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Van Leeuwenhoeck Issues Initiation of Coverage Research Report on Addex Therapeutics and Estimated ADXN Share Price of CHF 11.5 per Share
1 CHF ~ 1 USD these days
https://www.addextherapeutics.com/investors/press-releases/news-details/article/van-leeuwenhoeck-issues-initiation-of-coverage-research-report-on-addex-therapeutics-and-estimated-a/
Addex Awarded $5.3 Million Grant from US National Institute on Drug Abuse
https://www.addextherapeutics.com/investors/press-releases/news-details/article/addex-therapeutics-adx71441-program-awarded-53-million-grant-from-us-national-institute-on-drug-ab/
IMO, Addex has a decent possibility of a partnership for Dipraglurant Phase III, expected to start early next year. It would be nice to put that in place before they need to raise more capital. It has FDA OD status, and Phase II results were very positive (no AE's and clear efficacy) and now published in peer-review journals.
If they can get one molecule off the ground, it would help validate their entire allosteric discovery platform, and long-term Addex could be a multi $bn company.
Orphan designation granted for Dipraglurant! Next up, phase 3 pivotal study. Will Addex finally breakout in 2018?
Shares up a little on 15x volume because of this news: http://www.addextherapeutics.com/investors/press-releases/news-details/article/addex-dipraglurant-demonstrates-anxiolytic-and-antidepressant-like-activity-in-multiple-preclinical/
Addex up 20% on high volume, but no news (that I can find). I wonder what's up?
Turns out all that buying was some of the institutional investors increasing their stake.
Seems the former CFO also spent CHF 56k of his own money to buy shares on the open market recently.
That's gotta be a good sign.
3 days in a row with way over 10x average volume, and up 140% in all (on the Swiss Exchange as ADXN anyway).
Nice. Do I sense a licensing deal for one of their drugs?
whoa, something's up. 15x volume, up almost 100% in 2 days.. but no news. Hmm....
The news goes from bad to worse with this company and their drug tests:
http://www.six-swiss-exchange.com/issuers/services/tensid_news_en.html?id=7f2f3a20
That, coupled with a cash situation that must be near critical would seem to suggest this company is on its last legs. There are a few un-partnered molecules they are still working on, I believe, but I really wonder what the next 6 months look like for Addex.
That said, the PPS didn't suffer too much (yet?) with this bad news. And at this rate, any GOOD news (i.e. encouraging clinical studies and/or partnerships) could turn the share price around in a hurry.
Burn rate is 20M per year, where is 2014 cash coming from?
Addex to cut costs, focus R&D, and seek US-listing!
Addex to Focus Resources on Clinical Pipeline
http://www.addextherapeutics.com/investors/press-releases/news-details/?tx_ttnews[tt_news]%20=235&cHash=9b3ab1bd11b72d2495edcf23cf16c40e
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 (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 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)
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.
The good news just keeps pouring in:
http://www.addextherapeutics.com/investors/press-releases/news-details/article/addex-reports-top-line-data-from-a-successful-phase-2a-clinical-study-with-adx71149-in-schizophrenia/
Followed by an upgrade by at least one analyst:
Addex Reports ADX71441 Reduces Alcohol Intake in a Preclinical Model of Alcohol Binge Drinking
http://www.andhranews.net/Business/2012/Addex-Reports-ADX71441-Reduces-Alcohol-Intake-49115.htm
Article about PD-related diskinesia and mGluR5 from the MJFF:
https://www.michaeljfox.org/foundation/publication-detail.html?id=247
Taken from the article:
Misc analyst quotes about Addex on The Life Sciences Report website
http://www.thelifesciencesreport.com/pub/co/4060
(coopied without permission below, underlining added by me)
This stock is a screaming buy IMO.. hold for a few years and it's a potential 10-bagger from here.
Expert Analysis
Christopher Marai, Wedbush (9/10/12) "We view Addex Therapeutics' dipraglurant as likely to change the treatment paradigm for Parkinson's disease by prolonging and augmenting the benefits of levodopa, the current gold standard of care for the disease. . .we anticipate Phase 2 data for ADX71149 in schizophrenia from the company's partner Janssen Pharmaceuticals Inc. in early Q4/12. . .we are initiating coverage with an Outperform rating."
The Life Sciences Report Interview with Greg Wade (8/30/12) "We had a chance to catch up with our friends from Addex Therapeutics at the conference. I don't think the company has a strong U.S. following, despite what we believe are very compelling data for its metabotropic glutamate receptor 5 (mGluR5) inhibitor, dipraglurant. The company is confident that it will find a partner to develop the product, first in an indication for Parkinson's disease levodopa-induced dyskinesia (PD-LID). With support and validation, investors will come to appreciate the opportunities for the drug in the PD-LID indication. Addex is an interesting, undiscovered company, and is undervalued perhaps because of the stock's low trading volume, Swiss stock exchange listing, and the relatively modest number of patients treated in its dipraglurant clinical studies. . .with a partnership, I think Addex will be a different story. . . The trick has been specificity. I think some folks at Addex are getting to the heart of that issue as well."
