American Diabetes Association 74th Scientific Sessions

June 13-17, 2014; San Francisco, CA - Exhibit Hall - Draft

Executive Highlights

The ADA 2014 exhibit hall seemed to have less fanfare, attendance, and excitement than we’ve seen in the past. We took particular note of who was absent from the hall –Bayer, Roche, and Abbott – which likely reflects the challenging SMBG environment in the US, and perhaps these companies thinking more strategically about the return on investment from exhibit hall booths. In the modern era of digital and social media marketing, an argument could be made that exhibit hall booths are not as tactical a communications means as they used to be. Our coverage includes the following companies and organizations: Amgen, AstraZeneca (new Bydureon pen still deemphasized), BD, BI/Lilly, Boston Therapeutics, Dexcom (G4 Platinum Professional vs. Medtronic iPro2), Diasend/Practice Fusion, Eisai, Freedom MediTech, Glooko (Bluetooth sync and Joslin HypoMap), GSK (new Tanzeum pen), iHealth (new smartphone BGM), Insulet, Intarcia, J&J Janssen, J&J LifeScan/Animas, Lilly, Medtronic (MiniMed Duo on display, next-gen pump platform displayed), Merck, NeuroMetrix, Nipro Diagnostics, Novartis, Novo Nordisk (pre-launch of the FlexTouch pen), San Meditech (Chinese CGM company with a Telcare partnership), Sanofi, Takeda, Tandem, Telcare, Type 1 Diabetes TrialNet, Valeritas, and Vivus.

Exhibit Hall

Amgen

Amgen exhibited for the first time at ADA this year with a small blue and white booth more notable for its CardioChek cholesterol monitor (which generated a line of at least 10 people at any given time) than its size or grandeur. Amgen’s nearest term drug is evolocumab (AMG 145), a highly anticipated PCSK9 monoclonal antibody. Phase 3 results were presented at ACC 2014, and as of Amgen’s 1Q14 call, submission was expected in 2014. Without a product on the market to talk about, the medical information representatives were quite tight-lipped, though several animated videos taught passersby about the role of PCSK9 in cholesterol metabolism. As a reminder, Amgen has just one diabetes candidate left in its pipeline: AMG 876, an undisclosed fusion protein (we believe it to be an FGF-21 analog) that remains in phase 1, on which there was no new news in Amgen’s 1Q14 call (it has been in phase 1 for at least two years). Amgen used to have a phase 2 glucokinase activator (AMG 151), but returned rights to Array in September 2013.

AstraZeneca

AstraZeneca’s main booth was a towering, white and purple sleek booth in the center of the hall near the back wall. Featuring a double deck structure, big white banners along the top of the booth advertised the company’s diabetes and endocrine products (Bydureon, Byetta, Onglyza, Kombiglyze, SymlinPen, and the newly approved Myalept). The first floor was lined with wavy white leather couches, plush purple and gold carpeting, and had soft purple lighting - an aesthetic departure from the blue and white of old BMS/AZ joint alliance booths. A never-ending line of people queued up for coffee and tea at the booth's entrance.  Six-paneled flatscreens on the front and sides of central structure each advertised one of AZ's six main diabetes products. The main central structure was flanked by tall flat screen panels, each showing A1c, weight loss, and other clinical data for their products, with a focus on Byetta, Bydureon, and Farxiga. The panels extolled the extra-glycemic effects of each of these, including the weight loss and blood pressure benefits of these drugs. Unfortunately, as was the case at AACE, there was no mention of the new Bydureon dual-chambered pen in any of the booth's materials or anywhere on display. This is the new Bydureon device developed to eliminate the need for manual patient-end reconstitution of the powdered drug. The FDA approved it in March, and AZ has guided for a 2H14 launch. We had to ask a rep to walk us all the way around to the cave-like Medical Affairs nook hidden away in the back. There, a representative walked us through the steps to use the new pen. The pen is fairly large - we estimate that it was about 8-9 inches long fully extended with a circumference somewhat smaller than that of a US quarter. The needle was also relatively large, a 23-gauge needle, but is 1 mm shorter than the one in the current Bydureon system. We learned that the needle could not be any smaller due to the microsphere technology of the drug. For comparison, Lyxumia's pen in the EU can be used with 29- and 32-gauge needles. The current Bydureon system uses a 23-gauge needle as well, however, and we have not heard negativity around it (we've used it and it didn't hurt!). In general, we think the new pen will be a slight convenience upgrade over the old complex process. The representatives at the booth were not able to give us more specifics on when it might launch, although we did learn at AZ's exhibit hall booth at AACE that it would likely be priced similarly to the old Bydureon system. The instructions for use are as follows:

1) Take the pen out of the refrigerator and let it sit at room temperature for 15 minutes.

2) Inspect the powder and diluent through the chamber's viewing windows to ensure that they are not discolored.

3) Attach the needle to the pen.

4) Twist the knob at the bottom of the pen to combine the powder and solvent.

5) Shake until fully mixed. It is recommended to tap the pen against the palm about 80 times, rotating the pen 90 degrees ever 15-20 taps, to ensure proper mixing (the representative acknowledged that this sounded like a lot of shaking), but patients may also check halfway through to see if the powder has been fully mixed (there is an image in the user guide to help patients determine what the window should look like fully mixed). There was no actual powder or solvent in the demo pen, but there were images placed in the viewing window showing what the patient might see if it were fully mixed or not. The fully mixed suspension should be homogeneously white with no particles or clumps.

6) Twist the knob at the bottom of the pen again until you hear another click.

7) Remove the cover for the needle and swab the injection site.

8) Inject, pressing down and holding for 10 seconds.

