Teaming Up to Make Medical History

Bringing a Revolutionary Drug to Market

In a first-of-its-kind breakthrough, our client Otsuka America Pharmaceutical Incorporated developed a new “digital” version of its antipsychotic drug Abilify. By giving patients with schizophrenia, bipolar I disorder and other debilitating psychiatric illnesses, as well as their doctors and their caregivers, the ability to track ingestion of the prescribed medication, it is hoped that adherence may be improved. Evidence that the product improves adherence has not been established.

“Digital” Medicine a Lynchpin to Successful Therapy

The new Abilify MyCite incorporates a tiny digital sensor embedded in the pill itself. When the pill is swallowed, it triggers a signal to a patch worn by the patient, which, in turn, relays that signal to a smartphone, confirming adherence to the regimen. With patient consent, that information can also be received— through a web-based portal—by a clinician or caregiver. Nonadherence, the term for failure to take medication as prescribed, is regarded as one of the most intractable problems in psychiatric care. However, objective evidence of whether a patient is taking his or her medication as prescribed has been hard to come by.

A Five-Year Effort

As with all revolutionary medical products, success hinges on reimbursement by the Centers for Medicare and Medicaid Services. Otsuka’s John Bardi, Vice President, Public Affairs & Digital Medicine Business Development, described our role in helping them cross that hurdle: “Akin Gump provided invaluable guidance with various regulatory and legal issues that arose during the development and application for approval of Ability MyCite, which we appreciate very much. We look forward to continuing our work with the Akin Gump team.”

A Collaborative Approach Pays Off

Our team included lawyers from multiple practices—health policy, health care and life sciences, food and drug, intellectual property, and antitrust—to advise them on a host of critical regulatory, legal and privacy issues. Otsuka credits this collaborative approach with successfully shepherding Abilify MyCite through its entire development cycle, emerging from the process with a product that may be a true game-changer.