LEAWOOD, Kan., Dec. 20, 2017 /PRNewswire/ -- Aratana
Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company
focused on the licensing, development and commercialization of
innovative therapeutics for dogs and cats, today announced the
United States Department of Agriculture (USDA) Center for
Veterinary Biologics granted Aratana conditional licensure for
Canine Osteosarcoma Vaccine, Live Listeria Vector (AT-014) for the
treatment of dogs diagnosed with osteosarcoma, one year of age or
older.
"Osteosarcoma is the most common primary bone tumor in dogs and,
since there haven't been advances to raise the standard of care in
nearly 20 years, dogs often face a poor prognosis," states
Ernst Heinen, DVM, PhD, Chief
Development Officer of Aratana Therapeutics. "We are hopeful that
our Canine Osteosarcoma Vaccine will be a new tool for veterinary
oncologists to prolong survival in dogs with osteosarcoma."
Canine Osteosarcoma Vaccine is a novel immunotherapy developed
by Aratana using a listeria based antigen delivery system licensed
from Advaxis, Inc. (NASDAQ: ADXS). Canine Osteosarcoma Vaccine is a
lyophilized formulation of a modified live, attenuated strain of
listeria that activates cytotoxic T-cells. Because the therapeutic
expresses a tumor-associated antigen, it directs the T-cells to
fight cancer cells, even after the bacteria are cleared. Thus, the
therapeutic capitalizes on the dog's immune system and its ability
to attack bacterial infections, redirecting it to fight cancer
cells.
Data from a clinical study in 18 client-owned dogs with
osteosarcoma suggests that the immunotherapy may be able to delay
or prevent metastatic disease and may prolong overall survival in
dogs with osteosarcoma. The single-arm study evaluated dogs that
had primary tumor removal and four doses of carboplatin
chemotherapy, followed by the therapeutic vaccine every three weeks
for three doses. Median survival time was 956 days compared to 423
days for a historical control group (p<0.05). A separate
field safety study submitted to USDA for conditional licensure
demonstrated that the most common adverse events included lethargy,
diarrhea and fever. Four serious adverse events were observed.
As required by USDA to progress from conditional licensure to
full licensure, Aratana plans to conduct an extended field
study in a clinical setting and anticipates initiating the study in
early 2018. Initially, the therapeutic will be made available for
purchase at approximately two dozen veterinary oncology practice
groups across the United States
who participate in the study.
About Aratana Therapeutics
Aratana Therapeutics is a
pet therapeutics company focused on licensing, developing and
commercializing innovative therapeutics for dogs and cats. Aratana
believes that it can leverage the investment in the human
biopharmaceutical industry to bring therapeutics to pets in a
capital and time efficient manner. The Company's pipeline includes
therapeutic candidates targeting pain, inappetence, cancer, viral
diseases, allergy and other serious medical conditions.
Aratana believes the development and commercialization of these
therapeutics will permit veterinarians and pet owners to 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 planned field safety study of
AT-014 as required by USDA for full licensure; timing of
anticipated study initiation and enrollment period; increased
market recognition of and demand for our therapeutics; our hope
that AT-014 will be a new tool for veterinary oncologists to
prolong survival in dogs with osteosarcoma; 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: 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; risks relating to
the discontinuation of BLONTRESS and TACTRESS; 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.