Tysabri related Press Releases

Quest Diagnostics STRATIFY JCV(TM) 1st FDA Market Authorized Antibody-based Blood Test to Help Stratify PML Risk in MS patients

Mark Hollmer — Mon, 23 Jan 2012 08:17:40 -0500

Quest Diagnostics STRATIFY JCV(TM) First FDA Market Authorized Antibody-based Blood Test to Help Stratify PML Risk in Multiple Sclerosis Patients

Based on exclusive collaboration with Biogen Idec, the test is only available in the U.S. through Quest Diagnostics' Focus Diagnostics lab

MADISON, N.J., Jan. 20, 2012 /PRNewswire via COMTEX/ --Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that the U.S. Food and Drug Administration (FDA) has granted a de novo classification petition to its STRATIFY JCV(TM) Antibody ELISA testing service. STRATIFY JCV is the first blood test to be FDA market authorized for the qualitative detection of antibodies to the polyomavirus JC virus (JCV) for stratifying risk for progressive multifocal leukoencephalopathy (PML), an infrequent but serious brain infection, in patients with multiple sclerosis (MS) receiving TYSABRI® (natalizumab), a highly effective therapy for relapsing forms of MS.

The market authorization follows FDA approval today of a product label change for TYSABRI. The new label identifies JCV antibody status as a PML risk factor; other risk factors include duration of treatment with TYSABRI and prior immunosuppressant therapy use.

STRATIFY JCV was developed under an exclusive collaboration for the United States market with Biogen Idec (NASDAQ: BIIB), co-manufacturer with Elan Corporation, plc (NYSE: ELN) of natalizumab. The test employs technology licensed from Biogen Idec, and is exclusively offered through Quest Diagnostics' Focus Diagnostics laboratory in the United States. It is based on a test validated and performed by Focus Diagnostics in clinical trials.

"STRATIFY JCV is a great example of the capacity of pharmaceutical and diagnostic companies to collaborate to bring important medical innovations to market," said Kathy P. Ordonez, senior vice president, discovery and development, Quest Diagnostics. "The test has demonstrated its value as a tool that enhances PML risk assessment, and marks a significant step forward in the personalization of clinical management of MS patients who may benefit from natalizumab."

Approximately 50% to 60% of MS patients have been infected with JCV. In the general population, JCV can, in rare instances, reactivate and progress to PML, which may lead to severe neurological disability or death.

MS is an immune disorder that affects the central nervous system, can alternate between remission and relapse, and often progressively worsens over time. As many as 400,000 people have MS in the United States, and about 200 people are diagnosed each week.

About STRATIFY JCV

The STRATIFY JCV Antibody ELISA testing service provided by Focus Diagnostics is intended for the qualitative detection of antibodies to John Cunningham Virus in human serum or plasma. The assay is intended for use in conjunction with other clinical data, in multiple sclerosis and Crohn's disease patients receiving natalizumab therapy, as an aid in risk stratification for progressive multifocal leukoencephalopathy development. The assay is for professional use only and is to be performed only at Focus Diagnostics' Reference Laboratory.

About Quest Diagnostics

Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at QuestDiagnostics.com. Follow us at Facebook.com/QuestDiagnostics and Twitter.com/QuestDX.

TYSABRI is a trademark of Biogen Idec Inc. and Elan Corporation, plc.

STRATIFY JCV is a trademark of Biogen Idec.

Quest, Quest Diagnostics, Focus Diagnostics, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third-party marks are the property of their respective owners.

Quest Diagnostics Contacts:
Wendy Bost (Media): 973-520-2800
Kathleen Valentine (Investors): 973-520-2900

SOURCE Quest Diagnostics

FDA Updates TYSABRI® (natalizumab) Label to Include Anti-JC Virus Antibody Status as a PML Risk Factor

Fri, 20 Jan 2012 17:21:00 -0500

WESTON, Mass. & DUBLIN--(BUSINESS WIRE)-- Today Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced that the U.S. Food and Drug Administration (FDA) has approved a product label change for TYSABRI that will help enable individual benefit risk assessment for patients with multiple sclerosis (MS). The new label identifies anti-JCV antibody status as a risk factor for developing an infrequent but serious brain infection known as progressive multifocal leukoencephalopathy (PML). This marks the third risk factor identified to help physicians and people with MS have more confidence in their treatment decisions when considering TYSABRI, a highly effective treatment for relapsing forms of MS.

