Year Established: 1887
Revenues: $16,560 (+4%)
Net Income: $1,624 (-19%)
R&D: $5,920 (+31%)
TOP SELLING DRUGS
|Eliquis||deep vein thrombosis and pulmonary embolism||$1,860||n/a|
|Opdivo||melanoma, lung cancer, renal cancer||$942||n/a|
Investing in the future of its R&D operations is a top priority for Bristol-Myers Squibb (BMS), which recorded sales of $16.56 billion in the year under review. On the R&D front BMS bolstered its organization when it unveiled plans to expand its presence within hubs of scientific excellence and innovation with the opening of a new state-of-the-art research site in Cambridge, MA, in addition to the ongoing expansion of the company’s R&D Discovery site in the San Francisco Bay Area.
The new facility in Cambridge is expected to open in 2018 while the ongoing site expansion in the San Francisco Bay Area adds 61,000 square feet of laboratory and office space at the Woodside Technology Park life science campus and is expected to be completed in 2016. Consistent with evolution of the R&D organization’s strategic focus, which was previously announced in 2013, the company also discontinued discovery research efforts in virology. BMS made a deal during the year with ViiV Healthcare to divest its pipeline of investigational HIV medicines in various stages of development, for $350 million upfront with potential development and regulatory milestone payments of as much as $518 million for clinical assets and as much as $587 million for discovery and preclinical programs.
In Cambridge, Bristol-Myers Squibb scientists will focus on the company’s ongoing discovery efforts in genetically defined diseases, molecular discovery technologies and discovery platform chemistry. The company will relocate up to 200 employees from its Wallingford, CN, and Waltham, MA, sites, and a limited number from its central New Jersey locations. As part of this transition, the Waltham site is expected to close in early 2018. The existing site in Wallingford will also close in early 2018 with up to 500 employees relocating to a new location in Connecticut.
The Woodside Technology Park life science campus in the San Francisco Bay Area serves as BMS’s Discovery hub for researching breakthrough cancer immunotherapies. The company will fully occupy two of the three buildings at the campus totaling 194,100 square feet and will provide additional capacity to conduct biologics drug discovery research. The site expansion is expected to be completed in 2016.
In other expansion news, at the tail end of 2014 BMS unveiled plans to construct a new large-scale biologics manufacturing facility in Dublin, Ireland to produce multiple therapies for the company’s biologics portfolio. Once completed, the investment will in the new facility total nearly $1 billion and will significantly increase BMS’s biologics manufacturing capacity and play a central role in its global manufacturing network.
The company’s portfolio of approved and investigational biologics covers multiple therapeutic areas including oncology, virology and immunoscience. The 30,000-square meter project will house six 15,000-liter bioreactors and a purification area as well as office and lab space. The plant will be built on the grounds of the company’s existing bulk pharmaceutical manufacturing plant and the cost is expected to be comparable to the approximately $900 million investment in the company’s biologics manufacturing facility in Devens, MA. Approximately 350 to 400 scientists, engineers, bioprocess operators, quality specialists and other professionals are expected to work at the facility when operational in 2019.
During the year, BMS made a $1.25 billion deal with Promedior to acquire its lead asset PRM-151, a recombinant form of human pentraxin-2 protein in Phase II development for the treatment of idiopathic pulmonary fibrosis (IPF) and myelofibrosis (MF). PRM-151 has been granted Fast Track designation in the U.S. and Orphan designation in the U.S. and Europe for the treatment of MF and Orphan Designation in the U.S. and Europe for the treatment of IPF. Promedior is a clinical stage immunotherapy company developing targeted therapeutics to treat fibrotic diseases. Total aggregate payments to Promedior under the agreement have the potential to reach $1.25 billion, which includes an upfront cash payment for the right to acquire Promedior, an exercise fee payable if Bristol-Myers Squibb elects to exercise its right to acquire the company, and subsequent clinical and regulatory milestone payments.
BMS also acquired Flexus Biosciences, a privately held biotechnology company focused on novel anti-cancer therapeutics, for a potential total consideration of $1.25 billion, including $800 million upfront and development milestones. BMS gains full rights to Flexus’ lead preclinical small molecule, F001287, an IDO1-inhibitor targeted for IND filing in 2H15, as well as its IDO/TDO discovery program, which includes its IDO-selective, IDO/TDO dual and TDO-selective compound libraries. A newly formed entity established by the current shareholders of Flexus will retain all non-IDO/TDO assets of Flexus including those related to Phase I FLT3 and CDK4/6 inhibitor, its earlier stage small-molecule Treg cancer immunotherapy programs, and its current personnel and facilities.
BMS bought another private biotech, Cardioxyl Pharmaceuticals, which is focused on the discovery and development of novel therapeutic agents for the treatment of cardiovascular disease. The acquisition gives BMS full rights to Cardioxyl’s lead asset CXL-1427, a novel nitroxyl (HNO) donor (prodrug) in Phase II clinical development as an intravenous treatment for acute decompensated heart failure (ADHF). The transaction includes upfront and near-term milestone payments of up to $300 million and potential additional consideration of up to $1.775 billion upon the achievement of certain development, regulatory and sales milestones.
In addition to acquisitions, BMS entered several strategic alliances during the year. Together with Bavarian Nordic it entered an agreement that provides it with an exclusive option to license and commercialize Prostvac, Bavarian Nordic’s Phase III prostate-specific antigen (PSA)-targeting cancer immunotherapy in development for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
Other collaborations include a deal between BMS and uniQure that provides BMS with exclusive access to uniQure’s gene therapy technology platform for multiple targets in cardiovascular disease. With the Moffitt Cancer Center BMS entered into a collaboration agreement as part of its Immuno-Oncology Rare Population Malignancy (I-O RPM) program in the U.S. Also, Five Prime Therapeutics entered into an exclusive worldwide license and collaboration agreement with BMS for the development and commercialization of its colonystimulating factor 1 receptor (CSF1R) antibody program, including FPA008 which is in Phase I development for immunology and oncology indications.