07.11.22
Headquarters: New York, NY
twitter.com/bmsnews
www.bms.com
Year Established: 1887
Headcount: 32,200
Revenues: $46,385 (+9%)
Earnings: $6,994
R&D: $11,354 (+2%)
TOP SELLING DRUGS
In 2021, Bristol Myers Squibb (BMS) reported revenues of $46 billion. This 9% increase from the previous year was driven by Eliquis and recently launched new products, Revlimid and Opdivo/Yervoy. During the year, BMS obtained more than 20 approvals for new medicines and additional indications and formulations of currently marketed medicines in major markets (the U.S., EU and Japan), including regulatory approvals of Breyanzi and Abecma in hematology malignancies, the first approvals of its cell therapy portfolio.
BMS also reported progress in its immuno-oncology portfolio with additional approvals for both Opdivo and Opdivo+Yervoy in various indications. The immunology portfolio expanded with the FDA approval of Zeposia for the treatment of adults with moderately to severely active ulcerative colitis (UC). The company also bolstered its cardiovascular franchise by adding mavacamten with the acquisition of MyoKardia in 2020. In 2021, the FDA accepted the NDA for mavacamten for patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
In another collaboration, BMS and Eisai entered a partnership for the co-development and co-commercialization of MORAb-202, a selective folate receptor alpha antibody-drug conjugate being investigated in endometrial, ovarian, lung and breast cancers. MORAb-202 is currently in Phase I/II clinical trials for solid tumors. The companies will jointly develop and commercialize MORAb-202 in the U.S., Canada, Europe, Russia, Japan, China and certain other countries in the Asia-Pacific region. Eisai will be responsible for the global manufacturing and supply. Profits, research and development and commercialization costs are shared in the collaboration territories. BMS will be responsible for development and commercialization outside of the collaboration territory and will pay a royalty on those sales. Eisai received a $650 million up-front collaboration fee and BMS is also obligated to pay up to $2.5 billion upon the achievement of milestones.
During the year BMS entered into a global exclusive license with Immatics for its TCR bispecific IMA401 program. IMA401 is being studied in oncology and a Clinical Trial Application has been filed with the German federal regulatory authority and began in the first half of 2022. BMS and Immatics will collaborate on development and BMS will be responsible for the commercialization of IMA401 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding and manufacturing. The transaction included an upfront payment of $150 million and Immatics is eligible up to $770 million in milestones.
With Prothena, BMS exercised an option under the global neuroscience research and development collaboration for the exclusive U.S. rights to PRX005, an anti-tau antibody that specifically targets an area within the microtubule binding region for the potential treatment of Alzheimer’s disease. PRX005 is currently in a Phase I clinical trial.
Lastly, with Rockefeller University, BMS obtained a global exclusive license to develop, manufacture and commercialize Rockefeller’s novel monoclonal antibody duo treatment that neutralizes the SARS-CoV-2 virus for treatment and potentially for prevention of COVID-19. Phase I clinical trials to assess dosing for IV and subcutaneous formulations and to assess safety have been completed by Rockefeller University. In May 2021, enrollment initiated in the Phase II study within the NIH ACTIV-2 protocol at a network of sites within the U.S. Phase II enrollment was completed in August 2021 and topline data was expected in the first quarter of 2022.
In April 2021, BMS said it selected Leiden as the locations to house a new cell therapy manufacturing site in Europe, leveraging the growing life sciences region near Amsterdam and convenient access to transportation for shipping patient cells.
As part of BMS’ continuing commitment to patients with aggressive hematological cancers and its growing cell therapy franchise, the company is making this significant new investment to expand global manufacturing capacity and bring treatments to patients faster. Leiden will be the company’s fifth state-of-the-art cell therapy manufacturing facility and first in Europe, in addition to major contract manufacturing partnerships globally.
The European facility will be commercially focused with capabilities for multi-product cell therapy manufacturing and the ability to scale up capacity. It will leverage innovative technologies, the latest manufacturing equipment and advanced digital systems to deliver these critical cell therapies to patients.
In addition to the new Leiden facility, construction is underway for the new cell therapy manufacturing facility in Devens to further support clinical and commercial manufacturing of cell therapies for patients with aggressive hematological cancers.
The 244,000 square foot facility adds to the company’s already established state-of-the-art cell therapy manufacturing network with cutting-edge technologies and highly trained manufacturing teams. The Devens site will be equipped to enable quick ramp up of capacity for clinical and commercial cell therapy products.
