Guten Tag from Vienna, where the second full day of the European Association for the Study of Diabetes (EASD) 2014 just came to a close. The day was bookended by a set of stellar keynote addresses and award lectures. The middle of the day was packed with oral presentations on SGLT-2 inhibitors, GLP-1 agonists, diabetes education, and more – much of this we had seen at ADA. The exhibit hall also opened today, and we took a thorough tour of the floor. Included below are our top five highlights from the day, followed by detailed coverage of selected exhibit hall booths and talks from the day.
1. New 52-week results from one of Lilly/BI’s phase 3 studies on “empa/lina” (a SGLT-2/DPP-4 inhibitor FDC) showed sustained superior A1c lowering over Tradjenta (linagliptin) and Jardiance (empagliflozin) alone. Generally what we’ve learned here on SGLT-2 inhibitors have reinforced our views that this is going to be a big class.
2. Three-year data on GSK’s once-weekly GLP-1 agonist Tanzeum/Eperzan (albiglutide) vs. placebo as an add on to pioglitazone showed low nausea, no weight loss, and solid efficacy, consistent with other phase 3 results.
3. The very busy exhibit hall opened today, with exciting showings from Abbott, Novartis, and more.
4. A standing-room-only overflow hall was necessary to accommodate the ~5,000 attendees at Dr. Domenico Accili’s (Columbia University, New York, NY) stirring keynote address on “the new biology of diabetes”.
5. We had high hopes for an oral session addressing “Evolving Tools in Education,” though the data was somewhat disappointing.
- Executive Highlights
- Top Five Highlights
- Honorable Mentions
- Detailed Discussion and Commentary
- Oral Presentations: SGLT-2 Inhibitors – New Outcome Studies
- Exhibit Hall
Top Five Highlights
1. Dr. Ralph DeFronzo (University of Texas Health Science Center, San Antonio, TX) presented an expanded phase 3 dataset on Lilly/BI’s “empa/lina” SGLT-2 inhibitor/DPP-4 inhibitor fixed-dose combination during a very well-attended morning oral presentation session on SGLT-2 inhibitors. Results after 24 weeks were presented as a late-breaking poster at ADA – the 52-week results presented at EASD confirmed the rock-solid superior efficacy of the combination over Jardiance (empagliflozin) or Trajenta (linagliptin) alone, although the combination did not at that point provide truly additive efficacy in the overall study population. Empa/lina’s additive A1c benefit over empagliflozin monotherapy held fairly steady from week 24 to week 52 at ~0.6%, whereas the additive benefit over linagliptin monotherapy actually grew slightly to ~0.7% because linagliptin’s efficacy waned. A subgroup analysis showed that in patients with lower baseline A1c (<8.5%), the combination’s efficacy was indeed additive, perhaps because empagliflozin alone was only modestly effective in that group. In the same session, we also saw Dr. Julio Rosenstock present 24-week data on AZ’s saxagliptin/dapagliflozin, which we also covered as a poster at ADA; he hammered home the point that saxagliptin blunted the glucagon increase seen with dapagliflozin, and suggested that this class of FDCs could be ideally suited for patients that are poorly controlled on metformin alone, rather than just as a way to intensify therapy in patients already on either a SGLT-2 inhibitor or a DPP-4 inhibitor. Empa/lina is under review in the US (EU filing planned for 2015), while saxagliptin/dapagliflozin is on track for US/EU submissions in 4Q14. Based on the data we’re seeing, we believe the SGLT-2 class will do very well commercially; we still aren’t sure about the branded fixed dose combinations (FDC) because we don’t know much about pricing.
2. We saw the first full data presentation from Dr. Christopher Perkins (Boston Medical Center, Norwood, MA) on the phase 3 Harmony 1 trial for GSK’s new weekly GLP-1 agonist Tanzeum/Eperzan (albiglutide). We have to give GSK credit for conducting such a lengthy phase 3 program – five of the phase 3 trials ran for at least three years in order to more thoroughly exploring long-term efficacy and safety. However, as these results demonstrate, studies that run for that long can be somewhat tricky to interpret. Harmony 1 tested the lower 30 mg dose of albiglutide vs. placebo in patients on background pioglitazone with or without metformin. Although the placebo-adjusted reduction in A1c (from a baseline of 7.6%) was only 0.37% with albiglutide after 156 weeks, at that point barely a quarter of randomized patients were still in the trial. This group was self-selected, as patients that had required hyperglycemic rescue (45% of the albiglutide group and 72% of the placebo group) were not included. In a full intent-to-treat analysis (rescued patients continued on their blinded therapy), the A1c benefit at week 156 with albiglutide was a much more respectable 0.63% (keeping in mind that this study tested the lower albiglutide dose). Consistent with other phase 3 results on albiglutide, there was not much of a change in weight, but also a relatively low incidence of GI tolerability issues, both of which are differentiating factors against the rest of the GLP-1 agonist class. Less nausea may make HCPs like it more since nausea is a pain in the next to deal with for HCPs. Tanzeum was recently launched in the US, and we learned at the exhibit hall that the first EU launches might now be expected early next year; we think Lilly’s dulaglutide will be very competitive when it gets to market in the US due to a slew of factors including ease of use and absence of hassle factor.