Juan Sanchez, Ladenburg Thalmann (8/29/12) "We believe the schizophrenia glutamate hypothesis (the target pathway for Addex Therapeutics' ADX71149 and pomaglumetad methionilIn) is one of the strongest and most widely accepted by the scientific community. . .we look forward to top-line phase 2 results on ADX71149 in Q4/12. We are encouraged by the trial design, which evaluates (part B of the study) ADX71149 as an add-on to the currently prescribed antipsychotic. . .we reiterate our Buy rating."
Juan Sanchez, Ladenburg Thalmann (8/22/12) "In our view, Addex Therapeutics' value proposition is supported by: 1) dipraglurant for levodopa induced dyskinesia, which we believe represents a partially derisked asset in midstage of clinical development, 2) ADX71149 in Phase 2 clinical development for schizophrenia and major depressive disorder with anxiety symptoms and 3) the company's pipeline and discovery platform. . .we reiterate our Buy rating."
Juan Sanchez, Ladenburg Thalmann (6/21/12) "At the Movement Disorders Society conference in Dublin, Ireland, Addex Therapeutics presented a late breaking poster with detailed results from the dipraglurant Phase 2a trial in Parkinson's disease patients suffering from levodopa induced dyskinesia (LID). . .they confirm our assessment that the totality of the data supports the safety of dipraglurant and strongly suggests dipraglurant is an active compound (in treating LID). . .we believe the likelihood the company finds a corporate partner to continue development of dipraglurant are considerably high. . .we reiterate our Buy rating."
Sorry, that woule be August 2013.
Addex Partner to Initiate Phase 2 Clinical Trial of ADX71149 for the Treatment of Major Depressive Disorder with Anxiety Symptoms
(results due in August)
http://www.addextherapeutics.com/investors/press-releases/news-details/article/addex-partner-to-initiate-phase-2-clinical-trial-of-adx71149-for-the-treatment-of-major-depressive-d/
http://clinicaltrials.gov/ct2/show/NCT01582815
Up 92% in Zurich today. But it anybody listening? It's no fun picking winners if you're all alone.
This company has blockbuster potential folks -- a cutting edge R&D platform that has just yielded it's first potential blockbuster drug. There are over 40 candidate drugs in their pipeline.
After the news yesterday, shares are up 15% at CHF 7.50, which gives the company a mkt cap of CHF 60 million. In a few years, they should have earnings of more than that... it's a 10-bagger in the making (with the requisite risks, of course).
"These data for dipraglurant are positive and we are pleased to have demonstrated robust proof of concept," said Charlotte Keywood, MD, Chief Medical Officer of Addex. "Both dipraglurant doses had a good safety and tolerability profile and demonstrated efficacy. The increase in on-time without dyskinesia, combined with the decrease in off-time observed during week 4, is encouraging, and warrants further evaluation. It's particularly promising that the significant reduction in dyskinesia severity on the mAIMS was mirrored by a reduction in patient reported dyskinesia time and that both clinicians and patients favoured dipraglurant over placebo."
"Addex is leading the effort in developing this potential breakthrough therapy, which could change the treatment paradigm for Parkinson's disease," said Dr. Bharatt Chowrira, CEO of Addex. "With these promising positive data in hand, we intend to seek a partner to progress dipraglurant to the market as rapidly as possible."
While dipraglurant has broad potential for treating Parkinson's and other diseases, the most direct path to market is treatment of PD-LID. No drug is approved for PD-LID and LID has been identified by the regulatory authorities, patient advocacy groups, such as The Michael J. Fox Foundation, and key opinion leaders as a very important unmet medical need. The potential market opportunity for dipraglurant in Parkinson's disease is well in excess of $1 billion, according to Datamonitor. Potential label expansions could more than double the peak sales potential for dipraglurant.
Awesome news!!! Addex Reports Positive Top Line Phase IIa Data for Dipraglurant in Parkinson's Disease Levodopa-Induced Dyskinesia (PD-LID)
http://www.addextherapeutics.com/investors/press-releases/news-details/article/addex-reports-positive-top-line-phase-iia-data-for-dipraglurant-in-parkinsons-disease-levodopa-indu/
Addex changes name to Addex Therapeutics
http://www.addextherapeutics.com/investors/press-releases/news-details/article/addex-changes-name-to-addex-therapeutics/
Addex Pharmaceuticals (SIX:ADXN), a leading company pioneering allosteric modulation-based drug discovery and development, announced today that it has changed its name to Addex Therapeutics. The name change reflects more closely the company’s focus on oral small molecule-based therapeutics. Addex’s ticker symbol on the Swiss Stock Exchange remains unchanged at ADXN.
