CHAPEL HILL, N.C., and VALAIS, Switzerland, Nov. 5 /CNW/ -- 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
"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
"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.
For further information on Lantibio please contact:
Andrew Schiermeier, Ph.D.
Chief Executive Officer, Lantibio Inc.
Telephone: (212) 554 4305
Luis Molina, Ph.D.
President/CSO, Lantibio Inc.
Telephone: (919) 960 0217
For Further Information on TRB Chemedica, please contact:
Director of Business Development, TRB Chemedica S.A.
telephone: +41 22 703 49 00
For further information:
For further information: Andrew Schiermeier, Ph.D., Chief Executive
Officer, +1-212-554-4305, email@example.com, or Luis Molina,
Ph.D., President and CSO, +1-919-960-0217, firstname.lastname@example.org, both of
Lantibio Inc.; or Marco Betancourt, Director of Business Development of TRB
Chemedica S.A., +41 22 703 49 00, email@example.com Web Site: