THE TECFIDERA CHANNEL

Wednesday, April 20, 2016

Doctors Study Possible Link Between Tecfidera (Dimethyl Fumarate) and Shingles

A case report of a woman with relapsing-remitting multiple sclerosis (RRMS) who developed shingles while being treated with dimethyl fumarate (Tecfidera) has raised questions of whether the drug reactivates the varicella-zoster virus.

MS Therapy Tecfidera Might Exert its Actions by Increasing B-cells

While treatment of relapsing-remitting multiple sclerosis (RRMS) with Tecfidera (dimethyl fumarate) keeps relapse rates low, the details of immune changes induced by the drug are still evading scientists. A new study reported that the treatment increases the number of regulatory B-cells (Bregs), presenting a potential marker of treatment response.

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Study looks at mode of action in a relatively new, delayed-release treatment for RRMS

Delayed-release dimethyl fumarate (Tecfidera) was recently approved for patients with relapsing-remitting multiple sclerosis (RRMS), although the mechanisms by which the drug exerts its action were not fully understood. A new study from the University Hospital Münster, Germany, shows that dimethyl fumarate alters the balance between subpopulations of T-cells to promote a more anti-inflammatory state.

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Alkermes enrolling MS patients to assess safety of ALKS 8700 (MMF) compared to Tecfidera

Alkermes plc, a biopharmaceutical company focused on therapies for the treatment of central nervous system (CNS) disorders, announced that it has successfully met its 2015 goals for their product and late-stage pipeline drug portfolio, including ALKS 8700, a monomethyl fumarate (MMF) drug candidate for the treatment of multiple sclerosis (MS).

Tecfidera capsules and Aubagio tablets will be state-funded from February 1. Photo / iStock

Two more medicines will be funded by taxpayers for the treatment of multiple sclerosis, following a decision by Government agency Pharmac.

Image Source: MULTIPLESCLEROSISNEWSTODAY

Alkermes plc, a fully integrated global biopharmaceutical company, recently provided a regulatory update and positive clinical trial data for ALKS 8700, an oral, innovative and proprietary monomethyl fumarate (MMF) compound that is being developed to treat multiple sclerosis (MS).

Biogen will present new data that reinforce the proven efficacy and well-established safety profile of TECFIDERA® (dimethyl fumarate) in a broad range of people with relapsing-remitting multiple sclerosis (RRMS) at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain (7-10 October). The data show that TECFIDERA significantly reduced multiple sclerosis (MS) relapses and delayed disability progression in patients who are newly diagnosed and those early in their disease course; these effects were sustained over six years of follow-up.

Biogen (BIIB) will present new clinical data for its multiple sclerosis (MS) portfolio of therapies, including the most-prescribed oral treatment, TECFIDERA® (dimethyl fumarate), at the 31st meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain, 7-10 October 2015.1 TECFIDERA data will demonstrate its strong and sustained efficacy in relapsing-remitting multiple sclerosis (RRMS) among patients who were early in the course of their disease or newly diagnosed.

Merrill Lynch analysts Ying Huang and Catherine Hu commented on the future prospects of Biogen Inc (NASDAQ:BIIB) in a research report dated September 21. They maintain a Buy rating on the stock, with a price target of $400, signifying a return potential of more than 27% over Friday’s close at $314.67 apiece.

Dr. Daniel Kantor talks about switching from Tysabri to Tecfidera and the outcomes.
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Pegylated Interferon Beta-1a for Multiple Sclerosis: VIDEO

The MD Magazine Peer Exchange "Modifying the Course of Multiple Sclerosis in New Ways: The Latest Advances in Treatment" features a distinguished panel of physician experts discussing key topics in multiple sclerosis (MS) research and management, including the latest insights into MS pathophysiology, new medication options and their application in clinical practice, and more.

Image source: MULTIPLESCLEROSIS.NET

UG, Switzerland, Aug. 13, 2015 /PRNewswire/ -- Feedback gathered from 97 neurologists in June reveals that growing comfort with oral disease-modifying agents (DMAs) as well as multiple years of patient experience is driving neurologists to leave the injectables behind. While experience benefits oral agents moving forward in the treatment armamentarium, it is not the same story for established products such as Biogen's infused agent, Tysabri, which remains relegated further back in the treatment journey.

Cambridge, Massachusetts based Biogen Inc. has reported its second quarter 2015 results, posting a year-over-year seven percent revenue increase to $2.6 Billion in the quarter.

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.
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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?

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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

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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.
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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

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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

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AN IMPORTANT STUDY AVAILABLE TO EVERYONE ON TECFIDERA

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

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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)

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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.
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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

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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

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.
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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.
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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.
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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.
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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

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