Treatment with COPAXONE(R) Plus Minocycline Showed Substantial
Reduction of Disease Activity in Patients with Active Relapsing-
Remitting Multiple Sclerosis
Friday May 4, 8:00 am ET
Combination Treatment With Antibiotic Further Reduced Brain Lesions
and Was Well Tolerated
KANSAS CITY, Mo.--(BUSINESS WIRE)--New data from a randomized, double-
blind study showed that a combination of COPAXONE® (glatiramer
acetate injection) along with the oral antibiotic minocycline reduced
T1 Gadolinium (Gd)-enhancing lesions of the brain by 63 percent
(p=0.08) in patients with active relapsing-remitting multiple
sclerosis (RRMS), as measured by magnetic resonance imaging (MRI),
compared to those receiving COPAXONE® alone. Additionally, the nine-
month study demonstrated that treatment with COPAXONE® in combination
with minocycline reduced the number of new T2 lesions in patients by
65 percent (p=0.06). These results trended toward but did not reach
statistical significance.
These data were presented at the 59th Annual Meeting of the American
Academy of Neurology (AAN) in Boston, MA, April 28 - May 5, 2007.
"The results of this study indicated that further exploration of this
combination is warranted, as the established effect of COPAXONE® on
disease activity may be boosted when used in combination with
minocycline for the treatment of active relapsing-remitting
patients," said Luanne Metz, M.D., professor at the Department of
Clinical Neuroscience of the University of Calgary, and principal
investigator. "In these patients, the combination was safe and well
tolerated," she added.
Minocycline is a broad-spectrum antibiotic, which is used to treat
pneumonia, acne, and infections of the skin, genital and urinary
systems, and the central nervous system. In a small proof-of-concept
trial of 10 RRMS patients, minocycline demonstrated an 84 percent
relative reduction in mean total Gd-enhancing lesions and was well
tolerated, and data published in the Journal of Neuroimmunology
indicated that the combination of minocycline and COPAXONE® decreased
neuron-inflammation , axonal loss and demyelination in an animal model
of MS.
"COPAXONE® is one of the most frequently used RRMS therapies due to
its proven efficacy and safety and unique presumed mechanism of
action," said Metz. "In previous studies, COPAXONE® has shown
efficacy and safety both in combination with intravenous steroids and
after induction with the immunosuppressant mitoxantrone; its
compatibility with other compounds may make it unique among the
disease modifying class of drugs and a treatment of interest for the
future study of combination therapies for MS," Metz added.
About the Study
This double-blind, randomized study evaluated the safety,
tolerability and efficacy of the combination of COPAXONE® plus oral
minocycline in the treatment of RRMS patients with active disease.
Patients in this study (n=44) with one or more T1-enhancing lesions
on their screening MRI were randomized to receive either COPAXONE® 20
mg daily plus minocycline 100 mg twice daily or COPAXONE® plus
placebo for nine months. Patients were assessed clinically and by MRI
scans at screening and months 1, 3, 8 and 9. The primary outcome was
the total number of T1-enhancing lesions at months 8 and 9.
Forty patients completed the study. Groups were balanced at baseline
except for greater T1-enhancing lesion number in the COPAXONE® plus
minocycline group (median 3 versus 2; mean 7.62 versus 2.43
(p=0.07)). Despite this imbalance, treatment trended toward
significance in the COPAXONE® plus minocycline group. At months 8 and
9, the number of T1-enhancing lesions was reduced by 63 percent (mean
1.47 versus 2.95; p=0.08) and the number of new T2 lesions was
reduced by 65 percent (mean 1.84 versus 5.14; p=0.06), compared to
COPAXONE® alone. Relapse risk rate was also non-significantly reduced
in the COPAXONE® plus minocycline group (0.19 versus 0.41; p=NS).
About COPAXONE®
Current data suggest COPAXONE® (glatiramer acetate injection) is a
selective MHC class II modulator. COPAXONE® is indicated for the
reduction of the frequency of relapses in RRMS. The most common side
effects of COPAXONE® are redness, pain, swelling, itching, a lump or
an indentation at the site of injection, weakness, infection, pain,
nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE® is now approved in 47 countries worldwide, including the
United States, Canada, Mexico, Australia, Israel, and all European
countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical
Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is
marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva
Pharmaceutical Industries Ltd (NASDAQ:TEVA - News). COPAXONE® is a
registered trademark of Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is
among the top 20 pharmaceutical companies in the world and is the
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. Close to 90 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.
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.
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: 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, 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® and Neurontin®, the effects of competition on
our innovative products, especially Copaxone® 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.
