Friday, April 25, 2008
Nonprofit has collected 1,000 blood and data samples from MS sufferers and controls across the U.S.; Samples will be used in dozens of individual research studies this year
WALTHAM, Mass., April 23 /PRNewswire-USNewswire/ -- Accelerated Cure Project for Multiple Sclerosis, a national nonprofit organization, today announced that they have completed their initial drive to collect one thousand blood and data samples to build the largest openly accessible, multi-disciplinary repository ever assembled for use in Multiple Sclerosis (MS) research.
"This is a major milestone for the Accelerated Cure Project", says Art Mellor, founder of the Accelerated Cure Project. "Limited sample size is one of the most frequently cited reasons for inconclusive results in MS research. Our repository provides researchers with immediate access to a far greater number of samples than most scientists could collect themselves."
In addition, the repository will provide a common population of samples useful for a wide variety of different studies, which will enable results from different research perspectives to be easily combined and correlated. The repository contains various types of samples and data that can support scientists working in many fields - genetics, nutrition, virology, and more. Researchers gaining access to the repository must return their results to the database to be shared with other researchers; this will allow cross-correlation of their results with all other studies performed using the same samples.
Subjects enrolled in the repository will be followed over time to allow new samples to be taken and to record important changes in clinical status. Studying the same sample population over time, and pooling knowledge in a central database, is a major step toward understanding what causes MS, thereby accelerating a cure.
Additionally, samples and data are collected from a number of other similar diseases including Transverse Myelitis, Neuromyelitis Optica, ADEM, and Optic Neuritis to enable studies in these rare neurological disorders and to provide controls for MS studies.
Contributing to the success of the project is an impressive list of research centers across the country that have joined Accelerated Cure Project as collection sites for the repository. These include Johns Hopkins Medical Center (Baltimore, MD), University of Massachusetts Memorial Medical Center (Worcester, MA), University of Texas Southwestern (Dallas, TX), Multiple Sclerosis Research Center of New York (New York, NY), Barrow Neurological Institute (Phoenix, AZ) and the Shepherd Center (Atlanta, GA).
The Accelerated Cure Project intends to continue collecting samples from as many as 10,000 subjects for its MS Repository. If you have MS (or another demyelinating disease) or are related to someone with MS and would like to participate in the project, please call 781/487-0008, visit acceleratedcure.org/repository, or send an email to firstname.lastname@example.org.
About Accelerated Cure Project
Accelerated Cure Project for Multiple Sclerosis, http://www.acceleratedcure.org, is a national nonprofit organization dedicated to curing Multiple Sclerosis (MS) by determining its causes. Accelerated Cure Project believes this effort can be accelerated by organizing the research process and encouraging collaboration between research organizations and clinicians. A "Cure Map" is currently being developed by the Accelerated Cure Project to establish what is known and what is not known about the causes of MS. From the Cure Map, Accelerated Cure Project will facilitate research most likely to reveal the causes of MS in the shortest time through a large-scale, multidisciplinary, MS Repository. For more information about the Accelerated Cure Project or to make a corporate or individual donation, call 781/487-0008, visit acceleratedcure.org, or send an email to email@example.com.
About Multiple Sclerosis
Multiple Sclerosis is a chronic demyelinating disorder of the central nervous system that often results in severe disability including the inability to walk, blindness, cognitive dysfunction, extreme fatigue and other serious symptoms. MS affects over 400,000 people in the US and 2 million individuals worldwide. The disorder occurs twice as often in women as in men. The cause is not known and there is no known cure.
SOURCE Accelerated Cure Project for Multiple Sclerosis
The effects of multiple sclerosis could be reversed with stem-cell treatment within 15 years, a leading expert on the disease said today.
Professor Charles ffrench-Constant, the director of a groundbreaking MS research centre in Edinburgh, said the treatment could be used to help patients suffering from the condition that weakens their body's central nervous system.
He said stem cells could be used to help repair nerve damage caused by MS. Currently, only medicines can help reduce the inflammation that causes MS.
Prof ffrench-Constant said he wants to find a way to make the body rebuild myelin – the sheath that protects nerve fibres – using stem cells, which have the ability to turn into different types of tissue.
He told The Herald newspaper: "My vision for a patient coming into a clinic in 10 or maybe 15 years' time is they will be given a mixture of drugs to prevent the inflammation and to promote repair.
"That way, MS would no longer be a chronic, disabling disease."
The MS research centre is part of the Scottish Centre for Regenerative Medicine at the University of Edinburgh.
It was launched thanks to a major donation from Harry Potter author JK Rowling, whose mother died from the condition.
MS affects an estimated 85,000 people in the UK
Thursday, April 17, 2008
Opexa Therapeutics Presents Tovaxin Phase I/II Data at the American Academy of Neurology 60th Annual Meeting
THE WOODLANDS, Texas--(BUSINESS WIRE)--Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company involved in the development and commercialization of cell therapies, today announced that Brian Loftus, M.D., of Bellaire Neurology and the Principal Investigator of the Tovaxin Phase I/II studies, presented data titled “Autologous Attenuated T-Cell Vaccine (Tovaxin®) Dose Escalation in Multiple Sclerosis Relapse-Remitting and Secondary Progressive Patients Nonresponsive to Approved Immunomodulatory Therapies” at the American Academy of Neurology meeting today. The AAN meeting is taking place at the McCormick Place West Convention Center in Chicago, IL.
The objective of the Tovaxin Phase I/II dose escalation study was to assess the safety and effectiveness of T cell vaccine (Tovaxin®) in MS patients non-responsive to approved immunomodulatory therapies. The trial results indicate statistically significant improvements from baseline observed using the annualized relapse rate and myelin-reactive T-cell count effectiveness measurements.
“The positive therapeutic effects of safety, early effectiveness and tolerability observed in this study suggest that depletion of myelin-reactive T-cells using Tovaxin, a trivalent T-cell vaccine, may be an appropriate treatment strategy for patients with MS and warrants further study,” said Dr. Loftus.
About T-cell Vaccination
For a T-cell vaccine to be effective, it should be able to induce T-cell cytotoxic and/or regulatory immune responses against the pathogenic T-cells. Studies of T-cell vaccine have indicated that T-cell vaccination with peripheral blood-derived autologous myelin-peptide selected T-cells in multiple sclerosis patients resulted in the in vivo induction of CD8+ cytotoxic T-cells and CD4+CD25+FoxP3 Tregs specific for T-cell vaccine. The induction of anti-idiotypic cytotoxic CD8+ effector T-cells and anti-ergotypic CD4+CD25+FoxP3 positive Tregs is believed to provide a therapeutically effective dual mechanism of protection to patients treated with Tovaxin. The observed regulatory immune responses have been shown to collectively correlate with clinical improvement in some patients treated in earlier clinical studies.
About Opexa Therapeutics
Opexa Therapeutics develops and commercializes cell therapies to treat autoimmune diseases such as MS, rheumatoid arthritis, and diabetes. The Company is focused on autologous cellular therapy applications of its proprietary T-cell and stem cell therapies. The Company's lead product, Tovaxin, a T-cell therapy for multiple sclerosis is in Phase IIb trials. The Company holds the exclusive worldwide license for adult multipotent stem cells derived from mononuclear cells of peripheral blood. The technology allows large quantities of monocyte derived stem cells to be produced efficiently for use in autologous therapy, thus circumventing the threat of rejection. The Company is in preclinical development for diabetes mellitus. For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com.
