FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of April 2008
Commission File Number 0-16174
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
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(Translation of registrant's name into English)
5 Basel Street, P.O. Box 3190
Petach Tikva 49131 Israel
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(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F:
Form 20-F X Form 40-F
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Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101(b)(1):________________
Indicate by check mark if the registrant is submitting the Form 6-K in
paper as permitted by Regulation S-T Rule 101(b)(7):____________________
Indicate by check mark whether by furnishing the information contained
in this Form, the registrant is also hereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes No X
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If "Yes" is marked, indicate below the file number assigned to the
registrant in connection with Rule 12g(3)-2(b): 82-
[GRAPHIC OMITTED][GRAPHIC OMITTED]
Website: www.tevapharm.com
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Contact: Elana Holzman Teva Pharmaceutical Industries Ltd. 972 (3) 926-7554
Kevin Mannix Teva North America (215) 591-8912
For Immediate Release
EARLY TREATMENT WITH COPAXONE(R) SIGNIFICANTLY DELAYED
PROGRESSION TO CLINICALLY DEFINITE MULTIPLE SCLEROSIS
Teva Seeks Approval for the Extension of its Indication to Include the
Treatment of Patients with a First Clinical Event Suggestive of MS
Jerusalem, April 16, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA)
today announced new results from the PreCISe study, which demonstrated that
early treatment with COPAXONE(R) (glatiramer acetate injection) significantly
reduced the risk of developing clinically definite multiple sclerosis (CDMS) by
45 percent compared to placebo (hazard ratio 0.55, p=0.0001). These data were
presented as late-breaking science at the 60th Annual Meeting of the American
Academy of Neurology (AAN) in Chicago.
Based on the PreCISE results, an application for marketing authorization in
Europe to the Medicines and Healthcare products Regulatory Agency (MHRA) for the
extension of its indication to include the treatment of patients with a first
clinical event suggestive of MS, was submitted and is currently under review. A
similar application requesting an expanded label for COPAXONE(R) will also be
submitted shortly with the U.S. Food and Drug Administration (FDA).
"Clinically isolated syndrome, or CIS, is a first neurologic episode, usually
caused by inflammation or demyelination, which is indicative of possible
development of multiple sclerosis," said Giancarlo Comi, M.D., University
Vita-Salute San Raffaele, Scientific Institute San Raffaele, Milan, Italy, and
principal investigator. "The PreCISe study results clearly demonstrate that
early treatment with COPAXONE(R), as early as CIS, reduces the risk of
developing MS" he added.
COPAXONE(R), currently indicated for RRMS, is a unique disease modifying
treatment with a dual mode of action that has over 10 years of prospective
clinical trial data demonstrating long-term clinical treatment benefits and good
safety profile. The PreCISe results now extend COPAXONE(R) effect to CIS
patients, demonstrating a reduced risk of developing Clinically Definite MS
(CDMS). Furthermore, the safety profile of COPAXONE(R) in the PreCISe study was
consistent with the well-established safety profile of the product based on many
years of post-marketing surveillance and over 100,000 patients treated globally
with COPAXONE(R).
Moshe Manor, Group Vice President, Global Innovative Resources of Teva
Pharmaceutical Industries, Ltd., said, "These impressive results clearly
demonstrate the potency of COPAXONE(R) in treating early phases of multiple
sclerosis. Along with its lasting efficacy, confirmed over 10 years, it
positions COPAXONE(R) as the preferred treatment option for multiple sclerosis
patients."
About the Study
The multi-national, multi-center, prospective, double-blind, randomized, Phase
III study was conducted in approximately 100 centers located in the U.S.,
Europe, Argentina, Israel, Nordic countries, Australia and New Zealand. It
included a total of 481 patients presenting with a
single clinical episode and MRI suggestive of MS. Patients included were those
who had a unifocal disease manifestation (i.e., clinical evidence of a single
lesion). Patients received either COPAXONE(R) 20mg/day or placebo as a
subcutaneous injection and continued treatment for up to 36 months, unless a
second attack was experienced and they were diagnosed with CDMS. Patients who
converted to CDMS continued the trial on active treatment for an additional two
years. The primary efficacy outcome was time to CDMS, based on a second clinical
attack.