“This label change marks an important advance in assisting people with MS and their physicians to make better-informed decisions concerning the challenges of balancing effectiveness with safety,” said Dr. Nicholas LaRocca, Vice President Heath Care Delivery and Policy Research at the National MS Society. “We are encouraged by the proactive role that Biogen Idec and Elan are taking in addressing PML risk stratification.”

Infection with the JC virus (JCV) is required for the development of PML and the new label states that anti-JCV antibody negative status indicates that exposure to the JC virus has not been detected. Patients who are anti-JCV antibody positive have a higher risk of developing PML. Patients who are anti-JCV antibody positive, have received prior immunosuppressant (IS) therapy and received treatment with TYSABRI for more than two years have the highest risk of developing PML.

“TYSABRI has benefited thousands of patients worldwide who are living with multiple sclerosis, an often devastating disease affecting people in the prime of their lives,” said George Scangos, Ph.D., Chief Executive Officer, Biogen Idec. “Biogen Idec and Elan’s use of novel research and scientific expertise has allowed us to gain a better understanding of the benefit-risk profile for TYSABRI. Our development of the risk stratification algorithm and subsequent efforts to support the commercial availability of anti-JCV antibody testing reflect our commitment to providing patients and their physicians with additional guidance to help them make more personalized treatment decisions.”

The label update was based on analysis of data from Biogen Idec’s and Elan's quantitative risk stratification algorithm, which was presented at a number of major international medical meetings, including the American Academy of Neurology's annual meeting in April, 2011. In the analysis, patients who were anti-JCV antibody positive were at an increased risk for developing PML with varying degrees of risk depending on prior IS use and TYSABRI treatment duration. Irrespective of MS treatment, approximately 55 percent of MS patients are anti-JCV positive.

“We welcome the inclusion of PML risk stratification in the U.S. label as it significantly supports our aim to provide the information patients and physicians need to make a more informed treatment decision,” said Kelly Martin, Chief Executive Officer, Elan. “This further confirms the utility of the anti-JCV antibody status, which along with prior IS use and treatment duration enables the identification of differing levels of risk.”

The FDA has granted Quest Diagnostics (NYSE: DGX), the world’s leading diagnostic company, a de novo classification petition for the STRATIFY JCV Antibody ELISA testing service. STRATIFY JCV allows neurologists to determine their MS patients’ anti-JCV antibody status and is the first blood test to be FDA authorized for the qualitative detection of antibodies to the polyomavirus JC virus.

The U.S. label update follows the European Commission approval of anti-JCV antibody status as an additional factor to aid in stratifying patients at risk for developing PML in the Summary of Product Characteristics for TYSABRI in the European Union. Through the third quarter of 2011, globally there have been approximately 59,000 anti-JCV antibody tests administered commercially and through clinical trials.

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. 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 progressive multifocal leukoencephalopathy (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 country where it is approved.

TYSABRI is marketed and distributed by Biogen Idec Inc. and Elan Corporation, plc. For full prescribing information and more information about TYSABRI, please visit www.biogenidec.com or www.elan.com.

About Biogen Idec

Biogen Idec uses cutting-edge science to discover, develop, manufacture and market therapies for serious diseases with a focus on neurology, immunology and hemophilia. Founded in 1978, Biogen Idec is the world's oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies and the company generates more than $4 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Elan

Elan Corporation, plc is a neuroscience-focused 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 and Irish Stock Exchanges. For additional information about Elan, please visit www.elan.com.

