30th Nov 2005 13:02
GlaxoSmithKline PLC30 November 2005 Issued - Wednesday 30th November 2005 GlaxoSmithKline Presents Rapidly Expanding Pipeline Of Oncology And Supportive Care Compounds Philadelphia, PA, London, UK, November 30, 2005 - GlaxoSmithKline plc (NYSE:GSK)today updated investors and financial analysts in New York on the Company'srapidly expanding pipeline featuring innovative science that addresses a broadrange of patient needs for cancer prevention, treatment and supportive care. Seminar Highlights • GSK's substantial oncology and supportive care portfolio includes New Chemical Entities (NCEs), productline extensions (PLEs) and oncology-related vaccines. Four NCEs highlighted in this seminar are expected to be inphase III development in 2006: Tykerb (lapatinib), eltrombopag ('115), casopitant ('769), and pazopanib ('034). • Tykerb - A targeted oral therapy with the potential to become an essential component in the treatment ofbreast cancer: o Latest data demonstrate promise as first-line treatment for advanced breast cancer, with 40% of patients experiencing clinical benefit including tumor reduction or stable disease for at least 24 weeks. o Tykerb's clinical program has been expanded: • three new phase III trials are being initiated by January 2006, two in first-line therapy and one in refractory breast cancer • large phase II trial in the treatment of brain metastases associated with breast cancer started in November 2005 • in mid-November, the Breast International Group and GSK agreed to collaborate on a large global clinical trial to evaluate Tykerb as adjuvant therapy in early-stage breast cancer. • Eltrombopag - New clinical data demonstrate the potential for eltrombopag to become the first oral plateletgrowth factor for patients suffering from thrombocytopenia, a condition which can lead to uncontrolled bleeding,significantly reduced life expectancy and compromised treatment for cancer or liver disease. • Casopitant - New clinical data demonstrate the potential for casopitant when combined with Zofran as a newand improved therapy for the prevention of nausea and vomiting associated with chemotherapy and after surgery. • Pazopanib - Latest clinical data demonstrate prevention of tumor growth. Consequently an aggressiveclinical development program is expected to begin shortly in multiple cancer types including phase III trials inrenal cancer. • Other GSK oncology assets highlighted at the seminar include Arranon for T-cell acute lymphoblasticleukemia and lymphoma (launch in Q106), new indications for Hycamtin in relapsed cervical and relapsed small celllung cancer (filing Q405/2006), Avodart for reducing the risk of prostate cancer (phase III) and relacatib ('795) acathepsin-K inhibitor for the prevention and treatment of bone metastases (entering phase II in 2006). "Today's seminar clearly shows the progress GSK has made in building itsoncology pipeline," said Tachi Yamada, GSK's Chairman of Research & Development."From modest beginnings, we now have a pipeline which is one of the largest inour industry with seven major assets expected to be in phase III development inthe coming months, including the four NCEs highlighted today." "Cancer remains an area of substantial unmet medical need. Our strategy isfocused on meeting all aspects of a cancer patient's treatment - from control,reduction and prevention of tumors to novel medicines that will improvesupportive care for patients undergoing chemotherapy." Paolo Paoletti, Senior Vice President of GSK's Oncology Medicine DevelopmentCenter, commented: "GSK is pursuing therapies targeting cancer at a molecularlevel in order to block biochemical pathways that transform normal, healthyhuman cells into cancer cells. We are particularly excited that the promisingefficacy of Tykerb, our targeted dual-kinase inhibitor, has led to support amongleading cancer experts for the initiation next year of a large study of Tykerbin the treatment of early stage breast cancer." Allen Oliff, Senior Vice President of GSK's Oncology Center for Excellence inDrug Discovery, said: "We are very encouraged by the recent clinical data oneltrombopag. This product clearly has the potential to be a significant advancein the treatment of thrombocytopenia, a condition which has few therapeuticoptions and can lead to sub-optimal treatment for patients suffering from anumber of conditions including cancer and liver disease." Compounds reviewed at today's seminar include: • Tykerb - a targeted oral therapy with the potential to become anessential component in the treatment of breast cancer World-wide, 400,000 women die each year as a result of breast cancer, and itsprevalence is increasing with approximately 1.5 million new cases diagnosedevery year. Tykerb, a dual-kinase inhibitor, is an oral once-daily treatmentcurrently being developed for breast cancer and other tumors. It works byinhibiting two well-validated targets in oncology, the kinase components ofErbB1 (EGFR) and ErbB2 receptors, which are associated with cancer-cellproliferation and tumor growth. Data presented at today's seminar, and at the recent European Cancer Conference(ECCO) in Paris, illustrate the promising efficacy and safety profile of Tykerb.Interim results from an international phase II trial of Tykerb as first-linetherapy in 40 patients with advanced or metastatic breast cancer (with ErbB2overexpression) showed that 33% of patients had tumor reductions, with 40% ofpatients experiencing clinical benefit (tumor reduction or stable disease for atleast 24 weeks). A further update will be presented at the San Antonio BreastCancer Symposium on 8th December. Tykerb has also shown preliminary activity in the treatment of brain metastases,which represents a significant unmet medical need for breast cancer patients. Results were recently analyzed from a 416 patient phase II/III clinical trial inthe treatment of renal cancer. While the primary end-point was not met in thefull population, a preliminary analysis of the sub-group of 241 patients withover-expression of EGFR demonstrated a statistically significant survivalbenefit for patients receiving Tykerb. This data is expected to be presented atASCO in 2006. In the 3,500 patients who are part of its clinical development program, Tykerbto date has shown a low incidence of cardiotoxicity, a condition associated withsome breast cancer treatments. The most frequently reported adverse eventsassociated with Tykerb have been mild to moderate itching, rash, diarrhea, acne,and dry skin. Tykerb's clinical program has been expanded, with three new phase III trialsbeing initiated by January 2006, two in first-line therapy and one in refractorybreast cancer. A large phase II trial in the treatment of brain metastasesassociated with breast cancer started in November 2005. In mid-November, GSK andthe Breast International Group - one of the world's premier cancer researchgroups - agreed to collaborate on a large-scale global clinical trial toevaluate Tykerb as adjuvant therapy in early-stage breast cancer. GSK expects to file Tykerb for US Food and Drug Administration (FDA) approval atthe end of 2006 or in the first half of 2007. • Eltrombopag ('115) demonstrates potential to become the first oral bloodplatelet growth factor for patients suffering from thrombocytopenia Eltrombopag is an orally administered small molecule that interacts with thereceptor for thrombopoietin (TPO), a protein in the body that is the primarygrowth factor responsible for the production of blood platelets. By stimulatingthe TPO receptor on megakaryocytes, eltrombopag increases the production ofplatelets to help treat patients with thrombocytopenia (decreased plateletcount). As platelets are critically important in the first step of hemostasis,patients with thrombocytopenia are at significant risk of uncontrolled bleeding. Thrombocytopenia is prevalent in patients with many conditions such as thosewith the autoimmune disease idiopathic thrombocytopenia purpura (ITP), cancerpatients being treated with chemotherapy, and patients suffering from liverdisease, including hepatitis C (HCV). In the case of cancer and HCV,thrombocytopenia often becomes a complication that compromises therapy. In theUS alone there are approximately one to two million patients who suffer fromclinically significant thrombocytopenia each year. GSK is conducting clinicaltrials with eltrombopag in a variety of these patient populations. Most patients with ITP are treated with one of a number of 'broad' therapiesincluding steroids, intravenous immunoglobulin, splenectomy or platelettransfusions which can be invasive or have unpleasant side effects. Patientswith CIT are managed by chemotherapy dose delays, dose reductions or platelettransfusions. Consequently, eltrombopag has the potential to provide, in aconvenient oral formulation, a major advance for patients suffering fromthrombocytopenia. Today the company presented data from a phase II dose-ranging clinical trialthat showed eltrombopag significantly raised platelet counts in adult patientssuffering from chronic ITP who had failed at least one prior therapy. In thetrial, eltrombopag produced significant response rates in 66% of patientsreceiving the 50mg dose, and in 87% of patients receiving the 75mg dose,compared to 13% receiving placebo. The frequency of side effects was comparablebetween patients treated with placebo and those treated with eltrombopag. An interim analysis of phase II data also showed an encouraging plateletresponse in hepatitis C patients. A full analysis will be available during thefirst half of 2006. Current treatment options for thrombocytopenia, including immunosuppressiveagents, interleukins and blood platelet transfusions, have safety and efficacyissues that limit their use. As the first oral treatment to increase theproduction of platelets, eltrombopag potentially represents a significantbreakthrough for patients. GSK expects to file for approval of eltrombopag inits initial indication (ITP) by the end of 2006 or in 2007, depending ondiscussions with regulatory authorities. Eltrombopag has been developed in collaboration with Ligand Pharmaceuticals. • New data with casopitant ('769), demonstrate enhanced benefit overexisting therapy in the treatment of emesis associated with chemotherapy andsurgery NK-1 antagonist, casopitant, is an anti-emetic medicine currently beingdeveloped by GSK to prevent both chemotherapy-induced nausea and vomiting (CINV)and post-operative nausea and vomiting (PONV). There are more than 5 million patient visits per year in the US and EU forhighly or moderately emetogenic chemotherapy. Although almost all of thesepatients are treated with 5-HT3 antagonists such as Zofran, more than 