Thursday, July 2, 2015

Dimethyl fumarate for treating relapsing multiple sclerosis

Dimethyl fumarate (BG-12) first line oral treatment for people with multiple sclerosis: STUDY

TECFIDERA® (Dimethyl Fumarate) Data Reinforce Strong, Sustained Efficacy for Newly-Diagnosed MS Patients

Biogen (NASDAQ: BIIB) today announced new data that continue to support TECFIDERA® (dimethyl fumarate) as an effective, long-term treatment for people who are living with relapsing forms of multiple sclerosis (MS). Data show TECFIDERA significantly reduced relapses and disability progression in newly-diagnosed relapsing-remitting MS (RRMS) patients who had highly active disease. Additional data indicate TECFIDERA showed strong and sustained efficacy over five years in RRMS patients who were previously treated with an interferon (interferon beta-1a/b [IFN]) or glatiramer acetate (GA). These results will be presented at the 67th American Academy of Neurology (AAN) Annual Meeting in Washington, D.C.

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

Could This Study Help Lead to a Cure for Select Multiple Sclerosis Patients?

For a disease that affects 2.5 million people around the globe and more than 400,000 people in the United States, it's a shame that so little is known about multiple sclerosis despite the amount of money being put into research of the disease.

Alkermes' multiple sclerosis prodrug looks good in Phase I, has Biogen Idec's Tecfidera in its sights

Dr. Elliot Ehrich

Alkermes ($ALKS) said the safety profile of its clinical-stage multiple sclerosis drug compares favorably to that of Biogen Idec's Tecfidera, citing the candidate's Phase I trial results on 104 patients.

Baupost adds new stake in Forward Pharma
Seth Klarman’s The Baupost Group added a 11.72% stake in Forward Pharma (FWP). A 13G filing in November indicated that the fund owns 5,367,300 shares in Forward Pharma.

–– Novel, Oral Product Candidate Provided Monomethyl Fumarate Exposures Comparable to TECFIDERA®, With Favorable Gastrointestinal Tolerability ––

This Could Be Game-Changing News in the Battle Against Multiple Sclerosis

For a disease that affects more than 400,000 people in the United States and approximately 2.5 million around the globe, multiple sclerosis is arguably not getting its fair share of attention from drug developers and researchers. According to the National Institutes of Health, which has an annual budget near $40 billion, only $115 million is expected to be spent on MS research in 2015.

Dimethyl fumarate in the treatment of relapsing–remitting multiple sclerosis: an overview: STUDY

Multiple Sclerosis, Don’t Let It Define You

One way to understanding any disease is to talk to your doctor and another is to read about the disease from various medical sources. It is not always wise to rely on one source for information. With how much information we come across these days on the internet, it shows how much people are talking about a particular, disease, war, or anything else of great interest. One disease that is of interest is Multiple Sclerosis or MS.

Biogen Idec MS drug is approved by European regulators

European regulators Wednesday gave Cambridge biotech Biogen Idec Inc. approval to sell a new kind of injectable drug to treat multiple sclerosis.

TEVA'S COPAXONE PATENT IS UP AND ITS DESPERATE TO KEEP PATIENTS & INSURERS

Teva is trying to persuade patients and their doctors to switch from the daily injection to a new, three-times-a-week version! PLUS: trying to get insurers to pay for it!

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

Tecfidera and Ampyra Show Potential for Quality of Life Improvement in Patients With MS

New disease-modifying drugs in multiple sclerosis (MS) show potential for improving quality-of-life (QoL) of patients with multiple sclerosis. The clinical benefits of dimethyl fumarate and PR-fampridine were discussed at a Biogen Idec-sponsored satellite symposium at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

GREAT TECFIDERA NEWS: One Year Post-Launch, All Surveyed U.S. Neurologists Report Having Clinical Experience with Biogen Idec’s Tecfidera for the Treatment of Multiple Sclerosis

TECFIDERA RESEARCH REPORT

October 25, 2013
Biogen Idec Inc.
Expect Tecfidera to Beat with $220M+
Impact: BIIB reports Q3 results next Mon @ 9am ET. Based on IMS Rx trends, Tecfidera Q3 demand could be $220M+
First Impression
Reporting 3rd week of Q4:13 Multiple Sclerosis scripts.
Tecfidera TRx 4528, +2% wk/wk while "true" NRx is 769, -14% wk/ wk (reported NRx is 1855, -1% wk/wk)

Despite light "true" NRx due to Columbus Day, TRx market penetration
reaches 13%, maintaining its lead over Gilenya and Aubagio combined of 12.3%. Even though the "true" NRx has stabilized at ~900 (as previously anticipated), the TRx shows steady growth (TRx +20% QTD vs. +104% Q/Q in Q3) as patient compliance remains high. At this rate, we believe Tecfidera could reach 15%+ market share by YE:13.
Continue to reiterate that Q3 Tecfidera demand likely ~$220M (without stocking) per weekly scripts, higher than cons of $206-220M. Recall BIIB reported Q1 sales of $192M ($110M demand + $82M stocking), closely in line with our TecfiAPP estimate of $103M. BIIB will report earnings on 10/28 (Mon) at 9am ET.
Headline Q3 tecfidera sales could be $300M+ according to IMS and WK. WK monthly sales combined yields $273M for Q3 assuming 100% capture rate. Given the capture rate in Q2 was quite low at 54%, if we conservatively assume 90% capture rate for Q3, this yields $303M for Q3. If stocking is similar to Q2 ($80M), we believe end-user demand could be around $220M, which is in-line with trends from IMS monthly sales data as well.
Tecfidera tracking towards $700M+, according to our TecfiAPP. The two biggest variables are: 1) refill/compliance rate; and 2) "true" NRx normalization level. Both of these variable have stabilized over the past quarter (refill rate at ~88%, "true" NRx at ~900). We believe these are reasonable base assumptions going forward and anything above or below would be up/downside.

