Leadership Perspective:LISTENING & LEARNING FROM THE RARE DISEASE COMMUNITY
IMPROVE THE LIVES OF PEOPLE
WITH SERIOUS DISEASES
We are always looking for ways to make the drug discovery process faster and more efficient, especially in scenarios where help is desperately needed. To address emerging or rapidly spreading infectious diseases, Regeneron has applied our VelociSuite® technologies in a ‘rapid response’ manner that parallel tracks certain steps and speeds hand-offs between groups, allowing us to advance novel antibody treatments extremely fast. We’ve been proud to apply our homegrown technologies and novel scientific approach to respond to public health challenges like Ebola, Middle Eastern Respiratory Syndrome (MERS) and COVID-19.
Our robust pipeline spans eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.Learn more about our pipeline
We are intent on deepening our strong and sustainable portfolio of innovative medicines. We are improving the traditional drug development process through proprietary technologies that are designed to accelerate the time discovery to drug approval and improve the likelihood of success. We are also leading ambitious initiatives, such as the Regeneron Genetics Center®, one of the largest genetics sequencing efforts in the world.Learn about our technology
We have always approached pricing with fairness, affordability and access at the forefront. We also believe in transparency and work with independent organizations to conduct cost-effectiveness assessments when bringing treatments to market.Learn more about our U.S. Pricing Philosophy
Product Support Programs
We offer product support to both healthcare providers and patients, including contacting patients’ health plans to determine the requirements for coverage and reimbursement and educating healthcare providers about product coverage, reimbursement and claims coding. We offer co-pay assistance to eligible patients, and rebates and discounts to payers to help make our products more affordable.
We also provide patient assistance programs that are designed to increase access to medicine and provide education on using medicines safely and appropriately. Our programs help eligible patients throughout their treatment journey with insurance eligibility support, patient resources, financial assistance and access to free medicine.
Access to Medicines
We are committed to bringing important new medicines to people with serious diseases.
Before a new medicine is widely available to the public, it undergoes rigorous clinical testing to satisfy the safety and efficacy criteria required for regulatory approval. Approval by a country or region's health regulatory authority, such as the U.S. Food and Drug Administration, allows the appropriate group of people to access a medicine.
In some cases, a potentially beneficial therapy may not yet be approved by regulatory authorities. Our Compassionate Use Policy gives certain patients who have serious or life-threatening conditions access to a medicine. The patients who receive compassionate use usually have exhausted all, if any, available treatment options and are unable to participate in ongoing clinical trials.Learn more about Compassionate Use Requests
Patient Assistance Foundations
We are committed to ensuring that patients can afford and remain compliant with the therapy that best suits their medical needs. We donate to independent third-party charitable foundations, known as Patient Assistance Foundations, which provide financial assistance to patients who might not otherwise be able to afford their medications. Our charitable contributions support patients without regard to the beneficiary’s choice of product, provider, practitioner, supplier or health plan. We provide guidelines and training to our employees who might engage with the Foundations, and we review our activities regularly to ensure adherence to our guidelines.
Increasing Disease Awareness
We believe patients should be knowledgeable about their disease so they can advocate and make informed decisions around their care. Regeneron supports efforts to empower patients with information to help them better understand and manage their disease. We support organizations that create educational materials and disease management tools for patients and their caregivers. We know that patients are seeking information from the most trusted sources and we want to ensure that there is up-to-date and relevant information wherever they look.
Elevating the Patient Voice
We believe that it is important to include the patient voice early in the R&D and clinical development process. Under the guidance of patient advocacy groups, we bring patients together with our researchers, clinical development colleagues and health economic outcomes research groups to learn what it means to live with a disease, how patients manage their day-to-day lives and what they and their caregivers want in new therapies. Through this process, we have changed and added new outcome measures, or what clinicians call “endpoints,” to our clinical trials and have worked collaboratively to test and develop new patient-reported outcomes that have never been studied in the past.
Read page 33 of our 2019 Responsibility Report to learn how we put our patient advocacy into action.
Supporting Patient Access
We believe that patients should have access to appropriate, evidence-based medicines to get them to the best health. Patients are singularly able to tell their story about access challenges and how these obstacles can impact their daily lives and health. Regeneron has supported advocacy training, distribution of access tools, town halls and coalition building for patients and caregivers so that they can have a greater chance for successful outcomes.
Unfortunately, COVID-19 will not be the last pandemic or epidemic the world faces. This is why we see particular utility in building our core technologies, conducting deep biological research and investing in large-scale manufacturing infrastructure for antibody treatments and vaccines. We are committed to doing what’s right and we believe applying our resources and expertise to combat dangerous pathogens is crucial to our mission to improve lives through science.
WHAT CAN WE DO TO HELP?
During the 2014 West African Ebola outbreak, our team was reading increasingly concerning reports and began asking one another, “what can we do to help?” Our eagerness to get involved led to a realization that we could, for the first time, apply our VelociSuite® technologies to develop a novel antibody treatment for a deadly viral pathogen, and, potentially help address a daunting global health challenge.
We applied these core technologies to generate potent Ebola-neutralizing antibodies at an unprecedented speed and selected a cocktail of three complementary antibodies, condensing a process that normally takes years into less than 12 months. Thankfully, the 2014-2015 outbreak ended before our investigational compound entered clinical trials, and we instead focused on preclinical and early research to confirm safety in humans. When a new outbreak began in the Democratic Republic of the Congo in 2018, we were ready. We moved quickly to have our investigational medicine made accessible through a compassionate use protocol and included in an independently run clinical trial to test safety and efficacy.
Data from this trial ultimately supported the U.S. Food and Drug Administration’s approval of our antibody cocktail on October 14, 2020.Learn more about our technologies
Leadership Perspective:MAKING A DRUG YOU HOPE NO ONE WILL EVER NEED
Moving at Pandemic Speed
When the novel coronavirus, SARS-CoV-2, began to spread globally in early 2020, our team asked again, “what can we do to help?” Building on prior experience, Regeneron scientists applied the same VelociSuite® technologies and examined antibodies derived from human survivors of the disease to rapidly develop a large pool of antibody candidates capable of neutralizing the virus. The team selected a potent, tightly-binding, non-competing pair and began exploring the cocktail’s potential to be used as a preventative or treatment for COVID-19. Improving on our prior infectious disease timeline, this combination was ready to enter human clinical trials just five months after we first accessed the SARS-CoV-2 viral sequence.
As part of our rapid response approach and in recognition of the tremendous global need, we simultaneously initiated clinical trials and our large-scale manufacturing process. Manufacturing biologic medicines like antibodies is a time-consuming and precise process, and unfortunately biology can’t be hurried along. Despite the risks and uncertainties, we purposefully began this effort as early as possible, so that we would have as many doses as possible immediately available for people around the world.
To further increase access, we have also joined forces with Roche to develop and manufacture our COVID-19 treatment. This collaboration is expected to significantly increase global supply and hopefully provide the world with a critical line of defense against the COVID-19 pandemic.Learn more about our COVID-19 response efforts
Leadership Perspective:WORKING TOGETHER TO PROVIDE COVID-19 TESTING COMPONENTS