3. The very busy exhibit hall opened today, and below, we enclose our coverage of Abbott, AZ, Bayer, BD, BI, Dexcom, GSK, Lilly, Medtronic, Novo Nordisk, J&J Animas/LifeScan, J&J Janssen, Merck, Novartis, Roche, Sanofi, Takeda, and Ypsomed. It was a remarkably high-tech exhibit hall, with RFID tags and even 3D printing featured in addition to more social media than we’ve seen here before. In addition to the 18 booths we cover in this report, we dropped by a few more – stay tuned for our full report for details on those exhibits.
4. A standing-room-only overflow hall was necessary to accommodate the ~5,000 attendees at Dr. Domenico Accili’s (Columbia University, New York, NY) stirring keynote address on “the new biology of diabetes”. In a presentation that echoed his award lecture at this year’s ICE/ENDO, Dr. Accili focused on the underlying mechanism of beta cell failure in the pathophysiology of type 2 diabetes, describing how underexpression of the Fox01 gene leads to defective beta cells with impaired metabolic flexibility (meaning the cells are unable to properly choose between glucose and lipids as a fuel source). He presented data suggesting that beta cell failure stems largely from de-differentiation rather than apoptosis; several experiments have shown that people with and without type 2 diabetes have the same total number of endocrine islet cells, but people with diabetes have a smaller percentage that produce insulin (5-10% vs. ~40%). Dr. Accili also highlighted a potential application of his findings to the type 1 biological cure arena, presenting data showing that alteration of the Fox01 gene can cause human endocrine cells from the gut to produce insulin. He expressed cautious optimism regarding this approach, listing several potential advantages over stem cell-based therapies, including possible protection from autoimmune attack.
5. We had high hopes for an oral session addressing “Evolving Tools in Education,” though the data was somewhat disappointing – in particular, we were underwhelmed by the findings and rigor of many of the trials we saw. However, we took note of the findings of Dr. Henryk Zulewski (Triemli Hospital, Zurich, Switzerland), who retrospectively compared the cost-effectiveness (via the IMS CORE Diabetes Model) of educational therapy (n=223; patient data taken from a Germany education program), sensor-augmented pump therapy (n=166; patient data from the STAR-3 study), and standard management (n=1,375; patient data from DCCT-EDIC). Dr. Zulewski presented two provocative findings: (i) that investing clinicians’ time in education may be more cost-effective than investing in sensor-augmented pump technology; and (ii) that sensor-augmented pumps need to be associated with a 1.9% A1c benefit over standard management to be cost-effective. Ultimately, we hold reservations regarding the modeling and cost assumptions utilized in this analysis. Most importantly, it seems far fetched to cherry pick efficacy and cost data from three different trials and compare them in such a head-to-head fashion – drawing this sort of conclusion would only be realistic in a head-to-head-to-head randomized controlled trial. Clearly, education is cheaper than technology and has more potential to be cost-effective, but clinician delivery of education is typically not scalable, widely varying, and often ineffective. We commend Dr. Zulewski for examining this important question, but hesitate to hang our hats on it.
- In addition to the previously mentioned talks on albiglutide and the FDCs, we saw re-presentations of some of the most exciting data on SGLT-2 inhibitors and GLP-1 agonists from ADA. Those two oral presentation sessions drew immense crowds (well over 1,000 attendees), evincing the level of interest in the newest wave of type 2 diabetes therapies. See below for a list of the biggest presentations, as well as links to our ADA coverage.
- Dr. Martin Ridderstråle (Steno Diabetes Center, Gentofte, Denmark) presented results from the two-year EMPA-REG H2H-SU trial, which demonstrated that Lilly/BI’s Jardiance (empagliflozin) had a more favorable efficacy and safety profile compared to the sulfonylurea glimepiride as an add-on to metformin. Notably, he cited hypoglycemia as the major reason for the relatively low dose of glimepiride in the comparator group, commenting that this is in line with conventional clinical practice.
- Dr. Kaj Stenlöf (Sahlgrenska University Hospital, Gothenburg, Sweden) presented data demonstrating the long-term efficacy and safety of J&J’s Invokana (canagliflozin) in the older patients – a reassuring finding, given the growing need for effective options to treat an aging population with an increasingly high prevalence of diabetes.
