Medicines that Treat High Prevalence Conditions Offer Hope to Many as the Annual Drugs to Watch List from Clarivate Identifies 11 New Blockbusters…

Cortellis identifies new drugs for treating indications for breast cancer, lymphoma, multiple sclerosis (MS) and migraine touted for commercial and clinical success

PHILADELPHIAand LONDON , Feb. 10, 2020 /CNW/ --Clarivate Analytics plc (NYSE: CCC; CCC.WS), a global leader in providing trusted insights and analytics to accelerate the pace of innovation, today announced the launch of its annual Cortellis "Drugs to Watch " list, which identifies 11 new drugs that are scheduled to enter the market in 2020 and predicted to achieve annual sales of$1 billionor more (i.e., blockbuster status) by 2024.

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The Cortellis team at Clarivate Analytics has applied its proprietary technologies, tools and techniques, to produce the list of potential drugs for inclusion from drugs that advanced to phase II trials or beyond in early 2020. Each drug was subsequently scrutinized by in-house analysts - researched and evaluated in its individual context by interrogating annual filings, drug pipelines, clinical trials, patents, chemistry, deals, conferences and company announcements and regulatory status.

This year, editors and writers from award-winning life sciences news service BioWorld have examined the various disease landscapes from all angles, analyzed the pricing strategies, explored the science underpinning the new medicines to provide reality checks via the ultimate test: patients and advocacy groups who will seek beneficiary outcomes from the new drugs entering the market in 2020.

The list and corresponding analyses focus on the treatment and possible cure for chronic, progressive and often debilitating diseases and conditions, including drugs which target the indications of breast cancer, multiple sclerosis (MS), migraine and type 2 diabetes.

The drugs listed have been almost universally accelerated in their development by orphan drug status or other designation intended to speed their path to market. There is a high level of expectation of commercial success for each of these drugs - despite the fact that most medicines on the list are entering or are poised to enter markets already crowded with competitors, meaning they'll face substantial pressures to differentiate themselves. Many are expected to tout improved safety vs. alternative therapies, especially regarding cardiovascular risk, while others will seek to highlight novel mechanisms of action or even curative potential.

More than half of the medicines on the list are biologics, a fast-growing and increasingly expensive segment of prescription medicines for which regulators and payers alike have sought to rein in costs during recent years. Gene and cell therapies represented on this year's list by hemophilia A therapy Valrox (Biomarin Pharmaceutical, Inc.) and lisocabtagene maraleucel (Bristol-Myers Squibb Co) for large B-cell lymphoma, respectively have drawn particular attention for their high costs. If approved, Valrox will be crowned as the first potential curative approach for severe hemophilia A. The one-and-done therapy will be transformative as it corrects the genetic defect underlying the condition and eliminates the need for blood transfusions and FVIII replacement therapy. If, as expected, it takes a leadership position it could become the most expensive drug ever to reach the market with a cost of $2.5 million $3 million per treatment.

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Lynn Yoffee , News Director, BioWorld, "Despite the ongoing tension among scientific innovation, commercial motive and public good, as medical research and the pursuit of innovative medicines continues to accelerate, the success of these drugs will bring hope to many if they can afford them - and seek to provide the benefits of novel mechanisms of action alongside curative potential."

The full list and analysis are freely available online at:www.bioworld.com/drugstowatch2020

Join the conversation on Twitter: @BioWorld @Cortellis #DrugstoWatch2020

The Cortellis Drugs to Watch 2020:

Name(s)

Developer(s)

Indication

Mechanism of action

Route of administration

Rimegepant (BHV-3000)

Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn.

Migraine

CGRP antagonist

Oral and buccal

OMB-157 (ofatumumab sc)

Novartis AG, of Basel, Switzerland

Multiple sclerosis

Anti-CD20 (MAb)

Subcutaneous injection

Ozanimod (RPC-1063)

Celgene Corp., of Summit, N.J. (subsidiary of Bristol-Myers Squibb)

Multiple sclerosis

S1P1 and S1P5 receptor agonist

Oral

Vadadustat

Akebia Therapeutics Inc., of Cambridge, Mass., Mitsubishi Tanabe Pharma America Inc., of Jersey City, N.J., Otsuka Pharmaceutical Co., of Tokyo

Anemia due to chronic kidney disease

HIF-PH inhibitor

Oral

Valrox (valoctocogene roxaparvovec; BMN-270)

Biomarin Pharmaceutical Inc., of San Rafael, Calif.

