Bristol-Myers Squibb (BMS) is a New York-based pharmaceutical company with research operations in 12 locations. It is one of the world’s largest pharmaceutical manufacturers with focus on oncology, virology and immunology along with cardiovascular, metabolic and neurological disorders.
BMS is a self-described drug discovery and development company and invested over $3.7 billion into research to “address the unmet medical needs of patients with serious diseases”. Bristol-Myers Squibb has 29 marketed brand-name products with at least 26 additional medications in human research trials. The company had worldwide estimated revenue of $16.4 billion in 2013.
Bristol-Myers Squibb has had a number of dealings with the Food and Drug Administration related to improper marketing and FDA violations. The company has also faced lawsuits regarding its blockbuster diabetes medications, Byetta and Bydureon and may face additional liability for its “next generation” anticoagulant, Eliquis.
History of Bristol-Myers Squibb
Bristol-Myers Squibb is the result of the merger of two large drug manufacturers, Bristol-Myers and E.R. Squibb, both with histories dating back into the 1800’s.
Edward Robinson Squibb, a young Navy doctor founded E. R. Squibb in 1858 after he became disgusted with the quality of medications available during the Mexican War. Squibb became the main source for medications during the Civil War, developing the Squibb pannier which was a wooden chest filled with 50 medications used to treat battlefield casualties including chloroform for anesthesia during amputations, quinine for malaria and herbal medications for dysentery.
The Squibb Institute for Medical Research was founded in 1938 which led the way in antibiotic development, becoming the largest penicillin plant in the world by 1943. The Squibb company dabbled in consumer health, introducing the first electric toothbrush in 1961 opened a medical adhesives company, ConvaTec, but focused most of its efforts on research into cancers and cardiovascular disorders, introducing the first ACE inhibitor for high blood pressure, Capoten in the mid-1970’s. Squibb went public in 1946 as Squibb International.
Bristol-Myers was founded in 1887 when William McLaren Bristol and John Ripley Meyers purchased a failing drug manufacturing firm in New York, originally known as the Clinton Pharmaceutical Company. The name was changed to Bristol, Myers Company and was renamed Bristol-Myers in 1899. By 1924, the company had gross profits of over $1 million and went public in 1929. The company mainly concentrated on the consumer products market but in 1943, Bristol-Myers became a supplier of penicillin to the Allied armed forces.
During the late 40’s 50’s and 60’s, both Bristol-Myers and Squibb were heavy players in antibiotic development leading to discoveries of streptomycin, tetracycline, and other antibiotics. While Bristol-Myers continued its consumer expansion, purchasing Clairol and Mead Johnson & Company to manufacture cosmetics and infant formula, the company also introduced several early chemotherapeutic agents which are still in use today.
Bristol-Myers merged with Squibb in 1989, creating the second largest pharmaceutical company in the world. The company has continued to produce large-selling medications for cancer such as Taxol, cardiovascular disorders such as Pravachol and Monopril, antibiotics such as Cefzil and antidiabetics such as Glucophage and a new type of anti-clotting medication, Plavix.
After the turn of the century, BMS focused its attention solely on pharmaceuticals, divesting a number of divisions including Clairol, Zimmer Holdings, ConvaTec medical devices and the Mead-Johnson Nutritional division.
Over the past two decades, BMS has been honored for philanthropic work in AIDS/HIV and pediatric medicine and was given the National Medal of Technology by President Bill Clinton in 1998 and chosen as “America’s Most Admired Pharmaceutical Company” by FORTUNE Magazine in 2001. The company has continued expansion with a slew commercial agreements and acquisitions.
In August of 2012, BMS acquired Amylin Pharmaceuticals, giving BMS control of the blockbuster, novel anti-diabetes medications Byetta and Bydureon. Though these medications were revolutionary and big selling medications, they also brought big problems with a slew of personal injury lawsuits.
BMS’s next-generation anti-coagulant, Eliquis was approved in December of 2012, to join other manufacturer’s new type of anticoagulants, Pradaxa and Xarelto – both of which have resulted in personal injury lawsuits.
In February of 2014, BMS sold their global diabetes division to AstraZeneca, including the Byetta line along with other BMS products for approximately $2.7 billion.
Bristol-Myers Squibb Manufacturing and Marketing Issues
Despite the BMS century-old reputation of research and philanthropy, the company has had a number of recent escapades with federal agencies.
In 2001, Bristol-Myers Squibb was accused of requiring wholesalers to purchase more drugs than they needed. BMS sold approximately $2 billion “extra” drugs so that the company would meet its annual sales goals in a accounting trick known as “channel stuffing”.
After a dramatic revenue drop the following year, the BMS was subject to SEC and Department of Justice investigations, leading a securities fraud indictment for the former Chief Financial Officer, Frederick Schiff. Following the scandal, BMS paid $839 million in fines and restitution.
In 2007, Bristol-Myers Squibb settled cases for off-label promotion of the atypical antipsychotic Abilify and multiple accusations of overcharging the government and inflated prices at the cost of $515 million. In 2010, BMS received a warning letter from the Food and Drug Administration regarding microbial contamination, poor environmental conditions, and substandard testing and sampling procedures at BMS facilities, some of which were repeated violations, previously noted in 2005 and 2009.
Bristol-Myers Squibb Product Issues
Bristol-Myers may have significant product liability in some of their products. The company is facing a number of personal injury lawsuits and may be subject to more in the future months.
Byetta / Bydureon
In the acquisition of Amylin Pharmaceuticals, BMS acquired the novel diabetes medications, Byetta and Bydureon. On assumption of the assets, BMS also assumed liability surrounding the products.
Byetta, (exenatide) is a twice daily injectable medication used for the treatment of type 2 diabetes. Bydureon is a once-weekly form of the same medication. Study results published in a 2011 edition of Gastroenterology showed that patients using Byetta had a risk of developing pancreatitis that was six times greater than those not taking the medication.
Pancreatitis is a medical condition caused by inflammation of the pancreas (responsible for insulin production) that can cause a need for hospitalization or may result in death. The study also found that Byetta may increase the risk of pancreatic cancer and thyroid cancer, at possibly up to three times the rate.
Multiple lawsuits have been filed due to Byetta or Bydureon use and more lawsuits are expected. The Byetta/Bydureon product line is producing annual revenue of approximately $700 million and growing at about 15 percent annually.
Eliquis (apixaban) is a next-generation anti-coagulant medication used to prevent clot formation in patients with atrial fibrillation or irregular heartbeat. Eliquis is a member of a newer group of medications, known as direct factor Xa inhibitors that do not require blood testing as older medications did. Other members of the class include:
This class of medications has caused serious adverse events resulting in uncontrollable bleeding which may result in death. Unlike older medications, Eliquis and the other Xa inhibitors do not have an antidote.
The manufacturers of Pradaxa and Xarelto are facing multiple personal injury lawsuits due to injury caused by the medications. Bristol-Myers Squibb has not yet acknowledged any lawsuits due to Eliquis but as the medication is very similar and has no antidote, it may only be a matter of time until the first lawsuits are filed.
Bristol-Myers Squibb in the Future
Bristol-Myers Squibb has nearly 30 medications in their pipeline. They have been very successful with their alliance, partnering, and acquisition strategy to accelerate drug discovery and development and over 40 percent of the pipeline has come through cooperative or acquisition agreements. The company has a long history of commercial success and despite legal liabilities will likely continue its global growth.
No announcements have been made about future acquisitions or legal issues, though the company did divest the diabetes division, including the Byetta / Bydureon line to AstraZeneca in February of 2014.