SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) September 16, 1996
Pharmos Corporation
(Exact name of registrant as specified in its charter)
Nevada 0-11550 13-3207413
(State or other jurisdiction of Commission File Number (I.R.S. Employer
incorporation or organization) Identification Number)
2 Innovation Drive, Alachua, FL 32615
(Address of principal executive offices) (zip code)
(904) 462-1210
(Registrant's telephone number including area code)
None
(Former name, former address and former fiscal year,
if changed since last report)
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Item 5 Other Events
Bausch & Lomb Pharmaceuticals, Inc. and Pharmos Corporation announced on
September 15, 1997 that the U.S. Food and Drug Administration (FDA) has issued
an "approvable letter" to them for the New Drug Application (NDA) for
Lotemax(TM) (loteprodnol etabonate ophthalmic suspension 0/5%), a new ophthalmic
anti-inflammatory product.
The approvable letter is the FDA's formal response to the Lotemax NDA,
which was submitted by Bausch & Lomb and Pharmos. The letter states that Lotemax
is approvable subject to the companies satisfactorily addressing several
remaining issues.
The NDA for Lotemax is based upon clinical results that involved more than
1,600 patients, including seven pivotal Phase III clinical studies evaluating
the efficacy and safety of Lotemax in a variety of indications.
Lotemax is a topical steroid. The chemical structure of Lotemax is designed
to be transformed by enzymes in the eye to an inactive metabolite, aiming at
providing a better safety profile.
Bausch & Lomb obtained the U.S. rights to manufacture and market Lotemax
and two other products from Pharmos in June 1995. In December 1996, Bausch &
Lomb Pharmaceuticals was granted rights to manufacture and market the products
in selected international markets.
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SIGNATURE PAGE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
PHARMOS CORPORATION
Date: September 16, 1997 /s/ Gad Riesenfeld
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Gad Riesenfeld
President & Chief Operating Officer