- Dr. Jorma Lahtela (Tampere University Hospital, Tampere, Finland) discussed results from the LIRA-ADD2BASAL trial, demonstrating the safety and efficacy of Novo Nordisk’s Victoza (liraglutide) as an add-on to basal insulin in type 2 diabetes.
- Several speakers presented data from the AWARD-2, AWARD-4, and AWARD-6 phase 3 trials for Lilly’s Trulicity (dulaglutide), which is currently under regulatory review. We came away from day #1 of EASD with a great deal of optimism about this product, and about the potential for overall growth of the once-weekly GLP-1 agonist class. We were thinking about it more today and realized that in addition to other advantages, dula will also have the advantage of titrate-ability of basal insulin – not a small advantage. Eight shots a week vs. seven with lixi-lantus and IDegLira – we can’t wait to watch this area emerge.
- Dr. Melanie Davies (University of Leicester, United Kingdom) presented data from the SCALE-Diabetes study, which showed that liraglutide 3.0 mg led to significantly greater weight loss compared to placebo (6% vs. 2%). As background, an FDA Advisory Committee granted liraglutide 3.0 mg for obesity a 14-to-1 vote in favor of approval last week.
Detailed Discussion and Commentary
Oral Presentations: SGLT-2 Inhibitors – New Outcome Studies
Fixed Dose Combinations of Empagliflozin/Linagliptin for 52 Weeks as Add-On to Metformin in Subjects With Type 2 Diabetes
Ralph DeFronzo, MD (University of Texas Health Science Center, San Antonio, TX)
Although there were no real long-term outcomes studies presented in this block (as the title suggested), the session did feature some of the conference’s most exciting oral presentations, specifically those on SGLT-2 inhibitor/DPP-4 inhibitor fixed-dose combinations (FDCs). Dr. Ralph DeFronzo presented the full 52-week results of one of two pivotal phase 3 trials on Lilly/BI’s empagliflozin/linagliptin (“empa/lina”) – 24-week results were presented as a poster at ADA. The full year results were consistent with the half-year results: both doses of empa/lina achieved significantly greater A1c reductions from baseline (8.0%) than their component monotherapy (see table below). Also remarkable was how durable the reduction in A1c was for patients on the combination or empagliflozin, while the linagliptin group saw a slight upward creep during the second half of the study. A subgroup analysis found that empa/lina’s efficacy was close to additive in patients with lower baseline A1c (<8.5%), whereas its efficacy was largely driven by the empagliflozin component in patients with higher baseline A1c. As expected, there did seem to be a slight increase in genital mycotic infections with empa/lina, although the effect was not clearly dose-dependent and the incidence remained below 10% for all study groups. Dr. DeFronzo concluded by suggesting that in the future, all three therapies included in this study (empagliflozin, linagliptin, and metformin) could be combined into a triple-therapy tablet. We look forward to hearing more on formulation capabilities.
Table: Efficacy results at 52 weeks
Number of patients
Change in A1c from baseline
Empagliflozin 25 mg / linagliptin 5 mg
Empagliflozin 10 mg / linagliptin 5 mg
Empagliflozin 25 mg
Empagliflozin 10 mg
Linagliptin 5 mg
- The 52-week study randomized 677 type 2 diabetes patients to five dose groups (there were two doses of empagliflozin tested as both monotherapy and in combination with linagliptin). The majority of patients were male and white, although there was a fairly high representation of Asian patients (~15%). Nearly a quarter of patients had diabetes duration greater than 10 years at baseline, while around 10% were within one year of diagnosis. The remainder had diabetes duration between one and ten years. Mean A1c was 8%, while mean BMI was around 31 kg/m2.
- Over the 52-week study, both empa/lina dose combinations achieved significantly greater A1c reductions than their component monotherapy doses (see table above). A time-plot showed that the A1c reductions in the empagliflozin and combination groups were stable throughout the 52-week study period, whereas the A1c reduction from baseline seen with linagliptin was attenuated from -0.70% at 24 weeks to -0.48% at 52 weeks. Dr. DeFronzo noted that the efficacy seen in the primary efficacy results with the combination was not fully additive, although they were meaningfully and statistically greater than the monotherapy efficacy values.
- Dr. DeFronzo displayed an analysis of the 52-week efficacy by A1c status at baseline (>8.5% and <8.5%). In the low-baseline-A1c subgroup (comprising around 75% of the study patient population), empa/lina’s A1c reduction over 52 weeks was actually slightly greater than additive (-0.97% with empagliflozin 25 mg/linagliptin 5 mg, -0.44% with empagliflozin 25 mg, and -0.40% with linagliptin 5 mg). By comparison, in the high-baseline-A1c subgroup, the combination’s efficacy was not additive. Dr. DeFronzo suggested during Q&A that the difference might be due to the fact that empagliflozin’s efficacy is proportional to a patient’s level of hyperglycemia. This means that SGLT-2 inhibitors’ efficacy is likely more elastic (i.e.: they are particularly effective at achieving larger A1c reductions in patients with high baseline A1c), where as DPP-4 inhibitors’ efficacy is limited by limits in the body’s endogenous production of GLP-1.
