Tag Archives: MS

Danish woman runs 366 marathons in 365 days

A Danish woman who said she was diagnosed with multiple sclerosis three years ago just completed a marathon of marathons, running her 366th in 365 days.

Annette Fredskov, 41, of Naestved, ran 26.2 miles every day and wrapped up her feat on July 14 by running a double marathon — 52.4 miles — in 10 hours and 44 minutes, CPHPost.DK reported.

After being diagnosed with MS, Fredskov decided to run to try to overcome the disease.

“Three years ago, I was diagnosed with multiple sclerosis and today I have — without any medication — no problems or symptoms of MS. I believe that running marathons has played a large role in the fact that I am healthy today,” Fredskov wrote on her website. “Two years ago, I thought the same thing most people think: ‘Running a marathon isn’t healthy. A marathon is damaging tothe body and it takes a long time to recover.’ I have now changed my mind. Marathons are the best things that have happened for my body and soul.”

Dozens of supporters ran with Fredskov as she completed mile 9,589.2, CPHPost.DK reported.

Fredskov began her challenge on July 15, 2012. Most of the marathons took Fredskov about five hours, and took place in her Naestved, her hometown, which is an hour south of Copenhagen.

Click for more from CPHPost.DK.

…read more

Source: FULL ARTICLE at Fox World News

Navidea's Presentation of Top-Line Interim Analysis of Lymphoseek® Head and Neck Phase 3 Trial Selec

By Business Wirevia The Motley Fool

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Navidea’s Presentation of Top-Line Interim Analysis of Lymphoseek ® Head and Neck Phase 3 Trial Selected for Investigator Award

– Data presented at the 2 nd International Symposium on Thoracic and Upper Aerodigestive Malignancies –

DUBLIN, Ohio–(BUSINESS WIRE)– Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that a presentation of results from its Phase 3 clinical trial of Lymphoseek® (technetium 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma received the 1st Investigator Award at the 2nd InternationaI Symposium on Thoracic and Upper Aerodigestive Malignancies. The symposium was held April 4-6, 2013 in Athens, Greece. The presentation of recently announced top-line interim results for the Phase 3 Lymphoseek study and a summary of results from three of the study’s highest-accruing clinical trial sites were made by Dr. Michael Blue, MD, Senior Medical Director of Navidea Biopharmaceuticals, one of the authors.

Poster Title:

The CD206-Targeted, Molecular Sentinel Node Mapping Agent Tc99m-Tilmanocept Accurately Stages Head/Neck Squamous Cell Carcinomas (HNSCC): Prospective Interim Analysis Results From a Phase-3 Multi-Institutional Study.

Authors:

Frank Civantos, MD, FACS, University of Miami; Stephen Y. Lai, MD PhD, FACS, The M.D. Anderson Cancer Center; Amit Agrawal, MD, FACS, Ohio State University Wexner Medical Center; Douglas B. Chepeha, MD, MSP, University of Michigan; Kevin T. Brumund, MD, FACS, UCSD Medical Center; and Frederick O. Cope, PhD, Michael Blue, Wendy Metz, PhD, Bonnie C. Abbruzzese, MS, CCRA, Navidea.

The results presented by Dr. Blue et al included a summary of the pre-planned statistical interim analysis of the primary endpoint on the entire study, as recently announced by Navidea. The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes (that is, lymph nodes found to harbor cancer) following a multiple level lymph node dissection and required a minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease. Thirty-nine subjects were determined to have pathology-positive lymph nodes and were included in the interim analysis. Results from these 39 subjects demonstrated that Lymphoseek accurately identified 38, for an overall False Negative Rate (FNR) of 2.56%.

