At the start of every year, the JP Morgan Healthcare Conference hits San Francisco. With lots of men in suits running this way and that, it looks more like an East Coast event than what you’d expect in the California Bay Area. And really, it’s a big investor-fest, where healthcare companies gather to update the financial world on their standings in the context of their respective markets.
Aside from a few select demos, what these companies do is along the lines of back-to-back earnings calls packed into a few days, this year between Jan. 12-15.
You’ll pretty much find a who’s who in the diabetes industry at this conference, and for us patients, the highlights tend to be the peeks provided into company pipelines — giving us a glimpse of what’s coming down the road in next-gen devices and drugs.
We have a special guest report to share today on this conference, from one Cameron Scott, a Healthline staff reporter with a keen interest in all kinds of med tech.
But first, here are some #JPM15 updates that caught our eye specifically on companies we follow closely:
- Dexcom: New CEO Kevin Sayer who took the job at year’s start was on the scene to give an update, and although it was an audio-only presentation there was some good info about Dexcom’s next-gen tech — the G5 transmitter, a new “one-button push” insertion device that’s in the works, and eventually the smartphone and AppleWatch app to display G5 data. Dexcom says it’s also moving forward with clinical trials for a CGM insulin-dosing designation, to provide ammunition for regulators to allow CGM results to be used without the need for a fingerstick. Currently, no standards exist on that front and apparently the Medicare/Medicaid powers-that-be want to see that before expanding coverage for CGMs. So, Dexcom is leading the way to make that happen.
- Medtronic: Company CEO Omar Ishrak presented showed a slide presenting its pipeline for the next three years (below), with timelines on the next two generations of insulin pump-CGM combos we can expect to see: the Minimed 640G that’s launching overseas this year, and will hopefully come to the States sometime next year, to the next-gen hybrid closed loop 670G that interestingly is planned to hit the U.S. in 2017 before it launches in Europe the following year — perhaps the first instance of U.S. getting new D-tech first.
- JnJ: Yes, the recent Animas Vibe approval and launch got a quick mention in their presentation, but that was really about it when it comes to diabetes devices. Still, there was a hidden nugget that didn’t get much talk-time during the investor update — mention of progress on the Calibra Finesse, a 3-day “patch pen” pump that JnJ acquired in 2012 but hasn’t done anything with to date. We haven’t been able to find out more yet, but if JnJ is planning a regulatory filing or launch soon, that could finally bring some patch-pump competition to Insulet, which is the only game in town right now but may be facing its own struggles after new CEO Patrick Sullivan took over roughly three months ago and OmniPod sales are notably down.
- Sanofi: The insulin-maker has its sights set on new new basal insulin Toujeo that’s under FDA review, as it prepares for predecessor Lantus to see a patent expiration in February. R&D chief Elias Zerhouni spent a good chunk of time highlighting their hopes for Toujeo as “the new gold standard” of basal insulins once launched. Surprisingly, he made only a quick mention Mannkind Corp and its Afrezza inhaled insulin that Sanofi will launch in Q1 of this year. Sanofi is heavily engaged in the insulin wars between competitors Lilly, Novo, AstraZeneca, and while all are facing an uncertain future, all have their hopes — such as Lilly bringing a Humalog U-200 Kwikpen to the States and possibly its own basal insulin in the coming year.
But there was more going on at JP Morgan Healthcare than just these presentations. As we’re now a part of the Healthline family, we were happy to have some feet on the ground this year. As mentioned, news reporter Cameron Scott covered parts of the event, including a Tuesday morning biotech roundup put on by the JDRF.
A Guest Report by Cameron Scott
This year’s JP Morgan Biotech Roundup was something of a victory lap for those in the industry. Investment spiked in 2014, with hundreds treatments entering clinical trials and dozens becoming available to everyday patients.
At the center of the industry’s high-fiving was type 1 diabetes.
In a prominently billed panel on Tuesday morning, JDRF’s chief scientific officer Dr. Richard Insel gathered the people behind the most talked-about recent advances — including ViaCyte’s stem-cell driven islet implant pouch, Tidepool’s open data platform, and Thermalin’s fast-acting insulin — to talk about where diabetes care is headed and what the biggest challenges are.
