Regeneron and Sanofi to look into side effects of cholesterol drug candidate


The FDA requests that Regeneron (REGN) and Sanofi (SNY) assess potential neurocognitive side effects of their late stage cholesterol drug alirocumab, a PCSK9 inhibitor.

Memory loss, impaired concentration and paranoia, though rare, have been associated with the use of statins for lowering LDL cholesterol.

Both firms disclosed in their regulatory filings that the appearance of these side effects could delay or stop the product's development.

Pfizer (PFE) and Amgen (AMGN) are also working on PCSK9 inhibitors.

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Comments (5)
  • ravenben
    , contributor
    Comments (23) | Send Message
     
    Just to be clear... This information was given to REGN from the FDA, but the actual observed AEs are not from REGN's trials. In fact, real time reporting showed that Pfizer also denied seeing any of these AEs, but AMGN did not. Take a look at the most up to date statement from analysts at Credit Suisse:
    http://bit.ly/1chFXGx
    7 Mar 2014, 04:27 PM Reply Like
  • alacer
    , contributor
    Comments (4) | Send Message
     
    According to Live News in thinkorswim this incident started with a tweet. That led to panic selling and shutdown of REGN trading for about 5 minutes. Immediately after resumption of trading at about 1:07 PM EST massive buying kicked in and the price shot up $5 in 6 minutes and had climbed from a low of $304.10 at 1:03Pm to $320.59 by 1:33 PM. Then the price turned down on a second wave of selling reaching a low of $308 at 2:25 PM. The next two minutes completed a strong "three outside up" bullish reversal signal (see http://bit.ly/1imAVv4). From there the price went up at a 20 degree angle by more than 17 points to close at $328.11 with an additional +$0.89 during extended trading hours. This was a great opportunity to buy an already undervalued stock and make a fast (20%/day) 5.5% profit.
    8 Mar 2014, 09:11 AM Reply Like
  • User 18089782
    , contributor
    Comment (1) | Send Message
     
    PCSK9 is not a statin. It is a monoclonal antibody. Comparing the two is akin to saying that an apple is an orange. The physiological action of the two is not comparable.
    8 Mar 2014, 09:21 AM Reply Like
  • ravenben
    , contributor
    Comments (23) | Send Message
     
    No, I don't think that was the point of the note.

     

    I think the point of the note is that the standard of care (statins), also suffers from limited types of neurological AEs. That has bearing on just how significant these AEs would be for PCSK9s, which are often considered complementary or even possible replacements for statins.
    9 Mar 2014, 12:42 AM Reply Like
  • Merckman2008
    , contributor
    Comments (2) | Send Message
     
    Retired health scientist from a large pharmaceutical company. Main areas of research included(but not limited to)hyperlipidemia and metabolic bone disease.
    Currently living in the Southwest.
    9 Mar 2014, 03:03 PM Reply Like
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