Cautionary Statement Relating to Forward - Looking Information for the Purpose of "Safe Harbor" Provisions of the Private Securities Litigation Reform Act of 1995
This press release contains "forward-looking statements," including statements about Opexa Therapeutics' growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. These forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Opexa Therapeutics' ability to obtain additional funding, develop its stem cell technologies, obtain FDA approval for its therapeutic products, achieve its operational objectives, and obtain patent protection for its discoveries, that may cause Opexa Therapeutics' actual results to be materially different from any future results expressed or implied by such forward-looking statements. Opexa Therapeutics undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
FTY720, a novel oral therapy in development for MS, shows sustained benefits for the majority of patients after three years of treatment
Phase II study extension shows 68-73% of patients with multiple sclerosis remained relapse-free after three years of treatment with oral FTY720
New data demonstrate 89% of patients free from active brain lesions - the injury caused by MS - three years after starting treatment
MS, a devastating disease causing progressive disability, affects 2.5 million people worldwide including many young adults
FTY720 regulatory filings planned before end of 2009 in US and EU
Basel, April 15, 2008 - The investigational oral therapy FTY720 (fingolimod) continues to demonstrate sustained benefits in patients with multiple sclerosis (MS) after three years of treatment, according to new clinical data presented today from an ongoing Phase II study extension.
Results showed that 73% of patients who began the study on FTY720 5 mg remained free from relapses after three years, and 68% of those who began the study on FTY720 1.25 mg remained relapse-free. The figures after two years of treatment were 77% and 75% respectively. On the basis of comparable efficacy and a better safety profile, all patients have been transferred to FTY720 1.25 mg in the study extension.
The 36-month data also showed an average annualized relapse rate of 0.20, equivalent to one relapse in five years, while 89% of patients were free of the active brain lesions characteristic of MS as measured by magnetic resonance imaging (MRI) three years after starting treatment.
The results were presented at the 60th annual meeting of the American Academy of Neurology (AAN) in Chicago, USA.
"These new data demonstrate the exciting potential for FTY720 to reduce relapse rates in MS patients with a convenient once-daily pill," said Professor Giancarlo Comi, Professor of Neurology at the University Vita-Salute San Raffaele in Milan, Italy. "An effective oral treatment would be a significant breakthrough in the management of MS. That is why these results are encouraging - because we are seeing substantial benefits of FTY720 maintained over time in this clinical trial."
FTY720 is a novel, once-daily, oral treatment in worldwide Phase III clinical development for the treatment of relapsing-remitting MS, the form of the disease that affects approximately 85% of people diagnosed with MS.
More than 2.5 million people worldwide are affected by MS, the most common non-traumatic cause of neurological disability in young people. Regulatory filings for FTY720 are expected in the US and EU before the end of 2009.
"The FTY720 Phase III program is the largest conducted in MS to date, and demonstrates our long-term commitment to the field of MS therapy," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "It is especially encouraging to see that FTY720 continues to demonstrate sustained efficacy by helping the majority of patients to remain free of relapses as the study progresses."
FTY720 has the potential to be the first in a new class of therapies for MS that act on inflammation by modulating sphingosine-1-phosphate receptors (S1P-R), reducing the number of inflammatory immune cells, called lymphocytes, from reaching the brain. In addition, FTY720 reaches the brain and S1P-Rs are present on central nervous system (CNS) tissue, so FTY720 may have a direct beneficial effect on MS within the CNS. This additional potential mechanism of action is supported by new preclinical data being presented at AAN,.
The Phase II study presented at AAN began with a six-month placebo-controlled phase in which 281 patients with relapsing MS received placebo, FTY720 1.25 mg or FTY720 5 mg once-daily. This was followed by a long-term extension in which all patients took FTY720. At the end of three years, 173 patients were in the extension, which is still ongoing. The study has been conducted in Canada and 10 European countries.
Results from the six-month placebo-controlled trial showed that FTY720 reduced relapse rates by more than 50% compared to placebo. Current first-line therapies for MS reduced relapse rates by 30-35% on average in two-year studies.
Among patients originally on placebo who converted to active therapy in the extension, 51% were free of relapses at three years. The figure at two years was 57%.
FTY720 has been generally well tolerated throughout the three years of the Phase II study and its extension, with the most common adverse events being nasopharyngitis, headache, fatigue and influenza. Increases in alanine aminotransferase (liver enzymes) were observed in 16% of patients. Dermatological screening of patients was implemented in the extension after a small number of cases of localized skin malignancies were reported.
Novartis continues to study FTY720 in an ongoing, blinded Phase III clinical trial program. This program includes comprehensive monitoring that will further assess and characterize the safety profile of FTY720.
MS is caused by the destruction of myelin, which helps neurons carry electrical signals in the brain. The disease 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.
The foregoing release contains forward-looking statements that can be identified by terminology such as "planned", "potential", "would", "encouraging", "expected", "commitment", "may", "continues", "will", or similar expressions, or by express or implied discussions regarding potential future regulatory filings or marketing approvals for FTY720 or regarding potential future revenues from FTY720. Such forward-looking statements reflect the current views of the Company 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 submitted to regulatory authorities for approval, or will be approved for sale in any market. Nor can there be any guarantee that FTY720 will achieve any particular levels of revenue in the future. In particular, management's expectations regarding FTY720 could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; 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.
Novartis AG provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on growth areas in healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products. Novartis is the only company with leading positions in these areas. In 2007, the Group's continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 98,200 full-time associates and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
[1.] Comi G et al. Oral FTY720 (fingolimod) in patients with relapsing multiple sclerosis. 3-year extension shows sustained low relapse rate and MRI activity. Abstract presented at 60th annual meeting of American Academy of Neurology, Chicago 12-19 April 2008.
[2.] National Multiple Sclerosis Society website.
http://www.nationalmssociety.org/about-multiple-sclerosis/who-gets-ms/index.aspx Accessed March 11, 2008.
[3.] Kappos L. et al. Oral fingolimod (FTY720) in relapsing MS: 24-month results of the Phase II study. ECTRIMS 2006.
[4.] National Multiple Sclerosis Society website.
http://www.nationalmssociety.org/about-multiple-sclerosis/what-is-ms/index.aspx Accessed March 11, 2008.
[5.] Kappos L et al. Oral Fingolimod (FTY720) for Relapsing Multiple Sclerosis. N Engl J Med 2006;355, p. 1130.
[6.] Barske C et al. FTY720 (Fingolimod) and S1P-Receptor 1 and 5 specific Agonists Increase the Number of Oligodendrocytes in Vitro. Abstract presented at 60th annual meeting of American Academy of Neurology, Chicago 12-19 April 2008.
[7.] Schubart A et al. FTY720 suppresses ongoing EAE and promotes a remyelinating environment preventing axonal degeneration within the CNS. Abstract presented at 60th annual meeting of American Academy of Neurology, Chicago 12-19 April 2008.
[8.] National Multiple Sclerosis Society website.
http://www.nationalmssociety.org/about-multiple-sclerosis/symptoms/index.aspx Accessed March 11, 2008.
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BIOGEN IDEC AND ELAN PRESENT NEW TYSABRI® DATA AT THE 60th ANNUAL MEETING OF THE AMERICAN ACADEMY OF NEUROLOGY
Approximately 26,000 Patients on Commercial and Clinical Therapy Worldwide
Additional Analyses Show TYSABRI Significantly Increased the Proportion of Multiple Sclerosis (MS) Patients Who are Considered Disease Free for Over Two Years
Chicago, IL - April 15, 2008 - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced new data on the global utilization, safety and overall patient exposure of TYSABRI® (natalizumab). As of the end of March 2008, approximately 26,000 patients were on commercial and clinical therapy worldwide with no cases of progressive multifocal leukoencephalopathy (PML) reported since re-launch in the U.S. and launch internationally in July 2006. Growth in global utilization plus increasing confidence in the favorable benefit-risk profile of TYSABRI indicate the companies are making great progress toward the goal of 100,000 patients on therapy by year-end 2010. These data were presented today at the 60th Annual Meeting of the American Academy of Neurology (AAN).
"These data suggest that neurologists and patients are increasingly choosing TYSABRI for the treatment of their disease. The significant clinical benefits are established and TYSABRI continues to offer the potential for compelling efficacy and hope for those patients living with MS," said Michael Panzara, MD, MPH, Vice President and Chief Medical Officer, Neurology Strategic Business Unit, Biogen Idec.
