Actelion's selective S1P1 receptor agonist moves into advanced
clinical development in psoriasis - P
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ ALLSCHWIL, SWITZERLAND - 08 December 2009 - Actelion Ltd (SIX: ATLN)announced today that the company has decided to proceed with advancedclinical development with its orally available and selective S1P1receptor agonist (ACT-128800) in psoriasis. ACT-128800 is already inadvanced clinical development for multiple sclerosis, where adose-finding study has started recruiting patients in early October2009.Actelion will move forward in developing ACT-128800 in these twoprograms and other autoimmune indications. Basel-based Roche informedActelion on 7 December 2009 that it does not wish to continue theS1P1 alliance, following a comprehensive portfolio review. Since theintegration of the Genentech portfolio, Roche has been carrying outextensive reviews of its combined R&D portfolio.The decision by Roche to leave the alliance results in acceleratedrecognition of the deferred revenues from milestones previously paidto Actelion. As of the date of termination, the amount ofunrecognized revenue was USD 88.7 million, which will be recognizedover the 6 months starting in December of this year.Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelioncommented: "I would like to thank Roche for their contribution andtheir expertise in progressing this program to the present stage.Today, Actelion has all the assets at hand - medical know-how, globaldevelopment, global sales and marketing capabilities and strong cashflow - to successfully develop and commercialize our promisingselective S1P1 receptor agonist in several indications."Jean-Paul Clozel concluded: "I am convinced that Actelion's selectiveS1P1 receptor agonist, an oral and rapidly reversible immunotherapy -has the potential to improve therapy for patients. Especially, Iexpect that our selective S1P1 receptor agonist could have a widersafety margin compared to other therapies currently available or indevelopment, whether they are long-acting biologicalimmunosuppressive or other oral approaches."Actelion's decision to advance its selective S1P1 receptor agonistfor the treatment of psoriasis is based on a recently concluded PhaseIIa proof-of-concept study. While this short term study did not reachstatistical significance, sufficient information was obtained toproceed with a first pivotal study in psoriasis.The Phase IIa study also extended the safety information ofACT-128800, previously established in healthy volunteers, to a largergroup of psoriasis patients for up to six weeks of treatment. Fullstudy results will become available through future presentation atmajor scientific meetings and subsequent scientific publication.In multiple sclerosis, Actelion is currently undertaking amulti-center, randomized, double-blind, placebo-controlled,parallel-group, dose-finding study to evaluate the efficacy, safety,and tolerability of three doses of Actelion's S1P1 receptor agonistadministered for twenty-four weeks in 400 patients withrelapsing-remitting multiple sclerosis (RRMS). The study is designedto assess the efficacy of ACT-128800, as compared to placebo, onmagnetic resonance imaging endpoints.###Notes to the editorAbout selective S1P receptor agonismSphingosine-1-phosphate (S1P) is a phospholipid released byerythrocytes, platelets, mast cells and other cells. It is currentlyestablished [1,2] that S1P stimulates at least five differentG-protein coupled receptors (GPCRs): S1P1,2,3,4, and 5. Activation ofthese GPCRs mediates a complex variety of biological responses, suchas lymphocyte migration, endothelial cell proliferation, blood vesselconstriction and heart rate modulation.About Actelion and selective S1P1 agonistsActelion's efforts in the field of selective S1P1 receptor agonistsstarted in 1999 by focusing on GPCRs found on the endothelium, theinner lining of blood vessels. The result of these research effortsis Actelion's orally active selective S1P1 receptor agonist,ACT-128800. The company also has a comprehensive research effortongoing to discover and develop other S1P1 receptor agonists andantagonists.About ACT-128800ACT-128800 is a potent, orally active, selective sphingosine1-phosphate receptor 1 (S1P1) agonist. ACT-128800 blocks the egressof lymphocytes from lymphoid organs and thus reduces the availabilityof circulating effector T cells that can invade target organs. Thispharmacodynamic effect is sustained with continued daily oral dosing,but is rapidly reversible upon drug discontinuation. ACT-128800 istherefore considered a promising new oral agent for the treatment ofa variety of autoimmune disorders.About the former Actelion / Roche S1P1 allianceActelion and Roche entered into an exclusive worldwide collaborationin July 2006 to jointly develop and commercialize Actelion'sselective S1P1 receptor agonists. Upfront and milestone