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Copaxone (Glatiramer) Shows
Significant, Long-Term Benefit in Multiple Sclerosis
DENVER, CO -- April 18, 2002 -- The majority of
patients treated with CopaxoneŽ (glatiramer acetate for injection) remained
either unchanged or improved in their neurologic status during an eight-year
period in the longest prospective multiple sclerosis drug trial ever.
These results were released today at the
American Academy of Neurology (AAN) annual conference in Denver, Colorado.
"People in this study have had
relapsing-remitting multiple sclerosis (RRMS) for an average of 15 years. Based
on studies on the natural course of MS, half of those would be expected to use
walking aids, such as a cane or a wheelchair, if left untreated. This study
found that patients who received drug therapy had a mean EDSS of 3.17, which
means most of them are still walking without assistance," said Kenneth P.
Johnson, MD, professor of neurology, director of the Maryland Center for MS at
the University of Maryland, Baltimore.
This trial was originated in 1991, and 251
patients with RRMS were randomised into a double-blind, placebo-controlled trial
of Copaxone. The placebo-controlled phase lasted for approximately 30 months.
Patients were then invited to continue in the open-label phase of the trial in
which all patients received Copaxone. Of the 251 patients, 208 continued in the
open-label phase. At year eight, 68 percent or 142 patients remained in the
study. This study presented the results eight years into the 12-year trial.
"One of the key questions was how the group
that started on Copaxone compared with the patients who spent 30 months on
placebo. We discovered there was a consequence for delaying therapy," said
Dr. Johnson.
Patients who received placebo at the beginning
of the study were more likely to have worsened by more than one step on the EDSS
(Expanded Disability Status Scale) (p=0.0263). The EDSS measures the levels of
disability of a person with MS.
In addition, the relapse rate across the entire
eight years was significantly better for patients always on Copaxone versus
those who began on placebo (p=0.0459). The Copaxone group began the trial with a
yearly relapse rate of 1.49 and that rate fell to 0.16 by year eight. For the
group that began on placebo, the entry relapse rate was 1.45, falling to 0.23 by
year eight.
Copaxone is indicated for the reduction in the
frequency of relapses in RRMS. The most common side effects of Copaxone are
redness, pain, swelling, itching, or a lump at the site of injection, weakness,
infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
Copaxone is now approved in 40 countries
worldwide, including the U.S., Canada, Australia, Israel and all the European
countries. In Europe, Copaxone is marketed by Teva Pharmaceutical Industries
Ltd. and Aventis Pharma. In North America, Copaxone is marketed by Teva
Neuroscience.
SOURCE: Teva Pharmaceutical Industries Ltd.
Early Trial
Results of Teva's Oral MS Drug Disappointing
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NEW YORK (Reuters Health) Sept 17 -
Israeli drugmaker Teva Pharmaceutical Industries Ltd. on Monday announced
that interim clinical trial results on an oral formulation of the
company's approved injectable multiple sclerosis (MS) drug Copaxone
(glatiramer acetate) has failed to achieve statistical
endpoints.
In early morning trading on the NASDAQ, shares of Teva
dropped 5.98 to 61.07, a decline of almost 9%.
According to Teva, an independent Data Safety Monitoring
Committee (DSMC) has recommended that the trial still continue to
completion, expected by October, due to the favorable safety profile of
the drug. Henry McFarland, chairman of the DSMC, noted, however, that
there was little chance that the final results of the study would differ
from the interim results.
Although disappointed, Teva executives said during a
Monday morning conference call that they intend to continue pursuing an
oral MS treatment.
They added that since the early results of the oral
Copaxone trial showed a trend for a treatment effect in favor of the
higher dose, future studies of the oral formulation are expected to use
much higher doses.
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Glatiramer Acetate
Reduces Evolution of New MS Lesions into 'Black Holes'
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WESTPORT, CT (Reuters Health) Sept 14 - Glatiramer acetate
(Copaxone; Teva Pharmaceutical Industries) appears to have a favorable
modifying effect on the evolution of new multiple sclerosis lesions by
reducing the number that progress into "black holes" on magnetic resonance
imaging, representing lesions where severe tissue disruption has
occurred.
The European/Canadian Glatiramer Acetate Study Group, led
by Dr. M. Filippi of the University of Ospedale San Raffaele, Milan,
reports the finding in the August 28th issue of
Neurology.
The authors determined the effects of the drug on 1722 new
lesions in 239 patients with MS who underwent monthly cerebral MRI
studies. Patients received 20 mg of glatiramer acetate or placebo daily by
subcutaneous injection for 9 months.
The percentage of new lesions that evolved into black
holes was significantly lower in patients in the active treatment group
(18.9%) than in the placebo group (26.3%) on scans performed at 7 months
(p = 0.04), the researchers report. The benefits continued to be evident
at 8 months, with scans showing that 15.6% and 31.4% of new lesions had
evolved into black holes in glatiramer- and placebo-treated subjects,
respectively (p = 0.002).
These results, Dr. Filippi and colleagues conclude,
show that glatiramer acetate has a "favorable effect on tissue disruption
in MS lesions once they are formed." Neurology 2001;57:731-733.
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Early Copaxone (Glatiramer Acetate) Could Decrease
Permanent Multiple Sclerosis Disability
JERUSALEM, ISRAEL -- May 11, 2001
--
Teva Pharmaceutical Industries Ltd. announced today that
results from the longest ever multiple sclerosis (MS) treatment trial were
presented at the American Academy of Neurology this month.
The six-year, open label study showed that early
treatment with CopaxoneŽ (glatiramer acetate for injection) could decrease
the likelihood of permanent disability. "Delayed therapy was associated
with greater risk of disability as shown in all measures of the expanded
disability status scale (EDSS)," said Kenneth Johnson, M.D., University of
Maryland, Baltimore.
"Also, the relapse rate progressively fell,
reinforcing the rationale for using Copaxone as a first line drug early in
the course of relapsing-remitting MS."
Of patients always on Copaxone the whole six years,
69 percent showed neurological improvement of at least one EDSS step or
remained stable, compared with 57 percent if Copaxone treatment was
delayed by approximately 30 months (p=0.066).
The proportion of patients getting worse was smaller in
the group always on Copaxone: 31 percent vs. 43 percent. Moreover, of
patients always on Copaxone who were relapse- free over six years, three
out of 26 (11 percent) were worse by at least one EDSS step, whereas nine
out of 21 (43 percent) of those relapse-free in the placebo/active group
were worse (p<0.03).
This suggests the patients whose therapy was delayed were
probably entering a secondary progressive stage of MS, whereas those
always on Copaxone were neurologically stable due to treatment. The open
label trial was an extension of the multi-center, placebo- controlled
pivotal clinical trial on Copaxone.
After approximately 30 months of being randomized to
either Copaxone or placebo, 208 patients chose to continue in an
open-label study in which all received Copaxone; 101 were always on
Copaxone, while 107 received placebo for the first 30 months and then
switched to Copaxone.
The patients who received uninterrupted Copaxone therapy
showed a steady decline in relapse rate, from a mean of 1.5 at study entry
to a mean of 0.42 over the six years (95 percent confidence interval =
0.34-0.51), a 72 percent reduction (p=0.0001).
These patients, after six years of study, are now
experiencing, on average, only one relapse every four and a half years
(annualized rate 0.23 in year six) and 26 out of 101 remain completely
relapse-free. Patients did not do as well on placebo but they also
experienced a decline in relapses, which by year six was similar to those
always on Copaxone. A fifth remained relapse-free.
"Copaxone showed that for patients receiving Copaxone from
the onset, neurological deterioration became progressively less likely the
longer they remained on treatment," said Dr. Johnson. Copaxone is
indicated for the reduction of relapses in relapsing- remitting multiple
sclerosis. It reduced relapse rates by a mean of 29 percent in a 24-month
study (1.19 vs. 1.68 for placebo, p=0.055).