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BIOGEN IDEC CONTACTS:
Media Contact:
Jeff Boyle, +1 781-464-3260
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Investor Contact:
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ELAN CONTACTS:
Media Contact:
Niamh Lyons, +353 1 709 4176
or
Investor Contact:
Chris Burns, +1 800-252-3526
or
David Marshall, +353 1 709 4444

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Recent Multiple Sclerosis Market Events Have Resulted in Treatment Algorithm Modifications According to a Recent BioTrends

Mon, 07 Nov 2011 10:20:55 -0500

EXTON, Pa.--(BUSINESS WIRE)-- While Biogen Idec’s Avonex and Teva’s Copaxone continue to capture the majority of multiple sclerosis (MS) patients first starting on a disease-modifying agent (DMA), the introduction of Novartis’ Gilenya, the only oral DMA currently on the market, appears to have impacted the average length of the time that patients remain on their first-line therapy before a switch may be initiated. Gilenya, typically prescribed as a second or later-line DMA, has also negatively impacted the overall market share of certain DMAs compared to the 2010 audit fielded prior to the Gilenya launch, with Pfizer / EMD Serono’s Rebif and Biogen Idec’s Avonex, taking the greatest hit.

In addition to the introduction of Gilenya, another recent event impacting the MS market is the commercial availability of the anti-JC virus antibody assay to help mitigate the PML risk associated with treatment of Biogen Idec’s Tysabri. Based upon the patient-level audit data, the percent of patients tested for anti-JC virus antibodies differs based both on brand of DMA at the time of testing and MS disease classification. While patients who test negative for the antibodies are most likely to switch to Tysabri, patients who test positive are most likely to switch to Gilenya.

The majority of DMA-treated patients experience at least some MS-related symptoms with the most common including fatigue, abnormal sensory perceptions, and balance issues. Since there are currently very few FDA-approved symptomatic agents, the agents most often prescribed to help control MS-related symptoms are typically products without a formal indication for MS. Acorda's Ampyra, the first FDA-approved symptomatic agent for a MS-related symptom, is used by neurologists to treat walking impairment, spasticity, and / or fatigue. A number of important differences exist between patients treated with Ampyra and those who are not, including the severity of the disease at DMA initiation and current disease classification.

When asked to hypothetically switch audit patients to one of the DMAs in late stage clinical development, neurologists identify the greatest opportunity for Biogen Idec’s PEG-Avonex and Teva’s laquinimod. A number of patient characteristics appear to help identify the types of patients who are perceived by neurologists as more likely to be switched to a specific DMA in development upon approval.

ChartTrends^®: Multiple Sclerosis is a syndicated annual patient audit designed to compare what physicians self-report about disease management to what actually occurs at the patient level. The 2011 audit captures information from 1088 patient charts provided by 223 U.S. neurologists in September 2011. All audit patients are on a DMA at the time of the audit with all DMA-brands (Avonex, Betaseron, Copaxone, Extavia, Gilenya, Rebif, Tysabri) represented. A parallel report covering the European market (EU5) is also available. Through an in-depth review of specific patient charts, details such as product initiation, switching, concomitant medications, exacerbation management, and a host of test and patient demographic variables help define patient types and identify therapy triggers. Patient profiles for the seven DMAs in late clinical development (alemtuzumab, BG-12, teriflunomide, laquinimod, PEG-Avonex, daclizumab, ocrelizumab) are also characterized.

About BioTrends Research Group, LLC

BioTrends Research Group, LLC provides syndicated and custom market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at (610) 363-3872 or www.bio-trends.com.

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While Copaxone and Interferon-Betas Continue to Dominate Treatment in MS, Tysabri Shows Modest Increase in First-Line Use

Wed, 02 Nov 2011 09:21:08 -0400

Quarterly Treatment Algorithm Analysis for Multiple Sclerosis Now Available from Decision Resources

BURLINGTON, Mass.--(BUSINESS WIRE)-- Decision Resources, one of the world’s leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that in the treatment of multiple sclerosis (MS), Teva’s Copaxone and the interferon-beta drugs continue to dominate first- and second-line therapy among newly diagnosed patients. Meanwhile, examination of U.S. patient-level claims data finds that use of Biogen Idec/Elan’s Tysabri as a first-line therapy increased modestly among newly diagnosed MS patients treated within a year of diagnosis.

According to Treatment Algorithms in Multiple Sclerosis, use of Tysabri in the first line remains limited, with more-significant use seen in the second line. These findings are consistent with the drug’s label, which generally recommends the drug be prescribed for the treatment of relapsing MS patients who fail prior treatment owing to insufficient efficacy or intolerance due to a small, but potentially fatal, risk of progressive multifocal leukoencephalopathy (PML). However, Tysabri’s share of first-line patient share grew steadily over the past several quarters in our sample to 5 percent, a trend that may reflect growing comfort with the drug as the risk of PML becomes increasingly well-characterized.

“Since the risk of PML is now known to be greater in patients with identifiable risk factors, physicians may be more empowered to prescribe Tysabri in well-selected patients as a first-line therapy,” said Decision Resources Senior Analyst Jonathan Searles, “Patients in our sample who received Tysabri first-line could include those who show evidence of a more-aggressive early disease course and accept some additional risk with this highly effective, well-tolerated therapy.”

The analysis also finds that the initial uptake of Novartis/Mitsubishi Tanabe Pharma’s Gilenya has been gradual since it launched in the United Sates in October 2010, and mostly as a second- or later-line therapy.

The analysis is part of Decision Resources’ Treatment Algorithms series. Through examination of patient-level claims data, the Treatment Algorithms series provides exceptional insight into physicians’ prescribing trends and the factors that drive therapy choice, from diagnosis through multiple courses of treatment, for a specific disease. The Treatment Algorithms series is updated quarterly and allows for longitudinal analysis of prescribing trends.

About Decision Resources

Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources Group company.

About Decision Resources Group

Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at http://www.decisionresourcesgroup.com/.

All company, brand or product names contained in this document may be trademarks or registered trademarks of their respective holders.

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Biogen Idec Promotes Tony Kingsley to Run Global Commercial Operations

Thu, 29 Sep 2011 09:21:11 -0400

-- Has been instrumental in reinvigorating U.S. Commercial Operations --

WESTON, Mass.--(BUSINESS WIRE)-- Biogen Idec (NASDAQ: BIIB) today announced that Tony Kingsley has been promoted to Executive Vice President, Global Commercial Operations, effective Nov. 7. Kingsley, 48, will oversee development and execution of Biogen Idec’s global commercial business strategies, reporting directly to Chief Executive Officer George A. Scangos, Ph.D. Dr. Francesco Granata, 60, who has headed global commercial operations since early 2010, is leaving to pursue other opportunities but will remain at the company through the end of February to help ensure a smooth transition.

Since January 2010, Mr. Kingsley has served as Biogen Idec’s Senior Vice President of U.S. Commercial Operations, responsible for all U.S. commercial functions, including marketing, sales, market access, patient services, training and sales operations. Before joining Biogen Idec, he was Senior Vice President and General Manager, Gynecological Surgical Products at Hologic, Inc., and Division President, Diagnostic Products, at Cytyc Corp. In those roles, Mr. Kingsley ran global functions in commercial, manufacturing and R&D. Prior to that, he was a Partner at McKinsey & Co., Inc., where he worked with global biotechnology, pharmaceutical and medical device companies to improve their performance and drive revenue and earnings growth.

“Tony has demonstrated exceptional leadership since joining Biogen Idec, including playing a key role in strengthening U.S. AVONEX sales, growing TYSABRI sales and advancing our risk-stratification strategy for TYSABRI,” said Dr. Scangos. “Tony exemplifies the high-impact talent that we value at Biogen Idec. With his combination of strategic insight and operational expertise, I am confident he is the right person to build on the positive momentum in our global commercial business and prepare the organization for the potential launch of multiple products in the next several years.”

Dr. Scangos added, “Francesco’s leadership has been instrumental to the success of our global commercial operations, including the launch of FAMPYRA in EU and the commercial

availability of the JCV assay in the EU and US. We want to recognize the important role he has played in strengthening the commercial organization and positioning Biogen Idec for the next phase of our growth as a company. We thank him for his many contributions and wish him well in his future endeavors.”

Mr. Kingsley said, “With our strong global reach, talented work force and enviable late-stage pipeline, Biogen Idec is well positioned to bring to market therapies that make a real difference in the lives of patients with devastating diseases like multiple sclerosis, ALS and hemophilia. I am excited about my new role and look forward to working with the other members of the commercial team to ensure that our organization continues to be a core strength and competitive advantage for the company.”

About Biogen Idec

Biogen Idec uses cutting-edge science to discover, develop, manufacture and market therapies for serious diseases with a focus on neurology, immunology and hemophilia. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the company generates more than $4 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

Biogen Idec Safe Harbor

This press release contains forward-looking statements, including statements about product development and commercialization. These forward-looking statements may be accompanied by such words as "anticipate," "believe," "estimate," "expect," "forecast," "intend," "may," "plan," "will" and other words and terms of similar meaning. You should not place undue reliance on these statements. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from our current expectations include the risk that adverse safety events may occur, regulatory authorities may require additional information or may fail to approve any potential new therapy, reimbursement for our products may be limited or unavailable, we may encounter problems with our manufacturing processes, we may be unable to adequately protect our intellectual property rights, and the other risks and uncertainties that are described in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the SEC. These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements.

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Critical Therapeutic Objectives Continue to go Unmet for the Treatment of Multiple Sclerosis Even with the Assimilation of

Tue, 27 Sep 2011 10:20:48 -0400

EXTON, Pa.--(BUSINESS WIRE)-- Trial and share of Novartis’ Gilenya, the first oral disease-modifying agent (DMA) for the treatment of multiple sclerosis (MS), to grow suggesting increasing acceptance of Gilenya as part of the available armamentarium of DMAs. However, room exists for broader Gilenya education as almost one-half of Gilenya non-prescribers still do not know where or when they would use the DMA — presenting an obstacle to initial trial among these late adopters. And, even among prescribers, Gilenya tends to be reserved for second line use in patients who have efficacy or tolerability issues with other DMAs, an unenviable position also held by Biogen Idec’s Tysabri. For Tysabri, concern over liability issues associated with use of the product appears to be driving a strong agreement that the commercial availability of an anti-JC virus antibody assay would increase prescribing. For now, Teva’s Copaxone remains the market share leader within the DMA market, although it is no longer rated highest on product satisfaction or overall performance compared to the other DMAs. Copaxone and Biogen Idec’s Avonex are perceived as good choices for DMA-naïve patients with mild or moderately active disease, while Bayer’s Betaseron and Pfizer / EMD Serono’s Rebif are considered appropriate choices for DMA-naïve patients with more active disease.

Despite the availability of multiple DMAs, significant unmet needs remain. Reduction in disability progression, followed by improved efficacy and disease remission, continue to be considered the greatest unmet needs for DMAs in development. When asked about unmet needs not covered in the survey, neurologists clearly express a need for less expensive / more cost-effective DMAs. While interest is high for all seven DMAs in development profiled in this research, Biogen Idec’s BG-12 and Teva’s laquinimod are rated highest both on interest and on potential value brought to neurologists’ practice.

In the area of symptomatic management, three out of every four neurologists have initiated an MS patient on Acorda’s Ampyra after 18 months on the market, but less than one out five neurologists have tried Avanir’s Nuedexta in an MS patient seven-months post-launch stemming from major obstacles to Nuedexta trial including lack of appropriate patients and / or lack of product familiarity. When asked about products in development to treat spasticity associated with MS, significantly more neurologists perceive Otsuka’s Sativex and Impax’s IPX056 as potentially bringing the most value to their practice compared to XenoPort’s arbaclofen placarbil.

TreatmentTrends^®: Multiple Sclerosis is a syndicated quarterly report series that provides a comprehensive view of the current and expected future management of multiple sclerosis (MS) based on primary research. The Q3 2011 wave was fielded with 99 neurologists in the U.S. in mid-August 2011. A parallel report covering the European market (EU5) is also available. These reports cover the use of disease-modifying agents for the treatment of MS, as well as attitudes and perceptions toward these products, advantages and disadvantages, ideal patient types, barriers to growth, and expected future use. In addition, respondents are queried about their awareness of and interest in DMAs and MS-related symptomatic products in development.

