Chelsea Therapeutics International, Ltd. recently made some progress with its late-stage pipeline candidate, Northera.
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 study.
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 program.
Taking note of this, Chelsea Therapeutics included a bioequivalence study for the 300 mg dose in the resubmitted NDA.
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). Right now, Actelion Ltd. (ALIOF), Biogen Idec Inc. (BIIB - Analyst Report) and Gilead Sciences Inc. (GILD - Analyst Report) look attractive, each with a Zacks Rank #1 (Strong Buy).