Last $1.02 USD
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Company Description

Contact Info

4452 Beltway Drive

Addison, TX 75001

United States

Phone: 214-905-5145

Fax: 214-905-5130

ULURU Inc., a specialty pharmaceutical company, engages in developing and commercializing a range of wound care and mucoadhesive film products based on its patented Nanoflex and OraDisc drug delivery technologies, with the goal of improving outcomes for patients, health care professionals, and health care payers. Marketed Products The company has used its drug delivery technology platforms to develop the following products and product candidates: Altrazeal Altrazeal Transforming Powder Dressing, based on the company’s Nanoflex technology, has the potential to change the way health care providers approach their treatment of wounds. The product is indicated for exuding wounds, such as partial thickness burns, donor sites, abrasions, surgical, trauma, and chronic wounds, including diabetic foot ulcers, venous leg ulcers, and pressure ulcers. The powder fills and seals the wound to provide an optimal moist wound healing environment. The wound exudate is controlled through the high moisture vapor transpiration rate (MVTR) of the material generated by capillary forces that creates a low pressure environment at the wound bed, which supports cellular function and tissue repair and holds the dressing in place. The focus of the company’s commercial activities is introducing Altrazeal in all major international markets, in conjunction with its European partners, through its 25% owned company, Altrazeal Trading Ltd. Altrazeal is already marketed in Australia and Austria. The company has a licensing and supply agreement with Jiangxi Aiqilin Pharmaceuticals Group Company, a corporation in China (Aiqilin), for the development and commercialization of Altrazeal in China, including Hong Kong, Macau, and Taiwan. The agreement covers Altrazeal, Altrazeal Silver, and Altrazeal Collagen. In 2012, the company executed a license and supply agreement with Melmed Holding AG (Melmed) to market Altrazeal throughout the European Union, Australia, New Zealand, North Africa, and the Middle East. Aphthasol (Amlexanox 5% Paste) Aphthasol, amlexanox 5% paste, is the first drug approved by the United States Food and Drug Administration (FDA) for the treatment of canker sores. Marketing authorization for amlexanox 5% paste in the United Kingdom is received. Approval to market its granted in Austria, Germany, Greece, Finland, Ireland, Luxembourg, the Netherlands, Norway, Portugal, and Sweden. The therapeutic Products Programme, the Canadian equivalent of the FDA, has issued a notice of compliance permitting the sale of amlexanox 5% paste, called Apthera, in Canada by Pharmascience Inc., the company’s Canadian partner. In addition to the company’s license agreement with Meda AB, licensing agreements have been executed with Laboratories Esteve for Spain, Portugal and Greece; Pharmascience Inc. for Canada; EpiTan, Ltd. for Australia and New Zealand; Orient Europharma, Co., Ltd for Taiwan, Hong-Kong, the Philippines, Thailand, and Singapore; and KunWha Pharmaceutical Co., LTD for South Korea. Contract Pharmaceuticals Ltd. Canada is the company’s contract manufacturer for all markets, including the United States. OraDisc A The company has developed an adhesive film product that is bioerodible. This technology, known as OraDisc, comprises a multi-layered film having an adhesive layer, an optional pre-formed film layer, and a coated backing layer. OraDisc A is developed as a drug delivery system to treat canker sores using the same active ingredient (amlexanox) that is used in Aphthasol paste. OraDisc A is approved by the FDA. The company has a licensing and supply agreement with KunWha Pharmaceutical Co., Ltd for OraDisc A and Aphthasol (5% amlexanox) paste in South Korea. OraDisc B A second mucoadhesive disc product has also been developed for the treatment and management of oral pain. This product contains 15 milligrams of benzocaine, which is the maximum allowable strength that falls under the classification of an OTC monograph product. In 2012, the company executed a license and supply agreement with ORADISC GmbH to market worldwide all applications of its OraDisc erodible film technology for dental applications, incl

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