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, identifying drugs entering the market or launching key indications in 2022 which are predicted to achieve blockbuster status by 2026.  Leveraging Clarivate data and insights, analysts identified seven late-stage experimental treatments that they forecast will deliver annual sales of more than $1 billion within five years. These treatments span a remarkably diverse set of therapeutic areas, from conditions like Alzheimer's disease (AD), asthma and type 2 diabetes mellitus (T2DM), which afflict tens of millions of patients worldwide, to rare diseases, such as transthyretin amyloidosis (ATTR), among others.

The report also offers an in-depth analysis of key COVID-19 vaccines and therapies along with key therapeutic development areas to watch, such as cell and gene therapies, CRISPR, drug discovery driven by artificial intelligence and machine learning, RNA and targeted cancer therapies. In addition, the report examines blockbuster drugs and biologics facing generic competition due to U.S. patent expirys in 2022.

Navigating the global healthcare landscape is increasingly complex, and discovering, developing and commercializing successful treatments that change patient lives can be challenging, especially during today's unprecedented times. The Drugs to Watch report highlights experimental treatments with great promise to realize improved patient outcomes and efforts to finance the next generation of innovative medicines. Through adaptation, improvisation and crowdsourcing solutions, the companies behind these promising treatments are advancing a broad array of innovative treatment candidates – leveraging deep expertise in their relevant therapeutic areas and long-term strategies for pursuing therapeutic solutions for these conditions.

• Among new drugs and biologics that have either won approval or are poised to do, Clarivate has identified seven treatments that it believes are likely to achieve blockbuster status in the next five years. The 2022 Drugs to Watch, include: 

• Adagrasib, developed by Mirati Therapeutics Inc and Zai Lab Limited - This long-awaited, targeted treatment will likely be the first such treatment option in patients with colorectal cancer (CRC) with the KRASG12C mutation, who historically have had very few treatment options. The common variants of the KRAS oncoprotein are traditionally considered intractable drug targets which makes the forecasted entry of a KRAS inhibitor for patients with mutation-positive solid tumors so monumental.

• Faricimab, developed by Roche and Chugai Pharmaceutical - For patients with diabetic macular edema (DME) or wet age-related macular degeneration (AMD), faricimab offers a potentially more convenient option as it will be administered less frequently, on average, than the standard of care. As the first bispecific antibody to launch in ophthalmology, it also has the potential to be more efficacious than current standard of care, although data so far indicates it is non-inferior to the standard of care. Faricimab is the first dual VEGF/Ang-2 inhibitor to treat DME and wet AMD (and the first bispecific MAb in the ophthalmology therapeutic area overall).

• Lecanemab, developed by Eisai Co Ltd and Biogen Inc, and donanemab, from Eli Lilly and Company - In this underserved market, anti-Aβ MAbs lecanemab and donanemab are poised to follow on the heels of the U.S. FDA's landmark accelerated approval of ADUHELM for the treatment of AD. Lecanemab and donanemab could offer differentiated clinical profiles, which may be bolstered by phase 3 results that are expected to be reported beginning in late 2022. Data across clinical trials suggest that sufficient exposure to optimal doses of anti-Aβ MAb therapy could be clinically effective in early AD.

• Tezepelumab, developed by Amgen and AstraZeneca - Tezepelumab is a potential game changer for patients with non-TH2 or TH2-low asthma whose asthma is not well-controlled with inhaled corticosteroids, the current standard of care. If approved, it would be a first-in-class biologic for this patient population. Tezepelumab will likely be a first-line biologic for severe TH2-low asthma and a treatment option for patients with TH2-high asthma for whom existing therapies have been less successful.

• Tirzepatide, developed by Eli Lilly and Company - Tirzepatide offers indication-leading reductions in weight loss and improvements in glycemic control in a growing patient population, which has the potential to reduce the incidence of type 2 diabetes mellitus (T2DM)-related complications. A new treatment that can more effectively address both weight loss and glycemic control than existing treatments would potentially be of great benefit to patient outcomes.

• Vutrisiran, developed by Alnylam Pharmaceuticals - For a progressive disease with a lot of unmet need, this drug brings efficacy, a generally favorable safety profile, and improvements in delivery that will benefit patient quality of life. This patient population has few treatment options, especially for those with wild-type ATTR. Not only does this drug enter a relatively underserved market overall, it also has more convenient dosing than other ATTR-specific drugs on the market.

Mike Ward, Global Head of Life Sciences and Healthcare Thought Leadership, Clarivate: "While pharmaceutical and biotech companies have invested substantial intellectual capital in the past two years tackling the challenges wrought by COVID-19, they have also continued to harness new technologies to create medicines that will provide options for patients with poorly or currently untreatable diseases that still represent a significant medical burden. This year's drugs-to-watch picks, as well as the technologies-to-watch selections, highlight the robust innovation that is at the heart of the pharma and biotech sector and will underpin better outcomes for patients in the future."

Despite the COVID pandemic having disrupted the drug industry in many ways, from supply chain collapse-induced shortages of key components1 to clinical trial delays2, pharma and biotech companies continue to drive major advances in medicine. Drugmakers are making great strides towards unlocking technologies that will facilitate personalized medicines. Regulators are showing an openness to new technologies and methodologies and an eagerness to address diseases for which there are few or no treatments.  However, it remains critical for companies to prove their value to win market approval and make them accessible to patients.

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.

The full Drugs to Watch Report is freely available online 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 Twitter and LinkedIn. #DrugstoWatch2022

Methodology for the Clarivate Drugs to Watch 2022 Report

To identify this year's Drugs to Watch, we drew from the expertise of over 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 ScienceTM, 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 2021 were selected for analysis, including drugs launched for a new indication that could be particularly impactful on the industry; drugs launched prior to 2021 were excluded. The dataset was filtered for drugs that had total forecast sales of $1 billion or more by 2026. 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.  Please note that Clarivate analysts generated the data shown in this report prior to December 24, 2021.The Drugs to Watch 2021 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 identified in the Report and herein may differ significantly.

To learn more about how the evolving R&D landscape creates many new opportunities and challenges to the traditional blockbuster model, join Michael Ward and Kenneth Beers of Clarivate on January 20, 2022 for a presentation on "R&D in an Age of Multiplying Modalities and Targets," during 2022 Fierce JPM Week. Visit https://www.fiercejpmweek.com/ for more information.

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

About Clarivate?? 

Clarivate? is a global leader in providing solutions to accelerate the lifecycle of innovation. Our bold mission is to help customers solve some of the world's most complex problems by providing actionable information and insights that reduce the time from new ideas to life-changing inventions in the areas of science and intellectual property. 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.?? 

1 Source: Regulatory response to the COVID-19 pandemic: Careful planning to minimize disruptions. Clarivate. 2021. https://clarivate.com/blog/regulatory-response-to-the-covid-19-pandemic-careful-planning-to-minimize-disruptions/
2 Source: Delays in clinical trials present opportunities for pharma companies to evolve. Clarivate. 2021. https://clarivate.com/blog/delays-in-clinical-trials-present-opportunities-for-pharma/

Source: Clarivate Plc