Exhibit 99.1
Anika Therapeutics and Galderma Agree to Terminate License, Development
and Supply Agreements
Anika Therapeutics' to Reacquire Worldwide Rights to ELEVESS Brand
BEDFORD, Mass.--(BUSINESS WIRE)--Nov. 20, 2007--Anika
Therapeutics, Inc. (Nasdaq: ANIK) today announced that it has agreed
with Galderma Pharma S.A. and Galderma S.A. (together, "Galderma") to
terminate its license, development and supply agreements for the
ELEVESS family of products. The agreement is subject to certain
closing conditions and is expected to close before the end of
November.
Under the termination agreement, Anika will reacquire the
worldwide control of the future development and marketing of ELEVESS.
Anika will pay Galderma $4,250,000 for the worldwide rights and
ownership of the "ELEVESS" trademark, and all related packaging,
marketing and promotional materials, as well as the clinical studies,
marketing research, and training materials developed by Galderma. The
Company had previously announced that it is in negotiations to
terminate the license and supply agreements with Galderma.
"We believe the future is bright for ELEVESS," said Charles H.
Sherwood, Ph.D., Anika's President and Chief Executive Officer. "Our
product is ready for market and we want to proceed expeditiously
toward commercialization. With an enhanced product that now is
approved in the United States, the European Union and Canada, we would
like to launch the product as soon as possible in 2008 with a new
partner or initially on our own. There already has been considerable
interest expressed by new potential partners, which we are pursuing.
In the meantime, Anika sponsored pre-launch activities continue
including reaching out to opinion leaders."
About ELEVESS
ELEVESS is the first injectable soft-tissue filler for facial
wrinkles, scar remediation and lip augmentation to incorporate
lidocaine, a local anesthetic that improves patient comfort and
satisfaction and provides physicians with a new alternative for their
aesthetic practice. Designed for longer durability based on its new
proprietary cross-linking technology and its higher concentration of
Anika's chemically modified hyaluronic acid (HA), ELEVESS has been
approved for sale in the United States, the European Union and Canada.
About Anika Therapeutics, Inc.
Headquartered in Bedford, Mass., Anika Therapeutics, Inc.
develops, manufactures and commercializes therapeutic products for
tissue protection, healing and repair. These products are based on
hyaluronic acid (HA), a naturally occurring, biocompatible polymer
found throughout the body. Anika's products include ORTHOVISC(R), a
treatment for osteoarthritis of the knee available internationally and
marketed in the U.S. by DePuy Mitek; HYVISC(R), a treatment for equine
osteoarthritis marketed in the U.S. by Boehringer Ingelheim Vetmedica,
Inc.; the ELEVESS(TM) family of aesthetic dermatology products for
facial wrinkles, scar remediation and lip augmentation; AMVISC(R),
AMVISC(R) Plus, STAARVISC(TM)-II and Shellgel(TM) injectable
viscoelastic HA products for ophthalmic surgery; INCERT(R), an
HA-based anti-adhesive for surgical applications; and next generation
products for joint health and aesthetic dermatology based on the
Company's proprietary, chemically modified HA.
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," "plan," "efforts," "hope,"
"believe," "objectives," "opportunities," "will," "seek," "expect" 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: (i) the
Company's expectations regarding its cosmetic dermatology product,
ELEVESS, including statements concerning the market for ELEVESS,
anticipated product launch and potential partners, and (ii) statements
concerning Galderma and ELEVESS. 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 risk that the termination agreement between the
Company and Galderma does not close and the Company does not reacquire
all rights to the ELEVESS family of products; (ii) the Company's
ability to license ELEVESS to a new distribution partner on terms
favorable to the Company, if at all; (iii) 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; (iv) the Company's research and
product development efforts and their relative success, including
whether the Company has any meaningful sales of any new products
resulting from such efforts; (v) the cost effectiveness and efficiency
of our 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 or (vii) future determinations by the Company to
allocate resources to products and in directions not presently
contemplated. Any delay in receiving any regulatory approvals may
adversely affect the Company's competitive position. Even if
regulatory approvals are obtained, there is a risk that meaningful
sales of the products may not be achieved. There is also a risk that
(i) the Company's existing distributors (including its distributor in
Turkey) or customers will not continue to place orders at historical
levels or that any of them will seek to modify or terminate existing
arrangements, (ii) the Company's efforts to enter into long-term
marketing and distribution arrangements, including with new
international distributors for ORTHOVISC, will not be successful,
(iii) new distribution arrangements will not result in meaningful
sales of the Company's products, (iv) the Company will be unable to
achieve performance and sales threshold milestones in its distribution
agreements, (v) competitive products will adversely impact the
Company's product sales, (vi) the estimated size(s) of the markets
which the Company has targeted its products will fail to be achieved,
(vii) lack of adequate coverage and reimbursement provided by
governments and other third party payers for our products and
services, including non-reimbursement of ORTHOVISC in Turkey, could
have a material adverse effect on our results of operations, or (viii)
increased sales of the Company's products, including HYVISC(R),
ORTHOVISC , or its ophthalmic products, will not continue or sales
will decrease or not reach historical sales levels, or even if such
increases occur that such increases will improve gross margins, any of
which may have a material adverse effect on the Company's business and
operations. There can be no assurance that the Company will license
ELEVESS to a new distribution partner on terms favorable to the
Company or at all. 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 "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,
2006 and on Form 10-Q for the period ended September 30, 2007, as well
as those described in the Company's other press releases and SEC
filings.
CONTACT: Anika Therapeutics, Inc.
Charles H. Sherwood, 781-457-9000
Ph.D., CEO
or
Kevin W. Quinlan, 781-457-9000
CFO