Alongside the name change, Addex has revealed a new logo and website. The icon in the logo represents two things: the letter “X” from the Addex name and a receptor bound by a natural ligand or cell signaling molecule in the active site, depicted in blue, and an allosteric modulator bound to an allosteric site, in orange.
Addex has also introduced a new tag line: “expanding the realm of possible…” which is literally what the allosteric approach is doing for drug discovery. When applied to drug discovery, allostery offers the unique possibility of developing oral small molecule drugs for targets that were previously considered “undruggable” with conventional drug discovery approaches. Addex technology, therefore, expands the realm of druggable targets.
The new website provides information on the company’s strategy, pipeline and the allosteric modulation-based drug discovery and development technology platform. The new website also provides helpful information on the stock, corporate governance and corporate calendar featuring the company’s investor, media and scientific outreach activities.
Previously confidential but newly published white paper on Addex's ADX48621 (for Parkinson's Disease) shows the market & revenue potential!
http://www.addexpharma.com/fileadmin/user_upload/IR_Presentations/2012/Dipraglurant_IR_in_PD_and_beyond_22_Dec_2011_final_01.pdf
"The combined peak U.S. annual sales potential (excluding disease modification) for the PD indications alone is estimated to be in the range of $1.8bn to $2.7bn , (source Michael J Fox Foundation 2011)."
If the clinical results are good (due end March), Addex is in a great position as this particular modulator is wholly owned by them (no partner, just a $900k grant from the Michael J. Fox foundation).
With the ADX71149 they negotiated a "low double digit %" royalty fee with Janssen but early on... so they should be able to do even better with ADX48621 if it's proven!
From here (PPS today @ CHF 6.40) we could be looking at a 10x jump in a matter of months -- if the results are good and they announce a partnership soon thereafter.
Of course, the last time we expected good news from a Phase II Clinical trial, it was found their drug caused liver damage and the shares plummeted 80%. Nonetheless, the PPS is lower today than post-plummet, and even with bad news the company valuation is very attractive given their unique allosteric R&D platform and pipeline of candidate modulators.
Coverage by Ladenburg Thalmann: BUY with target price of CHF 17 (150% above today's price)
http://www.addexpharma.com/fileadmin/user_upload/Media_Exposure/Ladenburg_Thalmann_28_FEB_2012.pdf
Next R&D results expected end March.
2012 Addex Corporate Presentation
http://www.addexpharma.com/fileadmin/user_upload/IR_Presentations/2012/Addex_Corp_Pres_120101.pdf
This quarter we should hear the results of the Phase II clinical trials, and I can't imagine the news being anything short of really disappointing or really really great. PPS should move strongly UP if it's great, but should not suffer too much if it's bad news given the 2 other Phase II trials underway in Partner with Janssen.
Great overview of the company - CEO presenstaion from 27 September:
http://www.addexpharma.com/fileadmin/user_upload/Conference_slideshows/110925_Addex_Jefferies_FINAL.pdf
Article from Sep 5:
https://www.addexpharma.com/fileadmin/user_upload/Media_Exposure/T_11.09.05_Scrip_-_mGluR4_Returns.pdf
Addex Pharmaceuticals, the Swiss biotech, has found itself once again a potential innocent bystander in the integration of Merck & Co and Schering-Plough. On 2 September, just after the markets had closed, Addex announced that Merck had opted not to continue developing orally available positive allosteric modulators (PAM) targeting the metabotropic glutamate receptor 4 (mGluR4) as potential treatments for Parkinson’s disease and other undisclosed indications.
It appears that Addex is the victim of internal R&D debate at Merck. “The decision to discontinue the research collaboration was based on the continuing prioritisation of our pipeline,” Merck spokeswoman Caroline Lappetito told Scrip.
Merck will instead focus its Parkinson’s disease research on its Phase III candidate preladenant, a novel selective adenosine 2A (A2A) receptor antagonist.”It is a proven clinical target for Parkinson’s disease and one where we have developed deep knowledge around the clinical profile of the target. mGluR4 remains an attractive preclinical hypothesis with a potentially useful candidate but is still in early discovery and much remains to be learned about it,” added Ms Lappetito.
mGluR4 activators are thought to work via two distinct mechanisms to alleviate Parkinson’s disease and possibly slow disease progression. First, mGluR4 activation triggers a compensatory mechanism that may spare or potentiate the use of dopamine receptor activators. Second, mGluR4 activation may have a neuroprotective effect that helps to preserve the brain’s dopaminergic neurons.
