NEW TYSABRI® DATA TO BE PRESENTED AT THE EUROPEAN COMMITTEE FOR TREATMENT AND RESEARCH IN MULTIPLE SCLEROSIS

Study Shows Increased Proportion of Patients Achieve Disease-Free Status with TYSABRI

Separate Study Demonstrates Plasma Exchange May Be an Effective Tool to Accelerate TYSABRI Removal

Prague, Czech Republic - October 11, 2007 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that TYSABRI® (natalizumab) treatment significantly increases the proportion of disease-free patients with multiple sclerosis (MS) according to a post hoc analysis of the Phase III AFFIRM study to be presented on Saturday, October 13, 2007 at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic. Also to be presented on Saturday will be findings from the PLEX study which suggest that plasma exchange may be an effective means of accelerating the removal of TYSABRI from the circulation.

Post Hoc Analysis of Phase III AFFIRM Study
The proportion of disease-free patients in the AFFIRM study was determined based upon clinical and MRI criteria. The proportion of disease-free patients over two years was significantly higher in the TYSABRI-treated group compared with the placebo group regardless of how disease free was defined.

Clinically, disease free was defined as no relapses and no progression of disability (as defined by >1.0-point increase in Expanded Disability Status Scale (EDSS) score from a baseline score of >1.0, or a >1.5-point increase from a baseline score of 0.0, sustained for 12 weeks) over two years. MRI disease free was defined as no gadolinium-enhancing lesions and no new or enlarging T2-hyperintense lesions.

Using clinical and MRI disease-free criteria combined, the most stringent definition of disease free, 36.7% of TYSABRI-treated patients had no relapses, disability progression or MRI activity compared with 7.2% of placebo patients (p<0.0001). In the clinical analysis, 64.3% of TYSABRI-treated patients vs. 38.9% placebo-treated patients(p<0.0001) were disease free or without relapses and disability progression. Using MRI measures, 57.7% of TYSABRI-treated patients vs. 14.2% placebo-treated patients (p<0.0001); were disease free, or without gadolinium-enhancing lesions and new or enlarging T2-hyperintense lesions.

"These data demonstrate the dramatic effect TYSABRI can have on critical measures of multiple sclerosis. In addition to the impact on individual clinical and MRI outcomes, it is striking that more than one-third of patients were free of relapses, disability progression and MRI activity after two years of treatment. This suggests that TYSABRI may offer patients freedom from many of their MS symptoms," said Eva Havrdová, MD, PhD, Director of the Center for Demyelinating Diseases at the First School of Medicine, General University Hospital, Charles University, Prague, Czech Republic.

PLEX Plasma Exchange Study
Results from the PLEX study also to be presented suggest that plasma exchange may be an effective means of accelerating the removal of TYSABRI from blood serum. Plasma exchange is one of several research efforts the companies have underway to learn more about potential interventions or treatments for progressive multifocal leukoencephalopathy (PML), a rare side effect of TYSABRI.

"These data from the PLEX study are encouraging as they show the removal of TYSABRI is faster following plasma exchange. Time will tell whether plasma exchange develops as an effective treatment approach for PML," said Bhupendra O. Khatri, MD, Medical Director of the Regional MS Center, Aurora St. Luke's Medical Center, Milwaukee, WI.

PLEX is an open-label, single-arm, multicenter exploratory study involving 12 patients with relapsing-remitting MS designed to explore whether plasma exchange could significantly reduce the concentration of TYSABRI in blood serum and alpha 4-integrin receptor saturation. Based on the PLEX findings, plasma exchange was effective at accelerating the normal decline of serum TYSABRI concentrations.

Plasma exchange was generally well tolerated with no increase in MS disease activity following plasma exchange. There were no study discontinuations due to adverse events and all patients returned to TYSABRI treatment without complications. Further investigations are needed to determine whether plasma exchange holds promise as an intervention in the setting of PML.

About TYSABRI
TYSABRI is a treatment approved for relapsing forms of MS in the United States and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash.

In addition to the United States and European Union, TYSABRI is also approved in Switzerland, Canada, Australia, New Zealand and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.

For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.

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.

About Elan
Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.

Safe Harbor/Forward-Looking Statements
This press release contains forward-looking statements regarding TYSABRI and the PLEX study. These statements are based on the companies' current beliefs and expectations. The commercial potential of TYSABRI is subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that we may be unable to adequately address concerns or questions raised by FDA or other regulatory authorities, that concerns may arise from additional data, that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, or that the companies may encounter other unexpected hurdles. Drug development and commercialization involves a high degree of risk.

For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic and current reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.


For more information contact:

Media Contacts:
Biogen Idec

Amy Reilly
Ph: 617 914 6524

Elan

Jonathan Birt
Ph: 212 850 5664

Elizabeth Headon
Ph: 353 1 498 0300

Investor Contacts:
Biogen Idec

Eric Hoffman
Ph: 617 679 2812

Elan

Chris Burns
Ph: 353 1 709 4444
800 252 3526

Interferon Beta-1a Offers A Near 3-fold Improvement In Injection Tolerability Compared With The Original Formulation - 2-Year Phase IIIb Data

Merck Serono, a division of Merck KGaA, announced today new results of a two year (96 week) Phase IIIb study in 260 patients which has shown that the new formulation of Rebif® (interferon beta-1a) offers a near three-fold improvement in injection tolerability for patients with relapsing remitting multiple sclerosis (RRMS). These results are compared with historical data for the previous formulation of Rebif® (30.8% versus 85.8%) (1).

These study results will be presented today at a satellite symposium and tomorrow at a poster session at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic.

"Rebif is an established first-line disease modifying treatment for relapsing types of MS" said Professor Gavin Giovannoni from The Royal London Hospital. "Injection site reactions can lead to withdrawal from treatment. The reduction in these reactions with the new formulation should improve treatment benefit to patients."

