Dose-finding Phase IIb study started in patients with multiple
sclerosis - Actelion/Roche S1P1 allia
(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 - 09 October 2009 - Actelion Ltd (SIX: ATLN)announced today that the selective S1P1 receptor agonist ACT-128800/RG3477 has achieved an important clinical milestone. Actelion'sfirst-in-class selective S1P1 (Sphingosine-1-phosphate) receptoragonist has entered into a Phase IIb dose-finding study in patientssuffering from multiple sclerosis. This triggers a milestone paymentby Roche to Actelion of USD 20 million.Guy Braunstein, M.D., Ph.D. and Head of Clinical Development atActelion, commented: "Together with our partner Roche, we arecommitted to the rapid development of our selective S1P1 receptoragonist for patients suffering from autoimmune disorders. With thestart of this dose-finding study in patients with multiple sclerosis,we have made an important step forward."About the Actelion / Roche allianceActelion and Roche entered into an exclusive worldwide collaborationin July 2006 to jointly develop and commercialize Actelion'sselective S1P1 receptor agonist, an immunomodulator with thepotential for once-a-day oral dosing. The two companies plan tojointly develop and commercialize this novel compound for multipleautoimmune disorders. For the current selective S1P1 receptoragonist, Actelion will fully fund all development activities up tothe end of Phase II for the first two indications. All subsequentdevelopment and commercialization costs will be shared equallybetween Roche and Actelion. Both companies will co-promote anyproduct resulting from this collaboration and will equally shareprofit.This S1P1 collaboration covers both the current selective S1P1receptor agonist in clinical development, as well as any otherselective S1P1 receptor agonists resulting from Actelion's researchefforts in the field. Actelion received an upfront payment of USD 75million in July 2006. In the case of future development and approvalmilestones being achieved, Actelion will be eligible to receivefurther payments of up to USD 535 million for the first compound forall targeted indications. Further development and approval milestonepayments are due for additional compounds. Roche will pay Actelionundisclosed royalties on all product sales.Selective S1P1 receptor agonistsSphingosine-1-phosphate (S1P) is a phospholipid released byplatelets, mast cells and other cells. It is currently established[1,2] that S1P stimulates at least five different G-protein coupledreceptors (GPCRs): S1P1,2,3,4, and 5. Activation of these GPCRsmediates a complex variety of biological responses, such aslymphocyte migration, endothelial cell proliferation, blood vesselconstriction and heart rate modulation.Actelion'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.###Notes to the editorAbout 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, inflammatory bowel disease and rejection of transplantedorgans. These disorders affect millions of people worldwide.About multiple sclerosisMultiple sclerosis (MS) is an inflammatory autoimmune disorder of thecentral nervous system (CNS) and is the most common cause ofprogressive neurological disability in young adults [3,4]. Thischronic demyelinating disease is characterized by heterogeneousclinical expression, an unpredictable course and a variableprognosis. MS results from a cascade of events involving anactivation of the immune system, acute focal inflammatorydemyelination, and axonal loss with limited remyelination,culminating in chronic multifocal sclerotic plaques in brain andspinal cord. The large variety of symptoms and signs of MS resultfrom axonal demyelination which leads to the slowing or blockade ofaxonal conduction at diverse affected sites of the brain and spinalcord. Repeated episodes of disease activity may lead to progressiveloss of neurological function.The incidence of MS is about 7 cases per 100,000 persons per year andalthough the etiology of MS is still unknown, the prevalence ratevaries between races and geographical latitudes, ranging from 50-120per 100,000 [3]. It is widely accepted that it is an immune-mediated,demyelinating disease precipitated by unknown environmental factorsin genetically susceptible people.References1. Huwiler A, Pfeilschifter J. Biochem Pharmacol. 2008 May15;75(10):1893-900. Review.2. Rivera J, Proia RL, Olivera A.Nat Rev Immunol. 2008Oct;8(10):753-63. Review.3. Compston A, Coles A. Multiple sclerosis. Lancet2002;359:1221-31.4. 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 2000 employees focus on the discovery, development and marketingof innovative drugs for significant unmet medical needs. Actelionshares 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/1346473/323453.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: 09.10.2009 - 07:00 Uhr
Sprache: Deutsch
News-ID 6739
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 357 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Dose-finding Phase IIb study started in patients with multiple
sclerosis - Actelion/Roche S1P1 allia"
steht unter der journalistisch-redaktionellen Verantwortung von
Actelion Pharmaceuticals Ltd (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
