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Thursday, February 12, 2009



Jerusalem, Israel and Lund, Sweden, February 12, 2009 – Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced that oral laquinimod, an investigational treatment for relapsing-remitting multiple sclerosis (RRMS), has received a Fast Track designation from the U.S. Food and Drug Administration (FDA). Teva completed enrollment for the first of its two Phase III clinical trials for laquinimod (ALLEGRO) in November 2008 and is currently enrolling RRMS patients globally for the second Phase III study (BRAVO).

Drugs designated for Fast Track are intended for the treatment of a serious or life-threatening condition and have demonstrated the potential to address unmet medical needs. Fast Track designation can potentially facilitate development and expedite the review process. This may allow the drug to enter the market as soon as late 2011.

“As global leaders in the treatment of multiple sclerosis, Teva is committed to bringing additional safe, effective and convenient therapies to MS patients,” said Moshe Manor, Vice President, Global Innovative Resources Group at Teva Pharmaceutical Industries. “We are pleased that the FDA has awarded laquinimod with a Fast Track designation, and are hopeful it will be part of our growing portfolio of innovative therapies.”

“We're encouraged by the reports we've seen from the Phase II clinical trial of laquinimod, and if this agent continues to prove safe and effective, it would be a welcome new treatment option available to people with multiple sclerosis,” said Dr. John Richert, Executive Vice President, Research and Clinical Programs, National MS Society.

Laquinimod is a novel, once-daily, orally administered immunomodulatory compound being studied as a disease-modifying treatment for RRMS. For more information on the ongoing laquinimod Phase III clinical program, please visit www.TevaClinicalTrials.com or call 1-800-840-5601.

About Laquinimod

Laquinimod is a novel once-daily, orally administered immunomodulatory compound that is being developed as a disease-modifying treatment for RRMS. Active Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries, Ltd. in June 2004. Results from a Phase IIb study in 306 patients were published in June 2008 in The Lancet and reported that an oral 0.6 mg dose of laquinimod, administered daily, significantly reduced MRI disease activity by a median of 60 percent (51 percent mean reduction) versus placebo in RRMS patients. In addition, the study showed a favorable trend toward reducing annual relapse rates and in the number of relapse-free patients compared with placebo. Treatment was well tolerated, with some transient and dose-dependent increases in liver enzymes reported, without clinically-evident liver damage.

In addition to the efficacy that laquinimod has shown in Phase II RRMS clinical trials, laquinimod has demonstrated potent therapeutic efficacy in preclinical models of other autoimmune diseases such as Crohn’s disease, rheumatoid arthritis, insulin-dependent diabetes mellitus, Guillain Barré Syndrome, and Lupus. The broad profile of efficacy in animal models of inflammatory diseases suggests that laquinimod affects a pivotal pathway of inflammation and autoimmunity. Teva has also initiated a clinical study to evaluate laquinimod for Crohn’s disease and expects to initiate the clinical development of laquinimod for Lupus Nephritis in the near future.

About the Phase III Program

Allegro (assessment of oral laquinimod in preventing progression of MS), a pivotal, global, 24/30-month, randomized, double-blind, Phase III study designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo in the treatment of RRMS, completed recruitment of more than 1,000 patient at 152 sites throughout North America, Europe and Asia in November 2008.

Bravo (benefit-risk assessment of Avonex® and laquinimod), a pivotal, global, 24 month, randomized, double-blind, parallel-group, placebo-controlled Phase III study designed to compare the safety and efficacy of laquinimod with placebo and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, is currently enrolling patients at centers throughout the United States, as well as Canada, Europe and Israel. The enrollment goal is approximately 1,200 patients with RRMS. To learn more about Teva's ongoing clinical trials, please visit www.TevaClinicalTrials.com or call 1-800-840-5601.

About Multiple Sclerosis

Multiple Sclerosis (MS) is the leading cause of neurological disability in young adults. It is estimated that more than 400,000 people in the United States are affected by the disease and that two million people may be affected worldwide. MS is a progressive, demyelinating disease of the central nervous system affecting the brain, spinal cord and optic nerves. Demyelination is the destructive breakdown of the fatty tissue that protects nerve endings.

