ADA preview: 5 things to watch in diabetes
The 77th Annual American Diabetes Association conference is set to begin today in San Diego. Running through Tuesday, the convention will highlight advances for the metabolic disease and likely bring further attention to ongoing issues that have been plaguing the space — particularly, the rising cost of insulin and problems with patient adherence to treatment.
This year’s conference will include more than 15,000 participants looking to consume the 378 abstracts and 2,152 poster presentations. Much like the ADA conference last year, which was dominated by cardiovascular outcomes data for Eli Lilly & Co.’s SGLT-2 inhibitor Jardiance (empagliflozin), some of the most pressing data will be further CV outcomes results.
The show isn't as relevant as it once was due to a dwindling diabetes pipeline, but there are still major pharma companies working diligently in the space. "This show has changed so much over the years because the business has changed so much. Diabetes drugs have really become commodities," said David Kliff — long time investor, diabetic and author of industry newsletter the Diabetic Investor — in an interview.
Here are several items from the conference that could get your blood sugar up:
Potential class-wide effect
Now that Lilly and Boehringer Ingelheim have garnered an updated label from the Food and Drug Administration for Jardiance that includes cardiovascular outcomes data from the EMPA-REG trial, other drugmakers are looking to prove that it’s a class-wide effect.
"If you look at Jardiance and the EMPA-REG data, which was really revolutionary — it didn't really help them sales-wise," said Kliff. "This tells you about the power of the payer, it tells you that a lot of the experts believe it was a class-effect; these drugs are really becoming a commodity in a way."
Johnson & Johnson will be presenting data on Monday from its own cardiovascular outcomes trial for its SGLT-2 inhibitor Invokana (canagliflozin). The first in the class approved by the FDA, Invokana grew the market and has long been the market leader, but having outcomes data in hand has allowed Lilly and Boehringer to gain ground.
The 10,000-patient strong CANVAS clinical trial program will provide further insight into the cardiovascular benefits of one of diabetes youngest classes of drugs. Lilly and Boehringer will also be making six presentations beginning Saturday further discussing EMPA-REG.
More outcomes data
J&J isn’t the only company presenting cardiovascular outcomes data. Novo Nordisk will be presenting further data from the 7,000-patient DEVOTE study comparing its basal insulin Tresiba (insulin degludec) with long-time market leader Lantus (insulin glargine).
The initial results were announced last November and showed that Tresiba was non-inferior to Lantus — although not superior. Although the Novo drug did show superiority on the secondary endpoint of hypoglycemia.
Novo Nordisk is now seeking approval from the FDA to get the info added to the label. Yet, the agency has been fairly strict with diabetes companies and hasn’t considered things like hypoglycemia to be major differentiators.
Keep an eye out Monday for more insight on how the struggling Danish drugmaker might seek further differentiation from competitors.
Amgen and competitors Regeneron and Sanofi have been making headlines for two years now for their pricey cholesterol-lowering PCSK9 inhibitors. Those headlines have gotten ugly, as both Repatha (evolocumab) and Praluent (alirocumab) continue to struggle commercially. Those struggles are further compounded by the ongoing legal battle between the companies over patent rights.
Diabetes is an area that PCSK9 inhibitors have only dabbled in. The high-risk patient population has been included minimally in previous clinical trials, but new data to be presented on Sunday will focus on trials specifically geared toward diabetes patients.
Previous clinical data has shown correlations between PCSK9 levels and insulin levels, but the new studies will look at the safety, tolerability and efficacy in the glycemic-related endpoints.
If the PCSK9 inhibitors are successful in this patient population, then this could be the commercial boost that these players need to finally make a dent in the market.
Both Apple and Google have been moving beyond their respective realms of computer hardware and the internet to get into healthcare.
While neither company has yet to enter the realm of clinical trials and drug development, they are about to make a splash on the diabetes landscape. Apple has partnered up with Dexcom to bring constant glucose monitoring to the Apple Watch. This addition could be a major advancement for patient adherence, allowing patients to have easier access to glucose numbers and better monitor their blood sugar.
Meanwhile, Google’s sister company Verily teamed up with Sanofi to launch OnDuo, a company meant to combine Verily’s software expertise with Sanofi’s diabetes experience to bring disease management solutions to patients.
Both of these deals are part of a larger trend toward using technology to bring better drug adherence solutions to patients. Technology is bringing to patients tools such as smart pill bottles to help them track doses, and cell phone apps that give them reminders about both taking medications and getting to physician appointments.
One of the many symposia to be presented throughout the long-weekend will deal with the rising cost of insulin. On Saturday, conference goers will be able to hear about how the diabetes staple has risen in price and what it means for the market and patients.
Companies including Novo Nordisk, Lilly and Sanofi have been under fire — even facing law suits — over how insulin prices have risen in recent years.
Yet, some in the industry argue the pharma companies aren’t to blame, that they are just complying with market forces while dealing with a complex payment system. "This isn't simple math, it's algebra. There are just tons of variables," said Kliff. "Insulin really doesn't cost too much. People get lost in the cash-paying side of the market, which is small percentage. If you have insurance it costs like nothing. A lot of patients don't understand rebates and net prices and all these other things."
While the industry will continue to point to the third-party payers as the evil doers of pricing, expect that debate to rage on, especially as more biosimilar insulins enter the market and put further pressure on pricing dynamics.
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