BD

We quickly spotted BD’s booth from two prominent ceiling signs that read, “Helping all People Lead Healthier Lives.” The exhibit space included a three-foot wide panel at each corner, and a long wall across one of the shorter sides of the booth. The exhibit focused on “IT,” or injection technique, with the takeaway that BD’s shorter needles (Ultra-Fine 6 mm needle for syringes or the Ultra-Fine Nano 4 mm pen needle with EasyFlow technology) will improve technique (rotating injection sites and injecting the needle at the right angle, to name a few). Each panel included a short video demonstrating how better injection technique will reduce pain, decrease lipohypertrophy, and improve the consistency of insulin delivery. The video alternated between research results from BD’s own work and pictures of smiling patients with quotes such as, “Less Pain – IT matters” and “IT – consistent insulin delivery.” On the larger wall, there was a screen projecting an aerial view of the center table, where “Lipo Larry” was spread out on an examination table – this dummy invited attendees to feel the lipohypertrophy on Larry (surprisingly difficult!) – we found this didn’t draw as many attendees as the real patient at EASD; however, the hands on participation was nonetheless appreciated. Unsurprisingly, the representative we talked to could not provide any information on BD’s potential patch pump/pen or its CGM partnerships with JDRF (a standalone CGM as well as an insulin infusion set/CGM).

BI/Lilly

This booth was a bit toned down compared to last year, with a sleek white appearance instead of the signature exuberant purple. Large rectangular screens provided safety and efficacy data on Tradjenta and Jentadueto. There was little in the way of entertainment beyond the standard coffee and espresso stand. As the much more elaborate Lilly Diabetes booth also included information on Tradjenta and Jentadueto, there seemed to have been an effort to consolidate the two displays. A wall next to the medical information booth outlined the many new diabetes products in BI/Lilly’s pipeline (e.g., the SGLT-2 inhibitor empagliflozin and BI/Lilly’s new insulin glargine formulation), and it will be interesting to see whether this booth receives more attention in the future if those drugs are approved.

Boston Therapeutics

Boston Therapeutics occupied a small and mostly empty booth near the left side of the exhibit hall. The back wall was covered by a large blue poster that donned the company’s logo and two lines of text, one which read “Non-systemic approach” and a second one below which read “Post-meal blood sugar management.” A rep explained Boston Therapeutics’ oral diabetes management drug, BTI-320, a chewable tablet derived from glucomannan (a carbohydrate-hydrolyzing enzyme inhibitor) that inhibits release of glucose from complex carbohydrates. A handout discussed BTI-320’s phase 2a trial results published last year: a 40% reduction in post-prandial glucose in 45% of patients, with only mild GI side effects. The tablet is currently in a phase 2b trial to further assess safety and efficacy. The rep told us that BTI-320 is currently sold as an over-the-counter supplement named SUGARDOWN, two bottles of which were displayed next to the monitor – we must admit, the product’s website makes it look like the sort of supplement that would be sold on late night infomercials (“Doctor Recommended”; “Supports Healthy Sugar Levels”; $39.99 + $8.95 for a 70-tablet bottle that lasts an unspecified amount of time). Apparently, people without diabetes can also take SUGARDOWN after meals to ward off feelings of sleepiness associated with the postprandial blood glucose spikes. We remain somewhat skeptical, though appreciate that the company is conducting clinical trials to support its claims.

Dexcom

Dexcom had one of the largest booths we’ve ever seen it display, sporting yet another new clever marketing slogan: “Don’t just meter. Monitor.” We love that message for patients. The main news of the booth was Dexcom’s recently approved Professional version of the G4 Platinum (read our report) – bold signage offered providers that use the Medtronic iPro2 a free trade-in for the G4 Platinum Professional system (receiver + transmitter). To qualify, providers must purchase two boxes of G4 platinum sensors and send in their iPro2 system by September 30, 2014. A comparison table emphasized the advantages of the Professional G4 Platinum over the iPro2, including performance (real-time [Dexcom] vs. retrospective [iPro2]), flexibility (unblinded/blinded vs. blinded only), duration (seven days vs. three days), comfort (26 gauge vs. 23 gauge), and convenience (two calibrations/day at any time vs. four calibrations/day during stable glucose state). Meanwhile, providers currently using the professional edition of the Seven Plus will get a free upgrade to the G4 Platinum Professional system (provided they purchase two boxes of sensors). The remainder of Dexcom’s booth was dotted with marketing materials of all sorts, headlined by the first official brochure we’ve seen on Dexcom Share (in the final stages of FDA review, per Dexcom’s 1Q14 call). The flyer showed a mom hugging her son under a picture of the G4 Platinum receiver in the Share docking cradle – across the top was the phrase, “Remote viewing of glucose activity between your patients and their loved ones is now made possible through Dexcom Share.” Other signage and handouts marketed Dexcom’s two other recent developments – “many plans” now offer Dexcom CGM as a pharmacy benefit, “simplifying the process and making it more affordable than ever for patients” (a highlight of the AACE 2014 exhibit hall); and the FDA approval of a pediatric indication for the G4 Platinum.

