Preclinical Study Published in Nature Medicine Shows Anti-LINGO-1 Antibody Promotes Remyelination

Sep 30 2007, 1:01 PM EST

News source: Business Wire

Biogen Idec (NASDAQ: BIIB) announced today the publication of findings from a preclinical study reporting that the anti-LINGO-1 antibody can promote spinal cord remyelination and axonal integrity, suggesting a potential role as a treatment for multiple sclerosis (MS) and other demyelinating diseases of the central nervous system (CNS). The results are published in the October issue of Nature Medicine, and confirm previously published data that suggested a role for the anti-LINGO-1 antibody in CNS myelin repair.

LINGO-1 appears to act as a molecular switch that controls the ability of cells in the CNS to produce myelin, the protective cellular sheath surrounding nerve fibers that assists nerves in conducting electrical impulses. When myelin is damaged by autoimmune diseases such as MS, nerve cells lose their ability to send signals to the body. As this damage progresses, these cells may eventually die, contributing to disability. Although MS therapies can slow the progression of this damage, none are able to repair the lost myelin. Biogen Idec scientists had previously discovered that LINGO-1 may act to prevent myelin repair after injury. In the study published today, by blocking LINGO-1, scientists were able to promote myelin repair and improve recovery in an animal model of MS.

"While preliminary, these findings are encouraging and suggest that the anti-LINGO-1 antibody has the potential to repair some of the damage caused to the CNS. This may be an entirely new approach to treating MS," said Alfred Sandrock, MD, PhD, Senior Vice President, Neurology Research and Development, Biogen Idec. "The anti-LINGO-1 program is a key part of our research and development efforts in MS. We have a diverse pipeline of therapeutic candidates targeting multiple pathways and patient needs with the goal of offering a portfolio of options for people living with this devastating disease."

In the study, functional recovery from demyelination was modeled by tracking the disease progression of experimental autoimmune encephalomyelitis (EAE), a widely accepted animal model for studying the clinical and pathological features of MS. The anti-LINGO-1 antibody was administered before disease onset and was found to decrease the severity of EAE across all stages of disease progression, when compared to the control treatment group. In a related study, anti-LINGO-1 antibody treatment resulted in significantly reduced EAE symptoms even when it was administered after disease onset.

The study found that functional recovery, as measured by EAE scores, correlated with improved axonal integrity and axonal remyelination. Physiological improvements in axonal integrity were revealed by magnetic resonance DTI imaging. At the cellular level, the production of new myelin sheaths was revealed by histological staining and electron microscopy.

"This is a very exciting early indication that therapies targeted at myelin repair within the CNS can have a dramatic effect on behavioral functional outcome in models of multiple sclerosis, and opens the door for the identification of additional regulators of myelin repair that might be used to enhance functional recovery in patients with MS," said Robert H. Miller, PhD, Principal Investigator, Myelin Repair Foundation and Director of the Center for Translational Neuroscience, Case Western Reserve University.

Anti-LINGO-1 was discovered by Biogen Idec and is one of several programs in the company's industry-leading research and development efforts in MS. In addition to its two marketed products, the company has four programs in clinical development for the treatment of MS.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

Safe Harbor/Forward-Looking Statements

This press release contains forward-looking statements regarding anti-LINGO-1 antibody, which is currently in the preclinical stage of drug development. Drug development involves a high degree of risk. Only a small number of research and development programs result in commercialization of a product. Factors which could cause actual results to differ materially from Biogen Idec's current expectations include the risk that the company may not be able to demonstrate the safety and efficacy of anti-LINGO-1 antibody at each stage of the clinical trial process; technical hurdles relating to the manufacture of anti-LINGO-1 antibody may be encountered; the company may not be able to meet applicable regulatory standards or regulatory authorities may fail to approve anti-LINGO-1 antibody; and the company may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with Biogen Idec's drug development and other activities, see the periodic and current reports that the company has filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

MS treatment Tysabri wins approval in New Zealand

Fri Sep 28, 2007 11:06am EDT

NEW YORK, Sept 28 (Reuters) - Biogen Idec Inc (BIIB.O: Quote, Profile, Research) and partner Elan Corp (ELN.I: Quote, Profile, Research) said their drug Tysabri has been approved in New Zealand for treatment of the relapsing remitting form of multiple sclerosis.

