SAN FRANCISCO, Oct. 4,
2016 /PRNewswire/ -- Kindred Biosciences, Inc. (NASDAQ: KIN),
a biopharmaceutical company focused on saving and improving the
lives of pets, today announced it has received a technical section
complete letter for effectiveness from the U.S. Food and Drug
Administration's Center for Veterinary Medicine for Zimeta™
(dipyrone injection) approving the technical section.
The basis for this complete letter was a multicenter,
randomized, blinded, placebo-controlled pivotal study that enrolled
138 horses to assess the effectiveness of Zimeta. The primary
endpoint was improvement (a 2°F or greater decrease in temperature
from baseline) or resolution of fever (a return to normothermia
(≤101.0°F) ) at hour 6 following treatment. One hundred and
thirty-seven horses (103 Zimeta and 34 control product) were
included in the statistical analysis for effectiveness. At 6 hours
post-treatment, the success rate was 74.8% (77/103) of
Zimeta-treated horses and 20.6% (7/34) of control horses. The
results of the field study demonstrate that Zimeta administered at
30 mg/kg intravenously was effective for the control of pyrexia 6
hours following treatment administration.
Richard Chin, CEO of KindredBio,
stated, "This is a major milestone for KindredBio, and it is a
testament to the strength of the data that it was reviewed by the
FDA so rapidly. The entire clinical program, from initiation of
enrollment in the pivotal field study to the receipt of the
complete letter, was only 18 months, highlighting the quality of
our team and investigators. We look forward to the launch of the
first FDA-approved drug for fever in horses, a condition that
affects millions of horses every year."
KindredBio has responded to the first round of review by the FDA
for the CMC technical section. KindredBio is in the process of
responding to the first round of review by the FDA on the safety
technical section. KindredBio expects the approval of Zimeta in the
first half of 2017 if the FDA review process is rapid.
About Kindred Biosciences, Inc.
Kindred Biosciences is a development-stage biopharmaceutical
company 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 compounds and targets that have
already demonstrated safety and efficacy in humans and to develop
therapeutics based on these validated compounds and targets for
dogs, cats and horses. The Company has a deep pipeline of
novel drugs and biologics in development across many therapeutic
classes.
For more information or to download the corporate presentation,
visit www.KindredBio.com/LearnMore. Stay connected with KindredBio
on Facebook at www.Facebook.com/KindredBio.
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
revenue from our product candidates for the foreseeable future; our
potential inability to obtain any necessary additional financing;
our substantial dependence on the success of 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 of our product candidates;
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 develop a satisfactory sales organization; our
significant costs of operating as a public company; our potential
inability to obtain patent protection and other intellectual
property protection for 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.
Contact
Russell Radefeld
KindredBio
Russell.radefeld@kindredbio.com
(650) 701-7904
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SOURCE Kindred Biosciences, Inc.