) and partner
Concert Pharmaceuticals, Inc.
) announced the initiation of a phase I study (n=28) on JZP-386, a
deuterated version of sodium oxybate (the active ingredient in
Xyrem). Xyrem is marketed by Jazz Pharma in the U.S. for the
treatment of cataplexy and excessive daytime sleepiness in patients
suffering from narcolepsy.
The phase I study will be evaluating the safety, pharmacokinetics
(PK), and pharmacodynamics (PD) of JZP-386. The study will also
include Xyrem as an active control. The primary objective of the
study is to identify safe and tolerable dose/doses of JZP-386 to be
used in subsequent clinical studies. Jazz Pharma will also evaluate
whether JZP-386 is appropriate for once nightly dosing.
We remind investors that Jazz Pharma and Concert Pharma
collaborated in 2013 as per which the former gained the worldwide
rights to develop and commercialize JZP-386. Concert Pharma,
responsible for clinical activities of JZP-386 through phase I, is
eligible to receive milestone payments and tiered royalties on any
Xyrem contributed around 65.8% ($569.1 million) of net product
sales of Jazz Pharma last year. Jazz Pharma is facing a series of
patent challenges on the drug. The company is currently engaged in
several litigations with generic drug makers of Xyrem. The
sooner-than-expected entry of Xyrem generics would be a huge blow
for the company.
The development of JZP-386 is primarily to protect Xyrem revenues.
As a result, the successful development of JZP-386 is crucial for
Jazz Pharma. The company's shares gained around 2.8% on the
announcement of phase I study initiation on JZP-386.
Jazz Pharma holds a Zacks Rank #3 (Hold). Some better-ranked stocks
in the health care sector include
Synergy Pharmaceuticals, Inc.
). Both the stocks hold a Zacks Rank #1 (Strong Buy).
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JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
CONCERT PHARMA (CNCE): Free Stock Analysis
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SYNERGY PHARMAC (SGYP): Free Stock Analysis
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