Nanotechnology Now

Our NanoNews Digest Sponsors

Heifer International

Wikipedia Affiliate Button

Home > Press > ULURU Inc. Announces Filing of OraDisc(TM) B Regulatory Dossier in Europe

Abstract:
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.

For more information, please click here

Contacts:
Company
Kerry P. Gray
President & CEO
Terry K. Wallberg
Vice President & CFO
(214) 905-5145

Copyright © PR Newswire Association LLC.

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

Govt.-Legislation/Regulation/Funding/Policy

Computers aid discovery of new, inexpensive material to make LEDs with high color quality February 20th, 2018

Arrowhead Receives Regulatory Clearance to Begin Phase 1/2 Study of ARO-HBV for Treatment of Hepatitis B February 15th, 2018

Arrowhead Pharmaceuticals Receives Orphan Drug Designation for ARO-AAT February 15th, 2018

Rutgers-Led Innovation Could Spur Faster, Cheaper, Nano-Based Manufacturing: Scalable and cost-effective manufacturing of thin film devices February 14th, 2018

Nanomedicine

Arrowhead Receives Regulatory Clearance to Begin Phase 1/2 Study of ARO-HBV for Treatment of Hepatitis B February 15th, 2018

Arrowhead Pharmaceuticals Receives Orphan Drug Designation for ARO-AAT February 15th, 2018

'Living bandages': NUST MISIS scientists develop biocompatible anti-burn nanofibers February 15th, 2018

Understanding brain functions using upconversion nanoparticles: Researchers can now send light deep into the brain to study neural activities February 14th, 2018

Announcements

Oxford Instruments announces Dr Kate Ross as winner of the 2018 Lee Osheroff Richardson Science Prize for North and South America February 20th, 2018

Computers aid discovery of new, inexpensive material to make LEDs with high color quality February 20th, 2018

Unconventional superconductor may be used to create quantum computers of the future: They have probably succeeded in creating a topological superconductor February 19th, 2018

Photonic chip guides single photons, even when there are bends in the road February 16th, 2018

NanoNews-Digest
The latest news from around the world, FREE



  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project