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As Adoption Deepens Among Prescribers, Satisfaction with Gilenya Remains Muted Due to Continuing Issues with Novartis Supp

Mon, 16 May 2011 11:21:22 -0400

EXTON, Penn.--(BUSINESS WIRE)-- At six months post launch, market share of Novartis’ Gilenya, the newest disease-modifying agent (DMA) for the treatment of multiple sclerosis (MS), has increased significantly compared to earlier waves of research fielded at one month and three months post-launch. With a nonsignificant increase in physician trial over the past three months, much of the increase in market share is being driven by significant growth in volume per prescriber reflecting deeper adoption within individual practices. The product’s unique oral formulation continues to be perceived as its greatest advantage. Non-prescribers pinpoint concerns over Gilenya’s lack of long-term safety data and issues related to the initiation and monitoring of patients on Gilenya as major obstacles to trial. Overall, satisfaction with Gilenya remains significantly lower than that reported by early adopters one month post-launch. Dissatisfaction seems to be driven by lack of Novartis support, managed care concerns, and safety worries.

The recently released third wave of the LaunchTrends^®: Gilenya report series finds that neurologists perceive Gilenya as a second line DMA, following either an efficacy or tolerability failure. Although all DMAs — Biogen Idec’s Avonex and Tysabri, Bayer’s Betaseron, Teva’s Copaxone and Pfizer/EMD Serono’s Rebif — are expected to be impacted by Gilenya switches to some degree, neurologists continue to believe that Avonex and Tysabri are most at risk for cannibalization. The projected share trends for Gilenya remain favorable as surveyed neurologists anticipate a significant increase in use within the next six months. Interestingly, anticipated peak use for Gilenya, which has increased significantly compared to the previous waves, is not significantly different between current prescribers and non-prescribers suggesting that both groups see Gilenya as an important option in their MS treatment armamentarium.

LaunchTrends^®: Gilenya is a three wave syndicated report series designed to track the uptake of Novartis’s Gilenya at one month, three months and six months following its commercial availability. In the current wave of research, which measures Gilenya’s market impact at six months post-launch, BioTrends surveyed 76 neurologists and conducted qualitative interviews with a subset of 20 of the respondents in April 2011. BioTrends will continue to track the uptake of Gilenya in the ongoing TreatmentTrends^®: Multiple Sclerosis report series, which is published quarterly.

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LaunchTrends assesses trial and use of new products, obstacles to use, reasons to use, typical patient types, line of therapy, product perceptions, promotional efforts/messages and product satisfaction.

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Neurologists Anticipate Increased Use of Novartis’ Gilenya and Biogen Idec’s Tysabri over the Next Six Months Despite Safe

Tue, 29 Mar 2011 10:21:01 -0400

EXTON, Pa.--(BUSINESS WIRE)-- Physician trial and market share of Novartis’ Gilenya, the first oral disease modifying agent (DMA) for the treatment of multiple sclerosis (MS), have both increased significantly over the past quarter, according to a recent report by BioTrends. Despite uptake, neurologists report dissatisfaction with Novartis’ company support – an attribute that seems to have more impact on neurologists’ choice of DMA than they state. Use of Extavia, Novartis’s other DMA, has stabilized just over a year after launch with no anticipated changes in prescribing over the next six months. Gilenya share, on the other hand, is anticipated to increase substantially although safety concerns remain a primary obstacle for the newest DMA. The impact of Gilenya uptake is expected to be split across shares of Biogen Idec’s Avonex, Bayer’s Betaseron, Teva’s Copaxone and Pfizer/EMD Serono’s Rebif. While neurologists currently state an overall preference for Tysabri, long term safety concerns continue to hold them back from prescribing more of the brand — thus, the commercial availability of a JC antibody assay, which could help identify appropriate patients, is perceived as a possible game changer for Tysabri.