Rebif® has a favourable benefit-to-risk profile (2) and has a proven efficacy and safety profile, which has been demonstrated consistently across numerous phase III clinical trials and clinical practice (1, 3-5). The new study results have also confirmed consistent efficacy of the new formulation of Rebif® compared with previous experience (1). At 96 weeks, 53.3% of patients remained relapse-free and overall the expanded disability status scale (EDSS) score remained stable throughout the study.

The new formulation of Rebif® was approved on August 10, 2007, by the European Commission and is due to be launched in the UK in early 2008. The new formulation of Rebif® is the first and only therapy for multiple sclerosis that is serum free, both from animal and human-derived components (HSA-free and FBS-free) and is the latest product development from Merck Serono. Other recent enhancements have included the launch of a new initiation pack designed to make starting Rebif® therapy easier and more convenient.

References

1. Panitch H, Goodin DS, Francis G, Chang P, Coyle PK, O'Connor P, et al. Randomized, comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE trial. Neurology 2002; 59: 1496-506.
2. Francis GS. Importance of benefit-to-risk assessment for disease-modifying drugs used to treat MS. J Neurol 2004; 251 (Suppl 5): v42-9.
3. Li D, Paty D, UBC MS/MRI Analysis Research Group, PRISMS Study Group. Magnetic resonance imaging results of the PRISMS trial: a randomized, double-blind, placebo controlled study of interferon-b1a in relapsing-remintting multiple sclerosis. Ann Neurol 1999; 46: 197-206
4. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcultaneously in Multiple Sclerosis) Study Group. Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. Lancet 1998; 352: 1498-504, Erratum inLancet 1999; 353; 678.
5. PRISMS Study Group, University of British Columbia MS/MRI Analysis Group. PRISMS-4: Long-term efficacy of interferon-β-1a in relapsing MS. Neurology 2001; 56: 1628-36.

About the Study

The study was a two-year (96 weeks) Phase IIIb, international, multicenter, single-arm, open-label study with historical controls, evaluating the safety and immunogenicity of the new formulation of Rebif® (interferon beta-1a) 44 micrograms (mcg) subcutaneously (sc) three times weekly (tiw) in 260 patients with relapsing forms of multiple sclerosis (MS).

No unexpected adverse events were reported with the new formulation of Rebif®. Safety outcomes were consistent with the known profile of Rebif®. The majority of adverse events were mild or moderate in severity. The most frequent side effect was flu-like symptoms (71.5%), which is typical of interferon therapy; most were mild in severity. Flu-like symptoms are transient. Prophylactic antipyretic treatment is recommended.

About Rebif®

Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body's immune system and reduce inflammation.

Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. Rebif® has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity compared to placebo*. Rebif® is not approved for treatment of chronic progressive MS. Rebif® is available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and a titration pack (8.8 mcg and 22mcg).

Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif® with their doctors.

* The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

About Merck Serono and Multiple Sclerosis

Merck Serono is a leader in multiple sclerosis (MS) with Rebif® (interferon beta-1a), a disease-modifying drug used to treat relapsing forms of MS, which is registered in more than 80 countries worldwide. In addition to Rebif®, the Company also offers a second therapy within its US portfolio of MS therapies: Novantrone® (mitoxantrone for injection concentrate). Product information can be obtained by contacting the Company or visiting its website. Additional therapeutic options are currently under development at Merck Serono, including cladribine, currently in Phase III, as well as several products in early stage development. Merck Serono also is taking a leading role in developing an understanding of the role of genetics in MS.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. The World Health Organization estimates that up to 2.5 million people suffer from MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

About Merck Serono

Merck Serono, the new division for innovative small molecules and biopharmaceuticals of Merck was established following the acquisition of Serono and the integration of its business with the former Merck Ethicals Division. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, produces and commercializes innovative products to help patients with diseases with unmet needs. Our North American business operates in the United States and Canada under EMD Serono.

Merck Serono has leading brands serving patients with cancer, metabolic and cardiometabolic disorders, as well as psoriasis. With an annual R&D investment of EUR 1bn, we are committed to growing our business in specialist-focused therapeutic areas such as Neurology and Oncology, as well as new therapeutic areas potentially arising out of our research and development in autoimmune and inflammatory diseases.

About Merck

Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by 35,091 employees in 62 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

-- http://www.merckserono.net
-- http://www.merck.de

Merck KGaA's Rebif, Teva's Copaxone similar-study

Wed Oct 10, 2007 5:01am EDT

FRANKFURT, Oct 10 (Reuters) - Merck KGaA's (MRCG.DE: Quote, Profile, Research) Rebif multiple-sclerosis drug is not superior to rival Teva's (TEVA.O: Quote, Profile, Research) Copaxone, a study obtained by Reuters on Wednesday showed.

"The number of events (relapses) was insufficient to establish a statistically significant difference between the two products, despite a trend advantage for Rebif," the report said.

The 96-week Phase IV study involving almost 800 patients will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague.

Merck inherited Rebif through its recent 10.2 billion-euro

($14 billion) acquisition of Swiss biotech company Serono.

Serono had hoped to gain market share from Copaxone in the case of a positive outcome from the head-to-head study.

Merck shares were 1.6 percent lower at 88.20 euros at 0908 GMT, compared with a flat blue-chip DAX index (.GDAXI: Quote, Profile, Research).

((Reporting by Mantik Kusjanto; Reuters Messaging: mantik.kusjanto.reuters.com@reuters.net; E-mail: mantik.kusjanto@reuters.com; +49 69 7565 1203))

© Reuters2007All rights reserved

MS That Runs In Families Appears More Severe Than Non-Familial MS

Magnetic resonance images (MRI) of a large group of patients with multiple sclerosis has provided the first evidence that those with a history of MS in their families show more severe brain damage than patients who have no close relatives with the disease.

The results, based on brain MRIs of 759 consecutive MS patients, support the hypothesis that a patient's genetic make-up plays a role not only in development but also in severity of the disease.

