Acerus Pharmaceuticals Corporation, a fully-integrated, Canadian specialty pharmaceutical company, announced that Hyundai Pharm Co., Ltd. has filed for the marketing approval of Natesto with the Ministry of Food and Drug Safety (MFDS) in South Korea. Hyundai Pharm acquired an exclusive license to market Natesto in South Korea from Acerus in December 2016. If approved, Natesto will be the first and only testosterone nasal gel indicated for the treatment of low testosterone in South Korea.

“Acerus is very pleased by the speed with which Hyundai Pharm has been able to prepare the dossier and file Natesto with MFDS,” said Tom Rossi, president and chief executive officer of Acerus. “It’s a testament to their commitment to the future success of Natesto.”

“We look forward to working with the MFDS regulatory authorities to bring Natesto to the South Korean market,” said Young Hak Kim, CEO and president of Hyundai Pharm Co., Ltd. “This product is an important advance for patients suffering from low testosterone in South Korea. Its unique nasal administration, safety and efficacy represent a clear opportunity to improve patient’s quality of life.”

Natesto is a nasal gel formulation of testosterone developed by Acerus Pharmaceutical Corporation and indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). It is the first and only nasally-administered testosterone product approved by the US FDA and Health Canada and available in a ‘no-touch’ dispenser with a metered dose pump.

Acerus Pharmaceuticals Corporation is a fully-integrated, Canadian specialty pharmaceutical company engaged in the development, manufacture, marketing and distribution of innovative, branded products in men’s and women’s health.

Founded in 1965, Hyundai Pharm Co., Ltd. is a pharmaceutical company engaged in R&D, manufacturing and distribution of pharmaceutical products, health and food drinks, as well as medical equipment.