April 11, 2013 / 3:01 PM / in 5 years

Oramed applies for oral insulin trial in U.S.

JERUSALEM, April 11 (Reuters) - Oramed said it had applied to the U.S. Food and Drug Administration for approval to conduct a trial of an insulin capsule to treat Type II diabetes, which could slash the current $471 million in global costs for the treatment.

The Israeli company, which develops forms of drugs that can be administered by mouth, late in 2012 applied to the FDA for a Phase II trial of its insulin pill, but the U.S. regulator asked it to perform a sub-study first.

The one-week sub-study is expected to begin in about a month, pending FDA clearance, with the Phase II trial to begin in the third quarter, the company said on Thursday.

An oral version of insulin could make it easier for sufferers to start early treatment, slow progression of the disease and delay the need for needles, the company claims. Unlike injections, the ingested form passes first into the liver, which regulates the secretion of insulin into the bloodstream.

An initial trial “showed from a safety and efficacy side this can be a potential game-changer in the world of diabetes”, Oramed Chief Executive Nadav Kidron said.

The global expense for diabetes is about $471 billion, and an oral version could bring “a drastic reduction” in costs, he said.

The pill would not eliminate the eventual need for injections but it could delay the shift to injections by many years, the company said.

At least 90 percent of the more than 370 million diabetes sufferers worldwide are in the Type II category, and it is growing fast, according to the International Diabetes Foundation. It expects the number of diabetes patients to surpass 550 million by 2030. Diabetes led to nearly 5 million deaths in 2012.

At the end of 2012, Oramed raised about $6 million in private funds and has enough cash to finance a new trial. It began trading on Nasdaq in February.

“We will need to raise more funds down the line,” Kidron said.

As a small company, Oramed does not have marketing channels, and Kidron said it was in talks with “top-tier drug companies” as potential partners, declining to name them.

Oramed is also in the early stages of developing an oral alternative to exenatide, another potent drug for Type II diabetics that is now only available as an injection (Byetta).

The oral version, Oramed said, doesn’t seem to cause the nausea that plagues patients taking the injections. The company also hopes to develop an oral flu vaccine.

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