Drug candidate to be assessed for managing voluntary motor
disturbances in Huntington disease
JERUSALEM--(BUSINESS WIRE)--Sep. 27, 2012--
Teva Pharmaceutical Industries Ltd (NYSE: TEVA) announced today that it
has concluded an Asset Transfer Agreement with NeuroSearch A/S of
Denmark (OMX: NEUR) to purchase all rights, assets and obligations
relating to Huntexil® (pridopidine / ACR16), a drug candidate being
developed for the symptomatic treatment of hand movement, balance and
gait disturbances in Huntington disease (HD). Under the agreement, Teva
will pay to NeuroSearch approximately $26 million (DKK 150 million) over
a period of at least six months. Regulatory and commercialization
milestone payments may result in additional funding for NeuroSearch.
Previous trials in the US, EU and Canada demonstrated significant
symptomatic relief for patients with HD including improved hand
movements and improved gait and balance. These results were observed
without any side effects such as sedation and depression seen with other
therapies such as neuroleptics and tetrabenazine. Teva believes that
Huntexil® will, used as a symptomatic agent, make a real difference to
the quality of life for patients suffering from HD.
“Based on the clinical trial evidence to date, we believe Huntexil® holds
promise for symptomatic relief for HD and merits additional study in
late-stage clinical development,” commented Michael R. Hayden, M.D.,
Ph.D., one of the world’s leading experts on Huntington disease and
President of Global R&D and Chief Scientific Officer of Teva
Pharmaceutical Industries Ltd. “Teva has a broad commitment to find new
approaches to managing devastating CNS diseases, such as Huntington
disease. This promising development for Teva is just one example of our
covenant with patients to develop medicines to improve their quality of
life all around the world.”
Huntexil® Development Program
Huntexil® (pridopidine / ACR16) is an oral small molecule dopamine D2
stabilizer being developed for the symptomatic treatment of non-choreic
motor disorders, including for Huntington disease (HD). Huntington
disease affects about one person in 10,000 in North America and Europe
and generally results in death within 15 to 25 years of diagnosis.
Teva intends to design and complete new clinical studies of Huntexil®
to assess its potential for symptomatic relief of HD. Advanced-stage
clinical studies of Huntexil® conducted in the US, EU and Canada in
patients with HD demonstrated a significant treatment effect on Total
Motor Score [TMS]), but failed to meet the primary endpoint (Modified
Total Motor score [mTMS]). Data from the clinical studies were presented
to the FDA and EMA in the first half of 2011, but were found
insufficient to file for marketing approval.
About Huntington disease
Huntington disease (HD),is a fatal neurodegenerative disease
characterized by uncoordinated and uncontrollable movements, cognitive
deterioration, and behavioral and/or psychological problems. The classic
onset of HD symptoms typically occurs in middle age, but the disease
also manifests in children and the elderly. Disease progression is
characterized by a gradual decline in motor control, cognition, and
mental stability and generally results in death within 15‐25 years of
clinical diagnosis.
HD is a genetic disease, transmitted via autosomal‐dominant inheritance.
The defective gene, found on chromosome 4, causes the production of a
mutant protein, huntingtin, which aggregates in the central nervous
system (CNS) and results in the pathogenesis of HD. The prevalence of HD
is approximately 10 per 100,000 in the US and Europe. The only currently
marketed product in the US indicated for HD is tetrabenazine, which has
no effect on non‐choreic symptoms and disease progression, which remain
as significant unmet medical needs; also, tetrabenazine is associated
with serious side effects such as suicidality and depression.
About Teva Pharmaceutical Industries Ltd
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
1,300 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.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995: The following discussion and analysis
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, (including
the development Huntexil® (pridopidine / ACR16), competition from the
introduction of competing generic equivalents and due to increased
governmental pricing pressures, the effects of competition on sales of
our innovative medicines, especially Copaxone® (including competition
from innovative orally-administered alternatives as well as from
potential generic equivalents), potential liability for sales of generic
medicines prior to a final resolution of outstanding patent litigation,
including that relating to our generic version of Protonix®, the extent
to which we may obtain U.S. market exclusivity for certain of our new
generic medicines, the extent to which any manufacturing or quality
control problems damage our reputation for high quality production and
require costly remediation, our ability to identify, consummate and
successfully integrate acquisitions (including the acquisition of
Cephalon), our ability to achieve expected results through our
innovative R&D efforts, dependence on the effectiveness of our patents
and other protections for innovative medicines, intense competition in
our specialty pharmaceutical businesses, uncertainties surrounding the
legislative and regulatory pathway for the registration and approval of
biotechnology-based medicines, our potential exposure to product
liability claims to the extent not covered by insurance, 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
and pharmaceutical pricing and reimbursement, adverse effects of
political instability and adverse economic conditions, 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, interruptions in our supply chain or problems with our
information technology systems that adversely affect our complex
manufacturing processes, the impact of continuing consolidation of our
distributors and customers, the difficulty of complying with U.S. Food
and Drug Administration, European Medicines Agency and other regulatory
authority requirements, 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, 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 for the year ended December
31, 2011, in this report and in our other filings with the U.S.
Securities and Exchange Commission (“SEC”). Forward-looking statements
speak only as of the date on which they are made, and we undertake no
obligation to update any forward-looking statements or other information
contained in this report, whether as a result of new information, future
events or otherwise. You are advised, however, to consult any additional
disclosures we make in our reports to the SEC on Form 6-K. Also note
that we provide a cautionary discussion of risks and uncertainties under
“Risk Factors” in our Annual Report on Form 20-F for the year ended
December 31, 2011. These are factors that we believe could cause our
actual results to differ materially from expected results. Other factors
besides those listed could also adversely affect us. This discussion is
provided as permitted by the Private Securities Litigation Reform Act of
1995.
Source: Teva Pharmaceutical Industries Ltd
Teva Pharmaceutical Industries Ltd
IR:
United States
Kevin
C. Mannix, 215-591-8912
or
Joseph Marczely, 267-468-4281
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
Israel
Hadar
Vismunski-Weinberg, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974