TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) today announced the signing of an agreement granting the exclusive right to market NATESTO® in Saudi Arabia, the United Arab Emirates and Egypt to Therios Healthcare. Therios Healthcare is a U.S. based speciality services pharmaceutical company focused on commercializing FDA and EMA/European approved medical products in emerging markets such as the Middle East and North Africa (MENA) region.
“We are pleased to be partnering with Therios Healthcare for the commercialization of NATESTO® in MENA,” said Tom Rossi, President and Chief Executive Officer of Acerus. “Therios has a proven track record of successfully commercializing pharmaceutical products and are well respected in the industry. We look forward to maximizing the full potential of NATESTO® in MENA.”
“We are delighted about this partnership with Acerus which will allow us to bring this novel therapy to our patients in the region,” said Sajid Syed, President and Chief Executive Officer of Therios. “NATESTO® is an important advance for patients suffering from hypogonadism in Saudi Arabia, the United Arab Emirates and Egypt. Its unique nasal administration, safety and efficacy represent a clear opportunity to improve the patient experience. If approved, NATESTO® could potentially be available in Saudi Arabia as soon as the first half of 2018.”
Under the terms of the license and supply agreement, Acerus will oversee the manufacturing of NATESTO® and receive a supply price for the product. If regulatory approval is obtained, 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 the Middle East.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.
About Therios Healthcare
Therios is a specialty services company providing a convenient, one-stop market access solutions to the pharmaceutical, biological and medical device companies. Therios focuses on commercializing FDA and EMA/European approved medical products that address unmet medical needs and improve the patient experience in emerging markets such as the Middle East, Africa, Turkey and India.
For more information, visit http://www.theriosrx.com/
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 MENA, 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