Englewood, CO – January 18, 2017 – Aytu BioScience, Inc. (OTCQX: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products in the field of urology, today announced that two posters demonstrating clinical data for Natesto® (testosterone) Nasal Gel were accepted for presentation at the American Urological Association 2017 Annual Meeting to be held on May 12 – 16, 2017 in Boston, MA. Natesto is the first and only nasal formulation of testosterone approved by the U.S. Food and Drug Administration (FDA) as a replacement therapy for men diagnosed with hypogonadism (low testosterone, or “Low T”).
Josh Disbrow, Chief Executive Officer of Aytu, stated, “Natesto’s clinical benefits continue to be proven by studies such as the two accepted for presentation at the AUA, and Aytu is committed to continually growing Natesto’s body of scientific evidence through additional study with experts in the field of urology.”
The two abstracts accepted for presentation at the American Urological Association 2017 Annual Meeting are as follows:
Title: Preservation of Normal Concentrations of Pituitary Gonadotropins Despite Achievement of Normal Serum Testosterone Levels in Hypogonadal Men Treated with a 4.5% Nasal Testosterone Gel
Abstract ID: 17-6558
Presenter: William Conners, MD, Urologist at Men’s Health Boston and Clinical Instructor of Urology at Harvard Medical School, Boston, MA
Conclusions: Treatment with Natesto restores serum total testosterone to normal levels in hypogonadal men, while also mitigating the decline in luteinizing hormone (LH) and follicle-stimulating hormone (FSH) which remained within the normal range at Day 90 of treatment.
Title: Clinical Improvements in Erectile Function and Mood in Hypogonadal Men Treated with 4.5% Nasal Testosterone Gel
Abstract #: 17-6376
Presenter: Larry I. Lipshultz, MD, Professor of Urology and Chief of the Scott Department of the Urology’s Division of Male Reproductive Medicine and Surgery, Baylor College of Medicine, Houston, TX
Conclusions: Natesto achieves large, clinical improvements in erectile function, mood and sexual desire within 30 days of initiating treatment.
Mr. Disbrow continued, “These studies add to the growing body of clinical evidence demonstrating the safety and effectiveness of Natesto and the unique attributes of a nasally administered testosterone replacement therapy – beyond simply improving serum testosterone levels. Natesto represents an important new treatment option for the approximately 13 million men in the U.S. who have Low T, and we expect broad adoption as market awareness increases.
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 staging, 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 more information visit aytubio.com.
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 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, 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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