Diasend/Practice Fusion

Practice Fusion shared a booth with Diasend, with whom the company syncs data from blood glucose monitors, continuous glucose monitors, insulin pumps, and mobile apps (the two companies announced an EHR collaboration in March). The headline news for Practice Fusion was its new analytics product, “Insight,” which was unveiled earlier this month. The online program provides HCPs, payers, pharmaceutical companies, industry analysts – or any curious individual – with population-level data on key clinical trends. The basic, free package includes week-over-week diagnostic trends and drug market share trends, compared to other drugs in the class – a valuable tool for marketing or drug-class analysis. Significantly, many drugs for type 2 diabetes are in the database, including an array of SGLT-2 inhibitors, GLP-1 agonists, DPP-4 inhibitors, as well as metformin – in fact, the “preview” drug for patients, prescribers, and treatment was Janssen’s SGLT-2 Invokana. Insight analyzes this data in real-time, drawing data from a de-identified subset of more than 81 million patient records on Practice Fusion’s extensive EHR platform. Practice Fusion’s extensive EHR platform that covers 64 million patients. We were impressed with the big questions Practice Fusion has tackled, as well as the program’s easy-to-use interface. The program can be accessed for free here, and there is also a premium version that has more data. Insight is currently only drawing off of drug data, though Practice Fusion hopes to expand its market analysis into technology, as well.

Eisai

Eisai’s coral, navy blue, and white booth consisted of a number of interactive activities while highlighting Eisai/Arena’s anti-obesity medication, Belviq (lorcaserin). Similar to last year’s ADA, several flower arrangements were scattered around the booth, seemingly referencing to Belviq’s trial names: BLOOM, BLOOM-DM, and BLOSSOM. On the outside of the booth’s walls, screens lit up with animations of scales, sneakers, and stethoscopes, portraying Belviq as “proven weight loss with lasting impact.” In one corner – under a sign asking, “What are you made of?” – representatives conducted full body analysis on attendees, providing them with their BMI, percentage fat etc. The booth’s center wall declared “Pledge and Poll.” Here, attendees were asked questions about their experiences with obesity and to pledge to start conversations about weight with their patients. Another wall had illuminating screens of Belviq’s trial data. A representative offered to give us an overview of Belviq on an interactive screen, in which he showed us clinical data on its weight loss and glycemic levels, its safety profile, and Eisai’s free trial and savings programs. Upon asking how Belviq compared to Vivus’ Qsymia, the representative said that he was not going to “bad talk” Qsymia since he had heard positive reviews of that drug as well. We enjoyed the interactive and friendly atmosphere of Eisai’s booth.

Freedom Meditech

This small booth off the main convention floor offered impressive demonstrations of the company’s Clearpath DS-120 device, which measures autofluorescence on the lens of the eye as a diagnostic tool for diagnosing prediabetes and diabetes. Representatives invited visitors to have their autoflourescence measured – the test takes less than a minute, and most of that time was taken up by gathering basic biographical information! Other reps offered literature detailing the device’s success as a diagnostic tool relative to A1c and fasting plasma glucose tests; according to the data, autofluorescence achieves a sensitivity of 67% and a specificity of 94% in testing for diabetes, compared to 44% and 79% for A1c measurements and 50% and 95% for fasting plasma glucose tests. The device is designed to be used as part of an optometrist’s eye exam, where the company is optimistic that a far greater pool of potential patients will be tested; Freedom Meditech’s literature notes that an estimated 105 million people get eye exams in the United States each year, compared to just 40 million making a regular visit to their primary care physician. While ophthalmologists and optometrists are the most likely users of the device in practice, Freedom Meditech brought the Clearpath to the Exhibit Hall in the hopes that endocrinologists and other healthcare providers would be able to familiarize themselves with the device.

Glooko

Glooko’s small booth in the back of the hall attracted a crowd interested in learning about the Joslin HypoMap, which we first reported on earlier this week. As a reminder, this contextual survey will sit within the Glooko app and help providers and patients identify and improve hypoglycemia unawareness. Our trip to the Glooko booth was headlined by a demo of the company’s Bluetooth adaptor, which is hopefully expected to launch this summer. This small plastic rectangular box (about 1.5 in x 0.5 in) will plug into the 27+ meters that Glooko supports and wirelessly send data to the Glooko app. It looked quite seamless to us, and as we understand it, the company is working on seamless background sync that would not require the app to be open.

GSK

GSK’s booth was located towards the back of the exhibit hall. It was large, and fairly sparse, though very welcome – the only drug-related content came in the form of four displays featuring the raw label for GSK’s approved but not-yet-launched once-weekly GLP-1 agonist Tanzeum (albiglutide; branded Eperzan in the EU, where it was also recently approved). Most of the booth was uncluttered, with plush purple-carpeted floors and a few chairs and couches where attendees could rest, recharge their electronic accouterments, and much on some very sweet granola. Attendees had to walk to a separate GSK medical booth to see a demo of the single-use pen and administration process for Tanzeum – the drug does require reconstitution, and as with the new (much bigger) Bydureon dual-chambered pen, the reconstitution process is contained within the pen and takes slightly upwards of 15 minutes. As opposed to the Bydureon pen, however, albiglutide does not need to be stored in the refrigerator if it is used within a few weeks after purchase. Patients will first twist the pen to the first stop, mixing the contents of the powder chamber and water chamber. Next, the patient will gently shake the pen five times, then place it upright in an empty cup for at least 15 minutes (thankfully for forgetful patients, the pen can rest at this stage for up to eight hours and still be usable). After the break, the patient once again shakes the pen gently five times, twists to the second stop, and then administers the drug. We imagine that GSK’s conference booths will get much more exciting following Tanzeum’s launch, which will likely occur in the third quarter.

