Stu's Views and MS Related News http://msviewsandrelatednews.com/blog5/ MS (Multiple Sclerosis) Related Articles, containing info on Interferons, Rebif, Tysabri, Copaxone, Betaseron, Avonex, Serono, Biogen, Teva, Bayer, Vertigo, MRI, MS Society, Dirucotide, stem cell, en-us Nucleus CMS v3.32 © Weblog http://backend.userland.com/rss http://msviewsandrelatednews.com/blog5//nucleus/nucleus2.gif Stu's Views and MS Related News http://msviewsandrelatednews.com/blog5/ Participating in a Clinical Trial? Talk to Your Neurologist http://msviewsandrelatednews.com/blog5/index.php?itemid=1236

Wednesday, August 13, 2008

We are getting closer the release of the first oral medicines in the treatment of Relapsing-Remitting MS (RRMS) with the goal of preventing relapses (and hopefully progression and disability). Altruistic patients worldwide are taking part in multiple clinical trials testing the safety and efficacy (effectiveness) of these new forms of medicines.

Read Complete Story: Click Here
]]> General http://msviewsandrelatednews.com/blog5/index.php?itemid=1236 Wed, 27 Aug 2008 09:51:26 -0400 For Multiple Sclerosis Patients (& others): Device restores mobility after nerve damage http://msviewsandrelatednews.com/blog5/index.php?itemid=1235 Chicago Tribune

By Terri Yablonsky Stat | Special to the Chicago Tribune
August 26, 2008

Michaelene Needham, 44, of Northbrook has multiple sclerosis and relied on a cane and then a walker for years. Now the mother of three is finding new mobility and energy for her busy life.

Needham, like other people with upper motor neuron injuries including stroke, spinal cord injury and cerebral palsy, can now walk with greater ease using the Walk-Aide System. The WalkAide is an orthotic device made by Innovative Neurotronics that helps people with foot drop, a condition that inhibits a person's ability to raise the front part of the foot.

Approved by the U.S. Food and Drug Administration in 2006, the WalkAide uses advanced sensor technology to analyze the movement of the leg and foot. The system sends electrical signals to the peroneal nerve, which controls movement in the ankle and foot. Gentle electrical impulses activate the muscles to raise the foot at the appropriate time during the step cycle.

The device, which is the size of a pager and fits just below the knee, includes a control unit, a flexible cuff and two electrodes. It must be prescribed by a doctor and, in Illinois, fitted by a licensed orthotist who has completed the WalkAide training program.

"This is the biggest breakthrough in orthotics in 25 years," said Michael Oros, president of Scheck & Siress, the Chicago-based orthotic and prosthetic company that fitted Needham for the WalkAide. Patients with foot drop typically have used a plastic brace that fits inside their shoe and holds the foot at a 90-degree angle. "But with the WalkAide, the patient's own musculature pulls the foot up. It's a powerful feedback mechanism for patients. The WalkAide allows the patient to use their own muscles that in many cases have been dormant for 10 to 12 years."

In addition to improving the patient's gait, the WalkAide increases mobility and independence, increases range of motion, reduces atrophy and improves circulation, said Oros, a board-certified prosthetist and orthotist.

Needham, who was diagnosed with MS in 1991, started using a cane in 2004 and switched to a walker last September after she fell in her home. "That's when I started deteriorating," she said. "I couldn't walk far. I hung on to the walker and my legs dragged behind me. Because of the dragging, I was fatiguing. I could barely get through the grocery store."

She was fit for the WalkAide in April after her doctor determined she was a candidate. Those eligible for the device must not wear a pacemaker, nor can they have a history of seizures, have a metal implant in or around the lower extremity or be pregnant. In addition, patients need an intact peroneal nerve for the device to work. People with progressive diseases such as MS may use it indefinitely, Oros said.

"I keep it on all day, from 7 a.m. to 10 p.m.," said Needham. She uses the walker when walking long distances too. "I'm so excited about being able to do more. I'm building muscles and getting my strength back. My posture is better. ... It's finding all these muscles that didn't work for a while.

