Commercial Update – International Markets
ADDISON, Texas, Nov. 8, 2010 /PRNewswire/ — ULURU Inc. (NYSE Amex: ULU) today provided an update on its international commercial activities.
During the first half of 2011 it is anticipated that ULURU products will be potentially introduced into 10 international markets. From licensing agreements, orders currently in hand and forecast orders, it is projected that during the first half of 2011 revenue of $1 – 1.5 million will be generated from these activities.
Currently, we are working with MEDA, our European licensee of AphthasolÃ‚®, a product for the prevention and treatment of aphthous ulcers (canker sores), to launch the product in the first European market. It is anticipated that this will occur in the first quarter of 2011. Aphthous ulcers are the most common oral condition with a disease incidence of approximately 15% of the population. It is projected that approximately 30% of this group suffer from recurrent aphthous ulcers and are a candidate for AphthasolÃ‚®. Market research indicates that there is a clinical need for a treatment product. AphthasolÃ‚® is the only product to be proven clinically effective in treating this disease.
Commenting on the European launch of AphthasolÃ‚®, Kerry P. Gray, President and CEO, stated, “We are very pleased that MEDA is moving forward with the launch of AphthasolÃ‚® in Europe. They are a large company with the necessary resources to make AphthasolÃ‚® a success in Europe. In addition, MEDA plans to submit in 2011 OraDisc(TM) A, an erodible mucoadhesive film product containing the same active ingredient, for regulatory approval. Previous market research studies have indicated a potential $60 million opportunity throughout Europe for AphthasolÃ‚®. These are very positive developments in our oral care franchise.”
We are also working with our existing licensee to secure the necessary product approval to launch AltrazealÃ‚® in China. In addition, we are evaluating the possibility of launching AltrazealÃ‚® in additional Asian markets where the CE Mark is accepted or limited registration documents are required. Gray continued, “Launching AltrazealÃ‚® in China is a high priority as it is projected that the Chinese market, which is currently approximately $25 billion, will grow to $85 billion by 2013. Given the outstanding clinical data in diabetic foot ulcers and venous ulcers that has recently been presented, this positions us to gain an important share of the rapidly expanding wound segment. This expansion in wound incidence is being driven by diabetes and aging. Expanding our international presence is important as the advanced wound care segment of the global wound care market is $6.5 billion.”
Additionally, plans are being developed for the launch of AltrazealÃ‚® into the veterinary market. Gray added, “This is a very exciting time in the development of the company. We are rapidly moving forward on numerous fronts to commercialize our product lines as quickly as possible in international markets. Securing the CE Mark has given us a very positive shift in commercial momentum as this enables AltrazealÃ‚® to be launched in many global markets.”
We continue to work to expand our international licensing and distribution network for our entire product range. Activity in this area has accelerated due to the positive clinical data that has been generated and the CE Mark approval. In addition, ways to significantly increase our sales and marketing presence in the United States are being evaluated.
About ULURU Inc.:
ULURU Inc. is a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products to provide patients and consumers improved clinical outcomes through controlled delivery utilizing its innovative Nanoflex(TM) Aggregate technology and OraDisc(TM) delivery system. For further information about ULURU Inc., please visit our website at www.uluruinc.com. For further information about AltrazealÃ‚®, please visit www.Altrazeal.com.
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 clinical benefits of Aphthasol Ã‚®and AltrazealÃ‚®, the projected revenue, the proposed product launches, the regulatory filings for OraDisc(TM) A and AltrazealÃ‚® and projected market sizes. 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-K for the year ended December 31, 2009, and other reports filed by us with the Securities and Exchange Commission.
Contact: Company ---------------- Kerry P. Gray President & CEO Terry K. Wallberg Vice President & CFO (214) 905-5145
SOURCE ULURU Inc.