Wednesday, October 01, 2008

Acute Multiple-Sclerosis Relapses Rarely Result in Permanent Disability: Presented at ANA





By Andrew Wilner, MD

SALT LAKE CITY, Utah -- September 24, 2008 -- Acute relapses in patients with relapsing-remitting multiple sclerosis (MS) rarely lead to disability, according to a retrospective chart review presented here at the American Neurological Association (ANA) 133rd Annual Meeting.

Loren Rolak, MD, Marshfield Clinic, Marshfield, Wisconsin, explained that many patients with MS fear they "might wake up paralyzed" from an acute relapse.

To assess the likelihood of severe disability from an acute relapse, Dr. Rolak examined the clinical course of 1,078 patients with relapsing-remitting MS over the last 14 years from his own database of patients with MS treated at Marshfield Clinic.

The patients in the database had a total of 2,587 attacks (mean of 2.4 attacks per patient, range: 1-14 attacks over 1-34 years). Only 7 of 1,078 patients (0.6%) had an attack that resulted in severe disability, defined as an Expanded Disability Status Scale (EDSS) score of 6 or more sustained for longer than 6 months.

Two of the 7 patients who had an attack that resulted in severe disability presented with an acute severe attack at the time of their diagnosis with MS. Of the remaining 5 patients, 2 were taking interferon beta-1b, which did not prevent the severe disability. The other 3 were not taking interferon or glatiramer-acetate therapy.

Genetic analysis failed to reveal any association between major histocompatibility complex class II DR beta 1 (HLA-DRB1) or nitric oxide synthase (NOS2A) genotypes and severe disability from an acute relapse.

Dr. Rolak concluded, "These results allow me to reassure my patients that a relapse with severe disability is extremely unlikely -- whether or not they are treated with disease-modifying therapy. Consequently, the fear of irreversible disability should not influence their decision to take interferons or other treatment."


[Presentation title: What Is the Risk of Permanent Disability From an MS Attack? Abstract T-91]

Magnetic Resonance Imaging Can Predict Who Will Develop Multiple Sclerosis: Presented at WCTRMS





By Louise Gagnon

MONTREAL -- September 24, 2008 -- Specific magnetic resonance imaging (MRI) scans can predict which patients will develop multiple sclerosis (MS), according to retrospective research presented here at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRMS).

The Betaferon/Betaseron in Newly Emerging MS for Initial Treatment (BENEFIT) study is a randomised, double-blind, placebo-controlled, parallel-group clinical trial that was carried out among 468 patients whose first clinical event suggestive of MS happened within 60 days of trial entry. The study found that treatment with interferon (INF) beta-1b 250 mcg prevented the onset of clinically definite multiple sclerosis (CDMS) by 1 year.

Patients in the BENEFIT study were assigned to either early treatment, which was IFN beta-1b from the start of the trial, or delayed treatment, which was initial placebo followed by IFN beta-1b therapy after conversion to CDMS or upon completing 2-year follow-up.

Principal investigator Bastiaan Moraal, MD, VU Medical Center, Amsterdam, Netherlands, speaking at an oral session here on September 19, said that this analysis examined radiological rather than clinical endpoints.

"We were looking at which type of lesions measured at baseline would predict conversion to clinically definite multiple sclerosis or McDonald multiple sclerosis," said Dr. Moraal.

In this analysis, blinded raters assessed baseline MRI parameters using T2-weighted and postcontrast T1-weighted sequences. Statistical analysis was employed to assess the predictive value of each baseline MRI parameter and treatment interaction.

Investigators found overall conversion to CDMS was 42%, with factors such as the presence of =>9 T2 lesions and =>3 periventricular lesions demonstrating predictive value. They found that conversion rose with the cumulative number of positive criteria. No specific advantage was demonstrated for a threshold of =>3 Barkhof criteria.

"Patients whose treatment was delayed and had 4 positive Barkhof criteria had a higher chance of conversion to CDMS and McDonald MS compared to those with early treatment and fewer positive Barkhof criteria at baseline," explained Dr. Moraal.

Investigators found that prognostic value was affected by treatment (P = .002) for 4 positive Barkhof criteria. The prognostic value was not influenced by therapy for CDMS.

"We saw that, with one exception, the predictive value of MRI values was not affected by treatment," said Dr. Moraal.

Future analysis will examine the predictive value of MRI variables at 3, 6, and 9 months to assess the impact of those variables on conversion to either CDMS or McDonald MS.


[Presentation title: Baseline Magnetic Resonance Imaging Predictors for Conversion to Clinically Definite Multiple Sclerosis and McDonald Multiple Sclerosis, Based on Integrated 3-Year Data From the BENEFIT Study. Abstract 51]

BIOMS MEDICAL ANNOUNCES RECEIPT OF MILESTONE PAYMENT FROM ELI LILLY AND COMPANY





~ US$10 million received based on the positive review of interim analysis for international pivotal multiple sclerosis trial ~

Edmonton, Alberta, September 22, 2008 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that it has received the US$10 million milestone payment from its partner, Eli Lilly and Company.

The milestone payment is based on the previously announced positive review of the scheduled interim analysis of the Company’s pivotal phase II/III Canadian and European trial (MAESTRO-01) of dirucotide (MBP8298) in patients with secondary progressive MS. The independent Data Safety Monitoring Board (DSMB) for the MAESTRO-01 trial recommended that the trial proceed to completion based on the interim analysis which included efficacy and safety data from the first 200 patients to complete the trial.

To date, BioMS has received a total of US$97 million in payments from Eli Lilly and Company, based on the licensing and development agreement for dirucotide (MBP8298). An additional $400 million in milestone payments are possible under the terms of the licensing agreement, in addition to escalating royalties on sales.

“We are pleased that our partner has recognized the outcome of the interim analysis as a significant positive event,” said Kevin Giese, President and CEO of BioMS Medical. “We look forward to completing the MAESTRO-01 trial and reviewing the complete data set in the second half of 2009.”

About BioMS Medical Corp.

BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical’s lead technology, dirucotide (MBP8298), is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide (MBP8298) in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at www.biomsmedical.com.

This press release may contain forward-looking statements, which reflect the Corporation’s current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Corporation’s ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that dirucotide (MBP8298) will continue to demonstrate a satisfactory safety profile in ongoing and future clinical trials; and that BioMS Medical Corp. will complete the respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Ryan Giese
VP Corporate Communications
Phone: 780-413-7152
rgiese@biomsmedical.com

Tony Hesby
Executive VP Corporate Affairs
Phone: 780-413-7152
tony.hesby@biomsmedical.com

Amanda Stadel
Investor Relations Manager
Phone: 780-413-7152
astadel@biomsmedical.com

TYSABRI® DEMONSTRATES SUSTAINED IMPROVEMENT IN FUNCTIONAL OUTCOMES IN MULTIPLE SCLEROSIS PATIENTS ACCORDING TO NEW POST-HOC ANALYSIS





TYSABRI is the Only Marketed MS Treatment to Show Both Significant Slowing in Disability Progression and Sustained Improvement in Physical Disability

Montreal, Canada - September 19, 2008 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that a post-hoc analysis showed TYSABRI® (natalizumab) treatment increases the probability of achieving sustained improvement in physical disability over two years when compared to placebo. This post-hoc analysis provides the first evidence that TYSABRI is associated with a significant improvement in functional outcome, rather than only slowing or preventing progression of disability, in those living with relapsing multiple sclerosis (MS). These findings were derived from a subset analysis of the Phase III AFFIRM trial and were presented today as a poster presentation at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada. This is the first joint meeting of the Americas Committee on Treatment and Research in Multiple Sclerosis (ACTRIMS) and its counterparts in Europe and Latin America: ECTRIMS and LACTRIMS.