"Positive outcomes for patients continue to support TYSABRI's strength as a valuable treatment for multiple sclerosis patients in more than 30 countries around the world. We are also excited that patients with Crohn's Disease are now enrolling in the TOUCH program and beginning to receive TYSABRI treatment in the U.S.," said Gordon Francis, MD, Senior Vice President, Global Clinical Development, Elan.
According to data available as of the end of March 2008:
In the U.S., approximately 15,300 patients were on TYSABRI therapy commercially and approximately 2,750 physicians have prescribed the therapy;
Outside of the U.S., more than 10,200 patients were on TYSABRI therapy commercially;
In global clinical trials, more than 600 patients were on TYSABRI therapy; and
There have been no cases of PML since re-launch in the US and launch internationally in July 2006.
Cumulatively, in the combined clinical trial and post-marketing settings:
More than 36,700 patients have been treated with TYSABRI; and
Of those patients, over 9,900 have received at least one year of TYSABRI therapy and more than 3,600 patients have been on therapy for 18 months or longer.
TYSABRI is available in the U.S. through the TOUCH™ Prescribing Program. All U.S. prescribers, infusion sites, and patients receiving TYSABRI are required to enroll in TOUCH. Safety information is also collected through ongoing clinical trials and registries, including TYGRIS and the pregnancy registry, making this the largest long-term patient follow-up effort undertaken for any MS therapy.
The abstract for this study, "Natalizumab Utilization and Safety in Patients with Relapsing Multiple Sclerosis: Updated Results from TOUCH™ and TYGRIS" (Presentation #S02.002), is available online at the AAN's Web site.
TYSABRI Increases the Proportion of MS Patients Considered Disease Free
Biogen Idec and Elan also announced today at the meeting that TYSABRI treatment significantly increases the proportion of patients with MS considered to be disease free, according to post-hoc analyses of the AFFIRM and SENTINEL clinical trials. The proportion of patients considered disease free in the studies was determined based upon both clinical and MRI criteria. In the studies, the proportion of patients considered disease free 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 seen on annual MRI scans and no new or enlarging T2-hyperintense lesions over two years.
"The ultimate goal of an MS treatment is to help patients remain symptom free for as long as possible. These data show natalizumab may do just that as about one-third of patients were shown to have no relapses, no disability progression and no new MRI markers. This is further evidence that treatment with natalizumab can result in truly dramatic outcomes for a large group of patients," said the study's lead author, Steven Galetta, MD, Professor of Neurology, University of Pennsylvania School of Medicine.
In the AFFIRM trial, patients were randomized to receive TYSABRI or placebo, while in the SENTINEL trial, randomized patients received TYSABRI plus interferon beta-1a or placebo plus interferon beta-1a. Over a two-year period, patients were evaluated utilizing clinical criteria, MRI criteria and combined criteria with both trials demonstrating TYSABRI treatment significantly increased the proportions of patients considered disease free. Using clinical and MRI disease-free criteria combined, a stringent definition of disease free, 36.7% and 31.7% of patients in the TYSABRI groups were disease free compared with 7.2% and 10.9% given placebo in the AFFIRM and SENTINEL trials, respectively. By individual criteria, TYSABRI benefit was also demonstrated using clinical (AFFIRM: 64.3% vs. 38.9%; SENTINEL: 47.4% vs. 28.0%) and MRI definitions of disease free (AFFIRM: 57.7% vs. 14.2%; SENTINEL: 65.5% vs. 27.6%). In both studies, results were similar in patients with highly-active and non-highly active MS.
The abstract for this study, "Natalizumab Increases the Proportion of Patients Free of Clinical or MRI Disease Activity in Relapsing Multiple Sclerosis" (Poster #P02.156), is available online at the AAN's Web site.
About TOUCH™ and TYGRIS
Before initiating treatment, all U.S. patients, prescribers and infusion sites must be enrolled in the TOUCH Prescribing Program (TYSABRI Outreach: Unified Commitment to Health). TOUCH is designed to determine the incidence of and risk factors for serious opportunistic infections (OIs), including PML, and to monitor patients for signs and symptoms of PML while promoting informed benefit-risk discussions prior to initiating TYSABRI treatment. Physicians report on PML, other serious OIs, deaths and discontinuation of therapy on an ongoing basis.
TYGRIS (TYSABRI Global ObseRvation Program In Safety) is expected to enroll 5,000 patients worldwide, including approximately 2,000 - 2,500 patients from TOUCH. Patients in TYGRIS are evaluated at baseline and every six months thereafter for five years. Researchers will evaluate data including medical/MS history; prior TYSABRI use; prior use of immunomodulatory, antineoplastic, or immunosuppressive agents; and all serious adverse events, including PML and other serious OIs and malignancies.
Adverse event reporting in the post-marketing setting is voluntary. It is possible that not all reactions have been reported, or that some reactions are not reported to Biogen Idec or Elan in a timely manner.
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 was recently approved to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha.
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 and CD clinical trials, the incidence and rate of other serious adverse events, including serious infections, were similar in patients receiving TYSABRI and those receiving placebo. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash. Other common adverse events reported in TYSABRI-treated CD patients include respiratory tract infections and nausea. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting.
TYSABRI is approved in more than 30 countries including the United States and many countries throughout the European Union, as well as Switzerland, Canada, Australia, New Zealand and Israel.
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.
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. 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 the 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, that the companies may encounter other unexpected hurdles, or that new therapies for MS with better efficacy or safety profiles or more convenient methods of administration are introduced into the market. 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.
Biogen Idec Important Information
Biogen Idec and its directors, executive officers and other members of its management and employees may be deemed to be participants in the solicitation of proxies from the stockholders of Biogen Idec in connection with the Company's 2008 annual meeting of stockholders. Information concerning the interests of participants in the solicitation of proxies will be included in any proxy statement filed by Biogen Idec in connection with the Company's 2008 annual meeting of stockholders. In addition, Biogen Idec files annual, quarterly and special reports with the Securities and Exchange Commission (the "SEC"). The proxy statements and other reports, when available, can be obtained free of charge at the SEC's web site at www.sec.gov or from Biogen Idec at www.biogenidec.com. Biogen Idec stockholders are advised to read carefully any proxy statement filed in connection with the Company's 2008 annual meeting of stockholders when it becomes available before making any voting or investment decision. The Company's proxy statement will also be available for free by writing to Biogen Idec Inc., 14 Cambridge Center, Cambridge, MA 02142. In addition, copies of the proxy materials may be requested from our proxy solicitor, Innisfree M&A Incorporated, by toll-free telephone at (877) 750-5836 or by e-mail at firstname.lastname@example.org.
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BioMS Medical’s Phase III U.S. Multiple Sclerosis Trial Receives Positive Safety Review from Data Safety Monitoring Board
Edmonton, Alberta, April 15, 2008 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) has reviewed data from the Company’s on-going MAESTRO-03 U.S. pivotal phase III clinical trial of MBP8298 for the treatment of secondary progressive MS and recommended that the trial continue.
This was the second of several regularly scheduled reviews by the DSMB that will occur over the duration of the trial. The purpose of the DSMB is to provide objective, independent safety monitoring of the trial.
To date, more than 65% of the total number of required patients have been enrolled in the Company’s MAESTRO-03 clinical trial, with full enrollment anticipated for the end of the first half of 2008.
The MAESTRO-03 U.S. pivotal phase III clinical trial is a randomized, double-blind study enrolling approximately 510 patients at more than 60 clinical sites who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).
About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical’s lead technology, MBP8298, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to MBP8298 in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at www.biomsmedical.com.
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Genentech and Biogen Idec Announce Top-Line Results from a Phase II/III Clinical Trial of Rituxan in Primary-Progressive Multiple Sclerosis
South San Francisco, Calif. and Cambridge, Mass. -- April 14, 2008 -- Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) today announced that a Phase II/III study of Rituxan® (rituximab) for primary-progressive multiple sclerosis (PPMS) did not meet its primary endpoint as measured by the time to confirmed disease progression during the 96-week treatment period. Genentech and Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.
