Company Watch

Generex gets ok to sell its insulin spray

Our News Bureau - Mumbai

Generex Biotechnology has announced that Generex Oral-lyn, its proprietary oral insulin spray product, has been approved for importation and commercial marketing and sale in India for the treatment of diabetes by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India. CDSCO is responsible for authorising marketing approval of all new pharmaceutical products in India. Generex Oral-lyn becomes the first non-injectable buccalinsulin approved in India. It is delivered via the company's proprietary RapidMist device into the mouth. Unlike inhaled insulin products, buccally absorbed Generex Oral-lyn does not reach the lungs.

In connection with the approval, Generex has entered into a product licensing and distribution agreement with Shreya Life Sciences. Shreya is the fourth largest distributor of insulin in the Indian insulin product market with a compound annual growth rate of 38 percent. Shreya has interests in both pharmaceutical and biopharmaceutical products in key therapeutic segments including cardiology, neuropathy, and diabetes. The company has business operations in India, Russia, the Commonwealth of Independent States, and African countries. The parties are making arrangements for the expansion of extant production facilities to meet the anticipated demand for the product in India and other jurisdictions where governmental approvals are pending.

Generex believes that early intervention with insulin therapy could delay the onset and progression of diabetes and its numerous complications. Generex Oral-lyn, as a convenient and pain-free alternative to insulin injections, could encourage prandial insulin therapy among those patients who presently avoid injections.

"This approval in a market with one of the largest numbers of patients with diabetes comes after the Indian health regulatory agency conducted a rigorous review of clinical data demonstrating the safety and efficacy of Generex Oral-lyn," said Anna Gluskin, President and Chief Executive Officer, Generex.

"This represents the first major jurisdiction to provide approval and offers the prospect of a new treatment paradigm for diabetes and pre-diabetic conditions. We look forward to working with Shreya to offer a safe, simple, fast, flexible, familiar, convenient, and pain-free alternative to prandial insulin injections," she added.

Generex's in-house regulatory department along with Nectid Clinical Services, a Princeton, New Jersey based contract research company that provides clinical and regulatory consultation services in respect of the Indian market, spearheaded the regulatory effort. Indian approval was granted after a long and intensive review of the Generex Oral-lyn dossier by the Drugs Controller General (India) office. Indian government approved Generex Oral-lyn only after Generex submitted satisfactory responses to a series of regulatory interrogatories. As a result of this approval, Generex and Shreya are making preparations for the commercial launch of Generex Oral-lyn in the country in early 2008. Preparations include manufacturing scale-up, marketing plans, and post-approval clinical studies.