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CHAMPIONS TACKLING MS - AWARDS Dinner, Honoring Aaron Boster, MD and Jon e. Glaser, DDS - now open for registration. Visit www.events.msvn.org

Saturday, March 17, 2012

UK MS News Update: Cost body backs Novartis MS pill in about-turn


LONDON (Reuters) - Novartis's multiple sclerosis pill Gilenya, one of its top new drug hopes, has been recommended for use in the state health service after a change of heart by the country's healthcare cost-effectiveness watchdog.
Friday's verdict from the National Institute for Health and Clinical Excellence (NICE), whose opinions are also watched closely in other countries, is welcome news for a product that has run into problems recently.
Later on Friday, the European Medicines Agency (EMA) - the body responsible for licensing Gilenya in Europe in March 2011 - is expected to give an update on the safety of the medicine, following an in-depth review.
The safety probe was launched because of reports of heart problems in some patients and the death of one person in the United States within 24 hours of starting treatment.
Gilenya represents a significant change in multiple sclerosis (MS) treatment, since existing drugs such as beta interferons and Elan and Biogen Idec's Tysabri must be injected.
NICE initially said it was unclear if the new drug, which is known generically as fingolimod, was any better than existing treatments.
It changed its mind after Novartis presented data showing the benefits of using Gilenya in a subgroup of adults with highly active disease, whose relapses had increased or stayed the same compared with the previous year despite them taking beta interferons.
Carole Longson, director of NICE's health technology evaluation centre, said it was now clear that Gilenya was a cost-effective option for these patients, provided Novartis supplied the drug at the discounted price it previously suggested.
A NICE spokeswoman said the size of the discount remained confidential. The list price for 28 capsules is 1,470 pounds ($2,300) or just over 19,000 pounds per person for a year.
Novartis and Britain's MS Society welcomed the final NICE decision, which is expected to be officially published next month.
Gilenya's convenient dosing and encouraging results in clinical trials are widely expected to make it a popular alternative to current injections.
The average forecast from analysts suggests global sales will reach $2 billion a year by 2015, according to Thomson Reuters Pharma.
Gilenya is the first MS pill of its kind, but competitors in development include BG-12 from Biogen, teriflunomide from Sanofi and laquinimod from Teva.
(Editing by David Holmes)
 


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Friday, March 16, 2012

Back on Track: Phase III Study of Teva's Oral Laquinimod Published in the New England Journal of Medicine Demonstrates Clinical Benefits for Multiple Sclerosis Patients


March 15, 2012

Phase III ALLEGRO study results showed laquinimod reduced the annual rate of relapses, slowed the progression of disability, and decreased brain tissue loss 

Laquinimod was associated with favorable safety and tolerability profile 

European Union (EU) regulatory submission planned in H2 2012

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced the publication of results from the laquinimod Phase III ALLEGRO study in the March 15 issue of The New England Journal of Medicine (http://www.nejm.org/).Data from the two-year study showed that oral once-daily laquinimod reduced inflammatory disease activity as measured by clinical relapses and Magnetic Resonance Imaging (MRI), slowed disability progression and decreased brain tissue loss, while maintaining a favorable safety and tolerability profile in patients with relapsing-remitting multiple sclerosis (RRMS). 
 
"The positive findings from ALLEGRO provided evidence that laquinimod represents a unique approach in the treatment of multiple sclerosis - one that offers relapse management along with a significant reduction in the key outcome measures correlated to irreversible nervous tissue damage," said Principal Investigator, Professor Giancarlo Comi, Director of the Department of Neurology and Institute of Experimental Neurology at the San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Italy. "We are pleased to have the results published in The New England Journal of Medicine."
The ALLEGRO results, along with results from the second global Phase III study of laquinimod, BRAVO, will be included in the application for regulatory approval planned for submission to the European Medicines Agency (EMA) in the second half of this year.
"The publication of the ALLEGRO results in a prestigious peer-reviewed journal is an important landmark as we continue to research and develop laquinimod," said Lesley Russell, Senior Vice President of R&D, Teva Global Branded Products. "We look forward to continuing to work with regulatory authorities in both the EU and the U.S. to bring this novel therapy to the MS community."


