ENGLEWOOD, Colo., July 6, 2016 /PRNewswire/ -- Aytu BioScience Inc. (OTCQX: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products in the field of urology, will provide an overview of its Natesto launch activities, which are planned to commence this month, during a live conference call and webcast today at 4:30 p.m. ET.
- Acquired U.S. rights to Natesto (testosterone) Nasal Gel from Acerus Pharmaceuticals, paying $4 million upfront
- Natesto positioned favorably within $2 billion U.S. testosterone replacement therapy (TRT) market:
- Only FDA-approved, nasally-administered TRT product;
- Nasal delivery system offers unmatched convenience and simplicity for patients;
- Only topical TRT product without a 'black box' safety warning for risk of testosterone transference;
- Orange Book-listed patents in force through at least February 2024
- Expanded urology-centric commercial team with all sales management positions and U.S. sales territories fully staffed
- Appointed Senior Director of Marketing and Director of Channel Management
- Completed commercial channel and regulatory transition from Endo Pharmaceuticals, assuming all U.S. rights to Natesto on July 1, 2016
- First national sales meeting to finalize launch activities and sales training to begin July 11, 2016, with field promotional activities commencing July 25, 2016
"With approximately 13 million U.S. men suffering from some form of hypogonadism, or 'Low T', the opportunity for Natesto is substantial. It is a distinct product with significant benefits beyond the current TRT products or any new potential market entrants," stated Jonathan McGrael, Vice President of Commercial Operations of Aytu BioScience Inc. "With our launch team now in place, we are focusing initially on 5,500 of the highest TRT prescribers across the country – with a distinct focus on urologists."
Natesto is the only FDA–approved topical TRT product that doesn't have a black box safety warning associated with its use, eliminating concerns of transferring testosterone to a child, adolescent, or female partner living in the house. Additionally, it does not entail performing laborious application routine and can be stored easily for ready access and used "on the go".
Josh Disbrow, Chief Executive Officer of Aytu BioScience Inc., added, "With relatively little upfront expense, we successfully acquired an FDA-approved, commercial-ready product with significant resources and effort put into its development over many years by our partner Acerus. We are now ready to launch Natesto into a very large, yet concentrated specialty market. Given Aytu's dedicated urology-centric sales force and priority focus on Natesto, we believe we are positioned for a successful product launch and significant potential long-term growth over the coming years."
Conference Call and Webcast Information:
The audio webcast and accompanying slides will be accessible live and archived on Aytu's website, www.aytubio.com, for 90 days. Interested participants and investors may also access the conference call by dialing either:
- 1-855-656-0926 (U.S.)
- 1-412-542-4198 (international)
A replay of the call will be available for seven days. Access the replay by calling 1-877-344-7529 (U.S.) or 1-412-317-0088 (international) and using the replay access code 10088515.
About Aytu BioScience Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products in the field of urology. The company currently markets three products: Natesto®, the first and only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"), ProstaScint® (capromab pendetide), the only FDA-approved imaging agent specific to prostate specific membrane antigen (PSMA) for prostate cancer detection, and Primsol® (trimethoprim hydrochloride), the only FDA-approved trimethoprim-only oral solution for urinary tract infections. 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 product, and Aytu is conducting U.S.-based clinical trials in pursuit of 510k de novo medical device clearance by the FDA. Aytu's strategy is to continue building its portfolio of revenue-generating urology products, leveraging its focused commercial team and expertise to build leading brands within well-established markets.
For Investors & Media:
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: the ability to have Aytu common stock listed on a national securities exchange; 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; risks relating to gaining market acceptance of our products; obtaining reimbursement by third-party payors; our anticipated future cash position; and future events under our current and potential future collaborations. 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.
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SOURCE Aytu BioScience Inc.