Manufacturing cell therapies is both operationally and technically complex because they are manufactured uniquely for each individual patient, using a patient’s own T cells as the starting material. Each batch of engineered T cells is made for infusion back to the original cancer patient, and it is critical for companies to develop reliable quality supply, and rapid turnaround time.
The new cell therapy facility will be located on BMS’ current 89-acre Devens campus that supports process development, clinical manufacturing and commercial manufacturing for biologics medicines, including an immuno-oncology medicine. The new cell therapy facility allows accelerated career development for current and prospective employees across biologics and cell therapies on a single campus, with employees having access to all existing campus amenities. The company plans to hire several hundred employees over the next few years to support the new operations.
The Devens campus is part of BMS’ growing presence in Massachusetts. The company also operates two R&D facilities in Cambridge, MA and will be bringing those two sites together into a new building at Cambridge Crossing in 2023—construction is currently underway on the 480,000 square-foot state-of-the-art research and early development center that will bring together more than 550 employees now based in Kendall Square and Alewife.
The new biomedical hub at Cambridge Crossing will be situated on a 43-acre development at the intersection of Cambridge, Somerville and Boston. The company’s work on cancer resistance, neuroscience and immune-related diseases—such as discovery biology, translational science and chemistry research—will be housed at the new location. Additionally, work at the new site will facilitate end-to-end drug discovery: biotherapeutics, informatics and predictive sciences, drug metabolism pharmacokinetics and other research activities.
Current plans call for the building to be completed in January 2023, and employees are expected to relocate to Cambridge Crossing. The Cambridge Crossing property is being converted into a life science hub to inspire collaboration, innovation and connection through its proximity to MIT, Harvard and Kendall Square.
twitter.com/bmsnews
www.bms.com
Year Established: 1887
Headcount: 32,200
Revenues: $46,385 (+9%)
Earnings: $6,994
R&D: $11,354 (+2%)
TOP SELLING DRUGS
Drug | Indication | 2021 Sales | (+/-%) |
Revlimid | myelodysplastic syndrome | $12,821 | 6% |
Eliquis | deep vein thrombosis and pulmonary embolism | $9,168 | 17% |
Opdivo | melanoma, lung cancer, renal cancer | $7,523 | 8% |
Pomalyst | multiple myeloma | $3,332 | 9% |
Orencia | rheumatoid arthritis | $3,306 | 5% |
Sprycel | leukemia | $2,117 | -1% |
Yervoy | oncology | $2,026 | 20% |
Abraxane | lung, ovarian, and breast cancer | $1,181 | -5% |
Reblozyl | anemia | $551 | n/a |
In 2021, Bristol Myers Squibb (BMS) reported revenues of $46 billion. This 9% increase from the previous year was driven by Eliquis and recently launched new products, Revlimid and Opdivo/Yervoy. During the year, BMS obtained more than 20 approvals for new medicines and additional indications and formulations of currently marketed medicines in major markets (the U.S., EU and Japan), including regulatory approvals of Breyanzi and Abecma in hematology malignancies, the first approvals of its cell therapy portfolio.
BMS also reported progress in its immuno-oncology portfolio with additional approvals for both Opdivo and Opdivo+Yervoy in various indications. The immunology portfolio expanded with the FDA approval of Zeposia for the treatment of adults with moderately to severely active ulcerative colitis (UC). The company also bolstered its cardiovascular franchise by adding mavacamten with the acquisition of MyoKardia in 2020. In 2021, the FDA accepted the NDA for mavacamten for patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
R&D alliances
In 2021, BMS obtained a global exclusive license to Agenus’ proprietary AGEN1777 bispecific antibody program that blocks TIGIT and an additional target. AGEN1777 is being studied in oncology and a Phase I clinical trial was initiated in October 2021. BMS will be responsible for the development and any subsequent commercialization of AGEN1777 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding and manufacturing. The transaction included an up-front payment of $200 million and Agenus is eligible to receive milestones up to $1.4 billion.In another collaboration, BMS and Eisai entered a partnership for the co-development and co-commercialization of MORAb-202, a selective folate receptor alpha antibody-drug conjugate being investigated in endometrial, ovarian, lung and breast cancers. MORAb-202 is currently in Phase I/II clinical trials for solid tumors. The companies will jointly develop and commercialize MORAb-202 in the U.S., Canada, Europe, Russia, Japan, China and certain other countries in the Asia-Pacific region. Eisai will be responsible for the global manufacturing and supply. Profits, research and development and commercialization costs are shared in the collaboration territories. BMS will be responsible for development and commercialization outside of the collaboration territory and will pay a royalty on those sales. Eisai received a $650 million up-front collaboration fee and BMS is also obligated to pay up to $2.5 billion upon the achievement of milestones.