About Teva

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Europe.

About Active Biotech

Active Biotech AB (NASDAQ OMX NORDIC: ACTI), headquartered in Sweden, is a biotechnology company with R&D focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase are laquinimod, an orally administered small molecule with unique immunomodulatory properties for the treatment of multiple sclerosis, as well as ANYARA for use in cancer targeted therapy, primarily renal cancer. Further key projects in clinical development comprise the three orally administered compounds TASQ for prostate cancer, 57-57 for SLE and RhuDex™ for RA. Please visit www.activebiotech.com for more information.

Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin®, Lotrel® and Protonix®, the effects of competition on our innovative products, especially Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, our ability to successfully identify, consummate and integrate acquisitions, including the integration of Barr Pharmaceuticals Inc., potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").

Active Biotech’s Safe Harbor Statement in Accordance with the Swedish Securities Market Act:

This press release contains certain forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause the actual results, performance or achievements of the company, or industry results, to differ materially from any future results, performance or achievement implied by the forward-looking statements. The company does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this press release.

Active Biotech is obligated to publish the information contained in this press release in accordance with the Swedish Securities Market Act. This information was submitted for publication on February 12, 2009 at 9:00a.m. ET.


About MS


Approximately 400,000 Americans have MS and every week about 200 people are diagnosed. Worldwide, MS affects about 2.5 million people. There is no cure for the disease.

Available at: http://www.nationalmssociety.org/about-multiple-sclerosis/who-gets-ms/index.aspx


MS symptoms are unpredictable and vary from person to person, and from time to time in the same person. Sometimes major symptoms disappear completely, and the person regains lost functions. In severe MS, people have symptoms on a permanent basis.

Symptoms may include:

· Difficulties with vision, cognition and speech

· Abnormal fatigue and episodes of numbness and tingling

· Loss of balance and muscle coordination making walking difficult

· Tremors

· Stiffness

· Bladder problems

· Depression

· Pain

· Respiration/breathing problems

Available at: http://www.nationalmssociety.org/about-multiple-sclerosis/symptoms/index.aspx

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Wednesday, February 11, 2009

Introducing Talk MS – a new online video series!

Provided by Joe, in Miami

MS in Balance (SM): your life in full

Introducing Talk MS

a new online video series
presented by MS In BalanceSM
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MS LifeLines®: Services sponsored by EMD Serono, Pfizer

Tuesday, February 10, 2009

MS and Pregnancy

Article information provided by Cherie C. Binns RN, BS., MSCN

Immunomodulation and Postpartum Relapses in Patients With Multiple Sclerosis

Kerstin Hellwig, MD; Christian Beste; Sebastian Schimrigk; Andrew Chan

Ther Adv Neurol Disorders. 2009;2(1):7-11. ©2009 Sage Publications, Inc.
Posted 02/04/2009

Abstract and Introduction


Multiple sclerosis (MS) mainly affects young women during a life period with desire for children. Relapse rate decreases during pregnancy and rises after delivery. Therefore, studies on satisfactory postpartum relapse prevention and its efficacy are essential. Previous smaller and uncontrolled studies suggested that intravenous immunoglobulin (IVIG) administration reduced the relapse rate following delivery. The objective of our observational study was to compare the efficacy of IVIG application, treatment with other immunomodulatory compounds or no treatment at all on the postpartal relapse rate in female MS patients from our pregnancy database.

» Read More

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Treating MS Symptoms With Stem Cells

On February 2nd a similar article was posted to this blog - Click here to review if not already seen.


And today, this interview appeared on the CBS Early Show:

Promising Northwestern University Trial Uses Patient's Own Stem Cells To Treat Symptoms Of Multiple Sclerosis

Feb. 10, 2009

CBS) An estimated 400,000 Americans suffer from multiple sclerosis, but the findings of a new clinical trial shows promise in the fight to reverse symptoms of MS.

