30th Jun 2005 12:30
GlaxoSmithKline PLC30 June 2005 GLAXOSMITHKLINE REVIEWS PIPELINE OF NOVEL VACCINES WITH THE POTENTIAL TO DRAMATICALLY IMPROVE GLOBAL HEALTH Five Major New Vaccines to be Launched Over the Next Five Years London, UK & Philadelphia, US (30 June 2005) - GlaxoSmithKline plc (GSK) todayupdated investors and financial analysts on the Company's broad and expandingvaccines research pipeline, which is delivering innovative products forprotection against a wide range of diseases. These vaccines range fromprotection for infants through to the elderly, and are targeted against some ofthe biggest killers in society today. "The global vaccines market is poised for accelerated growth due to productinnovations and a growing appreciation of the benefits of prevention overtreatment," said David Stout, President of Pharmaceuticals for GSK. "With over20 vaccines in clinical development and five major launches expected in the nextfive years, GSK's vaccines business is set for rapid growth, and will be a majorcontributor both to the Company's overall success and to improved health acrossthe globe." VACCINE R&D SEMINAR HIGHLIGHTS • GSK expects to launch five major new vaccines within the next five years: - Cervarix for the prevention of HPV which causes cervical cancer - Rotarix for rotavirus gastroenteritis - Streptorix for pneumococcal disease - an improved vaccine for influenza - vaccine combinations against meningitis • These five products will enter markets that have the potential to reach a total market value of £6-10 billion ($11-18 billion) by 2010. GSK expects each of the products to be strongly competitive and capture significant market share. • GSK estimates that cumulatively, up to 80 million women could be vaccinated by 2010 for protection against cervical cancer. Cervarix is expected to make a major contribution to this effort to improve the health of women worldwide. • GSK highlighted new clinical data at the R&D Seminar on Streptorix, on its combination meningitis vaccines, and on its improved vaccine to protect against influenza. • The launch of GSK's new paediatric vaccines, combined with its existing portfolio, will give GSK a full range of products to meet all infant vaccination schedules in all major markets within the first six months of life. • GSK continues to be a world leader in developing vaccines that have global health impact, and remains committed to targeting diseases like malaria and dengue fever that affect the developing world. Jean Stephenne, President of GSK Biologicals, said: "GSK leads the field ofvaccine technology - including development of novel adjuvants - and thatleadership is delivering a pipeline of innovative vaccines. We are proud ofthe progress we have made in expanding our capacity to supply these vaccines,and in ensuring access for people across the globe. These are exciting times,both for our company, and for the opportunities we see ahead to dramaticallyimprove the quality of health worldwide." KEY VACCINES HIGHLIGHTED AMONG GSK'S BROAD AND EXPANDING PIPELINE GSK is currently conducting 140 vaccine studies in over 100,000 peopleworldwide. The strength of the pipeline from preclinical through Phase III willprovide opportunities for GSK to consistently deliver new vaccines for manyyears to come. The following key vaccines were highlighted during the R&DSeminar: Cervarix: Medical Breakthrough in the Prevention of HPV Which Causes Cervical Cancer Disease Impact: One woman dies every two minutes from cervical cancer, thesecond most common form of cancer in women worldwide. Cervical cancer is causedby human papilloma virus (HPV), which infects up to 70-80% of all women duringtheir lifetime, sometimes repeatedly. In those cases where the infection doesnot clear spontaneously but persists, women are at high risk of developingcervical cancer. Where screening programs exist, up to one pap smear of 15 is positive, whichrequires secondary diagnosis and follow-up. Vaccination provides the potentialto avoid most of the cervical cancer cases that remain undetected despite theearly detection programs; can also lead to a reduction in the anxiety andhardship which many women experience who have been diagnosed with abnormallesions; and can also reduce costs linked to diagnosis and treatment ofpre-cancer lesions. GSK Innovation: GSK's vaccine, Cervarix, focuses on two of the most importanthigh-risk subtypes of HPV - 16 and 18 - which cause more than 70% of allcervical cancer. Recent studies suggest that the added power of GSK'sinnovative ASO4 adjuvant provides Cervarix with enhanced immune responses.Clinical studies have shown that Cervarix offers 