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Wednesday

 

End-of-Year Task: Renewing Your DMT Prescription for 2016






























By Kim Dolce—December 8, 2015

December is upon us, and besides being the holiday season, ‘tis also the season to renew our prescriptions for disease-modifying therapies and reapply for co-pay assistance.
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FREE MS RESEARCH UPDATE: a comprehensive overview of research findings on all of the FDA-approved disease-modifying therapies, as well as many experimental treatments



This year's expanded MS Research Update incorporates new information about the approved disease-modifying therapies (DMTs), as well as numerous experimental drugs currently under investigation for the long-term treatment of multiple sclerosis (MS). Highlights and recent research results are provided for each drug. Please note that symptom-management drugs are not included in this report.

DOWNLOAD YOUR FREE PDF OR ORDER A FREE COPY
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Sunday

 

Wow! It's no wonder MS is seen as a Cash Cow: THESE MS DRUGS BROUGHT IN THE MOST MONEY LAST YEAR

Teva soaring out in front on a single product and it is no surprise that the Generics pack are waiting in the rear ready for the copaxone patents to expire starting May 2014. However Biogen are backing the most winners with a staggering $5.8 billion worth of business. 
#1 Glaterimer acetate Teva     $4.3 billion
#2 Avonex Biogen Idec           $3.0 billion
#3 Gilenya Novartis                 $1.9 billion
#4 Tysabri Biogen  Idec           $1.7 billion
#5 Betaseron Bayer                 $1.1 billion
#6 Tecfidera Biogen Idec        $0.9 billion
#7 Rebif EMD serono              $0.6 billion
#8 Ampyra Biogen Idec           $0.3 billion
#9 Aubagio Sanofi                   $0.2 billion
#10 Extavia Novartis               $0.2 billion

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Saturday

 

Multiple Sclerosis and Pregnancy: Current Considerations

 

HOW MS MEDICATIONS DIFFER FROM EACH OTHER

 

Tecfidera Captures the Largest U.S. Neurologist-Reported Patient Share Among Oral Disease-Modifying Multiple Sclerosis Therapies Ten Months Post-Launch

 

Synthetic Biologics Announces Issuance of U.S. Patent patents for MS and other autoimmune diseases covering the uses of its oral estriol candidate, Trimesta

 

FREE MS RESEARCH UPDATE: a comprehensive overview of research findings on all of the FDA-approved disease-modifying therapies, as well as many experimental treatments



This year's expanded MS Research Update incorporates new information about the approved disease-modifying therapies (DMTs), as well as numerous experimental drugs currently under investigation for the long-term treatment of multiple sclerosis (MS). Highlights and recent research results are provided for each drug. Please note that symptom-management drugs are not included in this report.

DOWNLOAD YOUR FREE PDF OR ORDER A FREE COPY
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Friday

 

BioTrends Research Group Rolls Out The TreatmentTrends: Multiple Sclerosis 2013 Report


BioTrends Research Group, a research and advisory firms for specialized biopharmaceutical issues, finds that physician-reported patient shares for Novartis's Gilenya and Biogen Idec's Tysabri are 8 percent and 10 percent among relapsing-remitting multiple sclerosis (RR-MS) patients treated with a disease-modifying therapy (DMT) across the EU5 (France, Germany, Italy, Spain and the United Kingdom); significantly higher than those reported by EU5 neurologists surveyed in 2012.
According to a release, surveyed neurologists also report that recent changes in treatment management include a shift toward earlier and more-aggressive treatment and increased use of the anti- JCV antibody assay, changes that are consistent with the increased patient shares reported for Gilenya and Tysabri. Survey data indicate that these agents occupy distinct niches, with Gilenya a preferred second-line therapy in JCV-positive patients and Tysabri a preferred second-line therapy in JCV-negative patients.

The TreatmentTrends: Multiple Sclerosis (EU) 2013 report finds that, despite fewer than 30 percent of surveyed neurologists reporting access to Genzyme's* Aubagio and Genzyme/Bayer HealthCare's Lemtrada--and given the limited time these agents had been available at the time the survey was fielded--these DMTs have nevertheless captured a 1 percent physician-reported weighted MS patient share. The data also reveal that surveyed neurologists anticipate substantial changes in DMT use in the coming months as access to Aubagio and Lemtrada expands and as new products, notably Biogen Idec's Tecfidera, become available. Neurologists indicate that Aubagio will most likely compete with first-line products (i.e., Biogen Idec's Avonex, Bayer HealthCare's Betaferon and Teva's Copaxone), while Tecfidera may replace these products as well as Merck Serono's Rebif and Gilenya. Lemtrada, conversely, will most likely compete with Tysabri or would not replace an existing DMT, suggesting anticipated use as a last-line therapy.

