TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) today announced the signing of an agreement granting medac Gesellschaft für klinische Spezialpräparate mbH (“medac”) the exclusive right to market NATESTO® in 15 European countries (Germany, United Kingdom, France, Italy, Czech Republic, Slovakia, Spain, Sweden, Finland, Denmark, Norway, Poland, Austria, Netherland and Belgium). medac is a German pharmaceutical company with business in 80 countries and more than 1,200 employees worldwide.
“We are delighted to be partnering with medac for the commercialization of NATESTO® in Europe,” said Tom Rossi, President and Chief Executive Officer of Acerus. “Their extensive reach and commercial expertise within the speciality pharmaceutical sector will be a key advantage as we aim to maximize the full potential of NATESTO®. This agreement represents a significant milestone for Acerus as we continue to execute on our strategy of expanding the brand’s reach on a global scale.”
“We are very pleased to announce this partnership with Acerus as it enables us to provide patients in Europe with an innovative product and address a medical need,” said Dr. Ulrich Kosciessa, Managing Director of medac. “NATESTO® is an important advance for patients suffering from hypogonadism. Its novel nasal administration and unique safety and efficacy profile represent a clear opportunity to improve patient quality of life and represents a perfect fit to our current portfolio. We look forward to working closely with Acerus as we prepare to file NATESTO® for European marketing approval.”
Under the terms of the agreement, Acerus will receive a non-refundable upfront fee and 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 €11,500,000 in upfront and 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.1
About NATESTO® (Testosterone) Nasal Gel
NATESTO® is approved and available in Canada for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). NATESTO® is a testosterone nasal gel available in a ‘no-touch’ dispenser with a metered dose pump for reduced transference risk. The recommended starting dose of NATESTO® in Canada is 11 mg of testosterone (one actuation per nostril) administered twice daily for a total daily dose of 22 mg, the lowest topical gel testosterone dose approved in Canada. A copy of the NATESTO® product monograph can be found at: http://www.aceruspharma.com/English/products-and-pipeline/natesto/default.aspx.
NATESTO® is also approved and available in the United States. For further information, specific to the U.S. product dosing and administration, please visit: www.NATESTO.com.
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. Acerus’ shares trade on TSX under the symbol ASP. For more information, visit www.aceruspharma.com and follow us on Twitter and LinkedIn.
medac is a privately held, global pharmaceutical company based in Hamburg, Germany, specialising in the diagnosis and treatment of oncological, urological and autoimmune diseases since 1970. Besides an already established product portfolio medac is dedicated to the refining of existing and the development of new therapeutic products providing patients with ground-breaking individualized treatments. medac prides itself in taking a personalized approach to medicine by supporting doctors and patients as they seek to overcome acute and persistent diseases.
Notice regarding forward-looking statements
Information in this press release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, including with respect to the regulatory approval of NATESTO® in Europe and the achievement of the milestone payments by Acerus, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 7, 2017 that is available at www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.
1. NATESTO® Product Monograph, October 25th, 2016 and Rogol et al. J Andrology 2015, 4(1), 46.