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Teva to Initiate Third Phase III Trial of Oral Laquinimod for the Treatment of Relapsing Remitting Multiple Sclerosis

August 8, 2012 - Jerusalem, Israel And Lund, Sweden

The clinical trial protocol has been granted a Special ProtocolAssessment agreement by the Food and Drug Administration

Teva PharmaceuticalIndustries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI)provided today an update on the clinical development program of once-dailyorallaquinimod for the treatment of relapsing-remitting multiple sclerosis(RRMS).The companies are to initiate a third Phase III study of laquinimod,followingthe written agreement reached with the U.S. Food and Drug Administration(FDA)on the Special Protocol Assessment (SPA).

The third Phase III laquinimod trial CONCERTO will evaluate two dosesof theinvestigational product (0.6mg and 1.2mg) in approximately 1,800 patientsfor upto 24 months. The primary outcome measure will be confirmeddisabilityprogression as measured by the Expanded Disability Status Scale (EDSS).

"The results achieved in the previous Phase III trials of laquinimodsupport theclinical utility of this compound as a unique treatment option formultiplesclerosis," said Dr. Michael Hayden, President of Global R&D andChiefScientific Officer, Teva Pharmaceutical Industries Ltd. "We areencouraged bythe FDA's agreement on the trial design and planned analysis, and lookforwardto further developing laquinimod as a potential treatment option forRRMSpatients."


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 in PhaseII ofdevelopment for Crohn's disease and Lupus.


A SPA is a written agreement between the FDA (Food and DrugAdministration) anda drug sponsor intended to confirm that the clinical trial protocol isadequateto meet current scientific and regulatory requirements for a potential newdrugapplication.


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 in whichinflammation and axonal damage and loss result in the development ofprogressivedisability.


Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading globalpharmaceutical company, committed to increasing access to high-qualityhealthcare by developing, producing and marketing affordable generic drugsaswell as innovative and specialty pharmaceuticals and active pharmaceuticalingredients. Headquartered in Israel, Teva is the world's leading genericdrugmaker, with a global product portfolio of more than 1,300 molecules and adirectpresence in about 60 countries. Teva's branded businesses focus on CNS,oncology, pain, respiratory and women's health therapeutic areas as well asbiologics. Teva currently employs approximately 46,000 people around theworldand reached $18.3 billion in net revenues in 2011.


Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company withfocus on autoimmune/inflammatory diseases and cancer. Projects in orenteringpivotal phase are laquinimod, an orally administered small molecule withuniqueimmunomodulatory properties for the treatment of multiple sclerosis, TASQforprostate cancer as well as ANYARA for use in cancer targeted therapy,primarilyof renal cell cancer. In addition, laquinimod is in Phase II developmentforCrohn's and Lupus. An additional project in clinical development is theorallyadministered compound 57-57 for Systemic Sclerosis. Please for more information.

Teva's Safe Harbor Statement under the U. S. Private SecuritiesLitigationReform Act of 1995: The following discussion and analysis containsforward-looking statements, which express the current beliefs andexpectations ofmanagement. Such statements involve a number of known and unknownrisks anduncertainties that could cause our future results, performance orachievementsto differ significantly from the results, performance or achievementsexpressedor implied by such forward-looking statements. Important factors thatcouldcause or contribute to such differences include risks relating to: ourabilityto develop and commercialize additional pharmaceutical products,competitionfrom the introduction of competing generic equivalents and due toincreasedgovernmental pricing pressures, the effects of competition on salesof ourinnovative medicines, especially Copaxone® (includingcompetition frominnovative orally-administered alternatives as well as from potentialgenericequivalents), potential liability for sales of generic medicines priorto afinal resolution of outstanding patent litigation, including thatrelating toour generic version of Protonix®, the extent to which we may obtainU.S. marketexclusivity for certain of our new generic medicines, the extent towhich anymanufacturing or quality control problems damage our reputation for highqualityproduction and require costly remediation, our ability to identify,consummateand successfully integrate acquisitions (including the acquisition ofCephalon),our ability to achieve expected results through our innovative R&Defforts,dependence on the effectiveness of our patents and otherprotections forinnovative medicines, intense competition in our specialtypharmaceuticalbusinesses, uncertainties surrounding the legislative and regulatorypathway forthe registration and approval of biotechnology-based medicines, ourpotentialexposure to product liability claims to the extent not covered byinsurance, anyfailures to comply with the complex Medicare and Medicaid reporting andpaymentobligations, our exposure to currency fluctuations and restrictions aswell ascredit risks, the effects of reforms in healthcare regulation andpharmaceuticalpricing and reimbursement, adverse effects of political instability andadverseeconomic conditions, major hostilities or acts of terrorism on oursignificantworldwide operations, increased government scrutiny in both the U.S. andEuropeof our agreements with brand companies, interruptions in our supplychain orproblems with our information technology systems that adverselyaffect ourcomplex manufacturing processes, the impact of continuing consolidationof ourdistributors and customers, the difficulty of complying with U.S. Food andDrugAdministration, European Medicines Agency and other regulatoryauthorityrequirements, potentially significant impairments of intangibleassets andgoodwill, potential increases in tax liabilities resulting fromchallenges toour intercompany arrangements, the termination or expiration ofgovernmentalprograms or tax benefits, any failure to retain key personnel or toattractadditional executive and managerial talent, environmental risks, andotherfactors that are discussed in our Annual Report on Form 20-F for the yearendedDecember 31, 2011, in this report and in our other filings with theU.S.Securities and Exchange Commission ("SEC"). Forward-looking statementsspeakonly as of the date on which they are made, and we undertake noobligation toupdate any forward-looking statements or other information contained inthisreport, whether as a result of new information, future events orotherwise. Youare advised, however, to consult any additional disclosures we makein ourreports to the SEC on Form 6-K. Also note that we provide acautionarydiscussion of risks and uncertainties under "Risk Factors" in our AnnualReporton Form 20-F for the year ended December 31, 2011. These are factorsthat webelieve could cause our actual results to differ materially fromexpectedresults. Other factors besides those listed could also adversely affect us.Thisdiscussion is provided as permitted by the Private Securities LitigationReformAct of 1995.

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 on August 8, 2012, at 2:00 p.m.

Teva to initiate third Phase III trial of oral laquinimod:

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Source: Active Biotech via Thomson Reuters ONE


IR Contacts:
Kevin C. Mannix
United States
(215) 591-8912

Joseph Marczely
United States
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Tomer Amitai
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PR Contacts
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Denise Bradley
United States
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Active Biotech
Tomas Leanderson
Active Biotech AB

Hans Kolam
Active Biotech AB


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