WESTON, Mass. & DUBLIN–(EON: Enhanced Online News)–Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced findings from several studies of TYSABRI® (natalizumab) evaluating its long-term safety and efficacy in the treatment of multiple sclerosis (MS) across the course of disease and impact on MS-related symptoms such as fatigue. These data, as well as data relating to the companies’ risk stratification algorithm as a way to help enable individual benefit risk assessment for patients with MS, were accepted for presentation at the 64th Annual Meeting of the American Academy of Neurology (AAN).

“TOP may help provide insight into the potential impact current treatment may have on long term efficacy and safety outcomes with TYSABRI”

“We continue to build on the extensive data we have for TYSABRI and are committed to studying its long-term use and potential effect on symptoms like fatigue, which MS patients struggle with every day,” said Douglas E. Williams, Ph.D., executive vice president of Research and Development at Biogen Idec. “Our research is aimed at discovering additional ways TYSABRI can help physicians and patients best manage the symptoms of MS and make informed and personalized treatment choices.”

Long-Term Observational Study of TYSABRI

Initial results from the TYSABRI Observational Program (TOP) indicate that post-baseline annualized relapse rates (ARR) after four years for patients receiving TYSABRI therapy decreased from 1.99 at baseline to 0.28 (p<0.0001); disability, as measured by the Expanded Disability Status Scale (EDSS), remained stable over time. TOP is an ongoing open-label, multicenter, observational study designed to assess long-term outcomes in patients with relapsing-remitting MS (RRMS) in Europe, Australia, and Canada. TOP is expected to enroll more than 4,500 patients who will be followed for 10 years.

neither reduction in ARR nor stabilization of a patient’s EDSS was affected by the type of treatment they were using before initiating TYSABRI therapy. however, ARR were lowest in immunosuppressant (IS) therapy-naïve patients and highest in patients who had used IS therapy (p<0.0001).

The incidence and type of serious adverse events (SAEs) seen in these patients after long-term use was consistent with TYSABRI’s known safety profile. There were no significant differences by baseline treatment history in the incidence of SAEs, infection-related SAEs, or progressive multifocal leukoencephalopathy (PML) during TYSABRI therapy, although there was a trend of higher incidence of PML in patients with prior IS use.

“TOP may help provide insight into the potential impact current treatment may have on long term efficacy and safety outcomes with TYSABRI,” said Professor Ludwig Kappos, MD, chair of Neurology, Research Group Leader Clinical Neuroimmunology and Neurobiology, Department of Biomedicine, University Hospital, Basel, Switzerland. “The reduction of MS relapse and stable disability progression that we observed with TYSABRI in the TOP study across naive and previously treated patients was sustained after four years of treatment.”

Risk-Stratification Initiatives

Biogen Idec and Elan developed a quantitative risk stratification algorithm to help physicians and people with MS have more confidence in their treatment decisions when considering TYSABRI. The algorithm provides guidance for physicians and patients about the varying degrees of PML risk associated with TYSABRI treatment. The variables impacting PML risk are: anti-JCV antibody status, prior IS use, and TYSABRI treatment duration.

“We are pleased to be able to offer MS patients and their physicians an approach for assessing the potential benefit-risk with TYSABRI,” said Ted Yednock, executive vice president and head of Global Research, Elan. “A significant advancement in this area is the inclusion of anti-JCV antibody status in the TYSABRI label as a risk factor for developing PML, as well as the commercial availability of the STRATIFY JCV™ blood test. use of this approach for risk stratification is supported by data presented at AAN.”

PML risk was quantified by assessing more than 92,000 MS patients from TYSABRI post-marketing sources and clinical studies; through September 2011 there were 159 cases of PML among this patient population and data show PML risk was lowest in anti-JCV antibody negative patients (no PML cases occurred in anti-JCV antibody negative patients; with the inclusion of one hypothetical anti-JCV antibody negative case, the risk is ?0.10 cases per 1,000 patients treated). PML risk was highest in patients with all three risk factors: anti-JCV antibody positive status; prior immunosuppressant use; and 25-48 months of TYSABRI treatment (10.6 cases per 1,000 patients treated). The use of anti-JCV antibody status in this algorithm marks the first time a safety biomarker for risk stratification has been used to inform treatment decisions in MS and these data will be updated during the AAN presentation.

