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Saturday, March 23, 2013

Biogen’s Tecfidera multiple sclerosis drug wins EU agency backing


Biogen Idec, maker of the multiple sclerosis drugs Avonex and Tysabri, won European Union backing for Tecfidera, its first pill for the central nervous system disease.
Biogen should be granted marketing authorization for the drug, the European Medicines Agency’s Committee for Medicinal Products for Human Use said in a statement Friday. The European Commission usually follows the committee’s advice.
The drug, formerly known as BG-12, will follow Novartis’s Gilenya to the market in the EU as an oral option for the treatment of MS. Because of its safety profile and efficacy, Weston, Mass.-based Biogen’s Tecfidera may generate $3.25 billion in annual revenue by 2017, based on the average analyst estimate compiled by Bloomberg.
Biogen employs more than 1,000 people at its Research Triangle Park campus.
Multiple sclerosis affects an estimated 2.1 million people worldwide, causing symptoms ranging from limb numbness to blindness and paralysis, according to the National Multiple Sclerosis Society. Other MS drugs, including Biogen’s, are given by injection or intravenous infusion, and patient anticipation for Tecfidera may drive it to capture as much as 20 percent of the MS market within a year, according to Eric Schmidt, a Cowen & Co. analyst.
“This will probably be the No. 1 drug in MS,” said Michael Yee, an analyst with RBC Capital Markets in San Francisco, in a telephone interview this week. He recommends buying Biogen shares.
Biogen’s stock has doubled since April 2011 when the company first reported positive data from a late-stage trial of Tecfidera. The results were better than analysts and investors had expected, and they were bolstered later that year with results from a second trial, dubbed Confirm.
The most common form of MS is relapsing-remitting, characterized by neurological attacks followed by periods of recovery. The studies together showed that Tecfidera reduced patients’ annual relapse rate by 49 percent when given either twice a day or three times a day, and cut the proportion of patients who relapsed by 43 percent at twice-daily dosing and 47 percent at three times daily compared with placebo.
Overall, side effects were similar across the placebo and treatment groups, with the most common adverse events associated with Tecfidera being flushing and gastrointestinal effects, the company said.
A decision on Tecfidera is due from the U.S. Food and Drug Administration by Thursday. The drug was delayed by the FDA in October for three months without asking for additional studies. The agency said it needed more time to review the application, Biogen said.
STAFF WRITER DAVID BRACKEN CONTRIBUTED.
SOURCE: News Observer
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Thursday, March 21, 2013

Testosterone Affects MS Outcomes in Men




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Wednesday, March 20, 2013

COMPLEMENTARY AND ALTERNATIVE MEDICINE

So Much to print about this.
CLICK here to READ More

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Multiple Sclerosis and Fatigue


Medically speaking, fatigue is not the same thing as tiredness. Tiredness happens to everyone -- it is an expected feeling after certain activities or at the end of the day. Usually you know why you are tired and a good night's sleep solves the problem.

Fatigue is a daily lack of energy; unusual or excessive whole-body tiredness not relieved by sleep. It can be acute (lasting a month or less) or chronic (lasting from one to six months or longer). Fatigue can prevent a person from functioning normally and affects a person's quality of life.

According to the National Multiple SclerosisSociety, 80% of people with MS have fatigue. MS-related fatigue tends to get worse as the day goes on, is often aggravated by heat and humidity, and comes on more easily and suddenly than normal fatigue.

What Can I Do About MS-Related Fatigue?

The best way to combat fatigue related to your MS is to treat the underlying medical cause. Unfortunately, the exact cause of MS-related fatigue is often unknown, or there may be multiple causes. However, there are steps you can take that may help to control fatigue. Here are some tips:

1. Assess your personal situation.
·         Evaluate your level of energy. Think of your personal energy stores as a "bank." Deposits and withdrawals have to be made over the course of the day or the week to balance energy conservation, restoration, and expenditure. Keep a diary for one week to identify the time of day when you are either most fatigued or have the most energy. Note what you think may be contributing factors.