VIDEO: Multiple sclerosis death due to Tecfidera unlikely but still investigated

A news release stated a 59-year-old female hadn’t been taking Tecfidera; Biogen Idec’s new multiple sclerosis (MS) pill-form therapy, at the time of her death, but they are still investigating as she had been on the therapy for 5 ½ weeks 2 weeks prior. Side effects like nausea, diarrhea and vomiting are what had decided the cessation of the therapy and a spokeswoman for Biogen stated the patient had a “history of irritable bowel disease and recurring infections including bronchitis” Tecfidera delayed-release capsules have surpassed Gilenya as chosen pill-form therapy in the fight against MS progression.

MS Drug Tecfidera More Trouble Than It’s Worth?

Click here to read

Gastro Effects Dog Oral MS Drug Tecfidera: one-quarter of patients switching to dimethyl fumarate from another MS medication in an independent study had stopped the drug within 3 months

Large proportions of patients starting on dimethyl fumarate (Tecfidera) for multiple sclerosis appear to need additional medications to manage the drug's gastrointestinal and other adverse effects, and a substantial minority are ultimately unable to tolerate the drug, multiple studies reported here found.

These findings were confirmed in the manufacturer's own studies -- for example, more than half of patients in an open-label study took over-the-counter medications to control stomach upset and diarrhea -- although symptoms eventually abated in those who stayed on the drug beyond 2 months.

But more mundane side effects such as flushing, gastrointestinal complaints, and itching were common.

Story Source: The above story is based on materials provided by MEDPAGE TODAY

Note: Materials may be edited for content and length

Click here to read

VIDEO: TEVA'S DISASTEROUS DROP IN STOCK PRICE:

STOCK DOWN 8%: WHAT'S BEHIND TEVA'S MASSIVE PLUNGE?

Solid growth from Tecfidera (Dimethyl fumarate) in the US and OUS

"We expect solid growth from Tecfidera in the US and OUS," the biotech team said. "Consensus OUS Tecfidera sales estimates are conservative compared to Gilenya’s launch trajectory and we expect upward revisions.
Click here to read more

VIDEO: Dr. Timothy Vollmer

Dr. Timothy Vollmer

"There have been significant advances in the last few years about the cause of MS
There appears to be several different factors. One is genetics; the disease is more prevalent in people from Northern Europe. The second one is low Vitamin D levels early in life, and possibly in in-utero, increase the risk of MS subsequently," University of Colorado Doctor Tim Vollmer said.

He says people in Colorado are normally diagnosed with low-levels of Vitamin D. Some experts believe Vitamin D levels may be low in the state because of Coloradan's use of sunscreen.

Vollmer says new MS research and treatments are progressing at a remarkable rate.

"The field Multiple Sclerosis is one of the most rapidly evolving fields of medicine right now. We have eight FDA therapies and three that are likely to be approved within the next year to 18 months. In the last year or so, we've developed a new blood test that would identify patients who are at risk of some of the serious side effects of the drugs. As a consequence, we can now identify people who are likely to do very well on a certain drug with a very low risk," Vollmer said.

Data Show Declining Use of Injectables as Oral Multiple Sclerosis Therapies Gain Traction

Today is day 5 on the "full dose Tecfidera" (240mg so far) am having no side effects and it's AWESOME (a little tired of peanut butter but LOVE not losing my weekends. I can't wait to fully get over the Avonex withdrawal and waking up)!

The numbness and pain my hands has subsided quite a bit, my "migraine headache" this morning went away very quickly and I THINK my memory is showing signs of improvement (feeling "cautiously optimistic").

I've written 14 columns for you.
Click on my photo on far left side
of this page to read them all

5th Place: Best Column of 2013

MY TECFIDERA FANTASTIC NEWS: My memory is improving as is some of my pain troubles & for the 1st time in 16 years I'm remembering dreams!"

"Researchers don’t know why some multiple sclerosis therapies work"

NEUROLOGISTS NEED TO HAVE "HEIGHTENED VIGILANCE"

The knowledge that epilepsy and multiple sclerosis occur together more frequently than by chance should heighten vigilance for both when diagnosing or treating patients with either condition. For example, unexplained cognitive symptoms in a patient with multiple sclerosis may turn out to be partial complex seizures, whereas an episode of painful blurry vision in someone with epilepsy could indicate optic neuritis as the first symptom of multiple sclerosis. If seizures require treatment, an antiepileptic drug should be chosen that does not exacerbate preexisting symptoms of multiple sclerosis, such as ataxia, tremor or impaired cognition.

