26th Sep 2007 16:04
BTG PLC26 September 2007 BTG plc: Campath(R) commences pivotal phase III trial in multiple sclerosis London, UK, 26 September 2007: BTG plc (LSE: BGC), the life sciences company,today announces that its licensee, Genzyme Corporation, and Bayer ScheringPharma AG have initiated a pivotal phase III trial of Campath(R) (alemtuzumab)as a treatment for multiple sclerosis. This follows the announcement of 20September that Campath(R) had been approved as a first-line treatment for B-cellchronic lymphocytic leukaemia. Louise Makin, BTG's CEO, commented: "We are excited by the prospects of Campathin multiple sclerosis and delighted that the pivotal phase III trials are underway. If the excellent results from the phase II trials are reproduced, patientswill have a new treatment option that has the potential to be much moreefficacious than any other existing treatment." The full text of Genzyme's announcement follows. "Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Programwith Alemtuzumab for Treatment of Multiple Sclerosis Date: September 26, 2007 Genzyme Corporation (Nasdaq: GENZ) and Bayer Schering Pharma AG, Germany todayannounced that the first patient has been treated in the first of two plannedPhase 3 trials examining the safety and efficacy of alemtuzumab for thetreatment of multiple sclerosis (MS). The CARE-MS I trial (Comparison of Alemtuzumab and Rebif Efficacy in MultipleSclerosis), a randomized, rater-blinded study, will compare alemtuzumab to Rebif(R) (interferon beta-1a) in patients with relapsing-remitting multiple sclerosis(MS). Alemtuzumab will be given in two annual cycles; Rebif will be administeredthree times per week. The CARE-MS I study will include patients who have beendiagnosed with relapsing-remitting MS but who have not yet begun treatment withany MS drug. CARE-MS II is scheduled to begin soon and will enroll patients whohave continued to experience relapse episodes while on currently availabledisease-modifying therapies. Initiation of this Phase 3 program follows the successful completion of theinitial treatment period in the Phase 2 trial. Interim results from the Phase 2trial indicated that alemtuzumab-treated patients experienced a statisticallysignificant reduction compared with Rebif-treated patients in the risk forsustained accumulation of disability and the risk for relapse for 24 months.Results of the primary outcomes from this trial at 36 months are expected to bepresented on Oct. 14 by Professor Alastair Compston during the Charcot Awardlecture at the annual meeting of the European Committee for Treatment andResearch in Multiple Sclerosis, in Prague. The CARE-MS I study will enroll up to 525 patients at approximately 60 medicalcenters throughout North America, Australia, Latin America, and Europe, and willagain compare alemtuzumab-treated patients to Rebif-treated patients accordingto two co-primary endpoints: the time to sustained accumulation of disability,and the annualized relapse rate. Alemtuzumab will be dosed at 12 mg/day for fivedays by daily IV infusion, with a second dosing 12 months later of 12 mg/day forthree days. All patients will be followed from their entry into the trial untiltwo years from the date that the last patient is randomized to treatment.Alemtuzumab-treated patients will continue to have safety evaluations for atleast three years after the last course of treatment. The companies anticipatefiling for marketing approval of alemtuzumab for the treatment of MS in 2011. Alemtuzumab is an investigational drug for the treatment of MS and must not beused outside of a formal clinical trial setting in MS patients. Physicians orpatients seeking additional information about the CARE-MS I trial should contactGenzyme Medical Information at 1-800-745-4447, option 2 in the United States, +31 35 6991499 in Europe, or visit www.clinicaltrials.gov. About Multiple Sclerosis Multiple Sclerosis (MS) is a chronic disease of the central nervous system (CNS)in which the immune system can attack the brain and spinal cord. The diseasecauses a wide range of symptoms including fatigue, difficulty walking, numbness,and vision problems, and can progress to cause severe disability.Relapsing-remitting MS is the most common form of this disease. About Alemtuzumab Alemtuzumab is licensed in the United States as a single agent for the treatmentof B-cell chronic lymphocytic leukemia (B-CLL), and outside of the U.S. for thetreatment of B-CLL in patients who have been treated with alkylating agents andwho have failed fludarabine therapy. The product was launched in its oncologyindication in 2001 in the US, where it is marketed by Bayer HealthCarePharmaceuticals Inc. as Campath(R), and in Europe, where it is named MabCampath(R). Alemtuzumab is a humanized monoclonal antibody that binds to a specific target,CD52, on cell surfaces and directs the body's immune system to destroy thosecells. It is the first and only monoclonal antibody approved by the FDA for thetreatment of patients with B-CLL. Genzyme and Bayer Schering Pharma AG, Germany are co-developing alemtuzumab inoncology, multiple sclerosis and other indications. Bayer Schering Pharma AG,Germany holds exclusive worldwide marketing and distribution rights toalemtuzumab. Campath has a boxed warning which includes information on cytopenias, infusionreactions, and infections. The most commonly reported adverse reactions inpatients with B-CLL were infusion reactions (fever, chills, hypotension,urticaria, nausea, rash, tachycardia, dyspnea), cytopenias (neutropenia,lymphopenia, thrombocytopenia, anemia), and