TIDMGSK
RNS Number : 3627E
GlaxoSmithKline PLC
03 November 2015
Issued: Tuesday 3 November 2015, London UK - LSE
announcement
GSK profiles innovative R&D portfolio to investors
40 potential new medicines and vaccines offer significant
opportunity to drive long-term performance and deliver new benefits
to patients and consumers
At a presentation to investors in New York today, GSK described
a deep portfolio of innovation, focussed across six core areas of
scientific research and development: HIV & Infectious diseases,
Oncology, Immuno-Inflammation, Vaccines, Respiratory and Rare
Diseases. Around 40 new potential medicines and vaccines were
profiled, supporting the Group's outlook for growth in the period
2016-2020 and the significant opportunity the Group has to create
value beyond 2020.
The portfolio represents some of the latest scientific
achievements from GSK's R&D organisation and its more than
1,500 company and academic collaborations. The company believes
approximately 80% of the medicines and vaccines presented have the
potential to be "first-in-class" with novel mechanisms of action.
As a result, many of these potential medicines and vaccines may
offer benefits beyond current standards of care and, in some cases,
could radically transform how patients are treated.
In developing this portfolio, the company's scientists have
focussed on:
-- Targeting immune mechanisms that could alter the fundamental
course of diseases, modifying disease progression and presenting
opportunities to achieve remission and functional cures.
-- Developing simplified treatment regimens and a new generation
of long-acting medicines to provide long-term control and improve
treatment outcomes for patients.
-- Using next generation technology platforms to increase
understanding of fundamental disease mechanisms, to develop new
approaches to disease management and control.
At the event, notable advances within the portfolio were
outlined, including potential:
-- Leading-edge molecules in the field of epigenetics and
immuno-oncology for the treatment of cancer;
-- The next generation of respiratory medicines beyond inhaled treatments;
-- A portfolio of new antibodies for inflammatory diseases
including rheumatoid arthritis, autoimmune diseases and
osteoarthritis;
-- New options for long-term control and prevention of HIV;
-- Opportunities designed to cure or induce long-term remission in both Hepatitis B and C;
-- Breakthrough cell and gene therapies for treatment of rare diseases;
-- A novel maternal immunisation platform for vaccines.
GSK also profiled a number of significant material opportunities
in late-stage development, including: Nucala (mepolizumab)* for
treatment of severe eosinophilic asthma, Shingrix (zoster)*, a
candidate vaccine for the prevention of shingles, sirukumab for the
treatment of rheumatoid arthritis, daprodustat for anaemia,
cabotegravir for HIV, a candidate combination vaccine for the
prevention of bacterial meningitis and a new inhaled triple therapy
for treatment of COPD.
In total GSK has the potential to file up to 20 assets with
regulators before 2020. Seven of these assets are in advanced
late-stage development (with the potential to launch before 2020)
with the remainder, being in earlier development, notably in the
areas of oncology, immuno-inflammation and respiratory disease. In
2016/2017 GSK has the potential to start phase II development of 30
new molecular entities (NMEs) and product line extensions (PLEs)
and to start phase III development of 20 NMEs and PLEs. * The names
Nucala and Shingrix have not been approved for use by the FDA or
EMA
During the period 2021-2025, GSK has the potential to file up to
20 additional innovative assets, now in clinical development.
Commenting on the event, Sir Andrew Witty, CEO GSK said:
"Earlier this year we set out our expectations for the Group to
generate sustained sales and earnings performance over the next 5
years. With the recent transaction, we have significantly
strengthened our Vaccines and Consumer Healthcare businesses.
"Today, we have profiled around 40 innovative potential new
medicines and vaccines which will support future growth in our
Pharmaceuticals and Vaccines businesses. Several of these assets
are in advanced late-stage development and, for the first time, we
have also outlined the scale of new opportunities GSK has in
earlier stages of development, notably in areas such as oncology
and immuno-inflammation.
"The level of innovation in this portfolio is substantial. We
believe this is critical in today's operating environment as payors
look to balance pressures of pricing and demand. It also provides
us with confidence that this portfolio can generate significant
value for shareholders and deliver widespread benefits to patients
and consumers."
HIV and infectious diseases
The burden from infectious diseases continues to grow,
presenting significant public health challenges. GSK's leadership
in HIV began with the development of the world's first breakthrough
medicine for HIV patients, Retrovir (zidovudine), in the 1980s.