The approval was based on favorable results of a two-year late-stage trial of the medicine, the companies said in a release, noting that an estimated 4,000 people in New Zealand are affected by MS.

The progressive disease -- which can lead to varying levels of paralysis, visual problems and other serious complications -- is caused by damage to the fatty myelin sheath that insulates nerves and helps neurons carry electronic messages.

The drugmakers said clinical data show the medicine, after two years of use, reduced by 68 percent the annual number of relapses in flare-ups of the disease compared to placebo and reduced the risk of disability progression by 42 percent.

© Reuters2007All rights reserved

Bayer Schering Pharma AG, Germany, and Genzyme Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis

Berlin, September 26, 2007 – Bayer Schering Pharma AG, Germany, and Genzyme Corporation, USA, today announced that the first patient has been treated in the first of two planned Phase 3 trials examining the safety and efficacy of alemtuzumab for the treatment of multiple sclerosis (MS).

The CARE-MS SM I trial (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), a randomized, rater-blinded study, will compare alemtuzumab to Rebif® (interferon beta-1a) in patients with relapsing-remitting MS. Alemtuzumab will be given in two annual cycles; Rebif will be administered three times per week. The CARE-MS I study will include patients who have been diagnosed with relapsing-remitting MS but have not yet begun treatment with any MS drug. CARE-MS II is scheduled to begin soon and will enroll patients who have continued to experience relapse episodes while on currently available disease-modifying therapies.

Initiation of this Phase 3 program follows the successful completion of the initial treatment period in the Phase 2 trial. Interim results from the Phase 2 trial indicated that alemtuzumab-treated patients experienced a statistically significant reduction in the risk for sustained accumulation of disability and the risk for relapse for 24 months compared with Rebif-treated patients. Results of the primary outcomes from this trial at 36 months are expected to be presented on Oct. 14 by Professor Alastair Compston during the Charcot Award lecture at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis, ECTRIMS, in Prague.

The CARE-MS I study will enroll up to 525 patients at approximately 60 medical centers throughout North America, Australia, Latin America, and Europe, and will again compare alemtuzumab-treated patients to Rebif-treated patients according to two co-primary endpoints: the time to sustained accumulation of disability and the annualized relapse rate. Alemtuzumab will be dosed at 12 mg/day for five days by daily IV infusion, with a second dosing 12 months later of 12 mg/day for three days. All patients will be followed for two years from the date that the last patient is randomized to treatment. Alemtuzumab-treated patients will continue to have safety evaluations for at least three years after the last course of treatment. The companies anticipate filing for marketing approval of alemtuzumab for the treatment of MS in 2011.

About Multiple Sclerosis
Multiple sclerosis is a chronic disease of the central nervous system (CNS) in which the immune system can attack the brain and spinal cord. The disease causes a wide range of symptoms including fatigue, difficulty walking, numbness, and vision problems, and can progress to cause severe disability. Relapsing-remitting MS is the most common form of this disease.

About Alemtuzumab
Alemtuzumab is an investigational drug for the treatment of MS and must not be used outside of a formal clinical trial setting in MS patients. Physicians or patients seeking additional information about the CARE-MS I trial should contact Genzyme Medical Information at 1-800-745-4447, option 2 in the U.S., +31 35 699 1499 in Europe, or visit www.clinicaltrials.gov.

Alemtuzumab is licensed in the United States as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). Outside of the U.S., alemtuzumab has been approved for the treatment of B-CLL in patients who have been treated with alkylating agents and who have failed fludarabine therapy. The product is marketed outside the United States as MabCampath® by Bayer Schering Pharma AG, Germany, and in the U.S. by the company's U.S. affiliate, Bayer HealthCare Pharmaceuticals, as Campath®.

