Therapeutic advancements for sickle cell disease, RSV, breast
cancer, Crohn's and other ailments poised to advance patient health
despite urgent challenges facing life science companies
LONDON, Jan. 8, 2024 /PRNewswire/ -- Clarivate
Plc (NYSE:CLVT), a global leader in connecting people and
organizations to intelligence they can trust to transform their
world, today announced the release of its annual Drugs to Watch™
report. The report provides in-depth predictive analysis of drugs
with the potential for standout commercial and/or clinical success.
The report, a key industry resource in the evolving healthcare
landscape, has identified over 85 Drugs to Watch over the 11-year
course of its publication.
This year, analysts identified 13 new-to-market therapeutics and
drugs poised to launch in 2024 which Clarivate predictive analytics
project will achieve blockbuster status by 2029 or deliver
game-changing benefits to patients. These promising advancements
include a broad spectrum of therapeutic innovation for conditions
including breast cancer, hemophilia A, sickle cell disease, Crohn's
disease, ulcerative colitis, respiratory syncytial virus (RSV) and
multiple myeloma, among others.
In addition, the report spotlights the growing chronic disease
market in Mainland China, highlighting seven drugs that are likely
to achieve $1 billion blockbuster
status by 2029 or to have a significant impact for Chinese patients
in need of better treatment options.
Mike Ward, Global Head of
Thought Leadership, Life Sciences and Healthcare, Clarivate
said: "The fundamentals underpinning the biopharma sector have
never been stronger, with new technologies fueling medical
advancements and providing treatment options to patients with
previously unmet needs. Leveraging deep industry expertise and
comprehensive therapeutic area differentiated data, this year's
Drugs to Watch report identifies innovative medicines based on
recent scientific breakthroughs poised to have extraordinary
impacts on patient outcomes."
2024 is anticipated to be a transformational year of innovation
for the pharma industry. New modalities like antibody drug
conjugates and AI/machine learning, underpinned by scientific
breakthroughs in the past decade, are achieving clinical successes
and providing therapies for patients with limited treatment
options. However, external influences such as government
initiatives to contain healthcare costs, the sustained high cost of
capital and global geopolitical disputes are negatively impacting
investor appetites for the sector.
The 2024 edition of Drugs to Watch highlights trends that will
likely be consequential to the discovery, development and delivery
of new medicines, and spotlights drugs and drug candidates that are
likely to achieve important milestones in the coming years as they
establish themselves as either blockbuster or breakthrough
medicines.
The 2024 Drugs to Watch, are:
Aflibercept (high dose; EYLEA® HD), developed by Bayer and
Regeneron Pharmaceuticals Inc
For individuals with wet age-related macular degeneration (AMD),
diabetic macular edema (DME) or diabetic retinopathy (DR) whose
treatment choices include invasive, burdensome administration that
limits treatment uptake, high-dose aflibercept offers less-frequent
administration while achieving similar efficacy and safety as the
current standard of care.
Budesonide (TARPEYO®/Kinpeygo®/Nefecon), developed by
Calliditas Therapeutics AB, Everest Medicines and STADA
Arzneimittel AG
TARPEYO®/Kinpeygo® (developed under the project name Nefecon) is
a second-generation, synthetic, non-halogenated form of the
corticosteroid budesonide. The delayed release formulation of
budesonide has shown greater efficacy for protein reduction and
slowing the decline in kidney function in primary immunoglobulin A
(IgA) as well as a much better safety profile than conventional
corticosteroids.
Datopotamab deruxtecan (Dato-DXd), developed by AstraZeneca
and Daiichi Sankyo
With the potential to become the best-in-class TROP2-targeted
antibody drug conjugate (ADC), datopotamab deruxtecan is set to be
second to market (after TRODELVY®; Gilead Sciences Inc) for both
HR-positive/HER2-negative and triple-negative breast cancer, and to
enter the non-small cell lung cancer (NSCLC) market. The
collaboration between AstraZeneca and Daiichi Sankyo combines the
former's strategic focus on NSCLC and breast cancers and investment
in ADCs with the latter's proprietary DXd ADC technology.
