India’s biotherapeutics leader Biocon Ltd is seeking approval from US FDA to conduct clinical trials for its oral insulin product code-named IN 105, reports said.
Biocon has filed an investigational new drug application (IND) with the U.S. Food and Drug Administration in December, reports said quoting Chairman and Managing Director Kiran Mazumdar-Shaw.
Biocon’s oral insulin is a conjugated peptide molecule in tablet formulation which is metabolically equivalent to human insulin.
Biocon has conducted 4 Phase 1 studies with oral insulin IN 105. A Phase 2 study using IN 105 has shown that the oral insulin pill’s absorption in the body is proportional to the dose administered.
Biocon’s oral insulin IN 105 is currently undergoing Phase 3 clinical studies in India. The six-month placebo controlled double-blind study is evaluating the efficacy of oral insulin as an add-on therapy in type 2 diabetes patients.
Oral isulin IN 105 is being studied as monotherapy as well as in combination with metphormin, sufonylurea, PPAR agonists, DPP4i etc and pre-meal insulin in combination with basal insulin.
Biocon is planning to begin commercial production of oral insulin pill in 2010 or early 2011, stated Biocon’s managing director Kiran Mazumdar- Shaw, in a recentinterview given to a leading newswire.
Insulin pill, IN-105, in which is in the final phase 3 stage of patient studies. All new drugs require three phases of human studies including study in real-time patients to prove the safety and efficacy of the drug to get marketing approval from regulatory agencies.
Insulin pill IN-105, if comes out successful in patient studies, will have huge potential with a certainty to become a multibillion dollar blockbuster.
“This is a product that we see to be a game-changer. It has huge potential and certainly can be a multibillion dollar blockbuster,” stated Mazumdar-Shaw, adding that she is “confident” of the outcome despite mounting skepticism about whether orally formulated insulin hormone would really do the job.
Insulin pills which could actually save millions of diabetics around the world from the wexing daily pricks have been one of the hot pursuits of drugmakers across the globe.
Efforts to produce needle-free delivery of insulin has come to a naught, so far. Exubera, an inhaled insulin product from world’s top drug maker Pfizer Inc was withdrawn in 2007 after it failed in the market.
Biocon presented the phase IIa trial data of its insulin pill IN 105 at the European Association for the Study of Diabetes meeting in Rome in Sept last year, suggesting that for the first time, oral insulin has shown good dose linearity – the effect of the drug is proportional to the units consumed.
Insulin pill IN-105 studies conducted in India showed a near-perfect linear dose response. IN-105 has also shown a significant two-hour post-prandial glucose drop indicating that the insulin pill has potential in demonstrating efficacy in longer-term trials.
Insulin pill IN105 is formulated as a tablet using a proprietary polymer technology, acquired by Biocon from US firm Nobex Corp. Nobex, whose IP assets were later bought by Biocon when it filed for bankruptcy in 2005, technology platform allows modification in the insulin structure so as to enable it suitable for oral delivery.
Insulin pill IN-105 also ensures better patient compliance, because it is not an injection. Further, injectable insulin has a tendency to get deposited under the skin leading to weight gain, oral insulin, gets around this dangerous problem through being either weight-neutral, or weight loss.
Insulin pill IN-105 is rapid acting and so it can cut down the problem of hypoglycemia, a common complication with injectable insulin.
Except from Biocon, no other insulin in oral form is currently in final stages of commercialization. Oralyn, an insulin spray to be delivered under tongue (buccal) developed by the Toronto, Canada-based Generex Biotechnology Corp is probably the only other product being marketed in some parts of the world including India by Shreya Life Sciences Pvt. Ltd, Mumbai.
Biocon expects to report the results of phase-3 studies in the first quarter of next year.
Global insulin market is expected to grow 15 percent annually through 2010, predicts New York-based MarketResearch.com.
Nearly 246 million people are suffering from diabetes worldwide, according to the International Diabetes Federation. India has the highest number of diabetes patients in the world- nearly 41 million sufferers, followed by China and the U.S.
Biocon sells injectable insulin in India. Biocon targets a 50% share of the domestic insulin market to from the current 15% in five years, Mazumdar-Shaw said.