"We are disappointed in the outcome of the primary endpoint, but not surprised given the significant clinical challenges presented by PPMS," said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. "There was some evidence of biologic activity, and we will continue to review all the data to better understand the role of B cells in MS."
"While the primary results are not what we had hoped, we continue to believe in the potential of B cell therapy for patients living with MS," said Michael Panzara, M.D., MPH, Vice President and Chief Medical Officer, Neurology Strategic Business Unit, Biogen Idec. "PPMS is widely considered a difficult form of MS to treat and historically no therapy has proven efficacy in this disease state."
About the Study
This Phase II/III randomized, double-blind, placebo-controlled, multi-center study was designed to evaluate the efficacy, safety and tolerability of four courses of Rituxan in patients with PPMS. A total of 439 patients from approximately 60 sites in the U.S. and Canada were randomized 2:1 to receive either four treatment courses of Rituxan six months apart or placebo. MRI evaluations were conducted at baseline, weeks 6, 48, 96 and 122.
Detailed safety data from the study is currently being evaluated. The incidence of overall adverse events was comparable between Rituxan and placebo treatment groups. Serious adverse events were 16.4 percent in the Rituxan arm versus 13.6 percent in the placebo arm, with an incidence of serious infections of 4.5 percent compared with <1.0 percent respectively. Infectious events reported in at least 10 percent of patients in either group included upper respiratory and urinary tract infections. Most infectious events in the Rituxan arm were reported as mild to moderate in severity, though events of greater severity were reported more frequently in patients receiving Rituxan. There were more infusion-related reactions with Rituxan, the majority of which were mild to moderate in severity. The companies continue to monitor the long-term safety of Rituxan treatment.
About MS and PPMS
MS is a chronic autoimmune disease where the body's immune system attacks the myelin sheath causing inflammation and destruction of this fatty, protective substance. The myelin sheath surrounds the body's nerve fibers in the central nervous system, which includes the brain, optic nerves and spinal cord. There are four generally accepted disease courses of MS with a wide variety of symptoms and variations of disease progression.
Symptoms of the disease vary from patient-to-patient. Neurological disability typically accumulates over time and may include weakness or fatigue; numbness or tingling; blurred vision, impaired color perception or visual loss; poor coordination of muscle movements; difficulty with bladder or bowel control; muscle stiffness (spasticity); speech problems and challenges with cognitive skills.
PPMS affects approximately 10 percent of the MS population and is evident by the slow and continuous progression of the disease. People with PPMS can experience plateaus in the progression of their disability, but generally do not experience distinct periods of relapse or remissions. The progressive nature of PPMS and severe debilitation associated with the disease can have a devastating impact on a patient's quality of life and ability to function.
Rituxan, discovered by Biogen Idec, is a therapeutic antibody that first received Food and Drug Administration (FDA) approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B cell non-Hodgkin's lymphoma (NHL). It was also approved in the European Union under the trade name MabThera® in June 1998. In February 2006, Rituxan also received FDA approval in combination with methotrexate to reduce signs and symptoms and, in January 2008, to slow the progression of structural damage in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF-antagonist therapies. Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B cells. Rituxan does not target the entire immune system.
CD20 is not found on stem cells, pro-B cells (B cell precursors), normal plasma cells, or other normal tissues. Rituxan does not target plasma cells. These cells make antibodies that help fight infections.
Rituxan does not target stem cells in the bone marrow, and B cells can usually regenerate and gradually return to normal levels after treatment with Rituxan in about 12 months for most patients.
In addition, Rituxan received FDA approval in February 2006 for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy and in September 2006, also was approved for the treatment of non-progressing low-grade, CD20-positive, B cell NHL as a single agent, in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy, and for previously untreated diffuse large B cell, CD20-positive, NHL in combination with CHOP or other anthracycline-based chemotherapy regimens.
Over the past ten years, there have been more than 1 million patient exposures to Rituxan.
Important Safety Information
Rituxan has been associated with fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions and progressive multifocal leukoencephalopathy (PML). Hepatitis B reactivation and cardiac arrhythmias and angina have also been observed. Patients should be closely observed for signs of infection if biologic agents and/or disease modifying anti-rheumatic drugs other than methotrexate are used concomitantly. Common adverse reactions (≥ 5%): hypertension, nausea, upper respiratory tract infection, arthralgia, pruritus, and pyrexia.
In addition to PPMS, for which there is currently no FDA-approved therapy, Rituxan is also being studied in other autoimmune diseases for significant unmet medical needs, including systemic lupus erythematosus, lupus nephritis and antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.
Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd. For a copy of the Rituxan full prescribing information, including Boxed Warning, please call 1-800-821-8590 or visit http://www.gene.com.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is listed on the New York Stock Exchange under the symbol DNA. For additional information about the company, please visit http://www.gene.com.
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 http://www.biogenidec.com.
This press release contains a forward-looking statement regarding the potential of B cell therapy for patients living with MS. Such statement is a prediction and involves risks and uncertainties such that actual results may differ materially. Actual results may be affected by a number of factors including, but not limited to, unexpected safety, efficacy or manufacturing issues, the need for additional data or clinical studies, FDA actions or delays, failure to obtain or maintain FDA approval, competition, pricing, reimbursement, the ability to supply product, product withdrawals and new product approvals and launches, and intellectual property or contract rights. Please also refer to the risk factors described in Genentech and Biogen Idec's periodic reports filed with the Securities and Exchange Commission. Genentech and Biogen Idec disclaim, and do not undertake, any obligation to update or revise any forward-looking statements in this press release.
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Pluristem's PLX Cells Show a Statistically Significant Advantage in a Pre-Clinical Study in the Multiple Sclerosis Model
2008-04-14 20:16:34 -
Pluristem Therapeutics Inc. (NASDAQ:PSTI) (DAX:PJT) a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for a variety of degenerative, ischemic and autoimmune indications, announced today that a preclinical study utilizing the Company's PLacental eXpanded (PLX) cells showed a statistically significant advantage in ameliorating functional deficiencies in a standard Multiple Sclerosis (MS) animal model. PLX cells are mesenchymal stromal cells (MSCs) obtained from the placenta and expanded using Pluristem's proprietary 3D PluriX(TM) technology.
Researchers at Pluristem utilized the Experimental Autoimmune Encephalitis (EAE) animal model for the study, the paradigm for MS in humans. After EAE was induced, a number of the animals were given PLX cells intravenously while the remaining served as a control. There was a significant reduction in the EAE score in those animals given PLX cells versus the control group and this beneficial effect was seen throughout the 25-day duration of the study. The EAE score is a measurement of functional outcomes in the EAE-afflicted animal and correlates closely with a histological improvement in EAE-induced lesions. Additionally, the beneficial effects were similar to when Zappia et. al. used MSCs that were non-placental in origin in this EAE animal model(1).
Zami Aberman, Pluristem's President and CEO said: "We are very excited that our PLX cells were able to demonstrate beneficial results that are statistically significant in this standardized model for Multiple Sclerosis. These results, in addition to our previously announced PLX STROKE results, demonstrate that PLX cells may be useful in the treatment of central nervous system (CNS) disorders and potentially help millions of people. Additionally, we believe this experiment demonstrates we can potentially utilize our off-the-shelf, easy to obtain PLX cells and achieve results that are as good as or better than MSCs obtained from other more difficult to find sources."
(1)Zappia et. al. Mesenchymal stem cells ameliorate experimental autoimmune encephalitis inducing T cell anergy. Blood. 2005;106: 1755-1761
About Multiple Sclerosis (MS)
Multiple sclerosis (MS), also known as disseminated sclerosis or encephalomyelitis disseminate, is an autoimmune condition in which the immune system attacks the central nervous system (CNS), leading to demyelination. Myelin is the insulating sheath that surrounds nerve cells (neurons). MS may cause numerous physical and mental symptoms, and often progresses to physical and cognitive disability. The World Health Organization (WHO) estimates that over 2.5 million people globally suffer from MS, which represents a current market of approximately $5.4 billion for disease-modifying agents to treat the disorder.
