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11/01/15
15:44
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Originally posted by TDA
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Regeneron Jumps On Favorable Cholesterol Drug Report
By
JAMES DETAR , INVESTOR'S BUSINESS DAILY
Posted 03:42 PM ET
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REGN ) said an experimental drug it's developing with Sanofi (NYSE:SNY ) was found in a late-stage trial to be effective in fighting "bad" cholesterol, even when injected once every four weeks instead of two weeks.
The report makes the drug, alirocumab, easier for people with high cholesterol to take, increasing the likelihood consumers will prefer it. The drug is expected to hit the market in the third quarter of this year.
Alirocumab is in a race with Amgen's (NASDAQ:AMGN ) evolocumab, another cholesterol drug. Both belong to a new class of injectables called PCSK9 inhibitors, and both have had similar results in trials.
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PCSK9 is an enzyme, and drugs that block it reduce low-density lipoprotein cholesterol, which can lead to heart disease.
Amgen seemed for awhile to be ahead in the race. But in July the Regeneron-Sanofi team acquired an accelerated review voucher, a tradable coupon that speeds up the approval process, from BioMarin Pharmaceutical (NASDAQ:BMRN ) for $67.5 million.
It's now projected that both drugs will hit the market at about the same time.
The potential market is huge and could put either or both drugs into the billion-dollar-a-year blockbuster category.
The Centers for Disease Control and Prevention says 71 million Americans have high cholesterol. Only one out of three adults with the condition has it under control, putting the rest at risk for heart disease and stroke, the two leading causes of death in the U.S.
Shares of Regeneron were up 3% in the stock market today , pushing it above its 50-day average again. Sanofi slipped 1.8%, and Amgen eased 1%.
Regeneron's stock consolidated from mid-August to mid-October before turning higher and hit an all-time high of 437.64 on Dec. 8 before consolidating again.
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The article said, "It's now projected that both drugs will hit the market at about the same time."
Well, SNY/REGN were supposed to file by the end of December. That hasn't happened yet. If this delay continues, AMGN will definately be regain clear front-runner status.
We follow this as if UNS has the contract for alirocumab in the bag. I sure hope so! Writer's comment that we won't be running full-scale commercial production until next FY has me concerned. I would think SNY/REGN will need full-scale production sooner than that for their rollout around July.