- Also during Q&A, Dr. DeFronzo warned against making too much of the paradoxical increase in glucagon secretion seen in his group’s study on AZ’s Forxiga (dapagliflozin) because there was also a decrease in insulin seen in patients on the drug. Dr. DeFronzo suggested that the reduction in insulin could be at least as important as the increase in glucagon.
- Improvements in blood pressure (~3 mmHg SBP) and body weight (~3 lbs) were in line with expectations, and driven nearly entirely by the empagliflozin component of the combination.
- There were no new or worrying imbalances in adverse events, including serious adverse events. Confirmed hypoglycemia was rare (1-4%) across groups, with most events occurring in patients on underlying SFU therapy, and there were no events requiring assistance.
Questions and Answers
Q: You showed that efficacy was additive in patients with low A1c at baseline, but not in patients with high A1c at baseline. Could this be related to glucagon secretion, which could be higher in patients with high A1c and less pronounced in those with low A1c?
A: That’s a possibility, although I do not have glucagon data to share with you today. Although everyone has jumped on this glucagon story, if you read our original paper, insulin levels fell inappropriately with SGLT-2 inhibitor use as well. I would be careful when ascribing the entirety of the paradoxical rise in hepatic glucose production to glucagon – I think the decrease in insulin is playing at least as much of a role. It may not just be an effect on the alpha cell, but one that is mediated by the central nervous system. Another obvious explanation is that these drugs lower the threshold for glucose excretion, and that the higher your glucose at baseline, the higher your drop in glucose and A1c will be. That’s probably the more likely explanation.
Q: Is there an explanation for the higher dropout rate in the linagliptin group?
A: I don’t think that the dropout rate was all that much higher in that group – the side effect profile with all of these drugs is quite benign, and most of the withdrawals were not attributed to significant increases in adverse reactions.
Abbott’s distinctive yellow booth was in the front right corner of the exhibit hall floor, no surprise following the company’s absence last year. The launch of the FreeStyle Libre provided plenty of reason to be present on the floor and was clearly an item of excitement among attendees – the booth was so packed it was difficult to make our way through it! Abbott representatives without diabetes proudly wore and demoed the new device (Adam and Kelly envied their flat-line glucose curves!), emphasizing that the sensor is so small they forget about it, even though it is worn on the upper arm. Meanwhile, promotional videos and posters advertised the simplicity and convenience of the factory-calibrated technology (we really like the saucy “You can do it without lancets”; “You can do it anytime, anywhere” campaign). Representatives also highlighted the novelty of launching a new technology in the EU as opposed to US. A smaller component of the booth promoted the software report readouts (ambulatory glucose profile); this lounge-like area featured a 15-minute live demonstration of the product and generated a surprising amount of interest in its own right. Following yesterday’s very detailed corporate symposium, we learned several new facts in the booth:
- Unlike current CGM devices, the FreeStyle Libre sensor cannot be “restarted”; the reader knows the sensor has been used for 14 days. This is good to know from a business perspective, since it means 24/7 users have to use two sensors per month – we imagine very soon the CGM companies will follow this convention. By contrast, the average 24/7 Dexcom user is said to use two to three sensors per month, since the seven-day sensor can be “restarted” and used beyond its indicated use.
- The reader keeps track of the number of scans, allowing HCPs to see how often patients are actually checking their glucose. Brilliant! We will be very interested to learn more about this – lots of behavioral interventions may come to the fore in combination use.
- The sensor patch stores eight hours of glucose data, while the reader can store 90 days of data. The data is only transferred to the reader with a scan, meaning if a patient goes 12 hours without a scan, the first four hours of data will be lost. We assume this was a compromise that allowed Abbott to drop the cost of the sensor patch, since the data is not sent continuously.
- We got a first demo of the sensor applicator, which looks incredibly easy to use: the round sensor fits into the round plastic applicator; patients line up two lines; and then press the applicator on to their skin. GO! It’s simpler than the slightly more involved Medtronic and Dexcom applicators.
- In the user experience study, 91% of patients surveyed (n=30) agreed that it is easier to check glucose with this system (which, granted, was only 30 patients), than with other glucose monitoring systems.
Fronting a very busy corridor near the entrance to the exhibit hall, AZ’s super high-tech booth showcased the enormous range of its diabetes portfolio. A large banner with a group of patients stated “Is a certain patient on your mind? AstraZeneca’s diabetes product range can help you personalize their care.” Upon entering the booth, attendees were presented with an RFID key that they could “tag” at the different displays to collect information to take away with them. The one product that received a disproportionate share of attention and space was SGLT-2 Forxiga (dapagliflozin), which was launched in Europe last year. Two large walls composed of television screens highlighted key efficacy data on Forxiga, and material related to Forxiga covered approximately one-third of the main section of the booth. A tall display on Onglyza (saxagliptin) and Komboglyze (saxagliptin/metformin) noted that the franchise (thanks to the SAVOR outcomes trial) provides proven glucose control with no increased risk of myocardial infarction, stroke, or cardiovascular death. One corner of the booth was dedicated to Bydureon (exenatide); due to its placement away from the center of the booth it did not seem to be drawing as much attendee attention as other parts of the exhibit and we were surprised at where this landed. A separate section of the booth (with a 3D printer making small models of different biological structures) focused on AZ’s clinical science in cardiovascular and metabolic disease, showcasing the company’s externally-sponsored research initiative as well as CVD products such as the blood thinner Brillinta (ticagrelor).
The focus of Bayer’s booth was spilt between its alpha-glucosidase inhibitor Glucobay (acarbose) and its line of blood glucose meters. The Glucobay half, oriented toward the rear of the exhibit hall, featured the same game as last year, giving attendees 40 seconds to identify five differences between two pictures of a hamburger and french fries shaped like a tarantula; each missing item in the second picture represented something that would have raised a patient’s post-prandial glucose level (for example, one french fry was missing). An accompanying booth cited multiple studies of Glucobay, highlighting the beneficial effect of the agent in combination with metformin on body weight and A1c. On the other side of the booth, Bayer featured the Contour line of meters. As expected, accuracy was the clear focus of the marketing campaign as representatives were quick to point out that the meter meets ISO 2013 criteria. However, we were impressed by accompanying signage noting that meeting standards it itself does not guarantee sufficient accuracy; instead, the poster featured a bulls-eye-like graphic that visually depicted Bayer’s significantly better-than-standard accuracy. We also saw the plug as a subtle – and clever – dig at other companies claiming to be in the same accuracy strata as Bayer based on ISO 2013 criteria. Bayer does seem to have the upper hand on the accuracy front, though we are not sure the extent to which they are benefiting from this as much as might be possible.
BD’s modern-looking booth, featuring neat neon colors and semi-translucent paneling, was located quite centrally in the exhibit hall. In contrast to past displays (most recently: AADE 2014), the company chose to focus largely on promoting lipohypertrophy awareness rather than the company’s pen needle product, the AutoShield Duo, that launched in the US in August. Notably, the latter was featured at a small demo station at the rear of the exhibit, where reps emphasized the safety of the product (front and back-end shields), ease of use (hidden needle, visual red indicator), and provided attendees with free samples. The remainder of the exhibit was data-driven, featuring multiple posters that highlighted the underappreciated importance of rotating insulin injection sites – 98% of people with lipohypertrophy do not rotate or rotate incorrectly! Indeed, one poster noted that rotation is “just as important as insulin, diet, and exercise,” while a separate corner of the booth shared clinical findings that proper rotation can reduce A1c up to 0.58%. We’re not sure most patients know or would believe this. Just like last year, the booth featured a live patient demo, allowing attendees to observe how a physician might go about diagnosing lipohypertrophy. Attendees were also offered a “Lipo Detection Starter Pack,” containing inspection gel (for a physician) and rotations tools (for patients) to promote rotation, while accompanying signage highlighted that appropriate rotation can allow patients to use up to 15 fewer units of insulin/day. Last, in addition to espousing rotation, company reps also highlighted the importance of using a shorter, 4 mm needle; this is the first time we have seen BD exclusively promote the 4 mm needle (often they also highlight the 6 mm and 8 mm versions), as reps were adamant that the shorter option is plenty long enough to penetrate skin (~2 mm depth) and is short enough to avoid reaching muscle. This is a familiar tune from launch of the 4 mm and we were happy to hear it (we don’t want patients to use longer needles if they don’t need to!)
