JERUSALEM & LUND, Sweden--(BUSINESS WIRE)--Jan. 24, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Active Biotech
(NASDAQ OMX NORDIC: ACTI) announced today that both companies remain
committed to the NERVENTRA® (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:
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 our ability to achieve expected
results through our innovative R&D efforts; risks relating to: our
ability to develop and commercialize additional pharmaceutical products,
competition for our innovative products, especially Copaxone® (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, , 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, 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 agreements with brand companies,
potential liability for sales of generic products 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
pharmaceutical products), uncertainties surrounding the legislative and
regulatory pathways for the registration and approval of
biotechnology-based products, adverse effects of political or economical
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, 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.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix
United
States
215-591-8912
or
Ran Meir
United States
215-591-3033
or
Tomer
Amitai
Israel
972 (3) 926-7656
or
PR:
Iris Beck
Codner
Israel
972 (3) 926-7687
or
Denise Bradley
United
States
215-591-8974
or
Nancy Leone
United States
215-284-0213
or
Active
Biotech
Tomas Leanderson
Active Biotech AB
+46-46-19-20-95
or
Hans
Kolam
Active Biotech AB
+46-46-19-20-44