a separate study, STRATIFY-2, an ongoing, longitudinal, observational U.S. study, is the largest data set to date to analyze anti-JCV antibody seroprevalence among MS patients. Baseline anti-JCV antibody testing results from more than 35,000 MS patients who were either receiving or considering treatment with TYSABRI showed that the overall prevalence of anti-JCV antibodies was 53.5 percent (95% confidence interval [CI]: 53.0%–54.0%), which is consistent with the prevalence of anti-JCV antibodies observed in MS patients in other clinical research. Interim results from STRATIFY-2 demonstrated prospectively that the PML incidence in TYSABRI-treated anti-JCV antibody negative patients was significantly lower than that in anti-JCV antibody positive patients (anti-JCV negative = 0, CI: 0–0.34; anti-JCV positive=1.02, CI: 0.53–1.78 [p=0.0004]). Final data from STRATIFY-2 will further characterize PML risk in anti-JCV antibody negative and positive patients.

TYSABRI Impact on MS-related Fatigue

Initial findings from the TYNERGY study (Effects of TYSABRI Over 12 Months on MS Related Fatigue in Patients with RRMS) show that TYSABRI treatment was associated with improved MS-related fatigue. TYNERGY was a multicenter, 12-month clinical follow-up study conducted to evaluate the effect of TYSABRI on MS-related fatigue in patients with RRMS. Fatigue is considered the most common symptom of MS, impacting 75-95 percent of patients. Further, 50-60 percent of MS patients report fatigue as one of their most disabling symptoms, which can contribute to cognitive and physical difficulties.

in the study, researchers measured MS-related fatigue at 0 and 12 months via the Fatigue Scale for Motor and Cognitive Functions (FSMC). Results indicate that treatment with TYSABRI impacted fatigue in patients with RRMS as evidenced by a median reduction of the FSMC score by 9.0 points (p<0.0001), which corresponds to an improvement from severe to moderate fatigue. Both the motor and the cognitive components of the FSMC showed similar improvement (p<0.0001). Researchers noted that these first results are promising but need further validation.

Data highlighted in this press release is featured in the following poster and platform presentations at the AAN annual meeting:

• Long-Term Safety and Efficacy and Association between Baseline Treatment History and Postbaseline Relapses in Multiple Sclerosis Patients Treated with Natalizumab in the TYSABRI Observational Program (TOP) (P04.134) was presented on Wednesday, April 25, 2012
• Updated Incidence of Progressive Multifocal Leukoencephalopathy in Natalizumab-Treated Multiple Sclerosis Patients Stratified by Established Risk Factors (S41.001) –presented by Dr. Gary Bloomgren on Thursday, April 26, 2012 from 1:00 to 1:15 p.m. CDT
• Anti-JCV Antibody Prevalence in Patients with Relapsing Multiple Sclerosis Receiving or considering Treatment with Natalizumab: Baseline Results of STRATIFY-2 (S41.002) – presented by Dr. Sandra Richman on Thursday, April 26, 2012 from 1:15 to 1:30 p.m. CDT
• Natalizumab Reduces Fatigue as Measured by the Fatigue Scale for Motor and Cognitive Functions (FSMC)—First Results from the TYNERGY trial (P07.081) – available for viewing on Thursday, April 26, 2012 from 2:00 to 6:30 p.m. CDT

Full session details and additional TYSABRI data presentation listings for the 2012 AAN Annual Meeting can be found through the AAN website (aan.com/go/am12).

About TYSABRI

TYSABRI is approved in more than 65 countries. TYSABRI is approved in the United States as a monotherapy for relapsing forms of MS, generally for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy. in the European Union, it is approved for highly active relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferon or have rapidly evolving, severe RRMS.

TYSABRI has advanced the treatment of MS patients with its established efficacy. Data from the Phase 3 AFFIRM trial, which was published in the New England Journal of Medicine, showed that after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42-54 percent (p<0.001).

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain, which usually leads to death or severe disability. Infection by the JC virus (JCV) is required for the development of PML and patients who are anti-JCV antibody positive have a higher risk of developing PML. Factors that increase the risk of PML are presence of anti-JCV antibodies, prior immunosuppressant use, and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in the post-marketing setting. a list of adverse events can be found in the full TYSABRI product labeling for each country where it is approved.

