INVESTIGATIONAL LAQUINIMOD DEMONSTRATES ITS POTENTIAL AS A NEW ORAL TREATMENT FOR RRMS
Oct 19, 2011 08:30 (CEST)
* Late-breaking presentation of BRAVO results and additional analyses from
ALLEGRO study reinforce novel clinical profile of laquinimod
* Pre-clinical evidence supports that laquinimod targets peripheral
inflammation and key neurodegenerative processes occurring directly in the
CNS
Jerusalem, Israel and Lund, Sweden, October 19, 2011 - Teva Pharmaceutical
Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI)
today announced the presentation of Phase III clinical and pre-clinical data,
which collectively demonstrate that once-daily oral laquinimod modulates the
pathological processes of multiple sclerosis to impact disease activity,
disability progression and brain volume loss. The data will be featured in more
than 20 scientific posters and presentations this week at the 5(th) Joint
Triennial Congress of the European and Americas Committees for Treatment and
Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in Amsterdam, The
Netherlands.
Findings from the second Phase III study, BRAVO, being highlighted as late-
breaking research, showed that at 24-months, the primary endpoint of reduction
in annualized relapse rates (ARR) did not reach statistical significance (0 =
0.075); however, after applying a pre-specified sensitivity analysis to correct
for meaningful imbalances in baseline characteristics (MRI) between treatment
groups, laquinimod significantly reduced ARR (21.3%, p = 0.026). Laquinimod also
demonstrated a significant reduction in the risk of disability progression as
measured by the Expanded Disability Status Scale (EDSS) (33.5%, p = 0.044) and
in MRI-measured brain volume loss (27.5%, p =< 0.0001). The safety and
tolerability profile of laquinimod was favorable.
New exploratory analyses from ALLEGRO, the first Phase III study in the
laquinimod clinical development program, demonstrated that laquinimod had an
effect on the rate of severe relapses, showing a 38 percent reduction in the
annualized rate of relapses requiring hospitalization and a 27 percent reduction
in those requiring intravenous steroids. Treatment with laquinimod was also
associated with a 36 percent reduction in the risk for three month confirmed
EDSS progression (p=0.0122) and a 48 percent reduction in the risk for six month
confirmed EDSS progression (p= 0.0023). Additionally, laquinimod had a positive
impact on patient-reported fatigue and cognitive functioning, as assessed by the
Modified Fatigue Impact Scale (MFIS) and the short-form (SF)-36 general health
survey.
"The life-long, debilitating nature of multiple sclerosis and well-recognized
clinical variability, underscore the need for therapies that can slow disease
progression and improve patient treatment experience," said Professor Giancarlo
Comi, Director of the Department of Neurology and Institute of Experimental
Neurology at the San Raffaele Scientific Institute, Vita-Salute San Raffaele
University, Italy. "Both Allegro and Bravo studies provide consistent evidence
of a clear impact of Laquinimod on progression of disability and brain atrophy,
measures of the neurodegenerative process of MS. These effects on disease burden
together with the effects on relapse management, the convenience of oral
administration and the excellent safety and tolerability profile represent a
unique approach to the treatment of MS.
"Several supportive pre-clinical studies being presented further elucidate the
potential novel mechanisms of action of laquinimod, which target both
neurodegeneration occurring directly in the CNS and peripheral inflammation,
said Wolfgang Brück, M.D., Director of Neuropathology at Georg-August-University
in Goettingen, Germany. "The cuprizone and EAE mouse model studies showed that
laquinimod reduced demyelination, axonal damage and resulted in dose-dependent
decreases in pro-inflammatory cytokines, further demonstrating that the compound
acts directly on resident CNS cells to decrease neurodegeneration and brain
tissue loss."
"The data presented at ECTRIMS contribute to the growing body of scientific
evidence supporting the novel clinical profile of laquinimod," said Jon
Congleton, Senior Vice President and General Manager, Teva Neuroscience. "We are
excited by the prospect of laquinimod providing a treatment option that
addresses important attributes of RRMS therapy, namely reduction of disability
progression and irreversible tissue loss, without compromising convenience,
safety or tolerability."