Alemtuzumab is a humanized monoclonal antibody that binds to a specific target, CD52, on cell surfaces and directs the body’s immune system to destroy those cells. It is the first and only monoclonal antibody approved by the FDA for the treatment of patients with B-CLL.

Genzyme and Bayer Schering Pharma AG, Germany, are co-developing alemtuzumab in oncology, multiple sclerosis and other indications. Bayer Schering Pharma AG, Germany, holds exclusive worldwide marketing and distribution rights to alemtuzumab.

About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 9,500 employees in locations spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, Genzyme was selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease, and other areas of unmet medical need.

Genzyme®, Campath® and MabCampath® are registered trademarks of Genzyme Corporation. All rights reserved.

Genzyme’s press releases and other company information are available at www.genzyme.com.

About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.


Forward-looking statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contact
Cantor, Maria

Study of bone marrow stem cells in multiple sclerosis

A new pilot clinical trial to test bone marrow stem cell therapy with a small group of patients with multiple sclerosis has started at Frenchay Hospital. The aim of the trial, conducted by the University of Bristol and North Bristol NHS Trust, is to find out what effects, good or bad, it has on patients with MS, and their disability.

Bone marrow is known to contain stem cells capable of replacing cells in many types of tissues and organs - and so is of great interest to those working to develop new treatments for many diseases, including those affecting the nervous system.

The potential of such cells to aid repair in multiple sclerosis has been examined in laboratory studies in Bristol and elsewhere but, until now, patients have not been treated in this way.

Neil Scolding, Professor of Clinical Neurosciences for North Bristol NHS Trust and the University of Bristol is leading the trial.

He said: “We believe this form of adult stem cell treatment, carried out in collaboration with colleagues in the Bone Marrow Transplant Unit at the BRI, will be safe and well-tolerated but, because patients with MS have never had this treatment before, safety has to be proven before any further studies of larger numbers of patients can take place.

“We will therefore be monitoring this small number of patients extremely carefully over the next 9-12 months. Provided, as is envisaged, we do not find serious adverse effects, we hope to raise the funds to undertake a larger study to examine the effectiveness of such treatment in MS.”

What does this study involve?

Patients meeting the entry criteria were assessed in the Neurology department and the Burden Centre at Frenchay Hospital to determine general fitness and degree of disability from MS.

They also have various types of brain scan, at Frenchay and also at The Hammersmith Hospital in London. Then, at the Bone Marrow Transplant Unit at the BRI, they undergo bone marrow collection under a short general anaesthetic.

The marrow is processed and then delivered back to the patient later the same day via a vein in the arm.

Over the following weeks and months, a range of various monitoring tests and scans at Frenchay and in London are then carried out.

Source: University of Bristol

Cell-surface Sugar Defects May Trigger Nerve Damage In Multiple Sclerosis Patients

Science Daily — Defects on cell-surface sugars may promote the short-term inflammation and long-term neurodegeneration that occurs in the central nervous system of multiple sclerosis patients, according to University of California, Irvine researchers.

The findings also suggest that a dietary supplement similar to glucosamine may be useful as an oral therapy to correct these defects and to treat both the short-term and the long-term symptoms of the disease. "The findings raise the possibility that these may both be treated by metabolic therapy," said Dr. Michael Demetriou, an assistant professor of neurology, and microbiology and molecular genetics. "This is particularly important, as therapies are not currently available to treat neurodegeneration in MS."

In tests on mice, Demetriou found that genetic deficiencies in a process called protein glycosylation led to a spontaneous disease very similar to MS, including paralysis associated with inflammatory damage to the protective myelin coating on nerve cells and degeneration of axons and neurons. Protein glycosylation refers to the addition of specific sugars to proteins; virtually all cell-surface and secreted proteins have complex sugars attached to them.

MS is a two-stage disease, with initial attacks of inflammatory demyelination, which damages myelin, followed approximately 10 years later by a slow, progressive neurdegenerative phase marked by loss of axons and nerve cells.