infections (CMV viremia, CMVinfection, other infections). In clinical trials, the frequency of infusionreactions was highest in the first week of treatment. Other commonly reportedadverse reactions include vomiting, abdominal pain, insomnia and anxiety. Themost commonly reported serious adverse reactions are cytopenias, infusionreactions, and immunosuppression/infections. About Genzyme One of the world's leading biotechnology companies, Genzyme is dedicated tomaking a major positive impact on the lives of people with serious diseases.Since 1981, the company has grown from a small start-up to a diversifiedenterprise with more than 9,500 employees in locations spanning the globe and2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive theNational Medal of Technology, the highest honor awarded by the President of theUnited States for technological innovation. In 2006 and 2007, Genzyme wasselected by FORTUNE as one of the "100 Best Companies to Work for" in the UnitedStates. With many established products and services helping patients in nearly 90countries, Genzyme is a leader in the effort to develop and apply the mostadvanced technologies in the life sciences. The company's products and servicesare focused on rare inherited disorders, kidney disease, orthopaedics, cancer,transplant, and diagnostic testing. Genzyme's commitment to innovation continuestoday with a substantial development program focused on these fields, as well asimmune disease, infectious disease, and other areas of unmet medical need. About Bayer Schering Pharma The Bayer Group is a global enterprise with core competencies in the fields ofhealth care, nutrition and high-tech materials. Bayer HealthCare, a subsidiaryof Bayer AG, is one of the world's leading, innovative companies in thehealthcare and medical products industry and is based in Leverkusen, Germany.The company combines the global activities of the Animal Health, Consumer Care,Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals businessoperates under the name Bayer Schering Pharma AG. Bayer HealthCare's aim is todiscover and manufacture products that will improve human and animal healthworldwide. Find more information at www.bayerhealthcare.com. Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.Its research and business activities are focused on the following areas:Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, SpecializedTherapeutics and Women's Healthcare. With innovative products, Bayer ScheringPharma aims for leading positions in specialized markets worldwide. Using newideas, Bayer Schering Pharma aims to make a contribution to medical progress andstrives to improve the quality of life. Find more information atwww.bayerscheringpharma.de. Forward-Looking Statements This press release contains forward-looking statements, including statementsabout the initiation of clinical trials, regulatory plans and expected timelinesfor alemtuzumab, including the initiation of a second Phase 3 trial in MSpatients and the timing thereof, the timing of obtaining clinical trial data,enrollment in clinical trials and the ability to manage patient safety. Thesestatements are subject to risks and uncertainties that could cause actualresults to differ materially from those projected in these forward-lookingstatements. These risks and uncertainties include, among others: that finalresults of the clinical trial demonstrate safety and efficacy comparable to theinterim data that have emerged to date, the actual timing and content ofsubmissions to and decisions made by the regulatory authorities, institutionalreview boards, data safety monitoring boards and treating physicians regardingthe continued administration of alemtuzumab to MS patients, Genzyme's ability todevelop and obtain approval of a patient safety plan, and the other risks anduncertainties described in reports filed by Genzyme with the Securities andExchange Commission under the Securities Exchange Act of 1934, as amended,including without limitation the information under the heading "Risk Factors" inthe Management's Discussion and Analysis of Financial Condition and Results ofOperations section of the Genzyme Quarterly Report on Form 10-Q for the quarterending June 30, 2007. Genzyme cautions investors not to place substantialreliance on the forward-looking statements contained in this press release.These statements speak only as of the date of this press release, and Genzymeundertakes no obligation to update or revise the statements. Genzyme(R), Campath(R), and MabCampath(R) are registered trademarks of GenzymeCorporation. All rights reserved. Rebif(R) is a registered trademark of EMDSerono, Inc." For further information contact: BTG Financial DynamicsAndy Burrows, Director of Investor Relations Ben Atwell+44 (0)20 7575 1741; mobile: +44 (0)7990 530605 +44 (0)20 7831 3113 Christine Soden, Chief Financial Officer+44 (0)20 7575 1591 About BTG BTG in-licenses, develops and commercialises pharmaceuticals and other medicaltechnologies. With a substantial and growing revenue stream of royalties andmilestone payments from out-licensed products, BTG continues to strengthen itspipeline of preclinical and clinical development programmes. Active in thefields of oncology, diseases of ageing, neuroscience, drug repositioning andmedical devices, BTG works from its offices in London, Philadelphia and Osakawith a global partner network of healthcare companies and researchorganisations. For further information, visit: www.btgplc.com. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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