iHealth

Tucked away in the very far right corner of the exhibit hall, iHealth’s small table was headlined by demos of the company’s newly launched Align smartphone blood glucose meter – as a reminder, the Align does not function as a standalone meter, but plugs directly into the headphone jack of a user’s smartphone and displays and stores results on the free iHealth Gluco-Smart app (you can view the device and app on the company’s webpage here). Representatives showed off the meter and emphasized the aggressive strip pricing ($0.25/strip, or $12.50 for 50 strips), which aims to make the strips so affordable that insurance reimbursement is not needed. The booth’s reps highlighted that the Align has “gotten a lot of good feedback in the last couple days.” As we noted in our original report, the product is available on the company’s website and eventually on Walgreens.com. In addition to the Align, iHealth’s Smart Gluco-Monitoring System was on display, the company’s first foray into the BGM market with a Bluetooth enabled standalone meter (launched in October 2013). The table also showed off iHealth’s other connected devices, from wireless scales to fitness trackers to blood pressure monitors. Reps touted the iHealth MyVitals and Smart-Gluco mobile apps, compatible with both Apple and Android systems, which sync with the company’s devices and enable users to measure, track, and share data. Certainly, iHealth has a broad ecosystem of consumer-friendly, connected health devices, and we look forward to seeing how the company integrates all of the products.

Insulet

Insulet sported a smaller booth than we’ve seen in the past, though it was well located near the hall’s main entrance – location is everything! A large sign proclaimed the benefits of the second-gen OmniPod, “Easy to use, wearable, and waterproof.” Pictures of patients tended to display the OmniPod on the tricep, putting a clear emphasis on the product’s small size and wearability. Eager attendees could step up to one of three podiums and receive a demo of the OmniPod system. We did not notice any of the giveaways that Insulet has had in the past, which have included general posters on pump therapy, solid chocolate OmniPods, or demo pod kits (though perhaps these were just not noticeable when we walked by). There was no mention of yesterday’s announcement that the integration partnership with Dexcom is back on. 

Intarcia

Intarcia did not bring a formal booth to the exhibit hall, but instead had a private training suite where their clinical nurse force were training investigators who are already participating in their global phase 3 program.  The nurses and investigators were demonstrating the insertion and removal process for the ITCA 650 exenatide mini-pumps. The placement and removal procedures were astoundingly simple. The mini-pumps can be inserted into the patient’s abdomen, upper thigh, or back of the arm. Once the area is sanitized and a local anesthetic is applied (which means the patient is awake during the procedure), a tiny incision is made with the tip of a scalpel – it looked to be about only 4 mm wide. The match-stick sized ITCA 650 device is then loaded into a thin tube in the insertion device. The insertion device looks like, and is about the size of, a small water squirt gun with the thin tub attached to the “spout” of the gun. The tip of the beveled tube is inserted into the incision at about a 45-degree angle until it is just under the skin, at which point the tube is slid further into the incision, but parallel to the skin keeping it very close to the surface. The insertion device is then stabilized with the free hand, and a sliding trigger is engaged such that the tube releases hold of the ITCA 650 mini-pump, leaving it in the body while the tube retracts back into the device out of the skin. No sutures are needed – the incision is essentially covered with a band aid. If the device has been properly inserted very close to the skin’s surface, retrieval takes a matter of seconds. One of the ends of the ITCA 650 mini-pump is tented up against the surface of the skin, where another tiny 4mm incision is made on the tip where you intend to remove it, and it simply pops right out. Then the new ITCA 650 mini-pump is loaded in the same location in just a matter of a couple minutes.  For chronic therapy this would only be done once or twice a year.  If the device has been placed too deeply beneath the skin, then retrieval may be more difficult – the company learned this in phase 2, so all investigators in phase 3 have been trained and certified by a global nurse educator force to ensure that the device is inserted just beneath the skin. Management informed us that over 5,000 procedures have been performed in phase 3 at this point, representing over 2,800 patients enrolled, who receive an initial three-month titration implants (20 ug/day) followed by six-month full-dose implants (60 ug/day).

J&J Janssen

Like last year, Janssen occupied about a third of the large, centrally located J&J exhibit. The company’s SGLT-2 inhibitor, Invokana, was of course the major focus, and it has now been on the market for four full quarters. [As of J&J’s 1Q14 financial update, we estimated that sales roughly reached $89 million, a nice sequential increase from our $40-75 million estimate for 4Q13].  Surrounding a lounge area with white sofas were several touchscreens where visitors could explore glucose reabsorption for healthy people and for patients with diabetes, as well as see the mechanism of SGLT-2 inhibition in action. The touchscreens also showcased the various benefits of Invokana on A1c, weight loss, and blood pressure. The booth continued the artistic theme from last year, with kidney shaped easels for painting tiles on a mosaic. 

J&J LifeScan/Animas

LifeScan/Animas’ presence is shrinking in J&J Diabetes Care’s real-estate, from approximately two-thirds of the booth at the EASD exhibit hall to only about one-third of the booth here at ADA 2014. Clearly, the success of Invokana has shifted the company’s marketing priorities. Fortunately, one Animas representative assured us that J&J is here to stay in Diabetes Care, an emphasis during the recent Medical Devices Business Review Day. At the very front of J&J’s booth was an approximately six-foot tall, one-foot wide white board with sticky notes covering almost one-half of it; upon closer examination, we found that J&J representatives had posed the question, “How can we engage families of patients with diabetes to be positive agents of change?” HCPs were invited to write their response on a sticky note and put it on the white board – creating a very crowd-sourced mini market research project. Some of the more common responses were to increase community and family education to reduce stigma and spread the responsibility of care (our sister company dQ&A has an entire poster on diabetes stigma this year – see it tomorrow in abstract 59-LB). Turning to Animas, it was not a surprise that representatives declined to comment on the timeline of the Animas Vibe – as a reminder, the Medical Devices Business Review Day noted that the company had just responded to questions from the FDA (this has been under review for over one year). Similar to booths over the past few years, Animas OneTouch Ping pumps floated in water to show off the water resistance feature. LifeScan was relegated to one small, circular counter space that displayed the company’s meters, including the OneTouch VerioSync recently launched in the US in January. Representatives from Animas and LifeScan were unable to comment on either a launch date for the Finesse (at the MD&D day, the Finesse was expected to launch within 24 months) or launch metrics on the VerioSync in the US. For those attendees who were feeling peckish, the center of the booth featured iced tea, sesame sticks, goldfish, almonds, peanuts, craisins, and dark chocolate covered pretzels.

