The first Takeda development program to potentially utilize this device will be for investigational use with Entyvio (vedolizumab), a monoclonal antibody for adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD), which is currently administered through intravenous infusion. A Phase III clinical trial program is currently evaluating the efficacy and safety of a subcutaneous formulation of vedolizumab in adults with moderately to severely active UC or CD.
“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.”
“Working with Takeda to adapt the Portal device underscores our mission to empower patients with a 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,” said Patrick Anquetil, CEO of Portal. “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.”
Portal’s needle-free drug delivery device delivers the biologic through a pressurized liquid instead of a needle, and has been clinically shown to be less painful and preferred by patients compared to a standard needle-based injection.1 This needle-free device is expected to be self-administered by patients at home.
Under terms of the agreement, Portal will receive an initial payment with the potential to earn additional payments of up to $100 million subject to achievement of specified development, regulatory and sales-based milestones and royalties.
Takeda Pharmaceutical Company Limited is a global research and development-driven pharmaceutical company that is translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and central nervous system therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners. The company employs more than 30,000 workers and connects with healthcare partners in over 70 countries.
Portal Instruments is a Series B-funded medical device company focused on advanced drug delivery and backed by strategic and venture investors. Portal Instruments is developing and commercializing a needle-free drug delivery platform technology to transform the administration of medicines and improve the patient experience for chronic diseases. Real time tracking and reporting sets a new standard for interactivity between the patient and care teams, monitoring adherence and potentially improving patient outcomes.
1. Kojic, et al. An Innovative Needle-free Injection System: Comparison to 1 ml Standard, 1 May 2017, AAPS PharmSciTech (# 2017).