"These results show that TYSABRI treated patients are significantly more likely to experience a sustained improvement in disability compared to placebo patients. This finding from a post-hoc analysis of the pivotal AFFIRM trial supports both the earlier findings from the AFFIRM trial that TYSABRI is associated with an improvement in quality of life as well as anecdotal evidence of recovery of function in some patients." said Frederick E. Munschauer, MD, Smith Professor and Chair, Department of Neurology, State University of New York at Buffalo. "While, like TYSABRI, other therapies have shown a slowing of progression in disability, this analysis represents the first evidence supporting a sustained improvement in function associated with an approved disease modifying therapy."

Post-hoc Disability Analysis of Phase III AFFIRM Study

The proportion of patients exhibiting sustained improvements in physical disability in the AFFIRM study was determined based upon the Expanded Disability Status Scale (EDSS) over two years in patients with relapsing MS. EDSS is one of the oldest and most widely utilized methods of quantifying disability in MS.

Post-hoc analysis of AFFIRM patients assessed sustained improvement in disability among patients with a baseline EDSS score ≥ 2.0. Improvement in disability was defined as a one-point decrease in EDSS score sustained for 12 weeks. The cumulative probabilities of 12-week sustained improvement in disability at two years were estimated using the Kaplan-Meier method. Treatment effects were analyzed using the Cox proportional hazards model adjusted for baseline EDSS score. The distribution of sustained improvement by baseline EDSS score for each treatment group was also examined.

TYSABRI produced significant results on the cumulative probability of sustained improvement in disability in those treated over two years compared with placebo. In patients with a baseline EDSS score ≥ 2.0, the probability of achieving sustained improvement was 29.6% with TYSABRI (n=417) compared with 18.7% with placebo (n=203) (p=0.006). In patients with an EDSS score ≥ 2.0 and highly active disease at baseline, the difference between groups was even greater, 35.5% for TYSABRI (n=103) and 15.4% for placebo (n=40) (p=0.045).

The submitted abstract for this study, entitled "Natalizumab significantly increases the cumulative probability of sustained improvement in physical disability" (ID #P474), is available on the World Congress̢۪ website.
About TYSABRI

TYSABRI is a treatment approved for relapsing forms of MS in the US and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).

TYSABRI was approved in early 2008 to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. According to the US full prescribing information, among patients who responded to TYSABRI, 54% sustain their response through every visit for one year compared to 20% of patients receiving placebo (p<0.001), for a treatment difference of 34%.

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Cases of PML have been reported in patients taking TYSABRI who were recently or concomitantly treated with immunomodulators or immunosuppressants, as well as in patients receiving TYSABRI as monotherapy. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS and CD clinical trials, the incidence and rate of other serious adverse events, including serious infections, were similar in patients receiving TYSABRI and those receiving placebo. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash. Other common adverse events reported in TYSABRI-treated CD patients include respiratory tract infections and nausea. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting.

TYSABRI is approved in more than 35 countries. At the end of June 2008, more than 31,800 patients were on commercial and clinical TYSABRI therapy worldwide. Patients on TYSABRI therapy have continued to increase. An update will be provided in October in conjunction with Biogen Idec's third quarter earnings release.

For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com or call 1-800-456-2255.
About Elan

Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.
About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

For more information contact:

Media Contacts:

Biogen Idec
Shannon Altimari
617-914-6524

Elan
Jonathan Birt
212-850-5664
or
+44 20 7269 7205

Niamh Lyons
Ph: +353 1 663 3602

Investor Contacts:

Biogen Idec
Eric Hoffman
617-679-2812

Elan
Chris Burns
+ 353 1 709 4444
800-252-3526

David Marshall
Ph: +353 1 709 4444

Results from IMPROVE Study Show Therapeutic Effect of New Formulation of Rebif® at 16 Weeks in Patients with Multiple Sclerosis




• Study meets primary endpoint by demonstrating significant effect of new formulation of Rebif® on disease activity as measured by MRI after 16 weeks of treatment

• Data presented at late-breaking session of the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada

Geneva, Switzerland, September 22, 2008 - Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the ongoing IMPROVE (Investigating MRI Parameters with Rebif imprOVEd formulation) study met its primary endpoint. The primary objective of the study was to evaluate the efficacy of the new formulation of Rebif®, compared to placebo, in patients with relapsing-remitting multiple sclerosis (RRMS) and active disease by means of magnetic resonance imaging (MRI) at the end of 16 weeks of treatment. The 16-week study results show that the mean number of combined unique active brain MRI lesions per patient was reduced by 69% in patients treated with the new formulation of Rebif® compared with those receiving placebo, a statistically significant result (p<0.001). These data were presented at the late-breaking session of the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada.

"Patients who received Rebif® experienced far fewer new active brain MRI lesions than the placebo group after 16 weeks of treatment,” said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa, Director of the MS Research Clinic at the Ottawa Hospital, and an investigator of the IMPROVE trial. “These data demonstrate a
significant effect of the new formulation of Rebif® on disease activity and provide further evidence of its benefit in treating patients with relapsing-remitting multiple sclerosis.”

The IMPROVE study is a two-arm, randomized, double-blind, controlled, multicenter, international Phase IIIb study to evaluate the efficacy, safety and tolerability of the new formulation of Rebif® in patients with RRMS according to the revised McDonald criteria and evidence of active disease. A total of 180 patients were randomized in a 2:1 ratio to receive either the new formulation of Rebif® 44 micrograms three times a week subcutaneously, or placebo for an initial period of 16 weeks. At the end of this initial 16-week treatment period, patients from the placebo group have been switched in a single-blinded fashion to treatment with the new formulation of Rebif® 44 micrograms three times a week subcutaneously for a period of 24 weeks (the physician assessing treatment response and side effects is blinded). Patients who were initially assigned to the new formulation of Rebif® group continue to receive active treatment for an additional period of 24 weeks. The duration of the whole treatment period is 40 weeks.

The primary endpoint of the study is the difference between the number of combined unique active MRI lesions at week 16 in the group treated with the new formulation of Rebif® versus the placebo group. Combined unique active MRI lesions are defined as an active lesion on T1 sequence with gadolinium or T2 sequence, or both, avoiding double counting. The primary endpoint mainly reflects inflammatory activity (gadolinium-enhancing T1 lesions), but also reflects disease progression (T2 lesions).

The primary efficacy analysis showed that, at week 16, the number of combined unique active brain lesions was significantly lower in patients treated with the new formulation of Rebif® than in patients who received a placebo (p<0.001). The mean number of combined unique active brain lesions per patient was reduced by 69% in patients treated with the new formulation of Rebif® compared with those receiving placebo (0.7 versus 2.2). The median number of combined unique active brain lesions at week 16 was 0.0 in the group treated with the new formulation of Rebif® and 1.0 in the placebo group. Over half (53%) of patients treated with the new formulation of Rebif® had zero combined unique active brain lesions at week 16, compared to only 16.7% in the placebo group.

Results for the secondary and tertiary endpoints of the IMPROVE study will be available at the end of the 40-week treatment period.

The safety profile of the new formulation of Rebif® reported in this study is consistent with the known safety profile of Rebif®. No unexpected safety concerns were identified in this study.

The new formulation of Rebif® was approved in the European Union in August 2007 and in Canada in September 2007. It is now marketed in all EU countries and in Canada. The new formulation of Rebif® is not available in the United States.

About Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif® in chronic progressive MS has not been established. Interferons are thought to help modulate the body’s immune system and reduce inflammation. The exact mechanism is unknown.

Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area.* Rebif® is available in a 22 micrograms and 44 micrograms ready-to-use pre-filled syringe and a titration pack (8.8 micrograms).

Rebif® should be used with caution in patients with a history of depression, liver disease and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors. For more information about Rebif®, please visit www.mslifelines.com for prescribing information.

* The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

About Merck Serono and multiple sclerosis

Merck Serono is a leader in multiple sclerosis (MS) with Rebif® (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, which is registered in more than 80 countries worldwide. Full prescribing information for Rebif® can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including oral cladribine, currently in Phase III and potentially the first oral therapy for MS, as well as several products in early stage development. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS.

About multiple sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, disabling, neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

About Merck Serono

Merck Serono is the division for innovative prescription pharmaceuticals of Merck, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®), multiple sclerosis (Rebif®), infertility (Gonal-f®), endocrine and cardiometabolic disorders (Glucophage®, Concor®, Euthyrox®, Saizen®, Serostim®), as well as psoriasis (Raptiva®).
With an annual R&D expenditure of around € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of € 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,946 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit www.merckserono.net or www.merck.de

Data From MediciNova's Two-Year Phase II Clinical Trial of MN-166 in Multiple Sclerosis Presented At the World Congress for Treatment and Research in





SAN DIEGO, Sep 18, 2008 (GlobeNewswire via COMTEX News Network) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced that data from the completed two-year Phase II clinical trial of orally administered MN-166 for the treatment of multiple sclerosis (MS) was presented today in two poster presentations at the World Congress for Treatment and Research in MS being held in Montreal, Canada.

The first presentation entitled "Clinical Effect of the Neuroprotectant MN-166 in Relapsing Forms of MS: Year 2 Data" (Poster 48), given by Dr. Richard Gammans, Chief Development Officer of MediciNova, reported that MN-166 treatment resulted in positive findings on three independent measures indicative of a potential disease-progression modifying effect. The poster can be accessed at: http://www.medicinova.com/MN-166-Relapsing-MS.html. The findings include:

* Sustained disability progression was significantly less likely (by approximately 50 percent) in those patients receiving MN-166 at either 30 or 60 mg per day for 24 months than in those patients receiving the drug for 12 months (p=0.026). Sustained disability progression was measured as a greater than or equal to 1.0 point increase from baseline in the Expanded Disability Status Scale (EDSS) score for four consecutive months. This positive clinical finding was corroborated by positive findings on two separate radiologic measures.

* The Phase II clinical trial demonstrated that the significant reduction in brain volume loss (p=0.035), as measured by cranial magnetic resonance imaging (MRI) scans, observed after 12 months in patients treated with 60 mg per day of MN-166 compared to placebo was again demonstrated in year two of the study. Brain volume loss was significantly less (p=0.030) in patients who received 60 mg per day of MN-166 for 24 months compared to the other treatment groups.

The second presentation entitled "Ibudilast Reduces Conversion of New Inflammatory Lesions to Persistent Black Holes in Active Relapsing Multiple Sclerosis" (Poster 271), given by Dr. Hanneke Hulst of VU University Medical Center, Amsterdam, The Netherlands, reported that the Phase II data demonstrated that MN-166 treatment resulted in positive findings on independent MRI measures indicative of a neuroprotective effect. The findings include:

* MN-166 treatment at 60 mg per day significantly reduced the relative risk for conversion of new inflammatory lesions identified at month two to Persistent Black Holes (PBH), an MRI indicator of neuronal loss, eight months later at month ten by 37 percent (p=0.011); such lesions that remain unchanged for eight months are considered PBHs as compared to transient inflammatory lesions that are more closely associated with relapses. MN-166 treatment at 30 mg per day resulted in a trend toward reducing evolution to PBH (p=0.074). Loss of brain volume and development of PBHs on MRI have been shown to correlate with clinical progression and disability in MS patients.

"We are pleased that the WCTRIMS Scientific Program Committee accepted two presentations on different aspects of the results from our recently completed Phase II clinical trial of MN-166," said Yuichi Iwaki, M.D., Ph.D., President and Chief Executive Officer of MediciNova, Inc. "The significant favorable effects on measures of disability progression and reduced neuronal damage observed in the study, as described in these presentations, are quite exciting and representative of the type of new treatment being sought by the MS scientific community according to our advisors. We are excited to be part of advancing MS treatment in a new direction and look forward to confirming these findings in future clinical trials with the assistance of a corporate partner."

The two-year randomized, double-blind, placebo-controlled Phase II clinical trial included 297 patients with relapsing MS. In the second year of the study, all patients were on drug. Patients who received 30 or 60 mg of MN-166 per day during the first 12 months of the study remained on the assigned dose for the second 12 months of the study; patients who received placebo during the first 12 months of the study were randomized to receive either 30 or 60 mg of MN-166 per day (double-blind maintained) during the second 12 months of the study. Clinical and radiological outcomes were evaluated.

MN-166 was well tolerated at all doses over the 24 months of this Phase II clinical trial. Of the 297 patients enrolled in the study, 82.5 percent, or 245 patients, completed the full 24 months of the study. The most common adverse events possibly related to MN-166 included mild, transient gastrointestinal disturbances and depression.

First-year efficacy results of this clinical trial were announced in March 2007 and described more completely at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in November 2007. Clinical results from the completed two-year clinical trial were announced in April 2008.

About MN-166

MN-166 is a novel, orally administered compound being evaluated for the treatment of MS. MN-166 increases the release of neuronal growth factors and inhibits leukotriene activity, phosphodiesterases and nitric oxide synthase. MN-166 may also suppress the production of pro-inflammatory cytokines (IL-1beta, TNF-alpha) and may enhance the production of the anti-inflammatory cytokines (IL-4, IL-10).

MediciNova acquired an exclusive, worldwide (excluding Japan, China, Taiwan and South Korea), sublicensable license to MN-166 for the treatment of MS, excluding ophthalmic solution formulations, from Kyorin Pharmaceutical Co. Ltd. For the past 18 years, MN-166 has been marketed in Japan and South Korea as Ketas(r) for the treatment of asthma and cerebrovascular disorders. Data from the existing clinical trial and post-marketing surveillance databases, which includes treatment of an estimated 3.2 million patients with these disorders, indicate that Ketas(r) is well tolerated.

About MediciNova

MediciNova, Inc. is a publicly-traded biopharmaceutical company focused on acquiring and developing novel, small-molecule therapeutics for the treatment of diseases with unmet need with a specific focus on the U.S. market. Through strategic alliances primarily with Japanese pharmaceutical companies, MediciNova holds rights to a diversified portfolio of clinical and preclinical product candidates, each of which MediciNova believes has a well-characterized and differentiated therapeutic profile, attractive commercial potential and patent assets having claims of commercially adequate scope. MediciNova's pipeline includes six clinical-stage compounds for the treatment of acute exacerbations of asthma, multiple sclerosis, asthma, interstitial cystitis, solid tumor cancers, Generalized Anxiety Disorder, preterm labor and urinary incontinence and two preclinical-stage compounds for the treatment of thrombotic disorders. MediciNova's current strategy is to focus its resources on the development and commercialization of two prioritized assets in its development pipeline: MN-221 for the treatment of acute exacerbations of asthma and MN-166 for the treatment of multiple sclerosis. MediciNova will seek to monetize its other product candidates at key value inflection points. For more information on MediciNova, Inc., please visit www.medicinova.com.

