TORONTO, July 30, 2019 /PRNewswire/ -- Acerus
Pharmaceuticals Corporation (TSX:ASP, OTCQB: ASPCF) today announced
that it will be taking an expanded role in the commercialization of
NATESTO® in the U.S. The company has entered into an
amended and restated licensing agreement with Aytu BioScience, Inc.
(NASDAQ: AYTU), which will, upon closing, move the partnership from
an out-license model to a co-promotion arrangement that the
companies believe will leverage their collective product,
marketplace and Men's Health experience to capture a significant
share of the U.S. market for NATESTO®.
Under the terms of the new agreement, Aytu returns the NDA for
NATESTO® in the U.S. back to Acerus. Going forward
Acerus will assume all regulatory and clinical responsibilities and
costs for the product in the U.S. Acerus will take on a more
expansive role in matters such as U.S. marketing, reimbursement and
medical strategy as part of the companies' joint commercialization
committee, and will launch a specialist sales force focused on
urologists and endocrinologists (Acerus Sales Channel). Aytu will
retain its primary care sales force (Aytu Sales Channel) and will
continue to book all product net revenue while serving as the
exclusive U.S. supplier of NATESTO® to wholesalers,
pharmacies and other customers that receive a direct shipment.
Financial payments will be based upon a tiered level of net
revenue, post cost of goods sold (COGS), based on annual sales
performance in the respective Acerus and Aytu Sales Channels.
"Based on the year-over-year growth we have seen in
NATESTO® sales in Canada, we believe that the performance of
NATESTO® in the U.S. will benefit from Acerus employing
a similar specialist-driven model focused in urology and
endocrinology," said Ed Gudaitis,
President and Chief Executive Officer of Acerus. "There continues
to be a need for an effective testosterone replacement therapy that
does not have the same transference and safety concerns associated
with topical products. With its unique nasal gel formulation and
delivery method, NATESTO® is ideally suited to meet this
need and the revised partnership with Aytu gives us the scale and
reach needed to increase awareness and adoption among physicians
and patients."
To establish a high performing commercial footprint in the U.S.,
Acerus has engaged Syneos Health (NASDAQ: SYNH), a leading
integrated biopharmaceutical solutions organization including the
industry's largest Contract Commercial Organization (CCO), to be
its commercialization partner. Syneos Health has extensive
experience in Men's Health and with NATESTO®, and offers
an end-to-end model that will enable Acerus to rapidly stand up a
U.S. commercial team; to scale across all aspects of
commercialization, including medical and regulatory affairs,
managed markets, marketing and sales; and will provide greater
flexibility and effectiveness in resource deployment.
Low testosterone is estimated to affect approximately 39% of men
over 45 years old in the U.S.; however, because the condition is
underdiagnosed the overall prevalence is uncertain.1
While patients have access to other treatment options,
NATESTO® is unique in that it is administered in seconds
via a convenient and simple nasal gel applicator, addressing the
risk of testosterone transference associated with other topical
products, which carry "black box" warnings on their product
labels.
NATESTO® remains fully available and accessible to
patients in the U.S.
Financial Terms of Amended and Restated Agreement
As part of the amended and restated partnership agreement,
Acerus did not pay Aytu to regain the marketing authorization for
NATESTO® in the U.S. The royalty structure currently in
place will be replaced with a pay-for-performance incentive
structure intended to drive NATESTO® revenue growth in
both Sales Channels. The revised agreement extends the partnership
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.
Aytu will now pay Acerus a variable rate commission for sales
made in the Acerus Channel as per the following schedule:
- Up to the current status quo of NATESTO® net sales
($0 – 5.5M), Acerus will receive a commission
equivalent to 25% of net revenue generated;
- For the next $4.5M in net revenue
($5.5M – 10M), Acerus will receive a commission equivalent
to 50% of net revenue generated; and
- Above $10M in net revenue, Acerus
receives a commission equivalent to the combination of 90% of
urologists and endocrinologists related net revenues and 10% of
Aytu's sales channel net revenue generated.