A University at Buffalo team of neurologists and imaging experts headed by Robert Zivadinov, M.D., Ph.D., professor of neurology, conducted the research at the Buffalo Neuroimaging Analysis Center (BNAC), which Zivadinov directs. The BNAC is an arm of the Jacobs Neurology Institute, UB's Department of Neurology in the School of Medicine and Biomedical Sciences. Patients were recruited at the Baird MS Center, also part of the Jacobs Neurological Institute.

The research findings were presented today (Friday, Oct. 12) at the 23rd Congress of the European Committee for the Treatment and Research in Multiple Sclerosis in Prague, Czech Republic.

'From the early 1980s on,' said Zivadinov, 'MS researchers thought that genetic factors likely played a role in the disease, that its traits were determined by several different genes, and our findings support this hypothesis.

'Our MRI analysis showed a difference between the severity of disease characteristics in familial MS patients versus what we call sporadic, or non-familial, MS patients,' he said. 'These differences may be related to some disease-modifying genes, but to prove this, we must do further investigation.'

MS destroys myelin, the fatty sheath that protects nerve fibers carrying message traffic from various muscles to and from the central nervous system. For reasons currently unknown, in some people the myelin sheath breaks down, resulting in destruction of the nerve fibers and the symptoms of MS.

This demyelization process leads to mild to serious disability, from slight numbness of the limbs to loss of vision and paralysis.

The cohort of 759 patients involved in the study ranged in age from 36-56, with an average disability score of 3.4 on a scale of 0-10. A higher number indicates more disability.

Of these patients, 478 had relapsing-remitting MS, involving acute attacks with full or partial recovery; 222 had secondary-progressive MS, characterized by occasional attacks and sustained progression; 30 had primary-progressive MS with steady worsening from onset, and 29 had experienced their first attack.

Twenty-six percent, or 198, had a positive family history of MS. The breakdown between first-, second- or third-degree relatives with MS was 81/35/82. All patients obtained full clinical and quantitative MRI evaluations.

Using MRI, researchers measured the number and volume of lesions (plaques), which represent areas of demeylination; atrophy of the whole brain, white matter (the neural pathways), grey matter (brain regions) and the cortex, as well as employing additional imaging techniques.

There were no significant differences between familial and sporadic cases based on age, disease duration, disease course, disability score and total lifetime use of disease-modifying drugs.

Analysis showed that compared to patients with no family history of MS, familial MS patients had significantly more destructed lesions, and significantly lower volume of whole brain, white matter and gray matter, as well as other indications of greater brain degradation.

'Patients whose parents, children or siblings [first-degree relatives] had MS showed more damage than patients who had cousins with MS,' Zivadinov said. 'This indicates that the closer the relationship, the greater the risk of MS.

'Of particular interest is the finding of more severe gray matter damage and more lesions, particularly in those with MS in first-degree relatives. These findings are very interesting and we will be investigating them further.'

Source-UB News Service
LIN/M

Antibody leads to repair of myelin sheath in lab study of multiple sclerosis and related disorders

Mayo Clinic researchers have found that a human antibody administered in a single low dose in laboratory mouse models can repair myelin, the insulating covering of nerves that when damaged can lead to multiple sclerosis and other disorders of the central nervous system.

The study will be presented on Oct. 9 at the American Neurological Association meeting in Washington, D.C.


“The repair of chronic spinal cord injury is seldom modeled in laboratory studies, but it is an important reality for the treatment of humans. The concept of using natural human antibodies to treat disease of this kind has not yet been tested in humans, but these research findings are very promising,” says Moses Rodriguez, M.D., a Mayo Clinic neurologist and the study’s corresponding author. “The findings could eventually lead to new treatments that could limit permanent disability,” states Arthur Warrington, Ph.D., a Mayo Clinic scientist and study author.

Myelin repair normally occurs spontaneously, but in multiple sclerosis and other disorders of the central nervous system, the myelin repair process occurs very slowly or fails altogether. Researchers are trying to determine how to speed up the myelin healing process, which they hope will eventually lead to new treatments for patients.

The antibody, which was genetically engineered from a single cell, binds to myelin and the surface of cells in the brain and spinal cord, then it triggers the cells to begin the repair process called remyelination. This antibody is the first known reagent designed to induce repair by acting within the central nervous system at the damage sites on cells responsible for myelin synthesis.

The study uses laboratory mouse models of chronic progressive multiple sclerosis in humans. The severity of the disease and also success of the treatment were largely defined by how naturally active the mice were, particularly during the night because mice are nocturnal and are especially active at this time. They received a single dose of the antibody. A minimum of 25 mcg/kg was needed to trigger remyelination, which is equivalent to about 2 mg in the average adult, considered a very low dose. The myelin repair plateaued after five weeks in the mice models.

In addition, when combined with daily methylprednisolone, (an immune modulating steroid) the antibody still promotes remyelination in mouse models. This is an important fact because the first multiple sclerosis patients treated with the antibody will have been treated first with methylprednisolone.

As a naturally occurring protein of the immune system, antibodies do not appear to carry any side effects, nor are they toxic -- even when administered at 4,000 times the minimal effective dose -- though the concept has not yet been tested in humans, the researchers say.

In summary, this antibody:

-- Promotes remyelination with a single dose as low as 25 mcg/kg in mice models

-- The remyelination plateaus at five weeks after a single dose

-- Converts a model of chronic immune mediated demyelination to one that repairs with the speed of a toxin induced model of demyelination

In terms of replicating the findings in humans, the researchers have already produced the antibody through genetic engineering and conducted preliminary toxicology experiments in mice showing that 1,000 times the therapeutic dose is not toxic. The study continues to be explored in animal models and eventually, in clinical trials.

In short, the critical finding is that when combined with methylprednisolone, the antibody still effectively promotes remyelination and does not make the mice worse, Dr. Warrington states.

