Amicus Therapeutics, a biopharmaceutical company, has received a new US patent, which covers the tartrate salt form of isofagomine, the active ingredient in the company’s investigational drug Plicera, and its use for the treatment of Gaucher disease. The patent will expire in 2027.
Plicera is currently being studied in an ongoing Phase II study in patients naive to enzyme replacement therapy. This six-month study is designed to evaluate safety and to demonstrate trends of efficacy, as measured by the standard endpoints in Gaucher disease. Amicus previously reported that enrollment has been completed for the study and the company expects the results to be available in the third quarter of 2009.
Amicus is developing Plicera as part of a strategic collaboration with Shire Human Genetic Therapies, a business unit of Shire, to develop and commercialize Amicus’s three lead pharmacological chaperone compounds for lysosomal storage disorders. Under the collaboration, Shire received commercial rights outside of the US. Amicus retains all US rights.
John Crowley, president and CEO of Amicus, said: The issuance of this patent further strengthens our protection in the US for Plicera in Gaucher and is one example of our ongoing efforts to establish a comprehensive intellectual property portfolio for our development programs and our pharmacological chaperone technology platform.