#12 Abbott Laboratories

100 Abbott Park Rd., Abbott Park, IL 60064
Tel: (847) 937-6100   Fax: (847) 937-9555
www.abbott.com

Headcount	68,000
Year Established	1888
Pharma Revenues*	$14,632	+9%
Total Revenues*	$25,914	+9%
Net Income	$3,606	+35%
R&D Budget	$2,505	+12%

* 2006 revenues did not include TAP Pharmaceutical Products income

Top Selling Drugs
Drug	Indication	Sales	(+/-%)
Humira	rheumatoid arthritis	$3,064	+50%
Depakote	bipolar disorder	$1,575	+20%
Kaletra	HIV/AIDS	$1,325	+17%
TriCor	cholesterol	$1,218	+16%
Ultane/Sevorane	anesthetic	$759	-5%
Biaxin	antibiotic	$724	-11%
Niaspan	cholesterol	$658	n/a
Synthroid	hyperthyroidism	$533	flat

Account for 67% of total pharma sales, up from 62% in 2006.

PROFILE

With the exception of being accused of “product switching” by generic manufacturer Teva — which is dying to launch its TriCor equivalent — Abbott went under the radar in 2007 but came through loud and clear in the battle of the autoimmune disease blockbuster biologics. Its flagship Humira barreled through 2007, gaining its fifth indication and surpassing an impressive $3.0 billion in sales, just shy of its closest rival, Johnson & Johnson’s $3.3 billion in Remicade sales. Which drug will take the lead in 2008? Humira sales were $878 million (+54%) in 1Q08 and Remicade sales were $1 billion (+37%) — it’s too close to call at this point, and with ever-increasing drug safety concerns, it’s hard to say.

Early in the year, the FDA approved Humira for Crohn’s Disease, and in early 2008 added treatment of psoriasis and juvenile rheumatoid arthritis. Humira is also being studied in ulcerative colitis, which is currently in Phase III development. Additional indications and long-term efficacy studies are making Humira the company’s most successful drug ever. 

The Lowe Down: Abbott Labs Abbott continues to roll along with drugs, diagnostics, and devices, and they seem reasonably happy with that mix. It doesn’t seem to be a golden age over there, exactly, but when you compare them to the rest of the industry they’ve looked pretty stable. But this has been the Year of Risk Assessment in the industry and the FDA, and Abbott is getting hit pretty hard right now, with both Humira and Depakote (and the others in their classes) being examined. I think the company is broad-based enough to get past these problems, and their relative lack of big patent expirations has to help, but no safety review makes anyone any happier — not the patients, not the company. One odd thing: you could actually assemble a pretty good-sized company out of all the ex-Abbott people around the industry. I’m not sure why that is, but there sure are a lot of them. —Derek Lowe

Needless to say, Abbott’s pharmaceutical business is holding its own, with sales up 18% to $14.6 billion thanks to blockbusters, Humira, Depakote, Kaletra and TriCor, and a pipeline poised to deliver several new drugs in the next year or so. The company’s diagnostics business, which includes medical products, also delivered. Sales were up 11% to $3.2 billion with vascular sales contributing more than half of that number ($1.7 billion, up 54%) thanks to international sales of Xience V, Abbott’s next-gen drug-eluting stent, as well as abating safety concerns in the stent market. In July 2008, the stent was approved in the U.S. The company’s success and focus on this aspect of the business may help differentiate it from other drug-focused competitors (except J&J, of course).

The big news this year was Abbott and Takeda ending the successful 30-year-old TAP joint venture, which produced revenues of $3.1 billion in 2007. In March, the two companies decided to go their separate ways and split the assets, which include two currently marketed products, Prevacid and Lupron, and two NDAs under FDA review, TAK-390MR for acid related diseases, and febuxostat, a treatment for gout. The strategic split establishes an on-market presence in oncology for Abbott with rights to the cancer drug Lupron, as well as cash payments for the next five years based on TAP’s other current and certain future products. 

Although considerable restructuring initiatives in the industry were rampant this past year, Abbott’s restructuring phase appears to have reached or at least neared its end — we’ll have to wait and see if any streamlining lies ahead. Plans for 2005-2007 included realigning its worldwide pharmaceutical and vascular manufacturing operations and selected commercial and R&D operations to reduce costs. In 2007, Abbott implemented facilities restructuring plans related to the acquired operations of Kos Pharmaceuticals, Inc., eliminating 200 research jobs — mostly related to early stage compounds for which Abbott discontinued development — and several hundred sales jobs in an effort to eliminate redundancies created by the $3.7 billion acquisition.  

The company appears to be maintaining control of manufacturing operations in an effort to advance some of its products using the latest, top-of-the-line facilities and equipment. Abbott made its largest capital investment to date last April, when it opened a $450 million state-of-the art biologics manufacturing facility in Puerto Rico to keep up with Humira demand and to support other future biologics. In June of this year, Abbott opened its new formulation development center at its headquarters in Abbott Park, IL, taking on the capabilities for the formulation of new investigational drugs for trials with the goal of this state-of-the-art center to expedite development programs, creating a link between the R&D lab and commercial manufacturing.

On the cholesterol front, Abbott received FDA approval this February for Simcor, the first fixed-dose cholesterol therapy combining, Niaspan (its niacin extended-release) and simvastatin. Simcor is approved for lowering total cholesterol levels, LDL “bad” cholesterol and triglycerides, and to raise HDL “good” cholesterol in patients when treatment with simvastatin or Niaspan monotherapies don’t work. Abbott dodged a bullet when in May the FDA rejected Merck’s cholesterol drug Cordaptive (niacin ER/laropiprant), which combines niacin with a new chemical entity, laropiprant, designed to minimize a skin-related side effect.

Also, Abbott and AstraZeneca are working together to co-develop and market a fixed-dose combination of TriLipix and Crestor to treat high cholesterol. Thanks to positive Phase III results announced in June, the companies plan to submit an NDA in 2009. 

In the pain arena, the company is working on an extended release version of its pain drug Vicodin. Taken twice daily, Vicodin CR with 12-hour dosing would outlast the currently available short-acting combinations that need to be taken every four to six hours. The NDA for Vicodin CR was submitted to the FDA in 4Q07.

In other lipid-lowering news, offering a lower dose of the blockbuster drug TriCor — and changing it from a capsule to a tablet — didn’t make Teva Pharmaceuticals happy, as Teva has been chasing the opportunity to market a generic version of the drug for years. Teva is claiming that Abbott is blocking generics by obtaining term-extending patents on the 33-year-old cholesterol drug. This isn’t against the law (neither is frustrating generic competition, for that matter) therefore Teva’s looming generic remains on hold. The dissolvable version of TriCor retains patent protection until 2018.

Nonetheless, the FTC is investigating Teva’s lawsuit alleging that Abbott acted improperly by employing “product switching,” which involves retiring an existing drug and replacing it with a modified version that is marketed “new and improved” solely to preserve its monopoly on the drug. Abbott denies these allegations. So far, 18 states and the District of Columbia have filed suit against Abbott for the alleged scheme.  

The patent expiration for Depakote for bipolar disorder expired this July and generics are ready to move. In 2007 sales were $1.6 billion, up 20%. No word on a “new and improved” version.  —KB

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For the full profile, including pipeline and patent information, download the PDF.