Hemophilia A

FVIII gene therapy (via AAV5 vector)

Intravenous infusion

Filgotinib (GLPG-0634)

Gilead Sciences Inc., of Foster City, Calif., NV, of Mechelen, Belgium

Rheumatoid arthritis

JAK1 selective inhibitor

Oral

Rybelsus (semaglutide, oral, once daily)

Novo Nordisk A/S, of Bagsvaerd, Denmar

Type 2 diabetes mellitus

Long-acting GLP-1 analog

Oral

Inclisiran (ALN-PCSsc; ALN-60212; PCSK9si)

The Medicines Co., of Parsippany, N.J. (subsidiary of Novartis)

Hypercholesterolemia

PCSK9 small interference RNA (siRNA)

Subcutaneous injection

Sacituzumab govitecan (IMMU-132)

Immunomedics Inc., of Morris Plains, N.J., Medicine Inc., of New York

Metastatic triple-negative breast cancer

Anti-TROP2-SN38 ADC

Intravenous infusion

Enhertu (trastuzumab deruxtecan; DS-8201a)

Daiichi Sankyo Co. Ltd., of Tokyo, Astrazeneca plc, Cambridge, U.K.

Unresectable or metastatic HER2-positive breast cancer

Anti-HER2-exatecan ADC

Intravenous infusion

Liso-cel (JCAR-017; lisocabtagene maraleucel)

Celgene, of Summit, N.J. (subsidiary of Bristol-Myers Squibb Co., of Princeton, N.J.)

Large B-cell lymphoma

Anti-CD19 CAR T-cell therapy

Intravenous infusion

Methodology for the Cortellis Drugs to Watch 2020 Data for this list were compiled from Cortellis, the suite of life sciences intelligence solutions from Clarivate Analytics. Cortellis 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. Drugs in phase 2 or phase 3 trials, at pre-registration or registration stage, or already launched early in 2020 were selected for analysis; drugs launched prior to 2020 were excluded. The dataset was then filtered for drugs that had total forecast sales of $1 billion or more in 2024. 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 2020, based on factors such as the company's expected approval or launch dates. Following this manual review, 11 drugs to watch for 2020 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). Sources used included SWOT analyses compiled by Cortellis editors, biopharma company press releases and other publications (e.g., annual filings), peer-reviewed publications and Cortellis sales data (sourced from Refinitiv I/B/E/S). Data extraction January 20 th, 2020.

About Cortellis Cortellis,a Clarivate Analytics solution, gives life to science by unlocking the hidden insights in data by curating broad and deep sources of intelligence to enable precise, actionable answers to specific questions across the R&D lifecycle from discovery and clinical development through regulatory submission and commercialization. By supporting data-driven decisions,Cortellishelps pharmaceutical companies, biotech and medical device/diagnostic firms accelerate innovation.

About BioWorld BioWorld's suite of news services delivers actionable intelligence on the most innovative therapeutics and medical technologies in development. With writers and editors stationed around the globe,BioWorldreports the breaking news and provides key perspective on hundreds of therapeutics and devices in development, the companies behind those candidates, the business development transactions that evolve the markets, and the regulatory hurdles that both challenge and guard the processes.

About Clarivate Analytics Clarivate Analytics is a global leader in providing trusted insights and analytics to accelerate the pace of innovation. We have built some of the most trusted brands across the innovation lifecycle, including the Web of Science, Cortellis, Derwent, CompuMark, MarkMonitor and Techstreet. Today, Clarivate Analytics is on a bold entrepreneurial mission to help customers reduce the time from new ideas to life-changing innovations. For more information, please visit clarivate.com.

Forward-Looking Statements This press release and oral statements included herein may contain forward-looking statements regarding Clarivate Analytics. Forward-looking statements provide Clarivate Analytics' current expectations or forecasts of future events and may include statements regarding results, anticipated synergies and other future expectations. These statements involve risks and uncertainties including factors outside of Clarivate Analytics' control that may cause actual results to differ materially. Clarivate Analytics undertakes no obligation to update or revise the statements made herein, whether as a result of new information, future events or otherwise.

Clarivate and its logo, as well as all other trademarks used herein are trademarks of their respective owners and used under license.

If you would like to speak to one of our experts at Cortellis or BioWorld regarding this analysis please contact us: media.enquiries@clarivate.com

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Medicines that Treat High Prevalence Conditions Offer Hope to Many as the Annual Drugs to Watch List from Clarivate Identifies 11 New Blockbusters...