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Generex Biotechnology
Completes Acquisition of Custom-Made, Fully-Automated Equipment for Commercial
Oral-lyn(TM) Production
TORONTO, Aug. 4 -- Generex Biotechnology Corporation (Nasdaq: GNBT), a leader in the area of buccal drug delivery, today announced that it has completed the acquisition of the custom-made, fully-automated equipment necessary to facilitate its initial commercial production of Oral-lyn(TM), the Company's proprietary oral insulin spray product, which is delivered into the human mouth by way of the Company's proprietary RapidMist(TM) drug delivery system.
Oral-lyn(TM) 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. The Company, together with its South American joint venture partner PharmaBrand, S.A. (www.pharmabrand.com.ec), is making preparations for the launch of commercial sales.
The equipment will allow Generex to produce up to 750,000 proprietary valves for its RapidMist(TM) device annually. The equipment, which includes molds and stamping tools, has been acquired from Valois of France (www.valois.com), a leader in the design and manufacture of spray and delivery systems. The consequent economies of scale will result in a significant decrease in the Company's cost-of-goods.
The equipment includes: - 4 molds (upper & lower stem, chamber, body) - 3 gasket stamping tools (1st, 2nd, neck gaskets) - ferrule stamping tool - metal stem tool - assembly line The acquisition of this equipment will augment the Company's ability to service the demand for Oral-lyn(TM) following the launch of commercial sales in Ecuador later this year. Based on the Company's current pricing model and its current estimates of prospective market share, Generex anticipates that this equipment will produce approximately $3 million in gross revenue over the 18 months following product launch. The Company and PharmaBrand are also preparing to file materials for the approval Oral-lyn(TM) by the other Andean Community countries and this equipment acquisition will allow Generex to service commercial sales in those markets as well.
This scale-up of production components signifies the first steps towards the establishment of a new industry: the production of aerosolized proteins.
About Generex
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)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.
For more information, visit the Generex Web site at www.generex.com.
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.
SOURCE Generex
TORONTO, Aug. 4 -- Generex Biotechnology Corporation (Nasdaq: GNBT), a leader in the area of buccal drug delivery, today announced that it has completed the acquisition of the custom-made, fully-automated equipment necessary to facilitate its initial commercial production of Oral-lyn(TM), the Company's proprietary oral insulin spray product, which is delivered into the human mouth by way of the Company's proprietary RapidMist(TM) drug delivery system.
Oral-lyn(TM) 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. The Company, together with its South American joint venture partner PharmaBrand, S.A. (www.pharmabrand.com.ec), is making preparations for the launch of commercial sales.
The equipment will allow Generex to produce up to 750,000 proprietary valves for its RapidMist(TM) device annually. The equipment, which includes molds and stamping tools, has been acquired from Valois of France (www.valois.com), a leader in the design and manufacture of spray and delivery systems. The consequent economies of scale will result in a significant decrease in the Company's cost-of-goods.
The equipment includes: - 4 molds (upper & lower stem, chamber, body) - 3 gasket stamping tools (1st, 2nd, neck gaskets) - ferrule stamping tool - metal stem tool - assembly line The acquisition of this equipment will augment the Company's ability to service the demand for Oral-lyn(TM) following the launch of commercial sales in Ecuador later this year. Based on the Company's current pricing model and its current estimates of prospective market share, Generex anticipates that this equipment will produce approximately $3 million in gross revenue over the 18 months following product launch. The Company and PharmaBrand are also preparing to file materials for the approval Oral-lyn(TM) by the other Andean Community countries and this equipment acquisition will allow Generex to service commercial sales in those markets as well.
This scale-up of production components signifies the first steps towards the establishment of a new industry: the production of aerosolized proteins.
About Generex
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)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.
For more information, visit the Generex Web site at www.generex.com.
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.
SOURCE Generex
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