·         Be alert to your personal warning signs of fatigue. Fatigue warning signs may include tired eyes, tired legs, whole-body tiredness, stiff shoulders, decreased energy or a lack of energy, inability to concentrate, weakness or malaise, boredom or lack of motivation, sleepiness, increased irritability, nervousness, anxiety, or impatience.

2. Conserve your energy.



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What is Multiple Sclerosis (MS) ?


What Is MS?

Multiple sclerosis, also known as MS, is a chronic disease that attacks the central nervous system, i.e. the brain, spinal cord and optic nerves. Read more...



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Tuesday, March 19, 2013

Brain Imaging Pinpoints Cognitive Impairment in MS Patients


An MRI imaging technique could be used to track the progression of cognitive impairment in MS patients and may provide insight into the effectiveness of MS medications.

By Mollie Bloudoff-Indelicato, Everyday Health Staff Writer

HURSDAY, March 7, 2013 — MRI scans can map the destruction of cranial white matter, providing a new way to track cognitive impairment in patients with multiple sclerosis (MS), according to a study published in the journal Neurology.
Up to 65 percent of patients with multiple sclerosis will experience some cognitive impairment such as memory lapses and the inability to multitask, but doctors previously had no way of precisely measuring the biological cause. Now, an MRI scan called “diffusion tensor imaging” (DTI) shows that the destruction of white matter in the brain could be behind such cognitive issues. The technology looks at the flow of fluid within the brain and uses it to detect abnormalities in white matter. DTI also provides an easy way for physicians to follow the progression of the disease, which affects about 2.5 million worldwide.
“We are looking for the biological basis for memory and cognitive problems in MS,” says Hanneke Hulst, MSc, a neuroscientist at VU Medical Center in the Netherlands and lead author on the study. “Diffusion tensor imaging is a method that has been used in the clinic as a diagnostic tool for stroke and white matter disease. It has never been used to investigate such stringently defined cognitively impaired MS patients.”
Hulst and her team performed DTI scans on 55 multiple sclerosis patients, 20 of whom previously tested positive for cognitive impairment during mental examinations. Researchers compared these brain scans with those of the non-impaired MS patients as well as 30 healthy controls who were matched to the patients accounting for gender and age. Hulst found that brain damage within the white matter was a significant predictor of cognitive impairment – a discovery that would have been difficult to uncover with a regular doctor’s visit.
“One of the problems with patients with MS is it’s very hard to tell that someone is having difficulties with their cognitive function,” says Lily Jung Henson, MD, a neurologist at the Swedish Neuroscience Institute who was not involved in the study. “This gives us some markers to identify some patients that are impaired.”
Multiple sclerosis patients with cognitive impairment can become sluggish and experience personality shifts as the disease attacks their white matter. They may perform poorly at work and strain personal relationships at home. This could explain why cognitively impaired MS patients have higher rates of depression and divorce when compared with healthy individuals, says Peter Joseph Jongen, MD, a neurologist at the MS4 Research Institute in the Netherlands who was not involved in the study but has done extensive research on the topic.
“Memory impairment is also a problem, forgetting things,” Dr. Jongen says. "Bosses don’t like that at all.”
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US Patent Office grants Biogen Idec broad protection for multiple sclerosis pill


Federal officials Tuesday gave Biogen Idec Inc. 15-year patent protection for its multiple sclerosis pill Tecfidera, which is awaiting US regulatory approval.

The biotechnology company, based in Weston, said the US Patent Office granted a patent covering the 480-milligram daily dose for dimethyl fumarate, the active ingredient in Tecfridera, through 2028. That is the dosing amount sought in Biogen Idec’s new drug application, which the Food and Drug Administration is expected to rule on this month.
“It’s a very good outcome for Biogen Idec and for multiple sclerosis patients as well,” said Steven Holtzman, the company executive vice president for corporate development.

The patent will hold off the entry of generic competition longer than previously anticipated. It will do so by preventing competitors from deploying oral MS drugs using the same active ingredient at the dosing level Biogen Idec found effective in late-stage clinical trials. Biogen Idec is proposing that patients take two 240-milligram Tecfidera capsules daily.

