LEAWOOD, Kan., Aug. 15, 2016 /PRNewswire/ -- Aratana
Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company
focused on the licensing, development and commercialization of
innovative biopharmaceutical products for companion animals, today
announced the U.S. Food and Drug Administration's Center for
Veterinary Medicine (CVM) approved NOCITA® (bupivacaine
liposome injectable suspension) as a local post-operative analgesia
for cranial cruciate ligament surgery in dogs. Aratana anticipates
Nocita will be commercially available to veterinarians in the fall
of 2016.
Nocita is a long-acting, local anesthetic that lasts up to 72
hours post-surgery by releasing bupivacaine over time from
multi-vesicular liposomes deposited in the tissue. The therapeutic
is administered as a single dose by tissue infiltration during
closure of cranial cruciate ligament surgery in dogs.
"We believe Nocita will help transform the way veterinarians
control post-operative pain for dogs undergoing cranial cruciate
ligament surgery," states Steven St.
Peter, M.D., President and Chief Executive Officer of
Aratana Therapeutics. "As our third FDA-approved therapeutic this
year, we are pivoting our attention to successfully bringing these
therapeutics to market over the coming months."
Important Safety Information
NOCITA®
(bupivacaine liposome injectable suspension) is for use in dogs
only. Do not use in dogs younger than 5 months of age, dogs used
for breeding, or in pregnant or lactating dogs. Do not administer
by intravenous or intra-arterial injection. Adverse reactions in
dogs may include discharge from incision, incisional inflammation
and vomiting. Avoid concurrent use with bupivacaine HCI, lidocaine
or other amide local anesthetics. Please see the full Prescribing
Information.
About Aratana Therapeutics
Aratana Therapeutics is a
pet therapeutics company focused on licensing, developing and
commercializing innovative pharmaceutical products 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
our ability to bring several innovative products to market;
expectations regarding the timing or scope of commercialization of
Nocita; our belief that Nocita will transform the way veterinarians
control post-operative pain for dogs; and statements regarding the
Company's plans and opportunities, including without limitation
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: 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 AT-004, AT-005,
AT-007 and AT-011; unstable market and economic conditions;
restrictions on our financial flexibility due to the terms of our
credit facility; our substantial dependence upon the success of our
product candidates; development of our biologic product 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
product candidates; failure of our product candidates that receive
regulatory approval to obtain market approval or achieve commercial
success; 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
product candidates, and failure to compete effectively; failure to
identify, license or acquire, develop and commercialize additional
product 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 product candidates; our small commercial sales
organization, and any failure to create a sales force or
collaborate with third-parties to commercialize our product
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 product candidates; effects of system
failures or security breaches; failure to obtain ownership of
issued patents covering our product 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 product
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 15, 2016, 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.
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.