Teva and Active Biotech Remain Committed to the Development of NERVENTRA(r) (laquinimod) for Multiple Sclerosis Following the Negative Opinion from the EMA's CHMP
LUND, Sweden, Jan. 27, 2014 (GLOBE NEWSWIRE) -- Teva Pharmaceutical
Industries Ltd. (NYSE:TEVA) and Active Biotech (NASDAQ OMX NORDIC:
ACTI) announced today that both companies remain committed to the
NERVENTRA(R) (laquinimod) clinical development program for multiple
sclerosis (MS) following the announcement of a negative opinion for the
treatment of relapsing-remitting multiple sclerosis (RRMS) by the
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA).
The CHMP has concluded that the risk-benefit profile of NERVENTRA is
not favorable at this time. In accordance with European regulations,
Teva and Active Biotech intend to request a re-examination of the CHMP
opinion. Teva and Active Biotech are focusing on evaluating the CHMP's
review and will continue to liaise closely with the EMA in working to
make NERVENTRA available as a new treatment option for patients with
RRMS in Europe.
ABOUT NERVENTRA
NERVENTRA is a once-daily oral, investigational, CNS-active
immunomodulator with a novel mechanism of action being developed for
the treatment of relapsing-remitting MS (RRMS) and progressive MS
(PMS). In extensive non-clinical and clinical studies NERVENTRA has
demonstrated both anti-inflammatory and neuroprotective properties and
effects that have been shown to provide clinically meaningful results.
The global Phase III clinical development program evaluating NERVENTRA
in MS includes two pivotal studies, ALLEGRO and BRAVO. A third Phase
III NERVENTRA trial, CONCERTO, is evaluating two doses of the
investigational product (0.6mg and 1.2mg) in approximately 1,800
patients for up to 24 months. The primary outcome measure will be time
to confirmed disability progression as measured by the EDSS.
The safety profile of NERVENTRA is based on 2645 MS patients that have
been exposed to NERVENTRA for a total duration of 7490.8 subject years,
with a maximal duration of seven years. Very common or important
adverse reactions include headache, abdominal pain, back and neck pain,
appendicitis, and mild, asymptomatic laboratory abnormalities,
including liver enzyme elevations, hematological changes, and elevation
of CRP or fibrinogen levels. Potential risks include teratogenicity and
carcinogenicity, both related to findings in rats, which are based on
non-clinical data and have not been encountered in patients.
In addition to the MS clinical studies, NERVENTRA is currently in
clinical development for Crohn's disease. Studies are also planned to
study the efficacy, safety and tolerability of NERVENTRA in other
neurodegenerative diseases, including Huntington's disease.
ABOUT TEVA
Teva Pharmaceutical Industries Ltd. (NYSE: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 leading generic drug maker, with a global product portfolio of
more than 1,000 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 46,000 people around the world and reached $20.3
billion in net revenues in 2012.
ABOUT ACTIVE BIOTECH
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company
with focus on autoimmune/inflammatory diseases and cancer. In pivotal
phase is laquinimod, an orally administered small molecule with unique
immunomodulatory properties for the treatment of multiple sclerosis.
Also tasquinimod for the treatment of prostate cancer, with a unique
mode of action, is in pivotal phase. In addition, laquinimod has
concluded Phase II development for Crohn's and Lupus. The company has
two additional projects in clinical development, ANYARA primarily for
the treatment of renal cell cancer and the orally administered compound
paquinimod (57-57) for systemic sclerosis. Please visit
www.activebiotech.com for more information.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995: The following presentation contains
forward-looking statements, which express the current beliefs and
expectations of management. Such statements 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 develop and commercialize additional pharmaceutical products,
competition for our innovative medicines, especially Copaxone(R)
(including competition from innovative orally-administered
alternatives, as well as from potential purported generic equivalents),
competition for our generic products (including from other
pharmaceutical companies and as a result of increased governmental
pricing pressures), competition for our specialty pharmaceutical
businesses, our ability to achieve expected results through our
specialty, including innovative, R&D efforts, the effectiveness of our
patents and other protections for innovative products, decreasing
opportunities to obtain U.S. market exclusivity for significant new
generic products, our ability to identify, consummate and successfully
integrate acquisitions and license products, our ability to reduce
operating expenses to the extent and during the timeframe intended by
our cost restructuring program, uncertainties relating to the
replacement of and transition to a new President & Chief Executive
Officer, the effects of increased leverage as a result of recent
acquisitions, the extent to which any manufacturing or quality control
problems damage our reputation for high quality production and require
costly remediation, our potential exposure to product liability claims
to the extent not covered by insurance, increased government scrutiny
in both the U.S. and Europe of our settlement agreements with brand
companiesand liabilities arising from class action litigation and other
third-party claims relating to such agreements, potential liability for
sales of generic medicines prior to a final resolution of outstanding
patent litigation, our exposure to currency fluctuations and
restrictions as well as credit risks, the effects of reforms in
healthcare regulation and pharmaceutical pricing and reimbursement, any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations, governmental investigations into sales and
marketing practices ,particularly for our specialty medicines (and our
ongoing FCPA investigations and related matters), uncertainties
surrounding the legislative and regulatory pathways for the
registration and approval of biotechnology-based medicines, adverse
effects of political or economic instability, corruption, major
hostilities or acts of terrorism on our significant worldwide
operations, interruptions in our supply chain or problems with our
information technology systems that adversely affect our complex
manufacturing processes, any failure to retain key personnel or to
attract additional executive and managerial talent, the impact of
continuing consolidation of our distributors and customers, variations
in patent laws that may adversely affect our ability to manufacture our
products in the most efficient manner, potentially significant
impairments of intangible assets and goodwill, potential increases in
tax liabilities resulting from challenges to our intercompany
arrangements, the termination or expiration of governmental programs or
tax benefits, environmental risks, and other factors that are discussed
in our Annual Report on Form 20-F for the year ended December 31, 2012
and in our other filings with the U.S. Securities and Exchange
Commission. Forward-looking statements speak only as of the date on
which they are made and the Company undertakes no obligation to update
or revise any forward looking statement, whether as a result of new
information, future events or otherwise.
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 1:05
p.m. CET on January 24, 2014.
Teva and Active Biotech Remain Committed to the Development of NERVENT
http://hugin.info/1002/R/1756936/593499.pdf
HUG#1756936
IR Contacts:Kevin C. Mannix, United States (215) 591-8912 Ran Meir
United States, (215) 591-3033 Tomer Amitai, Israel, (972 (3) 926-7656
PR Contact:Iris Beck Codner, Israel, 972 (3) 926-7687 Denise Bradley,
United States, (215) 591-8974 Nancy Leone, United States, (215)
284-0213