Seeking Alpha

Ruthanne Willia...'s  Instablog

Ruthanne Williams Roussel
Send Message
I'm Ruthanne Williams Roussel, a reformed sell-side analyst who has covered the obesity space for several years. Unlike anyone else I've met who covers these companies for the big banks, I am among the target market for most of these products, which allows me to bring a consumer's perspective.... More
My company:
Obesity Investor
My blog:
Obesity Investor
View Ruthanne Williams Roussel's Instablogs on:
  • Don't Be A PDUFA Doofus

    In spring the buds burst, ducklings and lambs frolic, Golf Galaxy has some sort of special on new clubs, and a young man’s fancy turns to thoughts of the Food and Drug Administration (FDA) approval process.  Or if it doesn’t, then this old girl’s does anyway. 

     

    I find it helpful to remember two things about this process:

     

    1        The Prescription Drug User Fee Act (PDUFA) sets a goal for the FDA to reach a decision on each New Drug Application (NDA) within ten months after it is filed (in special cases this can be reduced to six months).  

    2        The key word here is “GOAL.”   The FDA will make a really good effort to meet the “PDUFA date,” but it sometimes does not.  This is not an exact science.

     

    Be A PDUFA Date Investor, Not A PDUFA Date Trader

     

    For example, in the last week of December, 2009, Arena Pharmaceuticals (NASDAQ:ARNA) and Vivus, Inc. (NASDAQ:VVUS), competitors in the novel obesity drug market, both announced that they had submitted NDA’s to the FDA, in line with their previous guidance.  Counting forward ten months, we then expected their PDUFA dates to be in late October, 2010.  Sure enough, last week ARNA announced that the FDA had set its PDUFA date for October 22, 2010, and VVUS announced that the FDA had set its PDUFA date for October 28, 2010.  No surprises.

     

    However, given that the FDA doesn’t always make its own PDUFA dates right on the nose, we would not advise a short-term trading strategy based around getting in and out around one or both of these exact dates.  Nor do we attach great significance to the six-day difference.   Certainly it’s not worth losing sleep over the wordsmithing of the announcements of the PDUFA dates by either of the companies.

     

    Adivsory Panel

     

    It is likely that the FDA may convene an advisory panel before its decision on approval of one or both drugs.  We believe this not only because both managements are steering expectations toward a panel, but also because obesity is an evolving topic in public health.   When the weight-loss pill “fen-phen” was on the market in the 1990’s, it was widely perceived as a “vanity” or “cosmetic” medication.  By contrast, the anti-obesity candidates of ARNA and VVUS are to be marketed to physicians and payors for their health benefits, such as  reduction in cardiovascular risk and blood glucose levels.

     

    The recommendations of such an advisory panel, if there is one, would be non-binding, but the FDA usually gives them great weight.  The panel would most likely take place in September 2010.  Since the FDA must notify the subject company of the panel at least 55 days before its PDUFA date, we can expect to hear from the companies by late August 2010 if there is to be a panel.

    Disclosure: Long ARNA, VVUS
    Mar 19 1:10 PM | Link | Comment!
  • FDA to ARNA: OK, We'll Look At Lorcaserin Data Without Diabetics

    The FDA has accepted for review Arena Pharmaceuticals' (NASDAQ:ARNA) application (NDA) for its flagship obesity drug lorcaserin, Arena said Wednesday.  The main significance of this is that the FDA has apparently agreed to review Arena's data without waiting for data from its slow-enrolling clinical trials on diabetic patients.

    Arena expects the FDA to inform it in a few weeks of its PDUFA date, or deadline for the FDA's decision whether to approve lorcaserin.  This is supposed to be ten months out, but as we've noted before, in recent years has often slipped. 

    As a reminder, Arena submitted its NDA on December 22, 2009, and competitor Vivus (NASDAQ:VVUS) a week later on December 29 for its drug Qnexa.  Orexigen Therapeutics (NASDAQ:OREX) also is preparing an application for Contrave to be submitted in the first half of this year.  Vivus's and Orexigen's applications are both expected to include data from their completed trials on diabetic patients.


    Disclosure: Long ARNA, VVUS, OREX
    Feb 24 12:56 PM | Link | 2 Comments
  • Vivus's avanafil: Promising new ED drug

    A disclaimer to note that VVUS's erectile dysfunction drug avanafil, a fast-acting (they say 20 minutes) PDE5 inhibitor (same class as Viagra and Cialis, but acts faster and may be safe to use with heart medicine nitrates) is moving along.  Phase III results were announced this morning, have met endpoints (per the company) and can be found at the company web site vivus.com.

    I won't be following avanafil as closely as the obesity drugs, although it certainly is a very promising candidate.  I don't consider myself the most objective observer.  I understand that from a scientific point of view, we can track "successful" episodes of sexual intercourse where vaginal penetration was "achieved."  Just like I understand that when you're playing golf with men and one of them yells "Fore!" you don't pipe up with, "Oh, don't worry, it didn't go anywhere near them, you're just over by those trees on the right." 

    But I would not very much like to find out that I was on the receiving end, as it were, of this clinical trial.  (One would be tempted to try to help:  "Hey, you got it in there!  Good going, honey!")  And if I were to sit down with ten girlfriends for drinks, I might get ten different answers as to what should constitute "success" here.  That's not to knock the importance of men's sexual satisfaction, just to say I respect it enough to say it's WAY beyond the scope of what I'm willing to analyze.

    Nov 18 7:09 PM | Link | 1 Comment
Full index of posts »
Latest Followers

StockTalks

  • OREX 13 yes 7 no
    Dec 7, 2010
  • Just read Rocky Coscia's article on lorc, agree with his valuation methodology (not feeling ready to comment on anyone's numbers today)
    Sep 19, 2010
  • Like everyone, I didn't know about the cancers in ARNA's rats. If it is no big deal, why didn't they tell us earlier?
    Sep 19, 2010
More »

Latest Comments


Instablogs are Seeking Alpha's free blogging platform customized for finance, with instant set up and exposure to millions of readers interested in the financial markets. Publish your own instablog in minutes.