Healthcare Industry News: Clindamycin
News Release - December 13, 2006
European Zindaclin Licensing Agreements Restructured; Zindaclin Rights for U.S. Market Licensed; Revenue From Zindaclin Projected at $2.5 Million in 2007ADDISON, Texas, Dec. 13 (HSMN NewsFeed) -- ULURU INC. (OTC Bulletin Board: ULUR ; ULUR) today announced that its exclusive worldwide licensing partner ProStrakan Group plc ("ProStrakan") has restructured the European License for its product Zindaclin and licensed the rights to Zindaclin for the United States market.
Previously, certain Western European markets were licensed to a company that was acquired, which resulted in a conflict as the acquiring company was marketing a competitive product. Additionally, rights to Zindaclin in CEE countries were licensed to another company that had not commercialized the product. ProStrakan recovered the rights in these territories and out- licensed Zindaclin to Crawford Healthcare Ltd. ("Crawford"), a United Kingdom based specialty pharmaceutical company focused on dermatology. Crawford has also licensed the rights to Zindaclin in the United States market, where to obtain approval for the product, additional clinical work is required. It is anticipated that Crawford will commence this clinical work in 2007.
Zindaclin is a Clindamycin phosphate 1% gel for the treatment of mild and moderate acne and was the first once-daily topical treatment launched in Europe. Zindaclin uses our patented ResiDerm intradermal drug delivery system which allows for the administration of drugs in the presence of zinc ions. This creates an intradermal drug reservoir by enhancing penetration into the skin and, once there, prolonging their retention in the dermal layers.
Under the terms of the revised License Agreement, Crawford will make an undisclosed upfront payment, future milestone payments, both success and time related, and will pay royalties on product sales. The agreement between ProStrakan and ULURU provides for an equal sharing of revenue on all licensing agreements.
Commenting on the development, Kerry P. Gray, President and CEO of ULURU Inc. stated, "Although Zindaclin is not a strategic asset of ULURU the near term revenue which we project will be $2.5 million in 2007 will make a meaningful contribution to our financial performance next year. The actions taken by ProStrakan will ensure the maximization of both the short and long term revenue stream from this product."
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.
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 commencement by Crawford of additional clinical work in 2007, payment obligations of Crawford under the License Agreement with ProStrakan and the achievement by ULURU of Zindaclin revenue projections. 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, 2005, Quarterly Report on Form 10-QSB for the quarter ended September 30, 2006 and other reports filed by us with the Securities and Exchange Commission.
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