More research needs to be done to investigate the underlying reasons for the increased incidence of epilepsy in patients with multiple sclerosis, as well as an increased incidence of multiple sclerosis in patients with epilepsy. Inflammatory cortical demyelination in multiple sclerosis could cause neuronal loss and seizures. Could an inflammatory pathogenesis of epilepsy also lead to multiple sclerosis? As research continues to progress very rapidly in both of these disease states, maybe we won't have to wait long to find out.

Gastrointestinal Tolerability Study Of Tecfidera In Participants With Relapsing-Remitting Multiple Sclerosis: ClinicalTrials.gov

Biogen beats revenue estimates as Tecfidera hits blockbuster status

TECFIDERA DEMYSTIFIED

Although the mechanism of action of many multiple sclerosis treatments is unknown, scientists at Bad Nauheim’s Max Planck Institute for Heart and Lung Research and the University of Lübeck unlocked the mechanism for dimethyl fumarate (DMF), a multiple sclerosis drug that just received approval in Europe under the name Tecfidera. Dr. Nina Wettschureck’s and Dr. Markus Schwaninger’s research groups discovered the reason for immune function influence by DMF, which has also been used as a successful treatment for psoriasis.

Simply stated by Dr. Schwaninger, “In mice [with a standard model of multiple

Neurologists Expect to Prescribe Biogen Idec’s Tecfidera to 16% of their Relapsing-Remitting Multiple Sclerosis Patients in the Next 12 Months: Survey

Click here to read more

Researchers don’t know why some multiple sclerosis therapies work

Biogen Idec to Present New Clinical Data from Its Neurology Portfolio of Drugs at AAN Annual Meeting

Biogen Idec May Have Seeds For Next-Gen MS Drugs

Can new versions of Copaxone, Avonex drive market share retention?

Multiple Sclerosis Drug Tecfidera Becoming Increasingly Available In Twice-Daily Pill Form Worldwide

Click here to read more

AN IMPORTANT STUDY AVAILABLE TO EVERYONE ON TECFIDERA

A Single-center Prospective Measurement of Adherence to Treatment With Tecfidera™ in Multiple Sclerosis Patients.

Click here to read more

Tecfidera – The Good, the Bad and the Ugly

Tecfidera – The Good, the Bad and the Ugly

I started Tecfidera 9 months ago, I kind of expected side effects but I was trying to be positive so I expected none. Well, I got them; I got sharp pains in my abdomen, pains like I never experienced ever before but with medication my doctor recommended and eating fatty kind of foods like blueberry muffins when I took my medication during meals it helped with the pain. Diarrhea was also a side effect; not normal diarrhea but the kind that woke you up in the middle of the night running to the bathroom and not being able to make it. I lost lots of clothes due to this as well as the feeling that my whole body emptied with each episode which was only one time a day (there was nothing left inside me, I think stuff from high school came out, really). My doctor gave me medication finally for this as well.

After 2 to 3 months the side effects were gone, only occasional episodes when I ate something that wasn’t healthy for my body I guess, tacos, burritos, HYPERLINK "http://www.google.com/url?sa=t&rct=j&q=&esrc=s&frm=1&source=web&cd=2&cad=rja&uact=8&ved=0CDIQFjAB&url=http%3A%2F%2Fallrecipes.com%2Frecipes%2Fpasta%2Fspaghetti%2F&ei=CLw5U7LDH-LCyQHg2oCIBw&usg=AFQjCNG6SdEq5ewxY4JHhJX2_I8u9GTH1g&bvm=bv.63808443,d.aWc" Spaghetti , anything that had spice in it. You have to be careful what you eat and understand if it causes symptoms take it out of your diet.

I was doing so well with Tecfidera. I noticed I now had leg strength and I felt almost normal where I could now accomplish more things and could overdue it without getting too sick now. I felt good. I thought this was a great medication for me! I have tried everything else so there was really nothing left to try and this one was working.

Two months ago everything changed; my diarrhea was now back and back with a vengeance. It got to the point I could not even eat soup without it happening, everything I ate caused problems

HOW MS MEDICATIONS DIFFER FROM EACH OTHER

TECFIDERA: Biotech Stocks: Seeing Rainbows, Missing The Rain (Forbes Magazine)

Click here to read more

LEAD: Tecfidera is a new formulation of a drug that had been used to treat psoriasis in Germany.

many of these firm’s R&D successes have actually been “derivative” products based on approaches that were already known to work. Celgene’s success has come through drugs derived from its original success, repurposing thalidomide as a treatment for multiple myeloma and from Abraxane, an improved version of the 1990s cancer drug Taxol. Biogen’s big hit, Tecfidera for multiple sclerosis, is a new formulation of a drug that had been used to treat psoriasis in Germany.   Porges points out that Celgene is now betting on a new first-in-class molecule, sotatercept. And Biogen’s big event this year will be data for its anti-LINGO program, which is a brand new way to treat multiple sclerosis. He says Alexion and Vertex are likely facing longer odds than they have in the past. Drug research: it’s really, really hard.
Click here to read more

biogens-winning-strategy? Biogen's share of that market was about 1/3 in recent years: With Tecfidera's launch & success the company is now able to increase that share

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

Biogen Idec: A Biotech Pioneer With A Stellar Future

Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Tecifdera (BG00012) or Standard of Care

FDA panel supports approval of Sanofi's MS drug Lemtrada

Tecfidera Is Off to a Quick Start

Study: Does the patient know best? Quality of life assessment in multiple sclerosis trials

Yvonne Decelis

Insurance refusing to cover my Tecfidera

Hi there. For those of you who do not know me, my name is Yvonne Decelis and I have relapsing remitting MS.