In addition, the authors reviewed a preliminary evaluation of the NEO3-06 trial data from three of the highest-accruing clinical sites. A total of 50 subjects were evaluated from these sites; 21 had pathology-positive lymph nodes. Results indicated that Lymphoseek identified these pathology-positive lymph nodes in 21 out of 21 subjects for an FNR of 0%. The total

From: http://www.dailyfinance.com/2013/04/11/navideas-presentation-of-top-line-interim-analysis/

CORRECTING and REPLACING Interbrand Appoints Tim Newby as Chief Executive Officer of BrandWizard

By Business Wirevia The Motley Fool

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CORRECTING and REPLACING Interbrand Appoints Tim Newby as Chief Executive Officer of BrandWizard

NEW YORK–(BUSINESS WIRE)– Third graph, second sentence of the release dated April, 8, 2013 should read: including P&G, Citibank, Coca-Cola, and McDonald’s (sted including Proctor & Gamble, Altria, Nestle, and McDonald’s). Also, the fourth graph, second sentence should read: marchFIRST (sted matchFirst).

The corrected release reads:

INTERBRAND APPOINTS TIM NEWBY AS CHIEF EXECUTIVE OFFICER OF BRANDWIZARD

Interbrand, the world’s leading brand consultancy, announced today that Tim Newby has been named Chief Executive Officer of BrandWizard, the digital arm of Interbrand that combines brand and Digital Asset Management (DAM) to bring technology solutions to brand management challenges.

Newby will be based in BrandWizard’s New York office and will report to Lee Carpenter, Interbrand’s North American CEO, and Jez Frampton, Interbrand’s Global CEO.

Most recently, Newby was Chief Operating Officer of MarketForward, a Publicis Groupe-owned company that provides customizable digital brand management tools and strategic consulting services. Newby joined MarketForward in 2004 and oversaw efforts for many of its prominent clients, including P&G, Citibank, Coca-Cola, and McDonald’s. During his tenure, Newby led the worldwide operations of BrandGuard, the company’s core enterprise-level digital management tool.

Prior to his role at MarketForward, Newby held senior leadership positions at several top advertising and technology innovation agencies where he managed global teams across key offers and services spanning sales, strategy, account management, and technical support. He has also held senior Partner positions at OgilvyOne Worldwide and marchFIRST, formerly Whittman-Hart.

“Tim brings the unique combination of business and technological acumen that is required to lead a company like BrandWizard,” said Jez Frampton, Interbrand’s Global Chief Executive Officer. “I have the utmost confidence that with his successful track record developing and growing client relationships and developing innovative technological solutions, he will prove to be a vital asset to the firm and set the stage for the next phase of BrandWizard’s growth.”

Newby succeeds BrandWizard CEO Robin Rusch, who also founded brandchannel.com, Interbrand’s award-winning news resource that covers brands and marketing.

Newby holds an MS in Communications Systems from Northwestern University and a BA in Public Relations from Illinois State University.

About Interbrand

Founded in 1974, Interbrand is one of the world’s largest branding consultancies. With nearly 40 offices in 29 countries, Interbrand’s combination of rigorous strategy, analytics, and world-class design enables it to assist clients in creating and …read more

Source: FULL ARTICLE at DailyFinance

Annette Funicello Dead: Former ‘Mickey Mouse Club’ Star Dies At Age 70

By The Huffington Post News Editors

Former child star Annette Funicello has died at the age of 70, reports “Extra.”

The actress, who is best remembered for her time as a Mouseketeer on “The Mickey Mouse Club” from 1955 to 1957, died from complications related to multiple sclerosis, which she was diagnosed with more than 20 years ago.

Funicello first lost the ability to walk in 2004, and later lost the ability to speak in 2009. Family members told “Extra” that they were by her side when she was taken off life support, after being in a MS coma for years.

Read More…
More on Video

…read more

Source: FULL ARTICLE at Huffington Post

Genzyme's Once-daily, Oral AUBAGIO® (teriflunomide) Approved in Argentina for the Treatment of Relap

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Genzyme’s Once-daily, Oral AUBAGIO ® (teriflunomide) Approved in Argentina for the Treatment of Relapsing Multiple Sclerosis

Approval Expands Footprint of AUBAGIO Across Three Continents and Further Advances Genzyme’s Global MS Franchise

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today Argentina‘s National Administration of Drugs, Food and Medical Technology (ANMAT) has approved once-daily, oral AUBAGIO® 14 mg as a new treatment indicated for patients with relapsing forms of multiple sclerosis (MS).