Contact:
Teva Neuroscience
John Shaw, 816-508-5062
john.shaw@tevaneuro .com
Reduction of Disease Activity in Patients with Active Relapsing-
Remitting Multiple Sclerosis
Friday May 4, 8:00 am ET
Combination Treatment With Antibiotic Further Reduced Brain Lesions
and Was Well Tolerated
KANSAS CITY, Mo.--(BUSINESS WIRE)--New data from a randomized, double-
blind study showed that a combination of COPAXONE® (glatiramer
acetate injection) along with the oral antibiotic minocycline reduced
T1 Gadolinium (Gd)-enhancing lesions of the brain by 63 percent
(p=0.08) in patients with active relapsing-remitting multiple
sclerosis (RRMS), as measured by magnetic resonance imaging (MRI),
compared to those receiving COPAXONE® alone. Additionally, the nine-
month study demonstrated that treatment with COPAXONE® in combination
with minocycline reduced the number of new T2 lesions in patients by
65 percent (p=0.06). These results trended toward but did not reach
statistical significance.
These data were presented at the 59th Annual Meeting of the American
Academy of Neurology (AAN) in Boston, MA, April 28 - May 5, 2007.
"The results of this study indicated that further exploration of this
combination is warranted, as the established effect of COPAXONE® on
disease activity may be boosted when used in combination with
minocycline for the treatment of active relapsing-remitting
patients," said Luanne Metz, M.D., professor at the Department of
Clinical Neuroscience of the University of Calgary, and principal
investigator. "In these patients, the combination was safe and well
tolerated," she added.
Minocycline is a broad-spectrum antibiotic, which is used to treat
pneumonia, acne, and infections of the skin, genital and urinary
systems, and the central nervous system. In a small proof-of-concept
trial of 10 RRMS patients, minocycline demonstrated an 84 percent
relative reduction in mean total Gd-enhancing lesions and was well
tolerated, and data published in the Journal of Neuroimmunology
indicated that the combination of minocycline and COPAXONE® decreased
neuron-inflammation , axonal loss and demyelination in an animal model
of MS.
"COPAXONE® is one of the most frequently used RRMS therapies due to
its proven efficacy and safety and unique presumed mechanism of
action," said Metz. "In previous studies, COPAXONE® has shown
efficacy and safety both in combination with intravenous steroids and
after induction with the immunosuppressant mitoxantrone; its
compatibility with other compounds may make it unique among the
disease modifying class of drugs and a treatment of interest for the
future study of combination therapies for MS," Metz added.
About the Study
This double-blind, randomized study evaluated the safety,
tolerability and efficacy of the combination of COPAXONE® plus oral
minocycline in the treatment of RRMS patients with active disease.
Patients in this study (n=44) with one or more T1-enhancing lesions
on their screening MRI were randomized to receive either COPAXONE® 20
mg daily plus minocycline 100 mg twice daily or COPAXONE® plus
placebo for nine months. Patients were assessed clinically and by MRI
scans at screening and months 1, 3, 8 and 9. The primary outcome was
the total number of T1-enhancing lesions at months 8 and 9.
Forty patients completed the study. Groups were balanced at baseline
except for greater T1-enhancing lesion number in the COPAXONE® plus
minocycline group (median 3 versus 2; mean 7.62 versus 2.43
(p=0.07)). Despite this imbalance, treatment trended toward
significance in the COPAXONE® plus minocycline group. At months 8 and
9, the number of T1-enhancing lesions was reduced by 63 percent (mean
1.47 versus 2.95; p=0.08) and the number of new T2 lesions was
reduced by 65 percent (mean 1.84 versus 5.14; p=0.06), compared to
COPAXONE® alone. Relapse risk rate was also non-significantly reduced
in the COPAXONE® plus minocycline group (0.19 versus 0.41; p=NS).
About COPAXONE®
Current data suggest COPAXONE® (glatiramer acetate injection) is a
selective MHC class II modulator. COPAXONE® is indicated for the
reduction of the frequency of relapses in RRMS. The most common side
effects of COPAXONE® are redness, pain, swelling, itching, a lump or
an indentation at the site of injection, weakness, infection, pain,
nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE® is now approved in 47 countries worldwide, including the
United States, Canada, Mexico, Australia, Israel, and all European
countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical
Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is
marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva
Pharmaceutical Industries Ltd (NASDAQ:TEVA - News). COPAXONE® is a
registered trademark of Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is
among the top 20 pharmaceutical companies in the world and is the
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. Close to 90 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.
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.
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: 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, 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® and Neurontin®, the effects of competition on
our innovative products, especially Copaxone® 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.
Contact:
Teva Neuroscience
John Shaw, 816-508-5062
john.shaw@tevaneuro .com
posted by Bill at 5:12 PM
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