Oral Insulin Is Still Very Much Alive at Some New York and Boston Area Biotechs

Xconomy New York — 

Earlier this week, I wrote about MonoSolRx, a New Jersey company that hopes to start human trials later this year of an insulin product that’s packaged in an edible film. The film can be stuck to the side of the cheek, where it dissolves and distributes a dosage of insulin—the drug that most patients with diabetes currently take as an injection several times a day.

Insulin without painful needle sticks has long been the holy grail of the pharmaceutical industry. Companies all over the world, from the United States to Israel, have tried to package the protein in pills or as an inhalable drug—mostly to no avail. Pfizer’s (NYSE: PFE) inhaled insulin, Exubera, made it to market but failed to catch on, leading the New York company to abandon it in 2007. More recently, Valencia, CA-based MannKind (NASDAQ: MNKD) got a dreaded “complete response” letter from the FDA on its inhaled insulin, meaning the company will have to conduct more trials to get the product approved.

It’s somewhat surprising to me that the dream to develop alternatives to injected insulin is still alive. But it is, and I found a few examples of startups in the Boston and New York areas that are toiling away at inhaled and oral insulin.

Here’s a brief rundown of who those companies are, and the latest news on their efforts.

MonoSolRx: This Warren, NJ, company makes a drug-infused film that melts in your mouth. In January, it announced that a film version of insulin performed well in a monkey study. The company didn’t provide many details, saying in a statement that the film delivered “an active therapeutic dose” of insulin and that it did the same in an earlier trial in pigs. The company is planning to start human trials in Switzerland later this year.

Emisphere Technologies: In December 2010, Cedar Knolls, NJ-based Emisphere announced an exclusive licensing deal with Danish drug giant Novo Nordisk to develop oral insulin. Many attempts to make an insulin pill have failed because the protein is quickly degraded by stomach acid. Emisphere’s technology is designed to facilitate the transport of proteins and other ingredients across membranes, such as those found in the gastrointestinal tract. The companies haven’t predicted how long it will take them to develop a viable product, but if it works, it could be worth as much as $57.5 million to Emisphere.

Entrega: This company, which was formed by Boston-based Enlight Biosciences in January, is working on oral versions of several biologic drugs, including insulin. The startup has remained largely under wraps, but what we do know is that famed MIT inventor Robert Langer is on its advisory board, as are executives from Genentech and Johnson & Johnson.

Alkermes: OK, so this isn’t quite an example of an oral-insulin project that’s still alive, but it’s worth noting anyway. Waltham, MA-based Alkermes (NASDAQ: ALKS) once had a pact with Eli Lilly to develop inhaled insulin, but that project died in 2008, when Lilly decided to shelve it. Then, in January of this year, Alkermes spinoff Civitas Therapeutics secured $20 million in funding to resurrect Alkermes’s technology for inhaled drugs. But Civitas isn’t going near the insulin market: Instead it’s investigating the technology for use in Parkinson’s disease.

Is Civitas smart to forget about inhaled insulin? Or is non-injected insulin still a dream worth pursuing?

And have I missed any companies that are working on insulin alternatives? I’d like to hear your answers to those questions.

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3 responses to “Oral Insulin Is Still Very Much Alive at Some New York and Boston Area Biotechs”

  1. Richard says:

    It would seem to me that if a drug product like Nitroglycerin, which can be placed underneath the tongue, and can be absorbed almost instantly that dilates the blood vessels to help blood flow, it would seem logical to have an insulin product that would allow different grades of potency in accordance with the patients needs, help administer the proper dosage after every meal or as needed by the patient. The only risk or problem would be weakening of the tongue muscle with prolonged use, as is seen in regular injected insulin.

  2. mny says:

    There’s an Israeli Biotech Start-up called Oramed Pharmaceuticals that has had a lot of recent success with their oral insulin capsule.

    They’re planning on starting Phase II clinical trials in the beginning of 2012.

  3. Jim Thompson says:

    This will take off like Viagra did, only this under tongue film will become much more popular due to the boomers. Someone please move this into mainstream trials….quicker.