9 Diseases Treated by One Drug

You might call it the Swiss army knife of pharmaceutical drugs.

Since it hit the market in 2002 to treat rheumatoid arthritis, Humira has racked up one governmental approval after another to treat maladies ranging from your scalp (itchy, painful red patches) to your midsection (rigidity of the spine), to your entrails (inflammation of the colon).

And the approvals keep coming. Earlier this month, the drug's maker, AbbVie of North Chicago, won approval from the Food and Drug Administration to market Humira for yet another condition: inflamed lesions around the armpits, groin, buttocks and breasts.

The latest approval could generate an additional $1 billion a year in sales, the company said. Last year, Humira rang up $12.5 billion in sales, up 18 percent from a year earlier, making it the top-selling drug in the world.

One drug. Nine conditions.

And AbbVie isn't done. It is studying whether Humira can also treat eye inflammation and fingernail psoriasis.

It's the latest example of how drugmakers, under enormous pressure to bolster sales, are wringing every possible use out of existing drugs. It's happening at a time when the cost of developing new drugs keeps climbing, and insurance companies and government reimbursement programs are demanding lower prices.

"Drug companies are under stress," said Joseph A. DiMasi, director of economic analysis at the Tufts Center for the Study of Drug Development in Boston. "There is a greater need to seek out more revenue streams from existing drugs."

A few drugs have even notched up more than 20 approved uses, including the antipsychotic aripiprazole (24 uses), antibiotic ofloxacin (21 uses) and growth hormone somatropin (20 uses), according to a study DiMasi published in the journal Clinical Therapeutics in 2013.

Finding new revenue streams is an even more urgent goal at AbbVie. Humira will lose its patent exclusivity late next year, meaning it will likely face so-called biosimilars, lower-cost versions of the brand-name drug. Morningstar estimates AbbVie could lose nearly 40 percent of its revenue by 2020. Six biosimilars are in late-stage development, including products by Amgen and Novartis, Morningstar analyst Damien Conover said.

At the same time, he said, newer arthritis drugs on the market could steal sales from Humira, including Pfizer's Xeljanz, because such drugs can be taken orally, rather than through twice-monthly injections like Humira.

Humira has long been a moneymaker for AbbVie, accounting for about two-thirds of the company's total sales of $19.9 billion last year.

Meanwhile, AbbVie is investing heavily in research and development, trying to come up with other big winners. Last year, the company spent $3.3 billion on R&D, or 17 percent of sales, and said it had 40 experimental treatments in its pipeline, including 13 in late-stage clinical trials, in such areas as immunology, liver disease, cancer, renal disease, neurological diseases and women's health.

But AbbVie has had a tough time getting new products across the goal line. In the past few years, it has launched only one drug, Viekira Pak, which treats hepatitis C, and sales have been modest. In the second quarter, Viekira Pak rang up sales of $385 million, slightly below analysts' forecasts. The overall picture has made investors nervous. Since Jan. 1, shares of AbbVie have fallen 10.4 percent.

In the meantime, another use for Humira could buy a little more breathing room for the company.

Some analysts and investors say it's smart for a drugmaker to try to develop and market the most uses possible out of a single product. Cost is a factor. Developing and testing a brand new drug, from start to finish, can cost billions. But outlays for testing an existing drug for additional uses can amount to only a fraction of that, and pay huge dividends.

That's because drug companies usually don't have to repeat early-phase studies to determine such basic scientific findings as how a drug is absorbed and metabolized, or determining safe dosage levels — steps that every new drug goes through.

"If you've already sunk that money into testing a drug once, you don't have to do it every time," said Les Funtleyder, a health care portfolio manager at E Squared Asset Management, a New York hedge fund. "From a financial perspective, it's a good thing."

Last year, drug companies spent $51.6 billion to research and develop drugs, according to trade association Pharmaceutical Research and Manufacturers of America. Of that, $10.2 billion was spent in preclinical laboratory research — a type of expense they could avoid in studying additional uses for a drug that is already approved.

In fact, there's a term for coming up with new uses for an existing drug: "lifecycle management." Pharmaceutical companies do it to maximize return on investment.

