GENEVA--(Marketwire - Feb 7, 2013) -
Addex Therapeutics /
Addex to Focus Resources on Clinical Pipeline
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely 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 André 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]