Pluristem Therapeutics Inc. is a bio-therapeutics company dedicated to the commercialization of non-personalized (allogeneic) cell therapy products for the treatment of several severe degenerative, ischemic and autoimmune disorders. The Company is developing a pipeline of products, stored ready-to-use, that are derived from the human placenta, a non-controversial, non-embryonic, adult stem cell source.
These placental mesenchymal stromal cells (MSCs) are expanded in the Company's proprietary PluriX(TM) 3D bioreactor, which imitates the natural microstructure of bone marrow and does not require supplemental growth factors or other exogenous materials. Pluristem believes the resultant PLX (PLacental eXpanded) cells are multi-potent and able to differentiate into a variety of cell types. Recent evidence also suggests their efficacy may be related to the secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are immune privileged and have immunomodulatory properties, thus protecting the recipient from immunological reactions that often accompany transplantations.
Pluristem's first product, PLX-PAD, is intended to improve the quality of life of millions of people suffering from peripheral artery disease (PAD). The Company's PLX-I product is intended to resolve the global shortfall of matched tissue for bone marrow transplantation (BMT) by improving the engraftment of hematopoietic stem cells (HSCs) contained in umbilical cord blood (UCB). PLX-STROKE shows potential to become a new treatment for the functional recovery from an ischemic stroke.
Pluristem has offices in the USA with research and manufacturing facilities in Israel. www.pluristem.com
See our product animation on YouTube: www.youtube.com/watch?v=OFhWXyJT6Us
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. These forward-looking statements are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, when we say that the Company's PLacental eXpanded (PLX) cells showed a statistically significant advantage in ameliorating functional deficiencies in a standard Multiple Sclerosis (MS) animal model; that these results, in addition to our previously announced PLX STROKE results, demonstrate that PLX cells may be useful in the treatment of central nervous system (CNS) disorders and potentially help millions of people; that we believe this experiment demonstrates we can potentially utilize our off-the-shelf, easy to obtain PLX cells and achieve results that are as good as or better than MSCs obtained from other more difficult to find sources, we are using forward looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; results in the laboratory may not translate to equally good results in real surgical settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risk and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.
Pluristem Therapeutics Inc.
William Prather RPh, MD, Sr. VP Corporate Development
13 Apr 2008
A potential treatment for multiple sclerosis (MS), developed by University of Greenwich in association with Kings College, London, has begun clinical trials.
The life sciences company BTG plc, which has licensed the research, is running the trials on a new compound, known as BGC20-0134.
Dr Laurence Harbige and Dr Mike Leach, from the Biomedical & Drug Discovery Research Group in the University of Greenwich School of Science, developed the new treatment following many years of research.
Dr Laurence Harbige explains: "Although the cause of multiple sclerosis is unknown, there is strong evidence that it involves the regulation of the immune system through molecules in our bodies called cytokines. In MS, the balance of these cytokines is altered, leading to inflammation in the brain which can result in serious disability."
Dr Mike Leach adds: "This new treatment should encourage the immune system to rebalance itself, by inhibiting the production of inflammatory cytokines while promoting the production of helpful anti-inflammatory ones."
These initial trials, in volunteers, will look at how the new treatment works in the body and whether it leads to an increase in the helpful cytokines. A pilot study of a prototype treatment developed by the University of Greenwich team, which is related to this compound, has already shown promising results. It demonstrated clinical benefits in patients with a common form of multiple sclerosis, called relapsing-remitting. It led to decreases in relapse rates, disability and pain, along with improvements in quality of life. Preclinical research on the new compound, BGC20-0134, indicates that it may be three times as potent as this prototype.
Professor Tom Barnes, Pro Vice-Chancellor for Research & Enterprise at the University of Greenwich, congratulates the team behind the discovery: "It is very good news that this research is now in clinical trials. Our university aims to carry out work which is useful to society and this discovery is a classic example of that. It highlights the excellence of the research staff at Greenwich and also the business orientation of the university, through this partnership with BTG plc. Drs Harbige and Leach are to be congratulated on this important milestone."
Louise Makin, BTG's Chief Executive Officer, comments: "The effective treatment of multiple sclerosis remains a significant unmet need. We are pleased to have started clinical development of BGC20-0134, which has the potential to address different forms of the disease and has the advantage of being an oral product."
Old Royal Naval College
Park Row, Greenwich
Bayhill Therapeutics Announces Presentation of MS Drug Candidate BHT-3009 at American Academy of Neurology 60th Annual Meeting
PALO ALTO, Calif., Apr 10, 2008 (BUSINESS WIRE) -- Bayhill Therapeutics, Inc., a clinical-stage biopharmaceutical company leveraging its proprietary therapeutic BHT-DNA(TM: 98.28, +0.30, +0.30%) platform to develop novel and targeted autoimmune disease treatment candidates, today announced that the Company's co-founder and Vice President of Research, Hideki Garren, M.D., Ph.D., will present at the American Academy of Neurology 60th Annual Meeting (AAN) in Chicago. Dr. Garren's podium presentation will discuss Bayhill's lead product candidate BHT-3009 in relation to an abstract (#857) entitled "Results from a Phase 2 Trial of a Myelin Basic Protein Encoding DNA Vaccine for Relapsing Multiple Sclerosis" at session S22: "Multiple Sclerosis: Clinical Trials III" on Wednesday, April 16 at 2:30 PM central time at McCormick Place West Convention Center, Chicago, IL.
Please note, the details of the abstract remain under embargo until the commencement of Dr. Garren's presentation at the conference. Bayhill Therapeutics will provide additional details at that time.
About BHT-3009 an Investigational Product
BHT-3009 is an antigen-specific plasmid encoding myelin basic protein (MBP: 24.40, +0.30, +1.24%) that has the potential to gain a significant share of the multi-billion dollar MS market as an effective treatment with limited side effects and a superior administration profile. Early clinical data suggests that BHT-3009 reprograms the immune system to tolerize to, rather than attack, the MBP in the myelin sheath of the central nervous system of MS patients. In particular, data from two completed placebo-controlled clinical trials signaled BHT-3009's potential to treat Relapsing Remitting Multiple Sclerosis (RR-MS) patients with high levels of immune activity, with a safety profile similar to placebo.
About Multiple Sclerosis (MS: 45.89, +0.47, +1.03%)
MS is a chronic autoimmune disease characterized by the immune system's attack on specific self-antigens, such as myelin basic protein (MBP: 24.40, +0.30, +1.24%) present in the myelin sheath of the central nervous system. This attack on self-antigens leads to the onset of MS, which is characterized by symptoms of numbness, lack of coordination, blindness and paralysis.
According to an article published in The New England Journal of Medicine in 2006, MS is the most common non-traumatic cause of disability in young adults in the United States and Europe. According to the National Multiple Sclerosis Society (NMSS: 1.31, +0.06, +4.80%) an estimated 400,000 people in the United States have MS, while more than two million people are afflicted worldwide.
About Bayhill Therapeutics
Bayhill Therapeutics is a clinical-stage biopharmaceutical company leveraging its proprietary therapeutic BHT-DNA(TM: 98.28, +0.30, +0.30%) platform to develop a pipeline of novel and targeted treatment candidates for autoimmune diseases. The Company's product candidates are designed to restore the immune system to its normal state known as "tolerance," by selectively eliminating specific, harmful immune responses while leaving the rest of the immune system intact. The Company has two lead products in the clinic based on BHT-DNA(TM: 98.28, +0.30, +0.30%) that have demonstrated positive safety and tolerability, in addition to preliminary efficacy. The first product candidate, BHT-3009, was the subject of a completed Phase II trial for multiple sclerosis (MS: 45.89, +0.47, +1.03%). The second product candidate, BHT-3021, is currently in a Phase I/II trial for type 1 diabetes (T1D). More information about Bayhill Therapeutics is available at www.bayhilltx.com.
SOURCE: Bayhill Therapeutics, Inc.