Researchers at Northwestern University conducted a trial using patients' own stem cells to treat symptoms of multiple sclerosis, reports Early Show correspondent Debbye Turner Bell, and although the study group was small -- only 21 patients participated in it -- the findings are a huge breakthrough in the fight against MS.

Edwin McClure is strong and healthy now, but just four years ago, his life was very different.

"I would get fatigued. I couldn't deal with the heat," McClure said. "I had really bad balance."

In his senior year of high school, the star football player came down with what he thought was a cold. Then his vision changed.

"It was kind of like somebody turned down a dimmer switch 30 degrees," McClure said.

It was a neurologist who diagnosed what was happening to Edwin.

"He said, 'You have the signs of multiple sclerosis,'" McClure said.

"And what did you think?" Turner Bell asked.

"I remember hearing my mom say, 'Oh no.'" McClure said. "This is a disease 40-year-old white women get and I'm like 'I'm an 18-year-old black male. Somebody didn't get the memo somewhere.'"

For the next two years, Edwin received the conventional drugs used to manage MS, but his symptoms persisted. Then in 2005, he heard about a clinical trial being conducted at Northwestern University in Chicago.

"This therapy is designed to reset your immune system," said Dr. Richard Burt.

Burt led a study that looked at a completely new way to treat MS -- stem cell transplant. The patient's own stem cells are stimulated to grow more cells, then harvested. Next, chemotherapy is used to wipe out the immune system.

"It was rough," McClure said.

The treatment lasted nearly a month. Then Edwin's previously harvested stem cells were transplanted back.

"They call it your birthday when you get re-infused," McClure said. "So that birthday was January 21, 2006."

"When did you start thinking, 'This might have worked,'" asked Turner Bell.

"When my hair started growing back," McClure said.

"Well now for the first time in battling MS, I think you can say there's a study that's shown we've turned the tide against the disease," Burt said.

And today, Edwin's symptoms of MS have completely disappeared.

"I really don't feel like I have multiple sclerosis anymore," he said.

Edwin McClure and his mother, Bernice, visited The Early Show to share more of his story.

Click here Share/Embed and when their site opens click the link to watch the interview

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An "Executive Order" on Stem Cell Research

Support a Stem Cell Executive Order

President Obama has indicated that he plans to overturn the funding restrictions for stem cell research by signing an Executive Order. Currently, under the policy set by President Bush, federal funding for stem cell research can only be applied to human embryonic stem cell lines derived prior to August 9, 2001. If President Obama signs an Executive Order, then many new funding opportunities will be available for stem cell projects because the current funding barriers will be removed.
Click here to send President Obama a quick message thanking him for his support of stem cell research.
The time is now to make this important change in policy. Because stem cells have the unique ability to develop into many different cell types in the body, they are of great value to scientists and researchers looking for new ways to help cure diseases.

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Multiple Sclerosis - "The New Normal"

By: Cherie C.Binns, RN,BS,MSCN

How can you tell if a relapse is over and what you are feeling now is your “new normal”?

How do you know when an illness is resolved sufficiently to resume your normal activities or exercise schedule?

What determines when you’ve done too much and will suffer consequences from the activity?

For each of us with Multiple Sclerosis (MS) we must find our “new normal” following a relapse, an illness, childbirth, an accident or injury and must ask the questions above with a degree of self knowledge and care for our health and well-being. Some who are reading this may have just been diagnosed and are afraid that what is now being felt is your “new normal” and are scared out of your minds by this feeling. Others have had MS for longer and have successfully picked up and gotten on with your lives on more than one occasion after defining that “new normal” for yourself.

Continue to read this article by clicking here -then scrolling down the page to the Title of : "The New Normal"


Then return to this Blog Post to leave any comments that you may have, or if you have a question for Cherie, you can print and leave here too...

Monday, February 9, 2009

A Multiple Sclerosis patients' recent battle with Fatigue

I know this guy who has been plagued again with fatigue. Fatigue to the point that it almost hurts to lift his arms, and move his legs. Fatigue that he has not felt in quite some time and now is affecting him cognitively as well.