The MediciNova, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3135

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding MediciNova's clinical trials supporting safety and efficacy of product candidates and the potential novelty of such product candidates as treatments for disease, plans and objectives for present and future clinical trials and product development, strategies, future performance, expectations, assumptions, financial condition, liquidity and capital resources. These forward-looking statements may be preceded by, followed by or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "would," or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements, include, but are not limited to, the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for product candidates, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials and the timing, cost and design of future clinical trials and research activities, the timing of expected filings with the FDA, MediciNova's failure to execute strategic plans or strategies successfully, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to raise sufficient capital when needed, intellectual property or contract rights, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2007 and its subsequent periodic reports on Forms 10-Q and 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: MediciNova, Inc.

MediciNova, Inc.
Shintaro Asako, Chief Financial Officer
858-373-1500
info@medicinova.com

Rx Communications, LLC
Rhonda Chiger
(917) 322-2569
rchiger@rxir.com

Monday, September 22, 2008

ATL/TV1102 Trial Results Presented at World Congress on Treatment and Research in Multiple Sclerosis




MELBOURNE, Australia and CARLSBAD, Calif., Sept 22, 2008 /PRNewswire-FirstCall via COMTEX News Network/ -- Antisense Therapeutics Ltd. (ASX: ANP) and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) are pleased to advise that the results from the ATL/TV1102 Phase IIa clinical trial in patients with multiple sclerosis (MS) were presented Saturday at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal, Canada by the Principal Investigator for the trial, Volker Limmroth, M.D., Ph.D., Chairman of the Department of Neurology, Cologne City Hospitals, Germany.

As previously reported, ATL/TV1102 significantly reduced disease activity in patients with Relapsing Remitting Multiple Sclerosis (RRMS) in a randomized, double-blind, placebo-controlled Phase II study designed to obtain evidence of ATL/TV1102's effectiveness in reducing MS-related brain lesions as detected by magnetic resonance images (MRI). The study met its primary endpoint showing a significant reduction by 54.4% (p=0.01) in cumulative number of new active lesions in the ATL/TV1102 treated patients compared to placebo. Further details on the study design and outcomes are provided in the conference abstract which follows this document.

Dr. Limmroth said, "As VLA-4 is a clinically validated target in MS, there is high interest in the potential application of treatment modalities directed against this target. In our study we were able to demonstrate, for the first time, that a second-generation antisense drug designed to specifically inhibit the production of VLA-4 could significantly reduce disease activity in RRMS patients as early as 8 weeks. The level of efficacy achieved by ATL/TV1102 is very promising particularly when considering the short duration of dosing within the trial. As an antisense drug ATL/TV1102 will have a different, potentially preferable, safety profile to other drugs that target VLA-4 and therefore presents an exciting future treatment option for RRMS patients."

Mark Diamond, Chief Executive Officer of Antisense Therapeutics, said, "We are delighted to have our ATL/TV1102 Phase IIa trial results presented at such an important scientific meeting on MS. The development of ATL/TV1102 as an MS treatment continues with our partner Teva Pharmaceutical Industries (Teva) and we look forward to the prospect of Teva reporting on ATL/TV1102's future clinical progress. Importantly, the demonstration of significant disease activity with ATL/TV1102 in MS points to the potential of ATL/TV1102 in other disease settings such as autoimmune, inflammation and cancer. It also provides important validation for the application of second-generation antisense drugs outside of cardiovascular and metabolic diseases such as high cholesterol and diabetes where there has been success to date. We believe our results provide important substantiation for the broader clinical application of the second-generation technology."

"We are very encouraged by the data. Not only do they represent promising results for patients with MS, but they also evidence the significant progress we are making in demonstrating the effectiveness, efficiency and the breadth of opportunity of our antisense platform. It's another disease and another tissue where we have great proof-of-concept for antisense drugs," said Stanley Crooke, M.D., Ph.D., Chairman and Chief Executive Officer of Isis. "ATL/TV1102 and ATL's strategic relationship with Teva to move the drug forward further validates our business strategy. ATL has successfully moved the drug forward and now has established a very experienced partner to complete development and commercialization of the drug. This strategy benefits patients as well as Isis' pipeline, platform and balance sheet."

The presentation has been webcasted and will be available on http://www.msmontreal.org/home/default_e.asp in the coming weeks. The Company will provide login details on its website http://www.antisense.com.au once these are confirmed.

Conference abstract follows:

VLA-4 Antisense - An Oligonucleotide targeting VLA-4 mRNA (ATL1102) significantly reduces new active lesions in patients with RR-MS

Volker Limmroth(1), Frederik Barkhof(2), Nuket Desem(3)

(1) Department of Neurology, Cologne City Hospitals, University of Cologne, Cologne, Germany, (2) Department of Radiology, MS Center Amsterdam, VU University Medical Center, Amsterdam, Netherlands, (3) Antisense Therapeutics Ltd, Melbourne, VIC, Australia.

Background: Antisense oligonucleotides (ASOs) are an innovative new class of drugs that inhibit the expression of proteins by sequence-specific binding to the protein's mRNA. ATL1102 is a 2nd generation antisense inhibitor of CD49d, a subunit of Very Late Antigen 4 (VLA-4) which plays a key role in cell adhesion to vessel walls. VLA-4 blockade, as shown by monoclonal antibodies such as natalizumab, prevents activated lymphocytes from migrating into the CNS and significantly reduces disease activity in MS.

Objective: To evaluate VLA-4 Antisense (ATL1102) in the treatment of RR-MS

Methods: Randomized, double-blind, placebo-controlled multicenter Phase-IIa trial. 77 patients with RR-MS were treated for 8 weeks with either 200mg of ATL1102 or placebo subcutaneously twice weekly and evaluated for 16 weeks. MRI scans were performed at screening, and then monthly over 16 weeks. Primary efficacy variable: cumulative number of new active lesions (CNNAL; new gadolinium-enhancing T1 lesions (T1-Gd), new or enlarging T2 lesions) on MRIs taken at weeks 4, 8 and 12. Secondary efficacy variable: cumulative volume of T1-Gd lesions (CVT1L) on MRIs taken at weeks 4, 8 and 12.

Results: ITT population: 74 patients with a valid baseline MRI and at least one post-baseline MRI scan after first injection of study medication (n=39 placebo, n=35 ATL1102). ATL1102 showed a significant reduction, 54.4%, in CNNAL (6.2 placebo, 3.0 ATL1102; p=0.01). A reduction of 66.7% (p=0.002) was observed in the cumulative number (weeks 4,8,12) of new T1-Gd lesions with ATL1102. A reduction in CVT1L was also observed under ATL1102 but did not reach significance (589.4 mm3 placebo, 358.0 mm3 ATL1102; p=0.1068). Adverse events that were more frequent under ATL1102 included mild to moderate injection site reactions and a tendency for decreased platelet counts which were reversible after treatment interruption.

Conclusions: This proof-of-concept study of a drug designed to inhibit VLA-4 mRNA showed a significant reduction of the cumulative number of new active lesions in RR-MS patients following 8 weeks of treatment. These promising results warrant further investigation.

Background Information

ATL/TV1102 Phase IIa trial is a randomised, double-blind, placebo-controlled clinical trial of ATL/TV1102. Patients received either ATL/TV1102 or placebo injections over 8 weeks, and were monitored with monthly MRI (magnetic resonance imaging) brain scans during treatment, and for the 8 weeks following treatment. 77 patients were enrolled in the trial, which was conducted at multiple trial sites across six European countries.

