seems the fda is realy changing its pace
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Reuters
UPDATE - Abbott wins early US ok for key arthritis drug
Tuesday December 31, 6:38 pm ET
By Ransdell Pierson and Edward Tobin
(Adds details, quotes, share price, paragraphs 2, 9, 14-15)
NEW YORK, Dec 31 (Reuters) - Abbott Laboratories Inc. (NYSE:ABT - News) on Tuesday said U.S. regulators had approved its rheumatoid arthritis treatment, Humira, and said it sees sales of the drug reaching $1 billion because it is easier to administer than rival treatments and may be safer.
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The approval, which had not been expected until mid-2003, is a huge boost for Abbott. The suburban Chicago-based company has struggled recently with quality control problems at its diagnostics division and safety concerns surrounding its diet drug Meridia.
Humira will compete against Amgen Inc.'s (NasdaqNM:AMGN - News) Enbrel and Johnson & Johnson's (NYSE:JNJ - News) Remicade. All three products work by blocking a protein called tumor necrosis factor that causes inflammation which attacks the joints.
"This is a drug that Abbott really needed to take its pharmaceutical business to the next level," said analyst Jan Wald of A.G. Edwards & Sons, who doubled his revenue forecast for Humira to at least $120 million next year because it will reach patients months earlier than expected.
Wald sees Humira eventually generating $800 million to $1 billion a year. Abbott, which sells prostate treatment Flomax and nutritional product Ensure, has global annual sales of about $16 billion.
Amgen's Enbrel had revenues of $762 million in 2001, but its sales are expected to soon soar thanks to completion of a new manufacturing plant that will ease shortages of the popular injectable drug.
"We are projecting Humira to have sales of at least $1 billion and it could go higher if it is approved for other uses," Steven Fischkoff, a senior Abbott research executive, said in an interview.
Rheumatoid arthritis is an inherited disorder in which the immune system attacks the body's own tissue, resulting in inflammation of the joints of the fingers, wrists, knees and other parts of the body. The crippling disease affects an estimated 5 million people worldwide.
Humira is also being studied in late-stage trials for treatment of psoriasis and Crohn's disease, an inflammatory bowel condition.
Fischkoff said rheumatoid arthritis patients only need two injections per month of Humira, compared with eight monthly injections of Enbrel. Moreover, Humira comes in a pre-filled syringe, whereas patients must mix powder and liquid to create Enbrel.
J&J's Remicade is typically given only once every two months, but requires a visit to the doctor's office for an intravenous infusion.
Remicade, a monoclonal antibody that is 25 percent mouse particles, can also cause allergic reactions in some patients. Some patients also develop a resistance to the drug.
Humira, also a monoclonal antibody, is made from all human materials that Abbott said are less likely to cause reactions.
Abbott acquired Humira, formerly known as D2E7, in its $7 billion purchase of Knoll Pharmaceuticals from Germany's BASF (XETRA:BASF.DE - News) in March 2001.
"Humira is very important for Abbott because it one of first drugs to come from its acquisition of Knoll, and it has a better safety profile and better dosing regimen than rival drugs on the market," Wald said.
Abbott will sell the medicine worldwide and give a 5 percent royalty to Britain's Cambridge Antibody Technology Plc (London:CAT.L - News), which helped develop it.
Shares of Abbott closed up $2.90, or 8 percent, to $40 on Tuesday on the New York Stock Exchange. |