Lilly Diabetes

Walking into the exhibit hall, this booth was not hard to find thanks to the bright red circular display hanging from the ceiling. Just as at last year’s ADA, this exhibit was modeled after a home; visitors were greeted by a brick “fireplace” with a crackling onscreen fire and then proceed into a living room complete with a stand giving out delicious espresso and a huge flat-screen TV playing ESPN, along with photos of smiling patients and doctors on the walls and quotes about life with diabetes prominently displayed on screens. The other “rooms” of the house were more topical; one room featured Humulin U-500 and the chance to find out your “U-500 IQ,” and a window overlooking the “front porch” displayed the BI/Lilly products Tradjenta and Jentadueto along with several signs reminding providers to ask about new safety information, including a boxed warning about the risk of lactic acidosis with Jentadueto. The “kitchen” of the house was dedicated to Humalog, with Lilly’s various pen devices comprising the centerpiece of the table. Another creative “room” was modeled after an elementary school classroom complete with children’s desks and cubbies with lunchboxes, with an emergency glucagon rescue kit and reassuring messages for parents about hypoglycemia interspersed among these props. Several rows of iPads on one of the outer walls of the booth offered a trip through Lilly’s long research and development history, and a large screen was devoted to their novel basal insulin peglispro. Finally, Lilly continued to highlight its innovative partnership with Disney and its resources for children and teens.

Medtronic

Medtronic’s packed, expansive booth had a disproportionately large crowd gather in one area: the international section. On display was the company’s MiniMed Duo combination insulin infusion set/CGM sensor, which launched earlier this month (read our detailed report). Elsewhere in the booth, the emphasis was on the Veo with Enhanced Enlite (international section) and the MiniMed 530 with Enlite (US section). Notably, pictures on the wall showed the next-gen MiniMed 640G pump platform, which we cannot ever recall seeing displayed in a US exhibit hall. The new pump platform was flanked by a smartphone and tablet device running what looked like closed-loop control – this implied that a future Medtronic pump like the MiniMed 670G (which will offer hybrid closed loop, per the Analyst Day a couple weeks ago) will send data to smartphones and tablet devices. Dotted throughout the booth was a line of experimental Medtronic clothing, which had pump-sized pockets sewn directly into the shirt. Other pipeline items from the Analyst Day – the MiniMed Flex “hybrid pump,” the Enlite 3 sensor, and the type 2 business – were not mentioned in the booth.

Merck

Merck’s booth promoted the ability to use the Januvia franchise (Januvia, Janumet (combination sitagliptin and metformin HCl) throughout the natural history of type 2 diabetes. Large panels around the booth guided HCPs to “help patients on their journey.” For example, HCPs could visit different stations on this journey, including “newly diagnosed,” “earlier,” “later,” and “renal insufficiency.” The “newly diagnosed” area highlighted Janumet’s greater A1c improvement than metformin alone. Whereas, the “later” or “when insulin is added” section described how Janumet gets to the “root of the problem” by improving beta cell function, and has a “strong A1c lowering affect with insulin.” One corner (comprising a little over 25% of the booth’s footprint) was dedicated to Merck’s education program “Steps to Diabetes Goals” – a revamped version of its previous program “Steps to Balance.” “Steps to Diabetes Goals” features a more patient friendly website, where they can receive support and educational information on blood sugar, losing weight, being active, stressing less, eating smarter, and managing type 2 diabetes. Additionally, the website encourages patients to connect with their doctor, and provides tools to make appointments more effective (e.g., a discussion guide). Finally, this section enabled HCPs to experience one of the symptoms of hypoglycemia (blurred vision) with goggles that distorted one’s vision. The respectable aim of this activity was to help HCPs better empathize with their patients’ experiences – we have noticed an increasing trend at industry events and booths of having HCPs experience being a doctor (for example, at IDF 2013, Novo Nordisk had HCPs try taking a saline injection).

  • America’s Diabetes Challenge: The Merck-sponsored America’s Diabetes Challenge had floor space in the center of the exhibit hall. As background, the American Diabetes Challenge is urging people with type 2 diabetes across the country to know their A1c and talk to their HCP about setting and attaining their A1c goal. The booth asked visitors to symbolize their commitment to these actions by placing an “I Support America’s Diabetes Challenge” magnet onto where they are from in the US (given that a large portion of ADA attendees are international, we think it would have been nice for their to be some way for them to participate). In moving a magnet, visitors uncovered striking statistics on the small portion of people with diabetes who know their A1c goal, and even fewer who are reaching it (e.g., “Nearly half of people with diabetes are not at an A1c <7%”). People visiting the booth were also offered bottles of juice – we would have preferred to see a low sugar beverage offered instead.