Despite retreating from its deal with Addex, Merck confirmed to Scrip that it believes mGluR4 remains an attractive preclinical hypothesis with a potentially useful candidate profile. “We are committed to studying this and other hypotheses for developing potential treatments for Parkinson’s disease,” added Ms Lappetito.
Addex first attracted Merck as a partner for the mGluR4 programme in 2007, soon after it had identified and validated hits and started lead optimisation. The signing on fee was $3 million with the promise of additional potential milestones up to $167 million. Two preclinical milestones were received by Addex in 2008 and 2009, securing an additional $3.3 million in funding. In 2009, Merck extended the research collaboration beyond the scope of the original 2007 accord.
The collaborative phase of theagreement came to an end late 2010 and Merck had been expected to advance leads into late preclinical development, towards clinical testing.
While acknowledging that the programme is still preclinical, Addex’s management is convinced that the mGluR4 approach has much promise and that its efforts are more advanced than those of others. “A lot of companies are looking at this target. We hit two important preclinical milestones and have not seen anyone else achieve that yet. We will now get all the know-how, compounds, assays, data and assets back and will re-evaluate the package and then look for new partners,”Dr Bharatt Chowrira, Addex’s newly installed CEO, told Scrip.
“The financial market attributed no value to the programme as it was still preclinical. Now that it is unpartnered it is potentially more valuable as we will be able to monetise the assets,” Addex Chief Financial Officer, Mr Tim Dyer told Scrip. Mr Dyer estimates that the programme has attracted approximately $20 million of investment based on the full time equivalents contribution of both partners for the duration of the collaboration.
Addex has yet to decide what it will do with the mGluR4 programme. “We could look for another partner now or continue to develop it ourselves, which could help accelerate the pace of the programme. What we do know is that these assets will not end up sitting on a shelf. We will move them forward,” Dr Chowrira told Scrip.
This is the second programme that Merck has halted with Addex. At its first half year results on 27 July, Addex revealed that Merck had handed back all intellectual property associated with ADX63365 and other mGluR5-targeted PAM candidates, as well as back-ups, as potential treatments of schizophrenia. The deal was originally signed in January 2008 with an upfront fee of some $22 million and the potential for an additional $680 million in milestones.
Addex has two programmes currently in Phase IIa testing: dipraglurant (ADX48621), a mGluR5 negative allosteric modulator to treat Parkinson’s disease levodopainduced dyskinesia; and ADX71149, an mGluR2 PAM, being developed by partner Janssen Pharmaceuticals, to treat schizophrenia.
Addex to Present Progress on Multiple Allosteric Modulator Programs for Neurodegenerative and other Neurological Disorders
http://www.addexpharma.com/press-releases/press-release-details/article/addex-to-present-progress-on-multiple-allosteric-modulator-programs-for-neurodegenerative-and-other/
Geneva, Switzerland, October 3, 2011 – Addex Pharmaceuticals (SIX:ADXN), a leading biopharmaceutical company pioneering allosteric modulation-based drug discovery and development, announced today that its scientists will present data on multiple metabotropic glutamate receptor (mGluR) allosteric modulator programs, including small molecule modulators of mGluR subtypes 2, 4, 5 and 7. Held every three years, the prestigious International Meeting on Metabotropic Glutamate Receptors, in Italy, brings together the world’s leading researchers in this field.
“These six presentations represent our continued success in addressing the elusive mGluR targets and re-affirm our leadership position in addressing important previously undruggable targets with oral small molecule allosteric modulators,” said Bharatt Chowrira, CEO of Addex. “Our advances in this field are further illustrated by two lead products targeting mGluR5 and mGluR2, dipraglurant-IR for Parkinson’s disease levodopa-induced dyskinesia (PD-LID) and ADX71149 for schizophrenia, respectively; both are currently in mid-stage clinical testing and each has the potential to be first-in-class and best-in-class in treating these serious neurological disorders.”
Dipraglurant-IR, is an mGluR5 negative allosteric modulator, or NAM, which is in Phase IIa testing for PD-LID. Top-line data are expected to be reported in the first half of 2012. Addex partner Janssen Pharmaceuticals Inc. is developing ADX71149, an mGluR2 positive allosteric modulator, or PAM, currently in Phase IIa testing for the treatment of schizophrenia.
Glutamate, like dopamine and serotonin, is one of the major neurotransmitters in the brain and other parts of the central nervous system. Because of their importance, each of the many glutamate-specific receptors, including all eight subtypes of mGluRs, has been the subject of intense research and drug discovery efforts for more than 20 years. But, despite ever increasing knowledge about their role in various neurologic disorders, the industry has struggled to identify compounds that can selectively differentiate between the various glutamate receptor subtypes using conventional small molecule discovery techniques. In contrast, allosteric modulators have achieved excellent selectivity for each mGluR subtype. This is because the allosteric binding sites are less conserved compared to the receptor’s active site, which is the binding site for the body’s natural activators (i.e. endogenous ligands) and conventional small molecule drugs.
