The U.S. Food and Drug Administration (FDA) approved only 35
new drugs in 2011. The discouraging snail's pace of new drug
evaluation and approval is enough to turn many pharmaceutical
investors from buyers to sellers.
As of March 31, 2013,
Asset Management reduced its position with the biotech drug maker
Chelsea Therapeutics International Ltd. (
) by 46.4%, with current shares at 4,302,458. The current price
of CHTP is $1.87, with a change of average down 8%.
Founded in 2004, Chelsea Therapeutics is a specialty
pharmaceutical company, specializing in the acquisition and
development of innovative products and technologies that address
unmet medical needs or offer alternatives to current methods of
treating disease. Chelsea's compounds target a variety of
prevalent medical conditions; particularly rheumatoid arthritis,
psoriasis, cancer, other immunological disorders, neurogenic
orthostatic hypotension and other autonomic disorders.
Up 131% since January, CHTP is one stock in the
Asset Management portfolio of 321 stocks valued at $21.7 billion,
with 23 new stocks listed as of April 8, 2013.
has a quarter-over-quarter turnover of 7%.
The Columbia Wanger trading history of CHTP over nine quarters
since third quarter of 2010 shows an average cost of $4 per share
with a 53% loss.
The development pipeline of Chelsea Therapeutics International
shows seven product candidates in the second or third phase of
evaluation towards eventual drug commercialization. Chelsea's
investigational candidates include "droxidopa" (drug name:
Northera), a synthetic precursor of norepinephrine, for the
treatment of neurogenic orthostatic hypotension. The FDA granted
the company a priority review of Northera in 2011. As of February
2013, based on FDA guidance, Chelsea plans to file a resubmission
of the Northera new drug application (NDA) in the late second
quarter of 2013, for another six-month review.
Chelsea's Interim CEO, Joseph G. Oliveto, stated, "We appreciate
and are encouraged by FDA's willingness to consider data from
Study 306B in evaluating Northera for the treatment of NOH, and
look forward to submitting the totality of our clinical
experience to date to the Agency for review... We now have a
regulatory path forward, including the potential for an approval
of Northera later this year."
Other Chelsea product candidates under evaluation are for the
possible application in treating rheumatoid arthritis, autoimmune
diseases and transplant rejection.
According to the GuruFocus insider trading feature, Chelsea
Therapeutics International Ltd. (
) shows no insider trading activity in 2013 so far.
GuruFocus "Real Time Picks" reports the stock purchases and sales
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lag can be as short as 2 days after the date of the transaction.
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