100% protection againstpersistent HPV 16 and 18 infection and related lesions out to at least 27months. Data presented recently at the International Papillomavirus Conferenceand Clinical Workshop in Vancouver suggest that Cervarix may provide broaderprotection beyond HPV cancer types 16 and 18. Vaccines Market: GSK estimates that the cervical cancer vaccine market couldachieve a value of £2-4 billion ($4-7 billion) per year by 2010. Regulatoryfilings of Cervarix will take place in Europe in H1 2006, and in internationalmarkets during 2006. Discussions on filing with the US Food and DrugAdministration (FDA) are ongoing in the US, where the vaccine has been granted "fast track" status. Rotarix: Early and Broad Protection for Infants Against Rotavirus Gastroenteritis Disease Impact: Almost all children globally will contract rotavirus by their5th birthday, causing them to suffer fever, vomiting and diarrhoea that can leadto rapid and severe dehydration. One in 45 of these children is admitted to thehospital, making rotavirus one of the leading causes of childhoodhospitalisation in the US and Europe. Rotavirus is one of the top five causesof childhood death in the developing world, where one child in every 500 willdie of the disease. GSK Innovation: To meet this critical medical need, GSK has developed Rotarix,the only rotavirus vaccine with a 2-dose regimen that allows for earlyprotection, an important consideration since very young infants are particularlyvulnerable to more severe complications (dehydration) that lead to highmortality. Clinical data support the broad protection of Rotarix againstmoderate and severe disease, which will lead to substantial reduction inhospitalisation and death. In clinical trials, Rotarix has been administered toover 70,000 infants, and has been shown to be safe and highly effective. Vaccine Market: GSK estimates that the global market for rotavirus vaccinescould achieve a value of £1-1.3 billion ($1.8-2.4 billion) by 2010. GSK hassubmitted regulatory filings for Rotarix in Europe and 50 other markets.Rotarix has now been approved in 7 markets, including Mexico. Discussions onthe US filing are ongoing with the FDA. Streptorix: Beyond Prevnar Disease Impact: Each year, S. pneumoniae causes more than one million deaths inyoung children due to invasive pneumococcal infections like pneumonia,meningitis and bacteremia. S. pneumoniae is also a major cause of Acute OtitisMedia (AOM). AOM, an infection of the middle ear, is responsible for 20 milliondoctor visits each year in the US alone, as well as large numbers ofprescriptions written for antibiotics - contributing to the rise inantimicrobial resistance worldwide. Another bacterium, non-encapsulated H.influenzae, also causes AOM and accounts for a substantial number of cases. In arecent study in the US, non-encapsulated H. influenzae was shown to beresponsible for 57% of all bacterial AOM cases. The currently available vaccine,Prevnar, protects against a limited number of serotypes (7) of S. pneumoniae,and does not offer protection against non-encapsulated H. influenzae. GSK Innovation: GSK has developed a pneumococcal conjugate vaccine designed toprovide protection against the 10 most important pneumococcal serotypesworldwide, including three serotypes (1, 5, 7F) not contained in Prevnar. Thesethree additional serotypes seem to be particularly associated with severedisease and hospitalisation. The 10 types covered by Streptorix represent about80% of circulating invasive S. pneumoniae serotypes worldwide. GSK highlighted new data from a clinical efficacy trial with approximately 5,000children in which the study vaccine prevented approximately one-third of all AOMcases seen in the study. A high level of protection was seen against AOM causedby pneumococcal serotypes, similar to that with Prevnar. In addition,significant protection was observed against AOM caused by H. influenzae.Streptorix is the first vaccine to provide protection against non-encapsulatedH. influenzae. Overall, by protecting against AOM caused by S. pneumoniae and H. influenzae,Streptorix has the potential to significantly decrease the burden of AOMworldwide and lead to a significant reduction in doctor visits and antibioticprescriptions. This benefit is in addition to the anticipated major publichealth impact on reducing invasive pneumococcal disease. Vaccines Market: The current global market for pneumococcal vaccines isestimated to be in excess of £0.6 billion ($1 billion), primarily in NorthAmerica. GSK estimates the global market could achieve a value of £1.25-1.75billion ($2.3-3.2 billion) by 2010, with countries outside North America