“At Addex, we have developed a proprietary allostery-biased library and highly sensitive HTS screening systems tailored for discovery of selective and potent allosteric modulators. In short, by industrializing the process of discovering allosteric modulators, we are addressing an important bottleneck in small molecule drug discovery that has hindered drug developers for decades and has resulted in a growing number of undruggable validated targets,” said Dr. Sonia Poli, Head of CNS and Non-Clinical Development at Addex. “We believe these orally bioavailable small molecules are able to exert exquisite selectivity at the receptor subtype level and have the potential to be optimized into drugs with the fine-tuned control needed to address major CNS disorders such as schizophrenia, Parkinson’s and Alzheimer’s diseases, as well as non-CNS indications.”
Oral Presentations
Thursday, October 6, 4.30 – 4.55 pm
Selective mGluR2 negative allosteric modulators for the treatment of cognitive deficits associated with Alzheimer’s disease
Friday, October 7, 10.05 – 10.30 am
Anti-parkinsonian and anti-dyskinetic effects of dipraglurant (ADX48621), a novel mGluR5 negative allosteric modulator in clinical development
Friday, October 7, 1.25 – 1.50 pm
Novel metabotropic glutamate receptor 4 (mGluR4) allosteric potentiators for the treatment of Parkinson’s disease and anxiety
Poster Presentations
Wednesday, October 5 from 20.00 to 23.00 in the Pharmacology session
Discovery and characterization of novel metabotropic glutamate receptor 4 (mGluR4) allosteric potentiators
Wednesday, October 5 from 20.00 to 23.00 in the Pharmacology session
Identification, synthesis and SAR investigation of a series of novel metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulators
Wednesday, October 5 from 20.00 to 23.00 in the Psychiatric Disorders session
Development of novel metabotropic glutamate receptor 7 (mGluR7) negative allosteric modulators for treatment of anxiety disorders
Addex Pharmaceuticals discovers and develops an emerging class of small molecule drugs, called allosteric modulators, 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 address receptors and other proteins that are recognized as attractive targets for modulation of important diseases with unmet medical needs. The Company’s two lead products are being investigated in Phase IIa clinical testing: dipraglurant (ADX48621, an mGluR5 negative allosteric modulator or NAM) is being developed by Addex to treat Parkinson’s disease levodopa-induced dyskinesia (PD-LID); and ADX71149 (mGluR2 positive allosteric modulator or PAM) is being developed by our partner Janssen Pharmaceuticals, Inc., to treat schizophrenia. Addex also is advancing several preclinical programs including: GABA-BR PAM for pain, overactive bladder and other disorders; mGluR4 PAM for Parkinson's, anxiety and other diseases; GLP1R PAM for type 2 diabetes; mGluR2 NAM for treating Alzheimer's disease and depression; and FSHR/LHR NAM for sex hormone dependent tumors & reproductive system disorders. In addition, Addex has discovery programs to identify allosteric modulators of: receptor tyrosine kinase (RTK) superfamily, including TrkB PAM for treating neurodegenerative diseases (e.g. Alzheimer’s, Parkinson’s and Huntington’s diseases); and TNF receptor superfamily, including TNFR1 NAM for inflammation (e.g. rheumatoid arthritis) and other diseases.
Chris Maggos
Business Development & Communication
Addex Pharmaceuticals
+41 22 884 15 11
chris.maggos(at)addexpharma.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 Pharmaceuticals Ltd, 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 Pharmaceuticals Ltd 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 mGluR2, mGluR4,mGluR5, GABABR, FSHR/LHR, GLP1R, TNFR1, RTK, TrkB 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 mGluR2, mGluR4, mGluR5, GABABR, FSHR/LHR, GLP1R, TNFR1, RTK, TrkB 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 mGluR2, mGluR4, mGluR5, GABABR, FSHR/LHR, GLP1R, TNFR1, RTK, TrkB 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 mGluR2, mGluR4, mGluR5, GABABR, FSHR/LHR, GLP1R, TNFR1, RTK, TrkB 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 Pharmaceuticals Ltd 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.
Maybe, since the new CEO has an entirely new network, they will be able to find a new R&D partner for mGluR4? If one is announced soon, it could be a very good sign...
