Chelsea Therapeutics International, Ltd.
(
CHTP
) recently suffered a setback when the US Food and Drug
Administration (FDA), in a written statement, informed the company
that it has to conduct a new trial with its candidate, Northera
(droxidopa), before it can be considered for approval.
The US agency was of the opinion that data from the existing
study (306B) was inadequate for approval. The news has negatively
impacted the company's stock price.
Chelsea Therapeutics is looking to get Northera approved for
treating symptomatic neurogenic orthostatic hypotension (neurogenic
OH) in patients suffering from Parkinson's disease, multiple system
atrophy, pure autonomic failure, dopamine beta hydroxylase
deficiency and non-diabetic autonomic neuropathy. Neurogenic OH
refers to a chronic neurogenic disorder that causes
lightheadedness, dizziness, blurred vision, fainting etc.
We remind investors that Chelsea Therapeutics received a complete
response letter (CRL) from the FDA in March 2012 declining to
approve Northera on the basis of the submitted data. Chelsea
Therapeutics had submitted the new drug application (NDA) seeking
FDA approval of Northera for the above indication in September
2011.
The FDA asked for additional data while issuing the CRL.
Following the receipt of the CRL, Chelsea Therapeutics met with the
FDA in May 2012.
The latest advice from the FDA asking for an additional trial on
Northera would push up the research & development (R&D)
costs at Chelsea Therapeutics. Chelsea Therapeutics is currently
evaluating various options to resubmit the NDA on Northera.
Northera would be the first marketed product at Chelsea
Therapeutics, if the FDA ultimately approves it.
Apart from Northera, the pipeline at Chelsea Therapeutics includes
candidates such as CH-4051 and CH-1504, which are being developed
primarily to treat patients suffering from rheumatoid arthritis
(RA). The candidates, on approval, would have to compete with big
players such as
Abbott Labs
(
ABT
),
Johnson & Johnson
(
JNJ
) and
Bristol-Myers Squibb
(
BMY
) among others in the RA space.
Our Recommendation
We currently have a Neutral recommendation on Chelsea Therapeutics
in the long-run. The company carries a Zacks #3 Rank (Hold rating)
in the short-run.
ABBOTT LABS (ABT): Free Stock Analysis Report
BRISTOL-MYERS (BMY): Free Stock Analysis Report
CHELSEA THERAP (CHTP): Free Stock Analysis
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