Generex Biotechnology Establishes Presence in Europe and the Middle East
Generex Biotechnology Corporation announced the establishment of satellite offices in Europe and the Middle East. In anticipation of the 2005 submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in London of an Oral-lynT protocol for the commencement of Phase III clinical trials in Europe, Generex has established a satellite office in the United Kingdom from which the Company's European clinical and regulatory development program will be administered. The Company anticipates that its MHRA application for Oral-lynT Phase III approval will be the cornerstone of its European registration program.
The UK office will be headed by Dr. Munaf Ali, BSc, MSc, PhD, as the Company's Vice-President of Clinical & Regulatory Affairs. Dr. Ali has more than a decade of experience in regulatory affairs and drug development. From 1996 to 1999, Dr. Ali was a principle scientific reviewer at MHRA, including membership in the European Biotech Working Party and CPMP representative for the UK at the European Medicines Evaluation Agency (EMEA). From 1999 to 2003, Dr. Ali was Vice-President of International Regulatory Affairs & Pharmacovigilance and then Global Vice-President of Regulatory Affairs & Pharmacovigilance at Ingenix, Inc., a healthcare information and research company providing a comprehensive line of clinical and cost management solutions, where Dr. Ali provided scientific and regulatory strategic advice for the conduct of clinical trials across many therapeutic areas in 46 different countries. Dr. Ali has been President of Munaf Ali Consultancy Ltd. since 2003.
In addition, Generex, with the assistance of local consultants, is aggressively sourcing and evaluating prospective Oral-lynT licensing opportunities in the Middle East in respect of which the Company is expecting to receive significant nonrefundable, upfront license fees. In order to more effectively and efficiently facilitate the establishment of such arrangements and the consequent product registration initiatives, Generex has established a satellite office in Beirut, Lebanon.
Generex anticipates that, with the assistance of its local consultants, the Beirut office will act as a bridge for the introduction of Oral-lynT and other new and innovative medical and pharmaceutical technologies and products to the Middle East, a region often overlooked by multinational pharmaceutical concerns. More than 12 million people in the Middle East suffer from diabetes and its complications.
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