ABOUT LAQUINIMOD
Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel
mechanism of action being developed for the treatment of MS. 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 consists of two pivotal studies,
ALLEGRO and BRAVO. In the ALLEGRO study, laquinimod demonstrated a positive
impact on disease activity and disability progression, while maintaining a
favorable safety and tolerability profile. In addition to the MS clinical
studies, laquinimod is currently in Phase II development for Crohn's disease and
Lupus, and is being studied in other autoimmune diseases.
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 TEVA
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic drugs as
well as innovative and specialty pharmaceuticals and active pharmaceutical
ingredients. Headquartered in Israel, Teva is the world's largest generic drug
maker, with a global product portfolio of more than 1,300 molecules and a direct
presence in about 60 countries. Teva's branded businesses focus on CNS,
oncology, pain, respiratory and women's health therapeutic areas as well as
biologics. Teva currently employs approximately 45,000 people around the world
and reached $16.1 billion in net sales in 2010.
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. Further projects in clinical development comprise the two
orally administered compounds, 57-57 for SLE & Systemic Sclerosis and RhuDex(TM)
for RA. Please visit www.activebiotech.comfor more information.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation
Reform Act of 1995:
This release contains forward-looking statements, which express the current
beliefs and expectations of management. Such statements are based on
management's current beliefs and expectations and involve a number of known and
unknown risks and uncertainties that could cause our future results, performance
or achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include risks
relating to: our ability to successfully develop and commercialize additional
pharmaceutical products, the introduction of competing generic equivalents, the
extent to which we may obtain U.S. market exclusivity for certain of our new
generic products and regulatory changes that may prevent us from utilizing
exclusivity periods, potential liability for sales of generic products prior to
a final resolution of outstanding patent litigation, including that relating to
the generic version of Protonix®, the extent to which any manufacturing or
quality control problems damage our reputation for high quality production, the
effects of competition on sales of our innovative products, especially Copaxone®
(including potential generic and oral competition for Copaxone®), the impact of
continuing consolidation of our distributors and customers, our ability to
identify, consummate and successfully integrate acquisitions (including the
acquisition of Cephalon), interruptions in our supply chain or problems with our
information technology systems that adversely affect our complex manufacturing
processes, intense competition in our specialty pharmaceutical businesses, any
failures to comply with the complex Medicare and Medicaid reporting and payment
obligations, our exposure to currency fluctuations and restrictions as well as
credit risks, the effects of reforms in healthcare regulation, adverse effects
of political or economical instability, major hostilities or acts of terrorism
on our significant worldwide operations, increased government scrutiny in both
the U.S. and Europe of our agreements with brand companies, dependence on the
effectiveness of our patents and other protections for innovative products, our
ability to achieve expected results through our innovative R&D efforts, the
difficulty of predicting U.S. Food and Drug Administration, European Medicines
Agency and other regulatory authority approvals, uncertainties surrounding the
legislative and regulatory pathway for the registration and approval of
biotechnology-based products, potentially significant impairments of intangible
assets and goodwill, potential increases in tax liabilities resulting from
challenges to our intercompany arrangements, our potential exposure to product
liability claims to the extent not covered by insurance, the termination or
expiration of governmental programs or tax benefits, current economic
conditions, any failure to retain key personnel or to attract additional
executive and managerial talent, environmental risks and other factors that are
discussed in our Annual Report on Form 20-F and other filings with the U.S.
Securities and Exchange Commission.
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 required under the Financial Instruments Trading Act to make
the information in this press release public. The information was submitted for
publication at 08:30 a.m. CET on October 19, 2011.
Teva IR:
Elana Holzman,Teva Pharmaceutical Industries Ltd.,972 (3) 926-7554
Kevin Mannix, Teva North America, (215) 591-8912
Teva PR:
Yossi Koren, Teva Pharmaceutical Industries Ltd., 972 (3) 926-7687
Denise Bradley, Teva North America, (215) 591-8974
Active Biotech:
Tomas Leanderson, Active Biotech AB, +46 46 19 20 95
Hans Kolam, Active Biotech AB, +46 46 19 20 44
INVESTIGATIONAL LAQUINIMOD DEMONSTRATES ITS POTENTIAL AS A NEW ORAL:
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