Addex to Focus Resources on Clinical Pipeline
· 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 (GABAB-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 aGABAB-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."
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 http://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.
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