NeuroMetrix

After making their big debut at last year’s ADA, the makers of the Sensus pain management device for diabetic neuropathy offered a relatively low-key booth at this year’s Exhibit Hall. With their DPN Check product geared toward the Asian markets and the Sensus still gradually working its way to patients, the NeuroMetrix booth eschewed flashy promotions and simply focused on demonstrating the Sensus to visitors. Representatives walked around with pant legs rolled up to better display the wearability of the Sensus around the thigh, and we were told that several visitors to the booth had tried out the Sensus for themselves. In conversation with NeuroMetrix representatives, we learned that one larger technological trend could be a boon for the company: The huge popularity of Fitbit and similar devices has made the concept of wearable technology far more acceptable to people at large, and that in turn should make patients more receptive to the idea of wearing the Sensus. We imagine it will only help healthcare providers when discussing the Sensus with patients. Looking further ahead, representatives mentioned Sensus’ recent approval for overnight use and the potential in the long run for an over-the-counter version of the device.

Nipro Diagnostics

Nipro’s rectangular booth advertised a range of BGM products, setting up an interior that was plastered with slogans such as, “Accuracy is Confidence” (perhaps combatting perceptions that Nipro’s store-brand meters are not as accurate as branded offerings). The booth prominently featured the company’s two flagship blood glucose meters, the TRUEresult and TRUE2go, though management was particularly excited to discuss its new meter, the TRUEmetrix, which received FDA 510(k) clearance on April 24, 2013. The TRUEmetrix was touted for exceeding the newest, more stringent ISO standards and for its event-tagging feature (pre-post meal, exercise, sick, medication, and other) to help “users make the connection between personal lifestyle and results.” The booth also showed off Nipro’s new TRUEplus Diabetics’ Skin Care products that target the specific needs of patients, from those with moderately dry skin to those suffering from cracked feet. These creams were showcased alongside an already growing TRUEplus line that includes fast-acting glucose gels, tablets, and sharps (e.g., single-use insulin syringes).

Novartis

The company’s booth held its ground at the front of the Exhibit Hall this year, with a stylish and unique take on the global implications of diabetes – the overall theme was one of outreach, as Novartis does not have a diabetes drug on the US market (its DPP-4 inhibitor Galvus (vildagliptin) was not approved by the FDA in 2008). Posters displayed the emphatic slogan: “It’s time to do more in diabetes” – no argument there! As part of the focus on international medicine, the middle of the booth featured a spinning globe with printed facts about how diabetes impacts specific countries. The globe was positioned on a docking stand that displayed the phrase, “Time to recharge?” and provided outlets for ADA attendees (from all over the world) to charge their cellphones. Tablets around the booth provided data from the company’s international survey that we first saw at ADA 2013. The survey assessed international attitudes towards diabetes care and barriers to optimal patient care.

Novo Nordisk

Novo Nordisk’s central ADA booth once again received prime placement right at an entrance of the exhibit hall. As opposed to last year, this year’s booth lacked a second-story presence – that award went to AZ’s double-decker structure – but it compensated by having an expansive footprint. The design motif was once again a clean bright white, with hardwood floors and well-lit displays and screens for each of the major products on display. The continuous aerial banner that ran the circumference of the booth (which included video screens) highlighted two products: Novo Nordisk’s once-daily GLP-1 agonist Victoza (liraglutide) and the brand-new FlexTouch pen for the basal insulin Levemir (insulin detemir). We learned from a sales representative that the Flex Touch will be shipped out to wholesalers in just a few days, and that ADA is the product’s debut party. The most visible one-third of the booth, the side fronting the entrance to the hall, was entirely dedicated to the FlexTouch. The new pen is currently the only pre-filled insulin pen with no push button extension, meaning that the button end of the pen does not telescope out when dialing up to a bigger dose and requires less thumb extension. We found the company’s main catchphrase, “Because we can’t redesign thumbs, we designed the FlexTouch,” quite clever, especially when emblazoned on the image of a thumb struggling to reach a hyper-extended button on a non-FlexTouch pen. The same displays advertised other benefits, including: (i) maximum dosing up to 80 units; (ii) an end-of-dose click to notify patients when the pen has finished administering the drug – we tried this out, and it was clear from the very pronounced final click that the injection was complete; and (iii) that the pen is available on more than 96% of managed care plans nationwide (comparisons included on the FlexTouch displays suggested that this figure beats out coverage for the flagship Lantus pen). During the year following the FDA Complete Response Letter for Tresiba (insulin degludec), Levemir has benefitted from the marketing investments that were made in preparation for Tresiba’s launch, and has been Novo Nordisk’s fastest-growing insulin as a function of % sales growth (see our Novo Nordisk 1Q14 Report for details). The marketing metaphor for Levemir (the drug product itself) was a Newton’s Cradle (the row of swinging metal balls on strings that is a corporate office mainstay), with the tagline “Initiate the momentum of control with Levemir” – each of the metal balls represented one of Levemir’s benefits, including “better weight loss than Lantus.” 

  • Separated from the Levemir section by the A1c test desk, the central portion of the booth was largely given to the Victoza, and included displays noting that the product is the most-prescribed GLP-1 therapy worldwide and the number-one prescribed new-to-incretin brand among endocrinologists. The rearmost portion of the booth had a lot going on. One corner had a “live agenda theater” complete with stepped seating, featuring two rotating presentations, one on the FlexTouch, and another on the company’s “triple bottom line” approach to sustainability. Facing outwards onto the hall floor, a long line of people were signing up for Novo Nordisk’s signature 5K, while others were learning from a cluster of representatives talking about the Diabetes Attitudes Wishes and Needs 2 (DAWN2) study (tagline: “How can we change what we do not understand?”). A series of representatives and desks with pens were dedicated to the topic of Novo Nordisk devices (“imagined by patients, engineered by Novo Nordisk”).
  • We were wondering what happened to the main NovoLog (insulin aspart) and Team Novo Nordisk exhibits, until we found them co-locating at their own separate (albeit much smaller) booth nearby. Multiple members of the team were present, and two displays and a small group of sales representatives discussed NovoLog and the new NovoPen Echo (a half-unit-adjustable pen targeted for children, with a memory function that was drawn interest even from adults – apparently samples are flying off the shelves). Novo Nordisk was the sponsor of a set of rest-and-recharge stations around the exhibit hall.

