Research Update - Vaccines
GlaxoSmithKline PLC
30 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) today
updated investors and financial analysts on the Company's broad and expanding
vaccines research pipeline, which is delivering innovative products for
protection against a wide range of diseases. These vaccines range from
protection for infants through to the elderly, and are targeted against some of
the biggest killers in society today.
"The global vaccines market is poised for accelerated growth due to product
innovations and a growing appreciation of the benefits of prevention over
treatment," said David Stout, President of Pharmaceuticals for GSK. "With over
20 vaccines in clinical development and five major launches expected in the next
five years, GSK's vaccines business is set for rapid growth, and will be a major
contributor both to the Company's overall success and to improved health across
the 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 of
vaccine technology - including development of novel adjuvants - and that
leadership is delivering a pipeline of innovative vaccines. We are proud of
the 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 dramatically
improve 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 people
worldwide. The strength of the pipeline from preclinical through Phase III will
provide opportunities for GSK to consistently deliver new vaccines for many
years to come. The following key vaccines were highlighted during the R&D
Seminar:
Cervarix: Medical Breakthrough in the Prevention of HPV Which Causes Cervical
Cancer
Disease Impact: One woman dies every two minutes from cervical cancer, the
second most common form of cancer in women worldwide. Cervical cancer is caused
by human papilloma virus (HPV), which infects up to 70-80% of all women during
their lifetime, sometimes repeatedly. In those cases where the infection does
not clear spontaneously but persists, women are at high risk of developing
cervical cancer.
Where screening programs exist, up to one pap smear of 15 is positive, which
requires secondary diagnosis and follow-up. Vaccination provides the potential
to avoid most of the cervical cancer cases that remain undetected despite the
early detection programs; can also lead to a reduction in the anxiety and
hardship which many women experience who have been diagnosed with abnormal
lesions; and can also reduce costs linked to diagnosis and treatment of
pre-cancer lesions.
GSK Innovation: GSK's vaccine, Cervarix, focuses on two of the most important
high-risk subtypes of HPV - 16 and 18 - which cause more than 70% of all
cervical cancer. Recent studies suggest that the added power of GSK's
innovative ASO4 adjuvant provides Cervarix with enhanced immune responses.
Clinical studies have shown that Cervarix offers 100% protection against
persistent HPV 16 and 18 infection and related lesions out to at least 27
months. Data presented recently at the International Papillomavirus Conference
and Clinical Workshop in Vancouver suggest that Cervarix may provide broader
protection beyond HPV cancer types 16 and 18.
Vaccines Market: GSK estimates that the cervical cancer vaccine market could
achieve a value of £2-4 billion ($4-7 billion) per year by 2010. Regulatory
filings of Cervarix will take place in Europe in H1 2006, and in international
markets during 2006. Discussions on filing with the US Food and Drug
Administration (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 their
5th birthday, causing them to suffer fever, vomiting and diarrhoea that can lead
to rapid and severe dehydration. One in 45 of these children is admitted to the
hospital, making rotavirus one of the leading causes of childhood
hospitalisation in the US and Europe. Rotavirus is one of the top five causes
of childhood death in the developing world, where one child in every 500 will
die 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 early
protection, an important consideration since very young infants are particularly
vulnerable to more severe complications (dehydration) that lead to high
mortality. Clinical data support the broad protection of Rotarix against
moderate and severe disease, which will lead to substantial reduction in
hospitalisation and death. In clinical trials, Rotarix has been administered to
over 70,000 infants, and has been shown to be safe and highly effective.
Vaccine Market: GSK estimates that the global market for rotavirus vaccines
could achieve a value of £1-1.3 billion ($1.8-2.4 billion) by 2010. GSK has
submitted regulatory filings for Rotarix in Europe and 50 other markets.
Rotarix has now been approved in 7 markets, including Mexico. Discussions on
the US filing are ongoing with the FDA.