Neurologists continue to report a high unmet need for products with neuroprotective effects and significant impact on disability progression. Among the seven therapies in development that were profiled in the research, interest was highest for Teva’s laquinimod and Biogen Idec’s BG-12. Interestingly, much of the recent surge in interest in BG-12 is being driven by Gilenya early adopters.

One year post-launch, most neurologists have prescribed Acorda’s Ampyra (dalfampridine). With greater familiarity and usage, a clearer picture is emerging about the average discontinuation rate and where the product may have room for growth. On the other hand, trial, usage, and familiarity of Avanir’s Nuedexta, a recently launched agent for the treatment of pseudobulbar affect, remains limited following just weeks of commercial availability. While awareness of the four surveyed MS-related symptomatic products in development is low, neurologists report moderate levels of interest in the products and believe Otsuka’s Sativex, an agent for the treatment of spasticity, would provide the greatest clinical value to their practice.

TreatmentTrends^®: Multiple Sclerosis is a syndicated quarterly report series that provides a comprehensive view of the current and expected future management of multiple sclerosis (MS) based on primary research. The Q1 2011 wave was fielded with 104 neurologists in the U.S. in mid-February 2011. A parallel report covering the European market (EU5) will be published later this year. These reports cover the use of disease-modifying agents for the treatment of MS, as well as attitudes and perceptions toward these products, advantages and disadvantages, ideal patient types, barriers to growth, and expected future use. In addition, respondents were queried about their awareness of and interest in MS-related DMA and symptomatic products in development.

About BioTrends Research Group, LLC

BioTrends Research Group, LLC (www.bio-trends.com) provides syndicated market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends’ publications and research capabilities, please contact us at (610) 363-3872 or www.bio-trends.com. BioTrends Research Group, LLC is a Decision Resources, Inc. company.

About Decision Resources, Inc.

All company, brand, or product names contained in this document may be trademarks of their respective holders.

CONTACT:

BioTrends Research Group, LLC
Sharon Funk, 404-223-2963
sfunk@bio-trends.com
or
Decision Resources, Inc.
Christopher Comfort, 781-993-2597
ccomfort@dresources.com

KEYWORDS: United States North America Pennsylvania

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical

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While More Neurologists Are Using Gilenya Compared to Just Two Months Ago, a Number of Prescribing Obstacles Are Impeding

Tue, 22 Feb 2011 10:20:32 -0500

EXTON, Penn.--(BUSINESS WIRE)-- BioTrends Research Group, LLC finds that, while surveyed neurologists are almost unanimous in reporting that the unique mode of administration of Novartis’s Gilenya is its greatest advantage, they indicate that initial trial and adoption has been hampered by patient resistance, monitoring frustrations, managed care issues, and continued concerns related to potential safety issues. Although the percent of neurologists who have begun to prescribe Gilenya jumped significantly since November 2010, Gilenya’s current share and average patient volume remain relatively low reflecting narrow adoption within individual practices.

The recently released second wave of the LaunchTrends^®: Gilenya report series finds that both current Gilenya prescribers and non-prescribers perceive Gilenya as a DMA to be used for switches, although the groups differ with regards to the point at which they would first consider Gilenya for a patient. Although shares of all DMAs—Biogen Idec’s Avonex and Tysabri, Bayer’s Betaseron, Teva’s Copaxone and Pfizer’s Rebif—are expected to be impacted by Gilenya to some degree, neurologists are split on which one of two specific DMAs Gilenya is most likely to replace in their practices. The projected share trends for Gilenya remain favorable as current prescribers anticipate increased use and one-half of current non-prescribers expect to begin trial of Gilenya within the next six months.

LaunchTrends^®: Gilenya is a three wave syndicated report series designed to track the uptake of Novartis’s Gilenya at one month, three months and six months following its commercial availability. In the current wave of research, which measures Gilenya’s market impact at one month post launch, BioTrends surveyed 76 neurologists and conducted qualitative interviews with a subset of 20 of the respondents in January 2011. BioTrends will continue to track the uptake of Gilenya in the final wave of this report series, which will be published in May 2011, and in the ongoing TreatmentTrends^®: Multiple Sclerosis report series, which is published quarterly.

