Anika Announces First Patient Enrolled in Supplemental Phase III Trial of CINGAL for the Treatment of Knee Pain Associated wi...
May 25 2017 - 1:30PM
Business Wire
Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated
orthopedics medicines company specializing in therapeutics based on
its proprietary hyaluronic acid ("HA") technology, today announced
the enrollment of the first patient in its supplemental Phase III
trial evaluating the efficacy and safety of CINGAL®, its novel
HA-corticosteroid combination viscosupplement for the treatment of
symptoms associated with osteoarthritis (“OA”) of the knee.
“Advancing CINGAL towards FDA approval is one of our key
business priorities, and the enrollment of the first patient in our
supplemental Phase III trial is an important step towards achieving
that goal,” said Charles H. Sherwood, Ph.D., President and Chief
Executive Officer of Anika Therapeutics.
The newly initiated supplemental Phase III trial will enroll
patients at 30 European sites. These patients will be randomized to
receive CINGAL, MONOVISC®, or triamcinolone hexacetonide and will
be evaluated for 26 weeks for safety and changes in pain, function,
and quality of life measures.
CINGAL is the first and only viscosupplement that combines
triamcinolone hexacetonide, a well-established, FDA-approved
steroid that may be utilized to treat inflammation, with Anika’s
proprietary cross-linked, non-animal-derived hyaluronic acid, which
is the active "cushioning" ingredient in the global market-leading
viscosupplements, ORTHOVISC® and MONOVISC. Viscosupplements are
injected by a licensed medical professional into synovial joints to
replenish the natural cushioning within joints that depletes with
age and degenerative orthopedic diseases, causing pain.
Anika recently published results from its original Phase III
trial, which formed the basis for CINGAL’s Health Canada and CE
Mark and approvals in November 2015 and March 2016. The trial,
which compared the safety and efficacy of CINGAL to MONOVISC and
placebo (saline), showed that CINGAL provided superior immediate
and short term pain relief after injection as compared to HA alone,
and superior relief from OA-related pain, stiffness, and function
through 26 weeks as compared to placebo (saline).
Anika expects to complete the supplemental Phase III trial in
2018 and anticipates FDA approval in the following year.
About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated
orthopedic medicines company based in Bedford, Massachusetts. Anika
is committed to improving the lives of patients with degenerative
orthopedic diseases and traumatic conditions with clinically
meaningful therapies along the continuum of care, from palliative
pain management to regenerative cartilage repair. The Company has
over two decades of global expertise developing, manufacturing, and
commercializing more than 20 products based on its proprietary
hyaluronic acid (HA) technology. Anika's orthopedic medicine
portfolio includes ORTHOVISC, MONOVISC, and CINGAL, which alleviate
pain and restore joint function by replenishing depleted HA, and
HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and
regeneration. For more information about Anika, please visit
www.anikatherapeutics.com.
Forward-Looking Statements
The statements made in the sixth paragraph of this press
release, which are not statements of historical fact, are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. These statements
include, but are not limited to, those relating to the Company's
expectations regarding the timing for completion of the Company’s
supplemental Phase III study for CINGAL and FDA approval of CINGAL.
These statements are based upon the current beliefs and
expectations of the Company's management and are subject to
significant risks, uncertainties, and other factors. The Company's
actual results could differ materially from any anticipated future
results, performance, or achievements described in the
forward-looking statements as a result of a number of factors
including, but not limited to, (i) the Company's ability to
successfully commence and/or complete clinical trials of its
products on a timely basis or at all; (ii) the Company's ability to
obtain pre-clinical or clinical data to support domestic and
international pre-market approval applications, 510(k)
applications, or new drug applications, or to timely file and
receive FDA or other regulatory approvals or clearances of its
products; (iii) that such approvals will not be obtained in a
timely manner or without the need for additional clinical trials,
other testing or regulatory submissions, as applicable; (iv) the
Company's research and product development efforts and their
relative success, including whether we have any meaningful sales of
any new products resulting from such efforts; (v) the cost
effectiveness and efficiency of the Company's clinical studies,
manufacturing operations, and production planning; (vi) the
strength of the economies in which the Company operates or will be
operating, as well as the political stability of any of those
geographic areas; (vii) future determinations by the Company to
allocate resources to products and in directions not presently
contemplated; (viii) the Company's ability to successfully
commercialize its products, in the U.S. and abroad; (ix) the
Company's ability to provide an adequate and timely supply of its
products to its customers; and (x) the Company's ability to achieve
its growth targets. Additional factors and risks are described in
the Company's periodic reports filed with the Securities and
Exchange Commission, and they are available on the SEC's website at
www.sec.gov. Forward-looking statements are made based on
information available to the Company on the date of this press
release, and the Company assumes no obligation to update the
information contained in this press release.
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For Investor Inquiries:Anika Therapeutics, Inc.Sylvia Cheung,
781-457-9000Chief Financial OfficerorFor Media Inquiries:Pure
CommunicationsSonal Vasudev, 917-523-1418
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