Biocon sees oral insulin pill rival as Oramed’s ORMD-0801 enters crucial clinical trial phase

India’s biotherapeutics leader Biocon Ltd could see a more competition in the prospestive oral insulin pills market as more such formulation including the latest investigational insulin capsule ORMD-0801 from Oramed Pharmaceuticals Inc entered the crucial phase of clinical studies.

Oramed has announced that the company has completed its patient enrollment in the Phase 2B clinical study of its oral insulin capsule, ORMD-0801.

The last of the thirty Type II diabetes patients was enrolled for a study in which subjects will be administered the insulin-based capsule ORMD-0801 for a period of six weeks.

The randomized, double-blind, placebo-controlled, multi-centered study will evaluate the safety, tolerability, and efficacy of Oramed’s oral insulin ORMD-0801 delivery technology.

ORMD-0801 study is taking place in five locations throughout South Africa.

ORMD-0801 study results are expected by the end of first quarter of 2010.

Based in Jerusalem, Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines presently delivered via injection.

Recently, India’s Biocon has filed an application seeking approval from US FDA to conduct clinical trials for its oral insulin product code-named IN 105 in US.

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 is planning to begin commercial production of oral insulin pill in 2010 or early 2011, stated Mazumdar- Shaw, in a recent interview.

Biocon’s oral insulin is a conjugated peptide molecule in tablet formulation which is metabolically equivalent to human insulin. Insulin pillIN-105 is in the final phase 3 stage of patient studies.

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.

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, 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.

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.

The Danish insulin major Novo Nordisk is another company working on oral insulin pills.

Novo Nordisk has begun the first-in-man studies for its long acting oral diabetic pill NN9924, the company announced.

NN9924 is Glucagon-Like Peptide-1 (GLP-1), a protein which is normally administered into the body through injection.

GLP-1 (Glucagon-Like Peptide-1) is a natural hormone involved in controlling blood sugar levels. It stimulates the release of insulin only when blood sugar levels become too high. In people with type 2 diabetes, GLP-1 secretion is often impaired.

There are many challenges in developing a formulation of GLP-1 for oral use, in particular obtaining adequate bioavailability (absorption of the drug in the body).

NN9924 utilises the Eligen formulation technology from Emisphere to facilitate GLP-1 absorption from the gut.

Novo Nordisk will conduct the trials in the UK, is to investigate the safety, tolerability and bioavailability of NN9924 in healthy volunteers.

Results from the trial, which is planned to enrol about 155 people, are expected to be reported in 2011.

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.