Bayhill Therapeutics, Inc.
Mark W. Schwartz, Ph.D, President/CEO, 650-320-2800
Fred Kurland, Chief Financial Officer, 650-320-2800
The Ruth Group
Sara Ephraim, 646-536-7002 (Investors)
Janine McCargo, 646-536-7033 (Media)
email@example.comCopyright Business Wire 2008
But Surveys Show Many Multiple Sclerosis Patients Don't Discuss Walking Trouble With Doctors
By Denise Mann
WebMD Medical News Reviewed by Louise Chang, MD
April 10, 2008 (New York) -- The majority of people with multiple sclerosis (MS) say that trouble walking significantly affects their overall quality of life, yet many do not discuss their mobility issues with their doctors, according to two surveys.
The polls were conducted by Harris Interactive on behalf of Acorda Therapeutics Inc. and the National MS Society.
"We didn't expect to see that people who have mobility issues are not discussing them with their doctors because there are so many possibilities in terms of addressing mobility problems," Nicholas LaRocca, PhD, tells WebMD. LaRocca is the vice president of health care delivery and policy research at the National MS Society, based in New York City.
MS affects the central nervous system (the brain, spinal cord, and optic nerves). It results in loss of muscle control, vision, balance, and sensation. In MS, the body's own immune system attacks myelin, a fatty substance that surrounds and protects the nerve fibers in the central nervous system. Symptoms can range from mild, such as numbness in the limbs, to severe, such as paralysis.
The new polls comprised 1,011 U.S. adults with MS and 317 of their care partners. The participants were surveyed online between Jan. 28 and Feb. 25.
Almost two-thirds of people with MS experience trouble walking, the inability to walk, or the loss of balance at least twice a week; 94% of people with MS who have trouble walking say they find it at least somewhat disruptive to their daily life, with 63% percent finding it very disruptive or disruptive.
While 70% of people with MS who have difficulty walking say that it is the most challenging aspect of their disease, 39% of people with MS and almost 50% of their caregivers say that they rarely or never discuss this with their doctor.
Loss of mobility spills over into many aspects of the lives of people with MS and their caregivers. In the surveys, 21% of people with MS who experienced mobility loss said they changed their plans to have children because of it and nearly three of five people with MS who have mobility issues said they had missed out on personal events due to these issues.
Close to 70% of people with MS who have mobility problems say it affects their emotional health; about half say their mobility issues affect their ability to work and increase their daily expenditures.
Fatigue was also a very common symptom among survey respondents; 76% of people with MS said that they experience fatigue at least twice a week. Fatigue is known to affect mobility and balance.
Speak Up, Help Is Available
The onus may fall on the person with MS or a caregiver to broach mobility loss with a doctor, LaRocca tells WebMD. "The person with MS and their partner need to be proactive in terms of raising the issues that are concerning to them," he says.
In terms of mobility issues, "there are so many different areas to pursue," he says. Several mobility aids -- including canes, walkers, and electronic wheelchairs -- are available to help people with MS, he says. According to the surveys, 32% of people with MS do use some type of mobility aid to get around. Of these, 37% said they are embarrassed by their use of such aids.
"The tendency to underuse mobility devices is something we really want to address in the future," LaRocca says.
The first step is to evaluate the walking problem and identify the best strategies to improve it, he says. In addition to mobility aids, other tools are available depending on the problem. Exercise braces or electrical stimulation can help foot-drop (a compensatory technique that involves raising the heel on the stronger leg to make it easier to swing the weaker leg through); time and energy management can help curb MS-related fatigue, and there are drugs that can slow the disease course as well as treat spasticity and fatigue, he says.
Exercise can also help improve mobility problems among people with MS. "Seek out advice for a physical or occupational specialist to help develop an exercise program," says Brian Hutchinson, PT, MSCS, president of the Heuga Center for Multiple Sclerosis in Edward, Colo.
"People with MS can see the same benefits of regular exercise as people without MS," he says.
Acorda is investigating a drug called Fampridine-SR, which may improve walking ability in people with MS.
Takeda to Acquire Millennium for US$25.00 Per Share in an All Cash Tender Offer Valued at $8.8 Billion
- Acquisition Accelerates Takeda's Vision of Becoming a Global Leader in Oncology -
OSAKA, Japan, and CAMBRIDGE, Mass., April 10 /PRNewswire-FirstCall/ -- Takeda Pharmaceutical Company Limited ("Takeda", TSE: 4502) and Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM) today announced that they have entered into a definitive agreement pursuant to which Takeda will acquire Millennium for approximately $8.8 billion through a cash tender offer of $25.00 per share. The transaction was unanimously approved by the Boards of Directors of both companies. Upon completion of the acquisition, Millennium will become a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited, and will continue operations in Cambridge, Massachusetts, as a standalone business unit. Millennium will be known as Millennium Pharmaceuticals, Inc., a Takeda Company.
Millennium is a leading biopharmaceutical company. In the United States, Millennium markets VELCADE(R) (bortezomib) for Injection-a novel, market- leading oncology product approved in more than 85 countries. Millennium has an innovation-driven discovery and development organization, which is advancing a pipeline of novel product candidates in oncology and inflammation. This includes a potential therapy for inflammatory bowel disease (IBD), which is expected to enter Phase III clinical trials in late 2008/early 2009. Millennium reported total revenues of approximately $528 million for 2007.
The acquisition of Millennium accelerates Takeda's vision of becoming a global leader in oncology with critical mass in the areas of oncology discovery, development, regulatory affairs and commercialization. Millennium and Takeda have complementary research, development and commercialization capabilities, which have the potential to create a powerful new drug development engine and accelerate the potential of an emerging drug pipeline.
"Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product VELCADE, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, President of Takeda Pharmaceutical Company Limited. "Takeda is committed to becoming a global leader in oncology by delivering novel therapies that improve the standards of care for patients. Millennium has strong discovery, development and commercial capabilities led by a well-established management team. We are pleased that Dr. Deborah Dunsire, Millennium President and Chief Executive Officer, and the current management team intend to continue to lead the Company. Our strong desire is to retain Millennium employees, who have created an entrepreneurial and innovative culture."
"We are extremely proud of the commitment and passion of our employees, who have built this vibrant organization. We look forward to continued success as we join the Takeda Group," said Deborah Dunsire, M.D., President and Chief Executive Officer, Millennium. "Both companies share a common vision to develop breakthrough medicines for patients, become a global leader in oncology and expand the global reach of our IBD product candidates. We expect this transaction to help accelerate that vision and deliver tremendous value to patients, shareholders and our employees."
Key Strategic Benefits
Takeda expects that the acquisition of Millennium will:
Provide access to a fully-integrated oncology discovery, development and commercial platform with a seasoned management team and talented employee base;
Add VELCADE, a growing and market-leading oncology product with near- term worldwide blockbuster potential;
Supply access to Millennium world-class drug discovery organization, including expertise in the novel research area of protein homeostasis;
Capitalize on Millennium proven drug development capabilities and regulatory expertise, which allowed the Company to bring VELCADE to market rapidly;
Leverage the Millennium experienced sales force, established relationships with oncology thought leaders and highly-regarded marketing capabilities to launch future products; and
Expand Takeda's global pipeline in GI, adding a novel anti-alpha4beta7 antibody and an oral CCR9 inhibitor for the treatment of IBD.
Takeda will finance the acquisition through cash on hand. There is no financing condition to the tender offer or second step merger.
Takeda expects that the acquisition will enhance Takeda's earnings starting in the fiscal year ended March 2010 before transaction related amortization. The addition of Millennium will enhance Takeda's growth profile immediately.
The acquisition is structured as an all cash tender offer for all of the outstanding shares of Millennium common stock, followed by a merger in which remaining shares of Millennium would be converted into the right to receive the same US$25.00 cash per share price paid in the tender offer.
The transaction has been unanimously approved by the Boards of Directors of Millennium and Takeda.
