Friday, October 12, 2007

New Data Suggests Progression of Disability at Two Years Predicts Multiple Sclerosis (MS) Disability Progression at Eight Years





Treatment with AVONEX(R) (Interferon Beta-1a) for Two Years Reduces Probability of Reaching More Severe Disability Milestones at Eight Years

PRAGUE, Czech Republic, Oct. 12 /PRNewswire/ -- A post-hoc analysis from a Phase III clinical trial of AVONEX(R) (interferon beta-1a) and post-randomization eight-year follow up shows that six-month sustained progression of disability at two years, using the Expanded Disability Status Scale (EDSS), is a significant predictor of long-term disability, as measured by EDSS milestones of 4.0, 5.0, 6.0 and 7.0 at eight years, in patients with relapsing-remitting multiple sclerosis (RRMS). The analysis suggests that patients taking AVONEX for two years were less likely to experience disability progression over time (eight years) when compared to placebo. These data were announced today at the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) conference in Prague, Czech Republic.

The analysis involved 160 patients with RRMS who received at least two years of treatment (81 placebo, 79 interferon beta-1a), in the AVONEX Phase III trial and who were re-examined eight years post-randomization. 45 patients met the criteria for two-year disability progression sustained for six months (n=18 AVONEX, 27 placebo). The analysis revealed:

-- Patients initially treated with AVONEX were less likely than patients initially receiving placebo to progress to EDSS scores of greater than or equal to 4.0 at eight years
-- Six month sustained EDSS progression during the pivotal two-year trial was a significant predictor of disability progression eight years later
-- Almost twice as many patients who had sustained progression in EDSS during the two-year trial progressed to an EDSS of greater than or equal to 4.0 than patients who did not progress (84% sustained, versus 44% unsustained)
-- Almost three times as many progressed to an EDSS of greater than or equal to 6.0 (67% sustained, versus 24% unsustained)

"This new analysis presents further evidence that patients who are treated for two years achieve long-term, clinically significant disability benefits," said Dr. Richard Rudick, vice-chairman of Neurological Institute at the Cleveland Clinic Foundation. "For a person with RRMS, starting and staying with treatment slows disability progression, as measured by EDSS."

EDSS is a common disability outcome measure that is used in multiple sclerosis clinical trials. EDSS greater than or equal to 4.0 signifies relatively severe disability, such as impacting physical coordination or the ability to walk without assistance.

AVONEX is the number one prescribed treatment for relapsing forms of multiple sclerosis (MS) worldwide, and is the only once-a-week MS therapy that is effective after the first attack. AVONEX is also proven to slow the progression of physical disability (as shown by 37% reduction over two years) and reduce the number of relapses. AVONEX has been proven effective
in clinical trials for up to three years.

This study was funded by Biogen Idec.

About AVONEX

AVONEX is the number one most prescribed treatment for relapsing forms of MS worldwide, with more than 130,000 patients on therapy. It was launched in the U.S. in 1996 and later in Europe for the treatment of relapsing forms of MS to slow the progression of disability and reduce relapses. AVONEX has been proven effective in clinical trials for up to three years. AVONEX is marketed internationally in more than 90 countries. AVONEX was the first treatment approved for patients who have their first clinical MS attack and have a brain MRI scan consistent with MS; this use was approved in Europe in 2002 and in the U.S. in 2003.

The most common side effects associated with AVONEX multiple sclerosis treatment are flu-like symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.

AVONEX should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. AVONEX should not be used by pregnant women. Patients with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported.

Please see complete prescribing information available at http://www.AVONEX.com.

New Preclinical Data Suggests FTY720 May Repair or Reduce Damage Caused by Multiple Sclerosis Through a Direct Effect in the Brain





· Potential beneficial impact on central nervous system in addition to well established action on immune cells

· Recruitment complete for two of three pivotal Phase III trials; recruitment for third study is ongoing and on track

· MS most common neurological disorder in young adults, affecting more than an estimated 2.5 million people worldwide

EAST HANOVER, NJ, October 12, 2007- New preclinical data presented at European Committee for Treatment and Research of Multiple Sclerosis (ECTRIMS) in Prague suggests that FTY720 (fingolimod) directly reduces neurodegeneration and enhances repair of the central nervous system (CNS) damage caused by multiple sclerosis (MS) by interacting with sphingosine-1-phosphate receptors (S1P-R) expressed on brain cells. This mechanism of action may be in addition to the established anti-inflammatory role of FTY720 that is mediated by the reduction of inflammatory immune cells, called lymphocytes, from reaching the brain.

FTY720 is a novel, once-daily, oral treatment currently in worldwide Phase III clinical development to test its safety and efficacy as a disease modifying therapy for relapsing-remitting MS, which affects approximately 85% of people with multiple sclerosis.

The potential direct beneficial effect of FTY720 in the CNS is supported by the results of several preclinical experiments being presented at ECTRIMS, including research in animal models of MS and in vitro studies on CNS cells called oligodendrocytes.

In an animal model of MS (experimental autoimmune encephalomyelitis in rats), the administration of FTY720 directly into the CNS resulted in a statistically significant reduction in disease severity. This decrease in disease activity was seen in the absence of a reduction of lymphocytes in the bloodstream, suggesting that the favorable effect of FTY720 seen in this model is due to a direct effect in the CNS that is independent of the effects on peripheral lymphocytes.

In two experiments presented at ECTRIMS, the modulation of S1P-R by the addition of FTY720 resulted in an increase in the number, growth and survival of oligodendrocytes in cell culture. This effect of FTY720 on oligodendrocytes may help limit destruction of myelin and promote its repair and, thus, may contribute to the effectiveness of FTY720 in MS. Oligodendrocytes are cells in the CNS that make a fatty tissue, called myelin, which is necessary for normal signal transfer along nerve fibers in the CNS. Myelin and oligodendrocytes are typically damaged in MS.

"FTY720 crosses the blood-brain barrier and the drug's target - S1P receptors - are present on brain cells, including oligodendrocytes as shown in animal cell studies," said Jack Antel, Professor, Department of Neurology and Neurosurgery, McGill University, Montreal, Canada. "We are able to confirm that FTY720 directly modulates the S1P receptors on human oligodendrocyte progenitor cells."

FTY720 is currently being investigated in the largest worldwide Phase III clinical trial program to be conducted in MS to evaluate further its efficacy and safety as a disease modifying therapy for relapsing-remitting MS. This comprehensive program includes trials referred to as FREEDOMS, FREEDOMS II and TRANSFORMS. Recruitment is complete for FREEDOMS and TRANSFORMS. Recruitment is ongoing and on track for FREEDOMS II and FTY720 regulatory filing is planned for the second half of 2009. For more information about the clinical trial program, including eligibility criteria and location of U.S. study sites, patients can call the following toll-free number: 866-788-3930, or visit www.MSClinicalTrials.com.

"Novartis has a significant long-term investment and commitment to multiple sclerosis and neuroscience through its extensive research and development program," said Ludwig Hantson, PhD, Senior VP for Commercial Development & Specialty Businesses at Novartis Pharmaceuticals Corporation. "We believe oral FTY720 is an exciting and promising experimental therapy for MS as shown by the compelling Phase II data. As an oral therapy with a novel mechanism of action and promising efficacy, FTY720 has the potential to be a significant and innovative therapeutic advance."


Phase II Study Results

The six-month, placebo-controlled Phase II study conducted in 281 patients with relapsing MS in 11 countries (Europe and Canada) showed that oral FTY720, taken once-daily, reduced relapse rates by more than 50% compared to placebo and reduced MRI (magnetic resonance imaging) measures of inflammation with approximately 80% of patients free of active brain lesions.

In patients continuously treated with FTY720 for up to two years (placebo-controlled study plus the extension trial), up to 77% of patients were relapse-free and more than 80% of patients were free of active brain lesions at two years.

