Clarivate Identifies Fifteen Potential Blockbuster Drugs in Annual Drugs to Watch Report

Report highlights personalized medicines ensuring greater efficacy for rare diseases and previously untreatable conditions

Promising therapeutic developments for HIV,Parkinson's disease,Crohn's disease,alopecia,multiple myeloma and breast cancer on horizon

LONDON,Jan. 10,2023 --Clarivate Plc(NYSE:CLVT),a global leader in providing trusted information and insights to accelerate the pace of innovation,today announced the release of its annual Drugs to Watch™report. In its 10th year,the Drugs to Watch report provides in-depth predictive analysis of drugs with the potential to transform treatment paradigms and serve unmet patient needs. The report serves as a key industry resource in an ever-evolving drug innovation landscape - with more than 70 drugs having been identified as Drugs to Watch. This year's analysis identifies drugs entering the market or launching key indications in 2023 which are predicted to achieve blockbuster status by 2027 or be clinical game changers for millions of patients worldwide. Clarivate analysts identified 15 late-stage experimental treatments that are each forecast to deliver annual sales of more than $1 billion within five years. These promising advancements include a broad spectrum of therapeutic developments for rare diseases and tough-to-treat conditions,including HIV,multiple myeloma and breast cancer.

The Drugs to Watch 2023 list from Clarivate primarily features treatments targeted to a particular biomarker,ensuring greater efficacy and less precious time lost searching for a drug or biologic that will arrest or reverse the progress of disease. Personalized medicines have begun to evolve from promise to reality,accounting for more than 25% of FDA approvals for the last seven years1. The rise of personalized medicine has resulted in success beyond oncology and rare diseases,facilitating therapies for formerly untreatable conditions.

The report also highlights potential blockbusters in Mainland China. Clarivate identified nine drugs that are likely to achieve $1 billion in Mainland China by 2030,including both global and domestically manufactured assets. Of the nine selected,eight are oncology drugs,reflecting healthcare reforms under Healthy China 20302that have placed a focus on addressing the increasing cancer burden in Mainland China.

In addition,the report examines the industry's progress in addressing the diseases highlighted in the United Nations Sustainable Development Goals. These goals address infectious diseases such as tuberculosis,malaria,neglected tropical diseases and water-borne diseases,as well as maternal mortality and non-communicable diseases like mental illness and substance abuse.

Among new drugs and biologics that have either won approval or are poised to,Clarivate has identified 15 treatments likely to achieve blockbuster status in the next five years or transform paradigms to meet unmet patient needs. The2023 Drugs to Watch,are:

Bimekizumab (BIMZELX®) developed by UCB- Bimekizumab is the first dual IL-17 A/F inhibitor to treat moderate to severe plaque psoriasis. Phase 3 trial results showed superior skin clearance outcomes than existing treatments. Its less-frequent dosing schedule and good safety profile will likely be attractive to clinicians and patients.

Capivasertib (AZD5363) developed by AstraZeneca- For patients with breast cancer,Capivasertib is a novel,highly potent,selective ATP-competitive pan-AKT kinase inhibitor that exerts similar activity against the three isoforms AKT1,AKT2 and AKT3. Positive data have emerged from early-phase trials,with clinical benefit to patients irrespective of their PIK3CA/AKT1/PTEN mutational status,and several phase 3 trials are now underway.

Daprodustat (GSK1278863/Duvroq) developed by GSK plc.- Daprodustat belongs to a novel class of oral treatments for chronic kidney disease (CKD)-related anemia and is a HIF-PHI developed to treat anemia associated with CKD,which has a high incidence rate and few effective,safe treatment options. Already available for CKD-related anemia in Japan,its uptake has been impressive.

Deucravacitinib (SOTYKTU™/BMS-986165) developed by Bristol Myers Squibb- As a first-in-class oral,targeted agent that selectively inhibits tyrosine kinase 2 (TYK2),a Janus kinase (JAK) family member that mediates cytokine-driven immune and inflammatory signals,it has the potential to fill a gap in the treatment armamentarium for plaque psoriasis.

Foscarbidopa/foslevodopa (ABBV-951) developed by AbbVie- Foscarbidopa/foslevodopa is a novel reformulation of the gold-standard Parkinson's disease treatment (carbidopa/levodopa) delivered via a subcutaneous pump for the treatment of motor fluctuations in advanced Parkinson's disease. In addition to serving a niche group of patients with high unmet need,it offers better efficacy than orally administered carbidopa-levodopa,dosing flexibility and a more convenient pump than existing and upcoming competitors.

LEQEMBI™ (BAN2401) developed by Eisai Co Ltd and Biogen Inc,and Donanemab (LY-3002813),developed by Eli Lilly and Company- LEQEMBI and Donanemab are poised to help treat early-stage Alzheimer's disease. Supported by landmark clinical data from a phase 3 trial,next-in-class anti-Aβ monoclonal antibody (MAb) LEQEMBI has recently received accelerated approved by the U.S. and has ex-U.S. launches. Donanemab,and others in the class (e.g.,Roche's gantenerumab),may follow suit pending the results of ongoing trials.

Lenacapavir (Sunlenca®/GS-6207) developed by Gilead Sciences Inc.- Approved in Europe and under evaluation by the U.S. Food and Drug Administration (FDA),lenacapavir is the first-in-class,long-acting HIV-1 capsid inhibitor approved to treat multi-drug resistant (MDR) HIV in people who have been heavily treated,a patient population with unmet medical need. Also currently being investigated to treat HIV and for pre-exposure prophylaxis (PrEP),its infrequent dosing and self-administration will likely make it a favored choice in a population with treatment adherence challenges.

