Ecuadorian Ministry of Public Health Gives Company Go-Ahead to Sell Oral-lyn(TM) for Treatment of Diabetes Approval Paves Way for Similar Approvals Throughout South America
TORONTO, May 3 /PRNewswire-FirstCall/ -- Generex Biotechnology Corporation GNBT, a leader in the area of buccal drug delivery, announced today that Oral-lyn(TM), its proprietary oral insulin spray formulation, has been approved for commercial marketing and sale by the Ecuadorian Ministry of Public Health for the treatment of both Type-1 and Type-2 diabetes.
Since the medical miracle of the discovery of insulin by Dr. Frederick Banting and Charles Best in 1921, insulin, a life-saving drug for patients with diabetes, has been delivered solely by injection. Almost a decade of research and development at Generex has culminated in the world's first regulatory approval of an alternative method for insulin delivery, in which Oral-lyn(TM) is delivered via the Company's proprietary RapidMist(TM) device into the human mouth where it is absorbed with no lung deposition. Generex believes that Oral-lyn(TM) offers a safe, simple, convenient, fast and effective alternative to prandial insulin injections.
Generex's South American joint venture partner, PharmaBrand S.A., under the stewardship of Dr. Roberto Cid, spearheaded this regulatory effort. PharmaBrand is making preparations for the commercial launch of Oral-lyn(TM) in Ecuador this year. There are approximately 360,700 adult patients with diabetes in Ecuador (International Diabetes Federation, 2003). In addition, the Company is continuing its efforts to secure the participation of a multi-national pharmaceutical co-marketing partner for the balance of South America.
Generex believes that this approval will pave the way for additional jurisdictional approvals around the world. The Company expects to be in a position to commence Phase III clinical trials of Oral-lyn(TM) in Europe and Canada later this year.
"This milestone event represents the culmination of years of hard work," said Anna Gluskin, Generex's President & Chief Executive Officer. "This approval will mark our transition from a development-stage company to one that will generate revenues from commercial sales. This approval will also enhance our ability to procure additional similar jurisdictional approvals around the world. Oral-lyn(TM) stands ready to improve the quality of life for patients with diabetes through improved comfort and compliance which will also delay the onset of the many complications associated with this incurable disease. We would like to dedicate this achievement to the memory of E. Mark Perri, former Chairman of Generex and a founder and early inspiration of the Company."
Generex acknowledged the continuing support and invaluable contributions of its principal clinicians and their teams: Dr. Jaime Guevara, Professor Paolo Pozzilli, Professor Itamar Raz, Dr. Stuart Ross, Dr. Satish Garg, and Dr. Marko Mihic. The Company also noted the efforts of its laboratory management and technical team, Waseem, Nadeem and Naeem Qazi
This is a major break-through. Fred
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