Source: Mayo Clinic

BaroFold and Avecia Announce Development and Manufacturing Agreement

BaroFold, Inc., developers of PreEMT(TM) protein processing technology, and Avecia Biologics Limited have entered into an agreement for process development and cGMP manufacture of BaroFold's lead, proprietary compound, BaroFeron(TM), interferon beta-1b. Interferon betas are used as therapeutic agents in the treatment of multiple sclerosis and other autoimmune disorders. The program involves Avecia integrating operation of PreEMT(TM) technology alongside other stages of protein purification in both pilot and cGMP facilities. Avecia has both installed a PreEMT(TM) Plus system in its development laboratory and completed manufacture of BaroFeron(TM).

Dr. Jeff Cleland, Vice President of Therapeutic Development at BaroFold said "We are pleased to be working with Avecia on our lead compound and are confident that their competencies in process science and engineering will deliver an solid process for BaroFeron(TM), provide cGMP product for our clinical trials and facilitate the further development of PreEMT(TM) technology for BaroFold and our partners."

Completing the scale-up of the drug manufacturing process will be a significant milestone, providing a platform to potentially expand the use of PreEMT(TM) technology to address areas of fundamental importance for protein manufacturing. BaroFold's technology potentially enables its' corporate partners to develop next generation protein biologics to meet the need for safer and cost effective new therapeutics.

Dr. Stephen Taylor, Avecia's Business Director, said: "We are delighted to be working with BaroFold on development of a manufacturing process for BaroFeron. We are also excited that they have recognized Avecia's track record of technological innovation and have chosen to work with us on scale-up of the novel PreEMT(TM) technology."

Under this program, Avecia will carry out development work to optimize and scale-up the drug manufacturing process for BaroFeron(TM), using BaroFold's proprietary PreEMT(TM) protein processing technology.

About BaroFold

BaroFold is a bio-therapeutics company focused on developing and commercializing improved protein therapeutics based, in part, on its proprietary PreEMT(TM) technology. The PreEMT(TM) technology is intended to enable improved, safer, proprietary protein therapeutics, potentially providing enhanced product life-cycle and creating new protein therapeutics through the use of a patented protein refolding technology. PreEMT(TM) involves the use of high hydrostatic pressure to potentially disaggregate and refold proteins. BaroFold is currently developing its own proprietary protein therapeutic portfolio including BaroFeron(TM), a proprietary product candidate. BaroFold also develops select protein therapeutics in partnerships with other biotechnology and pharmaceutical companies. For additional information about the company, please visit www.barofold.com.

About Avecia

Avecia is a privately owned biotechnology group of companies with recognised leading positions in the process development and manufacture of biopharmaceutical and oligonucleotide medicines. It is also a leading developer of bio-defence vaccines. The Group's Tees Valley, UK site has been developing processes and making protein-based biologics to cGMP since 1998. Products currently being worked on include medicines targeted at forms of cancer, heart conditions, stroke, growth and blood disorders. Customers range from some of the world's largest pharmaceutical companies to small innovative biotech start-up businesses.

This press release contains forward-looking statements that involve risks and uncertainties, including statements relating to initiation and progress of the Company's clinical trial programs. Actual results could differ materially from those projected and the Company cautions investors not to place undue reliance on the forward-looking statements contained in this release.

Accentia Announces Investigational New Drug Application for Revimmune Usage in a Pivotal Phase 3 Study of Refractory Multiple Sclerosis

Revolutionary Treatment for Multiple Sclerosis Intended to Eliminate Autoimmunity and Restore Lost Function

TAMPA, Fla.--(BUSINESS WIRE)--Oct. 8, 2007--Accentia Biopharmaceuticals (NASDAQ: ABPI) announces that it met with the Food and Drug Administration (FDA) on September 26, 2007 for a scheduled pre-Investigational New Drug (pre-IND) meeting on Revimmune(TM). The FDA has indicated its support for Accentia to submit an IND for a pivotal Phase 3 randomized controlled, multi-center clinical trial of Revimmune, the company's potential therapeutic for refractory, relapsing-remitting Multiple Sclerosis (MS). The FDA indicated that they support the proposed submission from Accentia and that they are in overall agreement with the proposed design of the Accentia clinical program.

The Revimmune MS study will enroll subjects in a one-year study comparing baseline disability to disability at month 12 with an interim data analysis. After consultation with the FDA on the design of the trial, it was agreed that the primary endpoint will be recovery of lost function and that this unique study will be done under a special protocol assessment (SPA). Accentia will proceed diligently with submission of the IND under a SPA and of an application for Fast Track status, and currently projects commencement of the Phase 3 study in the first half of 2008. A Special Protocol Assessment is a declaration from the Food and Drug Administration that a proposed Phase 3 trial's design, clinical endpoints, and statistical analyses are acceptable for FDA approval. All prior approved therapeutics suppress rather than eliminate autoimmunity and they have used the more limited indication of a reduction in the rate of progression of disability as their primary endpoint, not a reduction in disability as for Revimmune.

Revimmune is the first drug to propose restoration of lost function in MS patients. Using a patent-pending, ultra-high intensity, short-course of an intravenous formulation of cyclophosphamide, Revimmune is intended to "reboot" a patient's immune system, thereby eliminating autoimmunity, whereas current therapies, including oral cyclophosphamide, are used chronically to attempt to suppress the inflammation of autoimmunity. Based on long-term follow-up with patients that showed complete remissions in previous studies, there is substantial evidence that Revimmune has the potential to cure cases of severe refractory autoimmune diseases, including aplastic anemia and myasthenia gravis. Revimmune uses a drug approved for other indications at other doses.

Developed by Dr. Richard Jones, Dr. Robert Brodsky, and colleagues at the Johns Hopkins University School of Medicine, Revimmune temporarily eliminates peripheral immune cells, including the immune cells causing the autoimmunity, while selectively sparing hematopoeitic stem cells in the bone marrow. Investigators at Johns Hopkins discovered that stem cells are unique in having high levels of a particular protective enzyme that can be measured in advance of therapy, which makes them impervious to Revimmune, and allows the surviving stem cells to give rise to a new immune system over two to three weeks. The newly reconstituted peripheral immune system typically lacks the misdirected immunity to self-antigens, which is characteristic of autoimmune diseases.