Efanesoctocog alfa (ALTUVIIIO™/BIVV001), developed by Sanofi
(Bioverativ Therapeutics Inc) and Swedish Orphan Biovitrum AB
(Sobi®)
Efanesoctocog alfa is the first once-weekly factor VIII (FVIII)
replacement intravenous infusion therapy, which will help reduce
the burden associated with the injection frequency of other
currently available FVIII therapies. For patients reluctant to
receive novel therapies, such as mAbs or gene therapy,
efanesoctocog alfa will likely be an appealing option. Clinicians
also view efanesoctocog alfa favorably given the attainable FVIIII
levels, injection frequency and safety profile demonstrated in
clinical trials to date.
Ensifentrine (RPL554), developed by Verona Pharma
Ensifentrine is an inhaled dual phosphodiesterase (PDE)3 and
PDE4 inhibitor that is expected to reduce exacerbations in moderate
to severe chronic obstructive pulmonary disease (COPD) without the
systemic side effects of current PDE inhibitors that are delivered
orally. If approved, it would be the first in class as well as the
first novel mechanism that has become available for maintenance
COPD treatment in more than 10 years. The clinical and safety
profile of ensifentrine makes it a promising addition to the
limited treatment class options available for this patient
population.
Exagamglogene autotemcel (CASGEVY™ /exa-cel) and
lovotibeglogene autotemcel (LYFGENIA™/lovo-cel/formerly
LentiGlobin™), developed by CRISPR Therapeutics and Vertex
Pharmaceuticals Inc (exa-cel) and Bluebird Bio (lovo-cel)
All eyes are on exagamglogene autotemcel (exa-cel) and
lovotibeglogene autotemcel, which are set become the first
disease-modifying therapies for sickle cell disease (SCD) and
beta-thalassemia, a significant achievement for a patient
population with debilitating, life-altering diseases that have
limited symptomatic and curative treatments currently available.
The excitement around exagamglogene autotemcel also stems from the
landmark first approval of a CRISPR/Cas9 gene-edited therapy
globally, and the approval sets the stage for upcoming approvals in
other regions.
Mirikizumab (Omvoh™/ LY-3074828), developed by Eli Lilly and
Company
Mirikizumab, an mAb targeting the p19 subunit of IL-23, was
approved as first-in-class therapy for ulcerative colitis by the
EMA and the U.S. FDA and will likely be the third in the class
approved for Crohn's disease. Included in Drugs to Watch 2023, a
delayed U.S. launch meant that it remains a drug to watch for
2024.
Niraparib + abiraterone acetate (AKEEGA™), developed by
Johnson & Johnson Innovative Medicine
This is the first and only dual action (or fixed-dose
combination [FDC]) tablet combining a PARP inhibitor (niraparib)
and a next-generation hormonal therapy (abiraterone acetate). Its
ability to serve as a treatment for patients with deleterious or
suspected deleterious BRCA-mutated, metastatic castration-resistant
prostate cancer (mCRPC) should help to fullfil the need for more
effective treatments.
RSVpreF (ABRYSVO™/PF-06928316) and RSVpreF3
(AREXVY/GSK-3844766A), developed by Pfizer Inc (ABRYSVO) and GSK
plc (AREXVY)
Respiratory syncytial virus (RSV) infections continue to be a
public health concern, particularly for infants and older adults
(65 years and older). A common upper respiratory infection that can
result in hospitalizations in severe cases, RSV infection tends to
be seasonal and present with symptoms similar to those of influenza
and COVID-19. The first approvals of RSV vaccines (RSVpreF and
RSVpreF3) targeted at infants and older adults mark a significant
public health milestone.
Talquetamab (TALVEY™), developed by Johnson & Johnson
Innovative Medicine
After receiving conditional and accelerated approval from the
European Commission and FDA, respectively, talquetamab became the
first-in-class bispecific antibody targeted to CD3 and GPRC5D to
treat multiple myeloma. It was approved based on the pivotal phase
1/2 MonumenTAL-1 trial for heavily pretreated patients with
relapsed or refractory (R/R) multiple myeloma. Ongoing phase 3
trials are expected to provide confirmation of clinical benefit in
talquetamab's approved setting and lead to label expansions in
other multiple myeloma patient populations, including in
combination with other approved agents. Talquetamab is poised as an
important addition to the treatment armamentarium for this
incurable, often-relapsing disease.