servingas major drivers of this growth. Streptorix is expected to offer a highlycompetitive clinical profile versus Prevnar, and drive the growth of the overallmarket due to its broader coverage - particularly against strains prevalent inEurope and other markets outside North America - and to its unique protectionagainst AOM. Regulatory filings for Streptorix in EU and international marketsare planned during 2007. Discussions on US filing are on-going with the FDA. Improved Flu Vaccine: Better Protection for the Elderly Disease Impact: Influenza is the leading cause of death by infectious diseasein the US and Europe. Each year, 36,000 people die from flu in the US; up to500,000 die across the globe. The current flu market is constrained by ashortage of capacity and limits to vaccine effectiveness. Despite currentvaccines, older adults (aged 65+) still have a 13-fold higher risk of death fromflu than younger people. This is due to older adults' weakened ability to mountan effective immune response to current flu vaccines. GSK Innovation: GSK is pursuing a number of strategies for growth to meetsocietal needs for increased access to flu vaccines: • doubling Fluarix manufacturing capacity to 80 million doses annually by 2008; • ensuring rapid development of an improved flu vaccine using a unique adjuvant; and • developing a new cell culture manufacturing process by 2010 to further increase production capacity. GSK's improved flu vaccine for the elderly uses a novel adjuvant designed torestore T-cell responses after vaccination to levels seen in younger people andto enhance protection against drift flu strains. The company highlighted newpreliminary clinical data from 360 elderly people that showed improved flu is aswell tolerated as Fluarix, and increases flu-specific T-cell responses by around60%. Vaccines Market: As the industry expands capacity to meet demand, GSK estimatesthat the influenza market could more than double from its current value of£0.7-0.9 billion ($1.3-1.6 billion) to a 2010 value of £1.6-2 billion ($2.9-3.7billion). Fluarix is licensed in 102 countries with 2004 sales of £79 million($144 million). The company filed Fluarix with the US FDA in May in time to beavailable for the 2005-2006 flu season, if it is approved. Large Phase IIItrials of the improved flu vaccine are due to start in 2006, and regulatoryfilings will take place in the US, Europe and international markets in 2008. Meningitis: First Vaccine Against Multiple N. meningitidis Strains in Infants Disease Impact: Bacterial meningitis is caused by three main bacteria: H.influenzae type b, S. pneumoniae, and N. meningitidis. In the US, N.meningitidis leads to death in 9-12% of children infected, and permanentneurological disability in 11-19% of survivors. By far the highest incidence ofmeningococcal disease is in children under age two. While conjugate vaccinescurrently protect US infants and young children against S. pneumoniae and H.Influenzae type b disease, no conjugate meningococcal vaccine is available inthe US for this age group. GSK Innovation: GSK has developed multiple combinations of new meningitisconjugate vaccines to prevent infection against four of the five serogroups ofN. meningitidis that cause bacterial meningitis: A, C, W and Y. GSK's multiplecombinations - Hib-MenCY, Hib-MenC (Menitorix), MenACWY, and Hib-MenAC-DTPw-HB -are specifically tailored to meet the medical and age-related needs of variousgeographical areas across the globe. The largest market opportunity for growth is the US, where meningococcal strainsC and Y are major causes of disease in children under two years of age. GSK hasdeveloped a Hib-MenCY combination vaccine for this group that could replace thecurrent Hib vaccine and fit into the vaccine schedule with no additionalinjections. GSK highlighted new data from clinical studies showing theexcellent safety profile of Hib-MenCY. Furthermore, 95% of infants who receivedthe vaccine achieved levels of bactericidal (i.e., bacterial killing) antibodiesknown to correlate with clinical protection. Vaccine Market: GSK estimates that the global N. meningitidis market couldincrease over the next five years from its current value of approximately £150million ($275 million) to £0.6-0.8 billion ($1.1-1.5 billion) by 2010, mostlydue to growth in the US. GSK expects to submit Hib-MenCY for filing in 2008 inthe US. FDA has given "fast-track" status to the regulatory process.Additionally, GSK submitted a file earlier this year to the UK authorities forMenitorix and is awaiting approval. Menitorix will be rolled out across Europeafter approval in the UK. GSK's other meningitis vaccines for global