Supernus Pharmaceuticals, Inc.
) recently provided information on its agreement with
) for the manufacture, formulation, development and supply of
commercial-grade quantities of oxcarbazepine, the active
pharmaceutical ingredient in Supernus' Oxtellar XR, in the US.
As per the terms of the commercial supply agreement, Patheon will
manufacture (including processing, packaging and labeling)
oxcarbazepine at its facility.
Supernus will provide Patheon with all relevant materials
required for manufacturing the product.
Oxtellar XR is a novel once-daily extended release formulation of
oxcarbazepine. Oxtellar XR is an antiepileptic drug (AED)
indicated for adjunctive therapy for the treatment of partial
seizures in adults and in children 6 to 17 years of age.
Oxtellar XR was approved by the US Food and Drug Administration
(FDA) in Oct 2012. In Nov 2012, Supernus received three years of
marketing exclusivity from the FDA. On Feb 4, 2013, Oxtellar XR
was launched in the US. Supernus' 75 person sales force has
started promoting the product.
The launch of Oxtellar XR is a significant milestone for the
company. Supernus' main area of focus is the development of
products for central nervous system (CNS) disorders. The
company's pipeline includes SPN-810 (completed phase IIb) for the
potential treatment of impulsive aggression in attention deficit
hyperactivity disorder (ADHD) patients and SPN-812 (completed
phase IIa) for ADHD.
In Nov 2012, the company had announced encouraging top-line
results from a phase IIb study on SPN-810, across three doses.
The company plans to advance the candidate into phase III trials
and will meet the FDA to discuss the trial design and protocol
for the same.
Supernus carries a Zacks Rank #3 (Hold). Right now,
Pernix Therapeutics Holdings, Inc.
) look more attractive with a Zacks Rank #2 (Buy).
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