Home > Press > ULURU Inc. Announces Filing of OraDisc(TM) B Regulatory Dossier in Europe
ULURU Inc. today announced that Meldex International PLC (previously BioProgress PLC) has filed the regulatory dossier for approval of ULURU's proprietary product OraDisc(TM) B in Europe.
ULURU Inc. Announces Filing of OraDisc(TM) B Regulatory Dossier in Europe
ADDISON, TX | Posted on December 19th, 2007
OraDisc(TM) B is a product developed from our adhesive film technology which incorporates 15 milligrams of benzocaine for the treatment of oral pain. The product is designed to adhere to the mucosal surface and selectively deliver pain relief to a localized area. Compared with currently marketed gel products, OraDisc(TM) B provides a significantly greater period of pain relief as the adhesive film is designed to erode over a 1 - 1.5 hour period.
Under the terms of the agreement this will trigger a major milestone payment from Meldex International PLC in February 2008 which was payable on the later to occur of the registration filing or the first anniversary of the signing of the agreement.
Commenting on the registration filing, Kerry P. Gray, President and Chief Executive Officer of ULURU, stated "I am very pleased with the progress Meldex has made preparing and submitting the OraDisc(TM) B Dossier. Securing a regulatory approval for our adhesive film technology in Europe is an important step in our overall commercialization strategy for this technology."
Steve Martin, Chief Development Officer of Meldex International PLC, added "Strategically this is an important product in our portfolio as it compliments our existing range of products in supportive care and pain management and our instant release Soluleaves(TM) technology. Given our expanding European presence this novel product offers us the potential to build a significant presence in the pain management market."
About ULURU Inc.
ULURU Inc. is an emerging specialty pharmaceutical company focused on the development of a portfolio of wound management, plastic surgery and oral care products to provide patients and consumers improved clinical outcomes through controlled delivery utilizing its innovative transmucosal delivery system and Hydrogel Nanoparticle Aggregate technology.
About Meldex International PLC:
Meldex International is a specialty pharmaceutical and healthcare product business that uses its XGEL(TM) polymer technologies to develop and enhance medicines and OTC products.
Meldex International possesses an array of innovative enabling systems which are applied to enhance its own pharmaceutical and healthcare products and those of its partners. The Company has product development agreements and strategic alliances with several global pharmaceuticals companies including Barr Pliva and FMC BioPolymer Inc.
Meldex is an international operation. It has sales and marketing infrastructure in the UK, Austria, Germany, France, Italy and the USA; distribution agreements covering Canada, South America, the CEE region, Asia the Far East and other territories, product development in the UK and USA and a product portfolio of branded and generic pharmaceutical and healthcare products across the globe.
This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, including but not limited to statements made relating to the registration of our adhesive film technology in Europe, the product advantages of OraDisc(TM) B and the potential to establish a significant presence in the pain management market. These statements are subject to numerous risks and uncertainties, including but not limited to the risk factors detailed in the Company's Annual Report on Form 10-KSB for the year ended December 31, 2006, Quarterly report Form 10-QSB for the quarter ended September 30, 2007 and other reports filed by us with the Securities and Exchange Commission.
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Kerry P. Gray
President & CEO
Terry K. Wallberg
Vice President & CFO
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