Everyone on this panel agreed that a closed-loop system, whether it’s electronic or bio-artificial, is an ideal way to treat those with type 1 diabetes. There’s some debate on whether those with type 2 could benefit from going on insulin sooner, so that the pancreas doesn’t wear itself out producing more insulin as the body becomes more insulin resistant.
We all know that financially speaking (as the participants of this conference are wont to do), type 2 diabetes is a much more lucrative area. The companies are clearly hoping that successes with type 1 diabetes, which affects roughly 1.3 million Americans, will lead to useful treatments to sell to the 30 million Americans with type 2 diabetes.
Readers here are also quite aware that the technology exists to offer a closed-loop pancreas now, but the devices are only available in clinical trials. Keys to making closed loop systems better for the masses involve easier data access, accurate CGM sensors, and fast-acting insulin.
On the panel, Tidepool CEO Howard Look spoke for the #WeAreNotWaiting movement, reminding the audience that it needs to be easier for patients to download and explore their data from insulin pumps and glucose monitors, since patients who do so can learn how to better keep glucose in check.
Richard Berenson, the CEO of Thermalin Diabetes that is developing a fast-acting insulin, said that quicker insulin action would do a lot to make artificial pancreases more responsive as the user’s needs change. Thermalin is also developing a more concentrated insulin that would require less of it inside a closed loop system. Patients who need more insulin could use it in a standard-size pump that exists now, or even the larger t:flex just approved by the FDA, but really it also means that those who take moderate amounts of insulin might be able to use slimmer hardware that might be even more discreet.
Thermalin is also working on insulin that doesn’t require refrigeration and could potentially survive a year at body temperature. That would allow for an implantable artificial pancreas, something mentioned by the panelists off-handedly as a hypothetical. Thermalin’s Berenson also noted that he doesn’t think an insulin pill will be very feasible, because people’s rates of digestion vary too much. Still, Thermalin does have open investigations into oral insulin, just in case.
As to insurance coverage of these new types of insulin, Thermalin is betting the farm that insurers will be willing pay for these premium meds. Insurance companies they’ve consulted so far “said tight glycemic control makes such a difference that, yes, we would continue to pay,” Berenson said.
Regarding Cure Research
If you’re of the mind that ViaCyte’s islet-in-a-pouch is the best way to go, stay tuned for results from the first human trials later this year. The company has just outfitted its third human patient with the pouch, called Encaptra, said CEO Paul Laikind. The Phase 1 trial is intended to test the safety of the device.
There are two questions about safety: Will patients will “reject” the banked embryonic stem cells as they would a transplanted organ, and will the sac ensure that any cells that veer off course and become tumors are contained.
Since all of the participants in ViaCyte’s trial are type 1s, if after the treatment they are producing insulin on their own, the trial will also prove that the pouch works. (The FDA will still require studies designed to test efficacy, though.)
The panel also talked about an even more radical idea: a “negative vaccine” that would prevent the body’s immune system from attacking itself and causing type 1 diabetes.
“One of the holy grails in immunology is to be able to induce immune tolerance,” JDRF’s Insel explained.
JDRF has funded Selecta Biosciences’ work toward a negative vaccine, which basically means is that patients at risk of developing type 1 diabetes would get a shot designed to teach their immune system not to turn against itself and destroy beta cells.
“This is in an antigen-specific way; it’s not like we are going to do immuno-suppression,” Selecta’s CEO Werner Cautreels said.
Of course, scientists still don’t know why the immune system attacks itself in first place, destroying the beta cells and leading to T1D. Amongst all the researchers globally studying this basic cause mystery, JnJ’s investment arm Janssen Pharmaceuticals is doing some of the most interesting work, developing what it calls a “disease interception” (see job description) to stop a disease from presenting, before it causes problems. JDRF is also focused on identifying biomarkers that would identify very early stages of the disease, and together all of that would add valuable pieces to the puzzle of trying to cure type 1.
Until the time of a cure arrives, tech and treatments are the holy grail, and thankfully experts are recognizing that different patients will continue to need different options.
“Patients are different, so in 10 years I hope we see a diversity of solutions,” Berenson said.