Beacon of Hope Summer 2013 • No. 115 Some Folks, When They Want To

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Beacon of Hope Summer 2013 • No. 115 Some Folks, When They Want To Beacon of Hope Summer 2013 • No. 115 Some folks, when they want to escape life's stresses, go to Cancun or Bali or Virginia Beach. I found my oasis in downtown Boston. A few weeks ago I took part in BEACON HILL, an outpatient trial for the bihormonal bionic pancreas developed by researchers at Mass General and Boston University. The study participants and I spent five days wearing a system that continuously monitored our glucose levels, delivering insulin or glucagon as necessary to keep us in the normal glucose range for as long as possible, with no effort from us (seriously). I pressed a button to tell the system when I was eating and whether the meal was bigger, larger, or similar relative to my typical schedule, but I didn't count any carbs or consult any nutrition facts or calculate any insulin doses. I looked at my continuous glucose monitor, but I didn't worry about going hypoglycemic or spending hours above 200 mg/dl or waking up at 4 AM with my blood sugar out of whack. In short, I knew that I still had diabetes, but I have never felt so carefree - so much like my 17- year-old, pre-diagnosis self - as during that week of glucose autopilot. I should clarify that the bionic pancreas is still a prototype and that a lot of challenges must still be overcome - especially if the researchers are to meet their ambitious goal of commercial launch in 2017. The system's effectiveness must be proven in longer and larger trials, a stabilized liquid glucagon must be developed, and a bihormonal pump must be built (that is, a pump that delivers both insulin and glucagon). Even the ideal version of the product won't be for everyone. Many patients won't be able to afford it, at least initially; some might not have the technology acumen to use it (though it was about a million times easier than my regular diabetic life). Still, if and when people can use a system like this and have experiences like mine every day, their lives will be changed in a very big way. To be honest, that made me cry about diabetes in a way that I haven't cried in a very long time. Life-changing therapies are also becoming available for type 2 patients. I'm talking about insulin / GLP- 1 coformulations that can give patients the best of both agents with fewer side effects, multi-drug "polypills" that can simplify adherence, glucose meters that help interpret test results in real time, and wearable delivery devices that can transcend the drawbacks of syringes and pens. Are these cures? No; but they can help patients live much healthier and easier lives. My optimism was bolstered by what I saw in Chicago in June during the 73rd Scientific Sessions of the American Diabetes Association, which we write about in this issue. And, as much as I believe in the new therapies and technologies, I hope that researchers can expand their efforts and move to much earlier stage, to include more clinical trials on prevention - especially in key patient groups such as children and the elderly (Leakey et al., Diabetologia 2013). Yes, our therapies are improving, but my hope is that with the help of better screening, targeted therapies, and/or smarter behavioral interventions, we will reach the day when no one will know what it's like to be diagnosed with diabetes at all. Best, Kelly L. Close P.S. For a more detailed description of my experience with the bionic pancreas, see http://diatribe.org/issues/55/test-drive. P.P.S. For more on the Diabetologia paper about the distribution of clinical research in diabetes, see this issue’s Literature Review. P.P.P.S. Similar to the last issue of DCU, we have listed in “Major Headlines” and highlighted in light blue the five most popular reports of the issue – including two literature reviews. Major Headlines Medtronic – US sales down 2%, international up 14% – page 33 Roche – Reportedly considering sale of its blood glucose monitoring business – page 41 WellDoc – Launches BlueStar for type 2 diabetes – page 46 Diabetes Care – Drs. Butler and Nauck debate incretins and pancreatitis – page 72 Diabetes – Dr. Steven Kahn writes critique of Dr. Peter Butler’s incretin study – page 73 In This Issue 1. Quotable Quotes ........................................................................................................................................ 6 2. diaTribe Fingersticks ................................................................................................................................ 7 3. DCU Company Watch ............................................................................................................................... 