JERUSALEM & LUND, Sweden--(BUSINESS WIRE)--Jun. 25, 2015--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Active
Biotech (NASDAQ Stockholm:ACTI) today announced that the patient
enrollment for the pivotal Phase III CONCERTO trial has been finalized,
as well as a planned sample size re-assessment analysis of the study.
CONCERTO, the third Phase III trial of laquinimod in patients with
relapsing-remitting multiple sclerosis (RRMS), is designed to evaluate
the safety and efficacy of laquinimod (0.6mg or 1.2mg/day) with a
primary endpoint of time to Confirmed Disability Progression (CDP), as
measured by the Expanded Disability Status Scale (EDSS).
The sample size reassessment was included as part of the protocol to
confirm that the original assumptions are in line with the study and
that the sample size is adequate. Based on recent agreement with FDA,
under a Special Protocol Assessment (SPA) agreement, study completion
will occur when either 260 events are reached or all patients complete
24 months of study treatment (whichever occurs first). CONCERTO study
results are expected to be available toward mid-2017. Regulatory
submission will follow study completion.
“We are committed to realizing the full potential of laquinimod. The
molecule has a unique mechanism for future treatment of MS and other
neurodegenerative diseases by working directly in the Central Nervous
System, showing promise to prevent brain atrophy and slow disability
progression in these patients,” said Michael Hayden, M.D., Ph.D.,
President of Global R&D and Chief Scientific Officer at Teva.
Laquinimod is also being tested in Phase II trials for the treatment of
subjects with primary progressive MS and Huntington disease; two
diseases for which no approved disease modifying therapies are
available. For further details on the Phase III CONCERTO study, please
visit https://clinicaltrials.gov/ct2/show/NCT01707992.
About Laquinimod
Laquinimod 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), progressive MS and
Huntington’s disease. The global, Phase III, clinical development
program evaluating laquinimod in MS includes two completed pivotal
studies, ALLEGRO and BRAVO (both 0.6mg/day). A third Phase III trial,
CONCERTO, is currently ongoing and evaluating two doses of laquinimod
(0.6mg and 1.2mg/day) in 2,199 patients for up to 24 months. The primary
outcome measure is time to three-month confirmed-disability progression
as measured by the Expanded Disability Status Scale (EDSS).
In the ALLEGRO and BRAVO trials, adverse reactions observed included
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.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every day.
Headquartered in Israel, Teva is the world’s largest generic medicines
producer, leveraging its portfolio of more than 1,000 molecules to
produce a wide range of generic products in nearly every therapeutic
area. In specialty medicines, Teva has a world-leading position in
innovative treatments for disorders of the central nervous system,
including pain, as well as a strong portfolio of respiratory products.
Teva integrates its generics and specialty capabilities in its global
research and development division to create new ways of addressing unmet
patient needs by combining drug development capabilities with devices,
services and technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
About Active Biotech
Active Biotech AB (publ) (NASDAQ Stockholm:ACTI) is a
biotechnology company with focus on neurodegenerative/inflammatory
diseases and cancer. Laquinimod, an orally administered small molecule
with unique immunomodulatory properties, is in pivotal phase III
development for the treatment of relapsing remitting multiple sclerosis.
Also, laquinimod is in phase II development for the treatment of primary
progressive multiple sclerosis and Huntington’s disease. Furthermore,
commercial activities are ongoing for the projects ISI, ANYARA and
paquinimod. 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 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
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents) and our ability to
migrate users to our 40 mg/mL version; the possibility of material
fines, penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters; our
ability to achieve expected results from the research and development
efforts invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; our ability to
identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
increased government scrutiny in both the U.S. and Europe of our patent
settlement agreements; our exposure to currency fluctuations and
restrictions as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the effects of
reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability, major
hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with internal
or third-party information technology systems that adversely affect our
complex manufacturing processes; significant disruptions of our
information technology systems or breaches of our data security;
competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
competition for our specialty pharmaceutical businesses from companies
with greater resources and capabilities; the impact of continuing
consolidation of our distributors and customers; decreased opportunities
to obtain U.S. market exclusivity for significant new generic products;
potential liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that are
not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial talent; any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access to
the capital markets; potentially significant increases in tax
liabilities; the effect on our overall effective tax rate of the
termination or expiration of governmental programs or tax benefits, or
of a change in our business; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2014 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 we assume 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
and/or the Financial Instruments Trading Act. This information was
provided to the media for publication at 2:00 p.m. CEST on 06-25, 2015.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150625005155/en/
Source: Teva Pharmaceutical Industries Ltd.
Investors
Teva Pharmaceutical Industries Ltd.
United States
Kevin
C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
Media
Teva United States
Denise
Bradley, 215-591-8974
Nancy Leone, 215-591-8974
or
Teva
Israel
Iris Beck Codner, 972 (3) 926-7687
or
Active
Biotech AB
Tomas Leanderson, +46-46-19-20-95
Hans Kolam,
+46-46-19-20-44