"The European MS market is entering a dynamic period with two recent DMT launches and as many as six new DMTs launching in the next five years," said Decision Resources Group Senior Business Insights Analyst Georgiana L. Kuhlmann, S.M. "Our data find that gains for new brands will likely come at the expense of the interferon-beta therapies and Copaxone."

BioTrends Research Group provides syndicated and custom primary market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets.
Decision Resources Group is a cohesive portfolio of companies that offers information and insights on sectors of the healthcare industry.
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Daniel Kantor, MD, on Specialty Pharmacy in Multiple Sclerosis

In the last two decades we’ve seen really an explosion of the treatments we have for multiple sclerosis (MS),” said Daniel Kantor, MD, medical director, Neurologique, immediate past president, Florida Society of Neurology. Until recently, self-injectables and intravenous medications were the only treatment options available for patients diagnosed with MS making specialty pharmacy, “hugely important for the treatment of MS.” Today, there are 10 disease-modifying agents approved by the US Food and Drug Administration:
  • Aubagio (teriflunomide)
  • Avonex (interferon beta-1a)
  • Betaseron (interferon beta-1b)
  • Copaxone (glatiramer acetate)
  • Extavia (interferon beta-1b)
  • Gilenya (fingolimod)  
  • Novantrone (mitoxantrone)
  • Rebif (interferon beta-1a)
  • Tecfidera (dimethyl fumarate)
  • Tysabri (natalizumab)
Dr Kantor notes that specialty pharmacies ensure facilities and patients receive medications in a timely manner. Specialty pharmacies also play a crucial role in both patient education and adherence. 
- See more at: http://www.ajmc.com/conferences/ectrims2013/Daniel-Kantor-MD-on-Specialty-Pharmacy-in-Multiple-Sclerosis-#sthash.qllKQSe0.dpuf

“In the last two decades we’ve seen really an explosion of the treatments we have for multiple sclerosis (MS),” said Daniel Kantor, MD, medical director, Neurologique, immediate past president, Florida Society of Neurology. Until recently, self-injectables and intravenous medications were the only treatment options available for patients diagnosed with MS making specialty pharmacy, “hugely important for the treatment of MS.” Today, there are 10 disease-modifying agents approved by the US Food and Drug Administration:
  • Aubagio (teriflunomide)
  • Avonex (interferon beta-1a)
  • Betaseron (interferon beta-1b)
  • Copaxone (glatiramer acetate)
  • Extavia (interferon beta-1b)
  • Gilenya (fingolimod)  
  • Novantrone (mitoxantrone)
  • Rebif (interferon beta-1a)
  • Tecfidera (dimethyl fumarate)
  • Tysabri (natalizumab)
Dr Kantor notes that specialty pharmacies ensure facilities and patients receive medications in a timely manner. Specialty pharmacies also play a crucial role in both patient education and adherence. 
- See more at: http://www.ajmc.com/conferences/ectrims2013/Daniel-Kantor-MD-on-Specialty-Pharmacy-in-Multiple-Sclerosis-#sthash.qllKQSe0.dpuf
“In the last two decades we’ve seen really an explosion of the treatments we have for multiple sclerosis (MS),” said Daniel Kantor, MD, medical director, Neurologique, immediate past president, Florida Society of Neurology. Until recently, self-injectables and intravenous medications were the only treatment options available for patients diagnosed with MS making specialty pharmacy, “hugely important for the treatment of MS.” Today, there are 10 disease-modifying agents approved by the US Food and Drug Administration:
  • Aubagio (teriflunomide)
  • Avonex (interferon beta-1a)
  • Betaseron (interferon beta-1b)
  • Copaxone (glatiramer acetate)
  • Extavia (interferon beta-1b)
  • Gilenya (fingolimod)  
  • Novantrone (mitoxantrone)
  • Rebif (interferon beta-1a)
  • Tecfidera (dimethyl fumarate)
  • Tysabri (natalizumab)
Dr Kantor notes that specialty pharmacies ensure facilities and patients receive medications in a timely manner. Specialty pharmacies also play a crucial role in both patient education and adherence. 
- See more at: http://www.ajmc.com/conferences/ectrims2013/Daniel-Kantor-MD-on-Specialty-Pharmacy-in-Multiple-Sclerosis-#sthash.qllKQSe0.dpuf













See Video Here

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Multiple Sclerosis Market (MS) Trends & 2018 Forecasts in New Study at MarketReportsOnline.com

Dallas, TX -- (SBWIRE) -- 11/29/2013 -- The report titled "Global Multiple Sclerosis Market: Trends & Opportunities (2013-18)" provide an insight into the market dynamics and various trends and opportunities associated with the global multiple sclerosis market. The report analyzes the various causes and symptoms related to the prevalence of MS in patients. Further, the report analyzes the global market sizing and growth of multiple sclerosis in terms of revenue, number of patients and sales of effective drugs. Also, the domestic market of United States which is the largest contributor to the global multiple sclerosis market has been assessed. The report concludes with a brief discussion of major factors driving the global multiple sclerosis market and profiles major players like Teva, Biogen Idec, Merck KGaA, Bayer and Novartis.

