Memorandum

Hello everyone, from Chicago! It's been a gorgeous day here and we're nearly all ready for ADA to start! Before that, we've now got big news from the AMA recognizing obesity as a disease, topline results from Onglyza's CVOT (SAVOR-TIMI-53), our ADA top 150 posters document, and updates from Transition/Lilly and a collaboration between MedImmune and NGM Biopharmaceuticals.

Obesity

1. AMA recognizes obesity as a disease - very important step forward for the field (summary below)

Diabetes Drugs

2. BMS/AZ announce topline SAVOR-TIMI-53 results - non-inferiority vs. placebo for the primary safety outcome of MACE and no superiority

3. Lilly decides to retain rights for GLP-1/glucagon co-agonist TT-401 - will fund all further development and commercialization efforts (summary below)

4. MedImmune and NGM Biopharmaceuticals to jointly investigate enteroendocrine cell-derived therapies for diabetes and obesity (summary below)

Conferences

5.ADA 2013 Top 150 Posters document, and in case you missed these from earlier this week, our picks for the Top 40 orals, our ADA 2013 preview, and our 12 category documents: GLP-1 agonists; DPP-4 inhibitors; Insulin; Novel drugs; SGLT inhibitors; Non-insulin, non-incretin therapies; Obesity care; CGM and closing the loop; Insulin pumps; Blood glucose monitoring; In-hospital monitoring and hospital care; and Late breaking abstracts. We'll be back next with abstracts integrated into these category documents.

SUMMARIES

1.Following in the footsteps of AACE and ACC, delegates at the annual meeting of the American Medical Association (AMA) voted to recognize obesity as a disease - read the NYT article here by veteran NYT healthcare guru Andrew Pollack.  The delegates voted against the recommendations of the AMA's Council on Science and Public Health, who feared that  the limitations of BMI as a diagnostic measure would limit the health outcomes of actually designating obesity. We think there is much more potential for benefit than harm in this case and applaud the AMA for taking this important step. Though the AMA resolution has no legal force, it could influence physicians to take stronger measures in the clinic and potentially stir policy changes and insurance policies related to obesity. Indeed, just one day after this story broke, the bipartisan "Treat and Reduce Obesity Act" bill was introduced by Sens. Tom Carper and Lisa Murkowski and Reps. Bill Cassidy and Ron Kind. If passed, this legislation would allow, among other benefits,  obesity drug coverage under Medicare and improved access to intensive behavioral counseling. We see this as a positive, if inevitable, development given the epidemic's size and the severity of obesity. From our recent coverage at the Annual Meeting of The Endocrine Society (read our highlights report, we remain confident that lifestyle intervention will remain the cornerstone of obesity therapy. However, it seems that obesity pharmacotherapy is moving in the right direction. We're also optimistic that the growing recognition of obesity as a disease by established bodies will spur a hesitant FDA to approve more pharmacological agents for use in obesity treatment. We'll be interested to hear reactions to this development at ADA 2013.

2. Early yesterday morning, BMS and AZ announced topline results for Onglyza's cardiovascular outcomes trial, SAVOR-TIMI-53 - see our report here. In this very large (n=16,500) three-year trial, Onglyza demonstrated non-inferiority compared to placebo for the primary safety outcome of MACE and did not achieve superiority. While it is a bit disappointing that the first CVOT for an incretin-based drug failed to show cardioprotection, the result is not completely unexpected since the primary purpose for commissioning these CVOTs was originally to fulfill the FDA's requirement for CV safety. [And importantly, patient enrollment was enriched for CV risk to accelerate data collection.] We are now curious whether we will see a substantial increase in Onglyza prescriptions given that it will be the only DPP-4 inhibitor for more than a year to have established CV safety through a CVOT (Januvia's TECOS will be the next DPP-4 inhibitor trial to complete, in December 2014). We speculate that since prescribers have had a great deal of experience with the various DPP-4 inhibitors at this point, and since DPP-4 inhibitors' CV safety was never quite in question, that this will not drastically shift the market towards Onglyza. See our full report for a breakdown of the DPP-4 inhibitor market, a timeline for other type 2 diabetes drugs CVOTs, and our thoughts on what other questions remain.

3.Transition Therapeutics just announced that Lilly has decided to retain rights to the GLP-1/glucagon co-agonist TT-401 - see the press release here. As a reminder, Transition recently released positive results of a five-week proof of concept study (please see item #8 in our May 7, 2013 Closer Look here). As background, Transition acquired rights to several preclinical compounds from Lilly in March 2010, including TT-401. Transition completed the phase 1 studies, and Lilly will now take it through phase 2. As previously agreed, Transition will receive a $7 million milestone payment. The two companies have made amendments to their financial agreement for future development efforts: Transition will contribute $14 million to Lilly during phase 2 in three separate payments; Lilly will fund and perform all further development and commercialization efforts. Transition is eligible to receive $240 million if TT-401 is brought to market, with double-digit royalties on TT-401 product sales and low-single-digit royalties on related compounds. To our knowledge, TT-401 is the only GLP-1/glucagon co-agonist in phase 2; other compounds in development include Zealand/BI's ZP2929 (phase 1) and Prolor Biotech's MOD-6030 (phase 1).

4. Earlier this week, NGM Biopharmaceuticals and MedImmune (AstraZenica's biologics arm) announced an agreement to jointly investigate and develop novel therapies for diabetes and obesity - see the press release. At the center of the collaboration are enteroendocrine cells (EECs), which produce metabolic regulatory hormones such as GLP-1. NGM has developed a platform which facilitates the sustenance and study of EECs and the peptide hormones they secrete. Under the terms of the agreement, MedImmune will have the right to license any products developed through the joint effort. In return, it will provide NGM with research funding as well as royalties on the worldwide sales of any drugs developed. We will be keeping a close eye on this partnership, and hope it proves fruitful. NGM has signed two other collaborations in the past year, one with Janssen in January to develop novel therapies for type 2 diabetes (goal to mimix bariatric surgery) [read our report], and one with Daiichi Sankyo in April 2012 for beta cell regeneration therapies [read our report].

5. We've put together an ADA 2013 notable 150 posters document - click here to read it. This document contains all the abstracts you don't want to miss in the poster hall! We didn't find them ALL most likely but we found a lot of them - let us know which ones we missed, of course as there is a lot to sort through and we're trying to be timely and we definitely won't have caught everything. On a similar note, you can find our ADA top 40 orals document here. Our 12 category documents are at the following links, and we'll be sending these again shortly with the abstracts pasted in: 1) GLP-1 agonists; 2) DPP-4 inhibitors; 3) Insulin; 4) Novel drugs; 5) SGLT inhibitors; 6) Non-insulin, non-incretin therapies; 7) Obesity care; 8) CGM and closing the loop; 9) Insulin pumps; 10) Blood glucose monitoring; 11) In-hospital monitoring and hospital care; and 12) Late breaking abstracts.

FAQ: What is a category doc?! These documents consolidate all the abstract titles, presentation times, and authors within each category. Now this is how to prepare for ADA 2013! In case you missed our ADA 2013 Preview, click here to read what we're most looking forward to seeing this year. To plan your conference or read through abstracts themselves, you can use the ADA's itinerary planner here.

We'll be back soon with abstracts integrated into our 12 category documents. In the meantime, you should know, our team is here working hard to get you all the best information - check out this preparation here ...

very best, kelly

 

Kelly L. Close

president

Close Concerns

T. 415 241 9500

M. 415 518 5336

kelly.close@closeconcerns.com

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