The most common side effects of Copaxone are redness,
pain, swelling, itching, or a lump at the site of injection, flushing,
chest pain, weakness, infection, pain, nausea, joint pain, anxiety, and
muscle stiffness. These reactions are usually mild and seldom require
professional treatment. Some patients report a short-term reaction right
after injecting Copaxone.
This reaction can involve flushing (feeling of warmth
and/or redness), chest tightness or pain with heart palpitations, anxiety,
and trouble breathing. These symptoms generally appear within minutes of
an injection, last about 15 minutes, and go away by themselves without
further problems.
SOURCE: Teva Pharmaceutical Industries, Ltd.
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Copaxone (Glatiramer Acetate) Reduces Number Of Relapses In
Relapse-Remitting Multiple Sclerosis
KANSAS CITY, MO -- March 6, 2001 --
Relapsing-remitting multiple sclerosis patients treated with CopaxoneŽ
(glatiramer acetate for injection) showed rapid effect on almost all
MRI-monitored disease activity and burden of disease parameters. These
parameters correlated with reduction in relapse rates compared to placebo,
according to a multi-center, placebo-controlled study published this month
in the Annals of Neurology. The study found a 29 percent reduction
in enhancing lesions compared with placebo.
Copaxone also significantly reduced
the number of relapses in RRMS patients by 33 percent over placebo
(p=0.012) during the nine months of the study. Researchers noted a
significant correlation between the cumulative number of enhancing lesions
and the total number of relapses over the study period in both
placebo-(p=0.0001) and Copaxone-treated patients
(p=0.01).
"This result is
consistent with findings in other clinical trials with Copaxone. Copaxone
has repeatedly shown that it can reduce the relapse rate by at least
one-third," said Jerry S. Wolinsky, M.D., director of the MS Research
Center at the University of Texas Health Science Center. "This study is
significant because these MRI trial results support the presumed mode of
action of Copaxone and its ability to affect lesions and relapses in a
timely and correlated manner."
The double-blind study determined the effect, onset
and durability of any effect of Copaxone (glatiramer acetate for
injection) on disease activity monitored with MRI. At 29 centers
throughout Europe and Canada, 239 patients with RRMS were randomized to
receive 20 mg of Copaxone (n=119) or placebo (n=120) by daily subcutaneous
injection for nine months. This trial targeted patients with active
disease because the eligibility criteria required patients to have one or
more relapses in the two years preceding the study.
The primary outcome measure was the total number of
enhancing lesions on T1-weighted images. Treatment with Copaxone showed a
significant reduction in T1 lesions compared with placebo (the mean number
of lesions were 36.8 for placebo and 25.96 for Copaxone, p=0.003). T1
enhancing lesions correlate to perivascular inflammation and blood brain
barrier disruption. T2-weighted images examine the disease burden of
lesions in the brain. This was one of the secondary outcome measures of
this study.
The differences in accumulation of new T2 lesions
over time in the placebo and treated groups paralleled those observations
for enhancing lesions. By the end of the third month of the nine-month
study, the rate of accumulation of new T2 lesions in the Copaxone-treated
group began to move away from the placebo group. After the sixth month of
treatment, the difference between the two groups became statistically
significant.
The median
percentage change in T2 lesion volume from baseline to the end of the
trial was 20.6 percent in the placebo group and 12.3 percent for the
Copaxone arm. This is a 40 percent reduction for the Copaxone group
compared with placebo (p=0.011).
The most common side effects of Copaxone
(glatiramer acetate for injection) are redness, pain, swelling, itching,
or a lump at the site of injection, flushing, chest pain, weakness,
infection, pain, nausea, joint pain, anxiety, and muscle stiffness. These
reactions are usually mild and seldom require professional treatment.
Patients should be sure to tell their doctor about any side
effects.