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NICE: fingolimod gets the thumbs up in the UK


In its final draft guidance, out today (16 March), NICE, has recommended fingolimod, to help reduce the number of relapses for some MS'ers with highly-active MS. This positive recommendation is a change from NICE's previous draft guidance from December and follows a public consultation during which the manufacturer (Novartis) and clinicians provided additional information and analyses.
" This is very good news and a big relief for all of us who work in the MS field in the UK. If fingolimod was turned down by NICE the implications for other drugs coming through the pipeline, in the future, would have been very dire. At last we now have something to offer MS'ers with highly-active MS in parallel with Natalizumab. In addition, we can now offer MS'ers on natalizumab at high risk of PML the option of switching. MS'ers must be aware that fingolimod comes with its own list of issues; no decision is going to be simple and straightforward."

Information source for this article is from: Multiple-Sclerosis-Research





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2012 MSAA Art Showcase


MSAA is proud to present our 2012 Art Showcase for People Living with Multiple Sclerosis. The theme this year isChange - a reflection on what has been a positive change in your life and experiences. 

We received 83 works of art submitted by 39 artists living with MS throughout the country. We are delighted to be able to present to you this artwork and we hope that you too are inspired. Enjoy! View The 2012 Showcase
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Myelin Repair Foundation appointed Dr. Alfred Sandrock, Chief Medical Officer from Biogen Idec to our Clinical Advisory Board


 
We are very pleased to announce that this week the Myelin Repair Foundation appointed Dr. Alfred Sandrock, Chief Medical Officer from Biogen Idec to our Clinical Advisory Board (CAB). As the quintessential expert on developing drugs for multiple sclerosis, Dr. Sandrock joins MRF's mission to accelerate the drug discovery process for a multiple sclerosis cure.

The Myelin Repair Foundation established the CAB to accelerate the clinical development phase of our research plan, in order to achieve our first clinical trial for myelin repair in 2014. Dr. Sandrock will serve alongside fellow board members Dr. Peter Calabresi, Dr. Roland Martin, Dr. Daniel Reich, Dr. Scott Zamvil and CAB chair Dr. Henry McFarland.

You may read the full press release here, or learn more about MRF's recent research breakthroughs by visiting our website at www.myelinrepair.org.

Best regards,
Myelin Repair Foundation Staff



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Though scientists haven't figured out a way to prevent MS, there are some things you may be able to do to reduce your risk


Medically reviewed by Cynthia Haines, MD
 

More than 400,000 people in the United States have multiple sclerosis, and someone gets newly diagnosed every hour, according to the National MS Society. But could these MS patients have done anything to prevent the chronic autoimmune disease?
Based on what experts know about MS, the answer is no — or at least not yet. One reason effective prevention measures have yet to be developed is that the cause of multiple sclerosis is still not fully understood.
Researchers believe that a combination of factors, both genetic and environmental, contribute to the development of multiple sclerosis.
Understanding Factors Involved in Multiple Sclerosis: Reducing Your Risk
There are a number of key factors that seem to be related to developing multiple sclerosis. They include:
Genetics
Hereditary propensities that come from your family appear to be a factor in multiple sclerosis risk. Tanuja Chitnis, MD, assistant professor of neurology and director of the Partners Pediatric MS Center at Massachusetts General Hospital for Children, says that in studies of identical twins, about 25 percent of people who have an identical twin with multiple sclerosis end up developing MS themselves. Dr. Chitnis also says that the incidence of MS in the general population is 1 in 100,000 people, compared with a 3 to 5 percent incidence in people with a first-degree relative with MS (a sibling, parent, or child). Although you can't change the family you're born into, eventually experts hope to learn enough about what causes MS to be able to tell people with a family history of MS what they can do to decrease their risk of developing the condition.
Viruses
The Epstein-Barr virus (EBV), a member of the herpes family of viruses, has been linked to MS, but has not conclusively been identified as a cause of multiple sclerosis. EBV is extremely common; the U.S. Centers for Disease Control and Prevention (CDC) reports that 95 percent of people in the United States between the ages of 35 and 40 have had this virus at some point in their lives. In children, it looks just like the common cold; in adolescents, it can develop into mononucleosis.
It is impossible to entirely avoid exposure to a virus this widespread without completely withdrawing from society. However, avoiding contact with people who are sick and washing your hands frequently during cold and flu season and after time spent on planes and other forms of public transportation are general illness prevention techniques that help. And while avoiding viral infections now may or may not protect you against developing multiple sclerosis in the future, staying healthy can certainly contribute to your quality of life in the short term.
Geography
According to the Partners Multiple Sclerosis Center, multiple sclerosis has a higher incidence in North America, southern parts of Australia, and northern Europe, suggesting that the farther you live from the equator, the greater your risk for developing multiple sclerosis.


