For most of us, getting an injection is a less-than-inviting experience. Many of us dread shots, or injections of medication directly into the bloodstream. Those who aren’t blessed with “easy-to-access” veins may be subjected to several attempts by medical personnel, some of whom are less skilled – and empathetic – than others. Diabetes sufferers and others who require daily injections may find them difficult to handle, and some people have to administer them themselves.
All the above have prompted Israel’s TransPharma Medical to spend close to a decade perfecting its unique ViaDerm Drug Delivery System. With a no-fail, painless applicator that never misses its mark, and its pre-measured patches, the ViaDerm system “is ideal for a wide range of medications and treatments,” says Dr. Daphna Heffetz, TransPharma’s CEO.
The genius of the ViaDerm system is in its use of basic principles of diffusion to push medication into the bloodstream. Most injected medications are pushed directly into the bloodstream or under the skin (subcutaneous) via a needle – but it turns out that there is another way to move medication into the bloodstream.
Below the outer layers of skin (the epidermis) lies the dermis, which contains elaborate networks of blood capillaries, and comes into direct contact with the epidermis. The ViaDerm system creates micro-channels through the outer layer of skin, allowing the medication to diffuse through them into the dermis and from there to seep into the blood system via the capillaries.
The system itself consists of a reusable battery-operated, handheld electronic control unit, a disposable low-cost microelectrode array and a patch containing a drug. The patient first snaps the array onto the controller, pressing it gently on the skin to create the micro-channels. The patch is then folded onto the micro-channel area, and the drug passively diffuses through them into the inner skin layer, and from there to the systemic circulation. When you’re done, you put away the control unit and dispose of the array and the patch. It’s easy, quick, painless, and effective.
Doctors, nurses and patients are unanimous
While the system could theoretically be used for almost any application, Heffetz says that the company – which adapts selected drugs for ViaDerm patch application – is concentrating on areas where there is the greatest need.
“We are focusing on biologics, protein-based drugs that cannot diffuse into the skin using current patch technologies. We’ve shown, however, that they can diffuse along micro-channels. These drugs currently constitute approximately 20 percent of the pharmaceutical market, but are predicted to become half of the market in 2015. They are regarded as the future of health care. So we have plenty to keep us busy,” she tells ISRAEL21c.
According to Heffetz, doctors and nurses love ViaDerm. “We’ve conducted dozens of tests with groups in countries around the world, from Japan to the US, and patients much prefer the system as well. So far, the ViaDerm system was applied 20,000 times on volunteers and patients around the world, and the vast majority has been very happy with it. ViaDerm is very user-friendly, and users appreciate that,” she says.
The system has several other advantages for patients as well: Many injected medications, for example, need to be refrigerated, limiting the mobility of the patient, who needs to have steady access to a refrigerator. But that’s not the case with patch versions of the medicines.
Elderly people who must self-administer their medications are free to travel with ViaDerm, without having to seek accommodation that includes a refrigerator. In addition, medications adapted for ViaDerm can be time-released, meaning that patients who require more than one treatment a day would only have to administer the patch once.
Lod-based TransPharma, with about 60 employees, was founded in 2000. Since then, the company has worked to perfect the technology that was created by Yossi Gross, the mechanical engineer who came up with the idea for ViaDerm. Gross, who is a TransPharma board member, believed that marrying medical treatment with engineering principles could make life easier for patients.
Partnership with pharma giant Eli Lilly
There’s still the hurdle of gaining FDA approval for each medication that the company develops as a patch. “While a medication we would want to adapt for patch diffusion delivery could be well-known and in use for years, the FDA requires a recertification for a change of form,” Heffetz explains. “We thus have been seeking to work with large pharmaceutical companies, who have the background and development experience to make this process easier for us.” The device itself received Europe’s CE Mark of Approvalin 2008.
TransPharma’s latest deal teams the company with one of the giants of the pharma world. Eli Lilly is working with the company on development of the ViaDerm version of Lilly’s hPTH(1-34), also known as Forteo, for the treatment of osteoporosis. That deal netted TransPharma an upfront payment by Lilly of $35 million in 2008 for worldwide licensing rights to the ViaDerm-hPTH osteoporosis product and a non-exclusive license for the ViaDerm drug delivery system.
The money is helping to fund the ongoing Phase II trials for the Forteo treatment, and followed an $18 million Series C financing round, led by Argonaut Private Equity, with backing from Teva among others. Aside from the development deal with Lilly, TransPharma is also developing two other products: ViaDerm-GLP1 agonist for the treatment of type II diabetes, currently in phase 1b testing, and the ViaDerm system combined with an undisclosed peptide, which has completed a Phase 1 clinical trial.
“Forteo is a very advanced drug, and is usually prescribed to patients with serious cases of osteoporosis, a progressive calcium disease that eventually crumbles the bone. There are other drugs to fight osteoporosis, but all of them just try to prevent bone loss. Forteo is the only one that helps build bones,” Heffetz relates.
Patients taking Forteo have to inject themselves every day – and there is a huge market for the drug, Heffetz says, which means that working with Lilly on Forteo is just what the doctor ordered for TransPharma Medical. “We’re very pleased with the results of tests we’ve conducted with this drug,” Heffetz says, adding that the partnership with the giant health care company “is an important step toward introducing the ViaDerm system as a household solution for the self-delivery of a variety of medical substances.”