Pharmaceutical company Otsuka America and software treatment firm Click Therapeutics have reached a collaboration agreement to develop and commercialise a prescription digital therapeutic treatment for Major Depressive Disorder (MDD).
The collaboration combines Click’s work in discovering and validating software applications and Otsuka’s in developing prescription therapies for patients with mental illness. The companies aim to bring to market a new treatment for patients with MDD, and believe digital therapeutics and psychiatry align.
Otsuka has agreed to commit capital to fully fund development of Click’s mobile application ‘CT-152’ for MDD, and to commercialise it following regulatory approvals. Otsuka will pay Click up to $10 million in upfront and regulatory milestone payments, along with an estimated $20 million in development funding. An additional $272 million in commercial milestone payments are contingent upon regulatory approvals. In addition, Click will receive tiered, double-digit royalties on global sales of the software and the digital therapeutic applications that result.
CT-152 will use cognitive therapy principles to treat patients either independently or in conjunction with prescribed pharmacotherapies. It is aimed the product will fall under the Food and Drug Administration’s regulatory framework and be classed as Software as a Medical Device (SaMD).
Kabir Nath, president and CEO, Otsuka North America Pharmaceutical Business Division said: “This collaboration signals Otsuka’s commitment to meet patients’ unmet medical needs by developing solutions far beyond medication. Our goal is to deliver evidence-based cognitive therapies to a broader population of patients with MDD than is currently feasible, due to the challenges of a shortage of mental health professionals and limited time for them to conduct cognitive therapy.
“We are proud to be one of the few pharmaceutical companies that continues to invest in developing medicinal and digital products for the treatment of mental illnesses, and we are doing so by breaking down barriers and collaborating with leading therapeutic technology companies, such as Click, which share our vision.”
Benshoof Klein, chairman and CEO of click said: “Otsuka has established itself as the leading innovator in digital medicine for psychiatry, and we are thrilled to collaborate with their clinical and commercial experts on our CT-152 digital therapeutic for the treatment of depression. This collaboration symbolises the growing recognition that digital therapeutics are a new category of treatment with the potential to become a routine treatment option for physicians for their patients.
“The potential value of these treatments is clear: they provide validated tools that may be an effective treatment option to bring the power and accessibility of digital technologies for the benefit of the patient and physician. This recognition is also shared by regulators helping to build new pre-market review programs uniquely suited for digital therapeutics, while still retaining the traditional level of rigor and scrutiny that clinical studies require.”