ULURU Inc., a specialty pharmaceutical company, develops and commercializes a range of wound care and mucoadhesive film products based on patented Nanoflex and OraDisc technologies. Products The company has used its drug delivery technology platforms to develop the following products and product candidates: Altrazeal Altrazeal Transforming Powder Dressing is indicated for exuding wounds, such as partial thickness burns, donor sites, abrasions, non-healing surgical wounds, 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 of the material. In 2010, the company entered into 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. Aiqilin also has been granted certain manufacturing rights. The agreement covers Altrazeal, Altrazeal Silver, and Altrazeal Collagen. Aphthasol (Amlexanox 5% Paste) Aphthasol, amlexanox 5% paste, is a drug approved by the United States Food and Drug Administration (FDA) for the treatment of canker sores. Aphthasol accelerates the healing of canker sores which results in a statistically significant reduction in the level of pain a patient experiences over the duration of the ulcer episode. 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 was developed as a drug delivery system to treat canker sores using the same active ingredient (amlexanox) that is used in Aphthasol paste. OraDisc A was approved by the FDA in 2004. OraDisc B A second mucoadhesive disc product also has 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 the United States. The product has been optimized and is ready for commercial scale-up. In 2012, the company executed a license and supply agreement with ORADISC GmbH (Ora-D) to market worldwide all applications of its OraDisc erodible film technology for dental applications, including but not limited to benzocaine (OraDisc B). Strategy The company’s strategy is twofold: establish a market leadership position in wound management by developing and commercializing a customer focused portfolio of innovative wound care products based on Nanoflex technology to treat the various phases of wound healing; and develop oral mucoadhesive film technology (OraDisc) for systemic drug delivery and for delivery of actives to the oral cavity. Research and Development During the year ended December 31, 2015, the company expended approximately $764,000 for research and development. Regulations The company is subject to extensive regulation by the federal government, principally by the United States Food and Drug Administration (FDA), and to a lesser extent, by other federal and state agencies, as well as comparable agencies in foreign countries where registration of products will be pursued. The Federal Food, Drug and Cosmetic Act and other federal, state and foreign statues and regulations govern the testing, manufacturing, safety, labeling, storage, shipping, and record keeping of the company’s products. Intellectual Property Patents: With regards to its Nanoflex technology, three patents have issued in the U.S. and multiple patents have been issued in international countries. There are also four PCT patent applications that have been filed and nine patent applications filed in nine international countries. The granted patents and patent applications have various potential applications, such as wound management, burn care, dermal fillers, artificial discs and tissue scaffold. The company has one U.S. patent and has filed one PCT patent application for its OraDisc technology. Competition Majority of the company’s competitors in the wound care market include Smith & Nephew plc; Systagenix Wound Management Limited; ConvaTec Inc.; 3M Company; and Molnlycke Health Care.
uluru inc (ULUR:OTC US)
4452 Beltway Drive
Addison, TX 75001
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