Back in July of 2013 I went off of Avonex, my MS disease modifying drug (DMD) that I had been on since 1998. I chose to switch to Tecfidera and as soon as it was available in the US I told my Neurologist to put me on it. Unfortunately, due to my insurance (Medicare Part D plan - Humana which I plan to change soon) refusing to cover it, I was off my DMD for 5 weeks. This unintended “medication vacation” made me quite a bit worse off physically. My fatigue became much more pronounced and I needed more sleep than I had in over a decade. It took me a long time to get over the med "break" and I never really fully recuperated.

Merck KGaA shores up Rebif defenses to fend off new MS rivals

Biogen Idec finished 2013 on a high note, with its highly touted oral multiple sclerosis drug Tecfidera producing nearly $400 million in sales during the fourth quarter

HERE'S ANOTHER OF THE MANY ARTICLES THAT SAYS TECFIDERA IS WONDERFUL BUT: NO ONE KNOWS HOW IT WORKS?!?!

Tecfidera is a modified version of a treatment that was originally used to treat the skin disease psoriasis. ‘Nobody is sure exactly how it works,’ explains Belinda Weller, consultant neurologist at the Anne Rowling Regenerative Neurological Clinic in Edinburgh.‘It’s a new approach to treating MS which is believed to help cells in the body defend themselves against the damage caused by MS.’ Read more

Britain's regulatory agency turns down Biogen Idec’s oral MS drug Tecfidera

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Biogen Idec hits its first price hurdle for Tecfidera in the EU: Is told that the drug's cost is not justified by its benefits

Click here to read more

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

Study: Effects of BG-12 (dimethyl fumarate) on health-related quality of life in patients with relapsing-remitting multiple sclerosis: findings from the CONFIRM study

click to read study

"COPAXONE IS HEADED OFF A CLIFF: It's painfully clear that generic competitors such as Mylan, Momenta, and Novartis' Sandoz unit will roll out generic Copaxone on time"

Oral MS drugs could exacerbate Copaxone's decline. Meanwhile, the three main oral MS drugs -- Novartis' Gilenya, Biogen's Tecfidera, and Sanofi's Aubagio -- could all bury Copaxone in its key U.S. market. Click to read how fast these treatments have been selling, despite their limited time on the market.

STUDY: The changing fortunes of Tecfidera (dimethyl fumarate)

Key points of this study:

Dimethyl fumarate is thought to defend against oxidative stress-induced neuronal death and support myelin integrity.
Dimethyl fumarate has shown to reduce annual relapse rates in relapsing remitting MS compared to glatiramer acetate.
It may also have a positive effect on progression of disability and the number of gadolinium-enhancing lesions.
It is generally well tolerated, with flushing, gastro-intestinal upset, upper-respiratory tract infections and erythema/pruritis being the most common affects reported.
Oral administration, good tolerability and likely safety in liver and renal disease patients may make this an attractive addition to existing MS therapies.

Biogen Idec Inc: Tecfidera Continues Its Blistering Pace

The company's new oral alternative to its top-selling Avonex racked up $286 million in third quarter sales, far above the $200 million forecast by some industry analysts. Its rapid roll-out helped it capture $876 million in revenue in 2013, including $398 million in the fourth quarter. For comparison, in the most recent quarter reported, competitor drugs Gilenya earned $521 million and Aubagio by brought in about $60 million. read more

Biogen Said to Name Papadopoulos as Chairman, Replacing Young

Read about Biogen's new Chairman & how it's shares have almost doubled as the company exceeded expectations with sales of its newest multiple sclerosis drug, Tecfidera

Tecfidera (Dimethyl Fumarate) and Tysabri (Natalizumab) Making Tons for Biogen Idec.

Tecfidera Qualifies as One of the Most Impressive Drug Launches of 2013

Biogen Idec said its fourth-quarter profit grew 57%, as sales of its multiple-sclerosis treatment Tecfidera continued to boost revenue.

Biogen Idec and UCB Enter Agreements to Commercialize Multiple Sclerosis and Hemophilia Therapies in Asia

PLEASE GIVE RENE ((((HUGS))) FOR SHARING HER NEWS WITH US

Hi Stan I wanted to share some great news. I had my MRI on Tues and I got my results back. No new spots on my brain or spine and my old spots are non active!!!! I am sooo happy tecfidera is working been on it for 7 months

And I've noticed my energy level is a lot better too. Nothing major in along time.

Over the next five years, the global multiple sclerosis market is set to grow from $14.4 billion in 2012 to $18.3 billion in 2017.