Multiple sclerosis is a lifelong chronic disease of the central nervous system which is believed to affect as many as 2.5 million people worldwide. Global drug sales for MS are in excess of $US 6 billion and are expected to grow with the introduction of novel treatment options. There remains a high demand for more effective and better tolerated treatments.

About ATL/TV1102 for MS: ATL/TV1102 is an antisense drug discovered by Isis Pharmaceuticals, Inc. and licensed to ANP. Antisense drugs specifically block disease-causing proteins from being produced by interacting with their intended target based on information in the genetic code. ATL/TV1102 is a second-generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very Late Antigen-4). In inflammation, white blood cells (leukocytes) move out of the bloodstream into the inflamed tissue, for example, the CNS in MS, and the lung airways in asthma. The inhibition of VLA-4 may prevent white blood cells from entering sites of inflammation, thereby halting progression of the disease. VLA-4 is a clinically validated target in the treatment of MS. Antisense inhibition of VLA-4 has demonstrated positive effects in a number of animal models of inflammatory disease including MS (Myers et al. J Neuroimmunol 160, p12-24, 2005).

About Antisense Therapeutics Limited: Antisense Therapeutics Limited (ASX: ANP) is an Australian publicly listed biopharmaceutical drug discovery and development company. Its mission is to create, develop and commercialize antisense pharmaceuticals for large unmet markets. ANP has two drugs in development and two drugs in pre-clinical research. ATL/TV1102 (injection) has completed a Phase IIa trial as a potential treatment of multiple sclerosis. ATL1103 is a second-generation antisense drug designed to lower blood IGF-I levels and is entering pre-clinical development as a potential treatment for acromegaly and vision disorders. ATL/TV1102 (inhaled) is at the pre-clinical research stage as a potential treatment for asthma. ATL1101 is a second-generation antisense drug at the pre-clinical research stage being investigated as a potential treatment for prostate cancer. ATL/TV1102 has been licensed to Teva Pharmaceutical Industries Ltd.

About Isis Pharmaceuticals, Inc.

Isis is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners. The Company has successfully commercialized the world's first antisense drug and has 19 drugs in development. Isis' drug development programs are focused on treating cardiovascular and metabolic diseases. Isis' partners are developing antisense drugs invented by Isis to treat a wide variety of diseases. Ibis Biosciences, Inc., Isis' majority-owned subsidiary, is developing and commercializing the Ibis T5000(TM) Biosensor System, a revolutionary system to identify infectious organisms. Isis is a joint owner of Regulus Therapeutics LLC, a joint venture focused on the discovery, development and commercialization of microRNA therapeutics. As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of over 1,500 issued patents worldwide. Additional information about Isis is available at http://www.isispharm.com.

Isis Forward-Looking Statement

This press release includes forward-looking statements regarding Isis' business, its drug discovery and development pipeline, and the therapeutic potential of ATL/TV1102 for the treatment of multiple sclerosis. Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement, including those statements that are described as Isis' goals. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such products. Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended December 31, 2007, and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from Isis.

Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals, Inc. Ibis Biosciences and Ibis T5000 are trademarks of Ibis Biosciences, Inc. Regulus Therapeutics is a trademark of Regulus Therapeutics LLC.

SOURCE Isis Pharmaceuticals, Inc.; Antisense Therapeutics Ltd.

New data presented at WCTRIMS* supports the importance of early and sustained treatment with Betaseron®





Earlier treatment initiation and longer exposure to Betaseron was associated with improved long-term outcomes in multiple sclerosis

MONTREAL, CANADA, September 19, 2008 Data presented at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRIMS) demonstrated that early initiation of Betaseron� (interferon beta-1b) treatment had a greater impact on long-term outcomes, when compared to delayed treatment.

The study, sponsored by Bayer HealthCare Pharmaceuticals, used data from the 16-Year Long-Term Follow-up Study of Betaseron to investigate the relationship between timing of drug initiation and length of exposure to treatment, and long-term outcomes. It demonstrated that initiating Betaseron treatment early in the disease reduced the risk of negative long-term outcomes, including conversion to secondary progressive multiple sclerosis (SPMS), reaching a confirmed EDSS of 6.0 or the use of a wheelchair. The study also found that the longer patients stayed on treatment, the better their long-term outcomes were.1

"The new analysis confirmed that in MS, timing of treatment is important. The findings showed that even if two patients are treated for an equivalent length of time, the one who started therapy earlier in the disease course had a better long-term outcome," said Douglas Goodin, MD, Director of the Multiple Sclerosis Center at UCSF Medical Center. "Patients and physicians should take these results into consideration when making treatment decisions."

A second study, called CogniMS, also presented at WCTRIMS, demonstrated that cognitive deficits can be measured early in the course of MS. The investigators suggested that such cognitive deficits may be clinically important for MS management decisions.

"Studies are now showing that apart from disease progression and relapse rates, cognition is another area that is impacted early in the course of the disease. In fact, there is a correlation between the level of disability at the start of treatment and cognitive function 16 years later. More research is needed to determine how treatment might benefit long-term cognitive outcome," said Dr. Goodin.

"The data presented here underscore the need to help patients start therapy earlier and stay on treatment for the long-term," said, Ludger Heeck, Ph.D. Vice President and General Manager, Specialty Medicine Bayer HealthCare Pharmaceuticals Inc. "Bayer is committed to helping provide both the medication and the support services that people need to help treat their MS. We pioneered the concept of customized MS support services, and our best-in-class BETAPLUSTM program goes far beyond treatment to offer a wide range of beneficial services for people with MS. From having dedicated MS nurses who can provide practical help and advice, to offering product enhancements like our new thinnest needle and optional autoinjector that can help make injection administration more comfortable, we continue to lead the way in helping people with MS start on and stay on treatment."

About the Trials
The 16-Year Long-term Follow-up Study is a multicenter observational study that collected data from patients with relapsing-remitting MS (RRMS) who participated in the pivotal North American trials for Betaseron. Several statistical methods were used to assess patient data and examine the relationship between timing of drug exposure and long-term outcomes. Drug exposure was measured as the medication possession ratio (MPR) defined as the actual time the patient received therapy divided by the total time possible before a negative outcome was reached (or at data censor). A statistical method called recursive partitioning was then used to divide treatment groups into "high" or "low" exposure and to determine the relationship between length of drug exposure and long-term outcomes. The use of MPR reduces the bias introduced in long-term trials by the tendency of patients who are doing well on therapy stay on therapy and for patients who are doing poorly to stop a particular therapy. Other statistical approaches including Propensity Scoring were used to control for other known sources of bias.1

CogniMS is a two-year observational study involving 1509 patients with early MS (diagnosed within two years) who were treated with Betaseron and assessed every six months using tests to measure cognition, fatigue and health-related quality of life. The trial includes patients from 32 countries2 and is currently ongoing.

About Betaseron
Betaseron is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

The most commonly reported adverse reactions are lymphopenia, injection-site reaction, asthenia, flu-like symptom complex, headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. Betaseron should be used with caution in patients with depression. Injection-site necrosis has been reported in four percent of patients in controlled trials. Patients should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information. More information, including the full Prescribing Information, is available at www.betaseron.com.

