Surf our Articles on Copaxone:

• New Pre-Filled Syringe For Copaxone® Users Makes Injection Process Easier
• Early Trial of oral Copaxone is Disappointing
• Glatiramer Acetate Reduces Evolution of New MS Lesions into 'Black Holes'
• Early Copaxone (Glatiramer Acetate) Could Decrease Permanent Multiple Sclerosis Disability
• Copaxone (Glatiramer Acetate) Reduces Number Of Relapses In Relapse-Remitting Multiple Sclerosis
• MS drug combats blindness
• Copaxone (Glatiramer) Shows Significant, Long-Term Benefit in Multiple Sclerosis
• COPAXONE(R) Shows No Increased Risk In Pregnancy

Copaxone (Glatiramer) Shows Significant, Long-Term Benefit in Multiple Sclerosis

DENVER, CO -- April 18, 2002 -- The majority of patients treated with Copaxone® (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 ---------------------------------------------------------------------- ---------- 

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 Copaxone® (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

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 Copaxone® Users Makes Injection Process Easier

Better quality of life for patients with MS

MONTREAL, QC -- May 16, 2002 -- A pre-filled syringe (PFS) for Copaxone® (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 Copaxone® PFS there is no mixing, no preparation and fewer supplies are needed, ensuring increased accuracy, better compliance, and less chance for error or contamination. Copaxone® 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 Copaxone®. "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 Copaxone® 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.

Copaxone® has demonstrated efficacy in several published clinical studies. Dr. Trevor Gray, neurologist at St. Michael's Hospital, Toronto, notes, "With Copaxone®, 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, Copaxone® 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 Copaxone® 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. Copaxone®, a selective immunomodulator with a unique mechanism of action, is indicated for the treatment of relapsing-remitting MS and was launched in 1997. Copaxone® is marketed in Canada by Teva Neuroscience G.P.-S.E.N.C., based in Montreal, Quebec, a subsidiary of Teva Pharmaceutical Industries, Ltd. Copaxone® 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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