The Mumbai-based Shreya Life Sciences Pvt Ltd, in collaboration with the US-based Generex Biotechnology Corporation, has announced launch of world's first buccal insulin spray under the brand name of Oral-Recosulin in India.
The recombinant DNA human buccal insulin spray for the treatment of type-1 and type-2 diabetes, which has been developed through a technology from Generex Biotechnology, is currently waiting for price fixation with the central government. The product, which is expected to cost around Rs 2200 per pack, will hit the domestic market within two weeks, informed Sujit Kumar Singh, chairman and managing director, Shreya Life Sciences.
The Oral-Recosulin is an ultra rapid prandial glucose regulator, which will reach the onset of action within five to 10 minutes of intake and will last for duration of 120 to 150 minutes. The product is developed with the RapidMist technology of Generex in insulin delivery, which will be marketed by the US-based company under the brand name Oral-lyn.
Under the agreement, the insulin crystals will be supplied by Shreya Life Sciences whereas the buccal device will be delivered from Generex Biotechnology Corporation. The company is expected to grab the 10 per cent of the total Rs 517.9 crore-human insulin market within the first six months to one year period of Oral Recosulin launch.
"We feel that the Oral-Recosulin is a simple solution for a worldwide problem, as diabetics would prefer buccal delivery of the drug to injections because it offers superior pharmacodynamic profile besides being pain free," said Ram Shelat, director, domestic business, Shreya Life Sciences.
Oral-lyn, the product from Generex is currently in the third phase of global clinical trials and has received approval in India and Ecuador. The Health Canada, the Canadian drug regulatory office, has granted a special access programme for the product and the company is negotiating with the US government for a similar special access approval, informed Anna Gluskin, chair, president and chief executive officer, Generex Biotechnology Corporation.
"We are concentrating on the Asian market for our operation as it the region has a higher of diabetes disease ratio. We are pursuing the markets in Korea and Middle East. We have a special interest in increasing the market presence in India and the partnership with Shreya is successful to accomplish the targets," said Gluskin. ]
The product has a potential to occupy nearly 25 per cent of the diabetes market in India, averred Shelat. He added that the company will initiate meeting more than 1000 diabetes specialist doctors in major cities in the country soon and will conduct a phase 4 clinical trial in India through the doctors soon.
The Indian Diabetic Market is estimated to be around 1722.7 crore with a growth rate of 20.6 per cent as per the ORG IMS. Human Insulin market is Rs 517.9 crore with a growth rate of 23.9 per cent while the oral anti diabetic market is Rs 1204.7 crore and is growing at the rate of 19.2 per cent.
Shreya has entered into diabetes care market as a serious long term partner for medical fraternity. The company has introduced products like recombinant human insulin (Recosulin, vial, cartridges and pen) oral antidiabetics (Glycifit - metformin) and diabetes specific nutrient (DSN).
Generex Biotechnology Corporation is a leader in drug delivery of metabolic diseases through inner lining of the mouth.