About LaunchTrends

About BioTrends Research Group, LLC

BioTrends Research Group, LLC (www.bio-trends.com) provides syndicated and custom market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at (610) 363-3872 or www.bio-trends.com.

About Decision Resources, Inc.

All company, brand, or product names contained in this document may be trademarks of their respective holders.

CONTACT:

BioTrends Research Group, LLC
Sharon Funk, 404-223-2963
sfunk@bio-trends.com
or
Decision Resources, Inc.
Christopher Comfort, 781-993-2597
ccomfort@dresources.com

KEYWORDS: United States North America Pennsylvania

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Pharmaceutical

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European Neurologists Expect Significant Increases in the Use of Both Tysabri and Extavia in Their Multiple Sclerosis Patients t

Tue, 21 Dec 2010 11:23:13 -0500

EXTON, Pa., Dec. 21, 2010 /PRNewswire/ -- BioTrends Research Group, Inc. finds that while neurologists in the EU tend to prescribe the established interferon betas as their first line disease modifying agents (DMAs) for the treatment of multiple sclerosis (MS) patients, they are most satisfied with Biogen/Elan's Tysabri. Prescribing of both Tysabri and Novartis's recently launched DMA, Extavia, is anticipated to increase over the next six months with Bayer's Betaferon suffering the most in terms of market share loss. Despite these expected changes, neurologists clearly associate most of the DMAs with a certain MS patient type and their reported prescribing reflects these preference patterns.

The recently released TreatmentTrends®: Multiple Sclerosis in the European Union report finds that neurologists in the U.K. have less clinical experience with many of the DMAs, prescribe DMAs to a smaller percentage of their MS patients, and are detailed less than their counterparts in France, Germany, Italy and Spain. In line with these regional differences, neurologists in the U.K. report relying on different attributes when making their DMA prescribing decisions and identify different unmet needs for DMAs in development compared to neurologists from the other EU regions.

Among the eight therapies in development that were profiled in the research, interest is rated highest for Novartis's Gilenya and Merck Serono's Movectro -- despite the recent nonapproval by the European Medicines Agency for the latter product which Merck has recently appealed. Neurologists in the U.K. again diverge in their reported interest in the DMAs in development with a greater level of enthusiasm for Genzyme/Bayer's alemtuzumab compared to their counterparts in the other EU regions. While familiarity and interest is currently low for Biogen's PEG-Avonex and BG-12, Teva's laquinimod, Sanofi-Aventis's teriflunomide and Abbott/Biogen's daclizumab, for some of these DMAs in development, neurologists appear to have already identified which established DMAs are most at risk with the introduction of these new agents. Knowledge of symptomatic products in development is low with Bayer/Almirall's Sativex and Biogen's Ampyra receiving the highest marks for familiarity, interest and clinical value.

TreatmentTrends®: Multiple Sclerosis in the European Union is a syndicated annual report that provides a comprehensive view of the current and expected future management of MS based on primary research fielded with 229 neurologists in the U.K., France, Germany, Italy and Spain. These reports cover the use of DMAs for the treatment of MS, as well as attitudes and perceptions toward these products, advantages and disadvantages, ideal patient types, barriers to growth and expected future use. In addition, respondents were queried about their awareness of and interest in MS-related DMA and symptomatic products in development. A parallel report covering the U.S. market was published in late November.

About BioTrends Research Group, Inc.

BioTrends Research Group, Inc. (www.bio-trends.com) provides syndicated and custom market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at (610) 363-3872 or www.bio-trends.com.

About Decision Resources, Inc.

All company, brand, or product names contained in this document may be trademarks of their respective holders.


For more information, contact:

BioTrends Research Group, Inc.	Decision Resources, Inc.
Sharon Funk	Christopher Comfort
404-223-2963	781-993-2597
sfunk@bio-trends.com	ccomfort@dresources.com

SOURCE BioTrends Research Group, Inc.