Amgen, Pfizer eye blockbuster purse in next leg of PCSK9 cholesterol drug race

Amgen ($AMGN) is readying to lift the curtain on data from four mid-stage studies for a major star in its experimental drug pipeline. The monoclonal antibody, AMG-145, has the potential to deliver the biotech giant a blockbuster hit if the compound can continue to generate positive results in clinical trials. Yet the company is seeking the spotlight on a crowded stage of similar drugs in development from Big Pharma rivals.

Industry-watchers are anticipating data presentations on several PCSK9-targeting drugs next week at an American Heart Association scientific meeting, as the experimental drugs represent one of the largest new classes of drugs to combat LDL or "bad" cholesterol, Bloomberg reports. Amgen will reveal how its candidate performed in trials that focus on patients with a genetic condition that leads to high cholesterol, those who can't tolerate statins and others. The data will help analysts evaluate how AMG-145 stacks up with experimental rivals from Sanofi ($SNY)/Regeneron ($REGN), Pfizer ($PFE) and Roche ($RHHBY). Pfizer is also unveiling results at the meeting next week.

Amgen aims to embark on Phase III development next year of AMG-145, which is intended to stymie the PCSK9 protein that messes with the ability of the liver to remove LDL from the blood. It's playing catch up with Sanofi and Regeneron, which began late-stage studies of a similar drug, REGN727, earlier this year. As Bloomberg reports, Amgen is on track to reach the finish line with its drug by 2015 as the Thousand Oaks, CA-based biopharma company will be in need of ways to recover from expected competition to a pair of big-selling anemia drugs, Aranesp and Epogen.

AMG-145 "is the biggest single thing we have in the pipeline, just in terms of raw horsepower from the perspective of how it affects patients in a positive way," Sean Harper, Amgen's executive vice president of R&D, told the news service. "This is a major focus for us because of the potential for impacting the numbers of patients we're talking about, at levels of outcomes that are very serious."

Yet drugmakers are rewarded based on performance, including the success of clinical trials, not need. And plenty of contenders--including Bristol-Myers Squibb ($BMY), Merck ($MRK) and the other mentioned--are elbowing for position in the PCSK9 race. The competition is just one of the challenges. The anti-cholesterol drug market is becoming flooded with cheap generics, and PCSK9 therapies are expected to be pricier and reserved for certain groups of patients, making it unlikely that any one of them would reach sales levels of Pfizer's now-generic statin, Lipitor.

- check out Bloomberg's article

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