The irreversible damage to the central nervous system induced by neurodegeneration in MS leads to long term disability, including paralysis, incoordination, dementia and pain, and is not targeted by currently available therapies.

Demetriou's findings provide the first genetic model of MS in which both inflammatory demyelination and neurodegeneration arise from defects in a single biological pathway.

In previous studies, Demetriou found that the dietary supplement N-acetylglucosamine (GlcNAc), which is similar but more effective than the widely available glucosamine, corrected defects in protein glycosylation in cells and inhibited inflammatory demyelination in mice. The new study opens the possibility that metabolic therapy with GlcNAc may also prevent neurodegeneration. Studies in humans are required to assess the potential of this therapy in MS.

Study results appear on the online version of the Journal of Biological Chemistry.

Sung-Uk Lee, Ani Grigorian, I-Ju Chen, Guoyan Gao and Dr. Tahseen Mozaffar of UC Irvine and Judy Pawling and Colin McKerlie of the Samuel Lunenfeld Research Institute in Toronto participated in the study, which was supported by the National Multiple Sclerosis Society, the Juvenile Diabetes Research Foundation, the Wadsworth Foundation and the National Institutes of Health.

Note: This story has been adapted from material provided by University of California, Irvine.

Study Highlights Disease Rebound Effects From Tysabri

FDAnews Drug Daily Bulletin
Sept. 24, 2007 | Vol. 4 No. 187

Patients with multiple sclerosis (MS) treated with Biogen Idec/Elan’s Tysabri may experience significant increases in disease activity after they stop using the drug, according to a study published in the online edition of Neurology.

According to study author Machteld Vellinga, a physician with the VU University Medical Center in Amsterdam, data from 23 patients who participated in registrational studies for Tysabri (natalizumab) in MS suggest that subjects developed new and enlarging T2 lesions following discontinuation of the treatment, an effect known as rebound. It appeared only to occur in patients exposed to the product for a short period of time.

The VU University Medical Center was a clinical trial site used during studies for the drug.

In response to the study, Biogen said it was not planning to study this issue further as clinical studies for Tysabri did not show evidence of disease rebound upon discontinuation of the drug.

Bayer completes acquisition of U.S. biologics manufacturing facility from Novartis

Berlin, September 14, 2007 — Bayer Schering Pharma AG, Germany, has completed the acquisition of a biologics manufacturing facility in Emeryville, California from Novartis. Bayer will manufacture its multiple sclerosis drug Betaseron® at the Emeryville site, retain full control of all manufacturing and process technology used in the production of Betaseron® (interferon beta-1b) and has retained the employees associated with the manufacture of the product.

As part of the transaction, which was announced in March 2007, Novartis has transferred manufacturing responsibility to Bayer Schering Pharma for Betaseron and has received a total one-time payment of approximately USD 200 million for the transfer of production equipment, inventory and the leasing of buildings at the site.

Bayer Schering Pharma will continue to pay Novartis royalties equivalent to those being paid currently on net sales of Betaseron® manufactured by Bayer at the Emeryville facilities until expiration of the original regulatory filing, development and supply agreement in October 2008. After this date, no more royalties will be due to Novartis on the sales of Betaseron®.

Bayer Schering Pharma will support Novartis in the regulatory filing process of a Novartis brand of the 250mcg version of interferon beta-1b. When approved by health authorities, Bayer Schering Pharma will supply the 250mcg version of interferon beta-1b to Novartis from 2009 forward and receive in return a double digit royalty payment from Novartis.

About Betaseron® / Betaferon®
Betaseron®, which is marketed outside the U.S. and Canada under the trademark Betaferon®, was the first disease-modifying drug introduced for MS and is a well-established treatment around the world. Betaferon® is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Betaferon® has the broadest experience of any MS medication. In the U.S., Europe and Japan, the drug has been approved for all relapsing forms of MS. It is able to reduce the number of MS episodes by one-third, and the frequency of moderate to severe episodes by as much as 50 percent. Sixteen years’ follow up of people treated with Betaferon® has shown that it is safe and well tolerated.

Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma AG. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.


Forward-looking statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our annual and interim reports to the Frankfurt Stock Exchange and in our reports filed with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contact
Renner, Oliver

Elan shares plummet on new MS drug concerns

Saturday September 15 2007


Shares in drugmaker Elan plummeted yesterday following fears that a patient taking the company's multiple sclerosis drug Tysabri had a virus called JC -- the precursor to the often fatal disease which caused the suspension of the drug's sales back in 2005.

The shares finished yesterday down 7.2pc at €13.13 having fallen over 9pc earlier, shadowing a drop in the US. The shares were at $18.86 in early US trade but had fallen to $18 earlier from a close of $19.48 on Thursday night.

Analysts said yesterday, there are growing concerns that the US Federal Drug Administration (FDA) has received an adverse event report from a doctor who had detected the JC virus which is a precursor to progressive multifocal leukoencephalopathy (PML).

Although 80pc of the population have antibodies to the virus, if a person has a weak immune system the JC virus can cross over the blood/brain barrier into the brain. The virus persists in the kidney.

Back in 2005, Elan shares plummeted by 70pc on the Dublin Stock Exchange after it and its partner Biogen said they were suspending sales of their much-heralded multiple sclerosis drug Tysabri.

The move followed the news that one patient died of PML, a rare and often fatal disease of the central nervous system known as an opportunistic infection, after being treated with Tysabri in combination with Biogen's MS drug Avonex.

This latest patient, however, has not been confirmed as having the PML virus. Elan said that it has no new confirmed cases of PML.

It added that it gave the FDA a full safety update at the end of July..

Analysts said yesterday that the share slump was probably a result of panic selling especially as no new cases of PML have been reported.

"Previous adverse reports when Tysabri was under a market suspension proved to be unfounded," said one analyst who did not wish to be named.

In 2005, the two companies said there was one fatal, confirmed case and one suspected case of PML.

The companies also suspended dosing in all clinical trials of the drug. The action was been taken in consultation with the US FDA at the time.

Earlier this week, Tysabri received backing from a Scottish health watchdog for its MS drug.

The Scottish Medicines Consortium (SMC) today advised the use of Elan's and partner Biogen's drug Tysabri in people with active relapsing remitting multiple sclerosis.

All NHS Health Boards in Scotland are now obliged to consider the SMC's advice and ensure that Tysabri is made available to meet patients' needs.

Hollis-Eden reports promising results for multiple sclerosis treatment

14th September 2007
By Staff Writer

Hollis-Eden Pharmaceuticals has announced new data showing that its pre-clinical drug candidate provides benefit in an animal model of multiple sclerosis.

The company is planning to present the results evaluating HE3286 at the 2nd International Congress on Immune-Mediated Diseases being held in Moscow, Russia. The company is also presenting preclinical data demonstrating that HE3286, along with other novel compounds under investigation - HE3413 and HE3177, appear to act by limiting the activation of the pro-inflammatory transcription factor NF-kappaB.

In the data presented, HE3286 showed marked benefit in a SJL/J female mouse model of experimental autoimmune encephalitis, a model widely used in industry and academia to test agents as potential treatments for multiple sclerosis.

In the study, mice were treated orally at disease onset with either HE3286 or placebo for approximately 20 days. HE3286-treated mice, at doses as low as 4mg/kg, had markedly reduced disease scores in comparison to placebo-treated animals. Benefit was maintained for over two weeks, even after treatment was discontinued.

Dr Halina Offner, professor of Neurology at Oregon Health Science Center, said: "We continue to be excited about researching these new steroid hormones because of their apparent ability to regulate critical inflammatory targets such as NF-kappaB and T-regulatory cells."

Richard Hollis, chairman and CEO, said: "We are pleased that HE3286 continues to perform well in preclinical models of diseases of inflammation. We intend to file an IND to support a Phase I/II clinical trial with HE3286 in diseases of inflammation this month. This IND would enable us to potentially test HE3286 not only in rheumatoid arthritis but in additional diseases of inflammation."