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. Bayer HealthCare Pharmaceuticals comprises the following business units: Women's Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Media Contact:
Marcy Funk
Bayer HealthCare Pharmaceuticals
973-305-5385

Forward-Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

*WCTRIMS is the first joint meeting of ECTRIMS (the European Committee on Treatment and Research in Multiple Sclerosis) and its counterparts in North and Latin America: ACTRIMS and LACTRIMS

*DS Goodin, G Ebers, AT Reder, et al. Early Treatment with Interferon Beta-1b is Associated with Improved Long-Term Outcome in Multiple Sclerosis. World Congress on Treatment and Research in Multiple Sclerosis 2008.

*S Fredrikson, DW Langdon, K Kim, et al. Cognition, Fatigue, Depression and Health-Related Quality of Life in Early Multiple Sclerosis: Baseline Data from CogniMS, a Multinational Longitudinal Study. World Congress on Treatment and Research in Multiple Sclerosis 2008.

Glatiramer Acetate Decreases Severity of Relapsing-Remitting Multiple Sclerosis: Presented at WCTRMS




By Louise Gagnon

MONTREAL -- September 20, 2008 -- Glatiramer acetate has been shown to be efficacious in several outcomes among patients with relapsing-remitting multiple sclerosis (RRMS) when a scale other than the Expanded Disability Status Scale (EDSS) was used, according to research presented here at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRMS).

A study of 251 patients was presented by investigator Joseph Herbert, MD, New York University, New York, New York, who described the EDSS as not truly reflective of clinical patient outcomes.

In the pivotal study, glatiramer acetate resulted in a 29% decrease in relapse rates compared with placebo. While patients treated glatiramer acetate did show improvement in their EDSS score, Dr. Herbert described the scale as an insufficiently sensitive measure of disease progression.

He presented the study findings in a poster session here on September 19

In this study, Dr. Herbert employed a Multiple Sclerosis Severity Score (MSSS) algorithm that relates MS disability as measured by EDSS to disease duration from the time of first symptom.

"This measure is a more useful outcome measure, because it corrects for certain flaws in the EDSS," said Dr. Herbert in an interview. "It accounts for duration of disease. The EDSS needs to be considered in the context of duration of disease."

This study enrolled patients who had EDSS scores of between 0 and 5. The researchers randomised 125 patients to subcutaneous injections of glatiramer acetate at 20 mg/day and 126 to placebo. Patients were followed for approximately 35 months.

Subjects in this study were divided into 6 groups according to their disease severity, explained Dr. Herbert. At study entry, the median MSSS scores for patients treated with glatiramer acetate and those treated with placebo were similar (4.59 vs 4.29; P = .1). At the end of the study, the median MSSS change from study entry was significantly greater in patients treated with glatiramer acetate compared with those treated with placebo (-0.73 vs -0.19; P = .0019).

With the revised grading of patients according to the MSSS, fewer patients who received glatiramer acetate were categorised as having severe disease. Specifically, more patients treated with glatiramer acetate were reclassified as having less severe illness (49% vs 31%) and fewer patients were reclassified as having more severe illness (16% vs 26%; P < .0014).

"There was a significant drop in severity for the treated patients," said Dr. Herbert. "There was a reassignment toward the higher grades with placebo patients."

The data support the use of the MSSS scale to measure changes in disability in patients with RRMS.

"We are suggesting that, since EDSS and duration of disease must be collected to begin with, that [MSSS] should be used as an outcome measure," said Dr. Herbert. "There is a true change in the intrinsic severity of the disease over 3 years, which is quite dramatic."

Funding for this study was provided by Teva Pharmaceutical Industries Ltd.

[Presentation title: Glatiramer Acetate Reduces Multiple Sclerosis Severity: Analysis of Patients From the US Pivotal Study Using the Multiple Sclerosis Severity Score. Abstract P454]

Vitamin D Levels Might Predict Risk for MS





FRIDAY, Sept. 19 (HealthDay News) -- Children with lower levels of vitamin D seem to be at a higher risk of being diagnosed with multiple sclerosis.

So say researchers who were expected to present the findings Friday at the World Congress on Treatment and Research in Multiple Sclerosis, in Montreal.

The idea fits nicely with previous research indicating that multiple sclerosis is more common the farther away you get from the equator, in other words, in areas where there is less sunlight.

Vitamin D synthesis is triggered when ultraviolet rays from the sun hit the skin. In addition, studies have also linked vitamin D with immune system function.

"In MS, the immune system is misregulated, and we do know that there's a susceptibility in the genes we inherit from our parents. We know that something triggers the disease," explained Patricia O'Looney, vice president of biomedical research at the National Multiple Sclerosis Society. "We know from epidemiological studies that there's a higher prevalence of MS the farther away you live from the equator and, more recently, we've learned that vitamin D does regulate the immune system."

"This is an interesting study of how environmental triggers and the immune system can be involved with MS, provided that one has these susceptibility genes," she added.

"Many studies have given us a good link between vitamin D status and immune function in MS," added study author Heather E. Hanwell, a doctoral candidate in nutritional sciences at the University of Toronto. "We wanted to see whether vitamin D status was lower in children who had their first demyelinating event and were subsequently diagnosed with MS."

A first demyelinating event is essentially an attack of symptoms that could indicate trouble with the central nervous system. One quarter of children who have such an attack go on to be diagnosed with MS.

The researchers measured levels of a vitamin D biomarker in children who had had a first event.

"The biomarker of vitamin D status was significantly lower in children diagnosed with MS to date," Hanwell said. "Children diagnosed with MS had lower vitamin D levels than those not diagnosed. Another way of looking at it, as vitamin D status increased, children had a lower risk of being diagnosed."

At this point, however, Hanwell believes the findings have more research than clinical implications.

"This type of work provides impetus for further research in this area, although, for a doctor, it would be important to look at vitamin D status in patients, particularly because 75 percent of our overall study group had vitamin D levels below what we considered to be optimal."

A second study also being presented at the World Congress found that the incidence of first demyelinating events increased by 9.2 percent for each higher degree of latitude up the eastern coast of Australia. The study was partially funded by the National Multiple Sclerosis Society, in the United States.

"There is growing evidence linking vitamin D and risk of MS," O'Looney said. "Further studies are certainly needed to see if vitamin supplementation could reduce the risk of MS. There is insufficient evidence that vitamin supplementation can influence the course of MS once it's begun."

More information

Visit the National Multiple Sclerosis Society for more on MS.

SOURCES: Patricia O'Looney, Ph.D., vice president, Biomedical Research, National Multiple Sclerosis Society, New York City; Heather E. Hanwell, doctoral candidate, department of nutritional sciences, University of Toronto

Tysabri PML patient deteriorates - researcher





By Reuters
September 19, 2008

BOSTON—One of two European patients, who developed a potentially deadly brain infection after taking the multiple sclerosis drug Tysabri, is deteriorating and likely to suffer brain damage, according to a researcher involved in their care.

The other patient diagnosed with the infection in July is recovering, the researcher said Friday.

The drug, made by Biogen Idec Inc and Elan Corp , was temporarily withdrawn from the market in 2005 after being linked with three cases of an often lethal infection known as progressive multifocal leukoencephalopathy, or PML.

Due to its advantages over older MS treatments and patient willingness to take on the risks, Tysabri was reintroduced with stricter warnings in 2006. No new cases were reported until the end of July, when Biogen announced that two patients had developed the infection.

Biogen said on Friday that no further new PML cases have been confirmed and its shares closed up 6 percent. Elan shares closed up more than 1 percent.

Dr. Ralf Gold of Ruhr University Bochum, Germany, said in an interview that a German patient, hospitalized near the town of Freiburg, is close to a coma and being fed through tubes, though he is breathing on his own.

The other patient, a 37-year-old Swede, is in a rehabilitation center near Stockholm and suffering only from mild weakness on one side of his body.

