ENGLEWOOD, Colo., April 25, 2016 /PRNewswire/ -- 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 both newly 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 markets.
About Acerus
Acerus Pharmaceuticals Corporation is a
Canadian pharmaceutical company focused on the development,
manufacture, marketing and distribution of innovative, branded
products that improve the patient experience.
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.
About Natesto
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.
Limitations of use:
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.
Serious hepatic adverse effects (peliosis hepatis, hepatic
neoplasms, cholestatic hepatitis, and jaundice) have been
associated with prolonged use of high doses of oral
methyltestosterone. Natesto is not known to cause these adverse
effects. Nonetheless, patients should be instructed to report any
signs or symptoms of hepatic dysfunction (e.g., jaundice). If these
occur, promptly discontinue Natesto while the cause is
evaluated.
Edema, with or without congestive heart failure, may be a
serious complication in patients with pre-existing cardiac, renal,
or hepatic disease.
Administration of exogenous androgens, including Natesto, may
lead to azoospermia through suppression of spermatogenesis;
gynecomastia; sleep apnea (especially in patients with risk factors
such as obesity and chronic lung disease); decreased concentrations
of thyroxine-binding globulins; and changes in serum lipid
profile.
Natesto should be used with caution in cancer patients at risk
of hypercalcemia (and associated hypercalciuria).
Periodic monitoring of prostate specific antigen (PSA),
hematocrit, and lipid concentrations is recommended, as changes may
require discontinuation of Natesto.
The most common adverse reactions reported by ≥3% of patients
were: PSA increased, headache, rhinorrhea, epistaxis, nasal
discomfort, nasopharyngitis, bronchitis, upper respiratory tract
infection (URI), sinusitis, and nasal scab.
Changes in insulin sensitivity or glycemic control may occur in
patients treated with androgens and may necessitate a decrease in
the dose of anti-diabetic medication. Changes in anticoagulant
activity may be seen with androgens. The concurrent use of
testosterone with corticosteroids may result in increased fluid
retention and requires monitoring particularly in patients with
cardiac, renal, or hepatic disease.
Please see full Prescribing Information.
For Aytu BioScience Investors & Media:
Tiberend
Strategic Advisors, Inc.
Joshua Drumm, Ph.D.:
jdrumm@tiberend.com; (212) 375-2664
Janine McCargo:
jmccargo@tiberend.com; (646) 604-5150
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 related to our planned launch and
commercialization of Natesto and the integration of Natesto into
our existing operations; our plans for product growth,
expansion and acquisition; the anticipated start dates, durations
and completion dates, as well as the potential future results, of
our ongoing and future clinical trials; 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 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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SOURCE Aytu BioScience, Inc.