Bangalore, Nov 14, 2008: India’s Shreya Life Sciences has launched world’s first recombinant DNA human insulin buccal spray under the brand name of ‘Oral- Recosulin.’

 

The Ultra Rapid Prandial Glucose Regulator is a buccal insulin spray used to treat Type I-II diabetes that is based on the technology developed by the company's US collaborator Generex Biotechnology.

 

Through its breakthrough “RapidMist” technology in insulin delivery, Oral Recosulin provides freedom from limitations of conventional insulin devices. The new technology delivers insulin through Buccal Mucosa directly to the Vascular System.

 

Shreya Life Sciences has revenues of about $85 million in India and will be the marketing and distributing partner of the product. While the RapidMist technology used in the spray is developed by Generex, Shreya Life Sciences will be supplying the raw material (crystals) to Generex, which has spent close to $220 million for this technology.

 

“Earlier in the past, some of the Big Pharma companies like Pfizer, El Lilly tried to bring out a similar product but the projects fizzled out primarily because the insulin was directed to the lungs rather than the vascular system leading to drastic side effects,” said a person close to the company who did not want to named.

 

It is observed that needle phobia is a primary reason, which at times prevents the patient

from taking insulin therapy although required. Oral-Recosulin is an alternative available for those diabetics who have an acute injection phobia.

 

“We feel that 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.

 

So far, Shreya has introduced products like Recombinant Human Insulin (Recosulin, vial, cartridges and pen) Oral Antidiabetics (Glycifit – Metformin), and Diabetes Specific Nutrient(DSN).

 

Surprisingly, the product is yet to be launched in countries like the US and UK, where typically it would have been first launched. Says Anna E Gluskin, Chair, President, CEO, Generex Biotechnology, “The drug Generex Oral Iyn has been first approved in India and Ecuador. We are looking at emerging markets as high growth areas and hence we have registered in South America, the Middle East, Asia and North Africa. There are  altogether six applications which have  been filed. We are expecting to receive the approvals within 6-8 months.” The company has been granted access for special programmes in the UK, US and Canada.  Says Bill Abajian, Senior Executive Advisor, Global Strategic Alliances and Business Development, Generex Biotechnology, “The US FDA has become extremely strict and above all India is the diabetes capital of the world. So we preferred to have the launch here first rather than a global launch.” At present, WHO has estimated that there are 40 million people who suffer from Diabetes in India and by 2025 the number will increase to 72 million.

 

Said Sujit Kumar Singh, Chairman and Managing Director, Shreya Life Sciences, “The product is to be launched within the next two weeks in India and we have been given the exclusive marketing and distribution rights in India and the subcontinent. Within the next six months we intend to have a market share of 10 per cent for this product.” Considering that it a new and high –end technology, the company maintained that initially the product will be priced on the higher side. “Any technology which is new and high-end will have a high price attached to it. The Government is yet to decide on the price but most probably it will be priced at Rs 2000-Rs 2,200 per pack. Later, we might go for cost effective measures and reduce the cost,” Shelat said.

 

Shreya will also be launching its third generation Hepatitis –B vaccine somewhere in January or February 2009. The vaccine will be made out of mammalian cells. “This is a different from other hepatitis-b vaccines in the sense that it will be 10 times more powerful, can be administered only in two doses (where other vaccines has to be given in three-four doses) and can also be given post exposure,” said Dr Arvind M Jha, Sr GM and Head, Medical Services. At the moment it is been tested in the Government’ testing lab in Kasauli, Himachal Pradesh.