Santhera and Biovail Enter into License Agreement to Develop and
Commercialize JP-1730/Fipamezole in
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Santhera Pharmaceuticals (SIX: SANN), and Biovail Corporation(NYSE/TSX:BVF) announced today that the two specialty pharmaceuticalcompanies have signed a license agreement for Santhera'sJP-1730/fipamezole. Biovail acquires the US and Canadian rights todevelop and commercialize the drug for the treatment of Dyskinesia inParkinson's Disease. JP-1730/ fipamezole is a first-in-class compoundthat, in a recent Phase IIb study, displayed the potential to reducelevodopa-induced dyskinesia."Biovail is an emerging key player in the area of neurodegenerativedisorders. With its commitment to this therapeutic area and thestrong track record it has developed in a short period of time, I amconfident that JP-1730/fipamezole will become a key product for theimproved management of Parkinson's disease," said Klaus Schollmeier,Chief Executive Officer of Santhera. "Importantly, today's agreementis consistent with our strategy of partnering larger indicationswhilst retaining co-promotional rights for our commercial operationsin the United States."Bill Wells, Biovail's Chief Executive Officer said, "This agreementwith Santhera is directly on strategy and another important step inour efforts to build a sustainable product-development pipeline inspecialty central nervous system disorders."Under the terms of the agreement between Biovail LaboratoriesInternational SRL and Santhera Pharmaceuticals (Switzerland) Ltd andsubject to customary closing conditions, Santhera will receive anupfront payment of USD 8 million and a further payment of USD 4million upon the successful closing of its acquisition of Oy JuvantiaPharma Ltd. Biovail will pay up to USD 35 million in potentialdevelopment and regulatory milestones associated with the initiationof a Phase III study, regulatory submissions and approvals ofJP-1730/fipamezole in Dyskinesia Parkinson's Disease. The agreementalso stipulates that Biovail make additional milestone payments of upto USD 145 million as certain sales thresholds are met. Santhera willalso receive royalty payments of 8% to 15% on net commercial sales ofJP-1730/fipamezole. Should Biovail pursue a second indication, up toUSD 20 million in additional success milestones would be payable toSanthera upon approval.Biovail will be responsible for the remaining clinical developmentprograms and costs in the United States and Canada. The companieshave agreed to collaborate on the development program. Santhera willhave the right to use and sublicense data generated for developmentand commercialization purposes outside of North America. Initiationof the first Phase III study in the United States is scheduled for2011. Santhera will retain co-promotion rights in the United States.In connection with the partnering of JP-1730/fipamezole, Santherarecently exercised its option to acquire Oy Juvantia Pharma Ltd, theowner of the compound. In consideration and subject to certainconditions, Santhera will issue 105,973 previously reserved sharesfrom its authorized capital to the shareholders of Juvantia.Santhera was advised by JSB Partners in this transaction.About Dyskinesia in Parkinson's DiseaseParkinson's disease is the second most common neurodegenerativedisease. Doctors prescribe levodopa and other dopaminergic compoundsas standard therapy. Over time, as the disease progresses, thebeneficial effects of this medication often diminish and additionalmovement disorders can appear (sometimes quite severe). Thesemovement disorders include dyskinesia which can be described assudden uncontrollable, often chaotic movements of limbs, face, tongueand body. These complications derive principally from long-termlevodopa use, but there is currently no alternative to using levodopaor dopamine agonists. It is estimated that approximately 400,000patients in Europe and North America are affected by troublesomedyskinesia associated with their levodopa therapy.About FipamezoleFipamezole is an antagonist of the adrenergic alpha-2 receptor with anovel mode of action in the treatment of Dyskinesia in Parkinson'sDisease. The rationale behind the development of fipamezole is toincrease noradrenergic release in certain areas of the brain,resulting in rebalancing of the distorted brain network andpotentially alleviating symptoms of advanced Parkinson's disease suchas dyskinesia, motor fluctuations, orthostatic hypotension andcognitive impairment without exacerbating the underlying Parkinsonianfeatures of the disease. In a recent Phase IIb study, Santherademonstrated that JP-1730/fipamezole has the potential to reduceDyskinesia in Parkinson's Disease with the study results alsosuggesting that the drug potentially reduces "off time" and improvescognitive function. Furthermore, the reduction in dyskinesia wasfound to be strongly correlated with the investigator's clinicalglobal impression of improvement in overall condition.* * *About SantheraSanthera Pharmaceuticals Holding AG (SIX: SANN) is a Swiss specialtypharmaceutical company focused on the development andcommercialization of small-molecule pharmaceutical products for thetreatment of severe neuromuscular diseases, an area of high unmetmedical need which includes many orphan indications with no currenttherapy. Santhera's first product, Catena® to treat Friedreich'sAtaxia, is marketed in Canada and in a well-advanced Phase IIIdevelopment program. Recently published study results showed that theCompany's second compound, JP-1730/fipamezole is efficacious inreducing levodopa-induced Dyskinesia in Parkinson's Disease. Forfurther information, please visit the Company's Web sitewww.santhera.com.Catena® is a trademark of Santhera Pharmaceuticals.About Biovail CorporationBiovail Corporation, Canada's largest publicly traded pharmaceuticalcompany, is a specialty pharmaceutical company engaged in theformulation, clinical testing, registration, manufacture, andcommercialization of pharmaceutical products. The Company is focusedon the development and commercialization of medicines that addressunmet medical needs in niche specialty central nervous system (CNS)markets. For more information about Biovail, visit the Company's Website at www.biovail.com.Webcast / TeleconferenceAt 15.00 CET / 14.00 UKT / 09.00 EST on August 24, 2009, Santhera'smanagement will discuss today's announcement. Anyone interested inparticipating may join either the webcast on www.santhera.com/webcastor the teleconference (ID: 26492918) using one of the followingdial-ins Switzerland 0565 800 007(local call) United States 1866 966 9439 Canada 1866 966 0399 Germany 0692 222 3479 or0692 222 4918 United Kingdom / International +44 (0) 1452 555 566The webcast will be available for playback one hour after thepresentation ends.For further information, contactSanthera:Klaus Schollmeier, Chief Executive OfficerPhone: +41 (0)61 906 89 52klaus.schollmeier(at)santhera.comBarbara Heller, Chief Financial OfficerPhone: +41 (0)61 906 89 54barbara.heller(at)santhera.comThomas Staffelbach, Head Public & Investor RelationsPhone: +41 (0)61 906 89 47thomas.staffelbach(at)santhera.comBiovail:Nelson F. IsabelVice-President, Investor Relations & Corporate CommunicationsPhone +1 905 286 3000nelson.isabel(at)biovail.comDisclaimer/Forward-looking statementsThis communication does not constitute an offer or invitation tosubscribe for or purchase any securities of Santhera PharmaceuticalsHolding AG. This publication may contain certain forward-lookingstatements concerning the Company and its business. Such statementsinvolve certain risks, uncertainties and other factors which couldcause the actual results, financial condition, performance orachievements of the Company to be materially different from thoseexpressed or implied by such statements. Readers should therefore notplace undue reliance on these statements, particularly not inconnection with any contract or investment decision. The Companydisclaims any obligation to update these forward-looking statements.http://hugin.info/137261/R/1336543/318126.pdf --- End of Message ---Santhera Pharmaceuticals Holding AGHammerstrasse 47 Liestal SwitzerlandWKN: A0LCUK; ISIN: CH0027148649; Index: SPI, SPIEX, SSCI;Listed: Main Market in SIX Swiss Exchange;
Datum: 24.08.2009 - 07:00 Uhr
Sprache: Deutsch
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