During the year BMS entered into a global exclusive license with Immatics for its TCR bispecific IMA401 program. IMA401 is being studied in oncology and a Clinical Trial Application has been filed with the German federal regulatory authority and began in the first half of 2022. BMS and Immatics will collaborate on development and BMS will be responsible for the commercialization of IMA401 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding and manufacturing. The transaction included an upfront payment of $150 million and Immatics is eligible up to $770 million in milestones.
With Prothena, BMS exercised an option under the global neuroscience research and development collaboration for the exclusive U.S. rights to PRX005, an anti-tau antibody that specifically targets an area within the microtubule binding region for the potential treatment of Alzheimer’s disease. PRX005 is currently in a Phase I clinical trial.
Lastly, with Rockefeller University, BMS obtained a global exclusive license to develop, manufacture and commercialize Rockefeller’s novel monoclonal antibody duo treatment that neutralizes the SARS-CoV-2 virus for treatment and potentially for prevention of COVID-19. Phase I clinical trials to assess dosing for IV and subcutaneous formulations and to assess safety have been completed by Rockefeller University. In May 2021, enrollment initiated in the Phase II study within the NIH ACTIV-2 protocol at a network of sites within the U.S. Phase II enrollment was completed in August 2021 and topline data was expected in the first quarter of 2022.
Investment in cell therapy operations
In support of continued investment in its cell therapy portfolio, BMS expanded its manufacturing capabilities in 2021 through the construction of new state-of-the-art cell therapy manufacturing facilities in Devens, MA, and Leiden, Netherlands.In April 2021, BMS said it selected Leiden as the locations to house a new cell therapy manufacturing site in Europe, leveraging the growing life sciences region near Amsterdam and convenient access to transportation for shipping patient cells.
As part of BMS’ continuing commitment to patients with aggressive hematological cancers and its growing cell therapy franchise, the company is making this significant new investment to expand global manufacturing capacity and bring treatments to patients faster. Leiden will be the company’s fifth state-of-the-art cell therapy manufacturing facility and first in Europe, in addition to major contract manufacturing partnerships globally.
The European facility will be commercially focused with capabilities for multi-product cell therapy manufacturing and the ability to scale up capacity. It will leverage innovative technologies, the latest manufacturing equipment and advanced digital systems to deliver these critical cell therapies to patients.
In addition to the new Leiden facility, construction is underway for the new cell therapy manufacturing facility in Devens to further support clinical and commercial manufacturing of cell therapies for patients with aggressive hematological cancers.
The 244,000 square foot facility adds to the company’s already established state-of-the-art cell therapy manufacturing network with cutting-edge technologies and highly trained manufacturing teams. The Devens site will be equipped to enable quick ramp up of capacity for clinical and commercial cell therapy products.
Manufacturing cell therapies is both operationally and technically complex because they are manufactured uniquely for each individual patient, using a patient’s own T cells as the starting material. Each batch of engineered T cells is made for infusion back to the original cancer patient, and it is critical for companies to develop reliable quality supply, and rapid turnaround time.
The new cell therapy facility will be located on BMS’ current 89-acre Devens campus that supports process development, clinical manufacturing and commercial manufacturing for biologics medicines, including an immuno-oncology medicine. The new cell therapy facility allows accelerated career development for current and prospective employees across biologics and cell therapies on a single campus, with employees having access to all existing campus amenities. The company plans to hire several hundred employees over the next few years to support the new operations.
The Devens campus is part of BMS’ growing presence in Massachusetts. The company also operates two R&D facilities in Cambridge, MA and will be bringing those two sites together into a new building at Cambridge Crossing in 2023—construction is currently underway on the 480,000 square-foot state-of-the-art research and early development center that will bring together more than 550 employees now based in Kendall Square and Alewife.
The new biomedical hub at Cambridge Crossing will be situated on a 43-acre development at the intersection of Cambridge, Somerville and Boston. The company’s work on cancer resistance, neuroscience and immune-related diseases—such as discovery biology, translational science and chemistry research—will be housed at the new location. Additionally, work at the new site will facilitate end-to-end drug discovery: biotherapeutics, informatics and predictive sciences, drug metabolism pharmacokinetics and other research activities.
Current plans call for the building to be completed in January 2023, and employees are expected to relocate to Cambridge Crossing. The Cambridge Crossing property is being converted into a life science hub to inspire collaboration, innovation and connection through its proximity to MIT, Harvard and Kendall Square.