Addex Achieves Second Milestone in Parkinson's Disease Collaboration with Merck & Co., Inc.

Addex Achieves Second Milestone in Parkinson's Disease Collaboration
with Merck & Co., Inc.>

ID: 3422

Addex Achieves Second Milestone in Parkinson's Disease Collaboration with Merck & Co., Inc.

(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Data Confirm Non-Dopaminergic Approach to Treating Parkinson'sDiseaseDeutsch (PDF)Français (PDF)English (PDF)Geneva, Switzerland, 10 July 2008 - Allosteric modulation companyAddex Pharmaceuticals (SIX:ADXN) announced today that the secondpreclinical milestone has been achieved in an exclusive collaborationand license agreement with Merck & Co., Inc. (through its affiliateMerck Sharp & Dohme Research Ltd). The collaboration is focused ondeveloping an emerging type of drugs, called allosteric modulators,for treatment of Parkinson's disease and other undisclosedindications. Allosteric modulators have broad potential to addressimportant therapeutic targets; this collaboration with Merck isfocused on developing drugs that specifically activate themetabotropic glutamate receptor 4 (mGluR4). The preclinical studyshowed the desired non-dopaminergic activity profile after oraladministration of mGluR4 positive allosteric modulator (PAM) in ananimal model of Parkinson's disease."We are pleased that these preclinical data show such promise in theanimal model used," said Emmanuel Le Poul, head of the CNS BusinessUnit at Addex. "This work is a further validation of the target andthe strength of our collaboration, as both teams have contributed tothis achievement.""Innovative non-dopaminergic therapies represent a significantopportunity to address an important unmet medical need in Parkinson'sdisease patients," said Vincent Mutel, CEO of Addex. "We are proudthat our allosteric modulation drug discovery and developmentplatform has generated highly innovative products in Parkinson'sdisease in addition to other important indications with unmet medicalneed including: gastroesophageal reflux disease, migraine,schizophrenia and anxiety."Addex will discuss the mGluR4 PAM collaboration and its clinical andpreclinical stage allosteric modulator pipeline and discoveryplatform during its R&D Day on July 16, 2009. A webcast and recordingof the Addex R&D Day will be made available at www.addexpharma.com.Addex will receive $500,000 for achieving the second preclinicalmilestone. Addex received $250,000 after achieving the firstpreclinical milestone during the first quarter of 2008. Under theterms of the agreement, first announced in December 2007, Addexreceived $3 million upfront and is eligible for up to $106.5 millionin research, development and regulatory milestones for the firstproduct developed for multiple indications. Additional milestones ofup to $61 million would be payable if a second and third product isdeveloped. Addex is eligible to receive undisclosed royalties onsales of any products resulting from this collaboration. Merck isresponsible for clinical development.mGluR4 may play an important role in Parkinson's disease, which is adebilitating movement disorder. Current treatments focus ondopamine-replacement strategies, however most patients reach a stagewhere dopaminergic treatments are no longer effective. There can alsobe debilitating side effects with dopaminergic treatments and manypatients limit doses so their side effects will be less cumbersome.The recent success of surgical approaches suggests that bypassing thedopamine system may provide a more effective treatment strategy. Itis believed that selective activation of mGluR4 is one way to do thisand could correct the circuitry that modulates motor excitability.This has the potential to provide significant benefit in Parkinson'sdisease.Published research* shows that mGluR4 activators, like those indevelopment at Addex, could work via two distinct mechanisms toalleviate symptoms of Parkinson's disease and, potentially, even slowthe progression of the disease: 1) mGluR4 activation triggers acompensatory mechanism that may spare or potentiate the use ofdopamine receptor activators; 2) mGluR4 activation may have aneuroprotective effect that helps to preserve the brain'sdopaminergic neurons.*Nature Reviews Neuroscience, Vol 6, Oct. 2005, pp 787-798Glutamate, like dopamine and serotonin, is a key neurotransmitter inthe human brain, an important signaling molecule involved in controlof multiple brain functions ranging from motor control to mood.Although marketed drugs modulate specific receptors involved in boththe dopaminergic and serotinergic systems, it has been difficult todevelop drugs that can selectively target specific receptors ofglutamate, which has many different receptors, some of which cancause serious side effects if improperly modulated.Merck has been a pioneer in research on mGlu receptors and themetabotropic glutamatergic system for multiple indications. Forexample, research by Merck scientists provided the first evidencethat mGluR4 activation has potential for treatment of Parkinson'sdisease. However, a remaining challenge has been to make drug-likemolecules that activate mGluR4 in a specific