Acerus Secures CDN$1.6 Million of New NATESTO® Orders from Its U.S. Licensee Aytu Bioscience
TORONTO--(BUSINESS WIRE)-- Acerus Pharmaceuticals Corporation (TSX: ASP) today announced CDN $1.6 million worth of NATESTO® purchase orders from its U.S. licensee Aytu BioScience (NASDAQ: AYTU). The current orders have been placed as a result of the acceleration of NATESTO® product sales in the United States and will support Aytu’s expected inventory requirements for the first part of 2018. These purchase orders include the delivery of an initial product shipment by Acerus to Aytu in November. As per the terms of the License and Supply Agreement with Aytu, revenues associated with these orders will be recognized on delivery of the product to Aytu, with additional revenues recognized quarterly based on a percentage of net sales.
“We are extremely pleased with the continued acceleration of NATESTO® product sales in the United States as Aytu continues to leverage its expanded commercial team” said Tricia Symmes, Chief Operating Officer of Acerus. “As indicated during our recent third quarter conference call, we expect product sales to grow sequentially over the coming quarters and these orders represent a strong evidence of our commercial progress.” said Luc Mainville, Interim Chief Executive Officer of Acerus.
“Now that we have exhausted the prior NATESTO® inventory acquired from Endo, these new product shipments will bear the Aytu label, the Aytu-specific National Drug Code (NDC), and will help increase market awareness for our company among our wholesale and retail channel partners as well as clinicians and patients,” said Josh Disbrow, Chief Executive Officer of Aytu BioScience. “We recently announced the significantly increasing prescription sales and prescribers for NATESTO® in the US, and we expect to continue to drive incremental adoption of NATESTO® among our expanding base of prescribers. Additionally, with the recent depletion of the Endo-labeled product from the wholesale distribution channel, our company is now well prepared to fulfill the increasing channel demand with our new Aytu-labeled NATESTO®.”
About NATESTO® (Testosterone) Nasal Gel
NATESTO® is approved and available in Canada and the United States for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism). NATESTO®’s marketing approval is pending in South Korea and filings are expected to be made in other jurisdictions over the course of the coming years. NATESTO® is a testosterone nasal gel available in a “no-touch” dispenser with a metered dose pump for reduced transference risk. NATESTO® is the only topical Testosterone Replacement Therapy approved without a Black-Box warning related to transference of testosterone. In Canada, the recommended starting dose of NATESTO® 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. 1
For information specific to the U.S. product dosing and administration, please visit: www.NATESTO.com.
About Acerus Pharmaceuticals Corporation
Acerus Pharmaceuticals Corporation is a Canadian-based specialty pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve the patient experience, with a primary focus in the field of men’s and women’s health. The Company commercializes its products via its own salesforce in Canada, and through a global network of licensed distributors in the US and other territories.
Acerus currently has two marketed products. ESTRACE®, a product for the symptomatic relief of menopausal symptoms is commercialized in Canada; and NATESTO®, the first and only testosterone nasal gel for testosterone replacement therapy in adult males diagnosed with hypogonadism is commercialized in Canada and the United States. In addition, NATESTO® has been licensed for distribution in 30 countries worldwide. Marketing approvals in those other jurisdictions would be expected over the course of the coming years. Acerus’ pipeline includes two new innovative products: GYNOFLOR™, an ultra-low dose vaginal estrogen combined with a probiotic, for which a NDS has been filed in Canada for the treatment of atrophic vaginitis, restoration of vaginal flora and treatment of certain vaginal infections; and TEFINA™, a clinical stage product aimed at addressing a significant unmet need for women with female sexual dysfunction. Finally, the Company owns or has a license to numerous patents relating to proprietary delivery systems as well as novel formulations of products currently in the early stage of development.
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty life sciences company focused on global commercialization of novel products in the field of urology, with a focus on products addressing vitality, sexual wellness, and reproductive health. The Company currently markets two prescription products in the U.S.: Natesto®, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”) and ProstaScint® (capromab pendetide), the only FDA-approved imaging agent specific to prostate specific membrane antigen (PSMA) for prostate cancer detection and staging. Additionally, Aytu is developing MiOXSYS®, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS® is commercialized outside the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k medical device clearance by the FDA. Aytu’s strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within growing markets. For more information visit aytubio.com. Aytu also now owns wholly-owned subsidiary Aytu Women’s Health (formerly Nuelle, Inc.), a personal health and wellness company focused on women’s sexual wellbeing and intimacy. Aytu Women’s Health markets Fiera, a personal care device for women that is scientifically proven to enhance physical arousal and sexual desire. Fiera is a consumer device and is not intended to treat, mitigate, or cure any disease or medical condition. For more information about the Fiera personal care device visit fiera.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, 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.
Acerus Pharmaceuticals Corporation
Tricia Symmes, 416-509-2116
Chief Operating Officer
Source: Acerus Pharmaceuticals Corporation