This collaboration brings the technology closer to commercial reality.
Microdermics Inc. and Vetter are planning to be at the forefront of novel alternatives to needle injections, as partners. The strategic cooperation agreement, said the joint announcement will cover the development of a “novel,” hollow metal microneedle drug and vaccine delivery system.
This demand is expected to reach over 480 million units by 2030 (according to a Roots Analysis report). This alternative injection technology is a major departure from the classic parenteral needle stick administration of liquid drugs. Among other things, injected drugs can elicit an immune response at the injection site; microneedle administered drugs avoid this complication which can impinge on the therapeutic effectiveness of medicines, such as vaccines. The technique can also improve the absorption and uptake of certain drugs, as well as manage their release into the body over time. The concept also thwarts other dosing safety and noncompliance issues; eliminating several problematic steps required to administer a sterile injection by caregivers, and for all patients, a way to avoid painful and often multiple injections. Similarly, most patients are capable of administering their own doses via this adhesive “patch” methodology.
According to Vetter and Microdermics, the roadblocks to commercialization are centered on limited investment (so far) in scalable aseptic manufacture at later stages of development. To move past these barriers, the companies said they have “joined forces” to leverage their expertise and “enable late-stage process development and device manufacture on a commercial scale.” Vetter, for example is known for its commercial-scale, sterile, fill-finish and manufacturing capabilities for parenteral products. Microdermics has expertise developing a viable intradermal delivery device. There are plans to initiate Phase I clinical trials in 2017 to demonstrate the methodology’s efficacy.
Vetter’s Senior Vice President of development services, Claus Feussner, said “We believe that microneedles are a particularly innovative technology and may prove to be a promising future alternative for selected areas of drug delivery.” Grant Campany, Microdermics’ President & CEO remarked that Vetter’s “decades of experience” in fill and finish will help them accelerate their commercialization strategy and that the opportunity will be invaluable for “a successful development path for our microneedle drug delivery technology.”