In the six-month placebo-controlled phase of the Phase II study, the most frequent adverse events reported for FTY720 were dose-dependent upper respiratory tract infections (mainly nasopharyngitis) and dyspnea, plus diarrhea and nausea. FTY720 treatment was associated with initial dose-dependent decreases in heart rate and expiratory air flow. Clinically asymptomatic increases in alanine aminotransferase (liver enzyme) and an increase in blood pressure were also observed. No unexpected adverse events emerged in patients treated for up to 24 months compared with the six-month placebo-controlled phase. There was no further elevation of blood pressure with continued treatment beyond the effect seen at six months.

The ongoing Phase III study program includes comprehensive monitoring, which will provide further characterization of the safety profile of FTY720.


Multiple Sclerosis

MS is the most common disorder of the CNS in young adults, affecting more than an estimated 2.5 million people worldwide. It is a progressive and debilitating disorder caused by the destruction of myelin, which helps neurons carry electrical signals in the brain. MS causes problems with muscle control and strength, vision, balance, sensation and mental function. MS typically presents in relapsing forms involving acute self-limiting attacks of neurological dysfunction (or "relapses") followed by complete or partial restoration of functions.


Disclaimer

This release contains certain forward-looking statements relating to Novartis' business, which can be identified by the use of forward-looking terminology such as "may," "suggests," "suggesting," "potential," "promising," "planned" or similar expressions, or by express or implied statements regarding the potential approval of FTY720 by health authorities for marketing, whether or not FTY720 will be the first orally effective MS treatment, the potential health effects or long-term impact of a patient's use of FTY720, or potential future revenue from FTY720. Such forward-looking statements reflect the current views of Novartis regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with FTY720 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that FTY720 will be approved for any indications or labeling in any market. Neither can there be any guarantee that, if approved, it will be the first orally effective MS treatment. Neither can there be any guarantee regarding the health effects or long-term impact of a patient's use of FTY720. Neither can there be any guarantees that FTY720 will reach any particular levels of revenue. In particular, management's expectations regarding FTY720 could be affected by, among other things, unexpected clinical trial results, including new clinical trial results and additional analysis of existing results; unexpected regulatory actions or delays or government regulation generally; competition in general; Novartis' ability to obtain or maintain patent or other proprietary intellectual property protection; government, industry and general public pricing pressures, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.


About Novartis

Novartis has been a leader in the neuroscience area for more than 50 years, having pioneered early breakthrough treatments for Alzheimer's disease, Parkinson's disease, Attention Deficit Hyperactivity Disorder, epilepsy, schizophrenia and migraine, many of which continue to be regarded as "gold standards" to this day. Novartis continues to be at the forefront of research and development of new compounds and is committed to addressing unmet medical needs and to supporting patients and families affected by these disorders.

Novartis Pharmaceuticals Corporation develops, manufactures markets and sells leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. Novartis is the only company with leadership positions in these areas. In 2006, the Group's businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com .


# # #

Novartis Media Relations

Christine Cascio
Communications

Novartis Pharmaceuticals Corporation
+1 862 778 8026 (direct)
+1 917 449 9982 (mobile)
christine.cascio@novartis.com christine.cascio@novartis.com>


Tom Jones
Communications

Novartis Pharmaceuticals Corporation
+ 1 862 778 3772 (direct)
+ 1 973 342-3136 (mobile)
tomc.jones@novartis.com

e-mail: media.relations@novartis.com media.relations@novartis.com>
blempert@engelpub.com>

PHASE 2 DATA SHOW DACLIZUMAB SIGNIFICANTLY REDUCED MULTIPLE SCLEROSIS LESIONS IN PATIENTS RECEIVING INTERFERON BETA THERAPY





Phase 2 monotherapy trial to be initiated by end of 2007

Prague, Czech Republic, October 11, 2007 -- Biogen Idec Inc. (Nasdaq: BIIB) and PDL BioPharma, Inc. (PDL) (Nasdaq: PDLI) announced today that Phase 2 data demonstrated a significant reduction in new or enlarged gadolinium-enhancing lesions when daclizumab is added to interferon beta therapy in patients with active relapsing multiple sclerosis (MS). These data will be presented tomorrow at the 23rd Congress of the European Committee for Treatment and Research of Multiple Sclerosis (ECTRIMS) in Prague, Czech Republic.

