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Anika Therapeutics Announces Termination of Worldwide Development and Commercialization Partnership with OrthoNeutrogena; Company Files Pre-Market Approval Application for Cosmetic Tissue Augmentation Product WOBURN, Mas

Key Takeaway: Anika Therapeutics Announces Termination of Worldwide Development and Commercialization Partnership with OrthoNeutrogena; Company Files Pre-Market Approval Application for Cosmetic Tissue Augmentation Product WOBURN, Mass. (BUSINESS WIRE) Sept. 1, 2005 Anika Therapeutics, Inc

Full Press Release Details

Anika Therapeutics Announces
Termination of Worldwide Development and Commercialization Partnership with OrthoNeutrogena; Company Files Pre-Market Approval
Application for Cosmetic Tissue Augmentation Product
WOBURN, Mass. (BUSINESS WIRE) Sept. 1, 2005 Anika
Therapeutics, Inc. (NASDAQ:ANIK) today announced
that it has reached a mutual agreement with OrthoNeutrogena,
a division of Ortho-McNeil Pharmaceuticals, for the termination of its
development and commercialization contract for Anika s
hyaluronic acid based cosmetic tissue augmentation (CTA) product, effective August 31, 2005.
In related news, Anika also announced that,
subsequent to such termination, it has filed a pre-market approval application
(PMA) with the U.S. Food and Drug Administration for
its CTA product and is currently exploring options
for its worldwide commercialization.
Headquartered in Woburn, Mass., Anika
Therapeutics, Inc. (www.anikatherapeutics.com)
develops, manufactures and commercializes therapeutic products and devices
intended to promote the repair, protection and healing of bone, cartilage and
soft tissue. These products are based on hyaluronic
acid (HA), a naturally occurring, biocompatible polymer found throughout the
body. Anika products include OrthoVisc(R),
a treatment for osteoarthritis of the knee available internationally and
marketed in the U.S. by DePuy Mitek
and Ortho Biotech Products, L.P., and Hyvisc(R), a
treatment for equine osteoarthritis marketed in the U.S. by Boehringer
Ingelheim Vetmedica, Inc.
Anika manufactures Amvisc(TM)
and Amvisc Plus(TM), HA viscoelastic
products for ophthalmic surgery. It also produces STAARVISC(TM)-II,
which is distributed by STAAR Surgical Company and Shellgel(TM) for Cytosol Ophthalmics, Inc.
The statements made in 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 and Section 21E of the Securities Exchange
Act of 1934, including, without limitation, statements that may be identified
by words such as expectations, remains, focus, expected, prospective,
expanding, building, continue, progress, efforts, hope, believe, objectives,
opportunities, will, seek, and other expressions which are predictions of
or indicate future events and trends and which do not constitute historical
matters identify forward-looking statements. These statements also include
statements regarding the Company s goal of obtaining FDA approval for its CTA product, including the timing and likelihood of the
filing of a PMA application. 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 the Company s ability to successfully
commence and/or complete clinical trials of its products on a timely basis or
at all, obtain clinical data to support a pre-market approval application
and/or FDA approval, and/or receive FDA or other
regulatory approvals of its products, or that such approvals will not be
obtained in a timely manner or without the need for additional clinical trials;
Even if regulatory approvals are obtained, there is a risk that meaningful
sales of the products may not be achieved. Certain other factors that might
cause the Company s actual results to differ materially from those in the
forward-looking statements include those set forth under the headings Business,
Risk Factors and Certain Factors Affecting Future Operating Results and Management s
Discussion and Analysis of Financial Condition and Results of Operations in
each of the Company s Annual Report on Form 10-K for the year ended December 31,
2004, its Quarterly Report on Form 10-Q for the quarter ended June 30,
2005, and Current Reports on Form 8-K, as well as those described in the
Company s other press releases and SEC filings.
CONTACT: Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D. / Kevin W. Quinlan
(781) 932-6616
or
PondelWilkinson Inc.
Rob Whetstone, (310) 279-5963
Wade Huckabee, (310) 279-5971
Last updated: Sep 1, 2005