Revimmune can be administered as an inpatient or outpatient infusion for four hours per day for four consecutive days. The treatment is intended to allow patients to recover at home while their immune system reconstitutes itself over a two to three week period. Revimmune includes a risk management program to enhance patient safety by ensuring appropriate patient selection, supportive care, and tracking of outcomes data.

The principal investigator for the Phase 2 study with Revimmune at Johns Hopkins University School of Medicine is Dr. Douglas Kerr, associate professor of neurology. The co-principal investigators on this study are Dr. Daniel Drachman, Dr. Robert Brodsky, and Dr. Adam Kaplin. The National Multiple Sclerosis Society has supported the clinical protocol at Johns Hopkins University.

About Accentia Biopharmaceuticals

Accentia Biopharmaceuticals, Inc. and its subsidiaries (collectively referred to as the "Company" or "Accentia") is a vertically integrated biopharmaceutical company focused on the development and commercialization of drug candidates that are in late-stage clinical development and typically are based on active pharmaceutical ingredients that have been previously approved by the FDA for other indications. Usually these drug candidates can access the accelerated 505(b)(2) regulatory approval pathway, which is generally less time-consuming and less expensive than the typical 505(b)(1) pathway that must be used for new chemical entities. The Company's lead product candidate is SinuNase(TM), a novel application and formulation of a known therapeutic to treat chronic rhinosinusitis. SinuNase has been granted Fast Track status by the FDA and it is currently in a pivotal Phase 3 clinical trial. During this fiscal year, the Company also plans to file an Investigative New Drug (IND) for a pivotal Phase 3 clinical trial of Revimmune, to treat numerous autoimmune diseases with an initial indication targeting refractory relapsing-remitting Multiple Sclerosis. Revimmune is based on pulsed, ultra-high dosing of a well-known chemotherapeutic agent under a risk management program. Additionally, through an investment strategy, the Company has acquired the majority ownership interest in Biovest International, Inc. ("Biovest"), (BVTI.OB) and a royalty interest in Biovest's lead drug candidate, BiovaxID(TM) and any other biologic products developed by Biovest. Biovest is currently conducting a pivotal Phase 3 clinical trial for BiovaxID which is a patient-specific anti-cancer vaccine focusing on the treatment of follicular non-Hodgkin's lymphoma. BiovaxID has been granted Fast Track status by the FDA. In addition to these product candidates, the Company has a specialty pharmaceutical business, which markets products focused on respiratory disease and an analytical consulting business that serves customers in the biopharmaceutical industry. For further information, visit the Company Web site at www.accentia.net.

Forward-Looking Statements

Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements about Revimmune(TM) SinuNase(TM), BiovaxID(TM), AutovaxID(TM), SinuTest(TM) and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Accentia to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Accentia undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.

CONTACT: Accentia Biopharmaceuticals, Inc., Tampa, FL
Susan Bonitz, PhD, 813-864-2554 - Extension: 277
sbonitz@accentia.net
or
The Investor Relations Group, New York
Investors:
Adam Holdsworth, 212-825-3210
or
Media:
Janet Vasquez, 212-825-3210
SOURCE: Accentia Biopharmaceuticals

AVANIR Granted Special Protocol Assessment (SPA) From FDA for Confirmatory Phase III Trial of Zenvia in Patients With PBA

AVANIR Pharmaceuticals (NASDAQ:AVNR) today announced that it has reached a definitive agreement with the U.S. Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of a single confirmatory Phase III clinical trial of Zenvia™ (dextromethorphan/quinidine [DM/Q]) for the treatment of patients with pseudobulbar affect (PBA). AVANIR trial 07-AVR-123 "A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients with Amyotrophic Lateral Sclerosis and Multiple Sclerosis" (otherwise known as the "STAR trial") is expected to begin enrolling patients by the end of 2007.

"We now have a clear path toward gaining regulatory approval for Zenvia in this important indication and continue on track to begin patient enrollment in this trial before 2007 calendar year end," said Randall Kaye, MD, Chief Medical Officer of AVANIR. "We have developed an alternative formulation of Zenvia with a lower dose of the quinidine component than the formulation used in earlier PBA studies. Based on our extensive PK/PD modeling, we expect that the new formulation of Zenvia will demonstrate acceptable safety and tolerability, while continuing to provide significant efficacy."

"The STAR trial represents an important milestone for greater than one million Americans thought to suffer from the debilitating episodes of PBA," said Jeffrey Cummings, MD, Executive Vice Chair of the Department of Neurology at the David Geffen School of Medicine at UCLA and lead investigator of the STAR trial. "With no currently approved treatment options available, the STAR trial is an essential step toward making Zenvia available to patients with PBA."

About the STAR Trial

The STAR trial (Safety, Tolerability And Efficacy Results of AVP-923 in PBA) will be a randomized, double-blind, placebo-controlled, multi-center international study that will enroll approximately 270 patients suffering from PBA secondary to either multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS). The trial will compare active treatment with Zenvia 30/10 mg (DM/Q) and Zenvia 20/10 mg (DM/Q) to placebo during a three month double-blinded phase followed by a three-month open-label extension study.

The primary efficacy analysis will be based on the changes in crying/laughing episode rates recorded in the patient diary. PBA episode counts will be reported and analyzed as a rate expressed as episodes per day. The secondary endpoints include: 1) Center for Neurologic Study-Lability Scale (CNS-LS) score, 2) Neuropsychiatric Inventory Questionnaire (NPI-Q), 3) SF-36 Health Survey, 4) Beck Depression Inventory (BDI-II), and 5) Pain Rating Scale score (MS patients only).

Safety and tolerability of Zenvia will be determined by reporting adverse events; physical exam, vital signs, electrocardiogram, respiratory function tests, and clinical assessment of clinical laboratory variables.

