Research and Development
We've been committed to the fight against HIV/AIDS for more than 20 years. As part of our commitment, we've been:
- developing medicines to treat the disease
- partnering with the HIV community to support people living with HIV/AIDS
- improving access to medicines
- supporting disease education efforts
We have a strong vision for continuing to transform the treatment of HIV to fulfill unmet medical needs. We also invest heavily in identifying and pursuing the most promising compounds that will improve treatments and deliver true advances to patient care.
Our current HIV development pipeline includes compounds aimed at multiple targets. We also have several compounds in preclinical development. We also continue to invest in the further development of our approved HIV medicines through clinical trials and innovations including simplified treatment regimens.
We are researching pediatric applications of our HIV medicines in collaboration with the Pediatric AIDS Clinical Trials Group. Pediatric formulations are available for Videx and Zerit.
Senior R&D leadership continues to actively participate in the ongoing Civil Society Dialogue on HIV Access as well as the Forum for Collaborative HIV Research.
We're researching ways to transform the treatment of hepatitis B in pursuit of a goal of serologic cure and finite therapy.
In hepatitis C (HCV), our primary goal is to reduce the disease burden by increasing cure rates (SVR-suppression of viral replication) across all genotypes. We take a multipronged approach aimed at establishing a new standard of care with a focus on increasing efficacy, reducing dose, limiting toxicities, addressing barriers to treatment, and shortening treatment duration.
Our HCV pipeline includes multiple agents with diverse mechanisms of action. These include direct acting anti-virals such as our NS5A replication complex inhibitor, an NS3 protease inhibitor, an NS5B polymerase inhibitor and PEG-interferon lambda (a type III interferon).
We also collaborate with other biopharmaceutical companies to improve care, combining Bristol-Myers Squibb clinical assets with other clinical stage and marketed HCV therapies to identify better treatment options for patients.
In addition, we are seeking to identify the basic hepatitis C genotype that exists in the Chinese population to better target potential new therapies for local patient populations.
An oncology compound in late stage development is being developed for possible use in liver cancers. Such diseases are of particular concern in India and China, as Asia's higher rates of hepatitis B and C often result in infections that advance from liver cirrhosis to liver cancer.
Our aim in Asia is to create a clinical development program specific to Asian needs. An important focus of this effort involves conducting clinical studies in Asia, and formulating drug development and commercialization strategies informed by an understanding and appreciation of Asian treatment practices. This requires gaining a better understanding of the epidemiology of the disease in the region through various study programs.
One program, Bridge, is enrolling tens of thousands of people in non-interventional studies across China to better understand how liver cancer is now diagnosed and treated. Similar studies are underway in Russia and Romania, where liver disease is also of increasing concern.
R&D is also involved in earlier studies around gastric cancers, which are more prevalent in Asia than in the U.S. or Europe. And to address large numbers of smokers in China as well as in Central and Eastern Europe, the company is making a concerted effort to review how its expertise in immuno-oncology may help in developing new treatments for lung cancer.
According to the World Diabetes Foundation, India has the world's largest diabetes population - some 50 million people. China is next, with more than 43 million. About 70 percent of the world's diabetes cases occur in low- and middle-income countries, according to the World Diabetes Foundation. Yet in developing countries, fewer than half of those with diabetes are even diagnosed.
We're currently working to develop new therapies to help meet these critical needs. Many researchers believe some Asian populations may exhibit a unique metabolic makeup leading to impaired glucose tolerance that may predispose them to type 2 diabetes. To help, we've introduced our newest diabetes drug in India and we currently have another in late stage development.
In January 2014, Bristol-Myers Squibb and AstraZeneca provided a 5 million dollar grant to the American Diabetes Association's Pathway to Stop Diabetes program, an innovative research initiative that provides resources and support for a new generation of diabetes researchers and is designed to generate exciting discoveries through excellence, innovation, collaboration and radical thinking.
Neglected Tropical Diseases
In the largest coordinated effort to date to combat Neglected Tropical Diseases (NTDs), 13 pharmaceutical companies, including Bristol-Myers Squibb, the U.S., U.K. and U.A.E. governments, the Bill & Melinda Gates Foundation, the World Bank and other global health organizations have pledged to bring a unique focus to defeating these diseases. NTDs together affect 1.4 billion people worldwide, most of whom are among the world's poorest.
Our participation in the NTD initiative reflects the company's commitment to working with industry, governments and global health organizations to address global health issues. As part of this coordinated effort, we'll provide access to select proprietary compound libraries to third parties, including Drugs for Neglected Diseases initiative (DNDi), to help develop potential new medicines for targeted NTDs.
In developing nations, our sponsored active clinical trials are currently ongoing in transplantation and rheumatoid arthritis in Brazil, India and Russia.
We've made major investments in building R&D infrastructure and capacity in the developing world, including in India, China, Brazil and Russia.
India: Biocon Bristol-Myers Squibb Research Center (BBRC) is a Bristol-Myers Squibb R&D center for Drug Discovery and Development in Bangalore, India, with approximately 450 scientists. BBRC started out as a simple outsourcing model started with Biocon in 1997. It later evolved to a major strategic R&D site for Bristol-Myers Squibb in emerging markets where new innovative medicines are discovered and developed for global diseases.