marketsare scheduled for regulatory filings in 2006 and 2007. Once approved, the launch of GSK's new paediatric vaccines, combined with theCompany's existing portfolio, will give GSK a full range of products to meet allinfant vaccination schedules in all major markets within the first six months oflife. Other Novel GSK Vaccines Malaria: In the developing world, malaria is responsible for 10-20 millioncases of severe disease each year, as well as 1-3 million deaths of mostlychildren and pregnant women. In clinical trials with over 2,000 children fromages one to four, GSK's Phase II candidate vaccine, Mosquirix, has proven tohave an excellent safety profile. Mosquirix also reduces the incidence ofsevere disease by 58% overall, and by 77% for children under two years of age.GSK expects Mosquirix to enter Phase III in 2007. Dengue Fever: Dengue fever affects more than 100 countries, placing 2.5 billionpeople at risk in South and Central America, the Southern US, Africa, and Asia.Dengue fever causes 30,000 deaths each year. GSK's vaccine is the firsttwo-dose vaccine to show a 100% immune response against all four virus subtypesthat cause the disease. The vaccine is expected to enter Phase III in 2007. Cancer: GSK is also evaluating vaccines that may prevent relapse in cancerpatients. GSK's vaccine approach uses proprietary adjuvant systems to target arobust T-cell response to prevent disease recurrence. Initial data is expectedlater this year against melanoma, and in 2006 for vaccines against recurrenceof breast, lung and prostate cancer. ABOUT GSK'S VACCINE GROUP GlaxoSmithKline Biologicals (GSK Biologicals), one of the world's leadingvaccine manufacturers, is located in Rixensart, Belgium. GSK Biologicals hadannual sales in 2004 of nearly £1.2 billion ($2 billion). Belgium is the centreof all GlaxoSmithKline's activities in the field of vaccine research,development and production. GSK Biologicals employs more than 1,300 researchscientists who are devoted to discovering new vaccines and developing moreeffective and convenient combination products to prevent infections that causeserious medical problems worldwide. In 2004, GSK Biologicals distributed more than 1.5 billion doses of vaccines to168 countries in both the developed and developing world, an average of 45 dosesper second. Approximately 140 million of the doses delivered last year werecombined paediatric vaccines that protect the world's children against a minimumof three and up to six diseases in one vaccine. GlaxoSmithKline is one of the world's leading research-based pharmaceutical andhealth care companies. GlaxoSmithKline is committed to improving the quality ofhuman life by enabling people to do more, feel better and live longer. Forcompany information visit www.gsk.com. Enquiries: UK Media enquiries: Philip Thomson (020) 8047 5502 David Mawdsley (020) 8047 5502 Chris Hunter-Ward (020) 8047 5502 Alice Hunt (020) 8047 5502 US Media enquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 Patricia Seif (215) 751 7709 European Analyst/Investor enquiries: Duncan Learmouth (020) 8047 5540 Anita Kidgell (020) 8047 5542 Jen Hill (020) 8047 5543 US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 GSK Biologicals Communications Anne P. Walsh +32 2 656 98 31 Under the safe harbour 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 vaccine discovery and development activities, the progress of whichdepends in significant part on factors not fully within the Group's control,including but not limited to the pace of clinical trial enrolment, the nature ofthe results of pending and prospective preclinical and clinical trials, theresolution of any unusual difficulties with vaccine formulation ormanufacturing, the outcome of review by regulatory authorities, changes in theprevailing legal/regulatory climate, and the like. The Group's currentexpectations and other information included in this Announcement and the relatedMeeting presentation materials reflect data currently in hand, which may bepreliminary in nature, whereas the ultimate progress of investigational vaccinesthrough remaining stages of development to regulatory submission, regulatoryapproval, and commercialisation may differ materially, given inherent risks anduncertainties. Brand names appearing in italics throughout this document are trade marks of GSKor associated companies. Rotarix base technology was in-licensed from AvantImmunotherapeutics Inc. in 1997. Cervarix base technology was in-licensed fromMedImmune Inc. in 1997. Prevnar(TM) is a trademark of Wyeth. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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