"When I'd go to the grocery store I had to sit in the car and rest before going home, where I'd lie down again. Now I come home and I'm able to go to my next errand."

Although the youngest person Scheck & Siress has fitted for the device is a teenager, Oros said children with cerebral palsy could benefit from the device. "Their gait is improved, they have better balance and they improve walking speed over time."

The WalkAide costs around $5,000 for one foot and is currently not covered by insurance, according to Mary Ann Schultz, spokeswoman for Blue Cross and Blue Shield of Illinois, the state's largest insurer. The device gets a thumbs-up from Dr. Dusan Stefoski, professor of neurology and director of the Multiple Sclerosis Center at Rush University Medical Center. "I am astonished by the WalkAide," he said. "I've been in the field of MS since the late '70s and what I see is quite beautiful from a functional point of view."

ctc-tempo@tribune.com

]]> Assistive Devices / Equipment http://msviewsandrelatednews.com/blog5/index.php?itemid=1235 Tue, 26 Aug 2008 14:19:43 -0400 MS Related: FDA Prompted to Seek Labeling Change after Tysabri PML Cases in Europe http://msviewsandrelatednews.com/blog5/index.php?itemid=1234 Date Published: Monday, August 25th, 2008
NewsInferno.com

Federal regulators informed healthcare providers today that monotherapy with Tysabri has been linked to two new European cases of progressive multifocal leukoencephalopathy (PML). The U.S. Food & Drug Administration (FDA) said it is working with Elan and Biogen Idec, the manufacturers of Tysabri, to amend the product labeling to inform prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy.

In the U.S. Tysabri was taken off the market in 2005 after three patients in clinical trials developed PML. But the dug was reapproved in 2006, although it was subject to restrictions. Tysabri is now available only to patients with relapsing multiple sclerosis (MS) or Crohn’s disease (CD) who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections.

It was once thought that taking Tysabri alone - known as monotherapy - lessened the risk of developing the brain disorder. But in both European cases, the patients - who were receiving Tysabri to treat multiple sclerosis - were not undergoing any other therapy. According to the FDA, one patient had been treated with Tysabri for 14 months, while the other received it for 17 months.

PML attacks the brain and central nervous system and is usually fatal. It is caused by a polyomavirus, called the JC virus. The JC virus is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) allows it to be reactivated and start to multiply. People with a weakened immune system or people taking drugs that suppress their immune system (immunosuppressants) are most likely to get the disease. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled.

In 2005, the law firm Parker Waichman Alonso LLP was retained by the estate of Anita Smith, a patient who died from a confirmed case of PML while taking Tysabri. In 2002, Smith, who had been diagnosed with multiple sclerosis, was enrolled in a clinical trial involving Tysabri along with 1,200 other patients. In November 2004, while her health was rapidly deteriorating, Tysabri gained a coveted “fast-track” approval FDA. Despite her PML symptoms, Smith was allowed to continue receiving treatment in the Tysabri trial, and took her last IV infusion of the drug in January 2005. On February 24, 2005 she died of from PML. Four days later, Tysabri sales were halted.

In its 2005 Annual Report, Elan Inc. informed shareholders that it had entered into settlement talks with the lawyers representing Anita Smith’s estate. When contacted, Jerry Parker, the managing partner of Parker Waichman Alonso LLP said the Anita Smith Tysabri case had been resolved, but that the case was confidential.

This entry was posted on Monday, August 25th, 2008 at 12:33 pm and is filed under Legal News, Pharmaceuticals.


Have a Comment? Leave at Stu's Views MS Blog]]> Tysabri Related http://msviewsandrelatednews.com/blog5/index.php?itemid=1234 Tue, 26 Aug 2008 09:03:13 -0400 24 / 7 Telephone Peer Assistance from " MS Friends " http://msviewsandrelatednews.com/blog5/index.php?itemid=1233 MSFriends is the first and only 24/7 telephone peer support Initiative for people living with Multiple Sclerosis. All of our highly trained volunteers are living with MS themselves so they understand and care about each caller. MSFriends was created to help end the isolation and fear that comes with a diagnosis of Multiple Sclerosis. We are here any time of the day or night to take your calls at 1-866-673-7436 (1-866-MSFriends). Please call us and visit our website at www.msfriends.org, we are here for you!


