Addex to Focus Resources on Clinical Pipeline
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Addex Therapeutics /
Addex to Focus Resources on Clinical Pipeline
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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.
Tim Dyer
Chief Financial Officer
Addex Therapeutics
+41 22 884 15 61
PR(at)addextherapeutics.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
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]
Unternehmensinformation / Kurzprofil:
Datum: 07.02.2013 - 07:30 Uhr
Sprache: Deutsch
News-ID 227113
Anzahl Zeichen: 13139
contact information:
Town:
Plan-les-Ouates, Geneva
Kategorie:
Business News
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