Acerus Announces Approval of NATESTO in South Korea

Acerus Pharmaceuticals Corporation announced 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.

“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.