If you are interested in becoming an MSFriends telephone peer support volunteer, please read the requirements on our website at http://msfriends.org/index.php?pg=volunteers.


If you feel you meet the requirements, please email szachary@msfriends.org.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Information contributed to MS Peers by Stuart Schlossman of "MS Views and Related News"

Be sure to read more educating topics relating to MS by opting-in to receive our weekly e-newsletter.

````````````````````````````````````````````````````````````````````````````````]]> ADDITIONAL MS Resource Sites http://msviewsandrelatednews.com/blog5/index.php?itemid=1233 Mon, 25 Aug 2008 17:05:55 -0400 Multiple Sclerosis decreases as the amount of vitamin D available to the body increases... http://msviewsandrelatednews.com/blog5/index.php?itemid=1232 Medical News Today
Article Date: 23 Aug 2008 -

Study Highlights Link Between Vitamin D And Multiple Sclerosis

Vitamin D, the principal regulator of calcium in the body, may prevent the production of malignant cells such as breast and prostate cancer cells and protect against specific autoimmune disorders including multiple sclerosis (MS) according to an article by Sylvia Christakos, PhD, of the UMDNJ-New Jersey Medical School.

In the article, Christakos reports that research shows that the incidence of MS decreases as the amount of vitamin D available to the body increases, either through sunlight exposure or diet. The article notes that MS is "for the most part, unknown in equatorial regions" and that the prevalence of the disease is lower in areas where fish consumption is high. The study is available online in the Journal of Cellular Biochemistry."Since vitamin D is produced in the skin through solar or UV irradiation and high serum levels have been shown to correlate with a reduced risk of MS, this suggests that vitamin D may regulate the immune response and may promote a host's reaction to a pathogen," Christakos said.

Christakos' report focuses on the immunosuppressive actions of the active form of vitamin D, which may inhibit the induction of MS, and emphasizes the importance of maintaining a sufficient vitamin D level.

"Evidence has shown that the maintenance of an adequate vitamin D level may have a protective effect in individuals predisposed to MS," Christakos said. "One device of vitamin D action may be to preserve balance in the T-cell reaction and thus avoid autoimmunity."

Despite the significant evidence of the benefits of vitamin D relative to MS and other autoimmune diseases, Christakos cautions that further studies are needed to determine whether vitamin D alone or combined with other treatments is effective in individuals with active MS.

The University of Medicine and Dentistry of New Jersey (UMDNJ) is the nation's largest free-standing public health sciences university with more than 5,500 students attending the state's three medical schools, its only dental school, a graduate school of biomedical sciences, a school of health related professions, a school of nursing and its only school of public health, on five campuses. Last year, there were more than two million patient visits to UMDNJ facilities and faculty at campuses in Newark, New Brunswick/Piscataway, Scotch Plains, Camden and Stratford. UMDNJ operates University Hospital, a Level I Trauma Center in Newark, and University Behavioral HealthCare, a mental health and addiction services network.

University of Medicine and Dentistry of New Jersey (UMDNJ)
Stanley S. Bergen Bldg., 65 Bergen St., Fl. 13
Newark, NJ 07101
United States
http://www.umdnj.edu ]]> M.S. Research Study Reports http://msviewsandrelatednews.com/blog5/index.php?itemid=1232 Sun, 24 Aug 2008 18:56:26 -0400 The Cost of feeling better can spell "Financial Ruin" for Many with Multiple Sclerosis http://msviewsandrelatednews.com/blog5/index.php?itemid=1230 Rising bill for new drugs threatens to overwhelm patients, employers

Putting a strain on mutual cashflow
BY CAROL M. OSTROM
The Seattle Times


SEATTLE --Sally Garcia, a 53-year-old lawyer disabled by multiple sclerosis, was torn.

A new-generation medication, Copaxone, was really working for her. After two decades of being in and out of hospitals, Garcia was taking steps to work again.

