Vivus: Consensus Calls For FDA Approval, But Watch For Label Restrictions
(Thomson Reuters ONE) -
The Prescription Drug User Fee Act (PDUFA) or FDA 'Action' date for Vivus'
(NASDAQ:VVUS) obesity drug, Qnexa, is July 17th - an event that's been widely
anticipated by Wall Street and Main Street alike. While the consensus among
analysts is that the drug will be approved next week, Vivus shares are likely to
trade higher on approval if prescribing restrictions for use are not too
onerous. Assuming that, post-approval, Qnexa can be prescribed to patients
similarly to Arena's recently approved obesity drug 'Belviq', investors will
shift focus to the question of 'who might acquire Vivus'. Hence, shares could
edge higher on speculation of a buy-out.
However, IPQ Analytics, an independent research firm, warns that there are
"risks that exist which are not currently being factored into expectations" and
that the drug may not do as well as analysts are modeling if the drug's label
(prescribing instructions) is more strict than Belviq. For reference, most Wall
Street analysts believe Qnexa has the potential to achieve annual sales of a
billion or more at peak. A risk management program is expected to accompany
approval of Qnexa, and while Belviq was approved without such a program,
analysts believe that a 'REMS' program for Qnexa will be relatively benign.
According to IPQ, "restrictions on prescribing Qnexa to women of childbearing
age and/or those with cardiovascular risk could reduce the market potential of
the product, depending on how limiting those restrictions are and how they are
implemented".
Dr. Michael Liebman, Founder of IPQ Analytics, notes that the FDA could have
concerns over how the drug may get used in a real world setting, and that the
agency could "restrict the drug by using a patient registry to protect against
abusive use of the drug, combining the drug with other obesity treatments prior
to clinical evaluation, or prescribing Qnexa to the wrong patients leading to
abuse of the product". In fact, IPQ notes that the patient criteria for testing
Qnexa in clinical trials changed over time, and that the patients tested may
represent a significant difference from those in the real world because of lack
of consideration of obesity as a complex disorder requiring personalized
diagnosis and treatment. Watching for these kinds of restrictions is key to
investors following the obesity market and the manufacturers of next generation
treatments.
A severely restrictive label, such as a patient registry, would be devastating
to the outlook for Qnexa (and consequently Vivus shares), but benefit companies
like Arena Pharmaceuticals (NASDAQ:ARNA) and Orexigen Therapeutics
(NASDAQ:OREX). Based on current intelligence, however, the bet is that Qnexa
receives the FDA's blessing next week, and as long as the drug can be freely
prescribed, the next trade is up into speculation of a take-out.
IPQ Analytics is offering a complimentary copy of their report on the risks pre
and post-approval for Qnexa.
Click Here to request a copy of IPQ Analytics' report on Vivus' obesity drug-
candidate Qnexa.
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About IPQ Analytics
IPQ Analytics, LLC provides risk assessment solutions and decision analytics to
constituents in life sciences and healthcare. The company's proprietary
ontology-based analytics engine enables customers to Identify, Prioritize and
Quantify unexplored dimensions of knowledge and associated risk within the
clinical, the molecular and the commercial domains. IPQ Analytics helps
customers to make better informed decisions about managing their healthcare
assets and the associated risks.
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: PropThink via Thomson Reuters ONE
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Unternehmensinformation / Kurzprofil:
Datum: 13.07.2012 - 13:30 Uhr
Sprache: Deutsch
News-ID 165125
Anzahl Zeichen: 4995
contact information:
Town:
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Kategorie:
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