FDA
Accepts Bausch & Lomb New Drug Application for
Ophthalmic Anti-inflammatory/Antibiotic Combination Product
ROCHESTER, N.Y. and ISELIN, N.J.
– Bausch & Lomb (NYSE:BOL) and Pharmos Corporation
(Nasdaq: PARS, Nasdaq Europe: PHRM) announced today that
the U.S. Food and Drug Administration has accepted for
review Bausch & Lomb’s New Drug Application
for an anti-inflammatory-antibiotic combination product.
The product under FDA review is a loteprednol
etabonate and tobramycin ophthalmic suspension (0.5% and
0.3%). The combination therapy is aimed at treating patients
with steroid-responsive inflammatory ocular conditions
who have or are at risk of developing superficial bacterial
ocular infections.
In 2001, Bausch & Lomb acquired the
rights to the loteprednol etabonate ophthalmic business
of Pharmos Corporation. Bausch & Lomb also agreed
to make future payments to Pharmos for certain future
extensions of the loteprednol etabonate formulation, with
the payments based on the date of market introduction.
The total payments to Pharmos potentially
could be in excess of $20 million, with the initial payment
based on the date of product launch and an additional
milestone payment of up to $10 million if product sales
exceed certain targets in the first two years.
Bausch & Lomb has indicated that, pending
FDA review, it expects to introduce the new combination
medication in 2004.
Bausch & Lomb Contacts:
News Media
Margaret Graham
585.338.5469
Margaret.Graham@Bausch.com
Investor Relations
Daniel L. Ritz
585.338.5802
Daniel.L.Ritz@bausch.com
Pharmos Corp. Contacts:
Gale T. Smith – U.S.
732.452.9556
Gale.Smith@pharmos-us.com
Irit Kopelov – Israel
08-940-9679
iritk@pharmos.com
_____________________________________
Bausch & Lomb is the eye health company, dedicated
to perfecting vision and enhancing life for consumers
around the world. Its core businesses include soft and
rigid gas permeable contact lenses and lens care products,
and ophthalmic surgical and pharmaceutical products. The
Bausch & Lomb name is one of the best known and most
respected healthcare brands in the world. Celebrating
its 150th anniversary in 2003, the Company is headquartered
in Rochester, New York. Bausch & Lomb’s 2002
revenues were $1.8 billion; it employs approximately 11,500
people worldwide and its products are available in more
than 100 countries. More information about the Company
can be found on the Bausch & Lomb Web site at www.bausch.com.
Copyright Bausch & Lomb.
Pharmos discovers, develops, and commercializes
novel therapeutics to treat a range of indications, in
particular neurological and inflammation-based disorders.
The Company's first neuroprotective product is dexanabinol,
a tricyclic dextrocannabinoid, currently undergoing clinical
testing as a treatment for traumatic brain injury and
as a preventive agent against post-surgical cognitive
impairment. Other dextrocannabinoid compounds and CB2
receptor agonist compounds from Pharmos' proprietary synthetic
cannabinoid library are being studied in pre-clinical
programs targeting a variety of other disorders. More
information about the Company can be found on the Pharmos
Web site at www.pharmoscorp.com.
back
to News Room
