Addex to Focus Resources on Clinical Pipeline

Thu Feb 7, 2013 1:38am EST

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  GENEVA, Feb 07 (Marketwire) -- 
 Addex Therapeutics / Addex to Focus Resources on Clinical Pipeline .
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responsible for the content of this announcement.


 2013 Value Drivers:

    - Initiate Phase 2 clinical testing of dipraglurant (mGlu5 NAM) in a rare
disease indication

    - Submit Orphan Drug Application in U.S. and Europe for dipraglurant

    - Complete Phase 1 testing of ADX71441 (GABA(B)-R PAM)

    - Select clinical candidate for an oral multiple sclerosis therapeutic
(mGlu4 PAM)

    - List on a U.S. stock exchange

    - Enter 2013 with CHF15.3 million of cash sufficient through year end 2013

    Geneva, Switzerland, 7 February 2013 - Addex Therapeutics (SIX: ADXN), a
leading company pioneering allosteric modulation-based drug discovery and
development, announced today that it will focus its resources on
developing its clinical stage pipeline for rare diseases. In pursuing
this strategy, Addex will advance current clinical and pre-IND programs
in certain diseases where orphan drug designation can be reasonably
achieved in the major commercial markets - U.S., Europe and Japan. In
executing this strategy and to maximize potential clinical success in at
least two programs over the next 12 months, the company will reduce its
overall cost structure, particularly around its early-stage discovery
efforts, while maintaining its core competency and expertise in allosteric
modulation. The result will be a development-focused company with a year
cash runway. In addition, the company will seek to increase its cash
position through non-dilutive partnerships by monetizing its platform
capability as well as current discovery programs via licensing and
strategic transactions. Finally, to improve the Company's liquidity and
long term outlook, Addex will secure a listing on a US stock exchange.

    The Company plans to focus its efforts on its current pipeline: (1)
dipraglurant, an mGlu5 negative allosteric modulator (NAM) currently in
Phase 2 development for the treatment of Parkinson's Disease Levodopa
Induced Dyskinesia as well as certain rare dystonias; (2) ADX71441 a
GABAB-R positive allosteric modulator (PAM) expected in Phase 1 studies
by mid-year for the treatment of Charcot-Marie-Tooth neuropathy (CMT1a);
and (3) an oral mGlu4 PAM currently in pre-IND studies for the treatment
of multiple sclerosis.

    "The transformation of Addex into a development focused company is an
important step in driving future success" said Bharatt Chowrira, CEO at
Addex. "While both data and partnering discussions continue to support the
advancement of dipraglurant in the treatment of Parkinson's disease
Levodopa Induced Dyskinesia, we have decided to invest our own resources
to advance dipraglurant into Phase 2 studies for rare dystonias. We plan
to apply for orphan drug designation while simultaneously seeking a
partner to fund the larger non- orphan indications of dipraglurant such
as PD-LID, anxiety and depression. In addition, we expect to complete
Phase 1 testing of our GABAB-R PAM while seeking orphan drug designation
for CMT1a. To maximize the resources that we can dedicate to these
clinical opportunities, we will look broadly at reducing our overall cost
structure including our discovery capability; however, we will continue
to maintain the core competencies that have made us a leading allosteric
modulator R&D Company. We believe that these measures will position Addex
for long-term success and build significant shareholder value."

    Following a careful review of Addex operations over the past several
months, the management and the Board of Directors decided that the
Company should focus its capital and resources on significant pipeline
opportunities in rare disease markets. To that end, Addex will reduce the
size of its operations in Geneva. Changes to organizational structure and
operations will focus on advancing pipeline programs but will ensure that
Addex maintains its core competencies and leadership position in oral
small molecule allosteric modulator-based drug discovery.

    "The Board of Directors fully supports the strategic direction taken by
the Company," said Andre J. Mueller, Chairman of Addex. "The Board
believes Addex is a world class research and development organization
capable of delivering on the promise of its pipeline in rare and orphan
diseases. Our objective is to maximize our resources to recognize both
near and mid-term key value drivers while providing a stronger financial
basis for the future."

    As part of the reorganization and as required under Swiss law, a
consultation process has been initiated. During the consultation period,
the Company will investigate a variety of options to determine the optimal
organizational structure and resulting operations necessary to execute
this strategy. An announcement detailing the changes to organization and
operations will be made shortly thereafter.

    "Addex is making excellent progress in advancing its proprietary pipeline
of novel oral small molecules against a number of validated high-value
targets," said Graham Dixon, CSO at Addex. "Positioning our pipeline in
the rare disease space will allow us to create significant shareholder
value by advancing programs to key value inflection points without
partners. Expected milestones in 2013 include: starting a Phase 2a trial
in a rare disease indication with dipraglurant, starting a Phase 1 trial
with ADX71441 with the intent to move rapidly to a Phase 2 study in
CMT1a, selecting a clinical candidate for our mGlu4 PAM program and
targeted completion by Janssen Pharmaceuticals, Inc. of the phase 2a
study with ADX71149 in patients who have anxiety and major depressive
disorder. We are confident in our ability to execute on this new strategy
and look forward to reporting clinical results on our programs throughout
the year."

    Financial update:

    Cash utilization for the year ended 2012 is CHF20.8 million resulting in a
cash balance at 31 December 2012 of CHF15.3 million in line with guidance
of CHF20- 21 million and CHF15-16 million, respectively. Based on the
current financial plan, current cash levels are sufficient to sustain
operations through year end 2013.

    A webcast and conference call will be held today at 16:00 CET (15:00 GMT
> 10:00 EST).To participate, please listen to the webcast or call one of
the following telephone numbers. RSVP is not necessary.

Dial-in numbers:  +41 91 610 56 00 (Europe)
                  +44 203 059 58 62 (UK)
                  +1 866 291 4166 (USA)

    
The live webcast, slides, webcast replay and transcript, as well as
the 2012 half year financial statements will be available at
www.addextherapeutics.com.

    Addex Therapeutics (www.addextherapeutics.com) is a development stage
company focused on advancing innovative oral small molecules against rare
diseases utilizing its pioneering allosteric modulation-based drug
discovery platform. The Company's two lead products are being
investigated in Phase 2 clinical testing: dipraglurant (ADX48621, an
mGlu5 negative allosteric modulator or NAM) is being developed by Addex
to treat Parkinson's disease levodopa- induced dyskinesia (PD-LID) and
rare forms of dystonia; and ADX71149 (mGlu2 positive allosteric modulator
or PAM) is being developed in collaboration with Janssen Pharmaceuticals,
Inc. to treat both schizophrenia and anxiety as seen in patients
suffering from major depressive disorder. Addex is also advancing several
preclinical programs including: GABA-BR positive allosteric modulator
(PAM) for Charcot-Marie-Tooth (type 1a) disease, spasticity in patients
with multiple sclerosis (MS), pain, overactive bladder and other
disorders; and mGlu4 PAM for MS, Parkinson's disease, anxiety and other
diseases. Allosteric modulators are an emerging class of small molecule
drugs which have the potential to be more specific and confer significant
therapeutic advantages over conventional "orthosteric" small molecule or
biological drugs. The Company uses its proprietary discovery platform to
target receptors and other proteins that are recognized as essential for
the therapeutic modulation of important diseases with unmet medical needs.

    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 Therapeutics, formerly known as, Addex
Pharmaceuticals, 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 Therapeutics 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 mGlu2, mGlu4, mGlu5, GABA-BR 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
mGlu2, mGlu4, mGlu5, GABA-BR or other therapeutics targets will be
approved for sale in any market or by any regulatory authority. Nor can
there be any guarantee that allosteric modulators of mGlu2, mGlu4, mGlu5,
GABA-BR 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 mGlu2, mGlu4, mGlu5,
GABA-BR 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 Therapeutics 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.

    This announcement is distributed by Thomson Reuters on behalf of Thomson
Reuters clients. The owner of this announcement warrants that: (i) the
releases contained herein are protected by copyright and  other
applicable laws; and (ii) they are solely responsible for the content,
accuracy and  originality of the information contained therein.

    Source: Addex Therapeutics via Thomson Reuters ONE

    [HUG#1676109]

Tim Dyer
Chief Financial Officer
Addex Therapeutics
+41 22 884 15 61
PR@addextherapeutics.com

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