Generex has registered a new patent in the US that covers broad claims for the delivery of macromolecules via the buccal cavity of the mouth, further safeguarding its RapidMist drug delivery technology which it uses to spray insulin into the mouth.
Entitled "Methods of Administering and Enhancing Absorption of Pharmaceutical Agents," the patent relates to the company's methodologies for the production of oral formulations for the delivery of macromolecular pharmaceutical agents into the human body via the buccal region of the mouth.
The small Canadian drug delivery firm recently stole a march on the pharma giants by launching the world's first non-injectable insulin in Ecuador last December in the form of an oral spray, so this patent may play an important role in protecting Generex' intellectual property when it eventually launches the product in the US.
Indeed, patents are becoming crucial in fending off competition in the highly competitive insulin delivery market, as demonstrated by the current legal dispute between Novo Nordisk and Pfizer sparked by the latter's inhaled insulin device Exubera, despite the patents in question having nothing to do with how the device is designed or produced.
In the case of RapidMist however, the new patent pertains to the making of the oral formulation that allows the absorption of a drug by the buccal cavity of the mouth.
"This important new patent will augment the protection of our proprietary RapidMist drug delivery technologies and, by extension, our flagship product, Generex Oral-lyn, an oral insulin spray product for the treatment of diabetes," said Rose Perri, Generex Chief Operating Officer
"In addition to insulin, this gives us broad intellectual property protection for the delivery of other agents via the buccal region of the mouth."
The process involves the creation of a stable mixed micellar solution containing the pharmaceutical agent, absorption enhancers, and other excipients.
When the solution is introduced to the buccal mucosa, the result is increased bioavailability of the active drug and more rapid onset of action.
As a technology, RapidMist is comprised of the oral formulation, which is aerosolised with a pharmaceutical grade chemical propellant, and a small, lightweight, hand-held, easy-to-use aerosol applicator comprised of a container.
Using the device, the patient self-administers the formulation by spraying it into the mouth without the medication reaching the lungs.
Oral-lyn, which utilizes RapidMist technology, can be used as a preventative pharmacologic agent by people with pre-diabetes to delay the onset of diabetes and by patients with type-2 diabetes to delay the onset of insulin dependence and the complications associated with diabetes.
To push Oral-lyn in the US and Europe, Generex is planning to start clinical trials involving thousands of patients in Canada, Israel, Italy and the UK by the end of August and Cardinal Health is now ramping up production of Oral-lyn to meet this deadline, Mark Fletcher, executive vice president of Generex told Outsourcing-Pharma.com in June.
Furthermore, the two firms that manufacture the drug delivery device, French firm Valois, who makes the rubber valves, and UK firm Pressport, who makes the metal canisters, have also ramped up production and business will continue to grow for these two firms if Generex achieves worldwide acceptance, particularly Valois.
All in all, Generex holds 77 patents worldwide and has an aggregate of 50 patent applications pending in various jurisdictions.