Acerus Pharmaceuticals announced the signing of an amendment to its existing licensing and supply agreement with medac Gesellschaft für klinische Spezialpräparate mbH (medac), expanding the company’s exclusive right to market Natesto in the totality of the 28 current EU member countries (including the United Kingdom) as well as Norway, Liechtenstein, Iceland, Turkey, Australia, New Zealand, Israel and South Africa. Additionally, Acerus has reported medac has submitted a dossier for Natesto in the first 21 European Member States under the Decentralised Procedure (DCP) on September 28th, 2018. The original agreement with medac spanned 15 European countries including Germany, the United Kingdom, France, Spain and Italy.
“With the signing of this amendment Acerus has now secured a presence for Natesto in 71 countries worldwide, supporting our goal of making Natesto a global brand,” said Ed Gudaitis, President and Chief Executive Officer of Acerus. “Consolidating Natesto’s European commercialization efforts under a single, experienced partner like medac, should yield meaningful synergies once sales begin.”
“We are very pleased to announce the expansion of our partnership with Acerus. This development enables us to provide patients throughout the EU and beyond with an innovative product”, said Heiner Will, medac’s Chief Marketing Officer. “With its novel nasal route of administration”, he added, “Natesto is offering an important advance in improving the quality of life of patients suffering from hypogonadism.”
Under the terms of the amendment, Acerus will receive an additional non-refundable one-time upfront fee upon signing. Pursuant to the terms of the original agreement, Acerus still expects to receive regulatory milestone payments upon medac receiving marketing approval in certain countries, as well as milestone payments based on achieving sales targets. In total, Acerus is eligible to receive up to €11,000,000 in milestone payments. Acerus will oversee the manufacturing of Natesto and, in addition, will receive a supply price for the product. If approved, Natesto will be the first and only testosterone nasal gel for androgen replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism) in Europe.