The transaction is subject to the tender of a majority of Millennium common stock on a fully diluted basis as well as other customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the antitrust laws of applicable foreign jurisdictions. The transaction is expected to close in the second-quarter of 2008.
Takeda America Holdings, Inc., which is wholly-owned by Takeda, has established Mahogany Acquisition Corp. as a wholly-owned subsidiary to effect the transaction. In the merger that follows completion of the tender offer, Mahogany Acquisition Corp. will be merged into Millennium, and the surviving entity will be an indirect wholly-owned subsidiary of Takeda.
Conference Call and Webcast Information
Takeda will host a Japanese-language investors meeting in Japan on April 10 at 8:00 p.m. JST (7 a.m. EDT) and an investors conference call in English at 10:00 p.m. JST (9 a.m. EDT) to discuss the transaction. The phone number for the English conference call is 1-877-887-6076 and the participant PIN is 160938#. The conference call recording of both events will be available on Takeda's website at http://www.takeda.com within several days.
Founded in 1781 and located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products.
Additional information about Takeda is available through its corporate website, http://www.takeda.com .
Millennium, a leading biopharmaceutical company based in Cambridge, Mass., markets VELCADE, a novel cancer product, and has a robust clinical development pipeline of product candidates. Millennium research, development and commercialization activities are focused in two therapeutic areas: oncology and inflammation. By applying its knowledge of the human genome, understanding of disease mechanisms and industrialized drug discovery platform, Millennium is developing an exciting pipeline of innovative product candidates. Additional information about Millennium is available through its website, www.millennium.com.
UBS Investment Bank is acting as exclusive financial advisor and Edwards Angell Palmer & Dodge LLP is acting as legal advisor to Takeda. Goldman, Sachs & Co. is acting as exclusive financial advisor and WilmerHale is acting as legal advisor to Millennium.
This press release contains "forward-looking statements" that involve significant risks and uncertainties. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including: statements regarding the anticipated timing of filings and approvals relating to the transaction; statements regarding the expected timing of the completion of the transaction; statements regarding the ability to complete the transaction considering the various closing conditions; any statements of expectation or belief; and any statements of assumptions underlying any of the foregoing. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements. Actual results could differ materially from those currently anticipated due to a number of risks and uncertainties. Risks and uncertainties that could cause results to differ from expectations include: uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of the Millennium stockholders will tender their stock in the offer; the risk that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the transaction; the effects of disruption from the transaction making it more difficult to maintain relationships with employees, licensees, other business partners or governmental entities; other business effects, including the effects of industry, economic or political conditions outside of Millennium or Takeda's control; transaction costs; actual or contingent liabilities; and other risks and uncertainties discussed in documents filed with the U.S. Securities and Exchange Commission by Millennium, as well as the tender offer documents to be filed by Mahogany Acquisition Corp. and the Solicitation/Recommendation Statement to be filed by Millennium. Neither Millennium nor Takeda undertakes any obligation to update any forward-looking statements as a result of new information, future developments or otherwise.
The tender offer for the outstanding common stock of Millennium referred to in this press release has not yet commenced. This press release is neither an offer to purchase nor a solicitation of an offer to sell any securities. The solicitation and the offer to buy shares of Millennium common stock will be made pursuant to an offer to purchase and related materials that Mahogany Acquisition Corp. intends to file with the U.S. Securities and Exchange Commission. At the time the tender offer is commenced, Mahogany Acquisition Corp. will file a Tender Offer Statement on Schedule TO with the U.S. Securities and Exchange Commission, and thereafter Millennium will file a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. THE TENDER OFFER STATEMENT (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY AND CONSIDERED BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. These materials will be sent free of charge to all stockholders of Millennium. In addition, all of these materials (and all other materials filed by Millennium with the U.S. Securities and Exchange Commission) will be available at no charge from the U.S. Securities and Exchange Commission through its website at http://www.sec.gov. Investors and security holders may also obtain free copies of the documents filed with the U.S. Securities and Exchange Commission by Millennium at http://www.millennium.com .
Seizo Masuda (Takeda)
Kyle Kuvalanka (Millennium)
Matt Kuhn (Takeda)
Karen Gobler (Millennium)
SOURCE: Millennium Pharmaceuticals, Inc.
Teva Seeks Approval for the Extension of its Indication to Include the Treatment of Patients with a First Clinical Event Suggestive of MS
Jerusalem, April 16, 2008 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced new results from the PreCISe study, which demonstrated that early treatment with COPAXONE® (glatiramer acetate injection) significantly reduced the risk of developing clinically definite multiple sclerosis (CDMS) by 45 percent compared to placebo (hazard ratio 0.55, p=0.0001). These data were presented as late-breaking science at the 60th Annual Meeting of the American Academy of Neurology (AAN) in Chicago.
Based on the PreCISE results, an application for marketing authorization in Europe to the Medicines and Healthcare products Regulatory Agency (MHRA) for the extension of its indication to include the treatment of patients with a first clinical event suggestive of MS, was submitted and is currently under review. A similar application requesting an expanded label for COPAXONE® will also be submitted shortly with the U.S. Food and Drug Administration (FDA).
"Clinically isolated syndrome, or CIS, is a first neurologic episode, usually caused by inflammation or demyelination, which is indicative of possible development of multiple sclerosis," said Giancarlo Comi, M.D., University Vita-Salute San Raffaele, Scientific Institute San Raffaele, Milan, Italy, and principal investigator. "The PreCISe study results clearly demonstrate that early treatment with COPAXONE®, as early as CIS, reduces the risk of developing MS" he added.
COPAXONE®, currently indicated for RRMS, is a unique disease modifying treatment with a dual mode of action that has over 10 years of prospective clinical trial data demonstrating long-term clinical treatment benefits and good safety profile. The PreCISe results now extend COPAXONE® effect to CIS patients, demonstrating a reduced risk of developing Clinically Definite MS (CDMS). Furthermore, the safety profile of COPAXONE® in the PreCISe study was consistent with the well-established safety profile of the product based on many years of post-marketing surveillance and over 100,000 patients treated globally with COPAXONE®.
Moshe Manor, Group Vice President, Global Innovative Resources of Teva Pharmaceutical Industries, Ltd., said, "These impressive results clearly demonstrate the potency of COPAXONE® in treating early phases of multiple sclerosis. Along with its lasting efficacy, confirmed over 10 years, it positions COPAXONE® as the preferred treatment option for multiple sclerosis patients".
About the Study
The multi-national, multi-center, prospective, double-blind, randomized, Phase III study was conducted in approximately 100 centers located in the U.S., Europe, Argentina, Israel, Nordic countries, Australia and New Zealand. It included a total of 481 patients presenting with a single clinical episode and MRI suggestive of MS. Patients included were those who had a unifocal disease manifestation (i.e., clinical evidence of a single lesion). Patients received either COPAXONE® 20mg/day or placebo as a subcutaneous injection and continued treatment for up to 36 months, unless a second attack was experienced and they were diagnosed with CDMS. Patients who converted to CDMS continued the trial on active treatment for an additional two years. The primary efficacy outcome was time to CDMS, based on a second clinical attack.
COPAXONE® (glatiramer acetate injection) was also demonstrated to be very well tolerated in the PreCISe study, with only 16 percent overall dropouts during the up to three-year study period, similar to that observed in RRMS patients treated with COPAXONE®. All patients in the study participated in a follow-up study with COPAXONE® to prospectively assess the impact of early versus delayed treatment with COPAXONE® on the long-term course of the disease for a total observation time of up to five years.
A pre-planned interim analysis was performed on data accumulated from approximately 80 percent of the three-year placebo-controlled study exposure. Results of the interim analysis, announced in December 2007, demonstrated the proportion of patients developing CDMS was reduced from 43 percent in the placebo group to only 25 percent in the COPAXONE® group (p< 0.0001). The PreCISe study also demonstrated that the 25th percentile of number of days to conversion to CDMS has more than doubled by COPAXONE® from 336 days to 722 days (hazard ratio 0.55, p=0.0005) compared with placebo.
