TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) (“Acerus” or the “Company”) today announced that it has entered into an exclusive distributor and license agreement with Metuchen Pharmaceuticals LLC (“Metuchen”), a privately-held specialty pharmaceutical company dedicated to improving men’s health, granting Acerus the exclusive rights to commercialize STENDRA® in Canada.
STENDRA® is a new chemical entity targeting the large and growing Erectile Dysfunction (“ED”) market. If approved, STENDRA® will be one of only two branded PDE5 Inhibitors in Canada. According to the Canadian Study of Erectile Dysfunction, approximately 49% of men over 40 suffer from ED, a condition affecting their physical and psychosocial well-being and quality of life.1 Contemporary treatment focuses on highly-effective, minimally invasive therapies, the most common of which is the PDE5 Inhibitor. The size of the ED market in Canada is estimated at $225M as of June 2017.2
“This is a great partnership for Acerus as STENDRA® is well-aligned with our strategy of becoming a Canadian leader in urology and men’s health and maintaining an active dialogue with Canadian patients and their physicians. Acerus intends to file a New Drug Submission with Health Canada for STENDRA® in the second half of 2018, and, if approved, expects commercialization in the second half of 2019”, said Tricia Symmes, Chief Operating Officer of Acerus.
“We are pleased to be partnering with Metuchen to bring this innovative PDE5 Inhibitor to the Canadian market and offering a new treatment option for patients. This transaction will help broaden our product portfolio and take full advantage of our existing salesforce,” added Luc Mainville, Interim Chief Executive Officer of Acerus.
Greg Ford, President and CEO of Metuchen, noted: “we are extremely pleased to be partnering with Acerus Pharmaceuticals, a company focused on men’s health, with a strong presence in Urology. We believe they have all the expertise required to make STENDRA® a commercial success in Canada.”
Under the terms of the sublicense agreement, Metuchen will receive regulatory milestone payments upon Acerus filing a NDS with Health Canada and upon Acerus receiving marketing approval in Canada. Metuchen will also receive milestone payments based on Acerus achieving sales targets. Metuchen will oversee the manufacturing of STENDRA® and will receive a supply price for the product comprised of a transfer price and royalties on net sales of the product.
STENDRA® (avanafil) is approved in the U.S. by the FDA for the treatment of erectile dysfunction. Metuchen has exclusive marketing rights to STENDRA® in the U.S., Canada, South America and India. STENDRA® is available through retail and mail order pharmacies.
SPEDRA®, the trade name for avanafil in the EU, is approved by the EMA for the treatment of erectile dysfunction in the EU. Vivus, Inc. (“Vivus”) has granted an exclusive license to the Menarini Group through its subsidiary Berlin-Chemie AG to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand.
Avanafil was licensed by Vivus from Mitsubishi Tanabe Pharma Corporation (MTPC).
For more information about STENDRA®, please visit www.STENDRA.com.
Acerus Pharmaceuticals Corporation is a Canadian-based specialty pharmaceutical company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve 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 U.S. and other territories.
Acerus currently has three marketed products: ESTRACE®, a product for the symptomatic relief of menopausal symptoms, is commercialized in Canada; NATESTO®, the first and only testosterone nasal gel for testosterone replacement therapy in adult males diagnosed with hypogonadism, is commercialized in Canada and the U.S.; and URIVARX®, a Natural Health Product that helps reduce symptoms of hyperactive bladder such as daytime urinary frequency, urgency and nocturia. URIVARX® was recently approved by Health Canada and will be offered over-the-counter to Canadians dealing with such symptoms. Also, NATESTO® has been licensed for distribution in 29 additional countries worldwide. Marketing approvals in jurisdictions outside of North America are expected to take place over the course of the coming years. Acerus’ pipeline includes four innovative products: ELEGANT™ Vaginal Moisturizer, which provides comfort to women suffering from vaginal dryness, and ELEGANT™ pH, which is a pH balanced vaginal product; GYNOFLOR™, an ultra-low dose vaginal estrogen combined with a probiotic, for which a NDS has been filed in Canada for the treatment of vaginal atrophy, 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, Acerus is working on expanding its product portfolio by leveraging its proprietary delivery systems, patents and formulation expertise. As such, Acerus has a number of products in various stage of development. One of these projects relates to cannabinoids (whether synthetic or naturally derived cannabinoids) to be delivered intranasally to patients, which may have multiple possible therapeutic applications (the “Cannabinoids Initiative”). Acerus has filed patent applications on the Cannabinoids Initiative, is currently working on setting up a series of pharmacokinetic clinical trials and is actively looking at potential partnering transactions for these initiatives.
Metuchen Pharmaceuticals LLC is a privately-held specialty pharmaceutical company dedicated to improving men's health through innovative proprietary pharmaceutical products that have unique and meaningful clinical benefits.
For more information, go to https://www.metuchen-pharma.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 commercial success of Stendra® in Canada, 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 20, 2018 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 laws.
1 2015 CUA Practice Guidelines for Erectile Dysfunction as
published in CAN UROL ASSOC J 2015; 9(1-2): 23-9
2(IQVIA Canadian Drugstore and Hospital Audit, MAT June 2017)