Interest in needle-free drug delivery has increased as biologics manufacturers look for ways to give their originator drugs a competitive advantage over oncoming biosimilar competition.
Takeda Pharmaceutical Co. Ltd has announced that it has partnered with Portal, a Massachusetts-based medical device manufacturer, to develop a needle-free approach to administering biologics that are currently administered via injection. The companies plan to initially test Portal’s delivery system, which uses pressurized liquids, on Takeda’s top-selling biologic, vedolizumab (Entyvio), which is used to treat ulcerative colitis and Crohn’s disease. The companies will eventually evaluate Portal’s needle-free delivery system across a range of Takeda’s investigational and marketed biologics.
The delivery system works by pressuring the liquid drug into a jet that pierces the skin on contact, and delivers the drug to the target area in approximately half a second. The Portal device is digitally-controlled and precise, and takes into consideration factors such as changes in drug viscosity due to temperature. The device has been clinically shown to be less painful than a standard injection, and is preferred by patients, according to the company. The needle-free device could be used by patients at home; patients load the reusable device with a disposable, pre-filled cartridge and self-administer the drug.
Takeda’s interest in needle-free drug delivery is consistent with industry trends, as the challenges of subcutaneous delivery of biologics have become a target for partnership and development. Patient adherence is an issue for drug companies marketing and developing biologics, as most biologics must be administered intravenously or subcutaneously rather than orally because of the size and complexity of the molecules involved.
Portal notes that administering biologics via injection often causes patient anxiety—different than “needle phobia”—because injection can be painful, especially as the needle must remain in the patient for 10 to 20 seconds to administer a complete dose. As a consequence, treatment adherence rates for biologics are less than optimal, and are thought to be in the 40% to 70% range, depending on the indication. Some patients may even refuse a therapy if it requires needle-based self-injection. In addition, drug volumes to be injected are getting larger, and concentrations are getting higher, increasing patient discomfort and the potential for infusion-site reactions as well as skin damage.
Thus, interest in needle-free drug delivery has increased as biologics manufacturers look for ways to give their originator drugs a competitive advantage over oncoming biosimilar competition. A needle-free delivery method for originator biologic drugs is expected to augment Takeda’s revenues; Entyvio is the company’s highest-selling drug, with $592 million in sales.