At the time of this analysis, the data monitoring committee (DMC) stopped the placebo arm of the study, as COPAXONE® successfully met the efficacy endpoint of the study.
Current data suggest COPAXONE® is a selective MHC (Major Histocompatability Complex) class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. COPAXONE® is very well tolerated and the most common side effects of COPAXONEv are redness, pain, swelling, itching, or a lump or an indentation at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONE® is now approved in 51 countries worldwide, including the United States, all European countries, Canada, Mexico, Australia, and Israel. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc.
See additional important information at http://www.COPAXONE.com/pi/index.html or call 1-800-887-8100 for electronic releases. For hardcopy releases, please see enclosed full prescribing information.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world's leading generic pharmaceutical company. The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: when and whether the proposed acquisition will be consummated, Teva's ability to rapidly integrate Bentley's operations with its own operations and achieve expected synergies, the diversion of management time on merger-related issues, Teva's ability to accurately predict future market conditions, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra®, Neurontin®, Lotrel®, Famvir® and Protonix®, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the impact of consolidation of our distributors and customers, the effects of competition on our innovative products, especially Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Teva Pharmaceutical Industries Ltd.
Teva North America
972 (3) 926-7554
Wednesday, April 09, 2008
Phase III MS Neuropathic Pain Trial Preliminary Results
- Very high patient response rate to Sativex but statistical significance narrowly missed due to large, unexpected placebo response -
- Ongoing Phase III trial in MS Spasticity on track and due to report in Q4 -
- MS Spasticity trial has specific features designed to address placebo response -
Porton Down, UK, 8 April 2008: GW Pharmaceuticals plc (AIM: GWP) announces preliminary results of a Phase III double-blind randomised placebo-controlled study of Sativex® in 339 patients with central neuropathic pain due to Multiple Sclerosis (MS), who have achieved inadequate pain relief with existing therapies.
This study is one of three Phase III trials for Sativex underway in 2008, each of which targets a distinct indication. The other European Phase III study in MS Spasticity, requested last year by the UK regulator in order to gain approval in this indication and which involves a different trial design, is on track to report later this year.
The primary efficacy endpoint in the study reported today was the proportion of patients whose pain reduced by at least 30% as measured on a 0-10 numerical rating scale (“responder analysis”). In this study, 50% of Sativex patients experienced a pain reduction of at least 30%, the second largest response rate seen in any Sativex study and amongst the largest seen for any pain treatment in the published literature. However, although the difference between the Sativex and placebo groups was clearly in favour of Sativex, it narrowly failed to reach statistical significance in this trial due to an unexpectedly large placebo response. Key secondary endpoints followed the same trend – in favour of Sativex versus placebo but not at a statistically significant level due to the very high placebo response.
The placebo response in the study reported today appears related to dosing design, whereby patients were able to self-administer the oral spray at will. This was intended to reflect as far as possible the “real world” use of Sativex whereby patients initially experiment with dosing of Sativex to find their optimum dose level and which, once established, is usually maintained thereafter. Analysis of the efficacy data at fixed dose levels demonstrates a highly significant difference between Sativex and placebo. However, a consequence of allowing patients to determine their own dose was that patients on placebo took significantly more doses than patients on Sativex, thus confounding the overall comparison. This validates the decision by GW last year to adopt a fixed target dose approach in both the ongoing studies of Sativex in MS Spasticity and Cancer Pain.
The safety profile of Sativex in this study is superior to that seen in previous studies. The withdrawal rate due to adverse events was 9% on Sativex vs 6% on placebo, the lowest seen in long duration Sativex studies. As in previous studies, the most common adverse event was dizziness. The rate of this adverse event was less than in previous studies (20% on Sativex vs 8% on placebo as compared with 32% vs 9%).
GW’s regulatory strategy is to file Sativex for approval in MS Spasticity in Europe and Cancer Pain in the United States. In Europe, regulatory discussions with the Medicines and Healthcare products Regulatory Agency (MHRA) have exclusively focused on MS Spasticity, a distinct indication supported by different clinical trials. Last year, the MHRA provided clear guidance on the additional clinical trial required for approval. As indicated above, this trial is on track and due to report later this year.
Dr Stephen Wright, R&D Director, said: “It is clear from the size of the response seen in this study that Sativex provides important improvements for these high need patients, even those that have failed to respond to all other pain treatments. It is frustrating that the extent of the placebo response has narrowly prevented the benefits seen on Sativex translating into a statistically significant outcome. The design of the MS Spasticity study due to report later this year is specifically focused on limiting the potential for placebo response and we expect the outcome of this trial and our other studies to confirm the benefits of Sativex.”
“MS Spasticity is a distinct indication supported by different clinical trials and the route to regulatory approval for Sativex as a treatment for this indication remains clear and unaffected by the data announced today.”
Dr Stuart Ratcliffe, Principal Investigator of the study and most recently Director, Pain Research Group, St Bartholomew’s and The Royal London Hospitals NHS Trust, added: “In seeking to replicate the real world usage of Sativex, where each patient finds his or her own optimum dose level, the design of this trial appears to have encouraged an abnormally high placebo response. However, this in no way should detract from the beneficial effects of Sativex seen in the study. Patients saw a marked improvement in their symptoms, a highly impressive effect since they are treatment resistant, and the study recorded the lowest drop-out rate, demonstrating the mild side effect profile of Sativex. My experience with Sativex continues to show that it is an extremely helpful medicine for these high need patients and I am confident that the ongoing trials which seek to address the placebo issue will demonstrate its value.”
Following a comprehensive review of this data, GW intends to carry out a further study in this patient population.
As at 31 March 2008, GW’s cash position stood at £18.5m.
There will be a conference call for analysts today at 8.30am BST. Analysts should contact Gemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113 for details. There will be a live audio web cast of this call, which will be accessible on the press releases page in the investor relations section of the GW website (www.gwpharm.com). A recording of this call will be available on the GW website later today.
GW Pharmaceuticals plc
(Today) + 44 20 7831 3113
Dr Geoffrey Guy, Executive Chairman
(Thereafter) + 44 1980 557000
Justin Gover, Managing Director
+ 44 20 7831 3113
David Yates / Ben Atwell
Notes to Editors
GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular pain and other neurological symptoms. GW has assembled a team of over 100 scientists with extensive experience in developing both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field.
Sativex Phase III trial in MS Neuropathic Pain
This study focused on high need MS patients, who were already taking a range of currently available pain treatments, and yet still suffered severe pain, and who remained on such treatments during the course of the study. Improvements seen in this study therefore represent benefits over and above that which can be achieved with currently available medication. The study recruited patients in the UK, Canada, France, Spain and the Czech Republic and the duration of treatment in the study was 14 weeks.
GW has previously carried out a similar Phase III study with positive results, which was published in the peer-reviewed journal, Neurology. That study showed that Sativex was significantly superior to placebo in reducing pain (p=0.005) and sleep disturbance (p=0.003)1. In this previous study the placebo response was less than that seen in the study reported today.
Clinical & Regulatory Strategy for Sativex
The strategy for Sativex is focused on four specific therapeutic indications, each of which represents a distinct regulatory opportunity and each of which requires a distinct set of clinical efficacy data. These indications are as follows:
Each of these target indications is supported by existing positive Phase III data and will continue to be supplemented by further late stage trials over the next few years in order to supplement globally approvable regulatory packages and provide more data to support the marketing of the product post approval.
The lead indication for Sativex differs across different regions of the world. In the US, Cancer Pain is the chosen initial target. In Canada, MS Neuropathic Pain was the first approved indication, which has now been successfully followed by the approval in Cancer Pain. In Europe, the entry point for Sativex is MS, with MS Spasticity representing the nearest term approval possibility.
This clinical and regulatory programme is designed to provide multiple opportunities over the next few years to obtain approvals for Sativex across various indications in a number of territories.
1. D.J.Rog, T.J.Nurmikko, T.Friede, and C.A Young. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology 2005;65:812