Memorandum

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Hello and happy Monday!

Today we have our AADE 2012 full report for you! If you would like the report in its entirety - click here. We've also got updates for you below on generic pioglitizone (Takeda's Actos), a DME oral drug in development from Ampio, and more on BGM and smart phones. Oh, and my BIG apology for a thoughtless typo last Thursday ...

First off, our full AADE report gives you our major themes from the meeting, as well as our specific take on eight sections of interest from AADE that ended two weeks ago today. The full report is comprehensive (another way of saying, 150 pages) and if you would prefer the "big picture" first, as always, we recommend you look at our Big Picture Themes here, which gives our high-level reaction from the meeting and which also contains the table of contents so you can pinpoint your favorite areas. We also did something a little different this year and also chose a mix of ten talks here that were the "top 10" from our team's perspective (note that there were SO MANY other incredible talks we couldn't choose - it's just that if you have limited time, here's a great ten to start - and then you'll want to go find more). Please see the links bellow for your favorite areas:

  1. AADE 2012 Full Report - click here
  2. AADE 2012 Big Picture Themes - click here
  3. Diabetes Devices - click here
  4. Diabetes Drugs - click here
  5. Weight Loss and Obesity Therapies [a new section this year for AADE] - clickhere
  6. Complications - click here
  7. Mobile Health - click here
  8. Health Policy, Reimbursement, and Health Care Models - click here
  9. Education and Self-Management - click here
  10. Exhibit Hall Report - click here

Again, here are some of the most favorite talks that we pulled out from the very large full report - click here for a way to dip your toe into AADE learnings if you weren't atthe meeting, or if you were, to read something that perhaps you didn't see live. Thanks ever somuch to AADE and so many educators for a meeting full of lots of learning.

Second, last Friday, Teva, Mylan, and Ranbaxy each announced the launch of generic versions of pioglitazone (Takeda's Actos) in the United States. All three companies will market the 15, 30, and 45 mg doses of the medication. In addition, Mylan and Teva's press releases note the launch of pioglitazone/metformin (ACTOplus met) fixed-dose combinations (FDC) in 15 mg/500 mg and 15 mg/850 mg doses - we are not completely sure if Ranbaxy has also launched a pioglitazone/metformin FDC, though we would assume they have. According to IMS, Takeda's Actos franchise had annual US sales of approximately $2.7 billion, while ACTOplus met had sales of approximately $413 million. We have not been able to track down current pricing information for these generic versions of pioglitazone, though according to Wolters Kluwer Pharma Solutions data provided in the May 2012 Consumer Reports, pioglitazone's branded retail price is $307 (30 mg) per month, expected to decline to $153 after one year and to just $15-$92 after two to three years (we've got to check that out!).

The FDA has only announced the approval of Mylan's generic pioglitazone calling it the "first generic Actos to treat type 2 diabetes" - we assume this is because Mylan's application was first in line. Teva, Mylan, and Ranbaxy have 180 days of shared generic marketing exclusivity in the US. As we noted in Closer Look last week, Watson has filed a suit against the FDA in response to the Agency's decision to delay Watson's abbreviated new drug application (ANDA) for generic pioglitazone, preventing the company from marketing at this time.

From a marketing perspective, we wonder how the lower price of generic pioglitazone will weigh against the ongoing controversy surrounding the risk of bladder cancer. Sales of Actos have been declining since June 2011 when the bladder cancer story broke. As we noted in our Takeda F1Q12 report on July 31, worldwide Actos franchise sales totaled 55.8 billion yen ($698 million), down 40% from 93.1 billion yen ($1.15 billion) in F1Q11 and 5.7% sequentially from 59.2 billion yen ($704 million) in F4Q11.

Third, South Korea-based Philosys recently announced that it expects FDA approval of its Apple and Android phone compatible Gmate Smart blood glucose meter in 3Q12. The device plugs into the headphone jack of an Apple iPhone, iPod, iPad, and Android phone, and similar to Sanofi's iBGStar, the Gmate Smart can also be used as a standalone meter. It has an associated mobile app for viewing results, currently available as a download on Apple's iTunes store - based on a quick trial, it is not as sleek or intuitive as the iBGStar app in our view. Philosys also has some fairly bold claims on its website, including "the world's first smartphone meter," (incorrect) "the first monitor completely integrated with Apple iPhone and Android smart phones," "the world's largest memory," and the "world's most detailed result log." We have not previously heard of Philosys or the Gmate Smart, so we'll be interested to hear if the company can indeed secure FDA approval before the end of the year. It's not clear when the device was submitted to the Agency, though we do recall that approval for the iBGStar took substantially longer than expected. According to the company's website, Philosys is entering the US market with offices in New York and Florida. "All circuits were busy" every time we tried to call, so we have not yet been able to connect with management - we have also tried email and we'll be reporting back if we are successful in reaching them.

Fourth, here's word on a potentail oral solution for DME - with all the chatter on Lucentis (see our recent in-depth report here on their recent FDA aproval), we're very interested in watching the entire landscape. There's not enough to know on this one yet, but we'll be watching it.

Last, my apologies - I should never write these in the wee hours! Amylin brought in $35 million for Bydureon in Q212, not (!) billion - thank you so much to all the KOLs and company execs who corrected me on that pronto! We will have the archive corrected asap.

On a final note - a postscript! - we hope you are enjoying the last couple of weeks of summer (if you're in our hemisphere!) ... We'll be back tomorrow with Medtronic quarterly results - we've got several more final reports to send, then we'll have our quarterly Diabetes Close Up and then Close Concerns will be off for a week from August 27 to August 31 re-charging for the fall season! We'll leave you lots to read while we're away and then we hope you'll join us in lots of anticipation for so much happening in the fall. That includes an FDA meeting on biosimilars, The Obesity Society, EASD, Cardiometabolic, ISPAD, AHA, the FDA ad comm for degludec, the Diabetes Tech meeting, CODHy (in China and Barcelona), Partnership for a Healthier America, and more ....

very best, kelly

 

Kelly L. Close

president

Close Concerns

T. 415 241 9500

M. 415 518 5336

kelly.close@closeconcerns.com

www.closeconcerns.com

www.diatribe.us

twitter: @diatribenews


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