Avonex remains its top seller and it bought in $733 million in revenue, down slightly from a year ago. The company also had $401 million in revenue from Tysabri, a newer drug that treats MS and Crohn's disease, and $287 million from Tecfidera.
READ MORE

Tecfidera EU launch not expected to do as well as in the U.S.

Biogen Idec's new MS pill won't see as rapid a reception in the EU as it has enjoyed in the US, CEO George Scangos conceded this week at an analyst conference.
READ MORE

Royalty Pharma Acquires Additional Interest in TECFIDERA (Dimethyl fumarate) for $510 Million

This acquisition follows Royalty Pharma's previous acquisition of an interest in the Fumapharm earn-out payments in May 2012 for $761 million.

Read more here: http://www.sacbee.com/2014/01/06/6049132/royalty-pharma-acquires-additional.html#storylink=cpy

By the end of the third quarter, Biogen's multiple sclerosis treatments Avonex, Tysabri, and Tecfidera had racked up $3.94 billion in sales so far for the year — about 80% of total revenue.
READ MORE

Tecfidera Makes Top 3 FDA Approvals of 2013

While the quantity might not have been there this year, we've still seen some high-quality drugs with blockbuster potential approved.
READ MORE

Sanofi MS Drug Added With Genzyme Fails to Win FDA Approval

Sanofi (SAN) failed to win U.S. regulatory approval for its multiple sclerosis drug Lemtrada, denting the company’s ambitions of capturing a larger share of the $20 billion market for the disease.

The U.S. Food and Drug Administration said Sanofi’s Genzyme unit didn’t submit evidence from “adequate and well-controlled studies” showing that the benefits of Lemtrada outweigh its side effects, the Paris-based company said in a statement today. Sanofi disagrees with the conclusion and said it will appeal.

Lemtrada, which was approved in the European Union in September, was a key part of Sanofi’s $20.1 billion acquisition of Genzyme in 2011. The FDA indicated one or more additional trials comparing Lemtrada with another drug are needed for approval, Sanofi said. That would delay the product’s entry to a market dominated by Teva Pharmaceutical Industries Ltd. (TEVA:US)’s Copaxone, Biogen Idec Inc. (BIIB:US)’s Tecfidera, Avonex and Tysabri, Novartis AGâ€™s (NOVN) Gilenya and Merck KGaA’s Rebif.

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.

Biogen Idec may be impressing Wall Street with its new Tecfidera treatment for multiple sclerosis, but the drugmaker is not impressing regulators with some of its practices for manufacturing a pair of older treatments – Tysabri and Avonex.

A recent inspection report issued by the FDA, which examined a facility last summer, noted that the drugmaker did not always challenge the validity of all testing results provided in certificates of analysis as part of qualification procedures. In other words, Biogen (BIIB) did not always ensure that active pharmaceutical ingredients were sterile, as suppliers claimed.

In addition, Biogen did not adequately or completely document control procedures to demonstrate that procedures are followed, and the FDA found at least one questionable instance concerning cleaning and sanitizing. READ MORE

Tecfidera claimed the number two spot on the nationwide list of drugs expected to sell the most in five years

Massachusetts biotechs saw the U.S. approval of five drugs in the past year, including treatments for breast cancer, epilepsy and multiple sclerosis. Combined, the drugs are expected to bring in more than $8 billion in 2018 - but not all of that money will come back to the Bay State.

By far the most widely watched local drug approval was at Biogen Idec (Nasdaq: BIIB), whose drug, Tecfidera, claimed the number two spot on the nationwide list of drugs expected to sell the most in five years (a common measure of newly-approved drugs, as it generally takes several years for drugs to reach their full market potential). In March, the Bay State’s largest locally-owned drug company saw the long-awaited approval of Tecfidera, its third drug to treat multiple sclerosis and its first to be administered as a pill. Bloomberg analysts predict the drug will generate annual revenue of $4.2 billion by 2018.

Biogen Idec has expanded its partnership with Samsung Bioepis after exercising its right to commercialise anti-TNF biosimilar product candidates in Europe.

The companies will work together to sell biosimilars for widely-used therapies to treat conditions such as rheumatoid arthritis and Crohn's disease in the EU, where a strong market for biosimilars and a defined regulatory pathway already exist.

This comes after Biogen Idec's new multiple sclerosis therapy Tecfidera was designated as a new active substance by the European Medicines Agency's Committee for Medicinal Products for Human Use last month. ADNFCR-8000103-ID-801673294-ADNFCR

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

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

Surveyed Neurologists Report Significantly Higher Relapsing-Remitting Multiple Sclerosis Patient Shares for Gilenya and Tysabri, Compared With One Year Ago

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."
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Multiple Sclerosis Cases Hit 2.3 Million Worldwide

The number of people living with multiple sclerosis around the world has increased by 10% in the past five years to 2.3 million, according to the most extensive survey of the disease to date.