Gold said the 52-year-old German patient was not diagnosed until at least three months after developing the disease, whereas the Swedish patient's condition was identified in less than a month. As a result, the German patient had a higher level of the virus in his brain.

The two were treated through plasmapheresis, a procedure in which a patient's blood is removed, cleared of the drug, and replaced.

Gold presented an update on the two cases at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal.

Investors have been watching the patients' progress to see whether PML can be reversed. They are also watching to see how many cases of the infection develop among patients taking the drug, which is considered a critically important growth driver for both companies.

Tysabri had second-quarter sales of $200 million, but its fortunes have been inextricably linked to PML concerns.

"The drug's strong efficacy profile should keep it as a preferred agent, in our opinion," Leerink Swann analyst William Tanner wrote in a research note.

In a report ahead of Gold's update, Geoff Porges, an analyst at Sanford Bernstein, said that if the disease becomes manageable through plasmapheresis then the impact of these cases will be blunted.

He said experts interviewed at the meeting have confirmed that in Europe and North America there are a number of patients with suspected PML whose physicians discontinued Tysabri use.

"We believe it is incumbent on Biogen to disclose this information to physicians in order for them to fully evaluate and disclose the risks associated with the product," he said.

Biogen spokeswoman Naomi Aoki said, "We have disclosed the only two cases of diagnosed PML that we have seen so far."

Gold added that while certain databases pick up cases in which a doctor suspects PML and discontinues Tysabri, the cases have not been confirmed either through an MRI or any other scientific measures.

Gold said the virus appears to be leaving the German patient's brain, but he is suffering from brain damage brought about by a condition known as immune reconstitution inflammatory syndrome, or IRIS. This occurs when the immune system, in eliminating an infection, produces an excessive inflammatory response that can worsen symptoms.

It is most likely the patient will be permanently brain damaged, Gold said. The only question is by how much.

The patient was started on a course of corticosteroids on Friday, the standard treatment for IRIS.

It typically becomes clear within a few days whether such a treatment is likely to work, Gold said. In the meantime, the patient is in a critical condition but not in intensive care.

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Laquinimod Demonstrated Significant and Sustained Impact on Multiple Sclerosis Disease Activity




New Crossover Data Presented at the World Congress on Treatment and Research in Multiple Sclerosis Shows Significant Reduction of Gadolinium-Enhancing Lesions

Jerusalem, Israel and Lund, Sweden, September 18, 2008 - New data from the extension phase of oral laquinimod in relapsing-remitting multiple sclerosis (RRMS) demonstrated a significant reduction in the mean number of gadolinium-enhancing (GdE) lesions in both patients who switched from placebo to laquinimod and patients who continued with their initial laquinimod dose.

In RRMS patients who switched from placebo to laquinimod, 52 percent reduction in the mean number of GdE lesions was observed (p<0.0007). The reduction was significant for both patients switching to high-dose (p<0.009) and low-dose laquinimod (p<0.03). In addition, the proportion of patients who switched to active treatment from placebo, and remained enhancing lesion-free, increased from 31 percent to 47 percent (p<0.012), further reinforcing the efficacy of laquinimod on magnetic resonance imaging (MRI) measured disease activity.

Patients initially treated with 0.6mg/day and 0.3mg/day during the double-blind trial remained on the same dose during the 36-week extension phase. An additional significant reduction in the mean number of GdE lesions was also observed in these patients (n=94, p=0.0062 and n=80, p=0.0013, respectively), a high proportion of which remained completely free of GdE lesions, demonstrating the sustained effect of laquinimod on MRI disease activity.

"These latest data show the rapid onset and sustainability of laquinimod efficacy in MS patients," said Giancarlo Comi, M.D., University Vita-Salute San Raffaele, Scientific Institute San Raffaele, Milan, Italy, principal investigator of the study. "Just as exciting is the fact that, with increased number of patients exposed to laquinimod, we found no new risks or safety issues. This reinforces earlier results demonstrating the laquinimod safety profile. The MS community looks forward to future data as we continue enrolling patients in the laquinimod Phase III clinical program."

These new data from the extension study build upon the initial 36-week, Phase IIb study results published in The Lancet*, which demonstrated that once-daily, oral 0.6mg laquinimod significantly reduced MRI disease activity by a median of 60 percent, compared to placebo, and was well tolerated.

Teva is currently enrolling patients for Allegro and Bravo, two pivotal Phase III clinical trials of laquinimod. For more information please visit www.TevaClinicalTrials.com.

*Lancet 2008; 371:2085-92

About the Study
In the study, "Oral laquinimod in patients with relapsing�remitting multiple sclerosis: 36 weeks double-blind active extension of the multi-center, randomized, double-blind, parallel-group placebo-controlled study," subjects originally assigned to placebo were equally randomized to receive either 0.3 or 0.6mg/day laquinimod, while others continued their original treatment for a 36-week, double-blind extension. Magnetic resonance imaging (MRI) was performed at the beginning and at the end of the active extension phase. The mean number of GdE lesions in patients who switched from placebo to laquinimod was reduced by 52 percent (from 4.46�6.55 to 2.12�3.73; p<0.0007) from the time patients began receiving active treatment.

Two hundred and fifty seven patients (91 percent) entered the extension phase to receive laquinimod 0.3mg/day or 0.6mg/day. Neither new safety signals nor an increase in the incidence rate of adverse events and laboratory abnormalities have emerged following new or prolonged exposure to laquinimod.

Patients on continuous 18 month laquinimod 0.6mg treatment continued to show low MRI disease activity, with a high proportion remaining free of GdE-lesions. A good tolerability profile was also observed. Treatment effects on MRI activity witnessed during the placebo-controlled phase were reproduced when placebo patients switched to laquinimod.

About Multiple Sclerosis
Multiple Sclerosis (MS) is the leading cause of neurological disability in young adults. It is estimated that more than 400,000 people in the United States are affected by the disease and that two million people may be affected worldwide. MS is a progressive, demyelinating disease of the central nervous system affecting the brain, spinal cord and optic nerves. Demyelination is the destructive breakdown of the fatty tissue that protects nerve endings.

About Laquinimod
Laquinimod is a novel once-daily, orally administered immunomodulatory compound that is being developed as a disease-modifying treatment for RRMS. Active Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries, Ltd. in June 2004. A Phase IIb study in 306 patients was recently published in The Lancet and demonstrated that an oral 0.6 mg dose of laquinimod, administered daily, significantly reduced MRI disease activity by a median of 60 percent versus placebo in RRMS patients. In addition, the study showed a favorable trend toward reducing annual relapse rates and the number of relapse-free patients compared with placebo. Treatment was well tolerated, with only some transient and dose-dependent increases in liver enzymes reported. Over 480 MS patients have received laquinimod in various clinical trials.

In addition to the efficacy that laquinimod has shown in Phase II RRMS clinical trials, laquinimod has demonstrated potent therapeutic efficacy in preclinical models of other autoimmune diseases such as rheumatoid arthritis, insulin-dependent diabetes mellitus, Guillain Barr� Syndrome, lupus and Inflammatory Bowel Disease. The broad profile of efficacy in animal models of inflammatory diseases suggests that laquinimod affects a pivotal pathway of inflammation and autoimmunity. Teva expects to initiate the clinical development of laquinimod for Crohn's disease and Lupus Nephritis in the near future.

About the Phase III Program
Allegro (assessment of oral laquinimod in preventing progression of MS) is a pivotal, global, 24/30-month, double-blind, Phase III study designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo in the treatment of RRMS. The enrollment goal is approximately 1,000 patients with RRMS.