TYSABRI is marketed and distributed by Biogen Idec Inc. and Elan Corporation, plc. for full prescribing information, including boxed warning and important safety information, and more information about TYSABRI, please visit biogenidec.com or elan.com.

About Biogen Idec

Biogen Idec uses cutting-edge science to discover, develop, manufacture and market therapies for serious diseases with a focus on neurology, immunology and hemophilia. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies and the company generates more than $4 billion in annual revenues. for product labeling, press releases and additional information about the company, please visit biogenidec.com.

About Elan

Elan Corporation, plc is a neuroscience-focused 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 and Irish Stock Exchanges. for additional information about Elan, please visit elan.com.

# # #

GW Pharmaceuticals plc

Phase III data on efficacy and tolerability of Sativex? in MS spasticity presented at ECTRIMS

Porton down, UK; 24 October 2011: GW Pharmaceuticals plc (AIM:GWP) is pleased to note the announcement by Almirall, S.A. reporting data from three Phase III trials involving over 1,500 MS patients as well as first everyday clinical practice data were presented by a panel of international experts at the European Congress of Multiple Sclerosis (ECTRIMS) in Amsterdam

The full text of the announcement by Almirall S.A. follows.

full Phase III data highlight the efficacy and tolerability of Sativex? as therapy for the treatment of spasticity in MS

?      Data from three Phase III trials involving over 1,500 MS patients as well as first everyday clinical practice data were presented by a panel of international experts at the European Congress of Multiple Sclerosis (ECTRIMS) in Amsterdam

?      Almirall announces sponsorship of two post-graduate clinical research projects

Barcelona, 24th October 2011 -Almirall, S.A. (ALM:MC) presented full results from three Phase III studies with Sativex?, in a satellite symposium at the 27th ECTRIMS congress,which took place in Amsterdam from 19th to 22nd October 2011.

These Phase III studies provide evidence of the long term efficacy of Sativex? (2.7 mg delta-9-tetrahydrocannabinol and 2.5 mg cannabidiol per puff) in symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. These data have led to the approval of this first-in-class medication in the UK, Spain, Denmark, Germany and Czech Republic, with additional countries expected to grant approvals in the near future. (1, 2, 3)

Professor H.P. Hartung, Chair of Neurology at Heinrich-Heine University, Dusseldorf, Germany and Chairman of the satellite symposium, commented: "Sativex? has proven to reduce the severity of symptoms and improve patients' quality of life and functional status, in patients with spasticity in multiple sclerosis, meaning that they can undertake everyday tasks more easily. Also, importantly, clinical experience to date has demonstrated that the tolerability profile of this medicine is favourable, with limited relevant adverse effects and – particularly reassuring – the drug does not appear to lead to withdrawal effects if patients suddenly stop using it."

"The Sativex? data show this is a unique opportunity to help patients with MS spasticity, a clearly underserved indication. We believe Sativex? will offer a new way to help the patients with MS spasticity", said Bertil Lindmark, Chief Scientific Officer at Almirall.

Professor Xavier Montalb?n, Director of the Multiple Sclerosis Center of Catalunya and the Unit of Clinical Neuroimmunology, Vall d?Hebron University Hospital, Barcelona, also announced the award of 2 post-graduate clinical research grants by Almirall, aimed at fostering clinical research in multiple sclerosis spasticity across Europe. The project selection board is comprised of Professor Montalb?n, who will provide guidance on the development of project proposals, Professor Hartung and Almirall's global Medical Affairs Department. The resulting projects will be developed in 2012, and results will be published by authors in Q2 2013.

Sativex? has been developed by the UK-based company GW Pharmaceuticals plc and is marketed in Europe (except the UK) by Almirall, S.A.

Almirall PR / Emanate

+44 (0)20 7611 3881

fiona.gildea@emanatepr.com ,

Notes to Editors

Sativex? is a first-in-class endocannabinoid system modulator and is indicated as treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication (4) and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. (4)

The main active ingredients, delta-9 tetrahydrocannabinol (THC) and cannabidiol (CBD), are extracted from selected chemotypes of Cannabis Sativa. Sativex? is administered as a mouth spray, which provides optimal delivery of the active ingredients and allows for dosing flexibility in order to enable each individual patient to manage the variable nature of their spasticity.

