Abbott’s Humira, the 3rd-in-Class Drug That Toppled Lipitor as No. 1

4/16/12Follow @xconomy

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via an intravenous infusion, which meant regular trips to the doctor. The Amgen drug had to be taken via self-administered injections under the skin twice a week. The BASF/Cambridge Antibody drug, by contrast, was designed to last longer in the bloodstream. Patients could inject themselves just under the skin, as little as once every two weeks.

As the clinical trial data mounted in the late 1990s and early 2000s, the product profile became clear. This was an anti-TNF drug that had a comparable safety and effectiveness record to its peers, and its advantage would be in convenience. Abbott agreed to pay $6.9 billion in December 2000 to acquire the BASF Bioresearch Center in Massachusetts, obtaining D2E7, and the beginnings of a massive biotech drug manufacturing center in Massachusetts. Abbott CEO Miles White, in announcing the deal, called D2E7 “a high-potential product.”

Abbott hit the ground running almost immediately with the product, named Humira, in the beginning of 2003. The price was set almost identically to the Amgen drug’s—about $1,100 a month wholesale at the time. Abbott had the good fortune to introduce its rival just at the moment when Amgen was working to boost manufacturing capacity for its drug and repair the damage done by product shortages that upset many doctors and patients.

And, just like Amgen and J&J, Abbott laid out a bold clinical development plan that said rheumatoid arthritis was just the beginning. Year after year, Abbott moved down the list, with Humira clinical trials that earned a string of FDA approvals for treating patients with related conditions like psoriatic arthritis, psoriasis, Crohn’s disease, ankylosing spondylitis, and juvenile idiopathic arthritis. Kamen, the former head of the BASF center, looks back with great pride on what Abbott did to make the most of the product. “It just might be the most valuable product ever manufactured in Massachusetts,” he says.

Despite that string of success, Abbott hasn’t been able to completely corner the market for TNF-blocking drugs. The rival J&J and Amgen products are multibillion-dollar blockbusters in their own right—on pace to be No. 2 and No. 3 on the worldwide sales chart, just behind Humira, according to Reuters. And Abbott’s reign at the top, like most anything else in life, won’t last forever. Abbott loses its key patent on the composition of matter for Humira in 2016, meaning it could face competition from cheaper “biosimilar” knock-offs. Plus, there’s competition on the way from Pfizer and others looking to develop the first oral pills for rheumatoid arthritis that can stand on par with injectable TNF-blocking drugs.

Most of the glory in innovation goes to those who get there first, proving big new concepts. In the biotech industry, Genentech rightly gets a lot of credit for groundbreaking work that showed you could fight cancer by choking off the blood supply to tumors (Avastin) and by creating the pioneering personalized medicine for breast cancer (Herceptin).

Those products have long inspired admiration in the biotech community, but innovation comes in many flavors, and Abbott has clearly earned a lot of respect from industry insiders for its accomplishment with Humira. Here’s what a few had to say Friday afternoon about lessons they took from the Humira story:

Doug Williams, who competed against Abbott as a senior executive at Immunex and Amgen: “From a patient convenience perspective, they hit the sweet spot. It was in a hot class, they were as effective as the competition, and they had what was a dosing advantage in the eyes of patients. They had the discipline to pursue it in a very systematic way. They have done a really good job.”

Abbie Celniker, the CEO of Cambridge, MA-based Eleven Biotherapeutics, which is seeking to develop targeted antibody drugs with improved properties: “The lesson is very important. They were listening to the market. Humira is easier for patients to use. While there may not have been a significant safety or efficacy advantage, over time it was recognized by patients as easier to use based on how it was delivered. That does make a difference. With a chronic disease, and when you’re on a drug for the rest of your life, it is different and has value.”

Clay Siegall, CEO of Seattle Genetics, a company developing targeted drugs for cancer: “It’s hard not to notice how well Abbott has executed. They have executed extremely well on their clinical development, distribution, manufacturing, marketing—you name it. All the pieces of the company have executed extremely well. It’s obvious. First-in-class doesn’t always win the day.”

We in the media—myself included—often gravitate to what’s first, what’s hot, and what we perceive as new. We often shrug off a “third-in-class” product as essentially old news. But the real story here, which unfolded over a period of years, is that Abbott has done a pretty amazing job of treating patients with a debilitating disease and being handsomely rewarded for it. And even more importantly, the long-term trend says that biotech drugs are ascendant, holding an estimated eight of the top 10 spots on the worldwide pharmaceutical sales list for 2014, according to Thomson Reuters.

Siegall, who has spent his career developing targeted antibody drugs, says he takes a certain amount of pride from a distance in seeing a biotech drug at the top of the heap.

“I do take pride in that, that biotech and biologics have made a positive impact on patients’ lives,” Siegall says. “I take more pride in that than I do with the business aspects that come with being No. 1 or No. 2 or No. 3. It’s hard to make it to No. 1, and it’s even harder to stay there. But biotech has really helped people, and I love to see it keep helping more people.”

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