Full Press Release Details
Aytu BioScience Expands Natesto Partnership with Acerus
Pharmaceuticals to Accelerate Natesto Growth in the
Acerus to Launch U.S. Specialty Sales Force; Nearly Doubles Natesto
ENGLEWOOD, CO / ACCESSWIRE / July 30, 2019 / Aytu
BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company
focused on commercializing novel products that address significant
patient needs, today announced the expansion of the company's
partnership with Acerus Pharmaceuticals ( Acerus ) to
accelerate the growth of Natesto in the United States.
Through this expanded commercial relationship, Acerus will fund and
launch a U.S.-based specialty sales force which will promote
Natesto to urologists and endocrinologists. Aytu will continue to
book all Natesto revenue and promote Natesto to all other
specialties including internal medicine and family
the closing of this revised agreement, Acerus will launch a
complementary U.S. commercial team and hire at least twenty-five
U.S-based specialty sales representatives, nearly doubling the size
of the Natesto field force. This co-promotion significantly
increases sales force coverage of targeted U.S. prescribers, puts a
higher promotional focus on urologists and endocrinologists, and
enables Aytu to increase its promotional efforts in primary care
and other specialties.
29, 2019, the companies agreed to expand their commercial
partnership and amend and restate the original 2016 Natesto
exclusive U.S. license agreement. Under the revised agreement, Aytu
will remain the exclusive U.S. supplier of Natesto and retain all
rights to revenues generated.
and Acerus will continue to operate a joint commercialization
committee in support of Natesto and will now more closely
collaborate on U.S. brand strategy and commercial initiatives.
Natesto total prescriptions grew 30% from fiscal 2018 to 2019, and
this partnership is expected to drive accelerated growth of the
brand through joint promotional efforts and a significantly
expanded U.S. presence.
Disbrow, Aytu BioScience Chief Executive Officer, commented,
We are thrilled to be expanding our partnership with Acerus
and increasing the U.S. commercial footprint to such a large
extent. With a coordinated promotional approach, this nearly
doubling of the Natesto commercial team stands to substantially
increase Natesto awareness and accelerate prescription growth.
Acerus' increased commitment to Natesto, as evidenced by
their significant investment in launching a U.S. commercial team,
is an important step in the evolution of the Natesto growth
Disbrow continued, We're pleased to be working
together with Acerus to significantly increase our reach to
physicians around the country. Additionally, with the recent
expansion of Aytu's therapeutic portfolio, that now includes
ZolpiMist and Tuzistra XR, this revised commercial
arrangement enables us to employ a more distinct focus on primary
care physicians to grow the entire product portfolio, while Acerus
increases the promotional focus on Natesto with key
will continue to serve as the exclusive U.S. supplier to purchasers
of Natesto, and Acerus will receive performance-based commissions
on prescriptions generated by urology and endocrinology
specialties. Acerus will assume regulatory and clinical
responsibilities and associated expenses and will serve a primary
role in the development of key opinion leaders in urology and
endocrinology. Aytu will focus on commercial channel management,
sales to wholesalers and other purchasing customers, and will
direct sales efforts in all other physician
the revised agreement, both companies have committed specific
commercial resources, dedicated sales representatives and activity
levels, and will jointly develop a Natesto commercialization
revised agreement extends the original agreement by at least three
years to the later of 2027, the launch of an FDA approved, AB-rated
generic equivalent to Natesto, or the expiration or invalidation of
the last to expire Natesto patent.
payment structure currently in place will be replaced with a
pay-for-performance commission incentive structure intended to
drive Natesto prescription growth across all physician specialties.
All previously agreed upon milestone payments payable by Aytu have
been removed. Additionally, Acerus will now pay all annual FDA
fees, current and future clinical trial costs, and all regulatory
and pharmacovigilance expenses.
will continue to book Natesto revenue and will pay Acerus quarterly
commissions based on sales from prescriptions generated by
urologists and endocrinologists.
effectiveness of the revised agreement is subject to certain
information is available on Form 8-K as filed today with the
Securities and Exchange Commission.
About Aytu BioScience, Inc.
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 , the only
FDA-approved oral spray prescription sleep aid. ZolpiMist is
indicated for the short-term treatment of insomnia characterized by
difficulties with sleep initiation. Aytu also 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 a patented, 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. Aytu is