News: Addex Regains Rights to Parkinson’s Drug Candidates from Merck
Unclear what "regains" means... did Merck give it back, or did they have a call option on the rights and claimed it back? Either way, shares off 10% on light volume this morning in Zurich.
http://www.addexpharma.ch/press-releases/press-release-details/article/addex-regains-rights-to-parkinsons-drug-candidates-from-merck/
Geneva, Switzerland, 2 September 2011 – Addex Pharmaceuticals (SIX:ADXN), a leading biopharmaceutical company pioneering allosteric modulation-based drug discovery and development, announced today that it will regain all rights to its metabotropic glutamate receptor 4 (mGluR4) positive allosteric modulator (PAM) program from Merck, known as MSD outside the United States and Canada, due to further pipeline prioritization.
"We continue to strongly believe that mGluR4 is a highly attractive target for treating Parkinson’s and other serious diseases,” said Bharatt Chowrira, CEO of Addex. “We recognize the substantial challenges for the pharmaceutical industry today and we thank our partner for this collaboration and the significant advances we made together in targeting this important receptor. We remain committed to pursuing mGluR4 PAM for Parkinson’s and other diseases.”
Under the agreement, Addex will regain rights to intellectual property and know-how and can pursue the program independently.
Looks like the CEO was granted rights/options representing 4% of the equity in the company.
Aug 15, 2011: Bharatt Chowrira (CEO) granted 320 Equity Sharing Certificates; each ESC carries the rights to 1000 ordinary shares
Nice to see he has some skin in the game! Let's see what the next few quarters can show .. new partnerships to help R&D funding and operating cash perhaps? But there is not much he can do to speed the R&D pipeline & trials, which IMO is the only thing that will matter to the share price.
Corporate Presentation from Aug 5
http://www.addexpharma.ch/fileadmin/user_upload/IR_Presentations/2011/2011_08_05_Addex_Corp_Slides.pdf
Insider: Buying by a executive director / management: 300 rights(?) worth CHF 3 million
Could this be some options the new CEO was granted?
Addex near all-time lows, a new CEO with turnaround experience and a fresh partnership network, and a robust R&D pipeline.. could be a great time to take a position. But is anybody reading this board? It's very lonely here.....
***Addex Pharmaceuticals SA (achat)
Date de la transaction: 15.08.2011
Transaction réalisée par un membre exécutif du conseil d'administration /
membre de la direction générale
Nature de la transaction: acquisition
Nature des droits: autres
Nombre de droits: 320
Montant de la transaction: CHF 3'036'800.00
New Edison report out (after CEO hire):
http://www.addexpharma.ch/fileadmin/user_upload/Financial_documents/analysts_reports/A_11.08.16_Edison_-_Addex_appoints_new_CEO.pdf
Taken from the report:
Our risk-adjusted NPV of key late-stage assets in the R&D pipeline yields a valuation of CHF212m, equivalent to CHF30/share including FY11 cash. This remains based on an assumption that dipraglurant is second to market for PD-LID; hence it would increase if this compound’s competitive position improves versus Novartis’s AFQ056.
(N.B. CHF30 on the Swiss exchange SWX:ADXN, not OTC:ADDXF)
Coverage of Addex by Edison from June
http://www.addexpharma.ch/fileadmin/user_upload/Financial_documents/analysts_reports/A_11.06.28_Edison_-_Competitive_boost.pdf
Corporate Presentation from Aug 5
http://www.addexpharma.ch/fileadmin/user_upload/IR_Presentations/2011/2011_08_05_Addex_Corp_Slides.pdf
News: Addex Pharmaceuticals Appoints Dr Bharatt Chowrira as CEO
http://www.marketwire.com/press-release/addex-pharmaceuticals-appoints-dr-bharatt-chowrira-as-ceo-swiss-adxn-1549301.htm
August 15, 2011 01:29 ET
Addex Pharmaceuticals Appoints Dr Bharatt Chowrira as CEO
GENEVA, SWITZERLAND--(Marketwire - Aug 15, 2011) -
Addex Pharmaceuticals /
Addex Pharmaceuticals Appoints Dr Bharatt Chowrira as CEO
Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
Geneva, Switzerland, 15 August 2011 - Addex Pharmaceuticals (SWISS: ADXN), a leading biopharmaceutical company pioneering allosteric modulation-based drug discovery and development, announced today the appointment of Dr Bharatt Chowrira as its Chief Executive Officer. Dr Chowrira has a strong track record in the biopharmaceutical industry with over 17-years of experience, combining a unique blend of research, licensing, corporate development, operations and legal expertise.
"We are delighted to have Dr Chowrira take the helm at Addex. Dr Chowrira has achieved much success in his career, including being involved in the turnaround of two biopharmaceutical companies," said André Mueller, Chairman of Addex Pharmaceuticals. "His expertise in R&D operations and corporate development will be a great asset to Addex in our efforts to develop a robust therapeutic pipeline. His leadership and experience will be important in finalizing and implementing a new strategy for the company that will aim to deliver significant value to its shareholders."