Streptorix: Beyond Prevnar
Disease Impact: Each year, S. pneumoniae causes more than one million deaths in
young children due to invasive pneumococcal infections like pneumonia,
meningitis and bacteremia. S. pneumoniae is also a major cause of Acute Otitis
Media (AOM). AOM, an infection of the middle ear, is responsible for 20 million
doctor visits each year in the US alone, as well as large numbers of
prescriptions written for antibiotics - contributing to the rise in
antimicrobial resistance worldwide. Another bacterium, non-encapsulated H.
influenzae, also causes AOM and accounts for a substantial number of cases. In a
recent study in the US, non-encapsulated H. influenzae was shown to be
responsible 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 to
provide protection against the 10 most important pneumococcal serotypes
worldwide, including three serotypes (1, 5, 7F) not contained in Prevnar. These
three additional serotypes seem to be particularly associated with severe
disease and hospitalisation. The 10 types covered by Streptorix represent about
80% of circulating invasive S. pneumoniae serotypes worldwide.
GSK highlighted new data from a clinical efficacy trial with approximately 5,000
children in which the study vaccine prevented approximately one-third of all AOM
cases seen in the study. A high level of protection was seen against AOM caused
by 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-encapsulated
H. influenzae.
Overall, by protecting against AOM caused by S. pneumoniae and H. influenzae,
Streptorix has the potential to significantly decrease the burden of AOM
worldwide and lead to a significant reduction in doctor visits and antibiotic
prescriptions. This benefit is in addition to the anticipated major public
health impact on reducing invasive pneumococcal disease.
Vaccines Market: The current global market for pneumococcal vaccines is
estimated to be in excess of £0.6 billion ($1 billion), primarily in North
America. GSK estimates the global market could achieve a value of £1.25-1.75
billion ($2.3-3.2 billion) by 2010, with countries outside North America serving
as major drivers of this growth. Streptorix is expected to offer a highly
competitive clinical profile versus Prevnar, and drive the growth of the overall
market due to its broader coverage - particularly against strains prevalent in
Europe and other markets outside North America - and to its unique protection
against AOM. Regulatory filings for Streptorix in EU and international markets
are 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 disease
in the US and Europe. Each year, 36,000 people die from flu in the US; up to
500,000 die across the globe. The current flu market is constrained by a
shortage of capacity and limits to vaccine effectiveness. Despite current
vaccines, older adults (aged 65+) still have a 13-fold higher risk of death from
flu than younger people. This is due to older adults' weakened ability to mount
an effective immune response to current flu vaccines.
GSK Innovation: GSK is pursuing a number of strategies for growth to meet
societal 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 to
restore T-cell responses after vaccination to levels seen in younger people and
to enhance protection against drift flu strains. The company highlighted new
preliminary clinical data from 360 elderly people that showed improved flu is as
well tolerated as Fluarix, and increases flu-specific T-cell responses by around
60%.
Vaccines Market: As the industry expands capacity to meet demand, GSK estimates
that 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 ($2.9-3.7
billion). 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 be
available for the 2005-2006 flu season, if it is approved. Large Phase III
trials of the improved flu vaccine are due to start in 2006, and regulatory
filings 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 permanent
neurological disability in 11-19% of survivors. By far the highest incidence of
meningococcal disease is in children under age two. While conjugate vaccines
currently protect US infants and young children against S. pneumoniae and H.
Influenzae type b disease, no conjugate meningococcal vaccine is available in
the US for this age group.
GSK Innovation: GSK has developed multiple combinations of new meningitis
conjugate vaccines to prevent infection against four of the five serogroups of
N. meningitidis that cause bacterial meningitis: A, C, W and Y. GSK's multiple
combinations - Hib-MenCY, Hib-MenC (Menitorix), MenACWY, and Hib-MenAC-DTPw-HB -
are specifically tailored to meet the medical and age-related needs of various
geographical areas across the globe.
The largest market opportunity for growth is the US, where meningococcal strains
C and Y are major causes of disease in children under two years of age. GSK has
developed a Hib-MenCY combination vaccine for this group that could replace the
current Hib vaccine and fit into the vaccine schedule with no additional
injections. GSK highlighted new data from clinical studies showing the
excellent safety profile of Hib-MenCY. Furthermore, 95% of infants who received
the vaccine achieved levels of bactericidal (i.e., bacterial killing) antibodies
known to correlate with clinical protection.