San Meditech

The TD Integrated CGM was on display at the San Meditech booth, which was decorated with a product timeline, a graphic describing the company’s partnerships, and photos of Chinese landmarks (including a large cutout of the Great Wall). The TD Integrated CGM is notable for its short, hard sensor wire (which allows the sensor to be inserted without a separate insertion device) and its lack of a dedicated receiver. Glucose data are sent directly from the transmitter to an app on the patient’s smartphone and to the cloud (we presume that the cloud connection is via the smartphone app, since the CGM transmitter itself is not a cellular device). According to the timeline on the booth, San Meditech’s previous offerings include retrospective CGM (2003), real-time CGM (2007), and wireless CGM (2012). Today San Meditech controls 80% of the Chinese CGM market, which is much smaller than the US’s but also faster-growing, according to a company representative. As for the US, San Meditech is “at least a couple years” away from FDA approval, but has teamed with Telcare and SOOIL to develop a platform integrating SMBG, CGM, and insulin delivery – a partnership that reportedly got started at last year’s ADA. We understand that Telcare plans to set up a private Android environment on its cellular-enabled blood glucose meter so that Telcare’s SMBG app and San Meditech’s CGM app would be able to communicate. Thus the meter could display CGM data and the CGM could be calibrated without manual entry of blood-glucose data. (For more on this partnership, see our coverage of Telcare at the 2013 Mobile Health Summit). To prepare for US trials, approval, and launch, San Meditech was on the lookout at ADA for strategic partners. The company was also exploring partnerships for distribution in Europe, where it gained CE Mark clearance in January 2014.

  • The TD Integrated CGM features a transmitter with a Bluetooth radio tethered by cable to a sensor with two short, hard wires; the transmitter sends data to a smartphone rather than a dedicated receiver. The sensor’s two wires (an anode and a cathode) are each 4 mm long and perpendicular to the skin. A company representative explained that no separate insertion device is needed: the wires are apparently sharp and sturdy enough to puncture the skin! Because the wires are so short, the sensor does not require much subcutaneous fat to be inserted, but it is also susceptible to dislodging. Evidently most patients wear their CGMs on the upper arm; San Meditech provides armbands designed to help keep the sensor and transmitter in place. (Cloth armbands are for general use, while plastic armbands are used for swimming or showering.) The sensor’s current lifetime is five days, but San Meditech is working towards 10-day wear time (we think that this would be in a future model). The transmitter lasts roughly six months.
  • In an accuracy study on display at the San Meditech booth, the CGM achieved a mean absolute relative difference (MARD) of 14.8%. (We did not learn the details of how this study was conducted and so do not feel confident making comparisons to the FDA-labeled MARDs of the Dexcom G4 [13%] and Medtronic Enlite [14%].) The San Meditech system’s Clarke Error Grid A and B scores were 76.5% and 22.2%, respectively.  
  • Two next-gen sensor/transmitter prototypes were on display at the San Meditech booth. The designs were slightly different shapes, but each had roughly the diameter of a paper-towel tube. The sensor and transmitter appeared so closely coupled that they almost looked like a single piece; we are not sure how patients would switch out the sensor.
  • The company’s partnership with Telcare is not strictly exclusive, so the company could theoretically port its CGM data to other apps in the US. (By the same token, we assume that Telcare could display data from other CGM systems.) That said, for now San Meditech seems to be keeping its US focus on its relationship with Telcare and SOOIL.

Sanofi

The massive spiral-shaped Sanofi booth of soft whites and deep blues has some familiar features: the massive line of people waiting for CDs containing all the ADA abstracts and posters (very useful for us as we finish our full report of the top posters and abstracts), and a five-foot tall Lantus Solo-Star pen that served as a major photo-op for exhibit hall attendees. In a time span of less than two minutes, we saw three different groups ask to have their picture taken with the pen, which – despite the ADA policy of no photography in the exhibit hall – didn't seem to bother the Sanofi representatives. We saw this popular structure last year in Chicago as well, and Sanofi keeps bringing it back, capitalizing on its unusual appeal. Also notable was Sanofi’s repeated emphasis on their Lantus mantra that was printed on nearly every wall of the exhibit: “The ONLY basal insulin with DATA that show proven sustained HbA1c control over 6 years, exclusive once-daily 24 hour coverage, and demonstrated long-term CV safety.” It appears that the message Sanofi wants to drive home is that Lantus is the most established and well-known basal insulin: the front of the booth, a ten-foot tall 3D message read out “Go with the one you know.” The booth largely stuck to that single product and message, as Lantus’ is Sanofi’s major product in the US (the GLP-1 agonist Lyxumia [lixisenatide] is currently only available in Europe).

Takeda

While many companies choose to display statistics and numbers to catch exhibit hall attendees’ eyes from afar, Takeda’s more intimate approach required attendees to walk up and interact with the handful of iPad-operated displays themselves. Takeda, who launched the DPP-4 inhibitor Nesina (alogliptin) about a year ago, is currently pushing Nesina as well as Kazano (alogliptin/metformin) and Oseni (alogliptin/pioglitazone). According to Takeda, although the ADA standards of care finds DPP-4 inhibitors to only offer modest A1c reductions in comparison to TZDs (thiazolidinedione), many providers and patient find similarly significant A1c reductions under both treatments. Further, they find that Oseni offers greater A1c reductions than either alogliptin or a TZD alone. The results of a Japanese head-to-head study (the COSVA trial) comparing Nesina to Merck’s Januvia (sitagliptin) and Novartis’ Galvus (vildagliptin) are being presented as a poster (1024-P).

