Full Press Release Details
Aytu BioScience Announces Launch of Natesto U.S. Co-Promotion
with Acerus Pharmaceuticals
Acerus Launches U.S. Specialty Sales Force; Sales Team Expansion
Nearly Doubles Current Natesto Sales Force
Expanded Commercial Operations Expected to Accelerate Natesto
ENGLEWOOD, CO / ACCESSWIRE / December 2, 2019 / Aytu
BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company
focused on commercializing novel products that address significant
patient needs, today announced the launch of the company's
co-promotion with Acerus Pharmaceuticals ( Acerus )
which is expected to accelerate the growth of Natesto in the
United States. Through this expanded commercial relationship,
Acerus has launched a U.S.-based specialty sales force promoting
Natesto to urologists and endocrinologists. Aytu will continue to
recognize all Natesto revenue and promote Natesto to all other
physician specialties including internal medicine and family
total prescriptions grew 30% from fiscal 2018 to 2019, and this
commercial partnership is expected to accelerate brand growth
through joint promotional efforts and a significantly expanded U.S.
Natesto co-promotion officially closed November 29, 2019 and was
effective December 1, 2019. This agreement significantly increases
sales force coverage of targeted testosterone prescribers and puts
a higher promotional focus on urologists and endocrinologists.
Further, this revised partnership enables Aytu to increase its
Natesto promotional efforts in primary care and other
accelerate the launch of Acerus' U.S. commercial team, Aytu
has agreed to transfer five current sales employees to Acerus as of
December 2, 2019. These staff will operate as Acerus employees, but
they will remain on Aytu's payroll until the earlier of the
date on which Acerus is ready to fully assume the personnel or June
30, 2020. Aytu will deduct the costs of these sales personnel from
quarterly payments otherwise owed to Acerus under the revised
agreement, with a final accounting to be done once per year.
Throughout 2020, Acerus will be building out a complete US-based
specialty sales force and other commercial functions, significantly
increasing the number of employees working directly on Natesto in
previously announced on July 30, 2019, the companies signed an
agreement 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
and Acerus will continue to operate a joint commercialization
committee in support of Natesto and will closely collaborate on
U.S. brand strategy and commercial initiatives.
Disbrow, Aytu BioScience Chief Executive Officer, commented,
We are excited to be launching our co-promotion with Acerus
as they launch their sales team. With a coordinated promotional
approach, this nearly doubling of the Natesto commercial footprint
stands to substantially accelerate Natesto 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 story.
This development, coupled with the two recently announced payer
formulary wins, should substantially accelerate Natesto's
Disbrow continued, We're excited to be working with
Acerus to increase our reach to physicians around the country.
Additionally, with the recent expansion of Aytu's therapeutic
portfolio that now includes ZolpiMist , Tuzistra XR,
and the recently acquired six-product portfolio from Cerecor, this
enhanced commercial arrangement enables us to employ a more
distinct focus on primary care physicians to grow our entire
product portfolio, while Acerus increases the promotional focus on
Natesto with urologists and endocrinologists.
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 urologists and endocrinologists above
specified revenue levels. 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
revised Natesto license 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, future clinical trial costs, and all regulatory and
pharmacovigilance and compliance-related expenses.
will continue to book Natesto revenue and will pay Acerus quarterly
commissions based on sales from prescriptions generated by
urologists and endocrinologists.
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 a portfolio of
prescription products addressing large primary care and pediatric
markets. The primary care portfolio includes (i) Natesto , the only FDA-approved
nasal formulation of testosterone for men with hypogonadism (low
testosterone, or "Low T"), (ii) ZolpiMist , the only FDA-approved
oral spray prescription sleep aid, and (iii) Tuzistra XR, the only FDA-approved
12-hour codeine-based antitussive syrup. The pediatric portfolio
includes (i) AcipHex
Sprinkle , a granule formulation of rabeprazole
sodium, a commonly prescribed proton pump inhibitor; (ii)
second-generation cephalosporin antibiotic suspension; (iii)