result, a product like
ADX63365 could become first-line anti-psychotic therapy that also
improves cognitive dysfunction, thereby offering substantial advantages
over other therapies on the market or in development. In schizophrenia
cognitive impairment is regarded as a core deficit and was recently
recognized by FDA as a separate indication within schizophrenia for
which a drug could win approval.
*Journal of Pharmacology and Experimental Therapeutics (JPET)
313:199-206, 2005; Neuroscience 142 (2006) 691-702; Psychopharmacology
(2004): 174:39-44
About Schizophrenia
Schizophrenia is a chronic, severe, and disabling brain disease.
About 1.1 percent of the U.S. population over 18 years of age, about 2
million Americans, are suffering from the illness in any given year,
according to the U.S. National Institute of Mental Health (NIMH).
Although schizophrenia affects men and women with equal frequency, the
disorder often appears earlier in men, usually in the late teens or
early twenties, than in women, who are generally affected in the
twenties to early thirties. People with schizophrenia often suffer
terrifying symptoms such as hearing internal voices, or believing that
other people are reading their minds, controlling their thoughts, or
plotting to harm them. These symptoms, called "positive symptoms",
often leave patients fearful and withdrawn and contribute to the
"negative symptoms," like depression and anti-social behavior. Patients
often have problems with speech and disorganized behavior that can
often be incomprehensible or frightening to others. A third group of
symptoms, cognitive dysfunction, further complicates the disease and
deepens the cost to society by preventing young patients from learning
new skills or keeping a job. Available treatments can relieve many
symptoms, such as the "psychotic" behavior that can result from the
combination of postive and negative symptoms but they do not reverse
cognitive dysfunction. As a result, even when properly treated with
marketed drugs, most people with schizophrenia continue to suffer some
symptoms, especially cognitive dysfunction, throughout their lives. It
has been estimated that no more than one in five individuals recovers
completely.
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 were communicated today in a separate press release.
The Addex allosteric modulation discovery and development
platform has been validated through collaborations with Merck &
Co., Inc. and Johnson & Johnson.
Webcast & Conference call
Title: Addex and Merck & Co. mGluR5 Deal
The webcast and slides will be available at: http://www.addexpharma.com
Teleconference for investors and analysts:
Date: 3 January 2008
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.
Contact:
Contacts
Chris Maggos
Head of IR & Communications
Addex Pharmaceuticals
+41 22 884 15 11
Email Contact
Ian McConnell
Director, Media Relations
Merck & Co., Inc.
+1 (908) 423-3046
Email Contact
Source: Addex Pharmaceuticals