Successful development continues as demonstrated by the recent
launches of new dolutegravir-based products, Tivicay (dolutegravir)
and Triumeq (dolutegravir/abacavir/lamivudine). Dolutegravir was
discovered through a collaboration between GSK and Shionogi. The
next stage of development for dolutegravir is investigating its
potential as a two-drug regimen. A phase III study is ongoing as
part of a collaboration with Janssen, to investigate dolutegravir
in combination with rilpivirine, as a potential maintenance therapy
for adult patients with HIV who have already achieved viral
suppression with a three drug regimen.
GSK is exploring new therapies for patients that could
potentially enable long-term HIV control through infrequent dosing.
The long-acting integrase strand inhibitor, cabotegravir, is at the
forefront of this work and is currently in phase II development.
Clinical data supporting the progression of cabotegravir
development for both treatment and prevention of HIV was presented
and included a positive headline data readout from the LATTE2
trial. Data from this phase IIb trial is expected to be presented
at a scientific conference in 2016. Cabotegravir is expected to
enter phase III development in 2016.
In a collaboration, the details of which will be announced later
this week, GSK will work with the National Institute of Allergy and
Infectious Diseases, part of the National Institutes of Health, to
optimise and develop broadly neutralising antibodies (bnAbs), to
recognise their potential to enable infrequent dosing in the long
acting treatment and prevention of HIV.
Through its collaborations, and by applying the latest
scientific breakthroughs, GSK is aggressively pursuing research
programmes focused on curing patients with other infectious
diseases.
A new collaboration with Regulus Therapeutics will undertake a
clinical combination study investigating the potential of GSK's
NS5B polymerase inhibitor, 2878175, currently in phase I
development, and Regulus' miR-122 antagonist, RG-101, to offer a
single treatment cure for hepatitis C. The company's collaboration
with Isis Pharmaceuticals, which began in 2010 to develop new
therapies using antisense technology, is also exploring use of the
antisense oligonucleotide, GSK3228836, as a functional cure/long
term remission for hepatitis B, with a phase II study planned for
2016.
GSK began its research into antibiotics over 40 years ago and,
while the number of large pharmaceutical companies involved in this
area has reduced in recent years, a dedicated research team at GSK
continues to focus on discovering the next generation of medicines
to treat bacterial infections. The company's topoisomerase
inhibitor, gepotidacin (GSK2140944), has a novel mechanism of
action and the potential to address multiple indications. It has
been developed in collaboration with BARDA and DTRA. The asset is
currently in phase II development with a phase III study planned to
begin in 2016.
Oncology
GSK has focussed its oncology discovery efforts to target the
fundamental drivers of cancer, exploring new technologies and
approaches to stimulate anti-tumour immunity, reprogram cancer
cells and improve long-term survival. Development timelines for
oncology drugs can be compressed, which offers potential for
several of these assets to be filed with regulators in the next 3
to 5 years.
Epigenetics, the 'control system' that helps regulate the DNA of
cells and determines cell function - including the initiation and
progression of cancer - holds significant potential for future
cancer therapies. GSK made a significant research commitment to the
field of epigenetics in 2008 and has a number of strategic biotech
and world-leading academic collaborations.
GSK has an industry-leading epigenetics pipeline including a
potential first in class BET inhibitor, GSK525762 - currently in
phase I clinical development - which has the potential to treat
many indications including solid tumours and heme malignancies.
GSK2879552, an LSD1 inhibitor, is also in ongoing phase I clinical
studies to treat small cell lung cancer (SCLC) and acute myeloid
leukaemia. The phase I studies have shown an early signal of
significant progression-free survival for some patients with
SCLC.
GSK also has a pipeline of potential next generation
immuno-oncology therapies to stimulate anti-tumour immunity in
patients. Its collaboration with Adaptimmune, is exploring use of
GSK 3377794, a T-cell receptor (TCR) therapy in phase I/II
development across multiple indications including sarcoma, myeloma,
NSCLC, melanoma and ovarian cancer.
(MORE TO FOLLOW) Dow Jones Newswires
November 03, 2015 06:56 ET (11:56 GMT)
Monoclonal antibody GSK3174998, an OX40 agonist antibody being
developed in collaboration with MD Anderson, is one of four OX-40s
currently in development across the industry. GSK has begun a
development programme in eight solid tumours and heme malignancies,
and announced today that in 2016 a study will commence exploring
the asset's potential for use in combination with Merck's anti-PD-1
therapy, pembrolizumab, in solid tumours.
