Tag Archives: RRMS

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Elan Announces Closing of TYSABRI® Collaboration Transaction with Biogen Idec

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By Business Wirevia The Motley Fool

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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

Business, Finance, Occupation & Industry

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

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By Business Wirevia The Motley Fool

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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 MS. Biogen 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

Business, Finance, Occupation & Industry

Early versus Delayed Treatment with Laquinimod Demonstrated Significant Reduction in Risk of Disabil

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Early versus Delayed Treatment with Laquinimod Demonstrated Significant Reduction in Risk of Disability Progression – Results of Three-Year ALLEGRO Study in Relapsing-Remitting Multiple Sclerosis

  • Data presented at the 65th Annual Meeting of the American Academy of Neurology (AAN) showed early treatment with laquinimod demonstrated significant benefit in terms of slowing disability progression compared to delayed treatment
  • 36-month data affirmed the safety profile demonstrated in the ALLEGRO pivotal clinical trial
  • Additional animal preclinical data demonstrated laquinimod restored myelination in the brain and spinal cord

JERUSALEM & LUND, Sweden–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd. (NYS: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today top-line results from the open-label extension of the Phase III ALLEGRO study that assessed the progression of disability and safety of oral laquinimod in early versus delayed-start relapsing-remitting multiple sclerosis (RRMS) patients. The study compared the effectiveness of laquinimod in patients who received 36 months (early-start) versus those who received 24 months of laquinimod treatment (delayed-start). Laquinimod is an oral, once daily, investigational drug in Phase III studies for RRMS.

Of the 864 RRMS patients who participated in the original double-blind ALLEGRO trial, 97% participated in the open-label extension and 87% completed one year of the open-label phase. Overall, during the entire conduct of the study (double blind and open label phase), early start patients were less likely to experience disease progression than those with a delayed start of Laquinimod (11.8% risk of confirmed disability progression vs 16.7%, HR = 0.62, p < 0.0038).

“The results of this longer-term study of laquinimod suggest a robust benefit in terms of early treatment for RRMS and in potentially delaying disability, which is a primary goal of RRMS treatment,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries, Ltd. “The development of laquinimod’s clinical profile has been full of exciting revelations about the compound’s unique mechanism of action, and we were dually encouraged by the preclinical data which demonstrated a potential direct effect on neuroregenerative processes.”

The study also supports a favorable safety and …read more
Source: FULL ARTICLE at DailyFinance

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Positive Year One Results from Biogen Idec Phase 3 ADVANCE Trial of PLEGRIDY™ (Peginterferon Beta-1a

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Positive Year One Results from Biogen Idec Phase 3 ADVANCE Trial of PLEGRIDY™ (Peginterferon Beta-1a) Presented at AAN Meeting

– Primary and Secondary Endpoints Met After One Year, Including Reductions in Relapses and Disability Progression –

– Additional Data Demonstrate Significant Effects in Decreasing Brain Lesions –

WESTON, Mass.–(BUSINESS WIRE)– Today Biogen Idec (NAS: BIIB) announced the positive, full first-year results from its two-year pivotal Phase 3 ADVANCE study of PLEGRIDY™(peginterferon beta-1a), the company’s investigational candidate for relapsing-remitting multiple sclerosis (RRMS) dosed once every two weeks or every four weeks. These data, presented today at the American Academy of Neurology’s 65th Annual Meeting, indicate that PLEGRIDY significantly reduced multiple sclerosis (MS) disease activity, including relapses, disability progression and brain lesions, compared to placebo at one year.

“These full first-year results provide a more complete picture of PLEGRIDY and its positive effects on the reduction of relapse, disability progression and lesion development,” said Peter Calabresi, M.D., director, the Johns Hopkins Multiple Sclerosis Center. “These data suggest that, if approved, PLEGRIDY may offer the benefit of a less frequent dosing schedule, which would be a meaningful advance for people living with MS.”

Study Results for Two-Week Dosing Arm at Year One:

Primary endpoint:

  • PLEGRIDY met the primary endpoint of reducing annualized relapse rate (ARR) at one year by 36 percent compared to placebo (p=0.0007).

