At a time when big pharma’s response to a dearth of novel diabetes drug classes is to combine existing products, Intarcia is comfortable that its single-agent glucose-lowering implant will be able to differentiate itself should it be launched as expected in 2017.
As ITCA 650 will provide a steady flow of GLP-1 exenatide to patients over six to 12 months, medication adherence should not be an issue, and the private Massachusetts-based group believes that this will be a winning message with payers.
“We’ve got a built-in advantage if you care about getting people treated to goal and keeping them there over time, which is what is really required to improve outcomes,” Intarcia's chief executive, Kurt Graves, tells EP Vantage.
“We live in a payer-driven world these days,” he says. “The payers are going to take a very rigorous evidence-based approach to see what the value proposition is of a pill, an injection, and in the future our once or twice-a-year mini-pump. The biggest part of our strategy is to get payers to be our biggest advocates.”
Head to head
To that end, Intarcia is embarking on several head-to-head studies against existing non-insulin treatments. It recently bested Merck & Co’s Januvia, the best-selling product in type 2 diabetes, and will also test it against sulfonylureas, SGLT-2s and the leading GLP-1 in Victoza (Besting Januvia sets Intarcia up for bigger deal – or not, August 19, 2015).
Meanwhile, it is awaiting the results of its cardiovascular safety outcomes trial, which will be necessary to gain approval from the US FDA and other regulatory agencies. That trial is expected to report by the end of the year.
The competitive landscape has changed in recent weeks, as Lilly and Boehringer Ingelheim’s SGLT2 Jardiance has shown that it can improve cardiovascular outcomes, rather than simply not pose an unacceptable risk (Cardiovascular radiance for Jardiance, August 21, 2015). Lilly and Boehringer are to present data on Saturday at the European Association for the Study of Diabetes meeting in Stockholm, which Mr Graves is attending.
He says Intarcia’s trial is not powered to test whether the implant will improve outcomes, partly because it has not raised sufficient funds to run a trial of that size.
However, Novo Nordisk is due to report results from the Leader outcomes trial within months, while AstraZeneca has a similar trial under way with Bydureon, which contains the same active ingredient as ITCA 650, reporting in 2017. If those GLP-1 injections can show a statistical reduction in myocardial infarctions and other cardiovascular events Intarcia should benefit from a halo effect, Mr Graves believes.
“In general, GLP-1s do everything an SGLT2 does, they just tend to do it a little bit better,” he says. “They lower glucose better; they cause a greater degree of weight loss; and importantly, in the context of cardiovascular benefit studies, both classes lower systolic blood pressure in a meaningful way.”
Hand in hand
The other big shift in diabetes care is the advent of combination treatments. Janumet, the Januvia-metformin pill, has been on the market since 2007, but new products combining both oral and injectable agents are queueing up now, including insulin/GLP-1 pens and SGLT-2/DPP-IV pills.
Mr Graves says Intarcia is positioning itself to respond. Earlier this year it began collaborating with Numab, a Swiss company specialising in antibody discovery. That collaboration is looking for a way to combine exenatide with an antibody fragment that will work with a known diabetes target outside the GLP-1 pathway, Mr Graves says; he expects more news on that once the intellectual property estate is secure, most likely in the first half of 2016.
“Our broader strategy is three or four shots on goal for combination therapies in our pump,” he says.
This also involves the unusual plan of a solo US launch in one of the biggest and fastest-growing disease areas while remaining private. Having raised more than a billion dollars and made two significant deals in Servier and a royalty-based financing that valued Intarcia at $5.5bn, Mr Graves says the group is sufficiently resourced for that launch (Intarcia, the $5.5bn private company with a $15bn drug, April 29, 2015).
This is true even though the target market will be general practitioners and endocrinologists alike, in part because he believes payers will be sold on the benefits.
However, Intarcia hopes to build a richer pipeline of projects in obesity and autoimmune disease, and should any of these pan out a strategic rethink could be in order.
“To realise our ambitions of becoming a multi-therapy, multi-market organisation, I think we’ll be a public entity. I just don’t know when that’s going to be,” he says.