Chelsea Therapeutics International, Ltd.
) recently made some progress with its late-stage pipeline
Chelsea Therapeutics submitted additional information to the
U.S. Food and Drug Administration (FDA) to resolve certain
technical deficiencies in its New Drug Application (NDA).
The NDA was accepted by the FDA in Jul 2013. However, the FDA
later informed the company of certain deficiencies in the NDA
regarding the formatting of certain submitted electronic datasets
and statistical programs describing the methods used to generate
tables and listings.
We note that Northera enjoys orphan drug status as well as
fast track status in the U.S. Chelsea Therapeutics is seeking FDA
approval of Northera for the treatment of symptomatic neurogenic
orthostatic hypotension (NOH) in patients with primary autonomic
failure (Parkinson's disease, multiple system atrophy and pure
autonomic failure), dopamine beta hydroxylase deficiency and
non-diabetic autonomic neuropathy.
We remind investors that the FDA had issued a Complete
Response Letter (CRL) to Chelsea Therapeutics in Mar 2012 in
response to its NDA filed in 2011 asking for data from an
additional study to support efficacy of the candidate in the 301
The company was also asked to design a study, which would
demonstrate durability of effect over a 2- to 3-month period.
In the CRL, the FDA also mentioned an additional
bioequivalence study for the approval of Northera 300 mg
capsules. Chelsea Therapeutics was considering making these
capsules commercially available to complement the 100 mg and 200
mg capsules, which were being utilized in the clinical
Taking note of this, Chelsea Therapeutics included a
bioequivalence study for the 300 mg dose in the resubmitted
We expect investor focus to remain on the FDA's decision on
Northera. The successful development of Northera will be a major
milestone for Chelsea Therapeutics, which currently does not have
any marketed product in its portfolio.
Chelsea Therapeutics currently carries a Zacks Rank #3 (Hold).
Biogen Idec Inc
Gilead Sciences Inc
) look attractive, each with a Zacks Rank #1 (Strong Buy).
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