A first in class ICOS agonist antibody, GSK3359609, being
developed in collaboration with INSERM, is focused on enhancing
patients' anti-tumour T-cell response and is expected to enter the
clinic in Q1 2016, providing a potential universal mechanism across
multiple cancers either alone or in combination treatments.
Targeting the key biologic pathways thought to control cancer
stem cells is also a key area for the company's oncology research.
Tarextumab, being developed in collaboration with OncoMed, is a
first-in-class anti-cancer stem cell therapy in phase II
development for the treatment of pancreatic and small cell lung
cancer.
Immuno-inflammation
GSK's growth of research in this area, and the multiple
opportunities being explored, reflect the company's progress in
understanding the underlying cause of immune-related disease and
the potential for broad therapeutic utility from single pathway
interventions.
The company today highlighted a broad portfolio of innovative
immune-modulating therapies in clinical development, focused on
potentially altering the course of disease and inducing sustainable
remission.
GSK3196165, a granulocyte macrophage colony-stimulating factor
(GMCSF) antibody in-licensed from MorphoSys AG and in phase II
development in rheumatoid arthritis (RA), has shown a good
magnitude of effect with a fast onset of action in this indication
and further potential for early use to induce remission.
Understanding from this programme has also unlocked a clinical
development path for disease modification and analgesic activity in
hand osteoarthritis (HOA). An expedited phase II trial in this
indication is anticipated in 2016.
GSK also profiled a portfolio of potential first in class
antibodies for inflammatory diseases, with four assets already in
the clinic and set to enter phase II in 2016: GSK2618960, an
anti-IL-7R antibody for Sjögren's syndrome; GSK3050002, an
anti-CCL20 antibody for psoriatic arthritis in collaboration with
Morphotek/ Eisai; GSK2831781, a cell depleting anti-LAG3 antibody
for T-cell driven immuno-inflammation indications, and GSK2330811,
an anti-OSM antibody for systemic sclerosis.
RIP1 kinase inhibitor, GSK2982772, is a novel class oral
therapeutic with phase I and preclinical data that support the
potential for this drug to have activity in multiple potential
indications. Phase II studies in RA, ulcerative colitis and
psoriasis will progress in parallel in 2016.
The company also profiled two late-stage assets in this therapy
area. Sirukumab is an anti-IL-6 antibody currently in phase III
development with Janssen Biologics to treat rheumatoid arthritis
and with potential for further GSK development programmes in giant
cell arteritis and asthma.
When intravenous Benlysta (belimumab) was approved in 2011 it
was the first treatment for systemic lupus erythematosis (SLE) in
50 years and has established itself as a key therapy option. New
data presented today from a 3(rd) consecutive successful pivotal
study show efficacy in a subcutaneous formulation of belimumab,
which has potential to help patients manage their disease. Filing
for this subcutaneous formulation is planned for Q4 2015/ Q1
2016.
Metabolic
Daprodustat (GSK1278863), a low dose prolyl hydroxylase
inhibitor (PHI) in phase II development for the treatment of
anaemia in patients with chronic kidney disease, would be an oral
tablet to potentially replace the injectable current standard of
care (rhEPO), and has potential for improved cardiovascular safety.
A phase III study in this indication is expected to begin in 2016
and further development programmes are in phase I for the treatment
of diabetic foot ulcer and in muscle injury.
Vaccines
The company's leadership in vaccines R&D is reflected
through its short, mid and long term clinical development
programmes.
Shingrix (zoster), GSK's candidate shingles vaccine, represents
a significant advance in vaccination to help prevent shingles,
displaying high and potentially lasting efficacy across all age
groups from 50 to above 80 years old. Global filings are expected
in 2H 2016.
The company has the broadest portfolio of approved and candidate
meningococcal meningitis vaccines. This includes its commercialised
Menveo (MenACWY) tetravalent and Bexsero (MenB) vaccines and a full
pentavalent combination candidate vaccine, MenABCWY, which may
become the optimal option for disease prevention and is currently
in phase II development, with phase III planned for 2017.
The development of a vaccine against Respiratory syncytial virus
(RSV) is a key public health priority. RSV is a common cause of
bronchiolitis and pneumonia in infants and can lead to
hospitalisation and an enhanced risk of severe asthma. No vaccine
is currently available. GSK has two novel approaches to RSV
vaccination in phase II clinical development: a paediatric RSV
vaccine that uses a genetically engineered recombinant chimpanzee
adenovirus (CHAd155) - the same vector that is used in GSK's Ebola
vaccine candidate; and a recombinant glycoprotein maternal RSV
vaccine that, given to pregnant women, may provide infants with
protective maternally-derived RSV neutralising antibodies.