About a Special Protocol Assessment

A Special Protocol Assessment (SPA) from the FDA is a binding agreement that the Phase III trial protocol design, clinical endpoints, planned conduct and statistical analyses are acceptable to support regulatory approval. For more information about the Agency's Special Protocol Assessment process see http://www.fda.gov/cder/guidance/3764fnl.htm.

About PBA

Pseudobulbar affect (PBA), also known as involuntary emotional expression disorder (IEED) and emotional lability, is a neurologic disorder that occurs secondary to neurologic disease or brain injury causing sudden and unpredictable episodes of crying, laughing, or other emotional displays. PBA is estimated to impact more than 1 million people in the United States with underlying neurologic conditions such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), Parkinson's disease, dementias including Alzheimer's disease, stroke, and traumatic brain injury. PBA episodes may occur when disease or injury damages the area of the brain that controls normal expression of emotion. This damage can disrupt brain signaling causing a "short circuit" and triggering involuntary PBA episodes. PBA has been shown to impair the lives of patients in both social and occupational settings. There are currently no FDA approved treatments for PBA.

About Zenvia

Zenvia is a combination of two well-characterized compounds: the therapeutically active ingredient dextromethorphan and the enzyme inhibitor quinidine, which serves to increase the bioavailability of dextromethorphan. This first-in-class drug candidate is believed to help regulate excitatory neurotransmission in two ways: through pre-synaptic inhibition of glutamate release via sigma-1 receptor agonist activity and through postsynaptic glutamate response modulation via uncompetitive, low-affinity NMDA antagonist activity. Zenvia is currently in development for the treatment of pseudobulbar affect (PBA) and diabetic peripheral neuropathic (DPN) pain. In October 2006, the Company received an approvable letter for the treatment of Zenvia in PBA. The Company is initiating a confirmatory Phase III study under a Special Protocol Assessment agreement with the FDA utilizing a new lower quinidine dose formulation of Zenvia to address safety concerns raised in the Agency's approvable letter for Zenvia in the treatment of PBA. For more information about the Agency's Special Protocol Assessment process see http://www.fda.gov/cder/guidance/3764fnl.htm. In April 2007 AVANIR announced successfully meeting all primary endpoints in the Phase III study of Zenvia in DPN pain. The Company is considering the future development plan for Zenvia in this indication and expects to provide an update on this program later this year.

About AVANIR

AVANIR Pharmaceuticals is focused on developing, acquiring and commercializing novel therapeutic products for the treatment of chronic diseases. AVANIR's products and product candidates address therapeutic markets that include the central nervous system (CNS), inflammation and infectious diseases. AVANIR's lead product candidate Zenvia is being developed for the treatment of pseudobulbar affect (PBA) and is the subject of an approvable letter from the FDA for that indication. Additionally, in April 2007 AVANIR announced meeting all primary endpoints in a Phase III clinical trial with Zenvia in patients with diabetic peripheral neuropathic (DPN) pain. AVANIR has licensed a compound to Novartis International Pharmaceutical Ltd. for the treatment of inflammatory disease. AVANIR's infectious disease drug candidate, AVP-21D9, is a human monoclonal antibody in pre-clinical development for the treatment of anthrax with funding provided to date from an NIH/NIAID grant. The Company's first commercialized product, Abreva®, is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.

Forward Looking Statements

Statements in this press release that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate," "intend," "anticipate," "believe," "plan," "goal," "expect," or similar statements, are forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from the future results expressed or implied by such statements. There can be no assurance that the proceeds received by the Company from the recent sale of the Company's FazaClo® operations, together with the Company's other available funds, will be sufficient to fund the Company's operations as currently anticipated, or that the Company will be able to commence and complete planned clinical trials within the projected time periods. There can also be no assurance that the planned Phase III trial for Zenvia will be successful, that the new dose of Zenvia will be safe and effective, or that the FDA will approve Zenvia for this or any other indication. Risks and uncertainties affecting the Company's financial condition and operations also include the risks set forth in AVANIR's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and from time-to-time in other publicly available information regarding the Company. Copies of this information are available from AVANIR upon request. AVANIR disclaims any intent to update these forward-looking statements.

Smoking Has No Effect on Progression of Multiple Sclerosis

Newswise — Contrary to an earlier report, smoking appears to have no effect on the progression of multiple sclerosis (MS), according to a study published in the October 9, 2007, issue of Neurology®, the medical journal of the American Academy of Neurology.

Researchers in the Netherlands surveyed 364 people at both the initial and secondary stages of MS, 263 of whom were smokers.

The study showed there is no association between cigarette smoking and the progression of MS. Due to the high number of smokers with MS, it had previously been suggested there was a correlation between the progression of the disease related to smoking.

“Because the cause of MS as well as reasons for progression is generally unknown, there have been many genetic and environmental factors tested,” said study author Marcus W. Koch, MD, with the University of Groningen in the Netherlands. “Cigarette smoking is one more factor we can rule out.”

Koch says the finding is in conflict with a previous study that suggested cigarette smoking increased the rate of MS progress. “Differences in that study’s size and methodology may account for this discrepancy. Since our study involved more people, and participants were personally interviewed, we feel it makes our results more accurate.”

This study was supported by MS Anders in the Netherlands

The American Academy of Neurology, an association of more than 20,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as stroke, Alzheimer’s disease, epilepsy, Parkinson’s disease, and multiple sclerosis.

For more information about the American Academy of Neurology, visit http://www.aan.com.

© 2007 Newswise. All Rights Reserved.

Thalamic atrophy associated with cognitive impairment in MS

Source: Reuters

Date: Thu, 4 October 2007

Thalamic volume is lower in multiple sclerosis (MS) patients than in normal subjects and is related to cognitive impairment.