Dr Chowrira joins Addex after serving at Nektar Therapeutics, a NASDAQ- traded U.S. biopharmaceutical company developing therapeutics based on advanced polymer conjugate chemistry, as Senior Vice President & Chief Operating Officer until January 2011. Dr Chowrira's responsibilities included, managing Nektar's research, chemistry manufacturing control, manufacturing, operations, business development, licensing and marketing. He led a team that established several revenue-generating strategic alliances. He also led efforts to streamline, realign and integrate operations across research, manufacturing, business development, marketing and multiple R&D sites. This focused strategy and streamlined operations at Nektar resulted in the development of a robust clinical and preclinical pipeline and generation of significant shareholder value.
Prior to Nektar, Dr Chowrira served as Executive Director, Worldwide Licensing & External Research at Merck & Co. He was responsible for identifying and evaluating product and technology partnering opportunities across all therapeutics areas in Asia. His team attracted strategic partnership agreements with several leading firms in the region. Dr Chowrira also served as Vice President of Sirna Therapeutics, a wholly owned subsidiary of Merck, where his responsibilities included strategic planning and licensing.
At Sirna Therapeutics, which specialized in discovery and development of RNAi- based drugs, Dr Chowrira played pivotal roles in the restructuring and re- launch of the company, the development of its pipeline and intellectual property portfolio, all of which generated significant shareholder value and led to its acquisition by Merck & Co., Inc.
"I am excited about joining Addex, a pioneering company and the recognized industry leader in allosteric modulation-based drug discovery and development. This innovative approach is validated already by a handful of marketed allosteric drugs; Addex is now leading the process of industrializing the discovery and development of these previously elusive molecules," said Dr Chowrira. "Addex has strong fundamentals, intellectual property portfolio and technical expertise to leverage the tremendous untapped potential of its validated technology platform. My goal is to rapidly develop these capabilities to address exciting targets across multiple new disease areas with unmet medical needs. I look forward to building on the success achieved to date and expanding Addex's relationships within the global pharmaceutical and biotechnology industry." added Dr Chowrira.
Dr Chowrira earned his Ph.D. in Microbiology and Molecular Genetics from the University of Vermont and his J.D. degree from the College of Law at the University of Denver. He is a registered U.S. patent attorney and a licensed member of the Colorado Bar Association. Dr Chowrira also serves on the Board of Traversa Therapeutics, a biopharmaceutical company based in California.
Addex also announced today the dissolution of the transition committee, which was led by Addex Vice-Chairman Vincent Lawton and included André Mueller as well as Dr Ray Hill, Director. The transition committee was set up as an interim measure following the departure of the former CEO. In addition, Mr. Mueller has reverted to Non-executive Chairman from Executive Chairman.
Addex Pharmaceuticals (www.addexpharma.com) discovers and develops an emerging class of small molecule drugs, called allosteric modulators, 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 address receptors and other proteins that are recognized as attractive targets for modulation of important diseases with unmet medical needs. The Company's two lead products are being investigated in Phase IIa clinical testing: dipraglurant (ADX48621, an mGluR5 negative allosteric modulator or NAM) is being developed by Addex to treat Parkinson's disease levodopa-induced dyskinesia (PD-LID); and, ADX71149 (mGluR2 positive allosteric modulator or PAM) is being developed by our partner Janssen Pharmaceuticals, Inc., to treat schizophrenia. Another partner, Merck & Co., Inc., is developing mGluR4 PAM for Parkinson's disease. Addex also is advancing several preclinical programs including: mGluR2 NAM for treating Alzheimer's disease and depression; GLP1R PAM for type 2 diabetes; FSHR NAM for endometriosis and benign prostatic hyperplasia; and GABABR PAM for chronic pain, urinary incontinence and other disorders. In addition, Addex has discovery programs to identify allosteric modulators of: receptor tyrosine kinase (RTK) superfamily, including TrkB PAM for treating neurodegenerative diseases (e.g. Alzheimer's, Parkinson's and Huntington's diseases); TNF receptor superfamily, including TNFR1 NAM for inflammation (e.g. rheumatoid arthritis); and, interleukin receptor family, such as IL1R1 NAM for gout and type II diabetes.
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 Pharmaceuticals Ltd, 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 Pharmaceuticals Ltd 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 mGluR2, mGluR4,mGluR5, GABABR, FSHR, GLP1R, TNFR1, IL1R1, RTK, TrkB 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 mGluR2, mGluR4, mGluR5, GABABR, FSHR, GLP1R, TNFR1, IL1R1, RTK, TrkB 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 mGluR2, mGluR4, mGluR5, GABABR, FSHR, GLP1R, TNFR1, IL1R1, RTK, TrkB 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 mGluR2, mGluR4, mGluR5, GABABR, FSHR, GLP1R, TNFR1, IL1R1, RTK, TrkB 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 Pharmaceuticals Ltd 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.
