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Acerus Announces Approval of NATESTO in South Korea

Written by Gabrielle Lakusta
|
Jun. 14, 2018 09:42AM PST

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 …

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.

Click here to read the full press release.

south korea pharmaceutical investing tsx:asp acerus pharmaceuticals
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