Tandem

Tandem’s booth was smartly located near the product theater area of the Exhibit Hall, reprising the company’s modern, wood-floored, glassy look. The company did not have any new marketing or products to share information about – as a reminder, FDA submission of the G4 Platinum integrated t:slim is expected this month, while submission of the 480-unit t:slim is expected in mid-2014.

Telcare

Situated at the far end of the ADA exhibit hall, Telcare’s booth focused on a new partnership with the Joslin Diabetes Center – according to their press release, Joslin will help Telcare ensure that its messaging provides “diabetes management guidance that is accurate and helpful.” We’re not sure what changes or improvements this will entail, but the clinical expertise of Joslin should no doubt be a major asset. The new messaging will be available by July 1. As a reminder, Telcare’s cellular-enabled meter automatically sends the glucose value to the cloud and the MyTelcare.com web portal (along with a mobile app, if the patient uses it). Depending upon the reading, a message tailored to that situation (hypoglycemic, hyperglycemic, or normal) appears on both the meter and patient portal. Messages can be both general (“Good job – you’re in range!”) or clinically oriented, depending on what the patient’s provider or health system has authorized. A rep also discussed Telcare’s ambition to serve as a “hub” for other devices, which was first announced at the mHealth Summit last December. At the time, the company’s prototype Total Diabetes Management solution featured Bluetooth connectivity to the Qualcomm 2-Net hub, a DANA insulin pump, a SanMediTech CGM sensor, a smart prescription bottle cap (CleverCap), and a smart insulin pen cap (GoCap). No further launch details or updated were shared in the booth.

Type 1 Diabetes TrialNet

Type 1 Diabetes TrialNet had a table in the nonprofit wing of the exhibit hall. TrialNet representatives highlighted the group’s recently added ability to complete trial education and screening for its Pathway to Prevention study. The website www.pathway2prevention.org educates potential participants on the trial, and takes them through the screening and consent processes. People are then sent a testing kit, which they can take to any Quest Diagnostics site in the US to have blood drawn and kit completed. Approximately six weeks later people will either receive a letter stating that they do not have any autoantibodies, or a phone call explaining the autoantibodies they tested positively for and prevention trials they can participate in. TrialNet has enrolled over 300 people in this manner. TrialNet is currently enrolling patients in three prevention studies, depending on his/her risk level: (i) oral insulin prevention trial, for people with a low risk for type 1 diabetes, (ii) abatacept prevention trial, for people with a moderate risk, and (iii) a teplizumab prevention trial for people with a high risk (read Kelly’s open letter in diaTribe about the importance of people enrolling in this last trial here).

Valeritas

The company’s highly visible, elevated, green signage announced their presence near the rear of the exhibit hall. Advertising the V-Go, their simple, electronics-free insulin delivery device for type 2 diabetes, the booth featured numerous catchy slogans: “Disposable Delivery” and “Take the Next Step” were plastered on signage, while the pithier, “Freedom to Go,” subtly labeled the shirts of the booth marketers. The booth also featured persuasive educational materials delivered via iPads and interactive video presentations (lots of screens, to be sure!), comparing the hassle factor of traditional MDI to the ease of use of the wearable V-Go. The campaign also highlighted the tragic rates of non-adherence that lead to poor glucose control – the simplicity of discretely bolus dosing with the V-Go, especially through clothes, is certainly a key advantage of the product. Notably, the booth also featured a device demonstration, presented at the center of the display, which was a neat way to gain some insight into the actually use of the V-Go. As of Valeritas’ presentation at JPM 2014, the company had discussed potential to go public in 2H14 though we believe most who had considered this were likely not pursuing it given changes in the market even in this short period! Valeritas has a published-only abstract on the V-Go at ADA 2014 (2373-PO), with positive long-term follow-up data from the prospective, open-label, multicenter SIMPLE study – at nine months, the overall population of 149 patients had a 0.7% A1c decrease after switching to V-Go (Baseline: 8.7%), with the long-acting insulin cohort experiencing the greatest A1c benefit (-1.2%). We imagine “time in zone” changes were very positive though CGM wasn’t used.

Vivus

Vivus’ purple and white booth was positioned in the back right corner of the exhibit hall and stood tall with a projecting banner, advertising Qsymia (phentermine/topiramate ER) as providing “significant weight loss for 1 year in obese patients.” A larger-than-life-sized, semi-translucent-blue rendering of an obese individual on the front wall had a speech bubble exclaiming “significant weight loss that is clinically meaningful.” A representative gave us an overview of Qsymia on one of the several interactive touch screens, explaining how the drug was a combination of two drugs (phentermine and topiramate) and showing us graphs of its weight loss effects. On the safety and tolerability side, the representative commented that although the side effect dysguesia (altered taste) can be unpleasant, Qsymia’s distortions of the taste of carbonated beverages can actually help prevent patients from consuming excessive soda and other unhealthy drinks. Upon our asking how Qsymia related to Eisai/Arena’s Belviq, he responded that no head-to-head data is yet available, but that the drug works through a different pathway.

-- by Melissa An, Adam Brown, Hannah Deming, Jessica Dong, Alexander Ganninger, Varun Iyengar, Stephanie Kahn, Emily Regier, Katherine Sanders, Joseph Shivers, Tony Thaweethai, Manu Venkat, Alasdair Wilkins, Michelle Xie, Rebecca Xu