First Patient Enrolled in Third Phase III Study of Oral Laquinimod for Relapsing-Remitting Multiple Sclerosis
March 6, 2013 - Jerusalem And Lund, Sweden
CONCERTO Study Enrolling Patients Globally to Evaluate Impact of Laquinimodon Disability Progression
Teva PharmaceuticalIndustries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI)announced today enrollment of the first patient in the CONCERTO study- thethird Phase III placebo-controlled study designed to evaluate theefficacy,safety and tolerability of once-daily oral laquinimod in patientswithrelapsing-remitting multiple sclerosis (RRMS). The primary outcomemeasure ofCONCERTO will be confirmed disability progression as measured by theExpandedDisability Status Scale (EDSS).
"Previous Phase III studies in more than 2,400 people with RRMS suggest auniqueprofile of laquinimod, directly affecting the neurodegenerative processesthatlead to disability progression, the main concern in the treatment of RRMS,"saidCONCERTO principal investigator, Dr. Timothy Vollmer, Professor ofNeurology,University of Colorado Denver, Medical Director of the Rocky MountainMultipleSclerosis Center, and Co-Director of the RMMSC at Anschutz. "We arecurrentlyenrolling patients in this third pivotal study to further examine theclinicalbenefits of laquinimod on disability progression, the primary endpointof theCONCERTO trial, and brain atrophy, at both the previously studied 0.6 mgdose,and now a higher 1.2 mg dose."
The multinational, randomized, double blind placebo-controlled study willaim toenroll approximately 1,800 patients at more than 300 sitesglobally(http://clinicaltrials.gov/show/NCT01707992). Along with the primaryendpoint oftime to confirmed disability progression, the study will also examine theimpactof laquinimod on endpoints such as percent change in brain volume andotherclinical and MRI markers of disease activity.
"For nearly 30 years, Teva has been focused on improving the lives ofpeoplewith multiple sclerosis by delivering innovative treatment options thataddressthis complex disease," said Dr. Michael Hayden, President of GlobalR&D andChief Scientific Officer at Teva Pharmaceutical Industries, Ltd. "TheCONCERTOstudy demonstrates our commitment to collaborating with MS communitiesworldwideto further develop laquinimod and address unmet patient needs."
Laquinimod is an oral, once-daily CNS-active immunomodulator with anovelmechanism of action being developed for the treatment of MS. In animalmodelslaquinimod crosses the blood brain barrier to potentially have a directeffecton resident CNS inflammation and neurodegeneration. The globalPhase IIIclinical development program evaluating oral laquinimod in MSincludes twopivotal studies, ALLEGRO and BRAVO.In addition to the MS clinical studies, laquinimod is currently inclinicaldevelopment for Crohn's disease and Lupus.
CONCERTO is a multinational, multicenter, randomized, double-blind,parallel-group, placebo-controlled study followed by an activetreatment phase, toevaluate the efficacy, safety and tolerability of two doses oforaladministration of laquinimod 0.6 mg/day or 1.2 mg/day in subjects withRRMS.This third Phase III laquinimod study will evaluate laquinimod inapproximately1,800 patients for up to 24 months, after which patients will continueto anactive treatment period with laquinimod for additional 24 months. Theprimaryoutcome measure will be time to confirmed disability progression asmeasured bythe Expanded Disability Status Scale (EDSS). The study will alsoexamine theimpact of laquinimod on endpoints such as percent change in brainvolume, aswell as other clinical and MRI markers of disease activity.
ABOUT MULTIPLE SCLEROSIS
MS is the leading cause of neurological disability in young adults.It isestimated that more than 400,000 people in the United States are affectedby thedisease and that two million people may be affected worldwide.Multiplesclerosis is a degenerative disease of the central nervous system inwhichinflammation and axonal damage and loss result in the development ofprogressivedisability.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leadingglobalpharmaceutical company, committed to increasing access tohigh-quality healthcare by developing, producing and marketing affordablegeneric drugs aswell as innovative and specialty pharmaceuticals and activepharmaceuticalingredients. Headquartered in Israel, Teva is the world's leading genericdrugmaker, with a global product portfolio of more than 1,000 molecules and adirectpresence in about 60 countries. Teva's branded businesses focus onCNS,oncology, pain, respiratory and women's health therapeutic areas aswell asbiologics. Teva currently employs approximately 46,000 people around theworldand reached $20.3 billion in net revenues in 2012.
