) and Astellas Pharma Inc. recently announced the launch of Regnite
extended-release tablets in Japan for the treatment of
moderate-to-severe primary restless legs syndrome (RLS).
The Japanese Ministry of Health, Labor and Welfare approved the
drug in January 2012. In its press release, the company stated that
there are around 2.1 million people with RLS in Japan.
We note that in December 2005, XenoPort had entered into a
licensing agreement with Astellas for the exclusive rights to
develop and commercialize Regnite in Japan, Korea, the Philippines,
Indonesia, Thailand and Taiwan.
XenoPort has received $65 million to date under the
collaboration agreement and is entitled to receive additional
milestone payments of $20 million. The company is also eligible to
receive royalties on a percentage basis on net sales of Regnite in
the Astellas territory.
In addition, XenoPort and
) co-develop and co-promote the drug in the US under the trade name
of Horizant. Recently, it was approved by the US Food and Drug
Administration (FDA) for the management of postherpetic neuralgia
(PHN) in adults.
Horizant is already approved in the US for the treatment of
moderate-to-severe primary restless legs syndrome (RLS) in adults.
However, the product is not recommended for use in patients who are
required to sleep during the day and remain awake at night. Glaxo
recorded approximately $1.3 million in Horizant sales in the first
quarter of 2012.
We currently have a Neutral recommendation on XenoPort. The
stocks carry a Zacks #3 Rank (Hold rating) in the short run.
GLAXOSMITHKLINE (GSK): Free Stock Analysis
XENOPORT INC (XNPT): Free Stock Analysis Report
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