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 that regulatory
authorities in Australia granted approval to MONOVISC®,
Anika's single injection viscosupplement for the treatment of pain
associated with osteoarthritis of all synovial joints, including the hip
and knee. MONOVISC is commercially available in over twenty countries,
including the United States, Canada, and various European countries.
MONOVISC also recently received approval in the Asia-Pacific countries
of India and Taiwan. Anika intends to further expand MONOVISC into
additional international markets in 2018.
"The Asia-Pacific region presents an important growth opportunity for
our global orthobiologics franchise, and we're excited to bring MONOVISC
to patients in Australia and New Zealand," said Charles H. Sherwood,
Ph.D., Chief Executive Officer of Anika Therapeutics. "With this
approval, MONOVISC is poised to become the most widely available
single-injection viscosupplement in the world and will be a key driver
in growing global market share."
The global expansion of MONOVISC is an important international
orthobiologics revenue driver for Anika, and Australia and New Zealand
represent a large and growing market opportunity. Anika has a
multi-year, exclusive distribution agreement with Surgical Specialties
Pty. Ltd. to market MONOVISC in Australia and New Zealand. Established
in 2006, Surgical Specialties is an independent distributor of
innovative medical devices, with a team of over 70 people in sales
offices throughout Australia and New Zealand. Surgical Specialties is an
ideal partner for Anika with its established relationships with leading
orthopaedic surgeons and sports physicians, a successful track record,
and a highly skilled and dedicated national sales force.
is Anika's next-generation HA-based therapy for treating osteoarthritis
that features enhanced durability in a safe, easy-to-use, single
injection regimen. MONOVISC is made from highly purified, non-animal,
natural hyaluronan. Hyaluronan occurs naturally throughout the body,
especially in articular cartilage, synovial fluid in joints and in the
skin. For more information about MONOVISC, please visit www.monovisc.com.
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®, MONOVISC,
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 last sentences of the first and second
paragraphs and first sentence of the third 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 international expansion
plans for MONOVISC, the market for the Company's products in foreign
countries, including Australia and New Zealand, and the status of
MONOVISC as a global revenue driver for the Company. 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/20171016006027/en/
For Investor Inquiries:
Anika Therapeutics, Inc.
Chief Financial Officer
Sonal Vasudev, 917-523-1418
Source: Anika Therapeutics, Inc.
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