COPAXONE(R) (glatiramer acetate injection) was also demonstrated to be very well
tolerated in the PreCISe study, with only 16 percent overall dropouts during the
up to three-year study period, similar to that observed in RRMS patients treated
with COPAXONE(R). All patients in the study participated in a follow-up study
with COPAXONE(R) to prospectively assess the impact of early versus delayed
treatment with COPAXONE(R) on the long-term course of the disease for a total
observation time of up to five years.
A pre-planned interim analysis was performed on data accumulated from
approximately 80 percent of the three-year placebo-controlled study exposure.
Results of the interim analysis, announced in December 2007, demonstrated the
proportion of patients developing CDMS was reduced from 43 percent in the
placebo group to only 25 percent in the COPAXONE(R) group (p< 0.0001). The
PreCISe study also demonstrated that the 25th percentile of number of days to
conversion to CDMS has more than doubled by COPAXONE(R) from 336 days to 722
days (hazard ratio 0.55, p=0.0005) compared with placebo.
At the time of this analysis, the data monitoring committee (DMC) stopped the
placebo arm of the study, as COPAXONE(R) successfully met the efficacy endpoint
of the study.
About COPAXONE(R)
Current data suggest COPAXONE(R) is a selective MHC (Major Histocompatability
Complex) class II modulator. COPAXONE(R) is indicated for the reduction of the
frequency of relapses in RRMS. COPAXONE(R) is very well tolerated and the most
common side effects of COPAXONEv are redness, pain, swelling, itching, or a lump
or an indentation at the site of injection, weakness, infection, pain, nausea,
joint pain, anxiety, and muscle stiffness.
COPAXONE(R) is now approved in 51 countries worldwide, including the United
States, all European countries, Canada, Mexico, Australia, and Israel. In
Europe, COPAXONE(R) is marketed by Teva Pharmaceutical Industries Ltd. and
sanofi-aventis. In North America, COPAXONE(R) is marketed by Teva Neuroscience,
Inc.
See additional important information at http://www.COPAXONE.com/pi/index.html or
call 1-800-887-8100 for electronic releases. For hardcopy releases, please see
enclosed full prescribing information.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top
20 pharmaceutical companies in the world and is the world's leading generic
pharmaceutical company. The Company develops, manufactures and markets generic
and innovative human pharmaceuticals and active pharmaceutical ingredients, as
well as animal health pharmaceutical products. Over 80 percent of Teva's sales
are in North America and Europe. Teva's innovative R&D focuses on developing
novel drugs for diseases of the central nervous system.
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 Teva's 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: when and whether the proposed acquisition will be
consummated, Teva's ability to rapidly integrate Bentley's operations with its
own operations and
achieve expected synergies, the diversion of management time on merger-related
issues, Teva's ability to accurately predict future market conditions, potential
liability for sales of generic products prior to a final resolution of
outstanding patent litigation, including that relating to the generic versions
of Allegra(R), Neurontin(R), Lotrel(R), Famvir(R) and Protonix(R), Teva's
ability to successfully develop and commercialize additional pharmaceutical
products, the introduction of competing generic equivalents, the extent to which
Teva may obtain U.S. market exclusivity for certain of its new generic products
and regulatory changes that may prevent Teva from utilizing exclusivity periods,
competition from brand-name companies that are under increased pressure to
counter generic products, or competitors that seek to delay the introduction of
generic products, the impact of consolidation of our distributors and customers,
the effects of competition on our innovative products, especially Copaxone(R)
sales, the impact of pharmaceutical industry regulation and pending legislation
that could affect the pharmaceutical industry, the difficulty of predicting U.S.