Biogen Idec has received a “notice of allowance” for a similar patent in the European Union, the last administrative step before the patent is granted, Holtzman said. The company previously secured US and European patents covering the drug’s method of treating MS with the active ingredient. Those patents, which did not include the dosing regimen, expire in 2020, though the company would have the potential to extend both through the early 2020s.

The idea of extending them further grew out of the company’s recognition that the drug could prove effective at a lower dosage than the 700 milligrams given at earlier-stage trials.

“In clinical trials, we made the key discovery that by administering Tecfidera at this (480-milligram) dose we got good results in amelioration of the disease,” Holtzman said, noting that the dosing regimen ultimately “qualified as an invention” before the US Patent Office



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Vein "Liberation Treatment" Shows No Benefit In Multiple Sclerosis [VIDEO] ,,,,


Multiple Sclerosis is a devastating disease in which patients usually have progressive paralysis throughout their body. Treatment options are limited because researchers still have not found a cause for the initiation of the killing of nerve cells that occurs. What researchers do know is that something allows the immune system to become activated and attack components of the nervous system. However, what sets it off remains a mystery.


That is why, in 2009, when Italian vascular surgeon Dr. Paulo Zamboni proposed that MS might be caused by leaky veins leading to the brain people took notice. He said that a procedure to clear up the blood vessels would stop the disease in its tracks and called the condition chronic cerebrospinal venous insufficiency, or CCSVI. He suggested that opening the veins of the neck and chest with an angioplasty-like device would relieve the symptoms and eventually could stop the disease.  


He even offered proof that the procedure had worked on his wife, who had suffered from MS but had gone into remission after he had the surgery performed on her.
Since he had announced the procedure and toured the world giving lectures at medical conferences, universities and medical centers, an estimated 30,000 MS patients have sought out the procedure, which is performed in Poland, Bulgaria, Mexico, India and the United States. The procedure is not currently approved by the FDA for treatment of MS.

Now comes news of a small clinical trial at the University of Buffalo that examined the procedure in 30 MS patients. They found that while the procedure is safe, it had no benefit to patients' symptoms, quality of life or disease progression.

"What we found was rather surprising and unexpected," said neurosurgeon Dr. Adnan Siddiqui, co-principal investigator on the study. "It was quite the opposite of what we originally expected to find. The study showed that endovascular treatment of stenosed (blocked) veins had no effect in MS patients."

Additionally, MRI scans of patients who underwent the procedure found that in some patients there was an increase in brain lesions, a marker used to signify progression of the disease in MS.

"However, is this the last word on venous angioplasty? Absolutely not. I think a much larger cohort (group of patients) would be required to really demonstrate that definitivelysaid Dr. Siddiqu.

University at Buffalo researchers will present their results in an "Emerging Science" poster session March 20 at the annual American Academy of Neurology meeting in San Diego. 

To watch the University of Buffalo Reseachers Discuss the procedure and the clinical trial, view the video below.

CLICK THIS LINK to watch the Video




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Sunday, March 17, 2013

Vein Surgery for MS Fails in First Controlled Trial





SAN DIEGO -- Outcomes in multiple sclerosis patients were not improved with a controversial surgical procedure -- percutaneous transluminal venous angioplasty -- to improve blood flow in cerebrospinal veins, results of a small, double-blind, controlled trial indicated.
Among nine patients who underwent the venoplasty to clear blockages, clinical outcomes and brain lesion measures were generally worse after 6 months than in the 10 patients who received a sham procedure, Adnan Siddiqui, MD, of the State University of New York at Buffalo, and colleagues found.
Patients in the active-treatment group had a total of four clinical MS relapses during follow-up, compared with one relapse in the control group. MRI lesion volumes and numbers also were no better and, for some measures, showed strong trends toward worsened disease activity in the patients undergoing venoplasty.
Data from the study were released in advance of Siddiqui's formal presentation next week at the American Academy of Neurology's annual meeting here.
The findings were especially notable because they represent the first report of a randomized, controlled, double-blind trial of the procedure -- and also because Siddiqui and co-principal investigator Robert Zivadinov, MD, also of the University at Buffalo, have been more accepting than most U.S. neurologists of the theory underlying the venoplasty procedure.

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