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news.Hanmi, a Korean pharmaceutical company, has applied for orphan drug designation for LAPS-rhGH to the European Medicines Agency (EMA).
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LAPS-rhGH is currently being evaluated under phase II trial in patients with growth hormone deficiency in European countries.
According to the company, the orphan drug designation would be granted by March 2012.
Upon receiving the status, the company would benefit in terms of scientific advice, reduced regulatory fees and market exclusivity.
In addition, it would prove to be a key milestone in the development of LAPS-rhGH by Hanmi.