Bravo (benefit-risk assessment of Avonex® and laquinimod) is a pivotal, multinational, multi-center, randomized, double-blind, parallel-group, placebo-controlled study designed to compare the safety and efficacy of laquinimod with placebo and to provide risk-benefit data for laquinimod versus a currently available injectable treatment. The enrollment goal is approximately 1,200 patients with RRMS.

The globally conducted clinical program will include centers throughout the United States as well as centers Canada, Europe, and Israel. To learn more about the research please visit www.TevaClinicalTrials.com or call 1-866-550-0614 (Allegro) or 1-800-840-5601 (Bravo).

About Active Biotech
Active Biotech AB (OMX NORDIC: ACTI), headquartered in Sweden, is a biotechnology company with R&D focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, as well as ANYARA for use in cancer targeted therapy, primarily renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex® for RA. Please visit www.activebiotech.com for more 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 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 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 successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us 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®, Neurontin®, Lotrel® and Protonix®, 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, our ability to successfully identify, consummate and integrate acquisitions, including the pending acquisition of Barr Pharmaceuticals Inc., 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 this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").



Company Contacts:
Elana Holzman
Kevin Mannix

Teva Pharmaceutical Industries Ltd.
Teva North America

972 (3) 926-7554
(215) 591-8912

Copaxone® Demonstrated Protective Effect in Patients with Clinically Isolated Syndrome Suggestive of Multiple Sclerosis




PreCISe Data Presented at World Congress on Treatment and Research in Multiple Sclerosis

Jerusalem, Israel, September 19, 2008 - New data from PreCISe, in clinically isolated syndrome patients, have demonstrated that COPAXONE® (glatiramer acetate injection) significantly improved neuro-axonal integrity in patients presenting with a first clinical event suggestive of multiple sclerosis (MS) versus patients who received placebo (p=0.03), as measured by proton magnetic resonance spectroscopy (MRS). This effect was maintained over two years of treatment.

The data represent the first evidence of neuro-axonal protection by a disease modifying therapy in patients presenting with a first clinical event suggestive of MS.

Data were derived from an ancillary study from the Phase III, randomized, placebo-controlled PreCISe trial, which demonstrated that patients treated with COPAXONE® (n=243) had a 45 percent reduction in the risk of developing clinically definite multiple sclerosis (CDMS) compared to those on the placebo (n=238).

"These newly announced data, so far shown in RRMS patients treated with COPAXONE®, provide more evidence that treatment may control the neuronal damage associated with MS disease pathology," said Douglas Arnold, M.D., Professor of Neurology, McGill University and the primary investigator of this ancillary study. "The PreCISe trial demonstrated a significant benefit of COPAXONE® on both clinical and MRI disease activity, along with further reinforcing the excellent safety profile."

The data were presented along with two other presentations from the PreCISe study at the World Congress on Treatment and Research in Multiple Sclerosis, in Montreal, Canada. Additional data derived from the PreCISe study demonstrated that COPAXONE® significantly delayed time to conversion to CDMS and reduced magnetic resonance imaging (MRI) disease activity. The effect was robust among the PreCISe study population (n=481), as a whole and also in subgroups of patients (segmented by gender, age, type of unifocal manifestation as well as steroid treatment for the initial attack, and MRI findings at study baseline). Based on these data, applications for marketing authorization for the extension of its indication to include the treatment of patients with a first clinical event suggestive of MS were submitted in Europe and in the U.S. and are currently under review.

About the PreCISe Data
The study, "Treatment with glatiramer acetate protects axons in patients with clinically isolated syndromes: evidence from the PreCISe trial," determined that patients with clinically isolated syndrome (CIS) who received COPAXONE® showed improvement in their cerebral neuro-axonal integrity relative to patients treated with placebo.

Proton MRS was performed in a subgroup of patients in the PreCISe trial (n=34) to measure the concentration of N-acetulaspartate (NAA) levels. NAA/CR measurements were acquired each year from each patient enrolled at 10 clinical sites in seven countries. Patients terminated at the time of relapse.

Patients who received COPAXONE® showed significant improvement in their cerebral neuro-axonal integrity compared to patients treated with placebo, who showed the decline expected from natural history studies. Paired changes in NAA/CR ratio differed significantly between both patients treated with COPAXONE® (+0.14, n=11) compared to those treated with placebo (-0.33, n=9, p=0.03) at one year, and the change maintained at two years (COPAXONE® n=6, +0.17; placebo n=3, -0.23, p=0.15).

Previously announced PreCISe studies included:

"Treatment with glatiramer acetate reduces MRI-detectable disease activity in patients at presentation with CIS suggestive of MS"

* Demonstrated that early treatment with COPAXONE® is effective in both delaying time to conversion to CDMS and reducing MRI activity in patients presenting with CIS


"Treatment with glatiramer acetate delays conversion to CDMS in patients with CIS: subgroup analyses"

* Demonstrated that COPAXONE® treatment effect was robust among the PreCISe study population (n=481) as a whole ,as well as in subgroups of patients (broken down by gender, age and type of unifocal manifestation and steroid treatment for the initial attack, and MRI findings at study baseline)



About COPAXONE®
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 51 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. COPAXONE® is a registered trademark of Teva Pharmaceutical Industries Ltd.

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 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 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 successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us 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® , Neurontin®, Lotrel® and Protonix®, 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, our ability to successfully identify, consummate and integrate acquisitions, including the pending acquisition of Barr Pharmaceuticals Inc., 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 this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").



Company Contacts:
Company Contacts:
Elana Holzman
Kevin Mannix

Teva Pharmaceutical Industries Ltd.
Teva North America

972 (3) 926-7554
(215) 591-8912

Biogen Idec MS pill found to slow damage




Bloomberg News / September 19, 2008


NEW YORK - Biogen Idec Inc.'s experimental pill to treat multiple sclerosis prevented brain lesions associated with the disease from getting worse, a study found.

The pill, called BG-12, reduced the conversion of new spots of inflammation into permanent damage in a trial of 56 patients, Biogen said yesterday at the World Congress on Treatment and Research in Multiple Sclerosis in Montreal.

In MS, neurons are stripped of an insulating coating known as myelin by the immune system, causing the cells to malfunction. That leads to MS symptoms such as muscle weakness and loss of coordination, according to the Mayo Clinic. Biogen has received approval from US regulators to speed the review process for its pill, the company said yesterday. If cleared for sale in the United States, BG-12 could be the first oral medication for MS patients to reach the market.

"There are two elements: You want to keep the lesions from forming in the first place and then, even if a lesion developed, you want to know the damage is reduced, and that's what you're seeing," said Mike Panzara, the chief medical officer for Cambridge, Mass.-based Biogen in a telephone interview yesterday. "Even if a lesion does develop on BG-12, injury is less because it's less often the lesions become permanent."

About 29 percent of the lesions in the brains of patients on BG-12 turned into signs of permanent damage, compared with 44 percent of those in the placebo group, the study showed.

The company began final-stage testing on BG-12 in January. The trials, on more than 2,000 patients with a recurring form of the disease, will last two years. The drug is being compared with a placebo and with Teva Pharmaceutical Industries' Copaxone, an approved treatment for the disease.

Biogen Idec sells the MS drugs Avonex, which is given as a once-a-week injection, and Tysabri, an infusion given once a month in a doctor's office or hospital clinic. About 1 million people worldwide suffer from MS.

© Copyright 2008 Globe Newspaper Company.