Lantibio and TRB Chemedica Announce Licensing Agreement with Alcon for US Development and Marketing of Dr...( CHAPEL HILL N.C. and VALAIS Switz...)

CHAPEL HILL, N.C., and VALAIS, Switzerland, Nov. 5 /PRNewswire/ -- Lantibio, Inc. and TRB Chemedica announced today the signing of a licensing agreement with a subsidiary of Alcon, Inc. (NYSE: ACL) for the US development, marketing, and manufacture of a Dry Eye Syndrome product. The product consists of a TRB patented formulation containing sodium hyaluronate and is currently being studied in the US under an IND by a subsidiary of Lantibio. An ongoing multi-center Phase III pivotal study is being conducted under the FDA's Special Protocol Assessment program. Lantibio expects to file an NDA in 2008 for the product as a treatment for Dry Eye Syndrome.

In Dry Eye Syndrome, it is hypothesized that the product, administered via ocular instillation will hydrate the surface of the eye preventing dryness and long-term ocular injury. Sodium hyaluronate is a known natural molecule with viscoelastic properties that in preparation with specific ions and chelators, lubricates the eye and hydrates the ocular surface.

Under the terms of the agreement, Lantibio will conduct the development program and filing of the NDA, while Alcon will assume responsibility for subsequent marketing, sales and manufacturing for the US market. Terms of the agreement include up-front and development milestone payments, as well as royalties to be paid to Lantibio and TRB by Alcon on sales of the approved product.

"We believe this product will bring significant relief to patients with Dry Eye Syndrome and look forward to completing our clinical study and to filing an NDA with the FDA for approval in the US," said Andrew Schiermeier, Ph.D., Chief Executive Officer of Lantibio, Inc. "We are delighted by this agreement, and could not hope fo
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