There have been a number of new drugs in recent years to treat MS, particularly with the introduction of a new generation of oral therapies such as Novartis' Gilenya (fingolimod), Biogen Idec's Tecfidera (dimethyl fumarate) and Sanofi's Aubagio (teriflunomide). These medicines offer an effective alternative to older disease-modifying treatments that are given by injection. The survey found that injectable drugs like Biogen's Avonex (interferon beta-1a) and Teva's Copaxone (glatiramer acetate) were partly or fully funded in 96% of high-income countries, while Gilenya was available in 76%.
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Terrible days ahead for Teva & Copaxone: Teva's patent for Copaxone expires May 2014

Generic Copaxone would be an excellent development for MSers who pay $40,000 for the drug annually, but devastating to Teva who's monopoly will die!

Teva's biggest drug is Copaxone, a blockbuster multiple sclerosis drug that generated $1.05 billion in

5 Blockbuster Drugs Going Off Patent in 2014

Over the past decade, drug companies have become increasingly dependent on blockbuster drugs -- patented specialty drugs that generate more than $1 billion in sales annually.

However, when a major blockbuster loses patent protection, generic competition leaves a gaping hole in the top line, abruptly changing a company's greatest strength into its greatest liability. Let's take a closer look at five blockbuster drugs that will lose patent protection in 2014, and how four companies -- Teva Pharmaceutical (NYSE: TEVA ) , Eli Lilly (NYSE: LLY ) , Novartis (NYSE: NVS ) , and AstraZeneca (NYSE: AZN ) -- will be affected.

Terrible days ahead for Teva
Teva Pharmaceutical is best known for its generics business, but also owns a sizable large specialty pharmaceuticals business that accounts for 42% of its revenue.

Teva's biggest drug in its specialty portfolio is Copaxone, a blockbuster multiple sclerosis drug that generated $1.05 billion in sales last quarter -- half of the specialty pharma segment's revenue and 20% of Teva's total top line. Over the past four years, sales of Copaxone have steadily risen as the primary pillar of growth for Teva's top line.

However, Teva's key patent for Copaxone will expire in May 2014, opening the doors for generic competition. Mylan and Momenta Pharmaceuticals have already stated that their intent to release generic versions the moment Teva's patent expires. Generic Copaxone would be an excellent development for MS patients, who pay $40,000 for the drug annually, but it could be devastating to Teva's top line.

Biogen (NASDAQ: BIIB ) decided to delay the European launch of its new oral multiple sclerosis drug Tecfidera back in May, amid fears that patent protection for its 480 mg dose wasn't bulletproof from generics. That decision has now paid off.

The EU's Committee for Medicinal Products for Human Use, or CHMP, has granted Tecfidera new active substance designation, giving Biogen a 10-year window of exclusivity in the European Union, and paving the way for Tecfidera's Q1 2014 launch against competing drugs from Novartis (NYSE: NVS ) and Sanofi (NYSE: SNY ) .

Rapidly growing demand

Biogen's calculated risk to delay the rollout in Europe until the additional patent protections were in place looks savvy in hindsight, especially given its booming initial sales in the United States. In Q3, the drug generated $286 million in sales for Biogen, far above the $200 million some analysts forecast.

A NEW medicine that treats multiple sclerosis and is supposed to prevent its progression could be another option for those fighting the degenerative disease, a Newcastle academic says.

Newcastle based neurologist Associate Professor Jeannette Lechner-Scott was involved in the Australian clinical trials for a pill called Tecfidera.

It has just been listed on the public benefits scheme along with 50 new and amended medicines.

This means these drugs have become available to people who might not otherwise have been able to afford them.

Tecfidera is supposed to reduce the frequency of relapses and delay the progression of MS. The disease attacks a person’s central nervous system and can impact mobility, balance and sensation.

Professor Lechner-Scott, who is also a Hunter Medical Research Institute researcher, said having improved access to new evidence-based options for MS patients offered hope for the future.

Newcastle resident Sue Anthony was involved in the Australian clinical trial.

She responded well to the treatment and has not had a serious relapse in five years. Others had side effects, including flushing and did not continue with the treatment.
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15 STUDIES IN SUNDAY'S NEWS

PLUS: 396 new Studies we posted from 11/1 to Saturday 11/30 Start at the Bottom!

The Afferent Visual Pathway: Designing a Structural-Functional Paradigm of Multiple Sclerosis.

The Contribution of Resting State Networks to the Study of Cortical Reorganization in MS.

Does long-term partial sodium channel blockade alter disease progression in MS? Evidence from a retrospective study.
There is accumulating evidence that long-term disability and disease progression in multiple sclerosis (MS) are due to prolonged sodium channel opening along demyelinated axons. Despite good evidence in animal models of MS that partial voltage-gated sodium channel (VGSC) blockade reduces disease progression, little is known about its effects in patients, despite widespread use of such agents in the symptomatic management of MS. Despite preclinical evidence suggesting a neuroprotective role of VGSC blockers in animal models of MS, this retrospective study suggests that long-term exposure to the VGSC-blocking drug CBZ fails to alter long-term disability and disease progression in MS patients.

Lesional-targeting of neuroprotection to the inflammatory penumbra in experimental multiple sclerosis.

Presence of aberrant V<formula>_{H}</formula>6 domains in anti-interferon-γ autoantibodies in multiple sclerosis.

Feasibility of the Use of Combinatorial Chemokine Arrays to Study Blood and CSF in Multiple Sclerosis.

Indicators for cognitive performance and subjective cognitive complaints in multiple sclerosis: a role for advanced MRI?

Previous studies showed that advanced neuroimaging measures (functional MRI, diffusion tensor imaging) could distinguish multiple sclerosis (MS) patients with and without cognitive impairment. Are these measures indeed better indicators for cognitive impairment or subjective cognitive complaints than conventional MRI?Fifty MS patients and 29 controls were investigated. Regression analysis, including socio-demographic data, disease characteristics, psychological measures, and (advanced) neuroimaging, showed that worse cognitive performance was associated with male sex, lower education, and lower gray matter volume. Subjective cognitive complaints were associated with fatigue and less hippocampal atrophy. Advanced MRI measures did not add to the predictive power of our model.

Retinal Layer Segmentation in Patients with Multiple Sclerosis Using Spectral Domain Optical Coherence Tomography.
To evaluate the thickness of the 10 retinal layers in the paramacular area of patients with multiple sclerosis (MS) compared with healthy subjects using the new segmentation technology of spectral domain optical coherence tomography (OCT). To examine which layer has better sensitivity for detecting neurodegeneration in patients with MS. Analysis based on the segmentation technology of the Spectralis OCT revealed retinal layer atrophy in patients with MS, especially of the inner layers. Reduction of the ganglion cell and inner plexiform layers predicted greater axonal damage in patients with MS.

Detecting cognitive dysfunction in a busy multiple sclerosis clinical setting: a computer generated approach.
This study aims to explore the effectiveness of a brief, computerized battery of tests in detecting cognitive differences between clinically isolated syndromes (CIS), relapsing-remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) patients. The ability of this computerized cognitive battery to distinguish the progression of cognitive deficits across the entire multiple sclerosis disease spectrum from CIS through to SPMS enhances its construct validity. This finding, coupled with the battery's brevity (20 min) and ease of administration, highlights its potential utility in a busy clinic setting.

Differential Reconstitution of T Cell Subsets following Immunodepleting Treatment with Alemtuzumab (Anti-CD52 Monoclonal Antibody) in Patients with Relapsing-Remitting Multiple Sclerosis.

Vitamin D immunomodulatory potential in multiple sclerosis.

Cognitive fatigue in individuals with multiple sclerosis undergoing immunoablative therapy and hematopoietic stem cell transplantation.
Fatigue presents as a significant problem in multiple sclerosis (MS). Cognitive fatigue (CF) can be defined as a decrease in, or inability to maintain task performance throughout the duration of a continuous cognitive task. CF was evaluated using the Paced Auditory Serial Addition Test (PASAT) both pre- and post-immunoablation and hematopoietic stem cell transplantation (IA-HSCT) over a 3-year follow-up period. The magnitude of CF was examined and the impact of scoring methodology was evaluated. While results suggest that the procedure itself does not ameliorate an individual's susceptibility to CF; neither does it seem to negatively impact levels of CF. As such, results support the notion that the IA-HSCT procedure, despite its aggressive nature, does not exacerbate CF in this particular sample.

Improving the quality of mental health care in Multiple Sclerosis.
An exploratory study of mental health treatment of people with multiple sclerosis (MS) to identify hypotheses for future testing. The unmet need for mental health treatment for people with MS is high. Options for MS care providers to help meet this need include hiring mental health professionals to provide on-site treatment; providing mental health treatment themselves; and referring patients to mental health professionals in the community and collaborating in integrated care. This study provided preliminary data for two related hypotheses that warrant further testing: MS patients will receive better mental health care if their mental health treatment is co-located with their MS care and if it is provided by mental health professionals.

New Potential Serum Biomarkers in Multiple Sclerosis Identified by Proteomic Strategies.
Proteome analysis of body fluids is a powerful tool to identify biomarkers of neurological disorders. Multiple sclerosis (MScl) is a chronic disabling disorder of central nervous system (CNS) and is regarded as an autoimmune disease to myelin components. Clinical subtypes of MScl differ in course, prognosis and response to available therapy.

Initial Immunopathogenesis of Multiple Sclerosis: Innate Immune Response.

396 STUDIES FROM 11/1 to Saturday 11/30 are below:

Treating Multiple Sclerosis in 2013

DOCTORS DISCUSS EVERY MS TREATMENT NOW AVAILABLE INCLUDING:

(1) Alemtuzumab (marketed as Campath and currently under further development as LEMTRADA)
(2) teriflunomide (AUBAGIO)
(3) dimethyl fumarate (TECFIDERA)
(4) FINGOLIMOD
(5) TYSABRI (natalizumab)

Treating Multiple Sclerosis in 2013

DOCTORS DISCUSS EVERY MS TREATMENT NOW AVAILABLE INCLUDING:

(1) Alemtuzumab (marketed as Campath and currently under further development as LEMTRADA)
(2) teriflunomide (AUBAGIO)
(3) dimethyl fumarate (TECFIDERA)
(4) FINGOLIMOD
(5) TYSABRI (natalizumab)

15 STUDIES IN SATURDAY'S NEWS

PLUS: 381 new Studies we posted from 11/1 to Friday 11/29 Start at the Bottom!

