Biopharmaceutical company XenoPort, Inc. (XNPT) and Japan's Astellas Pharma Inc. (ALPMY.PK, ALPMF.PK) Wednesday said that Regnite (gabapentin enacarbil) has received marketing approval in Japan for the treatment of moderate-to-severe primary restless legs syndrome, or RLS. The approval of Regnite in Japan entitles XenoPort to an additional milestone payment of $10 million.
In 2005, Astellas obtained exclusive rights to develop and commercialize Regnite in Japan, Korea, the Philippines, Indonesia, Thailand and Taiwan. XenoPort has received payments of $55 million to date under the collaboration agreement. As per the deal, XenoPort is also eligible to receive royalties on net sales of Regnite in the Astellas territory at a royalty rate in the mid-teens on a percentage basis.
Restless legs syndrome is a neurological condition that is characterized by unpleasant and sometimes painful sensations in the legs. Discovered by XenoPort, Regnite is dosed once-daily.
Ronald Barrett, chief executive officer of XenoPort said, "We are very pleased that Regnite has been approved in Japan. We believe that Regnite can offer treatment benefits to RLS patients whose condition is severe enough to need medical treatment."
The companies filed the New Drug Application, or NDA, based on data supporting safety and efficacy from successful Phase 2 study in RLS patients and long-term safety study conducted by Astellas in Japan. In addition, XenoPort conducted RLS clinical program in the U.S and supporting pharmacokinetic studies in Japanese subjects.
"Each of the efficacy studies showed that treatment with Regnite was associated with improvement in the International Restless Legs Syndrome rating scale score compared to placebo," the companies stated.
"Astellas expects to provide an additional option for RLS therapy by introducing Regnite, which has a different type of mechanism of action than the existing therapy for RLS in Japan," said Yoshihiko Hatanaka, president and chief executive officer of Astellas.
XNPT closed Tuesday's regular trading at $4.12, down 5.07 percent on the Nasdaq.
ALPMY.PK finished on Tuesday at $39.81, while ALPMF.PK ended at $40.20.
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