LEAWOOD, Kan., Oct. 13, 2017 /PRNewswire/ -- Aratana
Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company
focused on the licensing, development and commercialization of
innovative pet therapeutics, announced the Company is making
ENTYCE® (capromorelin oral solution) commercially
available to veterinarians in the United
States for appetite stimulation in dogs.
ENTYCE is the only therapeutic approved by the U.S. Food and
Drug Administration to safely and effectively stimulate appetite in
dogs. ENTYCE is a first-in-class ghrelin receptor agonist that
works by mimicking the effect of ghrelin, the hunger hormone. Like
naturally occurring ghrelin, ENTYCE binds to specific receptors in
the hypothalamus and affects signaling to cause the feeling of
hunger.
"We know improper food intake inhibits the overall health of the
dog and has a negative impact on a dog's quality of life. Nutrition
is so imperative, veterinarians and pet owners often use appetite
as a fifth vital sign and go to great lengths to address
inappetence," explains Ernst Heinen,
DVM, PhD, Chief Development Officer of Aratana Therapeutics.
"Entyce was developed specifically to stimulate appetite and
provides the first therapeutic based on the natural physiology of
appetite."
More than 10 million dogs in the
United States present to veterinarians annually with
inappetence, a condition that can be caused by a multitude of
chronic diseases or acute conditions. Inappetence may present as
decreased appetite, complete lack of appetite or altered eating
patterns. Signs may include weight loss, muscle wasting, lip
smacking or a change from normal behavior.
Recently, the FDA's Center for Veterinary Medicine (CVM)
approved the Company's prior-approval supplement (PAS) for the
transfer and scale-up of manufacturing, and veterinarians may now
order ENTYCE through an Aratana Therapeutic Specialist or their
preferred distributor partner with shipments expected to commence
by the end of October. ENTYCE is available as a once-daily,
flavored oral solution in 10 mL, 15 mL and 30 mL bottles.
Important Safety
Information
ENTYCE® (capromorelin oral
solution) is for use in dogs only. Do not use in breeding, pregnant
or lactating dogs. Use with caution in dogs with hepatic
dysfunction or renal insufficiency. Adverse reactions in dogs
may include diarrhea, vomiting, polydipsia, and hypersalivation.
Should not be used in dogs that have a hypersensitivity to
capromorelin. Please see the full Prescribing Information for
more detail.
About Aratana Therapeutics
Aratana Therapeutics is a
pet therapeutics company focused on licensing, developing and
commercializing innovative pet therapeutics for dogs and cats.
Aratana believes that it can leverage the investment in the human
pharmaceutical industry to bring therapeutics to pets in a capital
and time efficient manner. The Company has multiple products
approved by the Food and Drug Administration's Center for
Veterinary Medicine or licensed by the United States Department of
Agriculture. The Company's pipeline includes therapeutic candidates
targeting pain, inappetence, cancer, viral diseases, allergy and
other serious, unmet or underserved medical needs. Aratana
believes providing innovative options to veterinarians and pet
owners will help manage pets' medical needs safely and effectively,
resulting in longer and improved quality of life for pets. For more
information, please visit www.aratana.com.
Forward-Looking Statements Disclaimer
This press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements, including without limitation statements with respect to
anticipated financial performance, our ability to bring innovative
therapeutics to the market; steps necessary for and timing of
regulatory submissions and approvals of therapeutic candidates;
study, development and commercialization of therapeutics or
therapeutic candidates, including our plans to make ENTYCE
commercially available to veterinarians in the United States and our expected shipping
date by the end of October; and statements regarding the Company's
efforts, plans and opportunities, including, without limitation,
advancing our therapeutic candidates and offering innovative
therapeutics that help manage pet's medical needs safely and
effectively and that result in longer and improved quality of life
for pets.
These forward-looking statements are based on management's
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: the risk that the securities offering will not close in
the timeframe we expect, or at all; the amount of net proceeds we
receive from such offering and how we use them may differ from our
current expectations; our history of operating losses and our
expectation that we will continue to incur losses for the
foreseeable future; failure to obtain sufficient capital to fund
our operations; risks relating to the impairment of intangible
assets, including BLONTRESS, TACTRESS, AT-007 and AT-011; risks
pertaining to stockholder class action lawsuits; unstable market
and economic conditions; restrictions on our financial flexibility
due to the terms of our credit facility; our substantial dependence
upon the commercial success of our therapeutics; development of our
biologic therapeutic candidates is dependent upon relatively novel
technologies and uncertain regulatory pathways, and biologics may
not be commercially viable; denial or delay of regulatory approval
for our existing or future therapeutic candidates; failure of our
therapeutic candidates that receive regulatory approval to achieve
market acceptance or achieve commercial success; product liability
lawsuits that could cause us to incur substantial liabilities and
limit commercialization of current and future therapeutics; failure
to realize anticipated benefits of our acquisitions and
difficulties associated with integrating the acquired businesses;
development of pet therapeutics is a lengthy and expensive process
with an uncertain outcome; competition in the pet therapeutics
market, including from generic alternatives to our therapeutic
candidates, and failure to compete effectively; failure to
identify, license or acquire, develop and commercialize additional
therapeutic candidates; failure to attract and retain senior
management and key scientific personnel; our reliance on
third-party manufacturers, suppliers and partners; regulatory
restrictions on the marketing of our approved therapeutics and
therapeutic candidates; our small commercial sales organization,
and any failure to create a sales force or collaborate with
third-parties to commercialize our approved therapeutics and
therapeutic candidates; difficulties in managing the growth of our
company; significant costs of being a public company; risks related
to the restatement of our financial statements for the year ended
December 31, 2013, and the
identification of a material weakness in our internal control over
financial reporting; changes in distribution channels for pet
therapeutics; consolidation of our veterinarian customers;
limitations on our ability to use our net operating loss
carryforwards; impacts of generic products; safety or efficacy
concerns with respect to our therapeutic candidates; effects of
system failures or security breaches; delay or termination of the
development of grapiprant therapeutic candidates and
commercialization of grapiprant products that may arise from
termination of or failure to perform under the collaboration
agreement and/or the co-promotion agreement with Elanco; failure to
obtain ownership of issued patents covering our therapeutic
candidates or failure to prosecute or enforce licensed patents;
failure to comply with our obligations under our license
agreements; effects of patent or other intellectual property
lawsuits; failure to protect our intellectual property; changing
patent laws and regulations; non-compliance with any legal or
regulatory requirements; litigation resulting from the misuse of
our confidential information; the uncertainty of the regulatory
approval process and the costs associated with government
regulation of our therapeutic candidates; failure to obtain
regulatory approvals in foreign jurisdictions; effects of
legislative or regulatory reform with respect to pet therapeutics;
the volatility of the price of our common stock; our status as an
emerging growth company, which could make our common stock less
attractive to investors; dilution of our common stock as a result
of future financings; the influence of certain significant
stockholders over our business; and provisions in our charter
documents and under Delaware law
could delay or prevent a change in control. These and other
important factors discussed under the caption "Risk Factors" in the
Company's Annual Report on Form 10-K filed with the Securities and
Exchange Commission, or SEC, on March 14,
2017, along with our other reports filed with the SEC could
cause actual results to differ materially from those indicated by
the forward-looking statements made in this press release. Any such
forward-looking statements represent management's estimates as of
the date of this press release. While we may elect to update such
forward-looking statements at some point in the future, we disclaim
any obligation to do so, even if subsequent events cause our views
to change, except as required under applicable law. These
forward-looking statements should not be relied upon as
representing our views as of any date subsequent to the date of
this press release.
Contacts
For investor inquires:
Craig Tooman
ctooman@aratana.com
(913) 353-1026
For media inquiries:
Rachel Reiff
rreiff@aratana.com
(913) 353-1050
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SOURCE Aratana Therapeutics, Inc.