Full Press Release Details
Therapeutics Announces Monovisc PMA News
BEDFORD, Mass.--(BUSINESS WIRE)--December 4, 2012--Anika Therapeutics,
Inc. (Nasdaq: ANIK) announced today that it has received correspondence
from the Chief Scientific Officer of the Center for Devices and
Radiological Health of the U.S. FDA upholding the non-approvable
decision for the Monovisc PMA that was previously disclosed. The company
had utilized the FDA's appeal process to continue to discuss the
Monovisc PMA with the FDA.
The company plans to schedule a meeting with the FDA as soon as possible
to determine the next steps concerning the Monovisc product.
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 range from orthopedic/joint health solutions
led by Orthovisc, a treatment for osteoarthritis of the knee, to
surgical aids in the ophthalmic and anti-adhesion fields. The company
also offers aesthetic dermal fillers for the correction of
facial wrinkles. Anika's Italian subsidiary, Anika S.r.l., provides
complementary HA products in orthopedic/joint health and anti-adhesion,
as well as therapeutics in new areas such as advanced wound treatment
and ear, nose and throat care. Anika S.r.l.'s regenerative tissue
technology advances Anika's vision to offer therapeutic products that go
beyond pain relief to protect and restore damaged tissue.
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, 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: (i) the company's
ability to obtain FDA approval of the Monovisc PMA, including the
design, timing, cost and similar uncertainties related to additional
clinical studies that the FDA may require for such approval and the
related expenses associated therewith; (ii) the company's expectations
regarding the likelihood of our obtaining FDA approval of Monovisc
and/or the anticipated timing thereof; (iii) the company's ability to
launch Monovisc in the U.S., if at all; and (iv) our distribution
partner's right to terminate a license agreement with the company in
accordance with the terms thereof. 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 the
company's Annual Report on Form 10-K for the year ended December 31,
2011, as well as those described in the company's other press releases
Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D.,
Kevin W. Quinlan, 781-457-9000