TORONTO, June 9 /PRNewswire-FirstCall/ -- Generex Biotechnology Corporation , a leader in the area of buccal drug delivery, announced today that an independent audit of the Company's Oral-lyn(TM) manufacturing and testing facility in Toronto, Canada has been completed. Generex commissioned Penn Pharmaceutical Services Ltd. of the United Kingdom to undertake the audit of the facility. The purpose of the audit was to assess the facility's compliance with (a) European Union Directive 2001/20/EC relating to the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use, and (b) European Union Directive 2003/94/EC relating to the principles and guidelines of Good Manufacturing Practice in respect of medicinal products for human use. Generex commissioned the audit in anticipation of the Company's application to the Medicines and Healthcare products Regulatory Agency (MHRA) in London for a Clinical Trial Authorization for Phase III trials of Oral-lyn(TM) in Europe.
Penn was granted unrestricted access to the facility and the Company's personnel to assess the quality systems and operational facilities of the Company and equivalence of GMP standard to those required under the EU directives. Penn also undertook a preliminary review of the draft Oral- lyn(TM) Investigational Medicinal Product Dossier.
While the Penn report, as expected, made several beneficial observations and recommendations in respect of compliance and readiness to support clinical manufacture, the report concluded that "Generex has suitable manufacturing and testing facilities to support the GMP manufacture of [Oral-lyn(TM)]." The auditor noted that the Generex personnel "were clearly committed to work in a compliant, high quality manner" and that "Generex will build a fully functional and cohesive quality management system around what is an excellent and very low risk design of manufacturing facility."
"We are pleased to have received such a positive audit report from Penn Pharmaceutical Services," said Rose Perri, the Company's Chief Operating Officer. "We can now proceed to prosecute our application for European Clinical Trial Authorization for Phase III trials with comfort and confidence."
Penn Pharmaceutical Services is a leading UK-based provider of fully integrated and cost-effective pharmaceutical out-sourcing services (including formulation and analytical development services, clinical trial manufacturing, packaging and supply management, contract manufacture, Chemistry Manufacturing and Controls consultancy, and Qualified Person release services) to the international healthcare industry, providing flexible pharmaceutical solutions enabling its customers to accelerate their route to market quickly, safely and cost-efficiently.
Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Oral- lyn(TM)), is in late stage clinical trials around the world.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward- looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward- looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
Generex Biotechnology Corporation