"Each new, FDA-approved indication opens up new patient populations as potential customers, and also helps differentiate a brand from its competitors," said Megan DiSciullo, spokeswoman for PricewaterhouseCoopers in Chicago, which does consulting work for health care clients.

AbbVie declined to say how much it spent to test Humira for the latest use, to treat painful lesions known as moderate to severe hidradenitis suppurativa. The company said it tested the drug on 633 patients around the world. That compares with thousands of patients typically tested in late-phase trials for some major drugs, on top of hundreds in earlier stages.

How much additional revenue and profit a drugmaker stands to reap from finding new uses for existing drugs varies widely. DiMasi said factors include the type of disease the drug would treat and the number of competing products. Some drugs can generate billions of dollars for new uses.

Humira also won an important "orphan drug" designation earlier this year from the FDA, a status given to drugs that treat rare diseases such as Japanese encephalitis or congenital fibrinogen deficiency. That gives Humira the potential to be granted seven years of market exclusivity for treatment of the hidradenitis suppurativa, even as it loses exclusivity next year for other uses, and competitors can move in with similar products.

AbbVie said Humira can treat so many conditions because they have something in common: inflammation in the body linked to a small protein called TNF-alpha. The protein circulates in the bloodstream and can hit in different areas, from the skin on your neck to your finger joints to your intestines.

Excess TNF-alpha can be measured in the joints of arthritis patients, the skin of psoriasis patients and in the gastrointestinal tract of Crohn's patients, said John Medich, AbbVie's vice president of clinical development for immunology. Humira works by blocking the TNF-alpha. The drug is injected under the skin.

The latest condition that Humira is expected to be approved for is a medical breakthrough, Medich said. Previously there were no treatments for hidradenitis suppurativa. People tried to manage symptoms with antibiotics and steroids, he said.

About 200,000 people suffer from the condition. "It can be very painful for patients ... and can really prevent them from functioning normally in their daily lives," Medich said.

Like other anti-inflammatories, Humira carries severe risks. The drug affects the immune system and can lower the body's ability to fight infections. That has led to some patients getting serious infections, including tuberculosis, and deadly infections caused by viruses, fungi or bacteria that spread throughout the body. The FDA requires Humira to carry a "black-box warning" on the label, the strictest type of drug warning.

And for some people taking Humira, the chance of getting lymphoma or other cancers, sometimes fatal, may increase, the drug label warns.

The company spent $363 million last year on direct-to-consumer advertising, trailing only industry leader Pfizer, which spent $1.1 billion, according to Nielsen, a media research firm. Of AbbVie's spending, $203 million went toward advertising Humira for arthritis and psoriasis.

Some industry critics who have blasted other drugmakers for promoting drugs for multiple conditions say AbbVie seems to have scientific reasoning behind promoting Humira's multiple uses.

"They seem to have a biologically plausible rationale for treating lots of similar conditions with one product," said Shannon Brownlee, author of "Overtreated: Why Too Much Medicine is Making Us Sicker and Poorer. "It's harder to justify when you see an antidepressant being promoted to treat fibromyalgia, for example."

Dr. Michael Carome, director of Health Research Group at Public Citizen, a consumer and health advocacy group in Washington, said there are medically sound reasons for using a single drug to treat related diseases, like those connected to inflammation.

"To the extent that the drug targets inflammatory pathways that is shared by many diseases, that makes sense," he said.

jrussell@tribpub.com

Twitter johnrussell99

One drug, many treatments

Humira at a glance

Launched: 2002

Sales (2014): $12.5 billion, making it the world's top-selling drug

Maker: AbbVie of North Chicago

Approved to treat:

•Rheumatoid arthritis in adults (2002)

•Psoriatic arthritis (2005)

•Ankylosing spondylitis in adults (2006)

•Crohn's disease in adults (2007)

•Chronic plaque psoriasis in adults (2008)

•Polyarticular juvenile idiopathic arthritis in children (2008)

•Ulcerative colitis (2012)

•Crohn's disease in children (2014)

•Hidradenitis suppurativa (2015)