40% stillsuffer from episodes of nausea and vomiting. New data from two phase IIdose-ranging studies (approximately 1,200 patients combined), presented attoday's seminar, showed that the use of casopitant in combination with Zofranand dexamathasone produced a complete response rate in up to 86% of patientsreceiving highly emetogenic chemotherapy, and in up to 85% of patients receivingmoderately emetogenic chemotherapy. These response rates were both significantlyhigher (43% and 21% respectively) than treatment with Zofran and dexamethasone. Casopitant also demonstrated significant activity in the prevention ofpost-operative nausea and vomiting, a problem experienced by up to 50% of highto moderate risk patients despite prophylactic treatment with 5-HT3 antagonists.In a 700 patient phase II dose ranging study, casopitant, in combination withZofran, demonstrated a complete response rate at 24 hours that was up to 48%higher than treatment with Zofran alone. Side effects of casopitant plus Zofran both in the CINV and PONV trials weresimilar to those seen in the control group. The most frequently observed sideeffects in the CINV studies were nausea, vomiting, constipation, fatigue andasthenia, and in the PONV studies were headache and dizziness. Casopitant is expected to enter phase III development for CINV and PONV in 2006with regulatory filing for both indications scheduled during 2007. • Potent new medicine, pazopanib ('034), prevents tumor growth in earlyclinical trials Cancer tumors require the formation of new blood vessels (angiogenesis) to growand spread. Vascular endothelial growth factor (VEGF) stimulates angiogenesis.The once-daily oral treatment pazopanib, a small molecule, potentially inhibitsblood vessel formation, thereby preventing subsequent tumor growth. Early clinical data has demonstrated that pazopanib has strong anti-canceractivity. In a 63 patient phase I study, 100% (6/6) of patients with renal cellcarcinoma who received a therapeutic dose of pazopanib had a clinical benefit(tumor reduction or stable disease). Tumor shrinkage and prolonged stabledisease was also observed in a number of other cancer types, includinggastrointestinal, neuroendocrine, lung, thyroid and sarcomas. The most commonlyreported adverse events with pazopanib were hypertension and fatigue. Based onthese positive results and the substantial base of scientific knowledge of VEGFinhibitors, GSK is pursuing an aggressive clinical development program forpazopanib with global phase III trials in renal-cell cancer expected to beginshortly. Furthermore, in vitro studies have suggested there is an additive effect whenpazopanib is used in combination with Tykerb. Phase II trials to assess the useof this combination are scheduled to begin next year. Pazopanib will also beassessed in combination with other cancer treatments, including cytotoxicagents. GSK Pipeline Update In conjunction with today's seminar, GSK issued an updated pipeline chart.Currently GSK has 146 projects in the clinic including 97 NCEs, 18 vaccines and31 PLEs. Of the 97 NCEs, 11 are in phase III/registration, 45 in phase II and 41in phase I. This represents a near doubling of the number of NCEs since the timeof the GSK merger in 2001. The new pipeline report is available on www.gsk.com. S M Bicknell Company Secretary 30th November 2005 About GlaxoSmithKline GSK, one of the world's leading research-based pharmaceutical and healthcarecompanies, is committed to improving the quality of human life by enablingpeople to do more, feel better and live longer. Under the safe harbor provisions of the US Private Securities Litigation ReformAct of 1995, the company cautions investors that any forward-looking statementsor projections made by the company, including those made in this Announcementand the Meeting presentation materials to which it relates, are subject to risksand uncertainties that may cause actual results to differ materially from thoseprojected. Factors that may affect the Group's operations are described under'Risk Factors' in the Operating and Financial Review and Prospects in theGlaxoSmithKline Annual Report on Form 20-F for 2004. Without limiting the foregoing, this Announcement and the Meeting presentationmaterials to which it relates contain forward-looking statements regardingongoing drug discovery and development activities, the progress of which dependsin significant part on factors not fully within the Group's control, includingbut not limited to the pace of clinical trial enrollment, the nature of theresults of pending and prospective preclinical and clinical trials, theresolution of any unusual difficulties with drug formulation or manufacturing,the outcome of review by regulatory authorities, changes in the prevailing legal/regulatory climate, and the like. The Group's current expectations and otherinformation included in this Announcement and the related Meeting presentationmaterials reflect data currently in hand, which may be preliminary in nature,whereas the ultimate progress of investigational drugs through remaining stagesof development to regulatory submission, regulatory approval, andcommercialization may differ materially, given inherent risks and uncertainties. Arranon, Hycamtin, Avodart, Tykerb and Zofran are trademarks of theGlaxoSmithKline Group of companies. 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