Vaccine Market: GSK estimates that the global N. meningitidis market could
increase over the next five years from its current value of approximately £150
million ($275 million) to £0.6-0.8 billion ($1.1-1.5 billion) by 2010, mostly
due to growth in the US. GSK expects to submit Hib-MenCY for filing in 2008 in
the US. FDA has given "fast-track" status to the regulatory process.
Additionally, GSK submitted a file earlier this year to the UK authorities for
Menitorix and is awaiting approval. Menitorix will be rolled out across Europe
after approval in the UK. GSK's other meningitis vaccines for global markets
are scheduled for regulatory filings in 2006 and 2007.
Once approved, the launch of GSK's new paediatric vaccines, combined with the
Company's 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.
Other Novel GSK Vaccines
Malaria: In the developing world, malaria is responsible for 10-20 million
cases of severe disease each year, as well as 1-3 million deaths of mostly
children and pregnant women. In clinical trials with over 2,000 children from
ages one to four, GSK's Phase II candidate vaccine, Mosquirix, has proven to
have an excellent safety profile. Mosquirix also reduces the incidence of
severe 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 billion
people 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 first
two-dose vaccine to show a 100% immune response against all four virus subtypes
that cause the disease. The vaccine is expected to enter Phase III in 2007.
Cancer: GSK is also evaluating vaccines that may prevent relapse in cancer
patients. GSK's vaccine approach uses proprietary adjuvant systems to target a
robust T-cell response to prevent disease recurrence. Initial data is expected
later this year against melanoma, and in 2006 for vaccines against recurrence
of breast, lung and prostate cancer.
ABOUT GSK'S VACCINE GROUP
GlaxoSmithKline Biologicals (GSK Biologicals), one of the world's leading
vaccine manufacturers, is located in Rixensart, Belgium. GSK Biologicals had
annual sales in 2004 of nearly £1.2 billion ($2 billion). Belgium is the centre
of all GlaxoSmithKline's activities in the field of vaccine research,
development and production. GSK Biologicals employs more than 1,300 research
scientists who are devoted to discovering new vaccines and developing more
effective and convenient combination products to prevent infections that cause
serious medical problems worldwide.
In 2004, GSK Biologicals distributed more than 1.5 billion doses of vaccines to
168 countries in both the developed and developing world, an average of 45 doses
per second. Approximately 140 million of the doses delivered last year were
combined paediatric vaccines that protect the world's children against a minimum
of three and up to six diseases in one vaccine.
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and
health care companies. GlaxoSmithKline is committed to improving the quality of
human life by enabling people to do more, feel better and live longer. For
company 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 Reform
Act of 1995, the Company cautions investors that any forward-looking statements
or projections made by the Company, including those made in this Announcement
and the Meeting presentation materials to which it relates, are subject to risks
and uncertainties that may cause actual results to differ materially from those
projected. Factors that may affect the Group's operations are described under
'Risk Factors' in the Operating and Financial Review and Prospects in the
GlaxoSmithKline Annual Report on Form 20-F for 2004.
Without limiting the foregoing, this Announcement and the Meeting presentation
materials to which it relates contain forward-looking statements regarding
ongoing vaccine discovery and development activities, the progress of which
depends 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 of
the results of pending and prospective preclinical and clinical trials, the
resolution of any unusual difficulties with vaccine 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 other information included in this Announcement and the related
Meeting presentation materials reflect data currently in hand, which may be
preliminary in nature, whereas the ultimate progress of investigational vaccines
through remaining stages of development to regulatory submission, regulatory
approval, and commercialisation may differ materially, given inherent risks and
uncertainties.
Brand names appearing in italics throughout this document are trade marks of GSK
or associated companies. Rotarix base technology was in-licensed from Avant
Immunotherapeutics Inc. in 1997. Cervarix base technology was in-licensed from
MedImmune Inc. in 1997. Prevnar(TM) is a trademark of Wyeth.
This information is provided by RNS
The company news service from the London Stock Exchange
Latest directors dealings
- 11 hours ago Savannah Energy
- 12 hours ago Buccaneer Energy PLC
- 13 hours ago Savannah Energy
- 13 hours ago Carclo
- 13 hours ago Schroder Japan Growth Fund