The patented large dose metering valve developed by Valois will be used in the inhaler device for the delivery of Generex' Oral-Lyn (liquid human insulin), an oral insulin spray for the treatment of diabetes.
The valve will be included within the existing drug master file for DF10 class valves, and was developed in partnership with metal component specialists, Presspart.
Generex' Oral-Lyn product is a liquid formulation of human insulin which is absorbed into the body via the lining of the inner mouth, the buccal mucosa, through use of the company's proprietary RapidMist inhalation device. The RapidMist product delivers drug directly to the oral cavity, with no deposition in the lungs.
The buccal mucosa allows for much faster absorption of insulin with a shorter activity period, making it particularly suitable for prandial insulin (delivered prior to meals) as it poses little risk of causing hypoglycaemia, according to the company.
The Generex technology offers a needle-free, painless alternative for those suffering from diabetes whose standard method of treatment is via injection. It also represents another avenue for delivery of insulin treatment in an industry that has been feverishly investing in other forms of inhalable insulin.
"Oral-Lyn is expected to lead to an enormous improvement in the quality of life, with the elimination of pain and a significant increase in convenience," say Generex of their alternative therapy.
"This will result in improved compliance with a relative decrease in complications and a significant reduction in the enormous costs associated with treating them."
Generex' Oral-Lyn product is currently on sale in Ecuador for the treatment of Type-I and Type-II diabetes, and is in various stages of clinical trials around the world with a Phase III study in the US currently being prepared.
Pfizer launched its inhaled insulin drug product, Exubera, in July last year for Type-II diabetes in the US, with estimates of market potential for the therapy as high as $1.5bn (€1.3bn) a year. However, analysts have commented on the slow increase in sales of the new drug in its first six months or so, and Pfizer is initiating an aggressive marketing campaign for the product directed at primary healthcare professionals and consumers later this year.