| JERUSALEM, April 11
JERUSALEM, April 11 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 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
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
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
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.