CHAPEL HILL, N.C., VOUVRY, VALAIS, Switzerland, Jan. 12 /PRNewswire/ -- Lantibio, Inc. and TRB Chemedica announced today the signing of a licensing and a supply/manufacturing agreement for the US development and marketing of VISMED(R). VISMED(R) is a patented formulation containing sodium hyaluronate, currently marketed in Europe by TRB. VISMED(R) will be studied in the US as a potential treatment for dry eye syndrome. Lantibio expects to commence late stage clinical studies with VISMED(R) in 2006.
In dry eye syndrome, it is hypothesized that VISMED(R), administered via ocular instillation, will hydrate the surface of the eye preventing dryness and long-term ocular injury. The sodium hyaluronate present in VISMED(R) is a known natural molecule with viscoelastic properties that lubricates the eye and hydrates the ocular surface.
"The acquisition of VISMED(R) brings Lantibio an exciting product to be evaluated for the potential treatment of dry eye syndrome. We hope to successfully develop and market VISMED(R) and to explore other products available for licensing from TRB Chemedica's ophthalmic portfolio," said Dr. Luis Molina, President and CEO of Lantibio, Inc.
Dr. Guido Di Napoli, President of TRB Chemedica, added, "This deal is a very important step forward for TRB Chemedica and VISMED(R). I believe VISMED(R) will improve the quality of life of many patients in the US. We hope that the commercialization of this product in the US will be a great success for both companies, paving the way for the introduction to the US market of other products from TRB Chemedica's research."
The most common causes of dry eye syndrome are hormonal changes in menopause, ocular surgery, and environmental factors such as dust and pollutants. In addition, 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 three million Americans. Symptoms of dry eye syndrome also 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. More than 90% of Sjogren's syndrome sufferers are women and while prevalence increases with age, the average age of onset is in the late 40s.
Lantibio, Inc. is a development pharmaceutical company focused on the discovery, development, and marketing of products for the treatment of ocular disease and serious respiratory conditions. Lantibio's lead product, Moli1901, is currently in clinical development in the United States for the treatment of dry eye syndrome in Phase II. The same molecule, formulated for inhalation, has been studied in Phase I clinical trials for cystic fibrosis in the US under Orphan Drug status and is currently in Phase II development in Europe under a Licensing Agreement between Lantibio and AOP Orphan Pharmaceuticals AG, Vienna, Austria.
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.
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 and/or TRB Chemedica'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 and TRB Chemedica assume no obligation to update any forward-looking statements as a result of new information or future events or developments, except as required by law.