Treatment of Multiple Sclerosis With Chinese Scalp Acupuncture.

Chinese scalp acupuncture is a contemporary acupuncture technique with just 40 years of history. It integrates traditional Chinese needling methods with Western medical knowledge of the cerebral cortex and has been proven to be a very effective technique for treating multiple sclerosis (MS) and other central nervous system disorders. A 65-year-old male patient who had had MS for 20 years was treated with Chinese scalp acupuncture. The motor area, sensory area, foot motor and sensory area, balance area, hearing and dizziness area, and tremor area were stimulated once a week for 10 weeks, then once a month for six sessions. After the 16 treatments, the patient showed remarkable improvements. He was able to stand and walk without any problems. The numbness and tingling in his limbs did not bother him anymore. He had more energy and had not experienced incontinence of urine or dizziness after the first treatment. He was able to return to work full time. At this writing, the patient has been in remission for 26 months. This case demonstrates that Chinese scalp acupuncture can be a very effective treatment for patients with MS. Chinese scalp acupuncture holds the potential to expand treatment options for MS in both conventional and complementary or integrative therapies. It can not only relieve symptoms, increase the patient's quality of life, and slow and reverse the progression of physical disability but also reduce the number of relapses and help patients with multiple sclerosis to remain in remission.

Transcranial direct current stimulation (tDCS) for fatigue in multiple sclerosis.

Visual search as a tool for a quick and reliable assessment of cognitive functions in patients with multiple sclerosis.
Despite the high frequency of cognitive impairment in multiple sclerosis, its assessment has not gained entrance into clinical routine yet, due to lack of time-saving and suitable tests for patients with multiple sclerosis. Visual search is a promising instrument for the assessment of cognitive functions and potentially cognitive changes in patients with multiple sclerosis thanks to its good discriminatory power and insusceptibility to practice effects.

Current and Future Therapies for Multiple Sclerosis.

Decreased circulating miRNA levels in patients with primary progressive multiple sclerosis.

Characteristics influencing therapy switch behavior after suboptimal response to first-line treatment in patients with multiple sclerosis.
The objective of this paper is to identify patient characteristics and clinical events predictive of therapy switching in patients with suboptimal response to DMT. Younger patients with disease activity, especially MRI changes, are more likely to have their therapy switched sooner than patients who are older at the time of MS diagnosis and DMT initiation.

Genetic burden of common variants in progressive and bout-onset multiple sclerosis.
The contribution of genetic variants underlying the susceptibility to different clinical courses of multiple sclerosis (MS) is still unclear. Our results suggest that the liability of disease is better captured by common genetic variants in BOMS than PrMS cases. The absence of inflammatory activity and male gender further raise the difference between clinical courses.

Age-Related Vascular Differences Among Patients Suffering from Multiple Sclerosis.

Role of Pathogens in Multiple Sclerosis.

Transplantation of umbilical cord and bone marrow-derived mesenchymal stem cells in a patient with relapsing-remitting multiple sclerosis.

Combination of robot-assisted and conventional body-weight-supported treadmill training improves gait in persons with multiple sclerosis: a pilot study.
The majority of persons with multiple sclerosis (MS) experience problems with gait, which they characterize as highly disabling impairments that adversely impact their quality of life. Thus, it is crucial to develop effective therapies to improve mobility for these individuals. The purpose of this study was to determine whether combination gait training, using robot-assisted treadmill training followed by conventional body-weight-supported treadmill training within the same session, improved gait and balance in individuals with MS. Combination of robot with body-weight-supported treadmill training gait training is feasible and improved 6MWT and FRT distances in persons with MS.Video Abstract available (see Video, Supplemental Digital Content 1, http://links.lww.com/JNPT/A62) for more insights from the authors.

Targeting the Immune System in Multiple Sclerosis

Endogenous Retroviruses and Multiple Sclerosis

Evidence for a two-stage disability progression in multiple sclerosis.

Sodium accumulation is associated with disability and a progressive course in multiple sclerosis.

381 STUDIES FROM 11/1 to Friday 11/29 are below:

Thursday, July 2, 2015

Sunday, May 3, 2015

Sunday, April 26, 2015

Wednesday, April 8, 2015

Sunday, March 29, 2015

Sunday, March 1, 2015

Saturday, February 7, 2015

Sunday, January 18, 2015

Friday, January 9, 2015

Thursday, January 8, 2015

Saturday, June 28, 2014

Thursday, June 26, 2014

Generic Copaxone would be an excellent development for MSers who pay $40,000 for the drug annually, but devastating to Teva who's monopoly will die! Teva's biggest drug is Copaxone, a blockbuster multiple sclerosis drug that generated $1.05 billion in

DOCTORS DISCUSS EVERY MS TREATMENT NOW AVAILABLE INCLUDING:

Tuesday, June 10, 2014

DOCTORS DISCUSS EVERY MS TREATMENT NOW AVAILABLE INCLUDING:

Generic Copaxone would be an excellent development for MSers who pay $40,000 for the drug annually, but devastating to Teva who's monopoly will die!

Teva's biggest drug is Copaxone, a blockbuster multiple sclerosis drug that generated $1.05 billion in