There are obstacles to effective treatment, however. Like all other therapeutic peptide hormones (the best-known example is insulin), a growth hormone cannot be taken orally. Be-cause the patient’s stomach would immediately destroy the hormone’s protein structure, somatotropin has to be injected into subcutaneous tissue.
Nowadays, an automated drug delivery device safely changes the needle, provides the right dosage, and correctly places the needle. For EMD’s growth hormone Saizen®, this autoinjector is a high-tech system known as easypod®. The latest generation consists of the injection device itself along with a wireless transmitter and the associated software. The device not only ensures gentle and precise injections but can also document the treatment.
As a result, it addresses the most important remaining difficulty in the treatment of impaired growth. The main problem is not side effects. As Rohrer explains, the side effects are very minor, because the recombinant hormone is identical to the natural one produced by the human body. Instead, the difficulty is in the patient’s compliance with, or adherence to, the treatment regimen. “Having to make daily injections for several years is a big challenge,” says Luis Fuente, the marketing director who is responsible for the growth hormone franchise at Merck KGaA, Darmstadt, Germany and thus also for easypod®. “Doctors, nurses, and patients have all told us repeatedly that this has to be improved.”
In an international survey, 79 percent of the specialists involved in growth hormone treatment said that inadequate adherence was one of the main reasons why treatments were not completely successful. But with the help of the injection data stored in the easypod®, doctors and their young patients can now observe how the treatment is progressing, and, if necessary, find ways in which to ensure the daily injection is never missed. In addition, successful treatments mean cost savings for the health care system as a whole. The company aims to focus on this aspect in order to prove that this device benefits funding agencies.