PropThink: Why Columbia Laboratories Collapsed
(Thomson Reuters ONE) -
By Jake King
Before noon, shares of Columbia Laboratories (NASDAQ:CBRX) have already
exchanged hands at more than ten times average volume, and the stock is down
40%. The blow comes after Columbia and partner Watson Pharmaceuticals (NYSE:WPI)
announced that CBRX's lead candidate, Prochieve, was denied an appeal for
further FDA review and approval. Prospects for Columbia Laboratories look bleak
without its single developmental product, and the future of the company falls to
its line of Women's Health products or a major strategic maneuver.
Prochieve is a topical gel to reduce the risk of pre-term birth in women with
premature cervical shortening. Columbia and Watson submitted a New Drug
Application to the FDA in April of 2011, which met resistance at a subsequent
Advisory Committee meeting, and then received a Complete Response Letter from
the FDA in February of 2012. Watson - which by then owned rights to the NDA -
appealed the denial through a Formal Dispute Resolution Request (FDRR) in
August; a response to the FDRR was announced Friday, causing CRBX's dive. Watson
plans to "review possible options related to the continued pursuit of the NDA."
What exactly that means - another trial? - is yet unclear, but for now, Columbia
Laboratories holds little growth prospect outside of its existing product
franchise; investors see - or saw - Prochieve as the major value-driver for
CBRX. Click here to continue reading.
See the "Why Columbia Laboratories Collapsed" at PropThink.com.
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Unternehmensinformation / Kurzprofil:
Datum: 26.10.2012 - 18:27 Uhr
Sprache: Deutsch
News-ID 196850
Anzahl Zeichen: 3802
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