Initiation of Pivotal Phase III Study with Catena®/Sovrima®
(Idebenone) in Duchenne Muscular Dystrop
(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, "Santhera"), a Swiss specialtypharmaceutical company focused on orphan neuromuscular diseases, andTakeda Pharmaceutical Company Limited (TSE: 4502, "Takeda") announcedtoday that Santhera has initiated the pivotal Phase III study withCatena®/Sovrima® (INN: idebenone) for the treatment of DuchenneMuscular Dystrophy, one of the most common and devastating types ofmuscle degeneration. The 12-month DELOS study will enroll up to 240patients in 25 centers in Europe and North America. The start ofpatient enrollment into this Phase III study has triggered amilestone payment of EUR 5 million from Takeda, marketing partner inthe European Union and Switzerland, already received by Santhera.The Phase III study named DELOS (DuchEnne Muscular DystrophyLong-term IdebenOne Study) is a double-blind, randomized,placebo-controlled clinical trial evaluating Catena®/Sovrima® in upto 240 ambulatory and non-ambulatory patients aged 10 to 18 years.The safety, tolerability and efficacy of one dose of Catena®/Sovrima®(900 mg/day) will be compared to placebo over a treatment period of12 months. The primary endpoint of the DELOS study is the change frombaseline to week 52 in respiratory function measured by peakexpiratory flow. Secondary endpoints include other respiratoryparameters, muscle strength and motor function over the treatmentperiod and improvement in quality of life amongst others. The studyis expected to involve up to 25 study centers in Europe, the UnitedStates and Canada.The principal investigator of the DELOS study is Professor GunnarBuyse, Professor of Pediatrics & Child Neurology at the UniversityHospitals Leuven, Belgium. Dr Richard Finkel, MD, Director ofNeuromuscular Programs at the Children's Hospital of Philadelphia(PA) will act as Lead Investigator in the United States and Canada.The study design, dose selection and duration of the treatment periodof the DELOS study are based on the positive results Santheraobtained in a Phase II study and were pre-discussed with the US Foodand Drug Administration as well as with the European MedicinesAgency. Furthermore, both agencies agreed that, subject to positiveoutcome, a single pivotal study could suffice for approval.Professor Gunnar Buyse said: "Duchenne Muscular Dystrophy is adevastating neuromuscular disease which affects the skeletal muscles,including the respiratory muscles as well as the heart. Followingencouraging preclinical findings in a placebo-controlled, long-termtrial in a disease-relevant model, a Phase II clinical trialdemonstrated efficacy of this drug on early respiratory and cardiacparameters, in which a decline represents life-threateningcomplications of the disease. We hope to confirm these observationsin the DELOS Phase III study and, as a result, developCatena®/Sovrima® as the first drug approved to treat DuchenneMuscular Dystrophy."Klaus Schollmeier, Chief Executive Officer of Santhera commented:"The start of the DELOS study is another significant landmark in thedevelopment of Catena®/Sovrima® as potential first therapies for rareneuromuscular diseases. Currently, sufferers and physicians have notreatment options for such devastating diseases. The high unmetmedical need is reinforced in the frequent, positive feedback wecontinue to receive from Canada, where Catena® is already availableto treat Friedreich's Ataxia.""The partnership with Santhera is a good example of our commitment tobring superior pharmaceutical products to those who need them,"commented Erich Brunn, CEO of Takeda Pharmaceuticals Europe Limited,Takeda's wholly-owned UK-based subsidiary for overseeing pan-Europeansales and marketing. "Through close cooperation with Santhera, wewill continue our efforts to bring this new treatment option topatients with Duchenne Muscular Dystrophy and healthcare providers asearly as possible."In August 2007, Santhera and Takeda entered into an agreement toextend their existing collaboration for Friedreich's Ataxia toinclude Duchenne Muscular Dystrophy. Under this second agreement,Takeda granted Santhera a certain right to access and use Takeda'sdata on idebenone, and Santhera granted Takeda an exclusive right tocommercialize the product in the European Union and Switzerland underthe brand name Sovrima®. The deal terms included an upfront paymentfrom Takeda and entitle Santhera to development milestones of up toEUR 18 million in total, whereof EUR 5 million became payable upondosing into this pivotal study.About Duchenne Muscular DystrophyDuchenne Muscular Dystrophy is one of the most common and devastatingtypes of muscular degeneration. The disease affects boys of allethnicities with an onset of symptoms as early as three to five yearsof age. Males affected by Duchenne Muscular Dystrophy suffer from anX-linked recessive inherited disease, caused by mutations in the genethat encodes dystrophin. In healthy individuals, this proteinstabilizes the muscle cells during cycles of contraction andrelaxation. Dystrophin acts as a mechanical linker between thecontracting elements and cell surface proteins in each muscle cell.Loss of this protein results in a characteristic form of progressivemuscle weakness and wasting throughout the body. Disease symptomsinitially start in the legs and pelvis and spread to shoulders, neckand arm muscles. Other complications include skeletal deformation,respiratory distress and cardiac failure. As the disease progresses,sufferers become confined to a wheelchair during their teenage years.The average life expectancy for Duchenne Muscular Dystrophy patientsis 30 to 35 years. An estimated 30,000 males in Europe and NorthAmerica suffer from Duchenne Muscular Dystrophy. With no effectivemedication available for chronic use, treatment focuses on supportiveaids aimed at delaying or alleviating the symptoms. * * *About SantheraSanthera Pharmaceuticals (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 show that theCompany's second compound JP-1730/fipamezole is efficacious in reducing levodopa-induced Dyskinesia inParkinson's Disease. For further information, please visit theCompany's web site www.santhera.com.Catena® is a trademark of Santhera Pharmaceuticals.About TakedaLocated in Osaka, Japan, Takeda is a research-based global companywith its main focus on pharmaceuticals. As the largest pharmaceuticalcompany in Japan and one of the global leaders of the industry,Takeda is committed to striving toward better health for individualsand progress in medicine by developing superior pharmaceuticalproducts. Additional information about Takeda is available throughits corporate website, www.takeda.com.Sovrima® is a trademark of Takeda Pharmaceutical Company Limited.For further information, contactSantheraKlaus 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.comTakedaRichard KenyonTakeda Pharmaceuticals Europe LimitedCorporate CommunicationsPhone: +44 20 3116 8861richard.kenyon(at)tpeu.co.ukSeizo MasudaTakeda Pharmaceutical Company LimitedPublic and Investor RelationsPhone: +81 3 3278 2037masuda_seizo(at)takeda.co.jpDisclaimer/Forward-looking statementsThis communication does not constitute an offer or invitation tosubscribe for or purchase any securities of Santhera and Takeda. Thispublication may contain certain forward-looking statements concerningthe Companies and their businesses. Such statements involve certainrisks, uncertainties and other factors which could cause the actualresults, financial condition, performance or achievements of theCompanies to be materially different from those expressed or impliedby such statements. Readers should therefore not place undue relianceon these statements, particularly not in connection with any contractor investment decision. The Companies disclaim any obligation toupdate these forward-looking statements.http://hugin.info/137261/R/1339065/319671.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: 02.09.2009 - 17:32 Uhr
Sprache: Deutsch
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