“Studied in one of the largest clinical trial programs of any MS treatment, AUBAGIO has had consistent effects across all the important measures of MS disease activity including slowing the progression of disability, reducing the number of brain lesions as detected by MRI and reducing relapses. The clinical data supporting AUBAGIO confirm its importance as a new treatment option for MS patients,” said Dr. Jorge Correale, Head of Neuroimmunology and Demyelinating Diseases, Raul Carrea Institute for Neurological Research FLENI, Argentina.

The decision by ANMAT represents the first approval for once-daily, oral AUBAGIO in Latin America. AUBAGIO is also approved in both the United States and Australia, with additional marketing applications under review by regulatory authorities around the world.

“The approval in Argentina of once-daily, oral AUBAGIO represents another important advancement for the Genzyme MS Franchise,” said Bill Sibold, SVP, Head of MS Business, Genzyme. “Genzyme is committed to becoming leaders in MS and developing differentiated treatments that can address the diverse needs of the MS community. Now approved on three continents, AUBAGIO‘s established efficacy and convenient dosing can provide many patients with an attractive alternative to frequent and potentially burdensome injections.”

The ANMAT approval of AUBAGIO was based on safety and efficacy data from the TEMSO (TEriflunomide Multiple Sclerosis Oral) trial. The ongoing AUBAGIO clinical development program, involving more than 5,000 patients in 36 countries, is amongst the largest of any MS therapy. Some patients in extension trials have been treated for up to 10 years.

AUBAGIO, in its clinical studies, has shown favorable efficacy and a well-characterized safety profile. With its once-daily oral administration and tolerability, AUBAGIO should contribute positively to the care of patients with Multiple Sclerosis,” said Dr. Edgardo Cristiano, Head of the Neurology Department of the Hospital Italiano de Buenos Aires, Argentina.

About AUBAGIO ®

AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for AUBAGIO …read more

Source: FULL ARTICLE at DailyFinance

Interbrand Appoints Tim Newby as Chief Executive Officer of BrandWizard

By Business Wirevia The Motley Fool

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Interbrand Appoints Tim Newby as Chief Executive Officer of BrandWizard

NEW YORK–(BUSINESS WIRE)– Interbrand, the world’s leading brand consultancy, announced today that Tim Newby has been named Chief Executive Officer of BrandWizard, the digital arm of Interbrand that combines brand and Digital Asset Management (DAM) to bring technology solutions to brand management challenges.

Newby will be based in BrandWizard’s New York office and will report to Lee Carpenter, Interbrand’s North American CEO, and Jez Frampton, Interbrand’s Global CEO.

Most recently, Newby was Chief Operating Officer of MarketForward, a Publicis Groupe-owned company that provides customizable digital brand management tools and strategic consulting services. Newby joined MarketForward in 2004 and oversaw efforts for many of its prominent clients, including Proctor & Gamble, Altria, Nestle, and McDonald’s. During his tenure, Newby led the worldwide operations of BrandGuard, the company’s core enterprise-level digital management tool.

Prior to his role at MarketForward, Newby held senior leadership positions at several top advertising and technology innovation agencies where he managed global teams across key offers and services spanning sales, strategy, account management, and technical support. He has also held senior Partner positions at OgilvyOne Worldwide and matchFirst, formerly Whittman-Hart.

“Tim brings the unique combination of business and technological acumen that is required to lead a company like BrandWizard,” said Jez Frampton, Interbrand’s Global Chief Executive Officer. “I have the utmost confidence that with his successful track record developing and growing client relationships and developing innovative technological solutions, he will prove to be a vital asset to the firm and set the stage for the next phase of BrandWizard’s growth.”

Newby succeeds BrandWizard CEO Robin Rusch, who also founded brandchannel.com, Interbrand’s award-winning news resource that covers brands and marketing.

Newby holds an MS in Communications Systems from Northwestern University and a BA in Public Relations from Illinois State University.

About Interbrand

Founded in 1974, Interbrand is one of the world’s largest branding consultancies. With nearly 40 offices in 29 countries, Interbrand’s combination of rigorous strategy, analytics, and world-class design enables it to assist clients in creating and managing brand value effectively, across all touchpoints, in all market dynamics. Interbrand is widely recognized for its annual Best Global Brands report, the definitive guide to the world’s most valuable brands, as well as its Best Global Green Brands report, which identifies the gap between customer perception and a brand’s performance relative to sustainability. It is also known for having created brandchannel.com, a Webby-award winning resource about brand marketing …read more

Source: FULL ARTICLE at DailyFinance

Biogen Hits Primary Endpoints in MS Study

By Dan Carroll, The Motley Fool

Filed under:

Biotech company Biogen Idec‘s developmental multiple sclerosis drug daclizumab succeeded in the SELECT phase 2b trial evaluating its safety and effectiveness in treating patients with relapse-remitting MS. The trial results, originally published in The Lancet and reported by Biogen in a recent press statement, showed that two injection treatment groups had annual relapse rates at least 50% lower than a placebo group after one year.

The two treatment groups also showed that daclizumab reduced MS-related brain lesions and improved quality of life in patients, as well as reducing disability progression.

Dr. Gilmore O’Neill, Biogen’s vice president of medical research, said of the results, “Based on these initial data from SELECT, we believe DAC HYP would complement our robust portfolio of four approved MS products by potentially offering people with MS a new treatment alternative.”

Daclizumab is Biogen’s latest developmental candidate in the multiple sclerosis market it has dominated. The company’s oral MS treatment, Tecfidera, won FDA approval in late March and is poised to compete in the promising oral MS market.

The article Biogen Hits Primary Endpoints in MS Study originally appeared on Fool.com.

Fool contributor Dan Carroll and The Motley Fool have no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools don’t all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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Source: FULL ARTICLE at DailyFinance

InVivo Therapeutics Receives Approval from FDA for First Human Trial Using Biomaterials for Traumati

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InVivo Therapeutics Receives Approval from FDA for First Human Trial Using Biomaterials for Traumatic Spinal Cord Injury

CAMBRIDGE, Mass.–(BUSINESS WIRE)– InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI) and other neurotrauma conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational Device Exemption (IDE) to begin human studies to test its biopolymer scaffold product, a technology developed to treat patients with acute, traumatic SCI.

With this approval, InVivo intends to commence a first-in-man clinical study in the next few months that will test safety and performance of its biopolymer scaffold in five patients. The Company expects the study to occur over approximately 15 months. There are currently no treatment options approved by the FDA, or in clinical trials, to intervene directly in the spinal cord following SCI. The trial will be conducted at multiple U.S. hospitals, and work to gain Institutional Review Board (IRB) approval at Massachusetts General Hospital in Boston is already underway.

“It’s heartbreaking for all of us for it to take even a minute longer than necessary to begin human studies, and we’ve all heard of, or experienced, treatments that have proven to be unsafe, but when conducting a first-in-man study, it is imperative to take the time to get it right, because any mistakes can lead to years of lost time for the scientists and patients that follow,” said Frank Reynolds, InVivo Chief Executive Officer.

“I want to thank my team for their years of dedication and hard work, and the FDA for its diligence, careful consideration and engagement during the stringent review of our technology, a true platform that we believe is capable of being leveraged into new treatments for a wide range of acute and chronic neurological conditions. Many of these neurological problems have limited options for care, and for the patients and families of those with lower incidence conditions, often called ‘orphan’ conditions, every day life can feel like there is no way out. We expect a successful safety study to provide not only the first treatment for acute SCI, but also a safe platform for next generation treatment options for conditions such as ALS, MS and Parkinson’s Disease. At InVivo we live by the mantra ‘What a drug or cell can do…We can optimize,’ and we believe that these treatments will include combination therapies that will be optimized with long-term release and localized delivery of agents or cells.”

Continued Reynolds, “Everyone knows my obsession with safe FDA studies. Over the next month or …read more

Source: FULL ARTICLE at DailyFinance

Opexa Therapeutics to Present at the Regenerative Medicine – A Fundamental Shift in Science &amp; Cultur

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Opexa Therapeutics to Present at the Regenerative Medicine – A Fundamental Shift in Science & Culture Conference

THE WOODLANDS, Texas–(BUSINESS WIRE)– Opexa Therapeutics, Inc. (NAS: OPXA) , a biotechnology company developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today announced that Neil K. Warma, President and Chief Executive Officer, will present at The Second International Vatican Adult Stem Cell Conference: Regenerative Medicine — A Fundamental Shift in Science & Culture, taking place from within The Vatican, April 11-13, 2013.

The conference is part of a five-year collaboration between The Stem for Life Foundation, a not-for-profit organization devoted to raising global awareness of the therapeutic potential of adult stem cells, NeoStem, a leader in the emerging cellular therapy industry and The Vatican’s Pontifical Council for Culture and its foundation, called STOQ International (Science, Theology and the Ontological Quest). Among the conference goals are to raise awareness of existing therapies, reduce misperceptions surrounding the field of cellular research and to foster dialogue among researchers, physicians, philanthropists, faith leaders and policy makers to identify unmet medical needs that can benefit from the development of cell therapies.

“Opexa is proud to be a part of this international forum designed to highlight the important contributions made by the cell therapy industry to date and to increase awareness of cellular research and the potential of cell therapies to address unmet medical needs,” commented Neil K. Warma, President and Chief Executive Officer of Opexa.

Opexa will be included in a special luncheon, Living with Multiple Sclerosis, featuring Meredith Vieira from NBC news and Richard M. Cohen, journalist and husband of Ms. Vieira.

About Tcelna

Tcelna is a personalized therapy that is specifically tailored to each patient’s disease profile. Tcelna is manufactured using ImmPath, Opexa’s proprietary method for the production of a patient-specific T-cell immunotherapy, which encompasses the collection of blood from the MS patient, isolation of peripheral blood mononuclear cells, generation of an autologous pool of myelin-reactive T-cells (MRTCs) raised against selected peptides from myelin basic protein (MBP), myelin oligodendrocyte glycoprotein (MOG) and proteolipid protein (PLP), and the return of these expanded, attenuated T-cells back to the patient. These attenuated T-cells are reintroduced into the patient via subcutaneous injection to trigger a therapeutic immune system response. Opexa believes the potential combination of efficacy, superior safety, excellent tolerability and administration may position Tcelna as the MS treatment of choice as compared …read more

Source: FULL ARTICLE at DailyFinance

The Lancet Publishes SELECT Study Evaluating Efficacy and Safety of Daclizumab HYP in Multiple Scler

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The Lancet Publishes SELECT Study Evaluating Efficacy and Safety of Daclizumab HYP in Multiple Sclerosis

-Data Demonstrated That DAC HYP Significantly Reduced Annualized Relapse Rate by up to 54 Percent at One Year-

-Phase 3 Study Underway to Further Assess Once-Monthly DAC HYP for Multiple Sclerosis-

WESTON, Mass.–(BUSINESS WIRE)– Today Biogen Idec (NAS: BIIB) announced that results from the daclizumab high-yield process (DAC HYP) SELECT clinical trial have been published as an online article in The Lancet. SELECT was a Phase 2b study designed to determine the efficacy and safety of DAC HYP in patients with relapsing-remitting multiple sclerosis (RRMS).

Published results demonstrate that both 150 mg and 300 mg subcutaneous injections of DAC HYP, administered once every four weeks, met the study’s primary endpoint by significantly reducing annualized relapse rate (ARR) by 54 percent (p<0.0001) and 50 percent (p=0.0002), respectively, compared to placebo at one year. In addition, results demonstrated that DAC HYP reduced multiple sclerosis (MS) brain lesions compared to placebo.

“DAC HYP represents the type of innovative research we are focused on cultivating as part of our MS pipeline because it potentially targets the disease in a new way,” said Gilmore O’Neill, M.D., vice president, Medical Research at Biogen Idec. “Based on these initial data from SELECT, we believe DAC HYP would complement our robust portfolio of four approved MS products by potentially offering people with MS a new treatment alternative. We look forward to continuing to work with our partners at AbbVie to progress the DAC HYP program further.”