Sativex? is manufactured through a controlled series of processes resulting in a reproducible finished product manufactured to good Manufacturing Standards. Each 100 microlitre spray contains 2.7 mg THC and 2.5 mg CBD. The formulation also contains other cannabinoids, terpenoids and flavonoids at standardized doses, which contribute to the uniqueness of the medicine. Sativex? was developed by UK-based GW Pharmaceuticals plc.

Sativex? is a registered trade mark of GW Pharmaceuticals plc and GW Pharmaceuticals plc is the Marketing Authorisation holder for Sativex?. Manufactured by GW Pharmaceuticals under Home Office licence, Sativex? is marketed in Europe (except the UK) by Almirall, S.A.

there are almost 500,000 people suffering of MS in the top five EU countries. (5)  Spasticity is a symptom defined by patients and carers as muscle spasms, stiffness, rigidity and/or difficulty to move, and is one of the most common symptoms of MS, occurring in as many as 75% of people with MS. Spasticity can affect many aspects of MS patients' daily life, and is a major contributor to their distress and disability. (6)

Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, it researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people's health and wellbeing.   

Almirall focuses its research resources on therapeutic areas related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and other dermatological conditions.

Almirall's products are currently present in over 70 countries while it has direct presence in Europe and Latin America through 12 affiliates.

1              Collin C, Davies P, Mutiboko IK, et al.Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. Eur J Neurol 2007;14:290-296.

2              Collin C et al. A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. Neurol Res 2010 ;32:451-459.

3              Ambler Z, Davies P, Gasperini C, et al. A two-phase study of Sativex in the relief of spasticity due to multiple sclerosis: Phase A single-blind response assessment followed by Phase B double-blind randomized, placebo-controlled, parallel-group study. Mult Scler 2009;15:S258.

4              Sativex? Summary of Product Characteristics, 2011.

, 16/06/2010. top five EU countries include: France, Germany, Italy, Spain and UK.

6              Rizzo MA Hadjimichael OC, Preiningerova J, et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler 2004; 10:589-595.

Copyright ©2010. the Associated Press. Produced by NewsOK.com all rights reserved. this material may not be published, broadcast, rewritten, or redistributed.  

For the patient with sudden dizziness, inability to walk, slurred speech or the host of other puzzling multiple sclerosis symptoms, a new clinic may offer reason to celebrate.

Officials Tuesday announced the upcoming opening of the OMRF Multiple Sclerosis Center of Excellence to be in the Oklahoma Medical Research Foundation’s new research tower.

“It is a humongous day. It is basically awesome,” said Dr. Gabriel Pardo, a nationally recognized MS researcher and the new center’s director. “What we’re going to be able to achieve here is completely unique.”

Along with diagnosing and treating MS patients, the center’s physician-scientists will conduct clinical and laboratory research on MS. the inflammatory, degenerative disease of the central nervous system affects about 400,000 Americans. about 3,400 Oklahomans are self-identified as having an MS diagnosis, though the number is believed to be at least 4,200.

Pardo said he is excited about the planned March 15 move to the new clinic at OMRF, 825 NE 13.

“Ultimately, we have the goal of curing multiple sclerosis. the complexity of the disease is very, very big. That’s why it will take the approach that we are going to embark on here,” Pardo said.

The new center will allow doctors to treat MS patients at bedside, consult with each other and MS researchers inside the clinic, study how the disease works in patients and ultimately apply what they’ve learned to improve the lives of multiple sclerosis patients everywhere.

The center will feature rooms and equipment dedicated to MS evaluation and treatment. these include high-tech examining rooms, a tower infusion suite, ophthalmological and dental facilities, MS-dedicated physical therapy and computerized testing of the brain.

MS patients also will have the chance to participate in clinical trials so they can use experimental therapies and contribute to the understanding of the disease.

MS patient Lucy Fraser said patients and their loved ones have waited for this and now have reason to celebrate. the Oklahoma City woman was diagnosed 15 years ago, after years of strange symptoms — from leg numbness to arm numbness to vertigo — coming and going during the course of the disease.

