The Accordion Pill technology will enable Intec to be a conduit for major slow release drugs that can be administered once daily cutting out the need for someone to take as many as five pills a day.Most people have heard of and been amazed by Given Imaging’s camera-in-a-capsule – the groundbreaking Israeli technology that has redefined gastrointestinal diagnosis and benefited tens of thousands of patients worldwide.

Well, it must be an Israeli thing, because now Jerusalem-based startup Intec Pharma has come up with its own equally innovative ‘in-the-capsule’ technology which could likely create the next big splash in the Pharma industry – the Accordion Pill.

An oral drug delivery system, the Accordion Pill may look like an ordinary-sized capsule, but once inside the stomach it unfolds like an accordion and positions itself as a controlled-release platform. This unique technology will enable Intec to be a conduit for major slow release drugs that can be administered once daily cutting out the need for someone to take as many as five pills a day.

Our bodies naturally have a hard time absorbing certain medication into the bloodstream. In some instances a drug dosing may be too sudden – and too much active ingredient enters the narrow absorption window; in other cases, an insufficient amount of drug is absorbed and the active ingredients get quickly flushed outside the body.

The Accordion Pill ultimately solves this problem by retaining the pharmaceutical ingredients in the stomach for as long as 24 hours, compared to a maximum stomach residency of three hours in a regular formulation. It can also be designed to release the ingredients at desired intervals according to a drug developer?s demands. Within a day the small accordion structure biodegrades and passes through the system.

The Accordion Pill targets drugs that need to be absorbed by the bloodstream in a limited area of the upper small intestine known as the ‘narrow absorption window’, a physical area of the lower stomach and the upper part of the small intestine. Drugs that could benefit from Intec’s technology are used for treating a wide variety of conditions such as Parkinson’s, Alzheimer’s, hypertension, AIDS, obesity and for pain relief.

The potential market for the Accordion Pill is so large that Intec succeeded in wooing CEO Efi Cohen-Arazi – a vice president of Amgen, the largest biotech company in the world – to its small offices in the hills of Jerusalem.

After just a few months on board, he was able to be part of Intec’s latest milestone – last month’s successful completion of Phase I clinical trials for a drug platform. The Accordion Pill will pass through further clinical trials depending on what company co-develops active compounds with them.

The study, conducted at the Sheba Medical Center in Ramat Gan, demonstrated that the Accordion Pill could double the amount of Riboflavin retained in the body.

The study was based on cross-over data from thirteen healthy volunteers who received alternate 75 mg. doses of Accordion Pill Riboflavin and regular immediate release Riboflavin following a low calorie meal (280 calories).

The study results showed that the Riboflavin Accordion Pill was retained in the stomach and continued to release Riboflavin to its absorption sites for significantly longer periods of time than regular Riboflavin. The stomach retention time for Accordion Pill Riboflavin was more than 6 hours compared to less than 2 hours with regular Riboflavin; the absorption time for Accordion Pill Riboflavin was 8 hours compared to 3 hours for regular Riboflavin. As a result, the total amount of Riboflavin absorbed by the body was 100 percent greater when the Accordion Pill was used than when it was not.

The study results were presented last month by Prof. Amnon Hoffman of the Hebrew University at the 32nd annual meeting of the Controlled Release Society in Miami, Florida. Hoffman together with Prof. Michael Friedman is co-developer of the Accordion Pill and a member of the Intec Pharma Scientific Advisory Board.

Besides working with drug developers on making new drugs more potent, or effective, Intec hopes to enter into what is known as the super-generic drug market. The goal here is to give one generic drug manufacturer a strong competitive edge over all others by substantially improving the drug’s absorption capability.

Intec is currently negotiating with several large US pharmaceutical companies and plans to soon begin working on several compounds.

No doubt having a former Amgen VP at the company’s helm will certainly help Intec company commercialize its technology as Cohen-Arazi is well-versed in international pharmaceutical culture and is already on a first name basis with heads from companies like Pfizer and Johnson & Johnson.

Over the last ten years, Cohen-Arazi made a meteoric rise in the drug industry. He started out working with InterPharm in Israel where he played a key role in developing beta-interferon (today the main drug used for the treatment of Multiple Sclerosis) from where he advanced to an executive position at the headquarters of Interpharm’s owner, Switzerland’s Serono.

He then obtained a leading position at Immunex and when the company merged with Amgen, he found himself as a VP at the world’s largest biotech company. There, he managed a $400 million budget and helped orchestrate a company of 15 000 employees.

One of Cohen-Arazi’s most fulfilling achievements at Amgen was developing what he calls the miracle drug, Enbrel, which gives a new lease on life to rheumatoid arthritis sufferers.

“I managed Enbrel’s development for the last five years and was enriched and rewarded by patients and families who told us on how drugs like Enbrel changed their lives,” Cohen-Arazi told ISRAEL21c. “I am always thrilled that I can do something good for humanity and get paid for it at the same time.”

Over the last three years, Cohen-Arazi has been following the fruits of Israeli biotech investments made in the late nineties. By last year already he was eager to help jumpstart a biotech company back in Israel.

“The year 2004 marked a completely new trajectory for Israel’s biopharma industry,” says Cohen-Arazi, “I was looking for opportunities in Israel because I wanted the challenge to learn and grow with a company from scratch.”

Although it is may be easier to grow in a big company like Amgen that has experts on hand in every field, Cohen-Arazi was looking for a new kind of challenge – one where his efforts wouldn’t feel diluted. Cohen-Arazi wanted the feeling of creating something completely unique, and Israel is where he knew he could do that.

Today Intec predicts its business will develop in two ways. First, the company will sign licensing agreements with large pharmaceutical companies and accept upfront payments as well as royalties from co-developments. Second, the company has identified and is developing certain target molecules which will be commercialized through a strategic partner.

Cohen-Arazi is downright excited to see what the future will bring at his new position at Intec. During those moments when he gets feedback from drug developers and potential investors from Israel and the US, he begins to understand that the Accordion Pill may be the biggest development he’s ever been involved in.