REHOVOT, Israel - Pharmos Corp.'s recent FDA approvals for Lotemax for inflammatory eye disorders and Alrex for ophthalmic allergies positioned it as the first company in Israel to receive U.S. clearance for more than one drug.
“Pharmos can be best described as a U.S.-Israeli company,“ said Haim Aviv, chairman and CEO of Pharmos, whose U.S. offices are in Iselin, N.J. Pharmos is a U.S.-registered company with a wholly owned Israeli subsidiary, Pharmos Ltd., where most of its R&D activities are conducted under the guidance of Aviv, who established the company in 1992.
Pharmos became the third Israeli company, after Biotechnology General Ltd. (BTG), in Rehovot, and Teva Pharmaceutical Industries Ltd., in Jerusalem, to win FDA approval to market a self-developed ethical drug.
Aviv, who is chairman of the Israel National Committee for Biotechnology, was also cofounder of BTG and its general manager from 1980 to 1985.
Aviv said, “This year, Pharmos is likely to post its first revenues. Lotemax developed into a drug with greater potential than initially considered, and is likely to be suitable for all sorts of eye infections. It is considered to be much safer to use than other steroids, so it may also be used for many types of eye inflammations for which steroids presently are not prescribed.“
Sales of Lotemax are scheduled to start in the second half of this year, said Michael Schickler, vice president of Pharmos.
Twenty million people in the U.S. wear contact lenses; worldwide, the number is around 50 million. Schickler said, “The worldwide ophthalmic inflammatory and allergy markets addressed by Lotemax and Alrex might reach $1 billion by 2000.“
Alrex, an anti-allergy ophthalmic product, is aimed at sufferers of seasonal allergic conjunctivitis (hay fever), the most common form of ocular allergy, which affects about 15 percent of the population.
“We feel optimistic with our strategic partner, Bausch & Lomb, a world leader in eyecare, for the marketing of Lotemax in the U.S., Europe and other countries,“ said Aviv.
Bausch & Lomb, of Rochester, N.Y., with sales of more than $2.5 billion, made a $5 million advance payment to Pharmos and is expected to make other milestone payments. Pharmos also will receive close to 30 percent revenue on net product sales in the U.S. and about 24 percent on sales in Europe.
Other Pharmos R&D activities include developing drugs based on cannabinoid derivatives for treatment of central nervous system disorders, stroke and head trauma.
The company's neuroprotective, Dexanabinol (HU-211), which originated from the research of Raphael Mechoulam at the Hadassah-Hebrew University of the Jerusalem School of Pharmacy, is aimed at protecting trauma victims from brain damage.
Dexanabinol has multiple mechanisms of action, combining N-methyl-D-aspartate receptor blocking activity with tumor necrosis factor-alpha inhibitory and antioxidant activities.
In ongoing Phase II multicenter, double-blind, placebo-controlled trials carried out in six hospitals in Israel, head trauma patients are being followed for six months following administration of the drug after diagnosis of injury but within six hours of occurrence. After severe head injury, most deaths occur within the first 10 days. *