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) March 10, 1998
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)
33 Wood Avenue South, Suite 466, Iselin NJ 08830
(Address of principal executive offices) (zip code)
(732) 603-3526
(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
On March 10, 1998, Pharmos Corporation (the "Registrant"), together with
Bausch & Lomb Pharmaceuticals, Inc ("BLP") announced the recent approval from
the Food and Drug Administration ("FDA") to manufacture and market its two
ophthalmic products, Lotemax(TM) (loteprednol etabonate ophthalmic suspension
0.5%) and Alrex(TM) (loteprednol etabonate ophthalmic suspension 0.5%).
Lotemax is a topical, site-specific steroid that will be used to treat
post-operative eye inflammation such as that experienced following cataract
surgery. The new prescription eye drop will also be used for various other
inflammatory eye conditions. The novel chemical structure of Lotemax allows it
to be predictably transformed by enzymes in the eye to an inactive metabolite,
and increases its safety profile. The safety profile of Lotemax was demonstrated
in clinical trials by a low incidence of increased intraocular pressure, a
significant side effect of ophthalmic steroid use. In addition, Lotemax will
have the broadest range of indications of any ophthalmic steroid on the market.
Alrex is a specially developed formula of loteprednol etabonate that will
be used in the treatment of ophthalmic allergies. Alrex is indicated for the
treatment of seasonal allergic conjunctivitis, an inflammation of the eye
usually caused by pollens. Seasonal allergic conjunctivitis produces itching,
tearing, redness and swelling in the conjunctiva, the membrane that covers the
inside of the eyelid and the white part of the eye.
The regulatory approvals for Lotemax and Alrex are the first two of three
sought for the Registrant's and BLP's line of ophthalmic products containing
loteprednol etabonate. The third product, which combines the active ingredient
loteprednol etabonate with an anti-infective agent, is in development.
BLP, a subsidiary of the global eye care company, Bausch & Lomb
Incorporated, co-developed Lotemax and Alrex with the Registrant after the
Registrant granted BLP the rights to process and market the new ophthalmic
pharmaceutical line in June 1995. In December 1996, BLP's rights were extended
to select international markets including Europe and Canada.
BLP expects to begin marketing Lotemax and Alrex to wholesalers and
pharmacies within the next few weeks.
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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: March 10, 1998 /s/ Robert W. Cook
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Robert W. Cook
Vice President Finance and
Chief Financial Officer