The center is well recognized for its innovative, entrepreneurial and vibrant culture and is making a significant impact on R&D productivity in Bristol-Myers Squibb. It possesses capabilities in:
- Medicinal Chemistry
- Pharmaceutical Development
- Targeted Medicines
The center has also taken the lead in shaping the scientific environment in India through a variety of initiatives including organizing and supporting scientific seminars, symposiums and training to researchers and by providing research fellowships and grants to students in eminent academic institutions.
In India, we also have clinical trials underway in diabetes, chronic myelogenous leukemia and liver disease, and expect additional trials in diabetes, rheumatoid arthritis, liver cancer and cardiovascular disease over the next several years.
China: Our R&D organization is continuing to expand its capacity in China. Five years ago, the R&D organization had about 30 employees there. Today it's about 120. That number is expected to grow further over the next few years as Bristol-Myers Squibb continues to invest in biopharmaceutical research and development in China.
These R&D efforts are aimed at providing innovative, high-quality medicines that address the unmet medical needs of patients with serious diseases, with a focus on disease areas of special concern to the region, such as liver disease.
We've also concluded a number of partnership agreements with pharmaceutical companies in Asia (China and Singapore) for developing early stage compounds. We also continue to locally manufacture a number of innovative products through its SASS joint venture in Shanghai, including products for hepatitis B and diabetes.
In June 2013, Bristol-Myers Squibb and Simcere Pharmaceutical Group expanded their strategic partnership in China to include the development and co-commercialization of the subcutaneous formulation of Bristol-Myers Squibb's biologic medicine Orencia® (abatacept). Orencia is used for the treatment of rheumatoid arthritis.
Early Stage R&D Discovery and Development: Along with full development programs in hepatitis, HIV, oncology and immunoscience, our R&D group has a number of earlier stage programs in discovery and development around diseases and therapeutic areas of particular concern in the developing world.
Click here for a chart that updates areas of significant exploration, particularly in parts of the developing world.
Accelerating Medicines Partnership
In February 2014, we joined the National Institutes of Health and nine other biopharmaceutical companies and several nonprofit organizations to create the Accelerating Medicines Partnership (AMP).
The AMP partners will collaboratively identify and validate promising disease targets in Alzheimer's disease, type 2 diabetes and autoimmune disorders such as rheumatoid arthritis and lupus. Our goal is to increase the number of new therapies and diagnostic methods in these diseases and reduce the time and cost of developing them.
International Immuno-Oncology Network
In May 2012, we announced the formation of the International Immuno-Oncology Network (II-ON), a global collaboration between industry and academia that aims to further the scientific understanding of immuno-oncology.
II-ON members include these leading cancer-research institutions:
- Clinica Universidad Navarra, Pamplona, Spain
- Dana-Farber Cancer Institute, Boston, MA
- The Earle A. Chiles Research Institute (Providence Health & Services), Portland, OR
- Institut Gustave Roussy, Villejuif, France
- Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione G. Pascale," Naples, Italy
- Johns Hopkins Kimmel Cancer Center, Baltimore MD
- Memorial Sloan-Kettering Cancer Center, New York, NY
- The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK
- The Netherlands Cancer Institute, Amsterdam, NL
- The University of Chicago, Chicago, IL
In August 2012, we partnered with nine other global biopharmaceutical companies to form a nonprofit organization, TransCelerate BioPharma Inc., to accelerate the development of new medicines.
The largest initiative of its kind, TransCelerate BioPharma has since grown to include 19 companies who share financial and other resources to identify and solve common drug development challenges with the end goals of improving the quality of clinical studies and bringing new medicines to patients faster.
The National Center for Advancing Translational Sciences (NCATS)
The National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) has established a program: Discovering New Therapeutic Uses for Existing Molecules.
We are one of eight pharmaceutical companies which have contributed a total of 58 molecules to jump-start a pilot program. The three molecules we contributed to the pilot program are:
- Pexacerfont (CRF1 receptor antagonist)
- BMS-820132 (glucokinase activator)
- BMS-830216 (MCH receptor-1 antagonist)
NCATS has solicited research proposals from researchers at academic medical centers to identify new therapeutic uses for these molecules. All of the molecules selected for the pilot program have advanced to clinical studies, but were not pursued for their original therapeutic indication. They have an appropriate safety profile to enable further clinical investigation to explore other potential therapeutic uses.
Grants from NCATS will provide research funding to the academic medical centers. Each pharmaceutical company will contribute to the program by providing information about its drugs as well as supplying the drugs for both preclinical and clinical studies. If a research project succeeds in identifying a new therapeutic use for the compound, the pharmaceutical company collaborator will have the first option to license the biomedical research partners' new intellectual property (IP) arising out of the research.
In cases where the pharmaceutical company collaborator owns active patents on a molecule, they will decide whether to advance the molecule through further clinical studies to commercialize the new indication or to enable another company to do so.