Amgen ($AMGN) marched through yet another Phase III study for the closely watched PCSK9 cholesterol drug evolocumab (AMG-145), racking up more promising data for one of the biggest late-stage programs in the business. Altogether Amgen laid out 13 Phase III studies of the drug in a quest to take a commanding lead in a field of rivals that include Sanofi ($SNY)/Regeneron ($REGN) and Pfizer ($PFE). And it has reported out positive results on four of the studies, with no misses to mar the sweep.
By blocking PCSK9, the drug developers are looking to flush more bad cholesterol out of the system through an unhindered liver. And they've been going all out in an attempt to grab a sizable share of what could go on to become a multibillion-dollar market.
Amgen is keeping the data close to its vest for now, but the biotech giant says the numbers are consistent with what it found in Phase II. Four mid-stage studies produced a whopping 59% drop in LDL, potentially addressing a serious cardiovascular risk.
Amgen R&D chief Sean Harper has called this drug the biggest single therapy in late-stage development at the company, which has reserved some serious assets to hurry through all the Phase III studies. Not everyone is sold on the potential, citing plenty of cheap generic statins that can help many of the potential patients. But don't expect Amgen to lower the volume on what is looking like a clear hit in the clinic.
The biotech believes it has its market clearly staked out.
"As statins continue to be an important treatment option in patients with high cholesterol, we are very encouraged by the Phase III data from the LAPLACE-2 study," said Harper in a statement. "Adding evolocumab to statin therapy may help patients control their LDL cholesterol levels when high doses of statins are not sufficient."
Amgen enrolled 28,000 patients for its Phase III effort, which may explain its R&D numbers for 2013. The biotech says it spent a bit more than $4 billion on research last year, up about $700 million.
- here's the release