LUND, SWEDEN--(Marketwire - July 17, 2012) - Active Biotech (NASDAQ OMX NORDIC: ACTI) today
announced that the European Medicines Agency (EMA) has completed the
process for the marketing authorization application (MAA) of the medicinal
product laquinimod for the treatment of relapsing-remitting multiple sclerosis
The completion of the MAA validation process and acceptance for review now
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
5 million to Active Biotech from Teva.
The MAA submission is supported by a pooled analysis of data from the two
Phase III clinical trials in RRMS involving more than 2,400 patients treated
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
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
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
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
immunomodulatory properties for the treatment of multiple sclerosis, TASQ for
prostate cancer as well as ANYARA for use in cancer targeted therapy,
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
This press release contains certain forward-looking statements. Such
forward-looking statements involve known and unknown risks, uncertainties and
important factors that could cause the actual results, performance or
achievements of the company, or industry results, to differ materially from
future results, performance or achievement implied by the forward-looking
statements. The company does not undertake any obligation to update or
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 ANNOUNCE THAT EUROPEAN MEDICINES AGENCY ACCEPTS:
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originality of the information contained therein.
Source: Active Biotech via Thomson Reuters ONE