Lilly's R&D Strategy: A Prescription for Growth

By Patricia Van Arnum - DCAT Editorial Director

May 25, 2016

At a recent investors' presentation, Eli Lilly and Company outlined its plan to potentially launch 20 new products through 2023/2024. In addition, Lilly could launch an average of two new indications or line extensions for already-approved products per year during that same time period.

Lilly's R&D efforts focus on five therapeutic areas: four core areas (diabetes, oncology, immunology and neurodegeneration) and one emerging area, pain. So what is behind Lilly's pipeline? DCAT Value Chain Insights (VCI) examines the potential. 

Pipeline progress
Table I (see end of article) outlines key recent developments in Lilly's late-stage pipeline.

Lilly's R&D efforts in diabetes focus on differentiated therapeutics and delivery devices within three key areas of unmet need: glucose control, metabolic control, and end-organ protection. The company aims to combine its in-house diabetes R&D capabilities with an external network to deliver continued innovation in this area of therapy. The company has four main R&D centers involved in diabetes research: Indianapolis, Indiana (preclinical and clinical diabetes and complications); Lilly Biotech Center, San Diego (protein engineering and structural biology); Lilly Cambridge Innovation Center (delivery and device R&D); and Lilly China R&D Center, Shanghai, China (dedicated diabetes clinical research). Key external partnerships include its diabetes alliance with Boehringer Ingelheim as well as with other partners (Adocia, Transition Therapeutics, TVM Capital, Beta Bionics, Glycostasis, Yabao, Companion Medical, and others). In 2015, the company had $4 billion in global insulin revenue, showing its strenght in this area.  

In oncology, the company has a balanced R&D approach across three key areas of disease modification: tumor-cell signaling, tumor microenvironment, and immuno-oncology. This approach allows for testing of combinations of internally derived agents to address tumor heterogeneity and drug resistance. Lilly has a portfolio of differentiated assets across these approaches, including Cyramza (ramucirumab), Portrazza (necitumumab), olaratumab and abemaciclib. Lilly's immuno-oncology portfolio will have five differentiated molecules in clinical testing by the end of 2016, and as many as 11 by the end of 2018, according to the company.

With the recent launch of Taltz (ixekizumab) and the submission of baricitinib for regulatory review, Lilly has designated immunology as the company's newest core therapeutic area. While these assets represent the foundational first wave of innovation, Lilly has built a pipeline of both internal assets and partnered molecules focusing on key pathways and interventions in multiple autoimmune diseases.In what it deems as its second-wave of innovation, the company's pipeline is based on antibodies, traditional oral new chemical entities, and biologics and includes assets with multiple possible indications, such as IL-23 Ab and BTKI.

In the area of neurodegeneration, treatment for Alzheimer's disease is a key area of focus with seven drugs in human testing. The company's Alzheimer's research includes disease prevention, detection, and treatment.

Pain is an emerging research area for Lilly, focusing on non-opioid treatment for chronic pain. The two late-stage innovative medicines currently in development are galcanezumab (CGRP Ab), being studied for cluster headache and migraine, and tanezumab, being studied for osteoarthritis pain, chronic lower back pain and cancer pain in partnership with Pfizer.

Table I: Eli Lilly and Company's Late-Stage Pipeline of New Molecular Entities and Diagnostics (As of March 2016).
Therapeutic area Compound Indication Developments
Endocrinology Nasal glucagon Severe hypoglycemia In Phase III development; development of commercial manufacturing process is ongoing.
Immunology Baricitinib Rheumatoid arthritis Submitted to regulatory authorities in the US, Europe, and Japan in the first quarter of 2016.
Immunology; Taltz (xekizumab) Psoriasis Approved and launched in the US, Europe, and Japan in the first quarter of 2016.
Immunology; Taltz (xekizumab) Psoriatic arthritis Phase III studies are onoing; submitted for regulatory review in Japan
Neuroscience BACE inhibitor Early Alzheimer's disease Moved into Phase III portion of the Phase II/III study in April 2016.
Neuroscience CGRP monoclonal antibody Cluster headache Phase III studies are ongoing
Neuroscience CGRP monoclonal antibody Migraine prevention Initiated first Phase III study in January 2016
Neuroscience Solanezumab Preclinical Alzheimer's disease Phase III study is ongoing
Neuroscience Solanezumab Mild Alzheimer's disease Announced change in primary endpoint for Phase III study in March 2016
Neuroscience Tanazumab Three indications: osteoarthritis pain, chronic low back pain, and cancer pain Phase III studies are ongoing
Neuroscience Tau imaging agent Alzheimer's disease Phase III study is ongoing
Oncology Abemaciclib Two indications" metastatic breast cancer and non-small-cell lung cancer Phase III studies are ongoing
Onology Olaratumab Soft tissue sarcoma Received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) in 2015. Based on Phase II data, submitted to European regulatory authorities and completed rolling submission in the US in the first quarter of 2016. Granted Priority Review from the US FDA in second quarter of 2016. Phase III study is ongoing.
Oncology Portrazza (necitumumab) Metastatic squamous non-small-cell lung cancer (first line) Approved and launched in Europe in the first and second quarters of 2016, respectively

Source: US Securities and Exchange Commission, Eli Lilly Quarterly Filing, March 2016.