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Active Biotech Announce That European Medicines Agency Accepts Start of Scientific Review of the Marketing Authorization Application for Laquinimod in Relapsing-Remitting Multiple Sclerosis July 17, 2012 - LUND, SWEDEN
Active Biotech (NASDAQ OMX NORDIC: ACTI) todayannounced that the European Medicines Agency (EMA) has completed thevalidationprocess for the marketing authorization application (MAA) of the medicinalproduct laquinimod for the treatment of relapsing-remitting multiple sclerosis(RRMS).
The completion of the MAA validation process and acceptance for review nowleadsto the formal scientific review process by EMA's Committee for MedicinalProducts for Human Use.
This acceptance of the EMA filing for review triggers a milestone payment ofUSD5 million to Active Biotech from Teva.
The MAA submission is supported by a pooled analysis of data from the twoglobalPhase III clinical trials in RRMS involving more than 2,400 patients treatedfortwo years, the ALLEGRO and BRAVO trials. This analysis further strengthens thepositive results achieved in the studies.
Additionally, Active Biotech and Teva continue to work with the Food and DrugAdministration to determine the regulatory path forward for laquinimod in theU.S.
ABOUT LAQUINIMOD
Laquinimod is an oral, once-daily CNS-active immunomodulator with a novelmechanism of action being developed for the treatment of MS. In animal modelslaquinimod crosses the blood brain barrier to potentially have a direct effecton resident CNS inflammation and neurodegeneration. The global Phase IIIclinical development program evaluating oral laquinimod in MS includes twopivotal studies, ALLEGRO and BRAVO.
In addition to the MS clinical studies, laquinimod is currently in Phase II ofdevelopment for Crohn's disease and Lupus.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 affected bythedisease 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.
ABOUT ACTIVE BIOTECH
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company withfocus on autoimmune/inflammatory diseases and cancer. Projects in or enteringpivotal phase are laquinimod, an orally administered small molecule withuniqueimmunomodulatory properties for the treatment of multiple sclerosis, TASQ forprostate cancer as well as ANYARA for use in cancer targeted therapy,primarilyof renal cell cancer. In addition, laquinimod is in Phase II development forCrohn's and Lupus. An additional project in clinical development is the orallyadministered compound 57-57 for Systemic Sclerosis. Please visitwww.activebiotech.com for more information.
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, uncertainties andotherimportant 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 press release.
Active Biotech is obligated to publish the information contained in this pressrelease in accordance with the Swedish Securities Market Act. This informationwas provided to the media for publication on July 17, 2012, at 8:30 a.m.
ACTIVE BIOTECH ANNOUNCE THAT EUROPEAN MEDICINES AGENCY ACCEPTS:http://hugin.info/1002/R/1627159/520740.pdf
This announcement is distributed by Thomson Reuters on behalf ofThomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Active Biotech via Thomson Reuters ONE
[HUG#1627159]
Active Biotech AB (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Tel: 46 19 20 00
Fax: 46 19 11 00
Active Biotech
Tomas Leanderson
Active Biotech AB
46-19-20-95
Hans Kolam
Active Biotech AB
46-19-20-44
http://www.andhranews.net/Business/2012/Active-Biotech-Announce-That-European-Medicines-33511.htm
Active Biotech (NASDAQ OMX NORDIC: ACTI) todayannounced that the European Medicines Agency (EMA) has completed thevalidationprocess for the marketing authorization application (MAA) of the medicinalproduct laquinimod for the treatment of relapsing-remitting multiple sclerosis(RRMS).
The completion of the MAA validation process and acceptance for review nowleadsto the formal scientific review process by EMA's Committee for MedicinalProducts for Human Use.
This acceptance of the EMA filing for review triggers a milestone payment ofUSD5 million to Active Biotech from Teva.
The MAA submission is supported by a pooled analysis of data from the twoglobalPhase III clinical trials in RRMS involving more than 2,400 patients treatedfortwo years, the ALLEGRO and BRAVO trials. This analysis further strengthens thepositive results achieved in the studies.
Additionally, Active Biotech and Teva continue to work with the Food and DrugAdministration to determine the regulatory path forward for laquinimod in theU.S.
ABOUT LAQUINIMOD
Laquinimod is an oral, once-daily CNS-active immunomodulator with a novelmechanism of action being developed for the treatment of MS. In animal modelslaquinimod crosses the blood brain barrier to potentially have a direct effecton resident CNS inflammation and neurodegeneration. The global Phase IIIclinical development program evaluating oral laquinimod in MS includes twopivotal studies, ALLEGRO and BRAVO.
In addition to the MS clinical studies, laquinimod is currently in Phase II ofdevelopment for Crohn's disease and Lupus.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 affected bythedisease 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.
ABOUT ACTIVE BIOTECH
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company withfocus on autoimmune/inflammatory diseases and cancer. Projects in or enteringpivotal phase are laquinimod, an orally administered small molecule withuniqueimmunomodulatory properties for the treatment of multiple sclerosis, TASQ forprostate cancer as well as ANYARA for use in cancer targeted therapy,primarilyof renal cell cancer. In addition, laquinimod is in Phase II development forCrohn's and Lupus. An additional project in clinical development is the orallyadministered compound 57-57 for Systemic Sclerosis. Please visitwww.activebiotech.com for more information.
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, uncertainties andotherimportant 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 press release.
Active Biotech is obligated to publish the information contained in this pressrelease in accordance with the Swedish Securities Market Act. This informationwas provided to the media for publication on July 17, 2012, at 8:30 a.m.
ACTIVE BIOTECH ANNOUNCE THAT EUROPEAN MEDICINES AGENCY ACCEPTS:http://hugin.info/1002/R/1627159/520740.pdf
This announcement is distributed by Thomson Reuters on behalf ofThomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Active Biotech via Thomson Reuters ONE
[HUG#1627159]
Active Biotech AB (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Tel: 46 19 20 00
Fax: 46 19 11 00
Active Biotech
Tomas Leanderson
Active Biotech AB
46-19-20-95
Hans Kolam
Active Biotech AB
46-19-20-44
http://www.andhranews.net/Business/2012/Active-Biotech-Announce-That-European-Medicines-33511.htm
