LUND, SWEDEN and PARIS--(Marketwire - Dec 10, 2012) - Active Biotech (NASDAQ OMXNORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced thatthePhase III clinical trial for tasquinimod, a novel compound for thetreatment ofprostate cancer, is successfully enrolled with over 1,200 randomizedpatients asplanned in the clinical protocol. This achievement triggers a EUR10 millionmilestone payment from Ipsen to Active Biotech.
This study is a global, pivotal, randomized,double-blind, placebo-controlled Phase III clinical trial of tasquinimod inpatients with metastatic castrateresistant prostate cancer (mCRPC). The aim of the study is to confirmtasquinimod's efficacy, with radiological Progression Free Survival (PFS)asprimary endpoint and overall survival (OS) as secondary endpoint. The studyrecruited patients in more than 250 centers all over the word.
Marc de Garidel, Chairman and Chief Executive Officer of Ipsen, said:"The on-schedule recruitment of tasquinimod phase III clinical trialhighlights Active Biotech's commitment and the growing interest from themedical community for an innovative and differentiated mode of action."Marc de Garidel added: "We nowlook forward to confirming the encouraging phase II results and bringing anewtreatment option to patients with mCRPC."
"I am very satisfied by the speed of recruitment of prostate cancerpatientsinto this study. We now look forward to the continued development of thisglobaltrial and the subsequent development of this unique drug also in otherindications", said Tomas Leanderson, President & CEO Active Biotech.
Tasquinimod has a pleiotropic mode of action which includesimmunomodulatory,anti-angiogenic and anti-metastatic activity. Today the development oftasquinimod is principally focused on the treatment of prostate cancer.It was announced in December 2009 that the primary endpoint of the Phase IIclinical study, to show a higher fraction of patients with no diseaseprogression during the six-month period of treatment using tasquinimod, hadbeenmet. Phase II results were published in Journal of Clinical Oncology inSeptember 2011. The results showed that 6 month progression-freeproportions forTASQ and placebo groups were 69% and 37%, respectively (p
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.
Ipsen is a global specialty-driven pharmaceutical company with total salesexceeding EUR1.1 billion in 2011. Ipsen's ambition is to become a leader inspecialty healthcare solutions for targeted debilitating diseases. Itsdevelopment strategy is supported by four franchises: neurology /Dysport®,endocrinology / Somatuline®, uro-oncology / Decapeptyl® andhemophilia.Moreover, the Group has an active policy of partnerships. Ipsen's R&D isfocusedon its innovative and differentiated technological platforms, peptides andtoxins. In 2011, R&D expenditure totaled more than EUR250 million, above21% ofGroup sales. The Group has total worldwide staff of close to 4,500employees.Ipsen's shares are traded on segment A of Euronext Paris (stock code: IPN,ISINcode: FR0010259150) and eligible to the "Service de RèglementDifféré" ("SRD").The Group is part of the SBF 120 index. Ipsen has implemented a SponsoredLevelI American Depositary Receipt (ADR) program, which trade onthe over-the-counter market in the United States under the symbol IPSEY.For more information onIpsen, visit www.ipsen.com.
Ipsen Forward Looking Statement
The forward-looking statements, objectives and targets contained herein arebased on the Group's management strategy, current views and assumptions.Suchstatements involve known and unknown risks and uncertainties that may causeactual results, performance or events to differ materially from thoseanticipated herein. All of the above risks could affect the Group's futureability to achieve its financial targets, which were set assumingreasonablemacroeconomic conditions based on the information available today.Moreover, the targets described in this document were prepared withouttakinginto account external growth assumptions and potential future acquisitions,which may alter these parameters. These objectives are based on data andassumptions regarded as reasonable by the Group. These targets depend onconditions or facts likely to happen in the future, and not exclusively onhistorical data. Actual results may depart significantly from these targetsgiven the occurrence of certain risks and uncertainties, notably the factthat apromising product in early development phase or clinical trial may end upneverbeing launched on the market or reaching its commercial targets, notablyforregulatory or competition reasons. The Group must face or might facecompetitionfrom Generics that might translate into a loss of market share.Furthermore, the Research and Development process involves several stageseachof which involves the substantial risk that the Group may fail to achieveitsobjectives and be forced to abandon its efforts with regards to a productinwhich it has invested significant sums. Therefore, the Group cannot becertainthat favorable results obtained during pre-clinical trials will beconfirmedsubsequently during clinical trials, or that the results of clinical trialswillbe sufficient to demonstrate the safe and effective nature of the productconcerned. The Group also depends on third parties to develop and marketsome ofits products which could potentially generate substantial royalties; thesepartners could behave in such ways which could cause damage to the Group'sactivities and financial results. The Group cannot be certain that itspartnerswill fulfill their obligations. It might be unable to obtain any benefitfromthose agreements. A default by any of the Group's partners could generatelowerrevenues than expected. Such situations could have a negative impact on theGroup's business, financial position or performance.The Group expressly disclaims any obligation or undertaking to update orreviseany forward looking statements, targets or estimates contained in thispressrelease to reflect any change in events, conditions, assumptions orcircumstances on which any such statements are based, unless so required byapplicable law.The Group's business is subject to the risk factors outlined in itsregistrationdocuments filed with the French Autorité des Marchés Financiers.
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 07:30 a.m. CET on December 10,2012.
Active Biotech and Ipsen announce completion of recruitment:
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Source: Active Biotech via Thomson Reuters ONE
- Pharmaceuticals & Drug Trials
- prostate cancer
- Phase III clinical trial
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