20th Sep 2007 15:46
BTG PLC20 September 2007 BTG plc: Campath(R) approved for first-line use in Adult Leukemia London, UK, 20 September 2007: BTG plc (LSE: BGC), the life sciences company,today announces that its licensee, Genzyme Corporation, has received approval tomarket Campath(R) (alemtuzumab) as a first-line treatment for B-cell chroniclymphocytic leukaemia (CLL). Campath(R) was previously approved only forthird-line use in CLL. Louise Makin, BTG's CEO, commented: "The approval of Campath as a first-linetreatment for CLL provides another effective treatment option for newlydiagnosed patients and should increase product sales and royalties to BTG. Weare also excited by the ongoing development of Campath in multiple sclerosis." The text of Genzyme's announcement on the approval follows. "FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatmentfor Leading Form of Adult Leukemia Study Data Demonstrated Improved Progression-free Survival with Campath Cambridge, MA and Wayne, NJ - Genzyme Corp. (Nasdaq: GENZ) and Bayer HealthCarePharmaceuticals Inc. (NYSE: BAY) today announced that the U.S. Food and DrugAdministration (FDA) has approved a supplemental biologics license application(sBLA) for Campath(R) (alemtuzumab) and granted regular approval forsingle-agent Campath for the treatment of B-cell chronic lymphocytic leukemia(B-CLL). Campath was initially approved in 2001 under accelerated approvalregulations and the FDA has determined that the study results submitted in thesBLA fulfill the post-marketing commitment to verify clinical benefit. A labelexpansion is under consideration in Europe. "Campath is clearly an important single agent for the first-line treatment ofCLL," said Peter Hillmen, MB, ChB, of the Leeds General Infirmary, Leeds, UnitedKingdom, and the lead investigator of the pivotal study comparing Campathagainst chlorambucil. "We are excited to be entering an era where our improvedunderstanding of CLL, coupled with more advanced laboratory tests and targetedtherapy options like Campath, have dramatically changed the first-line treatmentapproach for this type of leukemia." Campath works in an entirely different way than chemotherapy, and is the firstand only monoclonal antibody approved by the FDA for the treatment of B-CLL. "The data that supported this label expansion add to a growing body of evidenceabout the effectiveness of Campath across the entire B-CLL treatment pathway,"stated Mark Enyedy, president of Genzyme's oncology business unit. "A broaderrange of patients is now eligible for Campath treatment, regardless of whetherthey have received prior therapy. The approval also marks an important step ina long-term development plan that is exploring the full potential of Campath inhigh-risk CLL, combination and consolidation therapy." Presented at the 48th Annual Meeting of the American Society of Hematology (ASH)conference last year, data supporting the sBLA were part of an internationalPhase III clinical trial comparing Campath with chlorambucil in previouslyuntreated patients with B-CLL. The study met its primary endpoint bydemonstrating longer progression free survival (PFS) in patients treated withCampath versus chlorambucil, with Campath reducing the risk of diseaseprogression or death by 42 percent (p=0.0001). Patients receiving Campath exhibited higher overall and complete response ratesthat were statistically significant in comparison to patients who were treatedwith chlorambucil. Campath also demonstrated a manageable safety profile amongstudy patients. "We are excited that Campath can now be used to treat patients in the U.S.earlier in the course of their disease," said Gunnar Riemann, Ph.D., member ofthe Board of Management of Bayer Schering Pharma AG. "The ability to nowprovide Campath as a first-line treatment of the disease will make an importantdifference in battling B-CLL. It may help patients by offering a potentiallymore effective treatment approach that can extend progression-free survival." Campath is marketed in the U.S. by Bayer HealthCare Pharmaceuticals Inc., asCampath, and outside the United States as MabCampath(R). About B-Cell Chronic Lymphocytic Leukemia According to the Leukemia and Lymphoma Society, approximately 15,000 new casesof B-cell chronic lymphocytic leukemia (B-CLL) are diagnosed in the U.S. eachyear. It is the largest subset of chronic lymphocytic leukemia (CLL), the mostcommon form of adult leukemia in the western world. B-CLL is characterized bythe accumulation of functionally immature cells in the bone marrow, blood, lymphtissue and other organs. Because these cancerous B cells have a longer thannormal life span, they begin to build up and "crowd out" normal, healthy bloodcells and can become fatal. Symptoms include fatigue, bone pain, night sweats,fevers, and decreased appetite and weight loss. Bone marrow infiltration leadsto a lack of healthy blood cells, thus causing susceptibility to bleedings andweakening of the immune system, exposing the patient to a higher risk ofinfection. About Campath Campath is indicated as a single agent for the treatment of B-cell chroniclymphocytic leukemia (B-CLL). Campath has a boxed warning which includesinformation on cytopenias, infusion reactions, and infections. The most commonlyreported adverse reactions are 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. Genzyme(R) and Campath(R) are registered trademarks of Genzyme Corporation. Allrights reserved. About Bayer HealthCare Pharmaceuticals Inc Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals unit ofBayer HealthCare LLC, a division of Bayer AG. Its research and businessactivities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women'sHealthcare. The company's aim is to discover and manufacture products that willimprove human health worldwide by diagnosing, preventing and treating diseases. For more information about Campath, including full prescribing information, call1-888-84-BAYER (1-888-842-2937) or visit www.campath.com. This press release contains forward-looking statements, including statementsabout the regulatory plans and timing for, and the expansion of, the Campathproduct label into earlier-line CLL, high-risk CLL, and combination andconsolidation therapy. These statements are subject to risks and uncertaintiesthat could cause actual results to differ materially from those projected inthese forward-looking statements. These risks and uncertainties include, amongothers: the actual efficacy and safety of Campath in these indications; theactual timing and content of submissions to and decisions made by the U.S. Foodand Drug Administration and other regulatory authorities, and the other risksand uncertainties 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. This news release contains forward-looking statements based on currentassumptions and forecasts made by Bayer Group management. Various known andunknown risks, uncertainties and other factors could lead to materialdifferences between the actual future results, financial situation, developmentor performance of the company and the estimates given here. These factorsinclude those discussed in our annual and interim reports to the Frankfurt StockExchange and in our reports filed with the U.S. Securities and ExchangeCommission (including our Form 20-F). The company assumes no liabilitywhatsoever to update these forward-looking statements or to conform them tofuture events or developments" For further information contact: BTG Financial DynamicsChristine Soden, Chief Financial Officer Ben Atwell+44 (0)20 7575 0000, +44 7710 484199 +44 (0)20 7831 3113 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. 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