Clarivate Plc (NYSE:CLVT), a global leader in providing trusted information and insights to accelerate the pace of innovation, today announced the launch of its annual “Drugs to Watch” list, identifying drugs entering the market or launching key indications in 2021 which are predicted to achieve blockbuster status by 2025.
Beyond the unprecedented achievements of the industry’s response to COVID-19, drug developers have advanced milestone treatments for conditions affecting millions of patients worldwide. This year’s Drugs to Watch list and corresponding analyses focus on treatments for chronic, progressive and often debilitating diseases and conditions, including Alzheimer’s, prostate cancer and congestive heart failure.
Despite a challenging year, biopharma companies managed to produce highly-effective vaccines and treatments aimed at preventing SARS-CoV-2. This year’s Drugs to Watch report also features a snapshot of the fast-emerging field of COVID-19 vaccines which analyzes vaccines that were granted emergency use authorizations/conditional approvals as of February 10, 2021. Learnings from some of the adjustments the industry made in response to the COVID-19 pandemic will likely shape biopharma R&D and commercialization well beyond the immediate crisis, including: faster clinical trials, a surge in investment, increased collaboration and more remote care and consultation.
Among new drugs and biologics that have either won approval or are on the cusp of doing so, Clarivate has identified four treatments that are likely to achieve blockbuster status, delivering annual sales of more than $1 billion, within five years. The 2021 Drugs to Watch include:
- Aducanumab, developed by Biogen and Eisai – a potential game changer in the fight to build a pharmacopeia against Alzheimer’s disease, which affects an estimated 50 million patients worldwide. If approved, aducanumab would be the first disease-modifying therapy for Alzheimer’s disease and could unlock a monumental opportunity to radically change patient care and transform the market. In addition, demand for treatment could be enormous, potentially even decreasing willingness to forgo this treatment for an investigational drug in future clinical trials.
- Bimekizumab, developed by UCB – offers significantly fewer side effects to patients with psoriasis, a condition affecting an estimated 2-3% of the global population, and a host of other autoimmune diseases. While bimekizumab is a late-class entrant providing incremental improvement over existing treatment options, it is expected to have best-in-class efficacy and fewer serious side effects.
- Relugolix, developed by Takeda – one of the first of a new class of treatments, with an oral formulation to address prostate cancer, the second-most-common malignancy afflicting men, as well as endometriosis and uterine fibroids, painful conditions affecting millions of women. Its potential use for three indications increases its chances of success. The oral formulation provides advantages over the injectable GnRH agonist competitors, including convenience and better management of side effects.
- Vericiguat, developed by Bayer and Merck – an innovative heart failure treatment and the first indicated specifically for high-risk, chronic heart failure with reduced ejection fraction (HFrEF), a particularly at-risk population. Vericiguat’s novel mechanism of action should result in its acceptance as an add-on therapy to existing treatments. It will likely find its niche among high-risk HFrEF patients, become a welcome addition to the treatment armamentarium and expand their treatment options.
Mike Ward, Global Head of Thought Leadership, Life Sciences and Healthcare, Clarivate, said: “In the last five years we have seen an increase in approvals of innovative medicines at a rate more than double what it was a decade ago. A number of drivers have aligned to achieve this improvement, including greater insight into the biological roots of diseases, oncology research benefiting from the routine introduction of biomarkers to better target therapies, the emergence of gene and cell therapies and efforts by regulatory agencies to introduce processes to accelerate medicine assessment.”
Clarivate leverages proprietary data and insights from Cortellis Competitive Intelligence, Disease Landscape & Forecast, and Drug Timeline & Success Rates as well as 1000s of data points from within its wider intelligence cloud to produce the annual list of potential drugs for inclusion –from drugs that advanced to phase II trials or beyond in 2021. Each drug was researched and evaluated in its individual context by interrogating annual filings, drug pipelines, clinical trials, patents, chemistry, deals, regulatory status and more. Therapy area experts across a wide range of markets examined the various disease landscapes from all angles, reviewed the pricing strategies and explored the science underpinning the new medicines.
There is a high level of expectation of commercial success for each of the drugs featured in this year’s list, with some expected to tout improved safety vs. alternative therapies, while others will seek to highlight novel mechanisms of action. In addition to driving future innovation, these treatments have the potential to advance human health, redefine standards of care in their categories and save or improve patient lives.
Clarivate is committed to comprehensively supporting customers across the entire drug, device and medical technology lifecycles to advance human health. The new annual report further demonstrates how the combined expertise, data and technologies of Clarivate and Decision Resources Group (DRG), acquired by Clarivate in 2020, enable customers to make informed evidence-based decisions, boost clinical and commercial success, and bolster a robust, integrated platform of life science intelligence solutions from pre-clinical and clinical offerings.
The full Drugs to Watch report is freely available online here.
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The 2021 Clarivate Drugs to Watch List:
Methodology for the Clarivate Drugs to Watch 2021 Report
Data for this list were compiled from Cortellis Competitive Intelligence, Disease Landscape & Forecast, and Drug Timeline & Success Rates. Cortellis Competitive Intelligence includes the broadest and deepest range of sources of intelligence across the R&D lifecycle, including annual filings, drug pipelines, clinical trials, patents, chemistry, deals, conferences and company announcements. Disease Landscape & Forecast provides comprehensive market intelligence and actionable insights across 180+ indications to help optimize long-term disease strategies. Drug Timeline & Success Rates is an analytic tool that applies statistical modeling and machine learning to reliably and accurately forecast drug development milestones, timelines and probability of success. Drugs in phase 2 or phase 3 trials, at pre-registration or registration stage, or already launched early in 2021 were selected for analysis; drugs launched prior to 2021 were excluded. The dataset was then filtered for drugs that had total forecast sales of $1 billion or more in 2025. This filtering process produced a list of drugs which was then manually reviewed by our in-house experts and consultants to determine whether these products were likely to go to market in 2021, based on factors such as the company’s expected approval or launch dates. Following this manual review, four drugs to watch for 2021 were determined. Each drug was subsequently researched and evaluated in its individual context, including clinical trial results, regulatory status, the market for each drug (including analysis of competitor drugs) and regulatory designations (e.g., Orphan Drug, Priority Review). Data extraction – January 21, 2021. Our Drugs to Watch 2021 Report is based Clarivate’s current expectations based on existing data, but actual results derived from the drugs identified in the Report may differ significantly.