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Diet as a Risk Factor for MS: The Evidence



Medically reviewed by Cynthia Haines, MD
 



Doctors and other health-care professionals recommend a healthy diet to all their patients, and especially to people with a chronic illness like multiple sclerosis. The purpose of such a recommendation is to promote a healthy lifestyle, rather than trying to prevent any one specific disease. And, in the case of multiple sclerosis, with the exception of including sufficient levels of vitamin D, not a lot of evidence is available to help us understand how diet might play a role in the development of the disease.
Globally, multiple sclerosis is most prevalent in southern Australia, northern Europe, and North America: the farther from the equator, the higher the incidence. And this holds true for the United States as well: Incidence of multiple sclerosis is lower in the southern states and higher in the northern states. On the other hand, there is also some speculation about the role of high-fat diets or high-sugar diets. This is based on the idea that people who live in areas of higher incidence tend to eat different foods from people who live in areas with lower.
Diet as a Risk Factor for MS: The Evidence
While the jury is out on a definite link between diet and multiple sclerosis, there is a great deal of evidence to support link between multiple sclerosis and a vitamin D deficiency, and the number of studies is growing. But while it is clear that there is an association between the two, it remains uncertain just how vitamin D deficiency affects multiple sclerosis or its development.
MS and Diet: Vitamin D
A study of active-duty military personnel found that people with higher levels of vitamin D in their blood were less likely to develop multiple sclerosis than those with lower levels of vitamin D, although the finding applied to whites only, not blacks or Hispanics.
"Many studies have given us a good link between vitamin D status and immune function in MS," says Heather E. Hanwell, a doctoral candidate in nutritional sciences at the University of Toronto and author of a recent study of the affect of vitamin D on MS. "We wanted to see whether vitamin D status was lower in children who had their first demyelinating event [shedding of the myelin sheath, the protective covering of the nerves] and were subsequently diagnosed with MS." In Hanwell's study, presented at the World Congress on Treatment and Research in Multiple Sclerosis, in Montreal, vitamin D levels were significantly lower in children diagnosed with MS. "Another way of looking at it is that as vitamin D status increased, children had a lower risk of being diagnosed," she says.

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Thursday, March 15, 2012

MAKScientific, a company focused on therapeutics that modulate cannabinoid pathways, entered into an exclusive, worldwide option and collaboration agreement with Biogen Idec


MAKScientific, a company focused on therapeutics that modulate cannabinoid pathways, entered into an exclusive, worldwide option and collaboration agreement with Biogen Idec in multiple sclerosis (MS) and other neurodegenerative diseases. Biogen Idec will receive an option for an exclusive license to select discovery-stage MAKScientific drug candidates for all indications worldwide.
Upon Biogen Idec's exercise of the option, MAKScientific will receive an exercise fee of up to $3 million and up to an additional $31 million in milestone payments associated with the clinical development of the drug candidates. In addition, MAKScientific will be eligible to royalties on net sales worldwide.
The company says that its technology provides a way to create medications without the undesirable psychotropic side effects associated with cannabis. It has designed and synthesized compounds that are in advanced preclinical development for the treatment of obesity and metabolic disorders, neuropathic and inflammatory pain, addiction, and neurodegenerative diseases. The firm holds an extensive library of over 12,000 druggable compounds covering the key therapeutic areas it is pursuing.
The human body produces endogenous cannabinoids called endocannabinoids, a family of neurotransmitters and neuromodulators. A major role of the endocannabinoid system is to protect brain cells from neuronal damage. This is accomplished by releasing endocannabinoids that are subsequently deactivated by special enzymes, the most promising of which is fatty acid amide hydrolase (FAAH). Compounds capable of selectively inhibiting this enzyme can produce increased levels of endocannabinoids capable of neuroprotective action. 
For this reason, FAAH inhibitors can serve as medications for the treatment of neurodegenerative diseases such as multiple sclerosis as well as Parkinson and Alzheimer disease. MAKScientific says that it has developed FAAH inhibitors with demonstrated potent neuroprotective properties and excellent safety profiles. Of these, MAK5206 is being explored as a medication for multiple sclerosis.
Biogen Idec’s MS pipeline comprises Peg IFN, BG-12, and daclizumab, all of which are in Phase III for relapsing forms. Anti-Lingo is being investigated in Phase I. The company’s approved portfolio of MS medications include Avonex (relapsing remitting), Tysabri (relapsing remitting), and Ampyra (to improve walking). All approved candidates are being further studied in other types of MS as well as in different formulations.

source: GenEngNews


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