|By Marketwired .||
|February 7, 2013 01:38 AM EST||
GENEVA -- (Marketwire) -- 02/07/13 --
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."
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
Chief Financial Officer
+41 22 884 15 61
The 3rd International WebRTC Summit, to be held Nov. 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 15th International Cloud Expo, 6th International Big Data Expo, 3rd International DevOps Summit and 2nd Internet of @ThingsExpo. WebRTC (Web-based Real-Time Com...
Sep. 2, 2015 03:45 PM EDT Reads: 1,555
Moving an existing on-premise infrastructure into the cloud can be a complex and daunting proposition. It is critical to understand the benefits as well as the challenges associated with either a full or hybrid approach. In his session at 17th Cloud Expo, Richard Weiss, Principal Consultant at Pythian, will present a roadmap that can be leveraged by any organization to plan, analyze, evaluate and execute on a cloud migration solution. He will review the five major cloud transformation phases a...
Sep. 2, 2015 03:30 PM EDT
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding bu...
Sep. 2, 2015 03:30 PM EDT Reads: 1,635
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the ...
Sep. 2, 2015 03:15 PM EDT Reads: 1,618
SYS-CON Events announced today that the "Second Containers & Microservices Expo" will take place November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities.
Sep. 2, 2015 03:15 PM EDT Reads: 621
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ab...
Sep. 2, 2015 03:00 PM EDT Reads: 435
IBM’s Blue Box Cloud, powered by OpenStack, is now available in any of IBM’s globally integrated cloud data centers running SoftLayer infrastructure. Less than 90 days after its acquisition of Blue Box, IBM has integrated its Blue Box Cloud Dedicated private-cloud-as-a-service into its broader portfolio of OpenStack® based solutions. The announcement, made today at the OpenStack Silicon Valley event, further highlights IBM’s continued support to deliver OpenStack solutions across all cloud depl...
Sep. 2, 2015 03:00 PM EDT Reads: 287
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises ar...
Sep. 2, 2015 03:00 PM EDT Reads: 1,574
eCube Systems has released NXTmonitor, a full featured application orchestration solution. NXTmonitor, which inherited the code base of NXTminder, has been extended to support multi-discipline processes and will act as a DevOps utility in a heterogeneous enterprise environment. Previously, NXTminder was packaged with NXTera middleware to configure and manage Entera and NXTera RPC servers. “Since we are widening the focus of this solution to DevOps, we felt the need to change the name to NXTmon...
Sep. 2, 2015 02:45 PM EDT Reads: 101
DevOps Summit, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development...
Sep. 2, 2015 02:45 PM EDT Reads: 1,567
WebRTC services have already permeated corporate communications in the form of videoconferencing solutions. However, WebRTC has the potential of going beyond and catalyzing a new class of services providing more than calls with capabilities such as mass-scale real-time media broadcasting, enriched and augmented video, person-to-machine and machine-to-machine communications. In his session at @ThingsExpo, Luis Lopez, CEO of Kurento, will introduce the technologies required for implementing thes...
Sep. 2, 2015 02:15 PM EDT
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, will discuss how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a prac...
Sep. 2, 2015 02:00 PM EDT Reads: 249
Mobile, social, Big Data, and cloud have fundamentally changed the way we live. “Anytime, anywhere” access to data and information is no longer a luxury; it’s a requirement, in both our personal and professional lives. For IT organizations, this means pressure has never been greater to deliver meaningful services to the business and customers.
Sep. 2, 2015 02:00 PM EDT Reads: 817
Consumer IoT applications provide data about the user that just doesn’t exist in traditional PC or mobile web applications. This rich data, or “context,” enables the highly personalized consumer experiences that characterize many consumer IoT apps. This same data is also providing brands with unprecedented insight into how their connected products are being used, while, at the same time, powering highly targeted engagement and marketing opportunities. In his session at @ThingsExpo, Nathan Trel...
Sep. 2, 2015 02:00 PM EDT Reads: 263
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Sep. 2, 2015 01:30 PM EDT Reads: 937