Pharmos to receive $10m on Bausch & Lomb's FDA approval for opthalmic treatment
CEO Dr. Haim Aviv: Dexanabinol test results will be in by the end of 2004.
Gitit Pincas 16 Dec 04 14:21
Pharmos (Nasdaq:PARS) has announced that Bausch & Lomb, its previous marketing partner, received FDA approval of its New Drug Application (NDA) for Zylet as an opthalmic anti-inflammatory / antiobiotic combination product. Pharmos expects to receive a $10-12 million milestone payment from Bausch & Lomb within six months, the net amount of which will be calculated after accounting for certain expenses and fees.
The product is part of the lotepredenol etabonate business acquired by Bausch & Lomb from Pharmos in 2001.
Zylet is a combination of anti-inflammatory and antibiotic components (0.5% lotepredenol etabonate and 0.3% tobramycin) to treat steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of infection exists.
Zylet is the third product containing loteprednol etabonate approved by the FDA. Lotemax and Alrex have been marketed since 1998 as a result of three previous NDA approvals.
Zylet represents the final product resulting from the company's an earlier collaboration with Bausch & Lomb.
The next milestone
“Even in retrospect, I think that the sale to Bausch & Lomb was the right thing to do, although it left us without any revenue,” said Pharmos chairman and CEO Dr. Haim Aviv. “We preferred a large payment that we could use to finance the development of dexanabinol to posting a few million dollars in revenue each year.”
Bausch & Lomb will begin marketing Zylet in the first quarter of 2005.
The sale brought Pharmos’s cash reserves to $61 million, including inaccessible cash reserves, or $51.5 million, excluding the inaccessible cash reserves.
The sale is a glad occasion for Pharmos, albeit an expected one. The market is holding its breath, waiting for a much more significant event, the results of which are far less certain publication of the results of Phase III clinical trials of dexanabinol, Pharmos’s treatment for head trauma.
Aviv reassured all those concerned that results could be delayed until 2005, saying that the publication of the results “will definitely take place by the end of 2004,” i.e. in the next two weeks. Aviv declined to say anything further on the matter.
Pharmos has a $345 million market cap on Nasdaq.
Another party will share the first payment for FDA approval of Zylet, which Pharmos is due to receive shortly, as well as future payments linked to future achievement of milestones - Dr. Nicholas S. Bodor of the University of Florida. Bodor owns the patent for Zylet, and licensed it to Pharmos. Bodor is due to receive 11% of the payment, and 14.3% of the second payment if Bausch & Lomb achieve the planned sales targets.
Published by Globes [online], Israel business news - www.globes.co.il - on December 16, 2004
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