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Acerus Announces Approval of NATESTO in South Korea
Jun. 14, 2018 09:42AM PST
Pharmaceutical InvestingAcerus Pharmaceuticals (TSX:ASP) announced today that Hyundai Pharm Co., Ltd. (Hyundai), Acerus’ licensee, reported that South Korea’s Ministry of Food and Drug Safety (MFDS) has approved NATESTO® for the treatment of hypogonadism. As quoted in the press release: “Acerus is very pleased by the speed with which Hyundai has been able to prepare the dossier and …
Acerus Pharmaceuticals (TSX:ASP) announced today that Hyundai Pharm Co., Ltd. (Hyundai), Acerus’ licensee, reported that South Korea’s Ministry of Food and Drug Safety (MFDS) has approved NATESTO® for the treatment of hypogonadism.
As quoted in the press release:
“Acerus is very pleased by the speed with which Hyundai has been able to prepare the dossier and collaborate with the MFDS to obtain a notice of approval for NATESTO® in South Korea. This approval marks an important milestone in establishing NATESTO®globally as this is the first regulatory approval outside of North America,” said Ed Gudaitis, President and Chief Executive Officer of Acerus Pharmaceuticals.
Acerus will receive a regulatory milestone payment linked to the regulatory approval. Additionally, Acerus will oversee ongoing manufacturing of NATESTO® and receive a supply price for product. Commercial launch is planned in Q4 2018.
