Englewood, CO – March 29, 2016 – Aytu BioScience, Inc. (OTCQX: AYTU), a commercial-stage specialty healthcare company focused on commercializing treatments for urological conditions, today announced that the company has entered into a co-promotion agreement for Primsol® (trimethoprim hydrochloride) oral solution with Allegis Pharmaceuticals, a commercial-stage specialty pharmaceutical company focused on the US pediatric market. Under the agreement, Allegis will exclusively promote Primsol to pediatricians across the U.S. Aytu retains all other rights in the U.S. and around the world and will continue to market the product in urologic indications.
Primsol is the only FDA-approved liquid formulation of trimethoprim, an antibiotic that is well established in current guidelines for treating uncomplicated urinary tract infections (UTIs). This differentiated product is appropriate for UTI patients that have difficulty swallowing tablets, such as the elderly, and particularly for patients that experience adverse reactions to sulfamethoxazole (“sulfa”). Primsol is also indicated for the treatment of acute otitis media, or middle ear infection, caused by susceptible organisms in children age six months to twelve years. Otitis media is the leading pediatric infection in the U.S.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated, “We are excited to initiate this partnership with Allegis and believe that this co-promotional agreement makes sense on multiple levels. Allegis has an experienced commercial team and a strong sales history in pediatrics–where Primsol prescribing has been consistent since the product’s launch–with a product portfolio that is complementary to Primsol. Placing the pediatric-focused marketing efforts with Allegis enables Aytu to further monetize Primsol through a long-term promotional commitment, while enabling Aytu to stay focused on our core therapeutic area of urology. We expect Allegis to regain some of the historical prescribing of pediatricians as we align our efforts to the urology market, a specialty that has historically prescribed over one-quarter of Primsol prescriptions in the U.S.”
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty healthcare company focused on global commercialization of novel products in the field of urology. Aytu’s current portfolio of commercial and late-stage urology products addresses prostate cancer, urinary tract infections, male infertility and male sexual dysfunction, and the company plans to expand into other urological indications for which there are significant medical needs. The company currently markets ProstaScint® (capromab pendetide), the only radio-labeled monoclonal antibody that targets prostate specific membrane antigen (PSMA), a protein highly expressed by prostate cancer cells. ProstaScint is FDA-approved as an imaging agent for use in both newly diagnosed, high-risk prostate cancer patients and patients with recurrent prostate cancer. Aytu also markets Primsol® (trimethoprim hydrochloride) – the only FDA-approved trimethoprim-only oral solution for urinary tract infections. Additionally, Aytu markets the CE Marked MiOXSYS™ System outside the US and is conducting US-based clinical trials, following which the company expects to receive 510k de novo medical device clearance. The MiOXSYS System is a novel, rapid semen analysis system with the potential to become a standard of care in the diagnosis and management of male infertility. MiOXSYS is the only rapid test for assessing oxidative stress in semen and seminal plasma, a leading contributor of idiopathic male infertility. Aytu’s strategy is to continue building its portfolio of revenue-generating urology products and late-stage development assets, leveraging its commercial team and expertise to further build those brands within well-established markets.
Forward Looking Statement
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, including statements regarding our anticipated future clinical and regulatory events, future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. Forward looking statements are generally written in the future tense and/or are preceded by words such as “may,” “will,” “should,” “forecast,” “could,” “expect,” “suggest,” “believe,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others risks relating to: future events under our current and potential future collaborations; gaining market acceptance of our products; obtaining reimbursement by third-party payors; the potential future commercialization of our product candidates; the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials; the anticipated designs of our future clinical trials; anticipated future regulatory submissions and events; and our anticipated future cash position. We also refer you to the risks described in “Risk Factors” in Part I, Item 1A of Aytu BioScience, Inc.’s Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.