Some patients report a short-term reaction right
after injecting Copaxone. This reaction can involve flushing (feeling of
warmth and/or redness), chest tightness or pain with heart palpitations,
anxiety, and trouble breathing. These symptoms generally appear within
minutes of an injection, last about 15 minutes, and go away by themselves
without further problems.
Teva
Pharmaceutical Industries, Ltd. was granted approval by the U.S. Food and
Drug Administration (FDA) in December 1996, to market Copaxone. The drug
was launched in April 1997. Copaxone is marketed in the United States by
Teva Neuroscience, based in Kansas City, Mo.
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Tuesday, 6 March, 2001, 00:02 GMT
MS drug combats blindness
Glaucoma is the most common cause of blindness
A drug developed to treat multiple sclerosis may prove to be an effective
treatment for one of the most common causes of blindness. A team from the
Weizmann Institute of Science in Israel used the drug to block loss of
eyesight in animals with a disease resembling the human condition glaucoma.
The finding suggests that the drug, Copaxone, may also stop, or at least
slow down, the loss of eyesight in people who have a chronic form of the
disease.
The majority of patients with chronic glaucoma have increased pressure
inside the eye due to defective drainage of the transparent fluid that bathes
the eye and nourishes its outer cells.
We know that eye pressure is an important factor in glaucoma, but not
the only one so any other effective approach would be welcome
Keith Barton, Moorfields Eye Hospital
The increase in this intraocular pressure (IOP) damages the optic
nerve, causing it to degenerate and often leading to loss of
eyesight.
For many years, the search for improved glaucoma therapies focused on
correcting the eye's drainage system to reduce IOP.
Eventually, however, it became clear that reducing the pressure was
not enough to halt the ongoing degeneration of the optic nerve and
did not eliminate the risk of blindness.
Secondary damage
Professor Michal Schwartz, from the Weizmann Institute, discovered
that the initial damage to the nerve triggers the release of
chemicals that cause further damage.
These chemicals play an important role in keeping the eye healthy,
but when the optic nerve starts to degenerate they are released in
much higher, toxic quantities.
One of these chemicals is the neurotransmitter glutamate, which
spills from damaged nerve cells and adversely affects healthy
neighboring cells.
However, Professor Schwartz and her team found that Copaxone was
apparently able to shield the nerve from the toxic effects of
glutamate.
In rats immunised with Copaxone only about 4% of nerve cells died in
the glaucoma-affected eye, compared with 28% in rats that were not
immunised.
Human trials expected soon
Trials of the drug in human patients with glaucoma are expected to
begin soon.
Keith Barton, a consultant ophthalmologist in the glaucoma service at
Moorfields Eye Hospital in London, said the study sounded "very
exciting".
He told BBC News Online: "At the moment there is only one type of
treatment for glaucoma and that is to reduce the pressure in the eye.
"We know that eye pressure is an important factor in glaucoma, but
not the only one so any other effective approach would be welcome."
However, Mr Barton warned that the research was at a very early stage
and is was often difficult to draw conclusions on the back of studies
on rats.
Mr Barton estimated that around 7% of glaucoma patients do not
respond to current treatments.
The research was published in the Proceedings of the National Academy
of Sciences USA.
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New Pre-Filled Syringe For CopaxoneŽ Users Makes Injection Process Easier
Better quality of life for
patients with MS
MONTREAL, QC -- May 16, 2002 -- A pre-filled
syringe (PFS) for CopaxoneŽ (glatiramer acetate), indicated for the treatment
of relapsing-remitting multiple sclerosis (MS), has received a Notice of
Compliance from Health Canada and is now available at retail pharmacies across
the country. "With CopaxoneŽ PFS there is no mixing, no preparation and
fewer supplies are needed, ensuring increased accuracy, better compliance, and
less chance for error or contamination. CopaxoneŽ PFS is a consistent,
convenient, and complete way for patients with MS to manage their therapy,"
explains Dr. Jean Godin, Medical Director, Teva Neuroscience, maker of CopaxoneŽ.
