International pharma Boehringer Ingelheim and prescription digital therapeutics company Click Therapeutics have inked a $500 million-plus deal to jointly develop and commercialize a digital treatment for patients with schizophrenia.

The treatment, referred to as CT-155, will be a mobile app built on Click's proprietary tech platform, the companies said.

Employing cognitive and neurobehavioral mechanisms, it encourage patients to adjust their behavior with the ultimate aim of reducing their cognitive deficits and impaired social functioning. The companies intend for the final product to deliver these benefits when prescribed as a standalone treatment, or in combination with traditional pharmaceutical therapies.

In exchange for the exclusive global rights to the novel treatment, Boehringer Ingelheim agreed to provide Click with an upfront payment for R&D followed by additional payments for clinical, regulatory and commercial milestones. The companies said these payments will come to a total deal value in excess of $500 million, not counting tiered royalties on worldwide annual net sales that Click will also be receiving.

In addition to providing the platform, Click will be taking the lead on CT-155's R&D, and backing up Boehringer Ingelheim's worldwide commercialization efforts.

“Partnering with Boehringer Ingelheim allows us to leverage their considerable experience in the clinical development and global commercialization of new treatment options for neuropsychiatric diseases to improve the efficacy and reach of our digital therapeutic software,” David Benshoof Klein, CEO of Click Therapeutics, said in a statement. “We look forward to evaluating CT-155 in a pivotal clinical study, working together with Boehringer Ingelheim to achieve FDA and international regulatory authorization and to demonstrate the clinical efficacy of this prescription-based digital therapeutic software alone and in combination with traditional pharmaceutical treatments.”

WHY IT MATTERS

With this big ticket deal, Boehringer Ingelheim becomes the latest major pharma company to bet big on what many in the industry still consider to be an unexplored treatment modality. Of note, the company said in the announcement that its viewing the digital therapeutic as "a meaningful new treatment category" for neuropsychiatric disorders such as schizophrenia. Either alone or with a drug, they wrote, this type of approach could potentially improve access to the kind of tailored psychosocial interventions that are recommended in treatment guidelines for schizophrenia, but infrequently delivered.

"CT-155 is an excellent addition to our [central nervous system (CNS)] pipeline portfolio; it reflects our patient centric approach and translates evidence showing how behavioral modification can induce positive neuronal changes into a widely accessible solution," Cornelia Dorner-Ciossek, director of CNS diseases research at Boehringer Ingelheim, said in a statement. "Further it has the potential to be prescribed together with Boehringer Ingelheim’s schizophrenia pipeline compounds possibly enhancing the benefit of pharmacotherapy for patients.”

The development and commercialization is undoubtedly a big break for Click, but it's not the company's first brush up with the pharma industry. The digital therapeutics company counts Sanofi among its investors, and in early 2019 signed on with Otsuka America for a similar development and commercialization deal targeting a prescription digital therapeutic for treatment of major depressive disorder (MDD). Combining upfront payments with agreed upon milestones, that deal was set to bring roughly $300 million and sales royalties to the company.

THE LARGER TREND

Although the larger pharma and digital health industries still appear to be bullish on the potential of complementary or standalone digital therapeutics, Click and Boehringer Ingelheim's alliance falls in the shadow of some major breakups between the two parties.

Among the loudest of these was Novartis and Pear Therapeutics, which partnered in early 2018 to commercialize the reSET and reSET-O prescription digital therapeutics, but called it quits nearly a year ago amidst reorganization within Novartis' Sandoz division (of note, the companies are still collaborating to develop a separate unreleased treatment).

Meanwhile another high-profile agreement between digital pill maker Proteus and Otsuka ran out of steam when Proteus was forced to furlough employees and, as of June, file for Chapter 11 bankruptcy. Otsuka may not have completely discounted the technology though – the company picked up Proteus' remaining assets for $15 million.