Dexcom’s small, understated booth was lightly trafficked in the middle of the exhibit hall. The G4 Platinum’s approval in children 2-17 years old was the major focus of a large banner on the back wall. Other signs promoted the company’s tagline, “One step ahead,” and that the G4 Platinum has the lowest mean ARD in the CGM industry (the FreeStyle Libre is technically more accurate, per the label, though it is not considered a CGM). In speaking to a rep about the G4 Platinum’s major advantages over competitors, she first mentioned the greater possible distance between the receiver and transmitter – a point of differentiation from Medtronic’s MiniMed 530G/Enlite and Abbott’s FreeStyle Libre. We learned that the G4 Platinum is now approved in 32 countries, and notably, is covered by government insurance in Switzerland, Slovenia, and Czech Republic – we have heard it is absolutely insane in Switzerland, where that reimbursement has come online recently. Though EASD is a very drug focused meeting, the rep told us that the majority of boothgoers were familiar with Dexcom – that was a positive, we thought – now reimbursement just has to improve in the EU!. We caught sight of a flyer on our way out, promoting the G4 Platinum’s ability to reduce nocturnal hypoglycemia “regardless of insulin delivery method” – yet another understated point-of-differentiation from Medtronic’s CGM offering.
At an elongated booth at one corner of the exhibit hall (a fairly well-trafficked area), GSK representatives highlighted the relatively recently approved GLP-1 agonist Eperzan (albiglutide). For background, albiglutide was recently launched in the US, where it carries the brand name Tanzeum – see our GSK 2Q14 Report for more on the plans for Tanzeum in the US. We learned at EASD that the company is aiming for the first few European launches to occur in January or February next year, which represents a slight postponement of earlier guidance for launches to begin in 2H14. As we understand it, the first few European launch markets are likely to be the UK and Switzerland, among other countries. The gap between approval and launch does not appear to be a matter of manufacturing the pen, as sales representatives were showing off the device and demoing the administration protocol. Rather, negotiations with the many disparate European governmental reimbursement authorities will likely require time to complete. The main theme in the booth’s displays was Eperzan’s once-weekly simplicity: booth signage featured the message “Because type 2 diabetes patients have so much to think about each day.” Another display compared the one weekly injection with Eperzan to the ~21 weekly injections that might be required with a rapid-acting insulin (specifically mentioning insulin lispro).
A large poster of a smiling, young boy with his Vibe pump demarcated the Animas section of the exhibit; though the small booth represented only a sliver of the expansive J&J layout, the white paneled desk was packed. In particular, attendees crowded around a neat, touchscreen monitor that educated attendees about the speed, precision, and accuracy of the pump. Most notably, representatives actually discussed the timeline for the US launch of the device, noting that the company hopes to bring the pump stateside by the end of 2014. This timeline is consistent with what was reported at Dexcom 2Q14, and we certainly hope these words reflect a real time update of the company’s progress.
Janssen accounted for approximately half of J&J’s exhibit (see our LifeScan and Animas exhibit hall coverage, below and above, for the other half of the booth), which was prominently positioned close to the entrance of the exhibit hall. Not surprisingly, Janssen focused heavily on the SGLT-2 inhibitor Invokana (canagliflozin) – see our J&J 2Q14 report for updates on the drug’s recent success. What a big win it’s been for Janssen to be able to launch first in the US! The booth featured a giant rainbow framing a coffee bar, with questions about “how to change the conversation of diabetes treatment” displayed on scattered clouds. In keeping with the meteorological theme, one wall illustrated a patient’s transition from standing underneath a thundercloud to a rainbow, claiming that Invokana “provides a new option for sustained glycemic control when metformin is not enough.” Various screens around the booth quizzed attendees on how much weight loss or glucose excretion Invokana could produce, with real weights and sugar bowls available to represent the different choices. The company also focused on Invokana’s extra-glycemic beneficial effects on blood pressure and weight loss, as well as its potential for use in both dual and triple therapy. Vokanamet (canagliflozin/metformin) had a much smaller presence in the exhibit, with its name only mentioned on the floating ring above the booth.
LifeScan’s portion of the J&J exhibit captured a significant portion (~25%) of the booth’s real estate. Sleek white walls with dark blue accents framed a host of LifeScan’s OneTouch products that were displayed along the back wall. We particularly enjoyed our demo of the OneTouch Verio Sync, which launched in the US in January and was displayed prominently at the front of the exhibit. That said, representatives politely but firmly rebuffed our attempts to gain insight into the US timeline for the OneTouch Verio, maintaining the company’s silence on this front – we continue to await an update. Representatives did not discuss any other devices in the pipeline.
Lilly’s independent booth, though a bit more conventional than the “house” setup we’ve seen at recent conferences, still had a very homey feel. Shelves filled with children’s books and stuffed animals promoted Lilly’s powerhouse partnership with Disney, and another colorful area featured the company’s “Diabetes Conversations” program, with “conversation maps” designed to facilitate education for children with diabetes. Most of the information about specific Lilly products was addressed in the shared exhibit with BI, though a large section devoted to Humalog (insulin lispro) featured information about the AUTONOMY self-titration study, Displays on the walls emphasized Lilly’s wealth of experience in diabetes innovation, with an entire video focused on the insulin manufacturing process (perhaps an attempt to remind attendees of the company’s longstanding reputation in the insulin market in anticipation of the coming launch of its insulin glargine formulation). Another video offered a tutorial on the novel mechanism of BIL (peglispro), Lilly’s phase 3 novel basal insulin appears to be one of the most differentiated insulin products that we have seen in a while (both in terms of benefit and risk); overall, we were extremely impressed with all the offerings for patients. When we think about how comprehensive this booth will be in several years, we do a double take – wow! .