She was finally diagnosed and eventually found her way to Pardo’s offices at the Neuroscience Institute at Mercy, where he will serve as the medical director of the MS Center of Oklahoma until he moves to OMRF. Fraser, who has since taken a job with the National MS Society, said she was initially hesitant to become one of his patients because he had 800 patients at the time, though it was a fraction of the 2,000 he now sees.

Pardo, an internationally recognized neurologist and neuro-ophthalmologist, impressed her so much she choked up in telling it. she overheard him telling a doctor, “When I was with the university (U.M. Nueva Granada, Bogota), I fell in love with MS.”

Along with Pardo, Dr. Farhat Husain also will join the center’s medical staff. Husain is a neurologist who currently treats more than 300 MS patients through Southwest Neurological Associates in Oklahoma City.

Fraser said the potential is significant because the doctors, scientists, physician assistants, physical therapists and other MS personnel are within arm’s reach of patients and the research laboratories.

“We really do feel like there is a cure out there. It is so exciting to know that now that OMRF is joining the fight, it’s going to move faster,” Fraser said.

Edmond MS patient Lori Evans said it’s amazing how important the new clinic is to MS patients.

“That is unbelievable. all these clinical trials will hopefully lead to a cure and a way to regenerate the nerves of people like myself,” she said.

After the March move-in, the OMRF Multiple Sclerosis center will ultimately take up three floors in its seven-floor research tower home. Supported by private donors and grants from the state and the federal government, the tower is believed to be the first medical facility anywhere that will harness the wind to help power its labs.

The tower is the biggest expansion project in the 64-year history of Oklahoma Medical Research Foundation, increasing the 50 principal investigators and roughly 500 employees to 80 investigators and 800 employees.

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A new scientific article has been published demonstrating the profound impact of spasticity on patients with multiple sclerosis and the benefits and underutilization of intrathecal baclofen (ITB) therapy from Medtronic, inc. (NYSE: MDT) as a treatment option for these patients. the paper, published this week as an OnlineFirst article in Multiple Sclerosis Journal,recommends physician evaluation of ITB therapy as a treatment option for patients at all clinical stages of MS who are intolerant of or unresponsive to oral spasticity therapies.

“Severe spasticity is a debilitating condition that can have a negative impact on quality of life of patients with MS. while oral medications work to treat spasticity in some individuals, I see patients every day who can’t tolerate the side effects of large doses of medication necessary to treat the most severe cases,” said Mary Hughes, M.D., one of the article’s authors and chair, Division of Neurology, University Medical Group, Greenville Hospital System University Medical Center in Greenville, S.C. “The strong collection of clinical results on the use of ITB therapy in MS patients points to a clear need for physicians to help MS patients control their spasticity and restore quality of life with options like ITB therapy, which is safe and effective in carefully selected patients.”

The expert panel of authors, including leading MS clinicians from the United States and Europe, combined has more than 100 years of experience in MS management and has treated more than 1,500 MS patients worldwide. the article includes a review of literature on ITB therapy for spasticity in MS and provides expert opinion of the panel regarding patient selection and management of ITB therapy in MS patients. Medtronic sponsored the panel’s meeting and paper development.

According to survey results within the research summary, 84 percent of patients with MS reported at least some symptoms of spasticity, with 30 percent reporting moderate to severe symptoms. Of the 13 percent of MS patients who may be candidates for ITB therapy, only 1 percent of patients stated they were receiving the therapy. however, current data indicate that ITB therapy effectively and significantly reduces severe spasticity in ambulatory and non-ambulatory patients with MS.

The expert panel noted that the main barrier to the use of ITB therapy is that many physicians do not present ITB as a therapeutic option that is safe, effective and well-tolerated. this often occurs due to a lack of physician understanding of quality of life issues caused by spasticity, potential ITB benefits and appropriate patient selection, as well as their focus on disease-modifying therapies rather than symptom control.

“This article is a very powerful analysis of the need for greater consideration of ITB therapy by clinicians who manage MS,” said Tom Tefft, senior vice president and president of the Neuromodulation business at Medtronic. “We are hopeful that this paper will encourage more physicians to offer the therapy to appropriate patients.”