Both doses of DAC HYP met key secondary endpoints in the study by significantly reducing the proportion of patients who relapsed at one year, as well as MS brain lesion activity, including the cumulative number of new gadolinium-enhancing (Gd+) lesions between weeks eight and 24 and the number of new or newly enlarging T2-hyperintense lesions at one year. Both doses of DAC HYP also demonstrated a trend in improvements in quality of life (QoL) compared to placebo as measured by the Multiple Sclerosis Impact Scale (MSIS-29) physical impact score.

“Because MS is unique to each person, we need a variety of treatment options to attack the disease in different ways,” said Ralf Gold, M.D., professor/chair of the Department of Neurology at St. Josef-Hospital/Ruhr-University in Bochum, Germany, and …read more

Source: FULL ARTICLE at DailyFinance

Elan Announces Closing of TYSABRI® Collaboration Transaction with Biogen Idec

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Elan Announces Closing of TYSABRI® Collaboration Transaction with Biogen Idec

DUBLIN–(BUSINESS WIRE)– Elan Corporation, plc (NYS: ELN) is pleased to announce the closing today of the TYSABRI® (natalizumab) Collaboration Transaction with Biogen Idec. The agreement was announced on February 6, 2013.

Under the terms of the agreement, Elan has received $3.25 billion in cash and will receive double digit tiered royalty payments, on all indications, for the life of the complete TYSABRI asset. For the first twelve months Elan will receive 12% royalties on in-market sales of TYSABRI, and thereafter, Elan will receive 18% royalties on in-market sales up to $2 billion and 25% royalties on in-market sales exceeding $2 billion. In 2012, in-market sales of TYSABRI were $1.6 billion.

About TYSABRI

TYSABRI is approved in more than 65 countries. TYSABRI is approved in the United States as a monotherapy for relapsing forms of MS, generally for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy due to the risk of progressive multifocal leukoencephalopathy (PML). In the European Union, it is approved for highly active relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferon or have rapidly evolving, severe RRMS.

TYSABRI has advanced the treatment of MS patients with its established efficacy. Data from the Phase 3 AFFIRM trial, which was published in the New England Journal of Medicine, showed that after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42-54 percent (p<0.001).

TYSABRI increases the risk of PML, an opportunistic viral infection of the brain which usually leads to death or severe disability. Infection by the JC virus (JCV) is required for the development of PML and patients who are anti-JCV antibody positive have a higher risk of developing PML. Factors that increase the risk of PML are presence of anti-JCV antibodies, prior immunosuppressant use, and longer TYSABRI treatment duration. Patients who have all three risk factors have the highest risk of developing PML. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has also been reported in the post-marketing setting. A list of adverse events can be found in the full TYSABRI product labeling for each …read more
Source: FULL ARTICLE at DailyFinance

Biogen Idec Completes Purchase of Full Rights and Control of TYSABRI®

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Biogen Idec Completes Purchase of Full Rights and Control of TYSABRI®

WESTON, Mass.–(BUSINESS WIRE)– Biogen Idec (NAS: BIIB) today announced it has completed its purchase of Elan Corporation‘s interest in TYSABRI® (natalizumab) and has gained full strategic, commercial and decision-making rights to TYSABRI. The transaction was originally announced on February 6, 2013.

“Full ownership of TYSABRI is an important step for Biogen Idec that further solidifies our leadership in MS,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “The powerful efficacy of TYSABRI makes it an important treatment for many people living with MS and we believe it has a solid growth trajectory for years to come. We are grateful to Elan for more than a decade of collaboration on TYSABRI, and for their work to provide a seamless transition as we finalized the transaction.”

Further details and updated financial guidance will be provided during Biogen Idec‘s upcoming first quarter 2013 earnings announcement.

For more than two decades Biogen Idec has been a leader in multiple sclerosis (MS), offering a wide range of therapies, unsurpassed patient support, and a robust R&D program to improve the lives of people with MSBiogen Idec also has the deepest MS pipeline in the industry with compounds that include PLEGRIDY™ (peginterferon beta-1a); daclizumab high-yield process (DAC HYP) for monthly subcutaneous administration; and an ongoing study with TYSABRI as a treatment for secondary progressive multiple sclerosis (SPMS).

