Industry pundits have been chanting about "consolidation" for years, using each new buyout as a way of proving their forecast - which, let's face it, is pretty much a fail-safe prediction.
But another, similar-yet-not-the-same idea floated by World Markets Research Centre (WMRC) is that biotechnology firms will start behaving like big pharmaceutical companies, out of necessity.
Especially in the realm of major biotech, the research center said, "increased financial clout and pipeline gaps will see a greater urgency for [yes!] consolidation. In 2004, biotechs will be as likely to in-license drugs from their smaller counterparts as to license their own developments to Big Pharma." (See BioWorld Financial Watch, Jan. 5, 2004.)
That's been the case for a while. Many observers have pointed out the way compounds often are relayed from company to company before they turn into powerfully lucrative drugs of the caliber that few expected in the early days. (See BioWorld Financial Watch, Jan. 19, 2004.)
What might be new, however, are the zones where the main clashes will take place in the coming months. Hot spots foreseen by WMRC are, among the autoimmune disorders, ankylosing spondylitis and Crohn's disease. In oncology - always an area where biotechnology strives - the indications likely to be most contested are pancreatic cancer and colon cancer.
Ankylosing spondylitis may have a name you can almost dance to, but the condition is one that can painfully limit the flexibility that jitterbugging demands. AS is the main rheumatic disorder in a group called the spondyloarthropathies and is known more simply as spinal arthritis. It strikes about three times more men than women, usually in their late teens or early 20s. Chronic pain and swelling of the back are the symptoms, along with potential effects on the eyes, heart and lungs.
Amgen Inc.'s Enbrel (etanercept), the blockbuster anti-tumor necrosis factor drug developed by Wyeth and Immunex Corp. for rheumatoid arthritis and psoriatic arthritis, is approved for AS. Coming up fast are two would-be competitors, also TNF blockers: Remicade (infliximab), from Centocor Inc., and Humira (adalimumab), from Abbott Laboratories.
Remicade, of course, is well known as an RA treatment and therapy for Crohn's disease. It's approved for both indications in North America, the European Union and Japan, and already has gained marketing clearance for AS in Europe. In October, Centocor partner Schering-Plough Corp. offered Phase III data at the American College of Rheumatology and Association of Rheumatology Health Professionals meeting that showed Remicade in AS patients yielded an increased quality of life and reduced burden of disease.
Humira is making a name for itself, too. Yet another TNF blocker, the drug is approved for RA and could get a psoriasis label in 2005 or 2006. Earlier this month, Abbott began a global Phase III study evaluating the drug for AS.
COX-2 inhibitors, a type of non-steroidal inflammatory drug (NSAID), seem promising as well. One of the more recognized compounds in that class is Pfizer Inc.'s Celebrex (celecoxib), approved in 1999 for arthritis. Another is Vioxx (rofecoxib), from Merck & Co., also given marketing clearance by the FDA in 1999 for signs and symptoms of osteoarthritis, management of acute pain in adults and treatment of menstrual pain.
The causes of AS remain obscure, but scientists have some good leads, noting the undeniable link between the disease and the HLA-B27 gene. Twenty-four varieties of HLA-B27 exist. All but two have been linked to disease susceptibility.
In fact, every form of spondylarthropathy - a disease class that includes disorders known as reactive arthritis, psoriatic spondylitis, undifferentiated spondylarthropathy, spondylitis of inflammatory bowel disease, juvenile spondylarthropathy and AS - shows a high incidence of HLA-B27.
Treatment, until the arrival of anti-TNFs, has been mainly with NSAIDs, which can relieve pain but bring side effects that might include heartburn, gastritis and bleeding. That means yet another medication to take, usually an antacid, H2 blocker or stomach-coating agent such as Axcan Pharma Inc.'s Carafate (acquired last year from Aventis SA) or TAP Pharmaceuticals Inc.'s Prevacid.
Between 350,000 and 1 million people are believed to have the disease or a related disorder, according to the Spondylitis Association of America, though AS typically goes undiagnosed for as long as 10 years. Many chalk it up to simple back pain at first.
"This is not a huge patient population," said Alex Hittle, analyst with A.G. Edwards. He acknowledged the association's numbers but said that "the issue is how many of these people are actually severe. When you get to the question of severity, you get the population coming down fairly substantially."
For Amgen, "relative to the RA indication and psoriasis and so forth, it's a nice add-on, and it's one more thing, but it doesn't open up whole new rooms for [Enbrel]," he said. "Our estimate is that the penetration rate is on the order of 5 percent. That's $150 million in sales you're adding to the Enbrel base." He noted that Enbrel's base sales are about $1.5 billion and growing.
He allowed that "down the road, many of those people [not yet diagnosed with AS] could end up being treated," but at the moment they are not figured into the sales equation - even if Amgen might hope to broaden the market.
"This is classic Amgen," Hittle told BioWorld Financial Watch. "By the time you're done with an Amgen meeting, you suspect you need some Epogen. They talk a lot about huge, untapped markets, but [it's doubtful] you're going to be able to go in there and tap those markets in people who are suffering from back pain but not grievously crippled."
Other companies may gain labels for AS but they, too, will be adding the indication to a drug already approved for some larger-market disorder.
"Nobody's starting with it," Hittle noted. "That tells you something."