SAN FRANCISCO, Feb. 25, 2021 /PRNewswire/ -- Kindred
Biosciences, Inc. (NASDAQ: KIN), a biopharmaceutical company
focused on saving and improving the lives of pets, today announced
that it has submitted efficacy data to support the prophylactic
indication for KIND-030 to the United States Department of
Agriculture (USDA) Center for Veterinary Biologics for review. This
submission is part of the overall project data package that will be
submitted and evaluated for full approval. KIND-030 is a monoclonal
antibody targeting canine parvovirus.
"This data submission brings us a step closer to approval for
this tragic disease," said Chief Executive Officer, Richard Chin, M.D. "We are committed to
transforming how parvovirus is treated and prevented, and look
forward to commencement of the pivotal efficacy study for the
treatment indication."
On September 16, 2020, KindredBio
reported positive results from its pivotal efficacy study for the
prophylactic indication. As previously stated, approval of KIND-030
is subject to regulatory risk and timelines, and there is no set
review timeline at the USDA Center for Veterinary Biologics.
Regulatory consultants to KindredBio anticipate possible delays to
the regulatory review process due to COVID-19. KindredBio will
provide an update on the timing of KIND-030's expected approval at
the time of announcing the company's fourth quarter 2020 results.
Regulatory approval and review timeline are subject to the typical
risks inherent in such a process.
KIND-030 is being pursued for two indications in dogs:
prophylactic therapy to prevent clinical signs of canine parvovirus
infection, and treatment of established parvovirus infection.
Completion of the upcoming pivotal efficacy study for the treatment
indication for KIND-030 is now expected to extend into the second
quarter of 2021.
KindredBio does not expect the updated timing of completion of
the pivotal efficacy study for the treatment indication to impact
achievement of the terms contained in the parvovirus license
agreement with Elanco Animal Health Incorporated.
About Kindred Biosciences
Kindred Biosciences is a biopharmaceutical company
developing innovative biologics focused on saving and improving the
lives of pets. Its mission is to bring to pets the same kinds of
safe and effective medicines that human family members enjoy. The
Company's strategy is to identify targets that have already
demonstrated safety and efficacy in humans and to develop
therapeutics based on these validated targets for dogs and cats.
KindredBio has a deep pipeline of novel biologics in development
across many therapeutic classes, alongside state-of-the-art
biologics manufacturing capabilities and a broad intellectual
property portfolio.
For more information, visit: www.kindredbio.com
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. 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, but not limited to,
statements regarding our expectations about the trials, regulatory
approval, manufacturing, distribution and commercialization of our
current and future product candidates, and statements regarding our
anticipated revenues, expenses, margins, profits and use of
cash.
These forward-looking statements are based on our current
expectations. These statements are not promises or guarantees, but
involve known and unknown risks, uncertainties and other important
factors that may cause our actual results to be materially
different from any future results expressed or implied by the
forward-looking statements. These risks include, but are not
limited to, the following: our limited operating history and
expectations of losses for the foreseeable future; the absence of
significant revenue from our products and our product candidates
for the foreseeable future; the likelihood that our revenue will
vary from quarter to quarter; our potential inability to obtain any
necessary additional financing; our substantial dependence on the
success of our products and our lead product candidates which may
not be successfully commercialized even if they are approved for
marketing; the effect of competition; our potential inability to
obtain regulatory approval for our existing or future product
candidates; our dependence on third parties to conduct some of our
development activities; our dependence upon third-party
manufacturers for supplies related to our products and our
product candidates and the potential inability of these
manufacturers to deliver a sufficient amount of supplies on a
timely basis; the uncertain effect of the COVID-19 pandemic on our
business, results of operations and financial condition;
uncertainties regarding the outcomes of trials regarding our
product candidates; our potential failure to attract and retain
senior management and key scientific personnel; uncertainty about
our ability to enter into satisfactory agreements with third-party
licensees of our biologic products and uncertainty about the amount
of revenue that we will receive from such agreements; our
significant costs of operating as a public company; potential
cyber-attacks on our information technology systems or on our
third-party providers' information technology systems, which could
disrupt our operations; our potential inability to repay the
secured indebtedness that we have incurred from third-party
lenders, and the restrictions on our business activities that are
contained in our loan agreement with these lenders; the risk that
our 2020 strategic realignment and restructuring plans will result
in unanticipated costs or revenue shortfalls; uncertainty about the
amount of royalties that we will receive from the sale of MiratazĀ®
to Dechra Pharmaceuticals PLC; the risk that the revenue from our
delivery of services or products under any contract may be less
than we anticipate if the other party to the contract exercises its
right to terminate the contract prior to the completion of the
contract; our potential inability to obtain and maintain patent
protection and other intellectual property protection for our
products and our product candidates; potential claims by third
parties alleging our infringement of their patents and other
intellectual property rights; our potential failure to comply with
regulatory requirements, which are subject to change on an ongoing
basis; the potential volatility of our stock price; and the
significant control over our business by our principal stockholders
and management.
For a further description of these risks and other risks that we
face, please see the risk factors described in our filings with the
U.S. Securities and Exchange Commission (the SEC), including the
risk factors discussed under the caption "Risk Factors" in our
Annual Report on Form 10-K and any subsequent updates that may be
contained in our Quarterly Reports on Form 10-Q filed with the SEC.
As a result of the risks described above and in our filings with
the SEC, actual results may differ materially from those indicated
by the forward-looking statements made in this press release.
Forward-looking statements contained in this press release speak
only as of the date of this press release and we undertake no
obligation to update or revise these statements, except as may be
required by law.
The results stated in this press release have not been reviewed
by the Food and Drug Administration or the United States Department
of Agriculture Center for Veterinary Biologics, as applicable.
Contacts
For investor inquiries:
Katja Buhrer
Katja.buhrer@kindredbio.com
(917) 969-3438
View original content to download
multimedia:http://www.prnewswire.com/news-releases/kindred-biosciences-announces-submission-of-parvovirus-monoclonal-antibody-data-for-prophylactic-indication-301235319.html
SOURCE Kindred Biosciences, Inc.