Nasulin: Injection-less insulin on anvil |
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| March 05, 2007 Publication : Vijay Times |
| Drug Controller general of India's approval for phase II clinical evaluation of Nasulin among Type 2 diabetes patients is a big thumbs up for Biocon apart from providing a great relief for diabetic patients in terms of controlling the progression of the diseases as well as curtailing cost of treatment. According to Biocon sources, the DGCI approval has been given to Biocon's licensing partner Bentley Pharmaceuticals Inc of the USA. The approval follows completion of Bentley's pharmacokinetic clinical studies of Nasulin in India. The Phase II study will be initiated in March by Clinigene, a CAP accredited CRO and wholly-owned subsidiary of Biocon. The study is expected to be completed by the end of the year. Nasulin is Bentley's intranasal insulin product utilizing its proprietary delivery technology CPE-215. As per the licensing agreement, Biocon is responsible for developing and marketing Nasulin in India. Biocon provides the source of Nasulin powder, while Cardinal Health will manufacture clinical supplies for the phase II study under contract with Bentley. Biocon CMD Kiran Mazumdar-Shaw explained to Y Maheshwara Reddy of Vijay Times about the benefits of the DGCI approval for the common man and the industry. "Patients can look forward to larger doses of insulin intake without fear of injections," she stated. Excerpts What is your reaction to the approval from DCGI? This is an important approval that allows us to move to the next level of development. Nasulin is a partnered product with US based Bentley Pharmaceuticals. This approval will allow Biocon to undertake parallel studies in India and the USA. How would it benefit Biocon? The product has been developed using Biocon's Insulin. Success means that Biocon will benefit both from Insulin supplies as well as marketing opportunities in India and several world markets. Nasulin has the potential of being a multi-billion Dollar drug. How will Nasulin benefit diabetic patients in the country ? Any form of Insulin that needn't be injected will have better patient acceptance. It will thereby provide better compliance and better diabetes control. Diabetes is a huge disease in India. India in fact is the world's Diabetic capital. Indian diabetic patients can certainly benefit from such new Insulin therapies. What are the advantages for the use compared to insulin injections? Better compliance and hence better diabetes control What will the cost of benefit be for a patient? Better diabetes control will mean better control on progression of the disease. In fact, it is the progression of the disease that makes it expensive to control. Uncontrolled diabetes can lead to cardiac, renal, retinal and neural complications which are costly to treat. |
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