He awakes each morning feeling like he hasn't slept. He doesn't have the umph or the desire to even get behind the steering wheel of his car. He has felt actual fear that he might hurt himself or others because of the inability to think clearly and the almost constant feeling as if he is in another dimension or on another plane (and I am not referring to an airplane)..

This all started happening several weeks ago, while he was planning a party at his home. A party whose list seemed to keep growing and if he had-had the energy (and finances), he would have invited double the amount of people that he had.

In just under a week before his bash, he began feeling the effects of all the stresses he had placed upon himself.

And the fatigue factor reared its' ugly head from nowhere. Not in a long time had he felt as he was beginning to now feel. The eves leading up to his party were always cut short because of his inability to remain focused.

His party finally came and then ended.. All the hoopla in the planning and it finally happened, then ended just a few hours after it began.... The next day, he thought okay just another day or two and I will regain my energy. Two days post-party then three and then four and yet no end in site for this fatigue that came with a mighty force and has not found it's way to disperse and go away.

Now it being almost two weeks later and still he has problems upon awakening. Doesn't really want to get up in the morning even after a good 8+ hours of sleep and he surely still doesn't want to get behind the steering wheel of his auto until a few hours and a few cups of coffee had been first digested.. Finally feeling capable of getting on the road and then not knowing which way to turn or how to get from point "a" to point "b", a route that he has taken almost every day for the last few years. Confusion and yet he thought he was clear enough to drive...

Then he reminded me of another event that happened to him just a few morning ago..Having showered and washed his hair. Or had he? He couldn't remember, so he climbed back into the shower again, to shower.

And yesterday, he showered and watched his hair, only to leave the shower and while getting dressed, realized he forgot to rinse the shampoo from his hair.... Or how about this very day, when he left to go to the store and when getting from his car, realized that his pants were partially open and his belt was never secured... Now how the heck did that happen...

When will this fatigue go away?

Since his party he has been stressed with being stressed.
Stressed with this sudden onslaught of fatigue.
And of course the fatigue hampered by the stress. Where will it go from here?

His friends and family can't possibly understand what he tries to tell them.
They find him so astute and yet can't understand why he can't comprehend simple instructions...

Again he asks, When will this fatigue go away?

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IS Too Much Vitamin "D" a bad thing for those with Multiple Sclerosis?

According with Elaine Delack, RN it is:

In layman's terms, Ramagopalan and associate scientists report that persons having the HLA-DRB1*1501 gene are more likely to develop MS than those who don't have this gene. Those people who have two copies of this gene have even a greater risk of MS. Ramagopalan et al found that if vitamin D was given to cells that had two copies of this gene (HLA-DRB1*1501) that this would increase the activity of this gene even more.

Thus, their findings show that vitamin D will increase the gene expression activity of the HLA-DRB1*15 and this would put a person at greater risk of developing MS since increased HLA-DRB1*15 expression predisposes a person to the risk of developing MS.

Yet they state in their conclusion of their study that vitamin D would decrease the risk. This is not correct based on their study findings and instead supplementation with vitamin D could actually potentiate the development of MS.

Their findings that vitamin D can increase the HLA-DRB1*15 protein production which would increase a person's risk of developing MS is congruent with the trends that are seen in MS. MS is predominantly a Caucasian disease and the more fair-skinned persons have a higher incidence. Vitamin D serum levels are higher in light skinned persons than in darker skinned persons due to the melanin that inhibits the production of vitamin D in the darker skinned persons.


If you have questions or comments for Elaine, you can write to her at:
elaine@edmsllc.com OR leave a comment , below...

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Sunday, February 8, 2009

The National MS Society and MS LEARN ONLINE present...

Family Life and Relationships.
This Feature Presentation will discuss communicating with your child, helping your child cope with a parent's MS, and the transitions that may be required.
This Feature Presentation examines the issues of changing roles in your family and successful strategies for coping together.
Click here to view the webcast, or
copy into your browser: If you have a pop-up blocker, you will need to disable it prior to participating in a MS Learn Online webcast.

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An Interesting MS Video to share with you

From the MSRC in the UK:


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