Aytu BioScience Announces ZolpiMist(TM) Global Distribution Agreement with SUDA Pharmaceuticals

Aytu Assumes Milestone & Royalty-Based Licensing Agreement with SUDA Pharmaceuticals to Sublicense ZolpiMist Outside of the United States and Canada

ENGLEWOOD, CO / ACCESSWIRE / March 6, 2019 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs, today announced the Company’s licensing agreement with SUDA Pharmaceuticals Ltd (ASX: SUD) to distribute ZolpiMist^™ (zolpidem tartrate oral spray) outside the United States and Canada. ZolpiMist is a rapidly acting oral spray sleep aid and is the only FDA-approved oral spray formulation of zolpidem tartrate. Zolpidem tartrate tablets are marketed in the U.S. under the brand name Ambien^®.

SUDA Pharmaceuticals is a drug delivery company focused on oro-mucosal administration and is headquartered in Perth, Western Australia. SUDA has been granted the exclusive license to market and distribute ZolpiMist in major markets outside the United States and Canada. Aytu has assumed this perpetual, exclusive global licensing agreement with SUDA from Magna Pharmaceuticals, the former NDA holder of ZolpiMist.

The Aytu-SUDA licensing agreement calls for SUDA to lead commercial development and sublicensing efforts for ZolpiMist in major territories outside the United States and Canada, including Europe, Asia, and Latin America. The global sleep aid market is currently estimated at almost $50 billion in annual revenue, and annual revenue is estimated to reach nearly $80 billion in 2022.

SUDA has already signed sublicensing agreements in key markets with large, multi-national pharmaceutical companies and has agreements in place in China, Chile, Brazil, and throughout Southeast Asia. Additional sublicensing discussions are ongoing with additional prospective sublicensees for Mexico and other geographies.

Josh Disbrow, Aytu BioScience’s Chief Executive Officer commented, ”We are pleased to be partnering with SUDA as they develop ZolpiMist commercial opportunities around the world. In a short period of time the SUDA team has entered into several sublicensing arrangements with prominent pharmaceutical companies. As such, we expect to see regulatory clearance in at least one market in the coming year. We thank CEO Stephen Carter and the SUDA team for their partnership and look forward to working with SUDA as they continue their ongoing commercial efforts with ZolpiMist around the world.”

Stephen Carter, SUDA Pharmaceuticals’ Chairman and Chief Executive Officer added, ”SUDA is pleased to continue its ZolpiMist program with Aytu. We have a number of discussions in place to further the global footprint of the ZolpiMist brand. We are looking forward to the ongoing achievement of commercial milestones and the continued roll out of regulatory submissions with our partners.”

As specified in the companies’ global licensing agreement, SUDA will pay Aytu a portion of each upfront and milestone payment received from sublicensees, and Aytu will receive ongoing royalty payments on sales generated by SUDA’s sublicensees as ZolpiMist is launched in their territories.

More information about SUDA’s licensing agreements can be found on the SUDA Pharmaceuticals corporate website in the company’s announcements section at:

http://sudapharma.com/index.php/asx-announcements

About Aytu BioScience

Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on commercializing novel products that address significant patient needs. The company currently markets Natesto^®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”). Aytu also has exclusive U.S. and Canadian rights to ZolpiMist^™, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu recently acquired exclusive U.S. commercial rights to Tuzistra^® XR, the only FDA-approved 12-hour codeine-based antitussive syrup. Tuzistra XR is a prescription antitussive consisting of codeine polistirex and chlorpheniramine polistirex in an extended-release oral suspension. 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 of the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved, Mexican COFEPRAS approved product, and Aytu is planning 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 products, leveraging its focused commercial team and expertise to build leading brands within large therapeutic markets. For more information visit aytubio.com.

About SUDA Pharmaceuticals

SUDA Pharmaceuticals Ltd (ASX: SUD) is a drug delivery company focused on oro-mucosal administration, headquartered in Perth, Western Australia. The Company is developing low-risk oral sprays using its OroMist^® technology to reformulate existing pharmaceuticals. The many potential benefits of administering drugs through the oral mucosa (i.e.: cheeks, tongue, gums and palate) include ease of use, lower dosage, reduced side effects and faster response time. SUDA’s product pipeline includes ZolpiMist^™, a first-in-class oral spray of zolpidem for insomnia. ZolpiMist is marketed in the USA and SUDA has rights to the product outside of the US and Canada. SUDA has submitted a Marketing Authorisation Application to the Australian Therapeutic Goods Administration for ArTiMist^®, its novel sublingual malaria treatment for children. In a Phase III trial, ArTiMist was shown to be superior to intravenous quinine. Other products in development include oral sprays for the treatment of: migraine headache; chemotherapy-induced nausea and vomiting; erectile dysfunction; PAH; epileptic seizures and pre-procedural anxiety; and cancer.

Forward-Looking Statements

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 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 risks relating to gaining market acceptance of our products both domestically and internationally, 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 revenue growth, our anticipated future cash position and future events under our current and potential future collaboration. 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.

Contact for Investors:

James Carbonara
Hayden IR
(646)-755-7412
james@haydenir.com

SOURCE: Aytu BioScience, Inc.

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