BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Lantibio Inc. And TRB Chemedica Announce Special Protocol Assessment-Endorsed Phase III Trial Initiation Of VISMED(R) For Dry Eye Syndrome


1/17/2007 8:50:02 AM

CHAPEL HILL, N.C., US and VOUVRY, VALAIS, Switzerland, Jan. 16 /PRNewswire/ -- Lantibio, Inc. and TRB Chemedica announced today the initiation of a Phase III clinical trial with VISMED(R) in dry eye syndrome. The corresponding protocol was negotiated with the FDA under the Special Protocol Assessment (SPA) program and consists of a multi-center, randomized, controlled and double-blinded study. VISMED(R) is a patented formulation containing sodium hyaluronate, currently marketed to millions of dry eye syndrome sufferers in Europe by TRB Chemedica. VISMED(R) is being studied in the US as a treatment for dry eye syndrome, under IND 73,441 filed in June 2006. The SPA was cleared by FDA in December of 2006 and the first patients were enrolled in the study immediately thereafter. If the current Phase III study is successful Lantibio expects to file a New Drug Application (NDA) for VISMED(R) in 2008.

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. Several pre-clinical and clinical studies were performed previously in Europe with VISMED(R) indicating the safety and efficacy in relevant objective and subjective endpoints.

"During 2006, we engaged in multiple meetings with the FDA's Division of Anti-Infective and Ophthalmology Products where we were able to fully vet VISMED(R)'s background data on as well as agree on plans for the eventual NDA submission. We have high confidence in the ultimate success of VISMED(R)," said Dr. Luis Molina, President and CEO of Lantibio, Inc.

Dr. Guido Di Napoli, President of TRB Chemedica added, "I am very proud that our association with Lantibio is progressing so successfully, and I am now looking forward to the completion of the next regulatory steps so as to make VISMED(R) available to the US market as soon as possible. I strongly believe VISMED(R) will improve the quality of life of many patients in the US, as it has done for so many European patients already. TRB Chemedica International SA is continuously working to bring new generations of ophthalmic products on the market."

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 40's.

About Lantibio

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.

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.

Lantibio, Inc.

CONTACT: Luis Molina, Ph.D., President-CEO of Lantibio, +1-919-960-0217,or lmolina@lantibio.com; or Marco Betancourt, Director of TRB Chemedica, 4122 703 49 00, or marco.betancourt@trbchemedica.com



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES