Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

BioAlliance Pharma’s Sitavig® Receives Market Authorization in the US

Published: Tuesday, April 16, 2013
Last Updated: Tuesday, April 16, 2013
Bookmark and Share
Authorization from the U.S. FDA for Sitavig® in the treatment of recurring Herpes labialis, marking the successful conclusion to the assessment procedure carried out by the American authorities.

After Loramyc ®, registered in 26 countries including the United States, BioAlliance Pharma for the second time has successfully passed the FDA review. The registration of Sitavig, developed internally, shows once again the teams’ capacity and expertise.

Based on proprietary Lauriad® technology, Sitavig® comes in the form of a mucoadhesive tablet which the patient places on the gum and which delivers a high concentration of acyclovir directly to the lip, the site of the cold sore infection. In a phase III international study conducted on 775 patients, Sitavig® demonstrated a high level of efficacy in terms of healing time with one single tablet containing 50mg of acyclovir and an excellent tolerance profile.

In addition to its efficacy, Sitavig® offers a unique unobtrusive and simple formulation with a single application for the episode’s entire duration, representing major advantages for patients suffering from recurrent herpes sores.

“Herpes labialis is an infection that affects a very large number of patients around the world and for which there is a real need for effective treatment with appropriate presentation. We participated in the phase III clinical trial in our center and were able to test the benefits of Sitavig®. We are very pleased with the outcome of this development which will allow patients, once the product is on the market, to have a drug that meets their needs," says Professor Stephen Keith Tyring of the Dermatology Department at the University of Texas Health Sciences Center in Houston.

Herpes labialis is an extremely widespread condition. Its estimated annual prevalence is 15% of the adult population1, namely some 40 million people in the United States with more than 100 million episodes of Herpes labialis annually, representing a significant potential market of hundreds of millions of dollars.

Sitavig®, the second drug of BioAlliance’s 'Specialty Products' portfolio, is intended to be marketed via international partnership agreements and to generate significant income for the company. Obtaining the MA will allow the company to accelerate discussions with potential partners for marketing in the United States.

“Drug approval in the United States represents for all laboratories, whether large or small, both a challenge and a major success once it has been obtained since the process is so complex and significant levels of competence and expertise are required. This MA demonstrates once more the ability of BioAlliance teams to successfully complete the development and registration of a drug with international agencies such as those in Europe and the United States, and also strengthens its unique positioning within the current landscape of French Biotechs through its second drug registered for the major markets and three products in advanced clinical phase. This is a key step in creating company value for our shareholders and should allow us to generate revenue, thereby fully participating in the growth and success of BioAlliance,” states Judith Greciet, CEO of BioAlliance Pharma.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,300+ scientific posters on ePosters
  • More Than 4,900+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

BioAlliance Pharma Expands and Strengthens Its Industrial Property Assets
BioAlliance Pharma SA was granted two patents by the American and Japanese Offices protecting two of its products; Oravig® (miconazole) and Sitavig® (acyclovir).
Friday, July 12, 2013
BioAlliance Pharma Announces Shareholders’ Meeting and Appointment of Independant Board Members
As a result of the shareholder’s meeting, Dr Russell Greig and Danièle Guyot-Caparros have been appointed as independent Board Members.
Monday, July 01, 2013
BioAlliance Pharma to Continue its Phase III Clinical Trial with Livatag®
The Data and Safety Monitoring Board (DSMB) has again recommended continuing the ReLive Phase III trial without modification.
Tuesday, May 14, 2013
BioAlliance Announces Phase I Trial for Fentanyl Lauriad® and the Submission of a Clonidine Lauriad® Phase II Clinical Trial Application
This clinical trial will evaluate the plasma pharmacokinetic parameters of Fentanyl Lauriad® in healthy volunteers.
Tuesday, October 13, 2009
BioAlliance Announces Positive Preliminary Pivotal Phase III Results in Herpes Labialis with Acyclovir Lauriad®
Study compared the efficacy and safety of a single dose acyclovir Lauriad® 50mg MBT versus matching placebo in recurrent oro-facial herpes.
Thursday, August 27, 2009
BioAlliance Pharma Submits Clinical Trial New Drug Application
Company announces submission of a Fentanyl Lauriad® clinical trial application to the French Drug Agency and approval by the Ethics Committee.
Wednesday, July 29, 2009
Scientific News
Breakthrough Flu Vaccine Inhibited by Pre-existing Antibodies
Universal truths – how existing antibodies are sabotaging the most promising new human flu vaccines.
Gene Therapy for Metabolic Liver Diseases
Researchers have tested gene therapy in pigs from hereditary tyrosinemia type 1, with corrected liver cells being transplanted into the diseased liver.
Zika Vaccine Candidates Show Promise
Two experimental vaccines have shown promise against a major viral strain responsible for the Brazilian Zika outbreak.
New Medication Shows Promise Against Liver Fibrosis in Animal Studies
Liver fibrosis is a gradual scarring of the liver that puts people at risk for progressive liver disease and liver failure.
Raw Eggs Deemed Safe to Eat
A report published today by the Advisory Committee on the Microbiological Safety of Food (ACMSF) into egg safety has shown a major reduction in the risk from salmonella in UK eggs.
Monitoring TTX Toxin in Shellfish
In a number of small studies, mussels and oysters from the eastern and northern part of the Oosterschelde in Holland were found to contain tetrodotoxin (TTX).
Gene Terapy for Muscle Wasting Developed
New gene therapy could save millions of people suffering from muscle wasting disease.
NIH Begins Yellow Fever Vaccine Trial
NIH has initiated an early-stage clinical trial of a vaccine to protect against yellow fever.
Gene-Editing 'Toolbox' Targets Multiple Genes Simultaneously
Researchers have designed a system that modifies, or edits, multiple genes in a genome at once while minimising unintentional effects.
Detecting Alzheimer's with Smell Test
Odour identification test may offer low-cost alternative for predicting cognitive decline and detecting early-stage Alzheimer’s disease.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!