Her wallet, though, was in severe distress. Under her Medicare prescription plan, Garcia's share of the expensive drug was $330 per month. All together, medications were taking a third of her disability payments -- her only income -- and she couldn't swing it.Copaxone, Enbrel, Remicade: For some patients, such new-generation drugs, often called "biologicals" or "bioengineered" when they are created by genetically modified living cells, have performed magic. In some cases, they work when other drugs have failed, or for diseases that previously had no drug treatments at all.

But they cost a lot -- often $2,000 to $3,000 per month.

And in a double whammy, some insured patients who previously paid a fixed amount -- likely $30 to $50 even for the most expensive, brand-name drugs -- are suddenly finding the rules have changed.

For these new drugs, an increasing number of patients must pay a percentage of the tab, generally 25 to 30 percent. For many of those patients, that can mean a bill of $600 to $900 a month for a drug that they may need for many years.

"The idea of insurance is to protect people from catastrophic costs," says Gary Claxton, director of the Healthcare Marketplace Project for the Kaiser Family Foundation.

"At some point, people aren't going to consider themselves insured if they're at risk for a huge amount out-of-pocket just because they have one disease rather than another."

In 2007, the tab for bioengineered and "specialty" drugs was nearly $59 billion. Industry analysts predict it will reach $98 billion by 2011.

"The reality is that this is where the pharmaceutical industry is focusing their research," says Jim Carlson, Group Health Cooperative's pharmacy director.

Typical bioengineered drug treatments for rheumatoid arthritis now run about $16,000 a year, says Dr. Philip Mease, director of rheumatology research for Swedish Medical Center.
]]> General http://msviewsandrelatednews.com/blog5/index.php?itemid=1230 Sun, 24 Aug 2008 17:49:32 -0400 Multiple Sclerosis: "Plasmapheresis and MS" http://msviewsandrelatednews.com/blog5/index.php?itemid=1229
By the Accordant Medical Team

What is Plasmapheresis?
Plasmapheresis means "plasma separation." This medical procedure consists of exchanging a patient's blood plasma (the watery part of blood) with a replacement solution. First, blood is withdrawn so that the plasma can be separated from the blood cells. Once separated, the blood cells are recombined with a replacement solution that resembles plasma, and the new mixture is then transfused back into the patient. Plasmapheresis is also called plasma exchange.Why is Plasmapheresis Used to Treat MS?
Blood plasma contains antibodies and other substances that play a role in many autoimmune/immune mediated diseases.

Plasmapheresis has been successfully used for decades to treat many conditions, including autoimmune diseases like myasthenia gravis (a rare muscle disease) and Guillain-Barre Syndrome (a disease thought to result from an abnormal immune response to a virus).


Because MS is also an immune mediated disease, plasmapheresis is a very promising treatment. This procedure was used occasionally to treat severe MS in the early 90's, and recently gained attention when Mayo Clinic researchers noted "moderate to marked improvement" in 42 percent of patients treated. Some patients with severe problems, including paralysis and the loss of speech, experienced dramatic improvement, regaining full use of their arms, legs and speech.

Plasmapheresis is not a cure for MS, nor is it recommended for most patients. At this time, plasmapheresis is performed only on patients whose severe attacks are unresponsive to other treatments--only a very small proportion of those who have acute flares. Researchers hope to learn why this procedure works for some people and not for others. Some speculate that plasma exchange dilutes the damaging immune factors in the plasma.

How is Plasmapheresis Done?
Plasmapheresis is conducted while the patient reclines in a chair or lies on a bed. The patient may experience some discomfort, but the procedure is not painful.

A catheter is used to draw blood from a vein, usually in the crook of the patient's arm. The blood is then placed in a device known as a cell separator. The cell separator either spins the blood at high speed to separate the cells from the plasma or it passes the blood though a membrane that filters out the cells and allows only the plasma to penetrate.. The antibody-containing plasma is thrown away. The cells are combined with a replacement fluid (usually albumin or a synthetic fluid that mimics plasma) and returned to the patient through another tube connected to the hand or foot on the opposite side of the body. This arrangement allows the patient to have one hand free during the procedure, which takes several hours.