8 • Abbott – Nearly flat Diabetes Care growth • Abbvie – Initiates phase 3 for atrasentan; announces phase 2b data • Alere – Diabetes revenue totals $50 million in 1Q13 • Alkermes – Records $4 million in Bydureon royalties • Amgen - Phase 1 trials terminated for AMG 151 and AMG 876 • Arena – Withdraws MAA for Belviq in the EU • Array – Evaluation of AMG 151 phase 2a results to complete in 2013 • Asante – Partnering with Glooko and Diasend for Asante Snap insulin pump • Aspire Bariatrics – AspireAssist could be approved in Canada this summer • Astellas – Reaffirms ipragliflozin filed in Japan • AZ – Onglyza franchise up 27% • Baxter – EU approval of home hemodialysis device expected in 2013 • Bayer – Contour sales up 2% in 1Q13 • BD/JDRF – Extend collaboration to develop combined insulin infusion/CGM • BD – Phase 1/2 study of second-generation sensor completed • Biocon - Mylan partnership on analogs brings $20 million upfront • Biodel – Developing new glucagon rescue product, NDA filing in 2015 • BMS/AZ – Announce topline results for Onglyza’s SAVOR-TIMI-53 CVOT • Daiichi Sankyo – sNDA for Tenelia combination product filed in Japan • Dexcom – Revenue up 49%, company driving towards profitability • Echo Therapeutics – Receives IRB approval for CE Mark pivotal trial • Edwards – Remains “enthusiastic” about GlucoClear critical-care CGM • Forest – No updates on liver-selective glucokinase activator GK1-399 • GI Dynamics – EndoBarrier offered at 37 commercial centers worldwide • Gilead – Ranolazine for coronary artery disease remains in phase 3 Diabetes Close Up #115 ~ Summer 2013 ~ Beacon of Hope ~ www.closeconcerns.com 2 • GSK – No updates on albiglutide • Halozyme – PH20 closed-loop study approved by FDA • Insulet – Sales up 20% year-over year; second-gen pod shipments strong • Isis – Plans to initiate phase 3 for apoC-III inhibitor in early 2014 • J&J – Invokana performs strongly in first two months on US market • J&J – Diabetes Care revenue down 10% • Jawbone – Acquires BodyMedia • Lexicon – Presents new type 1 diabetes data for LX4211 • Lexicon – Phase 2 trial in type 1 advances to expansion phase • Ligand – No new updates on diabetes R&D • Lilly/Transition Therapeutics – Lilly retains its rights to phase 2 ready TT-401 • Lilly – Humalog sales up 7% and Humulin sales increase 1% • MannKind – Phase 3 Afrezza trials on schedule, data in mid-August • Medtronic – US sales down 2%, international up 14% • Merck – Januvia franchise sales fall 1% to $1.3 billion • Neurocrine – No updates on GPR119 agonist development program • NeuroMetrix – 145 Sensus devices shipped • Novartis – Galvus on track for blockbuster status • Novo Nordisk – Topline phase 3a SCALE-Obesity and Prediabetes results • Novo Nordisk – Diabetes Care up 13%; Victoza sales increase 35% • Orexigen – European rapporteurs assigned for Contrave • Perrigo – Diabetes over-the-counter segment grows 3% • Pfizer – New candidates added for type 1 diabetes and diabetic nephropathy • Rhythm – Announces positive phase 1b data for RM-131 • Roche – Reportedly considering sale of its blood glucose monitoring business • Roche – Diabetes Care down 4% on a reported basis and 5% operationally in 1Q13 • Sanofi – Diabetes Division sales grow 18% to $2 billion • Santarus – Glumetza sales total $42 million • Takeda – Reports first phase 3 results for GPR40 agonist fasiglifam • Telcare – Receives CE Mark for wireless blood glucose meter • Transition Therapeutics – Ends F3Q12 with $25 million in cash • Vivus – FDA approves Qsymia REMS modification • WellDoc – Launches BlueStar, FDA-cleared, mobile prescription therapy for type 2 diabetes • XOMA – No update on diabetes pipeline • Zealand – No Lyxumia revenue reported yet; ZP2929 remains in phase 1 4. Interview: Diabetes expert Dr. Stefano Del Prato weighs in on incretins and pancreatitis, the role of SGLT-2 inhibitors, pharmacotherapy in prediabetes, and what he learned from ORIGIN ......................... 48 5. Conference Pearls: American Diabetes Association – 73rd Annual Scientific Sessions ........................ 60 6. Literature Review .................................................................................................................................... 71 7. Comings and Goings ............................................................................................................................... 86 Diabetes Close Up #115 ~ Summer 2013 ~ Beacon of Hope ~ www.closeconcerns.com 3 Multimedia Dr. Peter Attia gave a very compelling TED talk on the stigmatization obese patients often face from their physicians – including Dr. Attia before he became overweight and was diagnosed with metabolic syndrome despite being physically active. In sharing his personal story, he challenges the cause-and-effect relationship between insulin resistance and obesity. He hypothesized that insulin resistance might cause obesity and result from a person having high blood glucose levels. http://www.youtube.com/watch?v=UMhLBPPtlrY
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