Anika Therapeutics Announces Monovisc PMA News
BEDFORD, Mass. -- December 04, 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 and SEC filings.
Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., 781-457-9000
Kevin W. Quinlan, 781-457-9000
Press spacebar to pause and continue. Press esc to stop.