Mahana’s company’s irritable bowel syndrome digital therapy was the first to digital therapy to gain clearance from the FDA.
Another global pharmaceutical giant is teaming up with a prescription digital therapeutics maker, this time in order to help commercialize digital therapies for irritable bowel syndrome (IBS), among other products.
Bayer AG has signed a commercialization deal with San Francisco-based Mahana Therapeutics, the companies announced last month. The agreement marks an expansion of Bayer’s efforts to enter the digital health space.
“Digital therapeutics are a perfect addition to our portfolio of care and tap into new tech-savvy consumers looking for drug-free treatments as well as help eliminate gaps in care provision,” said David Evendon-Challis, MA, the head of research and development and the chief scientific officer at Bayer’s consumer health division, in a press release.
Mahana’s lead product, Mahana IBS, utilizes cognitive behavioral therapy (CBT) in order to influence gut-brain communication, the company said. The product also helps patients change behaviors that can contribute to IBS, they said. In a clinical trial, digitally delivered CBT led to clinically significant reductions in IBS Symptom Severity Scores (IBS-SSS) after 3 months.
Those trial data helped the company win marketing authorization from the US Food and Drug Administration back in December 2020. At the time, the product was known by the trade name Parallel; it was subsequently rebranded as Mahana IBS. The following March, the company announced it had obtained a CE mark in the United Kingdom, indicating it complies with European Union regulations. Shortly thereafter, the company said it had raised $61 million Series B financing to support its commercialization program and the development of additional digital therapeutics.
Still, the company has faced similar headwinds to other companies in the prescription digital therapeutics (PDT) industry, including relatively low consumer awareness of PDTs and a reticence among payers to cover the products.
Earlier this year, the company hired Better Therapeutics’ former chief commercial officer, Justin Zamirowski Jr. to serve in the same role at Mahana. One of his tasks in the new position, the company said, is to work on strategic partnerships to help get Mahana’s products more firmly into the market.
Simon Levy, Mahana’s chief executive, said the deal with Bayer is a sign that both companies believe digital therapeutics “are a critical part of the future of healthcare.”
“Through this agreement, we can further expand the availability of our innovative prescription digital therapeutics for patients and their caregivers around the world who seek effective treatment for chronic conditions,” Levy said in the press release.
The new deal follows Bayer’s announcement in May that it was launching a new business unit within its consumer health division to focus on what it calls “precision health” products. The company said it wants to help connect consumers with digital health tools to help them take greater control of their health, citing internal research showing that 80% of consumers globally are seeking better healthcare personalization.
“We think the future of self care is increasing precision health,” said Heiko Schipper, president of the company’s consumer health division, in announcing the new unit. “Precision health enables people to take ownership of their health by providing health data and improving or even preventing unfavorable health conditions.”
Schipper said this kind of personalized, data-driven healthcare is key to creating a paradigm of health-care, rather than sick-care.
Bayer is not the first major pharma company to partner with digital health companies. Sanofi SA has partnered with Dario Health in a deal that includes research and development assistance.