Zolbetuximab (IMAB362), developed by Astellas Pharma
Inc
Metastatic HER2-negative gastric and gastroesophageal junction
(GEJ) adenocarcinoma is notoriously difficult to treat and has a
significant unmet need for new efficacious treatments. In contrast
to HER2-positive disease (for which HER2-targeted agents such as
trastuzumab [Genentech] and ENHERTU [Daiichi Sankyo] are
available), targeted treatment options are more limited for
HER2-negative patients. Zolbetuximab would address some of that
unmet need as a first-in-class claudin 18.2 (CLDN18.2) inhibitor in
oncology as well as first-line metastatic HER2-negative gastric or
GEJ adenocarcinoma.
New technology platforms that are likely to achieve
significant proof of medical use in the market in 2024 include
CRISPR-Cas9 gene-editing as well as artificial intelligence
(AI)/machine learning (ML) tool applications in drug discovery,
clinical development and commercial launch. In the long run, the
latter technologies hold enormous potential to help drugmakers cut
costs and shorten innovation cycles, enabling the delivery of more
innovative drugs to patients faster going forward.
Access the Drugs to Watch 2024 report from Clarivate,
here.
For more Drugs to Watch updates and analyses throughout the
year, visit the Drugs to Watch web page and follow Clarivate for
Life Sciences & Healthcare on LinkedIn and X. Join the
conversation, using #DrugstoWatch2024.
To learn more about how Clarivate can help healthcare companies
inform and shape the drug discovery, development and delivery
process, visit
https://clarivate.com/industries/life-sciences-and-healthcare.
Methodology for the Clarivate Drugs to Watch 2024
Report
To identify this year's Drugs to Watch, Clarivate drew from the
expertise of over 160 analysts covering hundreds of diseases,
drugs and markets, along with 11 integrated data sets that span the
R&D and commercialization lifecycle,
including: Cortellis Competitive
Intelligence™, Disease Landscape &
Forecast, BioWorld™, Drug Timeline & Success
Rates, Cortellis Clinical Trials Intelligence™, Cortellis
Generics Intelligence™, Cortellis Deals
Intelligence™, Access & Reimbursement payer
studies, Clarivate Real World Data and Analytics, Web of
Science™ Derwent Innovation™, and other industry
sources including biopharma company press releases, filings and
peer-reviewed publications. Candidate drugs in phase 2 or phase 3
trials, at pre-registration or registration stage, or already
launched in 2023 were selected for analysis, including both novel
treatments and already-marketed drugs pursuing new indications that
could be particularly impactful. Drugs launched prior to 2023 were
excluded. The dataset was filtered for drugs that had total
forecast sales of $1 billion or more by 2029. Clarivate
experts and analysts evaluated each drug in its individual context,
based on factors such as expected approval or launch dates,
competitive landscape, regulatory status, trial results, market
dynamics and other key factors, and added novel drugs that, while
likely to fall short of blockbuster status, are poised to be
therapeutic game-changers.
Please note that Clarivate analysts generated the data shown in
this report prior to December 31, 2023. The Drugs to Watch
2024 Report and the treatments referenced in this release are based
on Clarivate's current expectations per existing data, but actual
results derived from the drugs named in the report and here may
differ significantly.
Clarivate is committed to comprehensively supporting customers
across the entire drug, device and medical technology lifecycles to
advance human health. By combining patient journey data,
therapeutic area expertise, artificial intelligence and analytics
in ways that unlock hidden insights, data-driven decisions and
accelerating innovation, Clarivate's end-to-end research
intelligence is designed to enable customers to make informed
evidence-based decisions.
About Clarivate
Clarivate is a leading global information services provider. We
connect people and organizations to intelligence they can trust to
transform their perspective, their work and our world. Our
subscription and technology-based solutions are coupled with deep
domain expertise and cover the areas of Academia & Government,
Life Sciences & Healthcare and Intellectual Property. For more
information, please visit clarivate.com.
Media Contact:
Catherine
Daniel
Director, External Communications, Life Sciences &
Healthcare
newsroom@clarivate.com
Logo -
https://mma.prnewswire.com/media/1159266/Clarivate_Logo.jpg
View original
content:https://www.prnewswire.co.uk/news-releases/clarivate-identifies-thirteen-potential-blockbuster-drugs-and-gamechangers-in-annual-drugs-to-watch-report-302027302.html