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Tuesday July 10  5:15pm
Source: PR Newswire

ISELIN, N.J., July 10 /PRNewswire/ -- Pharmos Corporation (Nasdaq: PARS and Nasdaq Europe: PHRM) will report on the status of its products under development at the Company's Annual Meeting of Shareholders scheduled for July 12, 2001. The Company will note that the Phase III clinical trial of dexanabinol for severe Traumatic Brain Injury (TBI) is progressing as planned, and the process of selecting a new drug candidate for stroke is in its final stages. The revenues generated by products in its ophthalmics program, Lotemax(R) and Alrex(R), continue to fund the advancement of the Company's CNS programs. The Company's partner, Bausch & Lomb Pharmaceuticals, is expanding the clinical program for the third ophthalmic product, LE-T, the length of which trial is dependent upon the outcome of FDA review of the trial protocol.

"We have made important progress since last year's meeting," said Haim Aviv, Ph.D., Chairman and CEO. "Our pivotal Phase III study of dexanabinol for TBI is underway and our programs focused on CNS and neuro-inflammatory indications are showing very interesting results. Our existing cash position will support both of these important programs. We are confident that the final results of our ongoing clinical testing of LE-T will ultimately provide clear evidence of the product's qualities."

Neuro-inflammatory Pipeline

The clinical study with dexanabinol for TBI is progressing as planned. Thirty centers in Europe are currently recruiting patients. Up to 15 more centers are expected to be added over the next several months, which should further accelerate the rate of enrollment. By late 2001 the Company expects to start recruiting 20-30 centers in the US. The Company recently met with the FDA and is now preparing its submission to obtain FDA authorization to enroll patients in the US. Total worldwide enrollment of approximately 860 patients is expected to be completed by early 2003.

Dexanabinol is expected to be the first TBI product on the market and may generate significant revenues in the over $1.0 billion annual market. Pharmos is committed to completing the development of dexanabinol and may partner for its commercialization at a late stage of development.

The Company has narrowed the pool of drug candidates to move into human trials for stroke to two second-generation compounds. The final selection will be made next year. These compounds demonstrated neuro-protective and anti-inflammatory properties in animal stroke models. Efforts are now underway to assess the potential therapeutic window of these compounds, as well as to complete other pre-clinical testing.

Pharmos has designed and synthesized a large library of non-psychotropic dexanabinol derivatives with neuroprotective and anti-inflammatory properties to potentially treat other neuro-inflammatory and cardiovascular indications. Selected compounds are in early pre-clinical studies for potential use in the treatment of various diseases, among them multiple sclerosis, spinal cord injury, myocardial infarction and neuropathic pain. A new drug candidate for these indications may be selected by early 2003. Pharmos will seek strategic partnerships for the development and commercialization of neuro-inflammatory programs.

Ophthalmic Pipeline

The Company expects to report its second quarter 2001 revenues of Lotemax and Alrex together with its financial results in early August. According to IMS Health data, in May 2001, Lotemax and Alrex averaged 14.2% and 13.5% of new prescriptions by ophthalmologists, respectively. Total prescriptions written increased 34.4% for Lotemax and 17.4% for Alrex compared to May 2000. The global roll-out of the products is continuing.

The enrollment of patients in a Phase III trial of LE-T, which will include roughly 2,400 patients, will begin soon and may be completed in late 2002. The purpose of the study is to demonstrate that tobramycin does not alter the anti-inflammatory efficacy of Lotemax in the human eye. Technical and methodological issues unique to this development program have complicated the design and implementation of the trial, leading to a larger patient enrollment in the study than previously expected. The clinical protocol in this study reflects the knowledge Bausch & Lomb Pharmaceuticals and Pharmos have gained from the previous LE-T studies, including several pilot studies that were performed with LE-T in 1999 and 2000. Pharmos and Bausch & Lomb Pharmaceuticals remain confident that the development of LE-T will succeed and that the product will be a significant player in the combination ophthalmic anti-inflammatory/anti-infective marketplace, estimated at about $150 million annually in the U.S.

Pharmos Corporation discovers and develops novel therapeutics to treat a range of inflammatory and neurological disorders, such as traumatic brain injury and stroke. The Company has an extensive portfolio of drug candidates under development, as well as discovery, preclinical and clinical capabilities.

Statements made in this press release related to operational expectations of the Company and to the development and commercialization of the Company's pipeline products are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties which may cause results to differ materially from those set forth in these statements. Additional economic, competitive, governmental, technological, marketing and other factors identified in Pharmos' filings with the Securities and Exchange Commission could affect such results.

Source: Pharmos Corporation
Contact: U.S. - Gale T. Smith, 732-452-9556, or Israel - Irit Kopelov, +08-940-9679, both of Pharmos Corporation