The ongoing Phase 2, randomized, double blind, placebo-controlled clinical study, known as the CHOICE trial, studies MS patients who continue to have active MS disease while receiving interferon beta therapy. The study patients who received daclizumab 2 mg/kg subcutaneously every two weeks showed a statistically significant 72% reduction in the number of new or enlarged gadolinium-enhancing lesions (Gd+) at week 24, compared to patients on interferon beta therapy alone. Patients from the CHOICE study were followed for an additional 48 weeks after the daclizumab treatment period to further assess safety and efficacy.

"Patients who received daclizumab every two weeks experienced far fewer new or enlarged gadolinium-enhancing lesions than the control group, which indicates that the antibody may be a promising option for patients with MS," said Dr. Xavier Montalban, Director of the Unit of Clinical Neuroimmunology at the Hospital Val D'Hebron in Barcelona, Spain. "In addition, we were encouraged to see a trend in the reduction of the number of relapses, or exacerbations, that these MS patients experienced. Further study is warranted."

Daclizumab is a humanized monoclonal antibody that targets the IL-2 receptor on activated T cells. Biogen Idec and PDL plan to initiate the SELECT study, a Phase 2 trial of daclizumab alone in the same relapsing patient population, by the end of 2007.

"We are very pleased to see positive results from the CHOICE study, the first randomized trial of daclizumab in patients with relapsing MS," said Mark A. McCamish, M.D., Ph.D., chief medical officer, PDL BioPharma. "We recognize how monoclonal antibodies have changed modern medicine and see great potential in their ability to treat serious diseases, including cancer and select immunological diseases such as MS. We're very excited to move development of daclizumab forward with our partner Biogen Idec, the acknowledged leader in the MS field."

"Daclizumab represents an exciting opportunity within our growing MS portfolio," said Alfred Sandrock, M.D., Ph.D., senior vice president, neurology research and development, Biogen Idec. "MS is a complex disease that requires an arsenal of treatment options for patients. We look forward to advancing the daclizumab development program and initiating the SELECT trial by the end of the year."

Study Results
The CHOICE trial is evaluating the efficacy and safety of daclizumab or placebo added to interferon beta therapy in 230 patients with active MS who were enrolled at study centers in the U.S. and Europe. Patients were randomized to receive daclizumab 2 mg/kg every two weeks, daclizumab 1 mg/kg every four weeks, or placebo added to ongoing interferon beta treatment.

The primary efficacy analysis showed that at 24 weeks, the 75 patients in the 2 mg/kg group experienced 72% fewer new or enlarged Gd+ on average compared to the 77 patients who received a placebo (p=0.004). The 78 patients in the 1 mg/kg group experienced a 25% reduction in new or enlarged lesions compared with placebo but that measurement did not achieve statistical significance.

Based on data up to week 24, analysis of the relapse rate, which was a secondary endpoint, indicates that both daclizumab regimens revealed a trend in reducing the annualized relapse rate compared to placebo (an approximately 35% reduction), but these observations did not reach statistical significance.

Preliminary safety data showed similar rates of infection across all treatment groups with an overall greater incidence of serious infections in the daclizumab treated groups. (4.6% versus 1.3% placebo). Urinary tract infections were slightly higher with the 2 mg/kg dose (17% vs 13% placebo). The incidence of cutaneous events was higher in the combined daclizumab groups (34% daclizumab vs. 27% placebo) but was mild to moderate and most resolved with little or no treatment.