About Multiple Sclerosis and Spasticity

Approximately 300,000 Americans have MS, a chronic, often disabling disease of the central nervous system. Symptoms may include abnormal fatigue, impaired vision, loss of balance and muscle coordination, slurred speech, tremors, spasticity, bladder and bowel problems, difficulty walking, short-term memory loss, mood swings, and, in severe cases, partial or complete paralysis. Spasticity can occur when the part of the brain that controls voluntary movements is damaged or injured and results in tight, stiff muscles. In addition to being one possible symptom of MS, spasticity also can be a symptom of cerebral palsy, brain injury, spinal cord injury or stroke. for some people, the condition is so severe that it is impossible to voluntarily relax muscles.

About ITB Therapy

Medtronic ITB Therapy using the SynchroMed® II pump is the first and only fully programmable implantable drug pump available in the United States to treat severe spasticity. first approved in the United States in 1992, ITB is a complete drug delivery solution to optimize spasticity treatment and maximize function. the therapy delivers a baclofen injection directly to the intrathecal space where fluid flows around the spinal cord in patients with severe spasticity. more information is available at medtronic.com/your-health/severe-spasticity/about/index.htm

About Medtronic

Medtronic, inc. (medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Business Wirebusinesswire.com/

Last updated on: 05/02/2011 08:00:02

Expert Panel Publishes Findings on Benefits of UnderutilizedIntrathecal Baclofen Therapy for Severe Spasticity in MultipleSclerosis Patients

Consensus Paper Suggests Medtronic ITB Therapy is an EffectiveTreatment for Control of Severe Spasticity, a Frequent andDisabling Symptom of MS

MINNEAPOLIS–(BUSINESS WIRE)–A new scientific article has beenpublished demonstrating the profound impact of spasticity onpatients with multiple sclerosis and the benefits andunderutilization of intrathecal baclofen (ITB) therapy fromMedtronic, Inc. (NYSE: MDT) as a treatment option for thesepatients. The paper, published this week as an OnlineFirst articlein Multiple Sclerosis Journal, recommends physician evaluation ofITB therapy as a treatment option for patients at all clinicalstages of MS who are intolerant of or unresponsive to oralspasticity therapies.

“Severe spasticity is a debilitating condition that canhave a negative impact on quality of life of patients with MS.While oral medications work to treat spasticity in someindividuals, I see patients every day who can’t tolerate theside effects of large doses of medication necessary to treat themost severe cases,” said Mary Hughes, M.D., one of thearticle’s authors and chair, Division of Neurology,University Medical Group, Greenville Hospital system UniversityMedical Center in Greenville, S.C. “The strong collection ofclinical results on the use of ITB therapy in MS patients points toa clear need for physicians to help MS patients control theirspasticity and restore quality of life with options like ITBtherapy, which is safe and effective in carefully selectedpatients.”

The expert panel of authors, including leading MS cliniciansfrom the United States and Europe, combined has more than 100 yearsof experience in MS management and has treated more than 1,500 MSpatients worldwide. The article includes a review of literature onITB therapy for spasticity in MS and provides expert opinion of thepanel regarding patient selection and management of ITB therapy inMS patients. Medtronic sponsored the panel’s meeting andpaper development.

According to survey results within the research summary, 84percent of patients with MS reported at least some symptoms ofspasticity, with 30 percent reporting moderate to severe symptoms.Of the 13 percent of MS patients who may be candidates for ITBtherapy, only 1 percent of patients stated they were receiving thetherapy. however, current data indicate that ITB therapyeffectively and significantly reduces severe spasticity inambulatory and non-ambulatory patients with MS.

The expert panel noted that the main barrier to the use of ITBtherapy is that many physicians do not present ITB as a therapeuticoption that is safe, effective and well-tolerated. this oftenoccurs due to a lack of physician understanding of quality of lifeissues caused by spasticity, potential ITB benefits and appropriatepatient selection, as well as their focus on disease-modifyingtherapies rather than symptom control.

“this article is a very powerful analysis of the need forgreater consideration of ITB therapy by clinicians who manageMS,” said Tom Tefft, senior vice president and president ofthe Neuromodulation business at Medtronic. “We are hopefulthat this paper will encourage more physicians to offer the therapyto appropriate patients.”