The patient is given an anticoagulant drug during plasma exchange to keep the blood from clotting. At any given time during the procedure, the amount of blood outside the patient's body is similar to the amount one would donate at a blood drive.

What are the Risks?
Dropping blood pressure is the most common problem experienced during plasmapheresis. Patients whose blood pressure is falling may feel dizzy, faint, cold or sweaty, or experience blurred vision or abdominal cramps When these symptoms are reported, those attending the patient will assist by lowering the patient's head, raising the legs and administering IV fluids.

The anticoagulant medications given during the procedure can sometimes cause bleeding. These medications can also cause more serious reactions, such as an irregular heartbeat or seizures. These reactions can be avoided, however, if the patient reports the symptoms known to occur before the seizures or changes in heart beat: a metallic taste in the mouth, tingling around the mouth or limbs, or muscle cramps.

The most serious possible reaction is an allergic reaction by the patient to the plasma replacement fluids or the sterilizing agents used on the tubes. Itching, wheezing, or the eruption of a rash are signs of a medical emergency. If any of these symptoms occur, the procedure must be stopped immediately and IV medications administered.

Are There any Side Effects?
Sometimes blood clotting problems continue after plasma exchange. Infections are also more likely at this time because the immune system may be extremely suppressed. This is because the desirable antibodies have been filtered out along with the undesirable ones. The body will eventually recreate the necessary antibodies, but patients need to be especially careful to guard against infections right after plasmapheresis. Antibodies can be administered intravenously, if necessary.



References

1. "Multiple Sclerosis" Mayo Clinic.com Web site (http://mayohealth.org/home?id=5.1.1.13.8)
2. "Plasmapheresis (Plasma Exchange)," From The MS Information Sourcebook posted on the National Multiple Sclerosis Web site (http://www.nationalmssociety.org/\Sourcebook-Plasmapheresis.asp)


Reviewed by a member of the

First published October 1, 1999
Last updated May 3, 2003
Copyright © 1999 Accordant Health Services, Inc. All Rights Reserved.

>>Source LINK <<]]> Alternative Therapies http://msviewsandrelatednews.com/blog5/index.php?itemid=1229 Fri, 22 Aug 2008 19:28:41 -0400 The Swank Diet for MS http://msviewsandrelatednews.com/blog5/index.php?itemid=1228
The Swank Low-Fat Diet for the Treatment of MS, developed by Roy L. Swank, MD, Ph.D., is backed by over 35 years of research. Read actual patient testimonials and join our message forum.

www.swankmsdiet.com ]]> Alternative Therapies http://msviewsandrelatednews.com/blog5/index.php?itemid=1228 Thu, 21 Aug 2008 18:13:12 -0400 Multiple Sclerosis News: New drugs in late-stage trials offer promise for sufferers of the chronic and crushing disease http://msviewsandrelatednews.com/blog5/index.php?itemid=1227

Two Steps Forward


Mary Ellen Egan 08.07.08, 6:00 PM ET
Forbes issue date 09.01.08
{as of today (August 20, 2008), this is not yet in print}

New drugs in late-stage trials offer promise for sufferers of the chronic
and crushing disease multiple sclerosis

Robin Giese, 59, kicks off each day by getting out of her wheelchair for a half-hour ride on a stationary bike followed by 30 minutes of stretching exercises. Most afternoons she visits friends or one of of her five grandchildren, and in the evenings she and her husband, Clifford, entertain guests or go out to dinner.

Giese hasn't always been so active. She has multiple sclerosis, the degenerative disease of the central nervous system that afflicts 400,000 Americans. In MS the immune system attacks myelin, a fatty substance that protects nerve fibers much the way insulation protects electrical wires. When the unprotected nerve fibers, or axons, are damaged, signals are blocked or delayed traveling to and from the brain. This causes a variety of symptoms that can include blurred vision, incontinence, difficulty walking and paralysis.
Over three decades multiple sclerosis has slowly robbed Giese of her mobility and weakened her muscles, and without treatment she would be all but immobilized in her wheelchair. But an experimental drug has changed the course of her disease--and her husband's career path.

The compound, called dirucotide, is a chain of 17 amino acids that mimics a portion of the protein in myelin. It works by acting as a decoy to divert the attacking immune cells. It has had such a profound impact on Robin's condition that her husband has started a company, BioMS Medical, to bring it to market. Today dirucotide is one of two novel MS drugs in late-stage clinical trials. The other, from a small firm called Acorda, improves muscle strength.

There are four kinds of MS. Most sufferers are first given a diagnosis of a mild relapsing form of the disease marked by occasional flare-ups followed by months or years without symptoms. Ninety percent of patients with this condition eventually develop a progressive MS characterized by continuous deterioration. The two remaining types of MS, less common, entail a rapid decline.

Most existing MS therapies work by suppressing the immune system, and they're generally effective only when the disease is at an early stage. They include Biogen Idec (nasdaq: BIIB - news - people )'s monoclonal antibody Tysabri, beta interferons and anticancer drugs. They can be helpful (there is no cure), but their side effects can range from flu-like symptoms to fatal viral infections of the brain.

Dirucotide began with research conducted at the University of Alberta by doctors Kenneth Warren and Ingrid Catz. In 1989 Warren developed a synthetic peptide that mimics myelin protein. He began testing his compound on MS patients in 1994, and Robin Giese, who became a patient of his that same year, received her first infusion in 1996. Three weeks later, she says, her energy level had increased dramatically, and her head, which had felt "fuzzy" for years, was suddenly "clear." "It was the best I'd felt in years," she says.

Even though the drug didn't allow her to throw away her wheelchair, she credits it with restoring her zest in life. "Before I started taking it, I couldn't predict how I'd feel or what I could do each day. Now I wake up feeling great and have energy for the entire day." She gets dirucotide infusions twice a year.

The university lacked money for clinical trials, so Clifford, who had made a fortune with a chain of Canadian oil-change stores, stepped in to help. He and his brother, Kevin, licensed the drug from the university and founded BioMS in September 2000. The following year they started selling shares to the public, and they've raised $180 million so far on top of the $1 million that they estimate they invested themselves at the outset. Kevin took the role of chief executive, and Clifford became chairman.

BioMS moved to late-stage clinical trials of dirucotide in January 2005 and has done them with 611 patients with the progressive form of MS. Testing should wrap up in mid-2010.

The results so far have been very promising. Patients with either of two genes associated with autoimmune disorders, HLA-DR2 and HLA-DR4, have gone five years without any progression of the disease. Those genes are found in 65% to 75% of all MS patients, and because of that analysts estimate that the potential market for drugs like dirucotide, effective for patients at later stages of the disease, could reach $10 billion a year. The current market for all existing MS drugs is $6 billion.

Acorda's drug, Fampridine-SR, works differently from dirucotide and specifically addresses one of the most devastating symptoms of the disease, loss of muscle strength. Its key compound, 4-aminopyridine, has been around for 100 years. Academic researchers originally used the synthesized chemical to study nerve cell conduction. Not until the 1980s did they figure out how it works and how it might help with MS.

In MS the damage to myelin exposes channels on the surface of the axon, allowing potassium ions to leak out and thus dissipate the electrical current that carries nerve signals. The 4-aminopyridine molecule patches the exposed channels so the current can pass through.

But, early on, using the compound in humans proved to be tricky. Dosages were hard to control, and patients given too much had seizures. The drug languished until the mid-1980s, when Elan Corp. (nyse: ELN - news - people ), an Irish firm, began looking for ways to reformulate it.

In 1994, after a decade of tinkering, Elan began testing a sustained-release version in patients with MS. A year later Acorda, then privately held, approached Elan for permission to test Fampridine-SR, as the new version was named, in spinal cord injury patients. Acorda began clinical trials in 1998 and, five years later, when Elan was struggling, secured the rights for Fampridine-SR for all applications.

Acorda started its tests of Fampridine-SR in MS patients in late 1999, and in June this year the now public company completed late-stage trials in 540 patients with all four types of MS. The results are impressive: 43% of the patients showed consistent improvement in walking speed, as against 9% of patients on a placebo.

"One of the first questions patients ask is if they'll be in an wheelchair. Anything that helps to keep them out of a wheelchair longer is very important," says Dr. Hillel Panitch, one of the drug's clinical investigators and director of the University of Vermont's Multiple Sclerosis Center. Acorda plans to submit its data to the FDA early next year and ask the agency for fast-track approval.

Source: Forbes Magazine - at this link: http://www.forbes.com/business/forbes/2008/0901/062.html

Information provided for patients with MS seeking options, by Stuart Schlossman of MS Views and Related News

]]> Misc. Meds for MS Treatment http://msviewsandrelatednews.com/blog5/index.php?itemid=1227 Wed, 20 Aug 2008 12:15:22 -0400 Tysabri Forecast to Achieve Blockbuster Status by 2014 http://msviewsandrelatednews.com/blog5/index.php?itemid=1226 Pharmiweb
AVOS Life Sciences
Posted on:19 Aug 08

MORRISVILLE, N.C. (Aug. 18, 2008) - AVOS Life Sciences contends that Tysabri will exceed $1 billion in sales by 2014 as previously forecasted in the AVOS Therapeutic Market Outlook (TMO) Multiple Sclerosis Report released on July 1, 2008. In addition, the market dynamics featured in the report remain the same despite the recent cases of progressive multifocal leukoencephalopathy (PML) associated with Tysabri. On July 31, 2008, Biogen Idec and Elan filed a current report with the Securities and Exchange Commission which was the first public disclosure of the two cases of PML in patients treated with Tysabri monotherapy. The cases were the first report of Tysabri patients suffering from PML since Tysabri was reintroduced to the market in 2006. The speed with which the cases were identified and treated is a testament to the success of the risk-management plans for Tysabri in place in Europe and the U.S.

“The recent cases of PML will not significantly affect the uptake prospects for Tysabri in our model over the course of the entire forecast period,” said Jim Wahl, principle analyst and author of the TMO Multiple Sclerosis report. “We stand by our projection that Tysabri will achieve blockbuster status by 2014.”

Based upon information gathered from the AVOS Physician Panel, AVOS determined that neurologists were hopeful for Tysabri but remained apprehensive in prescribing the drug to a wider patient population until more long-term safety data becomes available. In addition to the investigation of input received from the AVOS Physician Panel, the AVOS TMO Multiple Sclerosis Report also probes five major developments affecting the market over the period from 2005-2014:
• Cautious optimism marks Tysabri’s return
• Oral therapies will alter the multiple sclerosis treatment paradigm
• Changes in physician attitudes and prescribing habits
• Market shifts will slow despite new treatment options
• Moderate market growth

AVOS asserts that the market model contained within the TMO Multiple Sclerosis report will be updated if fallout from the cases of PML associated with Tysabri alter the forecasts contained within the model.

About AVOS Life Sciences, LLC
AVOS Life Sciences, LLC (http://www.avoslifesciences.com) is a healthcare consulting and research firm headquartered in Morrisville, North Carolina. The firm helps clients understand the rapidly evolving pharmaceutical, biotechnology, medical device and diagnostic market segments, thereby assisting with strategic business development and investment decisions. AVOS’ analytical tools are structured to assist with real-time decision-making in a dynamic environment.
AVOS’ proprietary approach includes knowledge obtained through coverage of leading industry events, access to internal and external healthcare databases and the analysis and perceptive commentary of a network of experts such as leading pharmaceutical executives, global regulatory specialists, manufacturing and reimbursement consultants, and a team of analytical scientists.

For more information:
http://www.avoslifesciences.com

Editor's Details

Michael Goodman
AVOS Life Sciences
http://www.avoslifesciences.com
reports@avoslifesciences.com
]]> Tysabri Related http://msviewsandrelatednews.com/blog5/index.php?itemid=1226 Tue, 19 Aug 2008 18:18:56 -0400