The pharmaceutical industry relies on big successes. Drug companies pour hundreds of millions and even billions of dollars into pharmaceutical development, hoping that one will bring in the big bucks and make the whole process worthwhile.
For example, AbbVie’s Humira, which is used to treat several autoimmune diseases, made $19.8 billion for the company in 2018, accounting for approximately 61% of AbbVie’s net revenue that year.
But for every Humira, there are plenty of drugs that fail to live up to their initial promise. Drug-makers misjudge the market, their drugs sputter during clinical trials, and others fail so spectacularly as to spur the downfall of their makers.
Here are five of the most spectacular pharma failures.
Eli Lilly’s Xigris
Xigris was a drug developed by Eli Lilly in the early 2000s for treating sepsis. At the time, the company was about to lose its patent on Prozac and was eager to find its next big hit. Analysts estimated the drug would make as much as $2 billion over three years, with one calling it “an absolutely phenomenal opportunity” to target the “practically untapped market” of doctors in intensive care units.
The drug was approved by the FDA in late 2001, but its ROI was underwhelming. In September 2002, research shed doubt on the drug’s efficacy, with an article in the New England Journal of Medicine concluding that “the data are encouraging but insufficient to make Xigris the standard of care.”
The final nail in the coffin came after several physicians with the NIH criticized Eli Lilly’s actions in promoting Xigris. This included funding a task force called “Values, Ethics and Rationing in Critical Care,” which put out the word that doctors were “rationing” the pricey drug and financing a group called the Surviving Sepsis Campaign.
In 2006, the drug made just $98 million worldwide, a far cry from the $2 billion analysts initially forecasted and a 16% drop from the previous year’s sales.
Pfizer had high hopes for Torcetrapib, a cholesteryl-ester transfer protein inhibitor (CETP inhibitor) designed to manage cholesterol levels. The drug was the company’s best effort at taking the crown from Lipitor, which was one of the most profitable drugs of its time, with sales of more than $11 billion.
Pfizer spent more than $1 billion and 15 years developing the drug. In 2006, the pharmaceutical giant approached the FDA for approval. Quickly, everything fell apart.
In December, Pfizer announced it would pause development of the drug, which was in phase III trials at the time. It was later revealed that an independent Data Safety Monitoring Board had advised they halt development due to unexpected mortality and cardiovascular incidents during the 15,000-person trial. Researchers had found that patients taking torcetrapib with Lipitor were dying at a higher rate than those taking just Lipitor. And worse, they couldn’t figure out why.
The drug wasn’t the only casualty of the failure. Soon after it was discontinued, Pfizer cut 10,000 jobs due to financial losses.
Relenza (zanamivir) was originally developed by Biota before GlaxoSmithKline purchased the license for the drug in 1990. At the time, avian flu had led to greater public awareness of the dangers of influenza and Relenza was one of only two pandemic flu drugs approved for sale by the FDA. Not only had trials demonstrated that Relenza was more effective than Tamiflu, but it was also cheaper. GlaxoSmithKline felt it was onto a winner, but Tamiflu proved the better seller.
Relenza was beset with problems. The drug was only approved for use as a flu treatment, while Tamiflu could be used as a preventative. Its pill and liquid forms were only approved for children over the age of seven, while its competitor could be given to patients as young as two. To make matters worse, the powder form of Relenza led to respiratory problems in some patients.
In 2006, the drug made just $13 million for GlaxoSmithKline, while Tamiflu took the market for a total of $770 million in just the first half of the year. Biota ended up suing GlaxoSmithKline in 2004 for failing to market its drug properly, with Biota’s CEO claiming, “Relenza should be a billion-dollar product.”
In 1986, Upjohn (which later became part of Pfizer) saw Rogaine (minoxidil) as a sure-fire cash cow. Its claim to restore hair for bald men earned the drug a profile in Time magazine, and sales increased from $14 million in 1984 to $33 million in 1986.
However, the good times didn’t last. The FDA noted that press releases from the company featured “misconceptions and false impressions of safety and efficacy,” and reports from the press pointed out that the drug worked much better for young men with thinning hair, compared with older men who’d lost most of their locks.
By 1989, Rogaine only accounted for $11 million of the company’s $755 million in net sales over the first quarter. Ultimately, generic competition pushed it largely out of the market.
Nektar Therapeutics’ and Pfizer’s Exubera
Pfizer and Nektar Therapeutics believed that Exubera, a diabetes treatment that could deliver insulin through an inhaler rather than a shot, would be a big earner, anticipating it would generate more than $1.5 billion in annual sales in 2010. They were so sure, in fact, that just before the drug was approved in 2006, Pfizer purchased Sanofi-Aventis’ share of the drug for $1.4 billion.
However, in the first quarter following its approval, Exubera made just $4 million, capturing only 1% of the insulin market. Part of the problem was that the inhaler was large—roughly the size of a can of tennis balls—with some even comparing it to a bong. Research wasn’t kind to the product either, linking it to reduced lung function. Pfizer ultimately stopped producing Exubera, leaving the company with a $2.8 billion charge.
And finally, now that you’ve read about some of the most colossal drug flops, you may need a little pick-me-up. Click here to go back in time and read about some drugs that were so successful they revolutionized the medical landscape, at MDlinx.