TORONTO--(BUSINESS WIRE)--Acerus Pharmaceuticals Corporation (TSX:ASP) (“Acerus” or the “Company”) today announced that it has entered into an exclusive agreement to commercialize Pharmanest AB (“Pharmanest”) Short Acting Lidocaine product (“SHACT”), a novel pain relief drug device combination in Canada.
SHACT is a novel technology that provides pain relief on vaginal mucosal tissue. In a clinical study conducted in Sweden, the SHACT treatment was associated with significant reduction of pain and discomfort in women undergoing gynecological interventions without causing bothersome side effects. In the 218-patient study, women treated with SHACT experienced significantly less pain during intrauterine device (IUD) placement compared to those treated with placebo (p<0.0001). In Canada, over 220 000 IUDs were inserted in the twelve months ending June 2017.1 The market for IUD’s has been steadily increasing with double-digit annual growth as more women opt for that method of contraception.
“This is an excellent partnership for Acerus as SHACT is well-aligned with our strategy of becoming the Canadian leader in women’s health by providing innovative products addressing unmet medical needs. Acerus currently intends to file a new drug submission with Health Canada in the first half of 2019, and, if approved, expects SHACT to be commercialized in the first half of 2020”, said Tricia Symmes, Chief Operating Officer of Acerus.
“This transaction will help broaden our women’s health product portfolio and will leverage our existing salesforce. With SHACT, Acerus continues to build a unique product offering that will help accelerate and diversify our product revenues,” added Ed Gudaitis President and Chief Executive Officer of Acerus.
Helena Jansson, CEO of Pharmanest, noted: “We are extremely pleased to be partnering with Acerus Pharmaceuticals, an emerging Canadian leader in women’s health. We believe they have all the expertise and infrastructure required to make SHACT a commercial success in Canada.”
Under the terms of the license agreement, Pharmanest will receive an upfront and regulatory milestone payments upon Acerus receiving marketing approval in Canada. Pharmanest will also receive milestone payments based on Acerus achieving sales targets. Pharmanest will oversee the manufacturing of SHACT and will receive a tiered supply price for the product comprised of a percentage on net sales of the product.
SHACT is a novel delivery technology that provides pain relief on mucosal tissue. In a clinical study conducted in Sweden, SHACT treatment was associated with significant reduction of pain and discomfort in women undergoing gynaecological interventions without causing bothersome side effects. In the 218-patient study, women treated with SHACT experienced significantly less pain during intrauterine device (IUD) placement compared to those treated with placebo (p<0.0001).).
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 48 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 five innovative products: STENDRA®, a new chemical entity PDE5 inhibitor for the treatment of erectile dysfunction, which has been approved by the US FDA and the EU EMA and is commercialized in the US under the trade name STENDRA® and in the EU under the trade name SPEDRA®; 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.
About Pharmanest AB
Pharmanest AB (www.pharmanest.se) is a Swedish privately-held pharmaceutical company focused on new products for pain relief in the gynecology and obstetrics field. Pharmanest AB was founded by scientists at Karolinska Institute and the idea to develop mucosal analgesia is based on identification of sensory nerves in the reproductive tract. Pharmanest’s major shareholders include Östersjöstiftelsen (The Foundation for Baltic and East European Studies) which was founded by the Swedish Government in 1994. Its mission is to support research and doctoral studies at Södertörn University and the foundation currently manages a portfolio worth close to SEK 6 billion, Recipharm Venture Fund, part of Recipharm, a leading (CDMO) within the pharmaceutical industry and Praktikerinvest, an investment company within the Praktikertjänst Group, Sweden’s biggest provider of private health and dental care, owned and run by dentists, doctors and other therapists.
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 SHACT 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 IQVIA CompuScript Audit, June 2017.