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. 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 for a better partner than Alcon, the world's leading eye care company, to lead a broad and successful launch in the US market."
"TRB Chemedica is pleased to be associated with Alcon and Lantibio, through the signature of this licensing agreement, to bringing to the USA Dry Eye Syndrome patients our high-value eye drop therapy based on a unique hyaluronic acid and essential ions patented formulation," said Dr. Guido DiNapoli, founder and owner of TRB Chemedica. "TRB Chemedica is looking forward to working in close collaboration with Alcon and Lantibio."
The most common causes of Dry Eye Syndrome are ocular surgery, environmental factors such as dust and pollutants, and hormonal changes associated with menopause. Symptoms of dry eye syndrome include burning, itching, irritation, photophobia, and a feeling that there is a foreign body in the eye. If left untreated, it can cause permanent damage, including impaired vision. In 2003, Morgan Stanley Research estimated the prevalence of dry eye syndrome in the United States at 5.5 million diagnosed cases.
In a related affliction, Sjogren's syndrome patients suffer dry eyes and dry mouth. Sjogren's syndrome is one of the most prevalent autoimmune disorders, striking as many as 3 million Americans. More than 90 percent of Sjogren's syndrome sufferers are women and while prevalence increases with age, the average age of onset is in the late 40's.
About Lantibio & Paramount BioSciences
Lantibio, Inc. is a private pharmaceutical company funded by Paramount BioSciences and devoted to the discovery, development, and commercialization of products for the treatment of ocular disease and serious respiratory diseases. For more information on Lantibio, Inc., visit the Company's web site at http://www.lantibio.com. Paramount BioSciences, LLC is a global pharmaceutical development and healthcare investment firm that conceives, nurtures, and supports new biotechnology companies. For additional information about Paramount BioSciences, please visit www.paramountbio.com.
About TRB Chemedica
TRB Chemedica is a privately-owned Swiss pharmaceutical company with more than 20 years experience in research, development, manufacture and commercialization of innovative niche products in rheumatology, ophthalmology and neurology. TRB Chemedica has developed an expertise on the viscoelastic biopolymer, hyaluronic acid, manufacturing sterile finished products in its Swiss-based GMP facility. The company's product pipeline will help to fuel growth in each of the targeted therapeutic areas as well as introduce it into new areas of therapeutic focus. TRB Chemedica products are currently sold in more than 40 countries worldwide through wholly-owned subsidiaries, present in various countries in Europe, South America and Asia, and a growing network of licensing and distribution partners. For more information on TRB Chemedica visit the Company's web site at http://www.trbchemedica.com.
Caution Concerning Forward-Looking Statements. This press release might contain forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Lantibio's expectations and projections. Risks and uncertainties include success of clinical trials for Lantibio's products, intellectual property risks, need for additional financing or capital, ability to develop and successfully commercialize our products, ability to enter into licensing agreements, and the ability of the competition to render Lantibio's product candidates or technologies obsolete or noncompetitive. Lantibio assumes no obligation to update any forward-looking statements as a result of new information or future events or developments, except as required by law.
CONTACT: Andrew Schiermeier, Ph.D., Chief Executive Officer,
+1-212-554-4305, email@example.com, or Luis Molina, Ph.D.,
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Inc.; or Marco Betancourt, Director of Business Development of TRB
Chemedica S.A., +41 22 703 49 00, email@example.com
Web site: http://www.lantibio.com/