--- End of Message ---
Addex Pharmaceuticals 12, chemin des Aulx Plan-les-Ouates; Geneva Switzerland
ISIN: CH0029850754;
English (pdf): http://hugin.info/138017/R/1538328/469846.pdf
Français (pdf) : http://hugin.info/138017/R/1538328/469847.pdf
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 Pharmaceuticals via Thomson Reuters ONE
[HUG#1538328]
Board just created today. I have been following this company for several years now -- a very speculative play but in a niche space in the pharma sector.
See http://www.addexpharma.ch for more info.
Article in Geneva-based Le Temps newspaper about restructuring:
(translated by Google from http://www.addexpharma.ch/fileadmin/user_upload/Media_Exposure/agefi_2011-07-08_ven_04.pdf )
Addex forced to adapt its organizational structure
The Geneva group dismisses quarter of its workforce and is considering other measures of cost reductions. The objective is to decrease of 8 million per year by 2012.
Addex adapts its structures.
Never fully recovered from the loss enthusiastic post-crisis financial investors to the sector biopharmaceuticals, the Geneva group yesterday announced its willingness save about 8 million francs per year. And 2012. The management plans to eliminate up to 25% of the current workforce.
This measure should cover about 25 employees, since according to the latest annual report of the company, one hundred and ten people worked for her in late 2010.
"This is a maximum number, the phone says Chris Maggos, Head of Communications. There will be some attrition for which the positions will not be replaced. "
As required by the legal framework, a consultation is open for employees of Plan-Les-Ouates. Addex and to return to more Later, when the proposals of the employees have been heard by the management. During the agreed period of two weeks, the management work more pecifically to the precise contours of restructuring. The public will share timely announcement
The statement released in the morning. This decision was taken by the Board to ensure the development of a considered strong product portfolio and optimizing the use of balance sheet and capital continues Addex. Cited in the document, Chief Financial Officer Tim Dyer indicates that resizing will "to ensure funding" until the end of 2013. "Job losses are regrettable. But the future of society is better
secure" says the CFO in particular, often considered a central figure in the recent development of the company. Apart from human resources, other sources of expenditure will be also reallocated, said spokesman Chris Maggos, adding However, it would be premature to detail the steps to time. At the strategic level in any case, nothing particularly new has been announced.
Also in the news, Addex says will keep its priorities: research and development of therapies to treat diseases of the central nervous system, inflammatory diseases and metabolism. The group will also continue to seek new strategic partners. Particular product candidate for the mGluR, the receiver GLP-1, TNF family receptors, and interleukin-tyrosine. Last April, the then CEO Vincent Mutel had pointed a type misunderstanding between the model and market group, between approach biopharma industrial type claimed by Addex and Investors focused on the cash inflows. Last year, the loss net of the company amounted to 33.6 million francs, against 42.7 million francs in 2009. In September 2010, the fund Investment California Biotechnology Value Fund (BVF) has committed up to 20 million francs, bringing to 260 million francs the total capital raised by Addex since its inception in 2002. In our columns, Vincent Mutel, one of the creators of the
society, had also stressed the importance of controlling costs. An approach which he believes differentiates the models Addex more traditional in biopharma. It has clearly been heard on this point. Except that the next phase of relief will be without him since his departure from the company was announced in early June last.
The management has been assured by the Chairman of directors, André Müller.
"THE FUTURE OF THE COMPANY IS SAFE AND WELL." THE CFO TIM DYER INDICATES THAT THIS RESIZING WILL SECURE FUNDING UNTIL END 2013."
Selling non-executive director: 5000 on 4 July
Addex Pharmaceuticals SA
Date: 04-July-2011
Transaction realised by a non-executive member of the board of directors
Type of Transaction: disposal
Units: 5000
Transaction Total: 50,746.35 CHF
(taken from http://premium.swissquote.ch/sq_mi/bank/market/news/News.action?frame=true&id=4353779&code=G6be49724895119be0d0eee986dbffbdf )
Selling by non-executive director: 5000 on 11 July
***Addex Pharmaceuticals SA (sale)
Date of transaction: 11-July-2011
Transaction realized by a non-executive member of the board of directors
Nature of the transaction: disposal
Nature of the holding: ordinary shares
Number of units: 5000
Transaction total: CHF 50,000.00
(taken from http://premium.swissquote.ch/sq_mi/bank/market/news/News.action?frame=true&id=4369591&code=If45c3788aaa44e3b7f41fbe912381313 )
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