ABOUT ACTIVE BIOTECH
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company withfocus on autoimmune/inflammatory diseases and cancer. Projects in pivotalphaseare laquinimod, an orally administered small molecule with uniqueimmunomodulatory properties for the treatment of multiple sclerosis, TASQforprostate cancer and ANYARA primarily for the treatment of renal cellcancer. Inaddition, laquinimod is in Phase II development for Crohn's and Lupus. Thecompany also has one additional project in clinical development, the orallyadministered compound 57-57 for Systemic Sclerosis. Please visitwww.activebiotech.com for more information.
Teva's Safe Harbor Statement under the U. S. Private SecuritiesLitigationReform Act of 1995:
This release contains forward-looking statements, which express thecurrentbeliefs and expectations of management. Such statements arebased onmanagement's current beliefs and expectations and involve a number ofknown andunknown risks and uncertainties that could cause our future results,performanceor achievements to differ significantly from the results,performance orachievements expressed or implied by such forward-looking statements.Importantfactors that could cause or contribute to such differences includerisksrelating to: our ability to develop and commercialize additionalpharmaceuticalproducts, competition for our innovative products, especiallyCopaxone®(including competition from innovative orally-administered alternatives, aswellas from potential purported generic equivalents), competition for ourgenericproducts (including from other pharmaceutical companies and as aresult ofincreased governmental pricing pressures), competition for ourspecialtypharmaceutical businesses, our ability to achieve expected resultsthrough ourinnovative R&D efforts, the effectiveness of our patents and otherprotectionsfor innovative products, decreasing opportunities to obtain U.S.marketexclusivity for significant new generic products, our ability toidentify,consummate and successfully integrate acquisitions, the effects ofincreasedleverage as a result of the acquisition of Cephalon, the extent towhich anymanufacturing or quality control problems damage our reputation for highqualityproduction and require costly remediation, our potential exposure toproductliability claims to the extent not covered by insurance, increasedgovernmentscrutiny in both the U.S. and Europe of our agreements with brandcompanies,potential liability for sales of generic products prior to a finalresolution ofoutstanding patent litigation, including that relating to the genericversion ofProtonix®, our exposure to currency fluctuations and restrictionsas well ascredit risks, the effects of reforms in healthcare regulation andpharmaceuticalpricing and reimbursement, any failures to comply with complexMedicare andMedicaid reporting and payment obligations, governmental investigationsintosales and marketing practices (particularly for our specialtypharmaceuticalproducts), uncertainties surrounding the legislative and regulatorypathway forthe registration and approval of biotechnology-based products, adverseeffectsof political or economical instability, major hostilities or acts ofterrorismon our significant worldwide operations, interruptions in our supplychain orproblems with our information technology systems that adverselyaffect ourcomplex manufacturing processes, any failure to retain key personnelor toattract additional executive and managerial talent, the impact ofcontinuingconsolidation of our distributors and customers, variations in patent lawsthatmay adversely affect our ability to manufacture our products in themostefficient manner, potentially significant impairments of intangibleassets andgoodwill, potential increases in tax liabilities, the termination orexpirationof governmental programs or tax benefits, environmental risks and otherfactorsthat are discussed in our Annual Report on Form 20-F for the year endedDecember31, 2011 and in our other filings with the U.S. Securities andExchangeCommission. Forward-looking statements speak only as of the date on whichtheyare made and the Company undertakes no obligation to update orrevise anyforward-looking statement, whether as a result of new information, futureeventsor otherwise.
Active Biotech's Safe Harbor Statement in Accordance with the SwedishSecuritiesMarket Act:
This press release contains certain forward-looking statements. Suchforward-looking statements involve known and unknown risks, uncertaintiesand otherimportant factors that could cause the actual results, performance orachievements of the company, or industry results, to differ materially fromanyfuture results, performance or achievement implied by the forward-lookingstatements. The company does not undertake any obligation to update orpubliclyrelease any revisions to forward-looking statements to reflect events,circumstances or changes in expectations after the date of this pressrelease.Active Biotech is obligated to publish the information contained in thispressrelease in accordance with the Swedish Securities Market Act. Thisinformationwas provided to the media for publication 2:00 p.m. CET on March 6, 2013.
FIRST PATIENT ENROLLED IN THIRD PHASE III STUDY:
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Kevin C. Mannix
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Active Biotech AB
Active Biotech AB