"We should rethink MS as not just a disease of white matter demyelination," Dr. Rohit Bakshi from Brigham and Women's Hospital, Harvard Medical School, Boston, told Reuters Health. "Clearly there is gray matter involvement and tissue destruction occurring."

Dr. Bakshi and colleagues investigated thalamic volume and its relationship to cognitive function in 79 MS patients and 16 normal subjects. Their findings are published in the September 18th issue of Neurology.

Thalamic volume was 17.8 per cent lower in MS patients than in normal subjects, the authors report, and a significant 16.8 per cent difference persisted after adjusting for age, sex, and intracranial volume in each individual.

Thalamic atrophy in MS patients was associated with impairment on tests of processing speed/working memory and visuospatial memory, the researchers note. Thalamic fraction accounted for the greatest amount of variance in all models predicting neuropsychological test performance.

"We don't know enough yet to determine if patients (with thalamic atrophy) should be treated differently in terms of immunotherapeutic medications," Dr. Bakshi said. "However, our results suggest that when a patient is found to have thalamic atrophy on MRI scans, they should be carefully screened and tested for cognitive impairment, which could affect patient management, coping, and quality of life."

"Now more than ever we can see the importance of MRI technology towards the understanding of this complex challenging disease," Dr. Bakshi concluded.

Accelerated Cure Project for Multiple Sclerosis

Accelerated Cure Project for Multiple Sclerosis is a national nonprofit organization dedicated to curing MS by determining its causes.

Our main effort is the creation of a large-scale, multidisciplinary MS Repository of blood samples and data from people with MS and matched controls. We make these samples available to researchers investigating the causes of MS. In exchange for access to the repository, researchers agree to return the data they generate from the samples so that results from disparate experiments can be combined.

We are also developing a Cure Map to establish and document what is known and what is not known about the causes of MS. From the Cure Map, Accelerated Cure Project will facilitate the research most likely to reveal the causes of MS in the shortest time through use of our MS Repository.

Multiple Sclerosis
Multiple Sclerosis, or MS, is a chronic demyelinating disorder of the central nervous system affecting over 400,000 people in the US and 2 million individuals worldwide. MS often results in severe disability including the inability to walk, impaired vision or in some cases blindness, cognitive dysfunction, bladder and bowel problems, extreme fatigue and other serious symptoms. Unfortunately, no one knows what causes Multiple Sclerosis, there is no known cure for the disease, and treatments are modest at best.

Bayhill Therapeutics to Present Positive Data From a Phase IIb Trial of BHT-3009 in Multiple Sclerosis

October 04, 2007 06:00 PM Eastern Daylight Time

Preparations for a Phase III Trial Underway

BIO Investor Forum 2007
PALO ALTO, Calif.--(BUSINESS WIRE)--Bayhill Therapeutics Inc., announced today top line data from a phase IIb study of its lead investigational drug candidate, BHT-3009, for the treatment of multiple sclerosis (MS). Patients in a prospectively defined group with high anti-myelin basic protein (MBP) antibodies in their cerebral spinal fluid (CSF) showed statistically significantly fewer gadolinium-enhancing lesions in their brain after treatment with 0.5 mg of BHT-3009 compared with placebo. Reductions in T2 volumes and T1 black holes were also observed in this same population. In addition, there were strong trends in these same measures when applied to the trial’s intent-to-treat patient population. BHT-3009 was found to be well tolerated in this study. Furthermore, using the company’s proprietary protein microarray technology, statistically significant reductions in several CSF myelin-specific autoantibodies were achieved in all patients treated with 0.5 mg of BHT-3009, compared with placebo. These findings thus demonstrate strong evidence of antigen-specific tolerance produced by BHT-3009.

The Company announced that it intends to schedule an end of Phase II meeting with the FDA to discuss designs for registration trials.

Hideki Garren, M.D., Ph.D., Bayhill’s co-founder and Vice President of Research will present data from this trial at the American Neurological Association meeting in Washington D.C. on October 9 and at a podium presentation at the annual conference of the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic on October 12. Mark Schwartz, Ph.D., Bayhill’s CEO and President will also present data from this trial at the BIO Investor Forum 2007 in San Francisco on October 10.

The phase IIb trial is a multi-center, randomized, double-blind placebo-controlled trial of 289 relapsing remitting MS patients. Patients were dosed monthly for one year with intramuscular injections of the investigational product BHT-3009. The trial’s endpoints are brain magnetic resonance imaging (MRI) measures of disease activity including gadolinium-enhancing lesions, T2 lesions and T1 black holes. These endpoints are uniformly used in Phase II trials for multiple sclerosis.

Commenting on the data from the Phase IIb trial, Dr. Lawrence Steinman, Professor of Neurology and Neurological Sciences at Stanford Medical School and co-founder of Bayhill said, "A long sought after goal in immunology has been to obtain tissue specific tolerance, without globally suppressing the immune system. We are delighted with the demonstration of tolerization of the immune system to myelin proteins in individuals with multiple sclerosis.”

“We are pleased with the top line results of our Phase IIb trial. BHT-3009 is the first of several programs arising from our BHT-DNA technology platform,” said Dr. Schwartz. “This platform is capable of rapidly producing new molecular entities targeting major unmet medical needs in large autoimmune disease markets. Our second program from this platform is BHT-3021, currently in the clinic for autoimmune Type 1 diabetes. We are very excited about expanding our efforts in these programs.”

About BHT-3009

The investigational product BHT-3009 is an autoimmune DNA vaccine that encodes MBP. It is designed to reprogram the immune system to tolerate rather than attack the brain’s myelin sheath. After administration of BHT-3009, immunological studies indicated that MS patients demonstrated decreased MBP-specific T cells in their blood and decreased anti-MBP antibodies in their spinal fluid. Normal T cells were not affected.

About Multiple Sclerosis

MS is characterized by an errant autoimmune reaction that causes damage to the myelin sheath and axon. MBP is a component of the myelin sheath, and in MS this protein is targeted by MBP-specific active T cells. These T cells consequently damage the protective myelin sheath that encases the neurons responsible for nerve transmission, resulting in destructive short circuits in the body’s central nervous system.

