Full Press Release Details
Aytu BioScience Enters $3 Billion
Cough and Cold Market and Expands Primary Care Portfolio, with Exclusive U.S. Licensing of Revenue-Generating, FDA-Approved Antitussive
Armistice Capital to Make $5M Strategic Investment in Conjunction
with Tuzistra XR Acquisition to Accelerate Growth
ENGLEWOOD, CO / ACCESSWIRE / November 5, 2018 / Aytu BioScience,
Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant
medical needs, today announced the Company's entry into the $3 billion cough and cold market with an exclusive license of
FDA-approved Tuzistra XR from Tris Pharma.
Tuzistra XR is the only FDA-approved 12-hour codeine-based antitussive.
Tuzistra XR is a prescription antitussive consisting of codeine polistirex and chlorpheniramine polistirex in an extended-release
Along with Tuzistra XR, the Company has licensed a complementary
antitussive product pending FDA approval. Tuzistra XR and the complementary antitussive, upon FDA approval, will both be marketed
in the United States by Aytu's direct sales force. Tuzistra XR is expected to generate revenue this year after launching
promptly this cough and cold season. Tuzistra XR generated more than 40,000 prescriptions in 2017.
Tuzistra XR is a patented combination of codeine, an opiate
agonist antitussive, and chlorpheniramine, a histamine-1 receptor antagonist, indicated for relief of cough and symptoms associated
with upper respiratory allergies or a common cold in adults aged 18 years and older. Tuzistra XR is protected by two Orange Book-listed
patents extending to 2031 and multiple pending patents.
According to MediMedia, the US cough cold prescription market
is worth in excess of $3 billion at current brand pricing, with 30-35 million annual prescriptions. This market is dominated by
short-acting treatments, which require dosing 4-6 times a day. Tuzistra XR was developed using Tris Pharma's liquid sustained
release technology, LiquiXR , which allows for extended drug delivery throughout a 12-hour dosing period.
As part of this transaction, the Company also plans to enter
into a strategic financing with Armistice Capital, LLC ("Armistice"), an institutional healthcare investor with over
$800M in assets under management. Under the terms of this financing, Armistice is expected to provide the company with up to $5
million in the form of a three-year note, secured by the Tuzistra revenue streams. This funding will further support the Company's
growth and enable a rapid launch and integration of the Tuzistra portfolio in Aytu's current operations. Details of the financing
will be provided upon its closing, which is expected to occur in seven business days.
Josh Disbrow, Chief Executive Officer of Aytu BioScience explained,
"We are thrilled to be partnering with Tris Pharma in acquiring this license to Tuzistra XR and the complementary antitussive
therapeutic pending approval. We believe these products align well with our primary care portfolio, and Tuzistra XR provides another
attractive, revenue-generating therapeutic asset with clear clinical differentiation and patient benefits. We're equally
excited about the prospect of adding a complementary antitussive to the portfolio as that product gains approval. We thank the
Tris Pharma team for entrusting Aytu to build these products into strong brands and look forward to a successful long-term relationship
Tris Pharma's Founder and Chief Executive Officer, Ketan
Mehta said, "The combination of all day, all night, cough/cold relief in a liquid form makes a great deal of sense. We are
excited to continue to leverage our technology platform, LiquiXR, to improve patient care. Further, we are delighted to have Aytu
BioScience as our partner."
This press release shall not constitute an offer to sell or
the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in
any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under
the securities laws of any such state or jurisdiction. The securities described herein have not been registered under the Securities
Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from
registration requirements.
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical
company focused on global commercialization of novel products addressing significant medical needs. The company currently markets
Natesto , the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone,
or "Low T"). Aytu recently acquired 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.
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, growing markets. For more information visit aytubio.com.
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: risks relating to gaining market acceptance of our products
including Tuzistra XR, 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 collaboration. We also refer you to the
risks described in ' Risk Factors'' in Part I, Item 1A of the Company'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.