"Copaxone* PFS provides the same efficacy as the old format, in a more
convenient and easier-to-use injection format. It makes it easier for patients
with MS to focus more on their lives and less on their therapy." For
neurologists, nurses and pharmacists, compliance and adherence to treatment are
among the most important factors in any therapy. Patients frequently cited the
fact that the PFS saves time and is easier to administer than the previous
mixable formulation. "I'm very excited about the pre-filled syringe because
it will make it easier for me to maintain my therapy without feeling like MS is
controlling me. This will definitely improve my overall quality of life,"
comments Dave Chisamore, who has had MS since 1999 and been taking CopaxoneŽ
since June 2000.
Copaxone* PFS contains exactly the same drug and
the same dose of Copaxone* as the lyophilized version, which patients were
required to mix themselves. A new autoject 2TM device must be used with the
pre-filled syringe. It is important to note that the current autoject* device
cannot be used with the new pre-filled syringe. The combination of the new
pre-filled syringe and autoject 2TM simplifies the injection process for
patients. The autoject 2TM will be provided free of charge to all Copaxone*
patients by Shared Solutions*, which can be reached at 1-800-283-0034.
CopaxoneŽ has demonstrated efficacy in several
published clinical studies. Dr. Trevor Gray, neurologist at St. Michael's
Hospital, Toronto, notes, "With CopaxoneŽ, statistically significant
benefits on relapse rate reduction have been shown within nine months, with
demonstrated divergence between drug effect and placebo on various MRI
parameters as early as 2 months." Dr. Gray continued, "We also know
that reduction in relapse rate may be beneficial at the earliest stages of the
disease. With demonstrated safety and tolerability profiles, CopaxoneŽ is an
excellent choice for early treatment."
"Teva Neuroscience is committed to improving
the quality of life of people with MS, and the introduction of the CopaxoneŽ
PFS is another important benefit for the people who use our product,"
comments John Hassler, General Manager, Teva Neuroscience. "We are very
pleased to be bringing this innovation to Canadians with MS." Almost 50,000
Canadians live with MS, a chronic, progressive, sometimes devastating disease
for which there is, as yet, no cure. CopaxoneŽ, a selective immunomodulator
with a unique mechanism of action, is indicated for the treatment of
relapsing-remitting MS and was launched in 1997. CopaxoneŽ is marketed in
Canada by Teva Neuroscience G.P.-S.E.N.C., based in Montreal, Quebec, a
subsidiary of Teva Pharmaceutical Industries, Ltd. CopaxoneŽ is a registered
trademark of Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries
Ltd., headquartered in Israel, is among the top 35 pharmaceutical companies in
the world. More than 80 per cent of Teva's sales are in North America and
Europe. The Company develops, manufactures and markets generic and branded
pharmaceuticals and active pharmaceutical ingredients. Teva's innovative R&D
focuses on developing novel drugs for diseases of the central nervous system.
SOURCE: Teva Neuroscience
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COPAXONE(R) Shows No Increased Risk In Pregnancy
Researchers Reach Conclusion Based On 21 Global Clinical Trials
HONOLULU, April 1 /PRNewswire/ -- Women who took COPAXONE(R) (glatiramer
acetate injection) during part of their pregnancies demonstrated no more
risk than the general population of pregnancy outcomes, according to an
abstract presented this week at the American Academy of Neurology (AAN).
The study reviewed the pregnancy outcomes in women treated with COPAXONE(R)
through 21 global clinical trials and postmarketing surveillance data.
The relapsing-remitting multiple sclerosis (MS) patient population is
comprised of a high percentage of women of childbearing age. Despite
warnings that women should use adequate birth control and not take
immunomodulating drugs during pregnancy, many women become pregnant while
taking these drugs.
Of the disease-modifying drugs approved by the FDA, the interferons are
assigned FDA Category C because of the risk of spontaneous abortion shown
in animal studies. COPAXONE(R) is FDA Category B because studies have not
shown adverse effects on fetal development, delivery, or infant growth in
animal models.