Lilly & Boehringer Ingelheim
Lilly/BI’s eye-catching booth was half corporate exhibit, half rustic outdoor vacation backdrop, with sleek white displays and furniture interspersed with wooden floors and colorful fabric. A model of a mountain road, complete with iPad-controlled jeeps that attendees could “drive,” was intended to symbolize Trajenta (linagliptin) and Jentadueto’s (linagliptin/metformin) potential to “equip [patients] for the journey ahead.” This is very cool and very smart given how much men (not to be sexist) think about cars. The display was far more elaborate than what we’ve seen from the diabetes alliance partners at recent conferences in the US, and we would be interested to know if anything in particular stimulated this massive exhibit hall push – see our Lilly 2Q14 report for the most recent update on the shared portfolio. This was also the first time we have seen a large share of the exhibit dedicated to the recently approved SGLT-2 inhibitor Jardiance (empagliflozin); attendees were welcomed by an enormous banner describing the drug as “a pill that speaks to ME” and an invitation to help construct a fabric mural with the same message, with proceeds going to support the EASD.
For the first time, Medtronic’s booth had a major focus on type 2 diabetes. This was not a big surprise to see, given that the Opt2mise trial results were published in the Lancet in July (an RCT comparing pumps to MDI in type 2s), a type 2 partnership with Sanofi was announced at ADA, and Medtronic’s June 2014 Analyst Day had a major focus on type 2 diabetes. Signage at the top of the booth proclaimed, “Proven stellar results for type 1 and type 2 diabetes,” while Paradigm pump business cards advertised four posters on the Opt2mise trial here at EASD (#’s 999, 1002, 1009, and 1012). Another sign highlighted the trial’s finding of a 1.1% decline in A1c, a 20% reduction in insulin dose (vs. MDI), and zero severe hypoglycemia events/ketoacidosis. Color handouts displayed the nice infographic summarizing the trial’s results. The other side of Medtronic’s booth included display models of the Paradigm Veo, Enlite, and MiniMed Duo combination CGM/infusion set. Unlike recent exhibit halls we’ve seen, Medtronic did not choose to showcase any next-gen products (e.g., MiniMed 640G, closed-loop system) – we admit we wer quite depressed about this. .
- Off to the side of the booth, a small stand passed out brochures on the Mosaic Project, “A new paradigm for early diagnosis of T2DM and prediabetic states.” The project is co-funded by the EU and seeks to develop mathematical models and algorithms to enhance the current tools and standards for the diagnosis of type 2 diabetes and prediabetes. Medtronic – Spain is one of 10 partners on the project. Gosh we are glad to see some making movement on the pre-diabetes front. This is a solvable problem!
Merck had a fairly sizable booth located near the exhibit hall entrance, with its signature white and green color scheme. The company centered its booth around Januvia (sitagliptin) and Janumet (sitagliptin/metformin), with a slightly heavier focus on Janumet. This shift in focus may be a response to the fact that Janumet has been the main driver of Januvia franchise growth in recent quarters. While both Januvia and Janumet were featured on tablet screens around the booth, the company had a large wall solely dedicated to Janumet that urged visitors to “consider sitagliptin as your preferred partner to metformin instead of a sulfonylurea.” The wall emphasized the combination’s A1c-lowering efficacy, weight neutrality, and low risk of hypoglycemia, displaying results of two clinical studies and one observational study. In one corner of the booth, the company cleverly set up charging stations inviting attendees to “recharge [their] patients’ commitment to improve their glycemic control.” In addition, the booth featured a popular smoothie bar (a nice break from all of the coffee in the exhibit hall) as well as a tabletop interactive screen, where attendees could review clinical data and customize handouts for patients.
Novartis appeared to have one of the most well attended booths, which was full of interactive activities. Many attendees swarmed around the booth’s cycling area, where they had the opportunity to cycle on stationary bikes along a simulated scenic route displayed on screens in front of them, while being intermittently quizzed on facts about the global diabetes epidemic. As a representative explained, Novartis donates 10 Euros to IDF for each completed ride, no matter how well the cyclist performs; by mid-afternoon on Tuesday, the company had already raised over 1,500 Euros. We loved this! The cycling area was accompanied by a wall of interactive screens featuring statistics on the global diabetes epidemic and the Twitter hashtag #Time2DoMore, which was gaining substantial attention online. The ring above the booth featured Lucentis (ranibizumab for diabetic macular edema and other ophthalmologic indications), Eucreas (metformin/vildagliptin), and Galvus (vildagliptin); Lucentis seemed to be the biggest focus, as the back of the booth emphasized the importance of eye health with goggle simulators of diabetic macular edema. To top it all off, the Novartis booth also featured an A1c testing station (this has historically been Novo Nordisk’s exhibit hall mainstay).
