"With innovative thinking and efficient, parallel track use of Regeneron’s proprietary VelociSuite technologies, the team moved an investigational antibody cocktail against SARS-CoV-2 from lab to clinic in record time."
Can you provide an overview of Regeneron’s core brands?
EYLEA® (aflibercept) Injection continues to reach more patients in competitive eye disease markets, with its efficacy, safety and convenience setting a high bar for current and potential future entries. We are confident in the durability and continued growth of this important medicine for years to come. Annual EYLEA global net product sales reached nearly US$8 billion in 2020 (net product sales outside the US recorded by our collaborator Bayer), and US$4.9 billion in the US, still without a single price increase since its launch in November 2011.
Looking to the rest of our growing portfolio, more than 80% of our top-line growth in 2020 came from products and revenues other than EYLEA. Dupixent® (dupilumab) global net product sales in 2020 (recorded by our collaborator Sanofi) were more than US$4 billion, reflecting growth of 75% versus 2019. This ‘pipeline in a product’ continues to reach more patients in need with an expanded FDA indication for atopic dermatitis in patients ages 6 to 11 and an FDA acceptance of our supplemental application as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, with even more room to grow as it meets its potential to transform the treatment of certain type 2 inflammatory diseases. We also made Dupixent treatment more convenient with the FDA approval of a single-dose, 300 mg pre-filled syringe.
As the foundation of our oncology portfolio, our PD-1 inhibitor Libtayo® (cemiplimab) is achieving significant and steady growth with recent FDA approvals in two new indications, non-small cell lung cancer and basal cell carcinoma, in early 2021. Global net product sales for Libtayo were US$348 million in 2020, representing 80% year-over-year growth. We are making progress in other cancers as well, including in March 2021, when positive results in overall survival prompted us to stop our cervical cancer trial early, with the data forming the basis of upcoming regulatory submissions. With 11 investigational therapeutics in clinic for a wide range of cancers, including eight bispecific antibodies, we continue to diversify our approach to oncology and are positioned to lead the next wave of immuno-oncology innovation.
What factors enabled Regeneron to play such an important role in delivering COVID-19 antibody therapeutics to market?
Thanks to three decades of investment in our antibody discovery and development technologies, as well as our recent experience developing a multi-antibody cocktail for Ebola, our team was ready to quickly mobilize when COVID-19 hit. With innovative thinking and efficient, parallel track use of Regeneron’s proprietary VelociSuite technologies, the team moved an investigational antibody cocktail against SARS-CoV-2 from lab to clinic in record time. A process that would normally take years was achieved in under six months.
How does Regeneron’s antibody cocktail work against new COVID-19 variants?
REGEN-COV™ (casirivimab with imdevimab) is a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science. Just as we did for MERS and Ebola, we purposefully took a multi-antibody approach from the beginning, since we know that viruses are likely to evolve and this provides an ‘insurance policy’ if one of the antibodies loses some ability to block the mutant strain.
In March, the FDA confirmed that REGEN-COV retains potency against the main variants of concern known to be circulating within the US (those first identified in South Africa, Brazil, the UK, New York and California). In contrast, the other two FDA-authorized monoclonal antibodies had reduced potency against one or more of these strains. While REGEN-COV continues to be effective now, we recognize that the virus may continue to evolve and are staying vigilant by continuing to assess new strains in real time. Thanks to the power of our VelociSuite technology, we have a number of other potent antibody candidates standing by should we need to swap them in at some point in the future.
How do Regeneron platform technologies drive its efficient drug discovery and development engine?
Our core capabilities for target discovery and validation are enabled by a series of Regeneron-invented technologies that accelerate, improve and disrupt the traditional drug discovery and development process. Collectively, these VelociSuite technologies represent some of the most valuable biotechnologies ever created, and aid our efforts to continuously accelerate the average timeline from discovery to drug approval — ultimately allowing us to help more patients around the world, faster. These technologies are pivotal across all our research programs, but particularly so in the past year when the infectious disease preclinical research team created and evaluated thousands of fully human antibodies produced by VelocImmune® mice and antibodies isolated from humans recovered from COVID-19, screened them using VelociMab® and identified two potent, non-competitive ones to pair for the REGEN-COV antibody cocktail.
What inspired the creation of Regeneron’s Genetics Center and how is it empowering collaboration in that area?
Genetics has always been an important part of Regeneron’s approach to research, and we take great pride in going deep on the early biology of disease. You can read the full backstory on the Regeneron Genetics Center® (RGC) in our “journey of an idea” piece.
Since its founding in 2014, the RGC has been a true demonstration of the company’s entrepreneurial and curious spirit, and has become a core contributor to our early stage clinical and future pipeline. By understanding the genetic variations that may protect someone from a disease or make them more susceptible, we can discover the root causes of diseases and identify potential therapies. To further our collective understanding of how diseases impact different people, the RGC has developed one of the largest and most ancestrally diverse datasets in the world, using world-class automation and analytics to make it all possible. The RGC continues to build collaborations and expand our work globally, now with more than 100 unique partnerships and nearly 1.5 million patient volunteers sequenced since its inception.
How has Regeneron gone about establishing a pipeline that will reward shareholders long term?
As a science-driven biotechnology company, we follow the science to explore different therapeutic areas where our knowledge and expertise may be able to make a difference for patients. If you look at our pipeline, you’ll see more than 30 investigational medicines being studied across a myriad of diseases, including eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.
Our passion for science and our commitment to patients means Regeneron makes research and development one of our primary concentrations. It’s through that dedication to advancing science that we have produced proprietary technologies like VelociSuite®. Without continual investment and boundary pushing, we would not have been ready to jump in on immediate public health threats like Ebola and COVID-19. We have learned that investing in R&D and manufacturing capacity is about being ready for “someday.” In line with previous years, we invested more than 30% of our revenue in 2020 (US$2.735 billion dollars) into our Research and Development efforts – well above the industry average.
What drives Regeneron’s scientific agenda and how does it stay true to the company’s scientific roots?
Regeneron was founded and has been led for over 30 years by physician-scientists – a rarity in the industry – and we apply this science-focused mentality to our work. We pursue therapeutic pathways based on our ability to see early promise through genetic or deep biologic research. From there, we have found that commercial success will follow.