Phase IIa Laquinimod Trial Results Show Positive Data for Potential Use in Active Crohn's Disease

  Phase IIa Laquinimod Trial Results Show Positive Data for Potential Use in
  Active Crohn's Disease

  Newly Presented Data at 20^th United European Gastroenterology (UEG) Week
Conference Show Significant Impact of Laquinimod on Clinical Remission versus

Business Wire

JERUSALEM & LUND, Sweden -- October 22, 2012

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ
OMX NORDIC: ACTI) today announced the presentation of Phase IIa clinical data
for investigational laquinimod in moderate to severe Crohn’s disease (CD). The
findings demonstrated that treatment with orally administered laquinimod 0.5
mg/day resulted in a robust, early and consistent effect on remission (48.3%
vs. 15.9% of patients, respectively) and response rates (62.1% vs. 34.9% of
patients, respectively) in patients with moderate-to-severe CD versus placebo.
The data were reported in an oral presentation at the 20^th United European
Gastroenterology (UEG) Week conference

The full abstract can be found at:

“Our developmental program for laquinimod has demonstrated that the
immunomodulatory effects of this oral compound stand to apply to multiple
autoimmune diseases, and data presented at UEG showed an impressive impact on
clinical remission in Crohn’s disease as early as one week of treatment,” said
Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for
Teva Pharmaceutical Industries, Ltd. “These data provide a solid rationale for
potential future study of laquinimod in Crohn’s disease.”

The Phase IIa study evaluated the safety and efficacy of various doses of
laquinimod (0.5, 1, 1.5, or 2 mg/day) compared to placebo in active CD over
eight weeks of treatment with four weeks of follow up. No effect was noted on
remission/response at higher doses. Additionally, laquinimod 0.5 mg and 1 mg
doses were generally well-tolerated, with adverse events similar to those seen
with placebo. The data are currently undergoing further analysis and
evaluation to finalize next steps in the CD clinical development plan.


The Phase IIa, multicenter, randomized, double-blind, placebo-controlled trial
was designed to evaluate the safety and efficacy of laquinimod in 180 patients
with moderate to severe active CD, based on a CD Activity Index (CDAI) of
220-450 and serum C-reactive protein (CRP) levels of >5mg/L or mucosal
ulcerations evident on a recent endoscopy. The study tracked four dose cohorts
who received laquinimod 0.5 mg/day, 1 mg/day, 1.5 mg/day, 2 mg/day, or placebo
for eight weeks with four weeks follow-up. Approximately 45 patients were
enrolled in each cohort in a 2:1 ration between laquinimod and placebo. Stable
concomitant therapies and prior anti-tumor necrosis factor (TNF) use among
patients was permitted in the study.


Laquinimod is a novel oral immunomodulator under clinical development for the
treatment of multiple sclerosis (MS), Crohn’s disease (CD) and systemic lupus
erythematosus (SLE or lupus). Human and animal models suggest laquinimod
exerts its therapeutic effect by modulating the immune system cells, mainly
resulting in a down regulation of pro-inflammatory cytokines.


CD is a chronic inflammatory condition that affects the gastrointestinal
tract. The symptoms of CD can vary significantly among afflicted individuals.
The main gastrointestinal symptoms are abdominal pain, diarrhea, or weight
loss. CD can also cause complications outside of the gastrointestinal tract
such as skin rashes, arthritis, and inflammation of the eye.

The precise cause of CD is not known. CD is considered to be an autoimmune
disease. This autoimmune activity produces inflammation in the
gastrointestinal tract. CD is classified as an inflammatory bowel disease,


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 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 46,000 people around the world
and reached $18.3 billion in net revenues in 2011.


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 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 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(R), 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(R) (including
potential generic and oral competition for Copaxone(R)), 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

Active Biotech is obligated to publish the information contained in this press
release in accordance with the Swedish Securities Market Act.


Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix
United States
Joseph Marczely
United States
Tomer Amitai
972 (3) 926-7656
Hadar Vismunski-Weinberg
972 (3) 926-7687
Denise Bradley
United States
Active Biotech AB
Tomas Leanderson
Hans Kolam
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