Secondary endpoints:

  • PLEGRIDY reduced the proportion of patients who relapsed by 39 percent compared to placebo (p=0.0003).
  • PLEGRIDY reduced the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans by 67 percent compared to placebo (p<0.0001).
  • PLEGRIDY also demonstrated significant positive effects on disability progression by reducing the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), …read more
    Source: FULL ARTICLE at DailyFinance
Business, Finance, Occupation & Industry

US Patent Office Grants Patent Claiming Dosing Regimen for TECFIDERA™ (Dimethyl Fumarate)

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US Patent Office Grants Patent Claiming Dosing Regimen for TECFIDERA™ (Dimethyl Fumarate)

– Patent Offers Protection Until 2028 and Strengthens Growing Product Patent Portfolio –

– European Patent Office Also Determines Patent Application Covering the Same Dosing Regimen Allowable –

WESTON, Mass.–(BUSINESS WIRE)– Biogen Idec (NAS: BIIB) today announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. 8,399,514, which offers additional protection for TECFIDERA™ (dimethyl fumarate), the company’s oral therapeutic candidate for the treatment of multiple sclerosis (MS). The patent, which will expire in 2028, covers the dosing regimen of daily administration of 480 mg of TECFIDERA. This regimen is included in the proposed marketing application for TECFIDERA, which is currently under review by the U.S. Food and Drug Administration (FDA).

“The patent for this dosing regimen is recognition of the remarkable innovation TECFIDERA represents for the MS community,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “The tremendous research investment required to study and validate the patented dosing regimen is an example of innovation that leads to meaningful benefits to patients.”

The European Patent Office also recently determined that Biogen Idec‘s application for a patent covering the same dosing regimen of TECFIDERA is allowable. Once granted, this patent would also expire in 2028.

The TECFIDERA dose regimen patents add to the growing portfolio of granted patents covering TECFIDERA.

About TECFIDERA

TECFIDERA is the only currently known investigational compound for the treatment of relapsing-remitting multiple sclerosis (RRMS) that has experimentally demonstrated activation of the Nrf-2 pathway. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.

In 2011 and 2012, Biogen Idec announced positive data from DEFINE and CONFIRM, two global, placebo-controlled Phase 3 clinical trials that evaluated 240 mg of TECFIDERA, administered either twice a day (BID) or three times a day (TID), for two years. TECFIDERA is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.

About Biogen Idec

…read more
Source: FULL ARTICLE at DailyFinance

Business, Finance, Occupation & Industry

Teva to Present New Research on CNS Product Portfolio and Pipeline at 2013 American Academy of Neuro

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Teva to Present New Research on CNS Product Portfolio and Pipeline at 2013 American Academy of Neurology Annual Meeting

LATE-BREAKING ORAL PRESENTATION PLANNED FOR AZILECT ® (RASAGILINE TABLETS)

JERUSALEM–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd. (NYS: TEVA) today announced that 15 abstracts highlighting study results for Parkinson’s disease (PD) and relapsing-remitting multiple sclerosis (RRMS) will be presented during the 65th American Academy of Neurology (AAN) annual meeting in San Diego, Calif., March 16-23, 2013. New data for AZILECT® (rasagiline tablets), an MAO-B inhibitor for the treatment of PD, will be presented as part of the meeting’s Emerging Science program (formerly known as Late-Breaking Science) on Wednesday, March 20th at 5:45pm PST.

“We are pleased with the variety of topics and quality of research results that will be presented at AAN this year,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “Teva’s legacy in CNS is grounded in our commitment to ongoing collaboration with academia, medical institutions, and patient advocacy groups to find innovative solutions for patients who live with chronic and debilitating diseases, such as RRMS and Parkinson’s disease.”

Featured presentations include:

  • Results from a Phase IV clinical study evaluating AZILECT® as Add on to Dopamine Agonists in the Treatment of Parkinson’s disease (ANDANTE).
  • Findings from the first year of follow-up in the Therapy Optimization in Multiple Sclerosis (TOP MS) study, the largest prospective Phase IV study conducted in RRMS, providing insight into the impact of adherence to therapy, as well as data demonstrating that more patients on COPAXONE® (glatiramer acetate) persisted with treatment than those on beta interferon (IFN).
  • Results from the Phase III ALLEGRO study in RRMS at 36 months, comparing the progression of disability and safety of patients treated with laquinimod for three years (Early-Start) and in patients originally treated with placebo in the double-blind (DB) phase and switched to laquinimod treatment (Delayed-Start) in the open-label (OL) phase of the ALLEGRO trial.

Platform Presentation/Poster Session Details:


AZILECT
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