PDL and Biogen Idec entered into a collaboration agreement in 2005 to co-develop and commercialize daclizumab in MS and indications other than transplant and respiratory diseases. Under the collaboration, the companies are also co-developing volociximab (also known as M200), an antibody in Phase 2 development for the treatment of various solid tumors. PDL and Biogen Idec share equally the costs of all development activities and all operating profits for both products within the U.S. and Europe. The companies jointly oversee development, manufacturing and commercialization plans for collaboration products and divide implementation responsibilities to leverage each company's capabilities and expertise. Each party will have co-promotion rights in the U.S. and Europe. Outside the U.S. and Europe, Biogen Idec will fund all incremental development and commercialization costs and pay a royalty to PDL on sales of collaboration products.

About Multiple Sclerosis
MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and more than one million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 50 years of age. MS is caused by damage to myelin, the protective sheath surrounding nerve fibers in the central nervous system, which interferes with messages from the brain to the body. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

About Daclizumab
Daclizumab is a humanized monoclonal antibody that binds to the IL-2 receptor on activated T cells, inhibiting the binding of IL-2 and the cascade of pro-inflammatory events contributing to organ transplant rejection and autoimmune-related diseases. Hoffmann-La Roche, Inc. currently markets daclizumab under the name Zenapax under a license from PDL. Zenapax is indicated for intravenous use for the prophylaxis of acute organ rejection in patients receiving renal transplants. To conduct the CHOICE study, PDL prepared a high concentration formulation of Roche-produced daclizumab for subcutaneous administration. PDL has also developed a high yield manufacturing process and formulation for subcutaneously delivered daclizumab, which is in clinical development for MS by PDL and Biogen Idec. PDL has retained the rights for development of daclizumab for asthma and transplant maintenance.

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 PDL BioPharma
PDL BioPharma, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative therapies for severe or life-threatening illnesses. For more information, please visit www.pdl.com.

Forward-looking Statement
This press release contains "forward-looking statements" regarding PDL and Biogen Idec's development of daclizumab that are based on current expectations and assumptions that are subject to risks and uncertainties. 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 PDL and Biogen Idec's current expectations include the risk that preliminary results observed in the Phase 2 trial known as CHOICE are based on week 24 data and may not be predictive of the results that would be observed upon review of the full set of data PDL and Biogen Idec plan to obtain through week 72. In addition, these preliminary results may not be predictive of results to be obtained in the additional evaluations and studies that would be necessary to demonstrate daclizumab to be safe and effective in the treatment of patients with relapsing MS, nor can there be assurance that PDL or Biogen Idec will initiate subsequent clinical trials of daclizumab, including the Phase 2 monotherapy trial known as SELECT, which PDL and Biogen Idec are currently planning. In addition, the companies may not be able to meet applicable regulatory standards or regulatory authorities may fail to approve daclizumab; and the companies may encounter other unexpected hurdles. For further information regarding factors, risks and uncertainties that may cause such differences, please refer to the filings PDL and Biogen Idec have made with the Securities and Exchange Commission, including the "Risk Factors" sections of PDL's and Biogen Idec's Quarterly and Annual Reports, copies of which may be obtained at the "Investors" section on PDL's website at www.pdl.com, with respect to PDL's filings, and at www.biogenidec.com, with respect to Biogen Idec's filings. PDL and Biogen Idec assume no obligation to update and specifically disclaim any duty to update the information in this press release for any reason, except as required by law, even as new information becomes available or other events occur in the future. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.

Biogen Idec is considered a trademark of Biogen Idec, Inc. PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc. Zenapax is a registered trademark of Hoffmann-La Roche, Inc.


For more information contact:

Media Contacts:
Biogen Idec
Amy Reilly
Associate Director, Public Affairs
(617) 914-6524

PDL BioPharm
Kathleen Rinehart
Director, Corporate Communications
(650) 454-2543

Investor Contacts:
Biogen Idec
Eric S. Hoffman, Ph.D.
Associate Director, Investor Relations
(617) 679-2812

PDL BioPharm
Jean Suzuki
Manager, Investor Relations
(650) 454-2648

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

Wednesday, October 10, 2007

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

Tuesday, October 09, 2007

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.

Friday, October 05, 2007

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.

Wednesday, October 03, 2007

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.