Mirikizumab (LY-3074828) developed by Eli Lilly and Company -Mirikizumab,a monoclonal antibody targeting the p19 subunit of IL-23,will likely be first-in-class for ulcerative colitis and the third in the class approved for Crohn's disease. Part of a set of emerging therapies with novel mechanisms of action,it will contribute to the growing market share held by these therapies. 

Pegcetacoplan (EMPAVELI®/ASPAVELI®/APL-2) developed by Apellis Pharmaceuticals Inc. - Pegcetacoplan has launched already in the United States and Europe for Paroxysmal nocturnal hemoglobinuria (PNH),a rare hematological disease. As one of the few drugs to have completed phase 3 trials for GA,pegcetacoplan is expected to be the first drug to launch for geographic atrophy (GA)or "dry late age-related macular degeneration (AMD)," which has no approved pharmacotherapy.

Ritlecitinib (PF-06651600) developed by Pfizer Inc.- Ritlecitinib will likely benefit from its first-in-class status,rapid onset of action and expected label for both adults and adolescents,potentially providing an effective option to stimulate hair growth in a stigmatizing disease - Alopecia areata.

Sparsentan developed by Travere Therapeutics Inc - Sparsentan is a first-in-class,orally active,single molecule that functions as a high-affinity,dual-acting antagonist of both endothelin type A (ETA) and angiotensin II subtype 1 (AT1) receptors,which are associated with progression of kidney disease. Its development for IgA nephropathy and focal segmental glomerulosclerosis (FSGS) promises to halt that progression for many patients and fills a gap in the treatment armamentarium.

Teclistamab (TECVAYLI®/JNJ-64007957) developed by Janssen Pharmaceutical Companies of Johnson & Johnson - After receiving conditional approval from the EC (European Commission),teclistamab is the first-in-class bispecific antibody targeted to B-cell maturation antigen (BCMA) to treat multiple myeloma. Ongoing phase 3 trials are expected to provide confirmation of clinical benefit in teclistamab's approved setting and lead to label expansions in other multiple myeloma patient populations,including in combination with other approved agents.

Teplizumab (TZIELD™/PRV-031) developed by Provention Bio Inc- Teplizumab is the first immunotherapy to launch for T1DM and is a landmark drug given its potential ability to preserve beta cell function and delay the need for insulin treatment in those with type 1 diabetes mellitus (T1DM).

Valoctocogene roxaparvovec (ROCTAVIAN™/BMN-270) developed by BioMarin Pharmaceutical Inc - Approved by the European Commission (EC) in August 2022,valoctocogene roxaparvovec is also poised to be the first gene therapy to launch in the United States for severe hemophilia A. Treatment benefit is expected to last for years,reduce the number of bleeding events,minimize the need for replacement factor VIII (FVIII) and negate the use of otherwise burdensome prophylaxis treatment.

Mike Ward,Global Head of Life Sciences and Healthcare Thought Leadership,Clarivate:"While R&D productivity remained a challenge for pharma in 2022,the FDA only approved 37 NMEs during the year,we might expect the approval rate to recover in 2023 to pre-pandemic levels. While oncology remains a key focus for the industry,as the latest edition of Drugs to Watch shows,we can also expect to see approvals and launches for medicines in other disease areas."

Despite the many urgent challenges life science companies will face in 2023,from patent cliffs to capital investment,the industry is on the cusp of unlocking revolutionary technologies that could greatly advance human health.

Access the Drugs to Watch 2023 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 & Healthcareon LinkedInand Twitter. #DrugstoWatch2023.

To learn more about how Clarivate can help healthcare companies inform and shape the drug discovery,development and delivery process,join Dr. Robert Poolman on Tuesday,January 10,2023 for a presentation on integrating disparate datasets to maximize healthcare benefits for patients during 2023 Fierce JPM Week. For more information,visit: https://www.fiercejpmweek.com/fiercejpmweek/jpmweek-person-agenda.

To learn more about Clarivate data products,visit www.clarivate.com.

Methodology for the Clarivate Drugs to Watch 2023 Report

Increasingly,companies are targeting smaller patient populations with more targeted drugs,many of which will garner less revenue than the mass-market drugs that have traditionally formed the bread and butter of large pharmas but which stand to greatly advance patient care. Accordingly,Clarivate revised its methodology to recognize late-stage developmental therapeutics of clinical and commercial notes.

To identify this year's Drugs to Watch,Clarivate drew from the expertise ofover 160 analysts covering hundreds of diseases,drugs and markets and eleven 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 early in 2022 were selected for analysis,including those pursuing new indications that could be particularly impactful; drugs launched prior to 2022 were excluded. The dataset was filtered for drugs that had total forecast sales of $1 billion or more by 2027. 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 15,2022. The Drugs to Watch 2023 Report and the treatments referenced in this release are based on Clarivate's current expectations based on 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 global leader in providing solutions to accelerate the pace of innovation. Our bold mission information and insights that reduce the time from new ideas to life-changing inventions in the areas of Academia & Government,Life Sciences & Healthcare,Professional Services and Consumer Goods,Manufacturing & technology. We help customers discover,protect and commercialize their inventions using our trusted subscription and technology-based solutions coupled with deep domain expertise. For more information,please visit clarivate.com.

Media contact:

Catherine Daniel

Director External Communications,Life Sciences & Healthcare

newsroom@clarivate.com

1Source: The Personalized Medicine Coalition (PMC). PERSONALIZED MEDICINE AT FDA: The Scope & Significance of Progress in 2021. 2021. https://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/Personalized_Medicine_at_FDA_The_Scope_Significance_of_Progress_in_2021.pdf

2 Source: Peijie Chen,Fuzhong Li,Peter Harmer. Healthy China 2030: moving from blueprint to action with a new focus on public health. 2019. https://pubmed.ncbi.nlm.nih.gov/31493840/