Abbott and AstraZeneca combine cholesterol drugs
take on the $21.6bn (€15.8bn) cholesterol market with a combination
drug.
The two companies will advance the development of Abbott's next-generation fenofibrate ABT-335 and AstraZeneca's Crestor (rosuvastatin calcium) in a fixed-dose combination treatment into Phase III trials.
The new pill would directly compete with Merck & Co's and Schering-Plough's combination drug Vytorin (simvastatin and ezetimibe), marketed as Inegy in the US, which netted $1.96bn (€1.44bn) in sales last year, reflecting a 90 per cent increase over the full year of 2005.
Merck & Co and Schering-Plough also recently announced they would embark on a project to develop a new product combining ezetimibe with atorvastatin, the active ingredient in Pfizer's Lipitor, which looses patent protection in 2010.
The Abbott/AstraZeneca combination drug would target all three major blood lipids - LDL-C "bad" cholesterol, HDL-C "good" cholesterol, and triglycerides.
Based on the significant progress made in the drug's development programme, the two companies decided to move forward with the therapy.
"This decision highlights the opportunity for broader treatment in many higher at-risk populations," Abbott global pharmaceutical clinical development vice president Eugene Sun said in a statement.
"We're looking forward to exploring the potential of a combination treatment to address the needs of patients."
AstraZeneca strategic development vice president James Blasetto said: "The combination of Crestor and ABT-335 may be an important option to help patients with mixed dyslipidemia achieve their treatment goals."
Next-generation fenofibrate ABT-335 is an investigational compound belonging to the class of medications called fibrates, which have been shown to raise HDL-C, reduce triglycerides and moderately lower LDL-C. Other drugs on the market that contain fenofibrate include Oscient Pharmaceuticals' Antara, Abbott's Tricor, Cipher Pharmaceuticals' Lipofen, and Sciele's Triglide.
The current fenofibrate market was worth $1.7bn (€1.2) last year, which represented a 16 per cent increase on the previous year.
In the US alone, fenofibrate sales totalled $1.3bn in 2006.
Abbott plans to file ABT-335 as a monotherapy (as an adjunct to diet) by the end of this year, based on positive results from clinical trials, but the US-based company is also evaluating the drug as a co-administration therapy with other statins on the market.
Statins, such as Crestor and Lipitor, can significantly reduce levels of LDL or "bad" cholesterol in the blood in two ways.
They slow production by inhibiting an enzyme in the liver called HMG-CoA reductase.
Statins also increase the ability of the liver to remove LDLs from the blood by stimulating LDL receptors.
However, they only have a moderate ability to increase levels of HDL or "good" cholesterol.
According to the American Heart Association, more than 140 million US adults have excessive total blood cholesterol values.
Last year, Pfizer was forced to stop trials on torcetrapid, which would have been prescribed as a combination treatment with Lipitor, after an independent safety board found an imbalance of mortality and cardiovascular events.
Submission of a regulatory application for the ABT-335/Crestor combination drug is targeted for 2009.