Maternal immunisation is now a clinically validated strategy to
prevent diseases that afflict very young infants in the first weeks
of life. In addition to RSV, GSK is further advancing its new
maternal immunisation vaccines portfolio with a vaccine candidate
to prevent Group B Strep (GBS), a leading cause of pneumonia,
meningitis and sepsis in newborns. Beyond GBS and RSV, GSK is also
considering this approach for the prevention of pertussis and
influenza diseases using its currently available vaccines, thereby
building potentially the most comprehensive maternal immunisation
vaccines portfolio in development.
Epidemiological studies show an association between some
bacterial infections in the lung and exacerbation episodes in COPD
patients. GSK is investigating a candidate vaccine concept
currently in a phase II clinical proof of concept study, for the
prevention of exacerbations in COPD patients.
Respiratory
Following the recent launches of Relvar/Breo Ellipta, Anoro
Ellipta, Arnuity Ellipta and Incruse Ellipta, GSK's commitment to
developing the most innovative inhaled respiratory medicines
continues through the ongoing phase III development with Theravance
of the unique once-daily closed triple combination in the Ellipta
device of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI)
for patients with chronic obstructive pulmonary disease (COPD).
Filings are expected in 2016 (EU) and 2018 (USA).
Building on its heritage as a leader in respiratory research,
the company today unveiled a next-generation of treatments for
respiratory disease, beyond the current approach with inhaled
medicines.
While current options for the treatment of mild to moderate
asthma enable patients to achieve good control of their symptoms,
there remains significant unmet need in severe patients. GSK's
diverse portfolio of targeted and extended-duration biologicals
offer the potential to alter the fundamental course of disease,
with Nucala (mepolizumab), its subcutaneous anti-IL-5 mAb, leading
the portfolio - a first in class medicine with a strong profile,
significantly reducing exacerbations in patients with severe
eosinophilic asthma. The Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA) issued a positive
opinion recommending marketing authorisation for Nucala on 24
September 2015. An FDA decision is expected on 4 November 2015.
Following Nucala, other assets in the asthma biologic pipeline
include sirukumab, which is expected to enter phase II in 2016, a
long-acting anti-IL-5 mAb, expected to begin phase I/II studies in
2017 and an inhaled anti-TSLP domain antibody (dAb) expected to
enter the clinic in 2016.
GSK2245035, an intranasal TLR7 agonist in phase II development,
is supported by clinical data demonstrating prolonged suppression
of allergic response and reaffirms GSK's continued innovation into
allergic asthma, exploring the potential to achieve disease
remission.
By targeting the underlying drivers of disease, two novel assets
offer the potential to delay or halt progression of COPD, a disease
that affects 329 million people worldwide and is expected to become
the 3(rd) leading cause of death by 2030 - GSK2269557, an inhaled
PI3K inhibitor and danirixin (GSK1325756), an oral CXCR2 antagonist
are both in phase II development.
Beyond asthma and COPD, GSK is using its long-term leadership in
respiratory R&D to actively explore new diseases, including
idiopathic pulmonary fibrosis and acute lung injury. GSK2862277, an
inhaled TNFR1 dAb, is already in phase II clinical development for
acute lung injury.
Rare Diseases
GSK is developing potential breakthrough cell and gene therapies
for the treatment of rare diseases. In May 2015 the company filed
for European approval of the gene therapy, GSK2696273, to treat
patients with adenosine deaminase severe combined immunodeficiency
syndrome (ADA-SCID). This is the first autologous stem cell gene
therapy product to be submitted for marketing application review
worldwide, and represents the first in a set of innovative rare
disease programmes from GSK's collaboration with the Telethon and
Ospedale San Raffaele Institute in Italy. Further gene therapy
products are in clinical development in the rare diseases,
metachromatic leukodystrophy (MLD), Wiskott-Aldrich Syndrome (WAS)
and beta thalassemia.
(MORE TO FOLLOW) Dow Jones Newswires
November 03, 2015 06:56 ET (11:56 GMT)
Gsk (LSE:GSK)
Historical Stock Chart
From Apr 2024 to May 2024
Gsk (LSE:GSK)
Historical Stock Chart
From May 2023 to May 2024