The biggest news coming out of Abbott recently is the decision to split the company into two completely separate entities:
a research-based pharmaceuticals company (where Humira will reside), and a diversified medical products division. Miles White,
Abbott's CEO since 1998, will preside over the diversified medical products company (which will retain the name Abbott), and
Richard Gonzalez, currently executive vice president, global pharmaceuticals, will become chairman and CEO of the as-yet-unnamed
pharmaceutical company. The official reason for the split, according to company statements, is that the businesses were growing
in opposite directions. "The profile of the diversified group and the profile of the investor on the pharma side have really
diverged," says Stewart. Others have speculated that Humira's importance in the overall valuation of Abbott, and the drug's
inevitable patent loss down the road, could effectively harm other aspects of the business. Whichever motive is closest to
the mark—and it's likely a combination of the two—one thing is clear: with respect to anticipating the market, White was something
of a soothsayer when it came to Humira.
When Abbott announced that it would acquire BASF's pharmaceutical business, known as Knoll, in December 2000, Abbott's stated
goal was to "broaden its global infrastructure, acquire late-stage and marketed products, increase its pharmaceutical R&D
spending significantly, and access leading monoclonal antibody technologies," according to the issued press release at the
time. The last goal was the crucial one; Knoll's monoclonal antibody, called D2E7, came in with the purchase. In the release,
White said the acquisition would help to build Abbott's footprint in Europe and Japan, adding that, "Importantly, the acquisition
will also bring leading monoclonal antibody technology, and a strong research presence in immunology with a high-potential
product, D2E7 for rheumatoid arthritis." High potential indeed, considering Abbott paid $6.9 billion for BASF/Knoll, and Humira
earned almost $8 billion last year. Synthroid, a thyroid hormone already on the market, came with the acquisition too, and
has earned steady profits—it cleared $500 million in the U.S. in 2011, and sales were $638 million in total, a 14 percent
increase year-over-year. Sales of Synthroid have easily paid a chunk of the acquisition cost over the last 10 years. The acquisition
"was a little before my time," says Stewart, but "I have to give management a lot of credit—that was excellent anticipation
in terms of the changing mix between small molecules and large molecules like biologics."
The acquisition and subsequent development of Humira has had no small impact on the pharma sector and its direction, and hundreds
of thousands of patients with severe autoimmune diseases have used Humira to improve their quality of life. As biologic drugs
become increasingly prescribed and used, education for physicians—but especially patients—will be critical. While it's important
that patients know about potential drug side effects—they need to understand occurrence rates better, through quantitative,
not qualitative risk/benefit presentation—they also need to know about the risks of abstaining from medication. "My nephew
has severe Crohn's, and he lost his entire intestine, but now he's on a TNF inhibitor," says Ladd. "His mother and father
wouldn't put him on it until he nearly died, partly because they hear about all of the side effects of the drugs, and not
the side effects of the condition. Had my sister-in-law and brother been told that their son's condition is so severe that
he could end up with a life-threatening condition, or have to use a bag the rest of his life, they probably would have put
him on it," she says. As biopharmaceutical companies develop the next generation of biologic drugs for autoimmune diseases
and other conditions, they will need to maintain a focus on patient education; FDA could expedite this process with better
risk communication guidelines.
In 2011, Humira sales grew in all of the "big three" indications, due in no small part to patient communications, says Stewart.
"We were really able to talk to the consumer like never before in 2011 ... there was significant push in disease awareness,
mass-media campaigns, and branded Humira commercials." Given the low penetration rates, it makes sense to reach out to patients
with educational messaging. "I'm very proud of the way we've handled that, and I think it has aided both patients and the
performance of the brand," he said.