By investing into the commercialization effort behind
NATESTO® in the U.S. and continuing to work in
partnership with Aytu BioScience, Acerus should realize increased
financial value as growth in prescription volume and net revenue is
accelerated. While Acerus will receive a higher blended percentage
of net revenue as it grows to $10M to
offset its increase in commercial investment, in the long run both
companies will benefit as improved sales will drive an increase in
net revenue that will be split more equally.
Closing is conditioned upon Acerus raising capital, whether by
way of equity or debt, of at least USD $10
million on or before January 29,
2020.
Conference Call on Tuesday, July
30 @ 4:30 PM Eastern
Time
To access the call live, please dial the toll-free number
1-866-215-0058 (Canada/US) or
International/Local dial-in number 416-204-1547. Listeners
are encouraged to dial in 10 minutes before the call begins to
avoid delays.
A replay of the conference call will be available until
11:59 PM ET on Tuesday, August 6, by
dialing the toll-free number 1-800-408-3053 (Canada/US), or International/Local dial-in
number 905-694-9451, using access code: 7881826#.
The Investor Slide Deck that will be shared during the call will
be available for download on the Acerus website
(www.aceruspharma.com) as of Tuesday, July
30 @ 9:00 AM ET.
About NATESTO® (Testosterone) Nasal
Gel
NATESTO® is a nasal gel formulation of
testosterone developed by Acerus Pharmaceutical Corporation and
indicated as a replacement therapy for men diagnosed with
conditions associated with a deficiency or absence of endogenous
testosterone (hypogonadism). It is the first and only
nasally-administered testosterone product approved by the U.S. Food
and Drug Administration, Health Canada and South Korea Ministry of
Food and Drug Safety (MFDS), available in a 'no-touch' dispenser
with a metered dose pump. A copy of the
NATESTO® Canadian product monograph can be found
at: http://www.aceruspharma.com/English/products-and-pipeline/NATESTO®/default.aspx.
For further information, specific to the U.S. product dosing and
administration, please visit: www.NATESTO.com.
About Acerus
Acerus Pharmaceuticals Corporation is a Canadian-based specialty
pharmaceutical company focused on the commercialization and
development of innovative prescription products that improve
patient experience, with a primary focus in the field of men's
health. The Company commercializes its products via its own
salesforce in Canada, and through
a global network of licensed distributors in the U.S. and other
territories.
Acerus' shares trade on TSX under the symbol ASP and on OTCQB
under the symbol ASPCF. For more information,
visit www.aceruspharma.com and follow us
on Twitter and LinkedIn.
Notice Regarding Forward-Looking Statements
Information in this press release that is not current or
historical factual information may constitute forward looking
information within the meaning of securities laws. Implicit in this
information are assumptions regarding our future operational
results. These assumptions, although considered reasonable by the
company at the time of preparation, may prove to be incorrect.
Readers are cautioned that actual performance of the company is
subject to a number of risks and uncertainties, including with
respect to the commercial performance of
NATESTO® in the United
States, and could differ materially from what is currently
expected as set out above. For more exhaustive information on these
risks and uncertainties you should refer to our annual information
form dated March 4, 2019 which is
available at www.sedar.com. Forward-looking information
contained in this press release is based on our current estimates,
expectations and projections, which we believe are reasonable as of
the current date. You should not place undue importance on
forward-looking information and should not rely upon this
information as of any other date. While we may elect to, we are
under no obligation and do not undertake to update this information
at any particular time, whether as a result of new information,
future events or otherwise, except as required by applicable
securities law.
No Offer
This press release is not intended to and does not constitute an
offer of securities for sale in the
United States or any other jurisdiction.
Media contact:
Edward Gudaitis
President and Chief Executive Officer
egudaitis@aceruspharma.com
(905) 817-8194
1 Mulligan T, Frick MF, et al. Prevalence of
hypogonadism in males aged at least 45 years: the HIM study. Int
J Clin Pract. 2006 Jul 1; 60(7):
762–769
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SOURCE Acerus Pharmaceuticals Corporation