The global Multiple Sclerosis market is undergoing drastic change since the last few years. The rising diagnosis and treatment rate coupled with growing investment in research and development has played a key role in the determining the growth dynamics of the global Multiple Sclerosis (MS) market.

Currently, MS is known to affect an estimated 2.5 million people around the world with around 5000 new cases emerging each year. Since there is no particular cure or treatment for multiple sclerosis, the market is currently dominated by few drugs and medication like Copaxone, Avonex, Betaseron and Extavia which delay or reduce the progression of multiple sclerosis in individuals.

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2/3 of Neurologists Have Prescribed Aubagio to Their MS Patients at 1 Year Post-Launch



EXTON, Pa., Nov. 25, 2013 /PRNewswire/.....Two-thirds of surveyed U.S. neurologists have prescribed Genzyme's Aubagio, the second oral disease-modifying therapy (DMT) to reach the multiple sclerosis (MS) market, to at least one of their MS patients at one year post-launch. This increase in prescriber base represents a modest expansion compared with six months ago when Biogen Idec's Tecfidera, the third oral DMT to market, became commercially available.
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Tony Bodmer, Columnist, MSnewsChannel.com

I was having 3-4 exacerbations a year.  They finally stopped on Rituxan! Gilenya has been continuing that role for two years now.

 I'm still on Gilenya, and still loving it.
I have been on a number of different MS drugs in the 9 years since I was diagnosed with MS.  Copaxone, Betaseron, Tysabri, and Rituxan.  Rituxan was the only one that really worked for me but, my neurologist didn't want me on it more than 3 years.  As she said, "After three years, who knows what else will be out"  Fortunately for me, after 3 years, Gilenya had just been put on the market.
 
When I took my last dose of Rituxan, I already knew the drug I wanted to try.  Of course there are potential side effects, but what drug doesn't have that?  I was just excited after years of shots and IV's to have an MS drug that was just one pill a day.  Definitely easier than a shot a day.

After about a month, I was noticing changes.  I know Gilenya, like all MS drugs, wouldn't treat symptoms, but I felt like it was.  Biggest change for me was my balance sud
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How Multiple Sclerosis Is Treated

Now that you finally have a name -- multiple sclerosis -- to match the symptoms that have been plaguing you, you've probably got a lot of questions about how to treat those symptoms and keep your condition from getting worse. Although researchers haven't yet discovered a cure for MS, there are many effective medications to help manage your disease. Your doctor will work closely with you to find the treatment that works best for you while causing the fewest side effects.

Here is a rundown of your MS treatment options.

Changing the Course of Your MS: The Disease-Modifying Drugs


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"Tecfidera's gain is Teva's pain! Is Biogen Idec Cornering the Market for MS Treatments?""


Biogen Idec the fast growing biotech, which has risen more than 50% over the past twelve months -- won't slow down anytime soon. And that's according to new interim data from a long-term study of its multiple sclerosis, or MS, treatment Tecfidera.

The continuing study showed no new problems in patients taking the drug for at least four years. The patients in the group consisted of those who had participated in Biogen's earlier phase 3 studies, in which the efficacy of Tecfidera was favorably compared to the leading MS treatment on the market, Teva Pharmaceutical's (NYSE: TEVA  ) Copaxone.

Tecfidera was approved in March, and is considered a major threat to existing treatments from Teva Pharmaceutical, Novartis (NYSE: NVS  ) , and Sanofi (NYSE: SNY  ) . Tecfidera is an orally administered treatment, whereas the majority of other MS treatments are injected. The only other two orally administered MS drugs currently on the market are Novartis' Gilenya and Sanofi's Aubagio.
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Thursday

 

THIS IS MY 1ST COLUMN: MS...What a Strange and Random Disease

Tony Bodmer, Columnist, MSnewsChannel.com
    
My name is Tony Bodmer and I am 34 years old.  This is my 1st Column!
I'm looking forward to writing more here and hopefully educating some people about MS.  I know I didn't know anything about it til the day I was diagnosed and there's too many people out there who are just not educated on what MS is. I was diagnosed with ms 9 years ago when I was 25.  The first 5 years were pretty bad until I was referred to an MS specialist by my neurologist.  She finally got me on a med that actually worked and, it's kind of leveled off now. I was diagnosed right when tysabri came out for the first time.  I had one infusion and three days before my 2nd infusion, it was taken off the market.
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Monday

 

