Drugs that Melt in Your Mouth: MonoSolRx Has Its Sights Set on Oral Insulin

5/11/11Follow @arleneweintraub

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will get ahold of the drug accidentally, since each film is packaged in “highly child-resistant pouches.” The film also cannot be abused by crushing and snorting, as tablets can, and each unit-dose pouch bears a unique 10-digit code that helps doctors make accurate medication counts. [This paragraph has been updated to correct the detail about the film product's market share and clarify the comments from Reckitt Benckiser.]

As excited as Schobel is about his company’s marketed products, he becomes even more animated when he talks about the effort to develop oral insulin. “You and I know how many people have shouted from the highest building that they have the answer to oral insulin, but it’s been an uphill climb,” he says. Indeed, many efforts to develop an insulin pill have faltered because the protein degrades too quickly in the digestive tract. And Pfizer’s inhaled insulin product, Exubera, failed in the wake of safety issues and lagging demand.

Last year, MonoSol Rx formed a joint venture with UK-based Midatech, which developes nanoparticles—tiny synthetic molecules that are designed to carry drugs safely through the body. The two companies developed a film containing evenly distributed insulin-bearing nanoparticles. When the film is placed on the inside of the cheek, it slowly delivers the drug into the body.

In January, at the JP Morgan Healthcare conference in San Francisco, MonoSol Rx and Midatech announced positive results from a study of the insulin film in monkeys. The two companies are currently applying for permission to run human trials in Switzerland, which they hope will begin in the third quarter.

Schobel is well aware of the pitfalls of developing oral insulin. One problem is that every patient with diabetes is different. Some require more insulin, some less, and their needs can vary depending on their diet and lifestyle—a challenge that has complicated development efforts for inhaled insulin, which can be difficult to titrate. Schobel says he believes his films could be made in a variety of sizes, so patients can more easily adjust their doses on the fly.

But he also knows it will take a lot of work for MonoSol Rx and Midatech to prove their technology can work in diabetes. “We are going in a very stepwise fashion,” Schobel says. “We need to demonstrate it’s safe and get a view of the pharmaco-dynamics before we can determine how far we can go.”

Meanwhile, MonoSol Rx is diversifying the rest of its pipeline. It’s working on transforming a number of existing drugs into films, including montelukast (Singulair) for allergy and asthma, and zolmitriptan (Zomig) for migraine.

And on April 25, the company formed a partnership with Iowa City, IA-based KemPharm to develop a completely new treatment for attention deficit/hyperactivity disorder (ADHD). Unlike MonoSol Rx’s other products, which are based on drugs that already exist in other forms, this one is being designed from the start as a film. Schobel believes the ADHD market is ideal for his drug-delivery method. “To get kids to take a proper dose of medicine is difficult,” he says. “With film, you put just put it in, it dissolves, you swallow it, it’s done. It’s not a pill or liquid on a spoon. And if Mom needs to carry the product, it’s very easy and discreet.”

That’s not to say MonSol Rx is free from competition. Some big pharma companies are doing their own work with film, including Novartis, which has made over-the-counter film versions of Triaminic, Theraflu, and other famous products. Schobel, who once worked in Novartis’ consumer division, says he’s mindful of competition, but not worried. “I feel we have a very strong proprietary position in the delivery technology,” he says. “We have a huge IP portfolio on a global basis.”

The company isn’t shy about defending its IP, either. Earlier this year, MonoSol Rx filed a lawsuit against three companies alleging that their drug-infused film infringed one of MonoSol Rx’s patents. “We will vigorously defend our proprietary patent-protected position,” Schobel says.

The occasional patent dispute is unlikely to dampen Schobel’s enthusiasm for film-based drugs, however. “We’re not saying its going to take over existing tablets and the like, but we believe that even if we get single-digit market penetration, it will be a huge opportunity for us,” he says. “Film is here to stay.”

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