About Multiple Sclerosis and Spasticity

Approximately 300,000 Americans have MS, a chronic, oftendisabling disease of the central nervous system. Symptoms mayinclude abnormal fatigue, impaired vision, loss of balance andmuscle coordination, slurred speech, tremors, spasticity, bladderand bowel problems, difficulty walking, short-term memory loss,mood swings, and, in severe cases, partial or complete paralysis.Spasticity can occur when the part of the brain that controlsvoluntary movements is damaged or injured and results in tight,stiff muscles. in addition to being one possible symptom of MS,spasticity also can be a symptom of cerebral palsy, brain injury,spinal cord injury or stroke. For some people, the condition is sosevere that it is impossible to voluntarily relax muscles.

Medtronic ITB Therapy using the SynchroMed® II pump is thefirst and only fully programmable implantable drug pump availablein the United States to treat severe spasticity. First approved inthe United States in 1992, ITB is a complete drug delivery solutionto optimize spasticity treatment and maximize function. The therapydelivers a baclofen injection directly to the intrathecal spacewhere fluid flows around the spinal cord in patients with severespasticity. More information is available atmedtronic.com/your-health/severe-spasticity/about/index.htm.

Medtronic, Inc. (medtronic.com), headquartered inMinneapolis, is the global leader in medical technology -alleviating pain, restoring health, and extending life for millionsof people around the world.

Any forward-looking statements are subject to risks anduncertainties such as those described in Medtronic’s periodicreports on file with the Securities and Exchange Commission. Actualresults may differ materially from anticipated results.

Donna Marquard, 763-526-6248

Jeff Warren, 763-505-2696

Amber Dukes | Senior Account Executive|GCI Health

p.404.260.3561|c.828.217.1253

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Visit our new website at gcihealth.com

Posted: February 2011

Newswise — Multiple sclerosis (MS) can cause significant physical impairment, including fatigue, pain, muscle spasms, tremors and dizziness. for many with MS, the disease wreaks havoc with emotional well-being, too, and according to a new study, minorities might especially be at risk for developing depressive symptoms. Of study participants with the neurological condition, 44.2 percent of Latinos and 45.8 percent of African-Americans reported at least mild depression, compared with 38.7 percent of whites with MS. However, more Latinos never received mental health care, compared to whites or African-Americans with MS, according to lead study author Robert Buchanan, Ph.D.

Buchan is a professor in the department of political science and public administration at Mississippi State University. for the study in the December 2010 issue of the journal Ethnicity & Disease, authors used data from a registry of 26,967 white, 715 Latino and 1,313 African- American MS patients.

“Depression is even more common in people with MS,” said Staley Brod, M.D., director of the Multiple Sclerosis Research Group Clinic at the University of Texas-Houston. “In general it is a treatable problem and, in most cases, the neurologist that’s seeing the patient can deal with it effectively,” he said.

However, compared to African-Americans and whites, Latinos were significantly less likely to get mental health services, obtain medical care from a specialist or receive occupational therapy or home health care assistance.

“A surprising finding to me is that despite these inequities in mental health, rehabilitation and other medical subspecialties, there’s no disparity in treatment,” Brod said. Similar percentages of whites, Latinos and African-Americans received multiple sclerosis therapies, called disease-modifying therapies, which treat flares and prevent symptoms.

In terms of functioning and disability levels, Latinos with MS fared better than other ethnic groups, the study reported. more Latinos reported normal function for mobility, bladder and bowel function and vision, compared to whites and African-Americans.

Buchanan said that because the study results rely on the responses of voluntary participants, not a random data sample, the applicability of the findings to the larger MS population might be limited.

The National Multiple Sclerosis Society provided funding for the study.

TERMS OF USE: this story is protected by copyright. when reproducing any material, including interview excerpts, attribution to the Health Behavior News Service, part of the Center for Advancing Health, is required.

Ethnicity & Disease is a quarterly medical journal studying the ethnic patterns of disease. for more information, contact or visit ishib.org/ED_index.asp.

Buchanan, RJ, et al. Comparisons of Latinos, African Americans, and Caucasians with multiple sclerosis. Ethnicity Dis 20(4), 2010.

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