About Abbott / AbbVie
AbbVie Inc. is an Illinois-based pharmaceutical company that specializes in the production of biopharmaceuticals which was formed as a spinoff of pharma giant, Abbott Laboratories.
AbbVie is the manufacturer of the blockbuster medication, Humira is the largest selling drug in U.S. history and is used to treat autoimmune disorders such as Rheumatoid Arthritis, Psoriasis, and Crohns disease. Humira generated estimated worldwide sales of $19.9 billion in 2018, with over $13.7 billion in the US alone. Though the drug has been available since 2002, sales continue to grow as new uses are approved.
AbbVie’s main focus has been development of new, biopharmaceutical medications to treat complex disorders in virology, oncology, immunology, and neuroscience. AbbVie operates eight research centers, six of which are in the U.S.
AbbVie manufactures about 30 products that are marketed in over 175 countries worldwide with total 2013 global revenue of $33.3 billion and has approximately 30,000 employees. AbbVie has over 50 products in their research pipeline in the areas of immunology, virology, oncology, ophthalmology, eye disorders and a newly emerging field, aesthetics.
The company also manufactures AndroGel, a top-selling testosterone replacement gel that generated $1.04 billion in 2013 sales with 60% of the market, but which has faced serious concerns about marketing and safety.
History of AbbVie and Abbott
Abbott Laboratories was once one of the largest pharmaceutical companies in the world with a history dating back to 1888. Abbott premiered the “new” idea of production of “dosimetric granules” or tiny pills that offered a dramatic improvement over the handmade tablets that had been produced by individual pharmacists.
AbbVie was spun off from the pharmaceutical giant Abbott in 2012. It was the second spin-off undertaken by Abbott Laboratories who had split in 2004 to form a separate company, Hospira. Hospira had taken the hospital products division from Abbott to become the largest US manufacturer of injectable drugs and infusion technologies. Hospira produced more than $4 billion in 2013 revenue and is publicly traded as HSP on the NYSE.
In the 2012 split, AbbVie was established as the primary research and development company of Abbott’s branded pharmaceuticals and took the top Abbott products including Humira, AndroGel, Vicodin, Kaletra, TriCor and Niaspan. Abbott retained the diagnostics, medical devices, and nutritional divisions, along with the company name and a large generics business. In the first year of trading as a separate publicly listed product, AbbVie (ABBV) showed revenue of nearly $18.8 billion in worldwide sales.
In 2014, AbbVie began a series of acquisitions including:
- ImmuVen 2014
- Pharmacyclics 2015
- Stemcentrx 2016
- Allergan 2019
- Mavupharma 2020
AbbVie also conducted collaborations with Synlogic, Argenx, CytomX, Calico and Galapagos, however an attempt to acquire Shire pharmaceuticals was stopped in 2014.
As of 2019, AbbVie has shown estimated revenue of over $35 billion annually, most of which comes from the still-lucrative Humira brand which continues to expand in therapeutic use worldwide.
AbbVie currently markets around 30 separate products and has 50 developing drugs in its pharmaceutical pipeline.
Current Notable Products include:
Humira (adalimumab) is the best-selling pharmaceutical product of all-time in the U.S. It has estimated revenue of nearly $20 billion annually, with sales continuing to increase 18 years after its introduction. As a biologic, Humira is not expected to experience generic competition due to difficulty of manufacturing processes.
Abbott Product Issues
Though AbbVie has faced legal difficulties with AndroGel, the product was originally produced by Abbott Laboratories who also had a history of trouble with recalls, manufacturing violations and improper marketing dating back to the late 1960’s.
Some of the most notable issues over the life of Abbott, include a recall of over 200 products from 1969 to 1971 due to reports of bacterial blood poisoning or septicemia which resulted in approximately 50 deaths and 400 injuries from contaminated IV solutions. A 1971 for-cause investigation by the FDA found “objectionable” conditions of the building and equipment at Abbott’s North Carolina manufacturing plant where the IV solutions originated.
Abbott and five company officials were indicted for violation of interstate shipping regulations due to the contaminated products, and though all charges were dismissed, a 1976 report from the Centers for Disease Control and the FDA indicated bacterial contamination of the screw cap closures of the solutions.
In 2012, the company was accused of illegal marketing of Depakote, a top-selling anti-seizure medication and agreed to pay $1.6 billion to settle the claims. In 2013, Abbott was fined $524 million for paying kickbacks to physicians who used Abbott medications to treat circulatory disorders. A slew of blood glucose monitoring devices were also recalled in February of 2014.
With the 2013 split, AbbVie has assumed partial liability for the brand-name pharmaceutical products including AndroGel, though Abbott may still be named in lawsuits.
AbbVie and AndroGel Testosterone Replacement
Testosterone replacement therapy is approved to treat hypogonadism with low testosterone levels in men. AndroGel and other topical testosterone replacement medications have been prescribed for men with “Low-T” but many have never had their levels tested and some statistics have shown that 2 percent of all men over the age of 40 may be taking testosterone replacement therapy (TRT) for “Low-T” symptoms, many of which are similar to natural occurrences of aging and may not be attributed to low testosterone at all.
AndroGel is the number one selling testosterone replacement production the U.S. and has been the second largest AbbVie revenue producer. Like other testosterone products, AndroGel is approved to treat men with hypogonadism, a condition in which the male testes do not make enough testosterone. Millions of men are using testosterone replacement therapy for “Low-T” which is a term used in marketing of the therapy.
Even though there are a large number of testosterone replacement products on the market, AndroGel, produced by AbbVie garners approximately 60 percent of the market for testosterone replacement. Sales of testosterone products have nearly doubled in the past 5 years with the total market currently estimated at over $2 billion annually. The medication has caused severe side effects for hundreds of men resulting in personal injury lawsuits against AbbVie and other manufacturers.
Estimates show that over half of the men who use “Low-T” products, have not been tested for low testosterone levels and may not have the condition.
Testosterone has been shown to increase the risk of dangerous and possibly deadly medical conditions such as:
- Heart Attack
- Development of Blood Clots
Testosterone can also cause other side effects such as:
- Increases in sleep apnea
- Low sperm counts (oligospermia)
- Breast development in men (gynecomastia)
- Aggressive behavior
- Weight gain and edema
When a woman or a child comes into contact with the gel, even by skin to skin contact with a man using testosterone topical treatments, problems related to the hormone can develop such as:
- Premature puberty in boys
- Gynecomastia in boys
- Masculinization in women and girls (body hair growth, weight gain, deepening of the voice)
- Reproduction abnormalities
Recent studies and cases indicating a clear threat of severe side effects such as stroke, heart attack and blood clot risk have prompted the Food and Drug Administration to re-examine TRT products. Many men have been injured by testosterone replacement and several deaths are attributed to the medication. Hundreds of lawsuits have been filed against manufactures of testosterone replacement medications including many by users of AbbVie’s popular product, AndroGel.
Lawsuits claim that AbbVie and Abbott used aggressive marketing tactics with the “Low-T” approach and did not encourage the testing of blood concentrations of testosterone. Attorneys for the plaintiffs also claim that the manufacturers have downplayed the risk of serious adverse events which have resulted in permanent or life-threatening medical conditions. None of the testosterone lawsuits have been settled and many more are expected.
AbbVie in the Future
AbbVie has over 30 medications in the “late-stage” pipeline, which means approval may take place in the next several years if shown to be safe and effective. Dozens of additional pipeline drugs are in earlier stage development.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.