ACTIVE BIOTECH ANNOUNCE THAT EUROPEAN MEDICINES AGENCY ACCEPTS START OF SCIENTIFIC REVIEW OF THE MARKETING AUTHORIZATION APPLICATION FOR LAQUINIMOD IN RELAPSING-REMITTING MULTIPLE SCLEROSIS
Tue Jul 17, 2012 2:32am EDT
Lund, Sweden, July 17, 2012 - Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced that the European Medicines Agency (EMA) has completed the validation process for the marketing authorization application (MAA) of the medicinal product laquinimod for the treatment of relapsing-remitting multiple sclerosis (RRMS).
The completion of the MAA validation process and acceptance for review now leads to the formal scientific review process by EMA's Committee for Medicinal Products for Human Use.
This acceptance of the EMA filing for review triggers a milestone payment of USD 5 million to Active Biotech from Teva.
The MAA submission is supported by a pooled analysis of data from the two global Phase III clinical trials in RRMS involving more than 2,400 patients treated for two years, the ALLEGRO and BRAVO trials. This analysis further strengthens the positive results achieved in the studies.
Additionally, Active Biotech and Teva continue to work with the Food and Drug Administration to determine the regulatory path forward for laquinimod in the U.S.
Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of MS. In animal models laquinimod crosses the blood brain barrier to potentially have a direct effect on resident CNS inflammation and neurodegeneration. The global Phase III clinical development program evaluating oral laquinimod in MS includes two pivotal studies, ALLEGRO and BRAVO.
In addition to the MS clinical studies, laquinimod is currently in Phase II of development for Crohn's disease and Lupus.
ABOUT MULTIPLE SCLEROSIS
MS is the leading cause of neurological disability in young adults. It is estimated that more than 400,000 people in the United States are affected by the disease and that two million people may be affected worldwide. Multiple sclerosis is a degenerative disease of the central nervous system in which inflammation and axonal damage and loss result in the development of progressive disability.
ABOUT ACTIVE BIOTECH
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer. Projects in or entering pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, TASQ for prostate cancer as well as ANYARA for use in cancer targeted therapy, primarily of renal cell cancer. In addition, laquinimod is in Phase II development for Crohn's and Lupus. An additional project in clinical development is the orally administered compound 57-57 for Systemic Sclerosis. Please visit www.activebiotech.com for more information.
Active Biotech's Safe Harbor Statement in Accordance with the Swedish Securities Market Act:
This press release contains certain forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of the company, or industry results, to differ materially from any future results, performance or achievement implied by the forward-looking statements. The company does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this press release.
Active Biotech is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act. This information was provided to the media for publication on July 17, 2012, at 8:30 a.m.
Active Biotech AB (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Tel: +46 46 19 20 00
Fax: +46 46 19 11 00
Active Biotech Tomas Leanderson Active Biotech AB +46-46-19-20-95
Hans Kolam Active Biotech AB +46-46-19-20-44