Food and Drug Administration, European Medicines Agency and other regulatory
authority approvals, the regulatory environment and changes in the health
policies and structures of various countries, our ability to achieve expected
results though our innovative R&D efforts, Teva's ability to successfully
identify, consummate and integrate acquisitions, potential exposure to product
liability claims to the extent not covered by insurance, dependence on the
effectiveness of our patents and other protections for innovative products,
significant operations worldwide that may be adversely affected by terrorism,
political or economical instability or major hostilities, supply interruptions
or delays that could result from the complex manufacturing of our products and
our global supply chain, environmental risks, fluctuations in currency, exchange
and interest rates, and other factors that are discussed in Teva's Annual Report
on Form 20-F and its 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.
[GRAPHIC OMITTED][GRAPHIC OMITTED] Website: www.tevapharm.com
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Contact: Elana Holzman Teva Pharmaceutical Industries Ltd. 972 (3) 926-7554
Kevin Mannix Teva North America (215) 591-8912
For Immediate Release
TEVA ANNOUNCES TENTATIVE APPROVAL OF GENERIC MAXALT(R)
TABLETS
Jerusalem, Israel, April 17, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq:
TEVA) announced today that the U.S. Food and Drug Administration has granted
tentative approval for the Company's Abbreviated New Drug Application (ANDA) to
market its generic version of Merck's migraine pain treatment Maxalt(R)
(Rizatriptan Benzoate) Tablets, equivalent to 5 mg and 10 mg base. Final
approval of this product is anticipated upon expiration of patent protection for
the brand product in June 2012.
The brand product had annual sales of approximately $193 million in the United
States for the twelve months that ended December 30, 2007, based on IMS sales
data.
About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top
20 pharmaceutical companies in the world and is the world's leading generic
pharmaceutical company. The Company develops, manufactures and markets generic
and innovative human pharmaceuticals and active pharmaceutical ingredients, as
well as animal health pharmaceutical products. Over 80 percent of Teva's sales
are in North America and Europe.
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 Teva's 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: when and whether the proposed acquisition will be
consummated, Teva's ability to rapidly integrate Bentley's operations with its
own operations and achieve expected synergies, the diversion of management time
on merger-related issues, Teva's ability to accurately predict future market
conditions, potential liability for sales of generic products prior to a final
resolution of outstanding patent litigation, including that relating to the
generic versions of Allegra(R), Neurontin(R), Lotrel(R), Famvir(R) and
Protonix(R), Teva's ability to successfully develop and commercialize additional
pharmaceutical products, the introduction of competing generic equivalents, the
extent to which Teva may obtain U.S. market exclusivity for certain of its new
generic products and regulatory changes that may prevent Teva from utilizing
exclusivity periods, competition from brand-name companies that are under
increased pressure to counter generic products, or competitors that seek to
delay the introduction of generic products, the impact of consolidation of our
distributors and customers, the effects of competition on our innovative
products, especially Copaxone(R) sales, the impact of pharmaceutical industry
regulation and pending legislation that could affect the pharmaceutical
industry, the difficulty of predicting U.S. Food and Drug Administration,
European Medicines Agency and other regulatory authority approvals, the
regulatory environment and changes in the health policies and structures of
various countries, our ability to achieve expected results though our innovative
R&D efforts, Teva's ability to successfully identify, consummate and integrate
acquisitions, potential exposure to product liability claims to the extent not
covered by insurance, dependence on the effectiveness of our patents and other
protections for innovative products, significant operations worldwide that may
be adversely affected by terrorism, political or economical instability or major
hostilities, supply interruptions or delays that could result from the complex
manufacturing of our products and our global supply chain, environmental risks,
fluctuations in currency, exchange and interest rates, and other factors that
are discussed in Teva's Annual Report on Form 20-F and its 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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
(Registrant)
By: /s/ Dan Suesskind
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Name: Dan Suesskind
Title: Chief Financial Officer
Date: April 17, 2008