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The new digital therapeutic that Happify has agreed to develop for Sanofi is designed for treating co-morbidities of multiple sclerosis, rather than the disease itself. But it should bring added value to the pharma's MS franchise and help it stand its ground against increasingly fierce competition in this disease area.
Sanofi has partnered with Happify Health, a specialist in digital therapies for mental well-being, to develop a prescription digital therapeutic (PDT) that will treat depression and anxiety in multiple sclerosis patients. Sanofi has exclusive rights to commercialise the resulting PDT for use in the MS patient population, after the product has undergone clinical trials and gets US FDA clearance, Chris Wasden, Happify's head of digital therapeutics, told FirstWord MedTech.
This is Sanofi's and Happify's first foray in PDTs, the two companies confirmed.
The wider view
Sanofi's current MS portfolio consists of two disease modifying drugs (DMDs), Aubagio (teriflunomide) and Lemtrada (alemtuzumab), which have been in the market since 2012 and 2014, respectively. The uptake of each drug were at levels that many medtech companies could only dream of when they launch a new device, with combined sales growth rates in the high double-digits, year-over-year - except last year. Sanofi reported MS sales of €1.97 billion in 2018, a mere 4% YoY increase and a far cry from the 21% increase in 2017 and 56% in 2016. The company attributed the sharp downturn in growth to the decline in US sales of Lemtrada due to increased competition, likely from players such as Roche whose Ocrevus - also an infusion DMD for progressive MS - is said to show high efficacy, but fewer adverse side effects than Lemtrada. Furthermore, while Aubagio sales had helped to offset Lemtrada's decline with continued sales increase, this golden egg-laying goose - which placed Sanofi among the world's top 10 MS drug suppliers - is losing its lustre with the imminent arrival of generics competition (the US FDA approved Glenmark Pharmaceuticals' teriflunomide tablets in November last year).
This PDT that it is co-developing with Happify is undoubtedly part of Sanofi's strategy to add value to its MS offering and give its sales force more ammunition to fire away in their conversations with neurologists.
Substantial opp for PDT
Unlike Aubagio and Lemtrada, the PDT is not designed to treat the disease itself, but the existing co-morbidities of patients living with MS. That said, Happify's Wasden pointed out that the opportunity for the digital product is significant, as around 60% of MS patients suffer from depression and anxiety.
“There's no MS drug out there that has a label to treat anxiety and depression...it requires a separate therapy [for MS patients who present with these comorbidites] and currently, physicians would decide to either treat them with [antidepressants like] SSRIs or SNRIs or not treat at all. We are an alternative [non-pharmacologic] alternative to treat anxiety and depression, as well as other issues related to MS,” said Wasden.
When asked if Sanofi might need to build a new salesforce - one, perhaps, with more experience of digital technologies - to sell the PDT, Wasden said this was something the French pharma company has to determine. That said, he maintained that in spite of its digital nature, a PDT remains a form of therapy that makes the same claims as any FDA-cleared product or approved analog medicines - they have achieved certain set clinical end-points and will be prescribed according to the approved indication.
“Fundamentally, it’s hard to see why a sales rep who is already calling on a physician on a regular basis, who is already selling two products to that physician, couldn't sell a third product,” Wasden told FirstWord MedTech. “The other issue is: what is the number one thing a sales rep needs in order to have an engaging discussion with a physician? It's new information. Talking about a drug that has been on the market for 10 years is not as exciting as talking about something the physician doesn't know about. And so what a digital therapeutic provides is that new exciting product to bring to the physician, enabling the sales rep to justify the value of the visit,” he continued.
Happify's current digital therapy that is being offered is not an FDA-cleared product, as it is not positioned as a PDT. Similar to other PDTs, cognitive behavioural therapy is a key component of the programme and the aim is to bring about behavioural change and re-train the patient's thought processes that would typically bring about stress and anxiety. The company has conducted randomised controlled trials and the data look compelling: data published last year in the International Journal of Wellbeing showed that in the general population, the company's non-MS-specific platform was associated with an almost 25% reduction in anxiety symptoms and a more than 25% reduction in depression symptoms when used at the recommended level of a minimum of 16 activities completed over eight weeks.
The PDT for Sanofi will be a completely new product, but incorporate Happify's “secret sauce” that enabled the current app to effectively impact anxiety and depression, said Wasden, who estimates that it would take around two years for the product to complete clinical trials and get regulatory approval.
Sanofi has a couple of new MS candidates in its R&D pipeline, but they are in the early Phase I and II stages. The PDT would likely be in the company’s sales toolbox before then and probably not a moment too soon to help buoy MS sales.
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