Novo Nordisk’s glossy white exhibit featured the recently launched ultra-long-acting basal insulin Tresiba (insulin degludec). Excitingly, Ryzodeg (premixed insulin degludec/insulin aspart) was being featured prominently – a few weeks ago, Mexico became the first country to launch Ryzodeg, and it is exciting to see Europe now following suit, although we still see Xultophy (insulin degludec/liraglutide) as (BY FAR!) the most promising combination involving Tresiba. Novo Nordisk’s market-leading GLP-1 agonist Victoza (liraglutide) also received a substantial amount of real estate. The floor was filled with sales reps giving presentations on the company’s diabetes portfolio against a backdrop of enormous screens displaying efficacy and safety data, as well as members of the all-diabetes Team Novo Nordisk eagerly recruiting participants for the EASD 5K run/walk this coming Thursday.
The company’s bright white booth had prime placement right in front of the entrance to the exhibit hall. The floor plan was quite open, and Sanofi’s entire diabetes drug and device portfolio was represented across the space. The market-leading basal insulin Lantus (insulin glargine) received slightly more focus, and enjoyed prime placement in the section of the booth that fronted the busiest corridor and hall entrance. The “1 you know” message that we saw at ADA appeared again here, with a display emphasizing the over 60 million patient-years of experience that the product has under its belt. The GLP-1 agonist Lyxumia (lixisenatide) and rapid-acting insulin Apidra (insulin glulisine) were positioned as partners for Lantus, with Lyxumia (not currently approved in the US) described as “a positive addition” and Apidra labeled “an ideal partner” to Lantus. One corner of the booth was taken up by a mini-presentation stage, where a short trivia contest was occurring; each participant raised 10 Euros towards the overall donation goal of 25,000 Euros. At the center of the booth, the JuniorStar insulin pen received a lot of attention (see our EASD Exhibit Hall coverage from last year for more details) as part of the continued campaign to “lighten lives” of type 1 diabetes patients. The MyStar Extra BGM, which we first saw at EASD last year, was once again a focus product at the booth – the MyStar Extra provides patients with a three-day fasting glucose average, a trend arrow, and even an A1c estimate. It is now available in eight European countries: Spain, Italy, the UK, Germany, France, Estonia, Switzerland, and Belgium.
The Sooil booth at the back of the exhibit hall was advertising the Dana Ubiquitous insulin pump with a new feature, ANYDANA Android. This mobile app will allow patients to use an Android phone to dose insulin, adjust pump settings, and view pump history. The product is awaiting a CE Mark, which is expected early next year. Once cleared, the rep told us that the pump will be marketed in Europe through distributors (he specifically mentioned Italy). The rep attempted to demo the product for us, but after four tries, was unable to Bluetooth pair the smartphone and the pump (he admitted it was still under development and was not perfect). If it comes to market, this would represent the first commercially available pump that we are aware of that would allow insulin dosing from a smartphone app.
Takeda’s exhibit featured a red/blue/purple color scheme, with many of the company’s drugs’ names displayed throughout the booth. The ring above the booth highlighted Vipidia (alogliptin), Vipdomet (alogliptin/metformin), and Incresync (alogliptin/pioglitazone) as “new” drugs, and animated holograph-like Earth images were featured on stands with the words, “NEW Vipidia Alogliptin tablets.” In addition, several interactive screens sprinkled around the booth showcased information on drugs including Actos (pioglitazone) and the antihypertensive agent Edarbi. In addition, the booth included some impressive aesthetic touches, such as a chandelier hanging above its coffee bar and a bridge-like structure framing a room with a video promoting the company’s motto, “Better health, brighter future.”
Ypsomed’s Swiss themed, sleek white booth showcased the mylife OmniPod, Unio BGM, and Clickfine pen needles. We learned that the OmniPod is now available in eight European countries (Norway, Sweden, Netherlands, UK, Germany, Switzerland, Austria, and Italy), and a rep told us the company has a 10-20% market share in each. We also received a demo of the Unio meter and were reminded of its intelligent, low hassle design – the all-in one case enables patients to check their blood glucose without removing the meter, the strip vial, or the lancing device.
-- by Melissa An, Adam Brown, Varun Iyengar, Emily Regier, Manu Venkat, and Kelly Close