Anika Announces European Commercial Launch of CINGAL for the Treatment of Pain Associated with Osteoarthritis

BEDFORD, Mass.–(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 commercial launch of
CINGAL^®, its third-generation viscosupplement, in the
European Union. CINGAL, which will be initially available in Hungary,
Czech Republic, Poland, Germany, and Italy, received CE Mark approval in
March 2016 to treat pain associated with osteoarthritis. CINGAL will be
marketed and sold in Europe by a network of experienced commercial
partners under the terms of their respective commercialization
agreements.
“The launch of CINGAL in Europe marks an important milestone in our
global expansion, which is a key part of our overall growth strategy. It
strengthens our footprint in the European Union, and allows us access to
additional international viscosupplementation markets,” said Charles H.
Sherwood, Ph.D., President and Chief Executive Officer. “For the
millions of Europeans living with osteoarthritis pain, CINGAL offers a
safe, non-opioid, long-term pain management option that can help restore
day-to-day function and preserve normal quality of life.”
CINGAL is the first and only viscosupplement approved for use in the
European Union that combines triamcinolone hexacetonide, a
well-established, FDA-approved steroid to treat inflammation, with
sodium hyaluronate, the active “cushioning” ingredient in the Company’s
best-selling 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. In
addition to Europe, CINGAL is available in Canada, and the Company
continues to vigorously pursue regulatory approval of the product in the
U.S.
“With the global population aging at an unprecedented rate, we are
seeing a marked increase in chronic, degenerative diseases such as
osteoarthritis, that require safe, long-term, non-surgical management,”
said Prof. Laszlo Hangody, MD, Ph.D., DSc., Clinical Professor at the
Debrecen Medical School and Senior Consultant in the Orthopaedic
Department at Uzsoki Hospital, Budapest, Hungary. “CINGAL combines two
tried, tested, and proven treatments into a single injection that can
provide patients up to six months of pain relief, while avoiding the
harsh side effects associated with the daily use of oral pain
medications and staving off invasive joint replacement surgery. As the
Principle Investigator for the highly successful CINGAL 13-01 clinical
trial, I am very pleased that patients across Europe will now have
access to CINGAL.”
About Anika Therapeutics, Inc.
Anika
Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated
orthopedics medicines company based in Bedford, Mass. Anika is committed
to improving the lives of patients with degenerative orthopedic diseases
and traumatic conditions by providing clinically meaningful therapeutic
pain management solutions along the continuum of care, from palliative
care to regenerative medicine. The Company has over two decades of
expertise developing, manufacturing and commercializing more than 20
products, in markets across the globe, based on its proprietary hyaluronic
acid (HA) technology. Anika’s orthopedic medicine portfolio is
comprised of marketed (ORTHOVISC^® and
MONOVISC^®)
and pipeline (CINGAL^® and HYALOFAST^® in the U.S.)
products to alleviate pain and restore joint function by replenishing
depleted HA and aiding cartilage repair and regeneration. For more
information about Anika, please visit https://www.anikatherapeutics.com.
Forward-Looking Statements
The statements made in the second and third paragraphs 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 global expansion and overall
growth strategy and the U.S. regulatory status 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 (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.