Novartis' Gilenya Pill May Shake Up Global MS Market

(Posted By: Josi Creek) Novartis AG's novel multiple sclerosis pill Gilenya holds the potential to shake up the $10 billion multiple sclerosis market and give the Swiss pharmaceuticals giant a cutting edge over rivals such as Irish drug maker Elan Corp. PLC , U.S.-based Biogen Idec Inc. and Germany's Merck KGaA. The once-daily pill that promises to improve the lives of thousands of patients who suffer from the disease that debilitates the central nervous system has good chances to become the gold standard after a U.S. regulatory panel earlier this month recommended the drug for approval. Despite raising safety concerns, the U.S. Food and Drug Administration's panel, in an unanimous vote, found the drug to be so effective as to allow it to become a first-line multiple sclerosis treatment despite side effects such as lung, heart and eye problems. This, analysts say, raises the likelihood the FDA in September will fully back Gilenya's marketing launch that could come as early as in the third quarter of 2010 and net more than $1 billion in sales for Novartis. The FDA panel's decision was a positive surprise and will act as a confidence booster for the Swiss pharma giant, which with the help of Gilenya may curb the sales drop it faces when its two top medicines--heart drug Diovan and cancer medicine Gleevec--lose patent protection over the next few years. Analysts have hitherto been skeptical that Gilenya will make a deep impact, as early-stage trials raised the specter that the drug's side-effects could negate its benefits, limiting the sales and profit potential for the drug or even annihilating its chances to win approval. But after the U.S. drug panel's verdict, the market's view is slowly changing and analysts have started to upgrade their forecasts that range between $1 billion to $3.5 billion. "The strong endorsement [from the FDA panel] sets the stage for Novartis to shake up the multiple sclerosis market which is projected to grow to $15 billion by 2015," said Karl-Heinz Koch of brokerage Helvea. "We believe there is significant upside to our above consensus $1.4 billion sales forecast." Analysts also welcomed Gilenya's potential to become a first-line treatment, thus hurting existing players, who are set to lose massive market share. "The Gilenya recommendation for approval was expected, but the first line status wasn't", said Ian Hunter of Goodbody Stockbrokers. "The implication is that it is a greater setback for drugs already on the market." According to his estimates, Elan, for example, could lose some 10% of its patient base. Other market leaders could suffer too as think tank Datamonitor expects Gilenya to become the leading multiple sclerosis therapy by 2016 and could net sales of more than $1 billion. To date, the market for multiple sclerosis, which affects about 2.5 million people worldwide, is led by firms such as Biogen, Merck Serono, Bayer AG ( BAYN.XE), Elan and Teva Pharmaceutical Industries Ltd (TEVA.TV). Teva and Sanofi-Aventis SA's (SAN.FR) own the market's best-selling drug Copaxone, which had more than $2.8 billion in sales in 2009. Biogen's Avonex also had more than $2 billion in annual revenue, while Bayer's Betaseron and Merck's Rebif had more than $1 billion in sales. Most of these drugs, however, go with side-effects that could prove crippling for them once Gilenya is on the market. While many existing drugs need to be administered through a daily injection or infusion, the medicines also cause flu-like symptoms, a condition many patients dislike although it isn't dangerous. Gilenya's pill form is believed to appeal to both patients and doctors because it's easier to administer and analysts say the lack of flu-like symptoms could even help Novartis expand the market, as many early-stage patients avoid taking some of the existing drugs because of the hampering side-effects. "I believe the drug will be approved and will become a success because it is administered orally and is very efficacious," said Andrew Weiss, pharma analyst at Bank Vontobel. Still, he warns that Gilenya's dose related side-effects could prove a stumbling block and even delay the drugs approval. Weiss puts the approval probability at 50%, while he sees non-probabiltiy adjusted peak sales at about $2.9 billion. Concerns about the drug's side effects have diminished after the FDA's panel decision, they but haven't fully abated--partly because the FDA asked Novartis to provide more research data and to consider lowering the drug's dosage to reduce side effects. Fears that the drug could falter in late stage or even after approval are fueled by the fact that late-stage setbacks for multiple sclerosis drugs medicines are common. For example, one year after the launch of multiple sclerosis drug Tysabri, Biogen and Elan had to pull off the drug from the market due to serious side effects such as brain tumors. The drug was later reintroduced but has since failed to live up to the high hopes of its producers. Also, Merck's oral multiple-sclerosis drug needed be resubmitted after the FDA rejected approval, saying Merck's filing was incomplete. For brokerage Bernstein, these recent drug setbacks could serve to postpone Gilenya's market introduction. Also, the brokerage expects that Novartis' post- marketing efforts to highlight the drug's side effects will be strenuous. Nevertheless, the drug holds blockbuster potential and the brokerage sees sales of more than $1 billion by 2015.

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Neurologists Eagerly Await New Oral Treatment Options for Multiple Sclerosis Such as EMD Serono's Movectro, Extavia, & Novartis's Gilenya

(Posted By: Josi Creek)


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