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Aytu BioScience Enters $2 Billion Testosterone Replacement Market with Acquisition of U.S. Commercial Rights to Natesto Secures Long-term, Exclusive License from Acerus Pharmaceuticals Corporation Licenses Novel, FDA-App

Key Takeaway: Aytu BioScience Enters $2 Billion Testosterone Replacement Market with Acquisition of U.S. Commercial Rights to Natesto Secures Long-term, Exclusive License from Acerus Pharmaceuticals Corporation Licenses Novel, FDA-Approved Nasal Gel Testosterone Product; Planned for July

Full Press Release Details

Aytu BioScience Enters $2 Billion Testosterone
Replacement Market with Acquisition of U.S. Commercial Rights to Natesto
Secures Long-term, Exclusive License
from Acerus Pharmaceuticals Corporation
Licenses Novel, FDA-Approved Nasal Gel
Testosterone Product;
Planned for July 2016
Englewood, CO - April 25, 2016 - Aytu BioScience,
Inc. (OTCQX: AYTU), a specialty pharmaceutical company focused on commercializing novel products in the field of urology today
announced the exclusive licensing of its third commercial-stage urology product in just 11 months, with the execution of a long-term,
exclusive license agreement with an affiliate of Acerus Pharmaceuticals Corporation (TSX: ASP) for the U.S. commercial rights to
Natesto (testosterone) Nasal Gel. 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").
Aytu anticipates further expanding its current urology-centric sales force and initiating its promotion of Natesto into the $2
billion U.S. testosterone replacement market in July 2016.
The profile of Natesto is unique among currently marketed testosterone
products, offering convenient and simple administration via a nasal gel applicator within seconds, but without the risk of testosterone
transference associated with other topical products such as AndroGel and Axiron , which carry "black box"
warnings on their product labels. Natesto was approved by the FDA in May 2014 and is protected by multiple Orange Book-listed patents.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated,
"Securing the rights to commercialize Natesto in the United States represents Aytu's most significant transaction to
date. This partnership further expands on our strategy to build a complementary portfolio of unique urology assets, and we expect
Natesto to be a key value driver for Aytu going forward. Approximately thirteen million men in the U.S. have a form of Low T, and
we believe that Natesto has significant potential to satisfy the needs of many men that are not satisfied with current Low T treatment
options. We look forward to building a strong and long-lasting relationship with Acerus based on successfully establishing Natesto
as an important treatment option in the U.S. Our current sales force is already preparing to engage prescribers given our focus
on urologists and the key prescribers of testosterone replacement therapies."
Tom Rossi, President and Chief Executive Officer of Acerus,
stated, "We are very pleased to announce Aytu as our U.S. commercial partner for Natesto. Management's proven track
record of launching and scaling successful commercial operations within the specialty pharmaceutical industry, and the fact that
Aytu is focused on building a significant presence in men's health, were instrumental in reaching this decision. We look
forward to strengthening our relationship with Aytu in support of the planned U.S. launch of Natesto, and to supporting its growth
in this important therapeutic market."
Under the terms of the exclusive license, Aytu will pay Acerus
a total of $2 million upfront, and will additionally purchase of $2 million of Acerus common stock. Additional payments totaling
an aggregate of $6 million payable in fiscal 2017 will also be made. Acerus will also receive a supply price to manufacture the
product calculated as a percentage of the U.S. net sales of Natesto, throughout the term of the agreement, which will last until
at least February 2024, with the maximum milestone payable upon achievement of $125 million in annual U.S. net sales.
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. 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
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 U.S. and
is conducting U.S.-based clinical trials, following which the company plans to seek 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
Acerus Pharmaceuticals Corporation is a Canadian pharmaceutical
company focused on the development, manufacture, marketing and distribution of innovative, branded products that improve the patient
Acerus markets ESTRACE in Canada, a product indicated for
the symptomatic relief of menopausal symptoms. NATESTO , a product utilizing an Acerus licensed nasal gel technology, is the
first and only testosterone nasal gel approved in Canada, and available in the United States for replacement therapy in adult males
diagnosed with hypogonadism. GYNOFLOR , a product licensed to Acerus in Canada by Medinova AG, is an ultra-low dose vaginal
estrogen therapy with the addition of lactobacillus, for the treatment of atrophic vaginitis, certain vaginal infections and to
restore a healthy vaginal environment. TEFINA , a use as required' nasal testosterone gel, is an Acerus drug
development candidate aimed at addressing a significant unmet need for women with female sexual dysfunction.
Natesto (testosterone) Nasal Gel is an androgen indicated for
replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:
Primary hypogonadism (congenital or acquired): testicular failure
due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's
syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations
and gonadotropins (follicle-stimulating hormone [FSH] and luteinizing hormone [LH]) above the normal range; and
Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin
or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
These men have low serum testosterone concentrations but have gonadotropins in the normal or low range.
Safety and efficacy of Natesto in men with "age-related
hypogonadism" have not been established.
Safety and efficacy of Natesto in males <18 years old have
not been established.
IMPORTANT SAFETY INFORMATION FOR NATESTO
Natesto is contraindicated in men with carcinoma of the breast
or known or suspected prostate cancer and in women who are, or may become, pregnant or who are breastfeeding. Natesto may cause
fetal harm when administered to a pregnant woman and serious adverse reactions in nursing infants.
Nasal adverse reactions, including nasopharyngitis, rhinorrhea,
epistaxis, nasal discomfort, and nasal scabbing, were reported in the clinical trial experience with Natesto. Patients should be
instructed to report any nasal symptoms or signs to their healthcare professional. In that circumstance, healthcare professionals
should determine whether further evaluation or discontinuation of Natesto is appropriate.
Due to lack of clinical data on safety or efficacy, Natesto
is not recommended for use in patients with a history of nasal disorders, nasal or sinus surgery, nasal fracture within the previous
6 months or nasal fracture that caused a deviated anterior nasal septum, mucosal inflammatory disorders (e.g., Sjogren's
syndrome), and sinus disease.
Monitor patients with benign prostatic hyperplasia (BPH) for
worsening of signs and symptoms of BPH. Patients treated with androgens may be at increased risk for prostate cancer. Evaluation
of patients for prostate cancer prior to initiating and during treatment with androgens is recommended.
Increases in hematocrit, reflective of increases in red blood
cell mass, may require discontinuation of Natesto.
Venous thromboembolic events, including deep vein thrombosis
(DVT) and pulmonary embolism (PE), have been reported in patients using testosterone products. Patients with signs and symptoms
consistent with DVT or PE need evaluation and may require discontinuation of treatment with Natesto.
Some postmarketing studies have shown an increased risk of major
adverse cardiovascular events (MACE) with use of testosterone replacement therapy. Patients should be informed of this possible
risk when deciding to use or to continue to use Natesto.
Due to lack of controlled studies in women and potential virilizing
effects, Natesto is not indicated for use in women.
Last updated: Apr 25, 2016