About TYSABRI

TYSABRI is approved in more than 65 countries. TYSABRI is approved in the United States as a monotherapy for relapsing forms of MS, generally for patients who have had an inadequate response to, or are unable to tolerate, an alternative MS therapy due to the risk of progressive multifocal leukoencephalopathy (PML). In the European Union, it is approved for highly active relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferon or have rapidly evolving, severe RRMS.

TYSABRI has advanced the treatment of MS patients with its established efficacy. Data from the Phase 3 AFFIRM trial, which was published in the New England Journal of Medicine, showed that after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42-54 percent (p<0.001).

TYSABRI increases the risk of PML, an opportunistic viral infection of the …read more
Source: FULL ARTICLE at DailyFinance

Opexa Therapeutics Reports Year End 2012 Financial Results and Provides Corporate Update

By Business Wirevia The Motley Fool

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Opexa Therapeutics Reports Year End 2012 Financial Results and Provides Corporate Update

THE WOODLANDS, Texas–(BUSINESS WIRE)– Opexa Therapeutics, Inc. (NAS: OPXA) , a biotechnology company developing a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the year ended December 31, 2012 and provided an overview of recent corporate developments.

2012 and recent highlights include:

  • Clinical

    • Commenced a Phase IIb clinical study of Tcelna™ (imilecleucel-T) in patients with Secondary Progressive Multiple Sclerosis (SPMS). The randomized, double-blind, placebo controlled study is titled the “Abili-T” trial and will enroll 180 patients through approximately 30 leading clinical sites in the U.S. and Canada;
    • Gained approval from Health Canada to expand the Abili-T clinical trial to include several renowned sites in Canada; and
    • Initiated a comprehensive Immune Monitoring Program to capture valuable information from the Abili-T trial, including the potential identification of biomarkers for SPMS and further understanding of the immunopathology of SPMS.
  • Financial/Operational

    • Closed a private offering of convertible secured notes and warrants to purchase common stock for gross proceeds of approximately $4.1 million in July 2012;
    • Entered into two stock purchase agreements with Lincoln Park Capital Fund LLC in November 2012 in which Opexa may sell up to an aggregate of $16.5 million of shares of common stock to Lincoln Park subject to certain limitations and conditions over a 30-month period;
    • Executed a key strategic option and license agreement with Merck Serono in February 2013 for the development and commercialization of Tcelna in patients with MS. If Merck Serono exercises the licensing option, Merck would be solely responsible for funding development, regulatory and commercialization activities for Tcelna in MS. Potential milestone payments to Opexa if Tcelna is successfully commercialized could total $225 million. Additionally, Opexa is eligible to receive tiered royalties on commercial sales at rates ranging from 8% to 15% of annual net sales;
    • Raised $3.25 million of gross proceeds through a registered offering of common stock and warrants in February 2013; and
    • Strengthened our expertise in cell therapy through the hiring of several cell therapy experts in the areas of manufacturing, quality assurance, quality control and R&D.

“2012 was a transformative year for Opexa as we commenced the Abili-T clinical trial for Tcelna in patients with SPMS,” commented Neil K. Warma, President and Chief Executive Officer of Opexa. …read more
Source: FULL ARTICLE at DailyFinance

Biogen Gains Approval for MS Drug

By Tim Brugger, The Motley Fool

Filed under:

The U.S. Food and Drug Administration (FDA) has approved the use of tecfidera, Biogen‘s new oral treatment for people afflicted with recurring symptoms of MS, the company announced.

Tecfidera had undergone extensive testing prior to receiving FDA approval, including studying the results of more than 2,600 patients using tecfidera, some longer than four years. The studies indicate tecfidera is successful in reducing brain lesions and minimizing relapses, and even slowing the progression of MS.

CEO of Biogen, George Scangos PhD, said, “We will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill — a combination we believe will have a significant positive impact on the way people live with this chronic disease.” Tecfidera is Biogen’s fourth medication targeting MS, and is currently under regulatory review in Switzerland, Canada, and Australia.

With the FDA approval behind it, Biogen will begin making tecfidera available to U.S. patients “in the coming days,” according to the announcement. 

 

The article Biogen Gains Approval for MS Drug originally appeared on Fool.com.

Fool contributor Tim Brugger has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.

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Source: FULL ARTICLE at DailyFinance