paymentstotaling USD 105 million have been received by Actelion under thecollaboration contract, and have been recognized over the expectedclinical development time for ACT-128800. Following a comprehensiveportfolio review, Roche has decided to prioritize its other projectsin the area of autoimmune disorders. Since the integration of theGenentech portfolio, Roche has been carrying out extensive reviews ofits combined R&D portfolio. As of the date of termination, the amountof unrecognized revenue was USD 88.7 million, which will berecognized in Actelion's Profit and Loss Statements over the 6 monthsstarting December 2009.About autoimmune disordersAutoimmune disorders are diseases caused by the body producing animmune response against its own tissues. The cause of autoimmunedisorders is unknown. Some of the most common types of autoimmunedisorders include psoriasis, rheumatoid arthritis, multiplesclerosis, and inflammatory bowel disease. These disorders affectmillions of people worldwide.About PsoriasisPsoriasis is a chronic, relapsing, inflammatory and immune-mediatedskin disease affecting about 1-3% of the population worldwide. Plaquepsoriasis is the most common form of psoriasis constituting ~ 85% ofcases [1]. The most characteristic skin lesions of chronic plaquepsoriasis are sharply demarcated erythematous plaques, covered bysilvery white scales, which most commonly occur on the elbows, knees,scalp, umbilicus, and lumbar area. Children, adolescents, and adultsare affected. The causes are not known, however, both environmentaland genetic causes have been implicated. Current research suggeststhat the inflammatory mechanisms are immune based [2,3].About Multiple SclerosisMultiple sclerosis (MS) is an autoimmune disorder of the centralnervous system (CNS) and is the most common cause of progressiveneurological disability in young adults [4,5]. MS with its mechanismof inflammation, demyelination, and neurodegeneration ischaracterized by heterogeneous clinical expression, an unpredictablecourse and a variable prognosis. MS results from a cascade of eventsinvolving an activation of the immune system, acute focalinflammatory demyelinating lesions with limited remyelination, andaxonal loss with limited remyelination, culminating in chronicmultifocal sclerotic plaques in brain and spinal cord. The largevariety of symptoms and signs of MS result from axonal demyelizationor axon loss which leads to the slowing or blockade of axonalconduction at diverse affected sites of the brain and spinal cord.Repeated episodes of disease activity may lead to progressive loss ofneurological function.The incidence of MS is about 7 cases per 100,000 persons per year [4]and although the etiology of MS is still unknown, the prevalence ratevaries between ethnic origins and geographical latitudes, rangingfrom 50-120 per 100,000 [4]. It is widely accepted that it is animmune-mediated, demyelinating disease precipitated by unknownenvironmental factors in genetically susceptible people.References1. Naldi L, Gambini D. The clinical spectrum of psoriasis. ClinDermatol 2007;25:510-518.2. Nickoloff BJ, Quin JZ, Nestle FO. Immunopathogenesis ofpsoriasis. Clinic Rev Allerg Immunol 2007;33:45-56.3. Ghoreschi K, Weigert C, Röcken M. Immunopathogenesis androle of T cells in psoriasis. Clin Dermatol 2007;25:547-580.4. Compston A, Coles A. Multiple sclerosis. Lancet2002;359:1221-31.5. Compston A, Coles A. Multiple sclerosis. Lancet2008;372:1502-18.Actelion LtdActelion Ltd is a biopharmaceutical company with its corporateheadquarters in Allschwil/Basel, Switzerland. Actelion's first drugTracleer®, an orally available dual endothelin receptor antagonist,has been approved as a therapy for pulmonary arterial hypertension.Actelion markets Tracleer® through its own subsidiaries in keymarkets worldwide, including the United States (based in South SanFrancisco), the European Union, Japan, Canada, Australia andSwitzerland. Actelion, founded in late 1997, is a leading player ininnovative science related to the endothelium - the single layer ofcells separating every blood vessel from the blood stream. Actelion'sover 2'200 employees focus on the discovery, development andmarketing of innovative drugs for significant unmet medical needs.Actelion shares are traded on the SIX Swiss Exchange (ticker symbol:ATLN).For further information please contact:Roland HaefeliVice President, Head of Investor Relations & Corporate CommunicationsActelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil+41 61 565 62 62+1 650 624 69 36http://www.actelion.comhttp://hugin.info/131801/R/1359631/331429.pdf --- End of Message ---Actelion Pharmaceuticals LtdGewerbestrasse 16 Allschwil SwitzerlandWKN: 936767; ISIN: CH0010532478; Index: SBIOM, SLIFE, SMCI, SMIEXP, SMIM, SPI, SPIEX;Listed: Main Market in SIX Swiss Exchange;
Datum: 08.12.2009 - 07:00 Uhr
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