Companies to develop needle-free delivery systems for biologics.

The market for biologic drugs is expanding rapidly. Monoclonal antibodies and other protein-based biomolecules are being developed to treat many diseases that could not be successfully targeted with small-molecule therapies. Biologics do have disadvantages, however. Not only do they generally carry very high prices tags; they typically must be administered via injection, often requiring visits to the doctor’s office or hospital (self-injection is possible for some).

Takeda Pharmaceutical Company recently announced a collaboration with Portal Instruments to use the latter’s needle-free drug delivery device in conjunction with the former’s investigational or approved biologic medicines in new commercial products. Portal will receive an upfront payment of an undisclosed amount with the potential to earn up to an additional $100 million in milestone and royalty payments.

The needle-free technology was developed at the Massachusetts Institute of Technology (MIT) by Professor Ian Hunter and potentially can be used with many different types of biologic drug substances. The device, which is designed for self-administration by patients in their homes, delivers a biologic drug using pressurized liquid rather than a needle. This method has been shown clinically to be less painful for patients and preferred by them over standard needle-based injection, according to Portal.

Takeda and Portal will first focus on paring the device with Takeda’s approved monoclonal antibody (mAb) vedolizumab, which is sold under the trade name Entyvio^® for the treatment of adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD). The drug is currently administered through intravenous infusion. Takeda is presently evaluating the efficacy and safety of a subcutaneous formulation of vedolizumab in adults with moderately to severely active UC or CD in a Phase III trial.

“There is a need for options to keep improving the experience for patients with life-long, chronic conditions that are managed with the intravenous infusions of biologic medicines,” said Stefan Koenig, Global Program & Brand Lead at Takeda. “This partnership with Portal demonstrates Takeda’s leadership in supporting patients with GI diseases and our commitment to evolve the management of these diseases, such as inflammatory bowel disease, by potentially offering patients the ability to administer treatment in their own at home with a needle-free system.”

Commented Patrick Anquetil, CEO of Portal: “Working with Takeda to adapt the Portal device underscores our mission to empower patients with a leading, next-generation drug delivery platform for self-administration that is designed to reduce the pain and anxiety associated with needle injections in addition to reducing administration time. This partnership allows us to work collaboratively with Takeda’s highly experienced R&D team and provides the first opportunity to introduce the Portal device to patients, a pivotal step as we continue to expand its potential and grow our business.”