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Generex submits oral insulin Phase III trial dossier to Indian government

Canada’s Generex Biotechnology, through its Indian licensee Shreya Life Sciences, has submitted a dossier of recently concluded Phase III trial results of its oral insulin ‘Generex Oral-lyn’ to the Indian government for approval.

The Canadian drug deliver maker said that the approval, if accorded, will allow it to market and distribute the buccal insulin spray product in India as ‘Oral Recosulin’.

Generex president and chief executive officer Mark Fletcher said, "We are pleased to be working with our partner Shreya as Generex moves forward in the reestablishment of its global Generex Oral-lyn™ and diabetes programs."

The recent 12-week trial was conducted in India at 14 sites on about 209 patients with Type II diabetes who are not controlled completely while consuming oral anti-diabetic agents.

In addition to establishing non-inferiority, the outcome of the trial revealed that the patients have tolerated the oral insulin and showed preference towards the product over subcutaneous injection.

The company was advised by Shreya that the approval is expected to come in the summer of 2013.

Shreya also advised that the dossier was submitted to the Drugs Controller General (India) (DCGI), Central Drugs Standard Control Organization, Director General of Health Services, Ministry of Health and Family Welfare, Government of India.

Expressing contentment over the Phase III study results, Shreya CEO Ram Shelat said, "In anticipation of the DCGI’s approval, we have begun working with Generex to facilitate the commercialization of Oral Recosulin™ in India".