"It is important to understand the risks of a drug therapy for women who
may become pregnant," said Pat Coyle, M.D., department of Neurology, SUNY
at Stony Brook. "COPAXONE(R) had not shown adverse outcomes in animal
studies and this review of safety data indicates that in women with
relapsing-remitting MS the risk of congenital anomalies or spontaneous
abortion is within the expected range for the general population."
During clinical trials, 3,400 patients received COPAXONE(R) (glatiramer
acetate injection). Of these, 40 pregnancies were reported, and the
average duration of therapy before discontinuing therapy was within the
first trimester of pregnancy. Of those, 18 chose elective abortions, five
spontaneous abortions occurred, and there were seven live births; the rest
were lost to follow up.
In postmarketing surveillance, 345 pregnancies have been reported. More
than 90 percent of these women discontinued use of COPAXONE(R) when they
discovered they were pregnant, so they were mostly exposed in the first
trimester. There are 130 cases that either have not reached their due date
or that were lost to follow up.
Of the 215 pregnancies with known outcomes, there were 155 healthy live
births. Of the remainder, there were 43 spontaneous abortions, nine
elective abortions, six cases of congenital anomalies, one stillbirth, and
one ectopic pregnancy.
These results are consistent with the risk in the general population. The
risk of congenital anomalies is estimated at three percent, and the
incidence of spontaneous abortion is 15 to 20 percent in recognized
pregnancies, according to data from the March of Dimes Perinatal Center.
COPAXONE(R) is indicated for the reduction of the frequency of relapses in
relapsing-remitting MS. The most common side effects of COPAXONE(R) are
redness, pain, swelling, itching, or a lump at the site of injection,
weakness, infection, pain, nausea, joint pain, anxiety, and muscle
stiffness.
COPAXONE(R) is now approved in 42 countries worldwide, including the U.S.,
Canada, Australia, Israel and all the European countries. In Europe,
COPAXONE(R) is marketed by Teva Pharmaceutical Industries Ltd., and
Aventis Pharma. In North America, COPAXONE(R) is marketed by Teva
Neuroscience. Teva Pharmaceutical Industries Ltd., headquartered in
Israel, is among the top 35 pharmaceutical companies in the world.
Close to 90 percent of Teva's sales are in North America and Europe. The
company develops, manufactures and markets generic and branded human
pharmaceuticals and active pharmaceutical ingredients. Teva's innovative
R&D focuses on developing novel drugs for diseases of the central nervous
system.
Teva Pharmaceuticals USA is a subsidiary of Teva Pharmaceutical Industries
Ltd. Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical
Industries Ltd. Teva Neuroscience, Inc. markets COPAXONE(R) (glatiramer
acetate injection).
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.
COPAXONE(R) is a registered trademark of Teva Pharmaceutical Industries
Ltd.
This release contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements are based
on current 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 Teva's ability to successfully develop and commercialize
additional pharmaceutical products, the introduction of competitive
generic products, the impact of competition from brand-name companies that
sell their own generic products or successfully extend the exclusivity
period of their branded products, Teva's ability to rapidly integrate the
operations of acquired businesses, the availability of product liability
coverage in the current insurance market, 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 ("FDA") and other regulatory authority approvals, the
regulatory environment and changes in the health policies and structure of
various countries, acceptance and demand for new pharmaceutical products
and new therapies, uncertainties regarding market acceptance of innovative
products newly launched, currently being sold or in development, the
impact of restructuring of clients, reliance on strategic alliances,
exposure to product liability claims, dependence on patent and other
protections for innovative products, fluctuations in currency, exchange
and interest rates, operating results 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 ("SEC"). Forward-looking statements
speak only as of the date on which they are made, and the Company
undertakes no obligation to update publicly or revise any forward-looking
statement, whether as a result of new information, future developments or
otherwise.
SOURCE Teva Neuroscience, Inc.
CO: Teva Neuroscience, Inc.
ST: Hawaii
SU: WOM
http://www.prnewswire.com
04/01/2003 07:01 EST
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