MS is the most common non-traumatic cause of disability in young adults. Approximately 400,000 in the United States today suffer from the disease, at a national cost of nearly $10 billion. Symptoms of this chronic, progressive disease can include muscle, sensory and visual impairments, fatigue, bladder, bowel and sexual dysfunction.

About Bayhill Therapeutics

Bayhill Therapeutics Inc. is a clinical-stage biotechnology company focused on developing and commercializing therapeutics that fundamentally alter the way autoimmune diseases are treated. The company has developed two therapeutic platforms with broad applicability to a range of autoimmune diseases. Bayhill’s BHT-DNA autoimmune vaccine is designed to eliminate disease-causing cells without affecting normal protective immune system cells. BHT-DNA is being studied in a recently completed Phase II trial for multiple sclerosis and a Phase I/II trial for autoimmune diabetes. Bayhill’s second therapeutic platform is an oligonucleotide; the first product candidate is in preclinical development for systemic lupus erythematosus. More information about Bayhill Therapeutics is available at www.bayhilltx.com.


Contacts
Bayhill Therapeutics, Inc.
Mark W. Schwartz, Ph.D., 650-320-2801
President, CEO, Director
mschwartz@bayhilltx.com
Fred Kurland, 650-320-2808
Chief Financial Officer
fkurland@bayhilltx.com

Riley's last day with the landscaping company is Friday.

Fort Wayne MS Patient Back from China
Sep 26, 2007 04:33 PM

Riley thinks the physical demands of his job caused his tremors to come back.

(Fort Wayne - WANE) In May, Mikey Riley, 20, traveled to China for a controversial stem cell treatment in hopes of stopping the progression of his multiple sclerosis (MS).

"I think what surprised me the most was the acupuncture," Riley said. "But the treatment itself was astonishing with all the people it was helping."

Riley got four injections of 20 million umbilical cord stem cells and a bone marrow transplant in the five-week treatment in China. The transplant is supposed to help his myelin re-grow and slow the progression of MS.

MS makes the body attack the central nervous system, and the protective tissue around nerves called myelin get scraped away and replaced by scars.

Riley said his transplant went well in China, but it's too early to tell if its working.

"I'm going on eight and a half months since I had a bad MS attack that landed me in the hospital," Riley said. "That the longest I've gone since I was diagnosed. Can I equate that to the stem cells? Maybe. Time will tell."

Riley hasn't experienced any new symptoms which is a good sign, but his tremors in his legs did come back. The went away while he was in China and for the first month back home.

But in July, Riley went back to work for a landscape company, and the physical work, may have brought the tremors back.

"My doctors told me physically tasking jobs make it hard especially for me because the stress on the body is such a big factor that with MS it's just too much," Riley said.

Then Monday Riley had a close call when he blacked out at the end of his shift.

"When I came to and realized what happened, it made me stop and think. I need to get a new job because I don't want to hurt myself or someone else. What if that happened on the mower," Riley said.

Friday is Riley's last day with the landscapers. He hopes with a different, less physically demanding job, his tremors will go away again.

Peptimmune Initiates Phase I Study With a Novel Peptide Copolymer for the Treatment of Multiple Sclerosis

CAMBRIDGE, Mass., Oct. 3 /PRNewswire/ -- Peptimmune, Inc. a privately held biotechnology company, announced that physicians have treated the first participant in a clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PI-2301, a novel peptide copolymer for the treatment of multiple sclerosis and other autoimmune diseases.

The Phase I single ascending dose, double blind placebo controlled randomized study will involve 56 healthy male volunteers who will receive the drug in eight escalating dose cohorts. Following establishment of safety at potentially therapeutic doses, the Company will initiate its first repeat dose study in multiple sclerosis patients in early 2008.

PI-2301 is a second generation peptide copolymer from a similar compound class as Copaxone(R) (Teva Pharmaceuticals). PI-2301 works through immune modulation by enhancing the regulatory response of the immune system to control the pathogenic autoimmune response in certain diseases. PI-2301 has been optimized using Peptimmune's novel platform peptide chemistry and in pre- clinical studies, has shown to be more potent and effective than Copaxone(R) in treating disease models for multiple sclerosis. PI-2301 has also shown efficacy in pre-clinical models of autoimmune diseases where
immune modulation may be effective, such as Crohn's disease, rheumatoid arthritis and autoimmune uveitis. Peptimmune has also introduced highly reproducible manufacturing methods that allow very strict control and characterization of PI-2301 and should provide a superior level of batch to batch consistency.

"The commencement of this clinical trial is an important milestone for the development of PI-2301 and for the Company," stated Thomas Mathers, President and CEO of Peptimmune. "The goal for PI-2301 is to enhance the therapeutic benefit of a proven compound class in multiple sclerosis and give neurologists a new weapon as a primary treatment for patients with
this debilitating disease."

Over 400,000 Americans have multiple sclerosis (MS), and worldwide MS may affect over 2.5 million individuals. MS is an autoimmune disease in which the individuals' immune system responds against multiple components of nerve- insulating myelin. The effects of these immune-mediated attacks can range from relatively benign to somewhat disabling to devastating, as communication between the brain and other parts of the body is disrupted.

About Peptimmune

Peptimmune, Inc. is a privately held clinical stage biotechnology company focused on the development of peptide therapies to improve the management of chronic autoimmune and inflammatory disorders. The Company is in clinical development with second-generation therapeutics that are expected to result in safer and more effective products for multiple sclerosis and pemphigus vulgaris. Current investors include New Enterprise Associates, MPM Capital, Prism Venture Partners, Vanguard Ventures, Hunt Ventures, Boston Medical Investors, Silicon Valley Bank Capital, Itochu Corporation, and Genzyme Corporation. For additional information, access our website at http://www.peptimmune.com .


SOURCE Peptimmune, Inc.

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."