Japan's Hisamitsu bags Noven for $430M

Miami-based Noven Pharmaceuticals is being snapped up by Japan's Hisamitsu Pharmaceutical for $430 million. The news was announced simultaneously with a release touting the positive data gathered in a mid-stage study for a new therapy to treat hot flashes.

With an eye on expanding in the U.S., Hisamitsu agreed to pay $16.50 a share, a 38 percent premium on the company's 50-day close. Hisamitsu plans to make the company--which specializes in hormone therapies--a wholly-owned subsidiary with Jeffrey Eisenberg, now executive vice president of Noven, promoted to president and CEO.

"In Noven, we believe we have found the ideal catalyst to accelerate Hisamitsu's strategic objective of increasing our U.S. presence," says Hisamitsu President Hirotaka Nakatomi. "The transaction presents the opportunity to build upon Noven's impressive capabilities in transdermal drug development, clinical/regulatory affairs, manufacturing, and product commercialization. In addition, we believe products incorporating Noven's technologies have the potential to supplement Hisamitsu's development efforts in Japan and elsewhere."

Ninety-eight patients completed Noven's Phase II trial of Mesafem, which focused on mean changes in frequency and severity of moderate-to-severe hot flashes from baseline to the fourth and eighth weeks of the study.

"Although designed and powered to detect an efficacy signal, we were very pleased to achieve statistical significance in several primary outcome measures, and to identify clear efficacy signals in the others," says Joel S. Lippman, M.D., Noven's vice president--clinical development. "Safety and tolerability of Mesafem were similar to placebo, with no drug-related serious adverse events. In short, Mesafem appears to be efficacious and well-tolerated at the tested dose, and information from this study should permit us to develop and initiate a well-designed and cost-effective Phase III clinical program by year-end."

- read the announcement on the buyout
- check out the release on the Phase II trial
- read the story from Reuters

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