Additional Description:
Luphere Depot, a leuprorelin-based generic equivalent to Lupron/Leuplin, has been sold in Korea since January 2005 and is being developed for the US and Japanese markets. Acting as a GnRH agonist, it is indicated for prostate cancer, endometriosis, uterine fibroids, postmenopausal breast cancer, and central precocious puberty, with 1-, 3-, and 4-month US formulations and 1- and 3-month Japan formulations already researched. The sustained-release depot uses PLGA polymer encapsulation, matches the reference product's pharmacodynamic profile, and is produced in a cGMP facility; the company is seeking an overseas partner to handle bioequivalence studies, registration, and commercialization outside Korea.
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