Janus Kinase (JAK) Inhibitors - Pipeline Analysis 2019, Clinical Trials and Results, Patents, Designations, Collaborations, and Other Developments

Overview

JAK consists of four intracellular non-receptor tyrosine kinases that help in cytokine mediated signaling through the JAK-STAT pathway. It contains two almost identical phosphate transferring domains in which one domain shows kinase activity and the other regulates the activity of the first via negative inhibition.

The four receptors in the JAK family are JAK1, JAK2, JAK3, and tyrosine kinase 2 (TYK2). The mutation in any of these can lead to various medical conditions. The JAK inhibitors block cytokine mediated signaling via JAK-STAT pathway which plays an important role in immune regulation and growth.

As per the current scenario, drug developers are actively collaborating with other copmpanies to expand their pipeline portfolio for the treatment of diseases targeting the JAK-STAT pathway. For instance, Innovent Biologics Inc. and Incyte Corporation entered into a collaboration agreement in December 2018. Under the terms of this agreement, Innovent Biologics Inc. gained rights to develop and commercialize itacitinib (JAK inhibitor) and two other drugs in Mainland China, Hong Kong, Macau, and Taiwan.

In addition, inhibition of JAKs has shown potential in dermatology-based diseases and since, none of the three marketed JAK inhibitors are approved in this therapy area, it brings opportunity for the pipeline players to expand their horizon. A number of companies are already conducting clinical studies for dermatologic conditions. Some have also been granted drug designations by the United States Food and Drug Administration (USFDA) and European Medicines Agency (EMA) to accelerate their development process. For instance, Pfizer Inc.’s PF-06700841 and Concert Pharmaceuticals Inc.’s CTP-543 have been granted Breakthrough Therapy Designation and Fast-Track Designation for the treatment of alopecia areata, respectively.

Key Drivers

Positive clinical trial results and strategic decisions of the players to collaborate with other companies are facilitating the growth of the pipeline. Additionally, the issuance of patents helps in achieving different milestones in the form of grants and designations from the regulatory bodies and institutes including the USFDA, the EMA, and the National Institutes of Health (NIH) among others.

However, it has been observed that the nature of JAK inhibitors is quite specific and requires inputs from manufacturers, pharmacists, or scientists who have expertise in this domain. Therefore, hiring these experts increases the overall R&D expenditure of the company, thereby, causing hindrance in the drug development process.

Pipeline Analysis

The JAK inhibitors pipeline currently comprises of 45 therapeutic candidates in different stages of development.

Competitive Landscape

Some of the key players involved in the development of JAK inhibitors in the late stage include Pfizer Inc., Eli Lilly and Company, Incyte Corporation, AbbVie Inc., CTI BioPharma Corp., LEO Pharma A/S, Astellas Pharma Inc., Sierra Oncology Inc., and Galapagos NV.

The report comprises of detailed pipeline analysis of therapeutics being developed for targeting the JAK/STAT pathway, thereby estimating and analyzing the emerging therapies and their progress status in different phases of development. Comprehensive insights into the pipeline phase products has been provided with special focus on strategic development activities inclusive of collaboration and licensing agreements, drug designations, financing, grants, technological advancements, patent, and upcoming conferences. In addition, the report highlights the winning strategies of the companies involved in the development of JAK inhibitors followed by analyst views. Detailed regulatory approval procedures in the U.S., Europe, and Japan are also a part of this report. Furthermore, the report contains competitive analysis and extensive information on monotherapies, combination therapies, targets and mechanism of action, and drug origin with relevance to JAK inhibitors.