fashion. Addex is apioneer in developing allosteric modulators, truly selective smallmolecule drug candidates, for human health.Parkinson's disease is a brain disorder characterized by movementdisorders and other symptoms. It occurs when certain nerve cells(neurons) in a part of the brain called the substantia nigra die orbecome impaired. Normally, these cells produce a vital chemical knownas dopamine. Dopamine allows smooth, coordinated function of thebody's muscles and movement. When approximately 80% of thedopamine-producing cells are damaged, the symptoms of Parkinson'sdisease appear.About 1.5 million Americans currently have Parkinson's disease, andabout 60,000 new cases are diagnosed each year. Parkinson's is oneof the fastest growing diseases, driven by the ageing population.Parkinson's disease drugs had global sales of around $2.5 billion in2005, which analysts believe could grow to $3.8 billion by 2010.Although no marketed products slow the disease progression, there area number of medicines that effectively ease the symptoms. Themedicines most commonly prescribed attempt to either replace or mimicdopamine. They can improve the tremor, rigidity and slownessassociated with Parkinson's disease but they also can cause sideeffects like dyskinesia (involuntary movements) and eventually stopworking, as the dopaminergic neurons continue to die.Addex Pharmaceuticals (www.addexpharma.com) discovers and developsallosteric modulators for human health. Allosteric modulators are adifferent kind of orally available small molecule therapeutic agent,which we believe will offer a competitive advantage over classicaldrugs. Our lead allosteric modulator product, ADX10059, has achievedclinical proof of concept and is in Phase IIb testing for thetreatment of GERD and, separately, migraine headache. Both areimportant diseases for which existing products with limited efficacyhave established multi-billion dollar markets despite sub-optimalefficacy. ADX10059 is a first-in-class mGluR5 inhibitor, atherapeutic strategy that also is being pursued in multipleindications by large pharma competitors.Our products and technology already have proven their value throughour partnerships with four of the top 10 pharmaceutical companies inthe world. Specifically, two separate agreements with Merck & Co.,Inc., are focused on developing allosteric modulators as drugs totreat Parkinson's disease and schizophrenia, respectively. A thirdagreement with Ortho-McNeil-Janssen Inc. is focused on development ofallosteric modulators to treat anxiety and schizophrenia. Inaddition, GlaxoSmithKline and Roche have made equity investments inAddex.Chris MaggosHead of IR & CommunicationsAddex Pharmaceuticals+41 22 884 15 11chris.maggos(at)addexpharma.comDisclaimer: The foregoing release contains forward-looking statementsthat can be identified by terminology such as "not approvable","continue", "believes", "believe", "will", "remained open toexploring", "would", "could", or similar expressions, or by expressor implied discussions regarding Addex Pharmaceuticals Ltd, itsbusiness, the potential approval of its products by regulatoryauthorities, or regarding potential future revenues from suchproducts. Such forward-looking statements reflect the current viewsof Addex Pharmaceuticals Ltd regarding future events, and involveknown and unknown risks, uncertainties and other factors that maycause actual results with allosteric modulators of mGluR4, mGluR2 ormGluR5 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 mGluR4,mGluR2 or mGluR5 will be approved for sale in any market or by anyregulatory authority. Nor can there be any guarantee that allostericmodulators of mGluR4, mGluR2 or mGluR5 will achieve any particularlevels of revenue (if any) in the future. In particular, management'sexpectations regarding allosteric modulators of mGluR4, mGluR2 ormGluR5 could be affected by, among other things, unexpected actionsby our partners, unexpected regulatory actions or delays orgovernment regulation generally; unexpected clinical trial results,including unexpected new clinical data and unexpected additionalanalysis of existing clinical data; competition in general;government, industry and general public pricing pressures; thecompany's ability to obtain or maintain patent or other proprietaryintellectual property protection. Should one or more of these risksor uncertainties materialize, or should underlying assumptions proveincorrect, actual results may vary materially from those anticipated,believed, estimated or expected. Addex Pharmaceuticals is providingthe information in this press release as of this date and does notundertake any obligation to update any forward-looking statementscontained in this press release as a result of new information,future events or otherwise.http://hugin.info/138017/R/1327976/312982.pdfhttp://hugin.info/138017/R/1327976/313044.pdfhttp://hugin.info/138017/R/1327976/313045.pdf --- End of Message ---Addex Pharmaceuticals12, chemin des Aulx Plan-les-Ouates, Geneva SwitzerlandISIN: CH0029850754; Index: SLIFE, SPI, SPIEX, SSCI;Listed: Main Market in SIX Swiss Exchange;



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