Great expectations build for PCSK9 blockbuster prospect from Sanofi, Regeneron

In an industry like pharma, you're only as good as your next big Phase III study. And hopes are running very, very high for the first round of late-stage results on the PCSK9 drug alirocumab from Sanofi ($SNY) and Regeneron ($REGN).

Reuters correspondent Natalie Huet is clearly taken with the bull stance on the drug, which is set to deliver on the Phase III any day now. Analysts have guessed this new approach to cholesterol--a leader in a fast-paced showdown with other industry trendsetters like Amgen ($AMGN), Pfizer ($PFE), Eli Lilly ($LLY) and Roche ($RHHBY)--could earn $3 billion a year. That's the kind of money that can make up for a lot of new generic competition.

"Physician feedback suggests high awareness amongst cardiologists and planned prescribing habits support multi-billion dollar potential for the class," Deutsche Bank analysts wrote, according to Reuters, assessing the new drug as a potential multibillion-dollar asset.

Investors have been paying very close attention, driving shares of Regeneron to record highs. And its shares were trading up 4% this morning, at more than $304.

Investigators are pitting alirocumab against Merck's ($MRK) Zetia, which should be road kill if earlier results hold up. One of the reasons why so many analysts are so bullish about this approach can be seen in the mid-stage data, which reflected a drop of up to 72% in LDL, or bad cholesterol. Sanofi CEO Chris Viehbacher, who clearly would love to see a winner, agrees, calling its drug a "paradigm shift for healthcare and a potentially huge opportunity for us."

This is just the initial takeaway from the first Phase III, though. Any drug aimed at a large market like this has to be tested in thousands of patients. And that will take time. 

- here's the report from Reuters