BEDFORD, Mass.--(BUSINESS WIRE)--
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.
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
The newly initiated supplemental Phase III trial will enroll patients at
30 European sites. These patients will be randomized to receive CINGAL,
or triamcinolone hexacetonide and will be evaluated for 26 weeks for
safety and changes in pain, function, and quality of life measures.
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®
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
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.
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,
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.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170525005805/en/
For Investor Inquiries:
Anika Therapeutics, Inc.
Chief Financial Officer
Sonal Vasudev, 917-523-1418
Source: Anika Therapeutics, Inc.
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