Rumor Mill: OmniPods OK, Oculir Dies, Roche GLP-1 On the Way

Rumors will fly. They always do. Don’t ever think the world of health and medicine is any exception to that rule. Here are some details I’ve dug up on three that readers have run by me lately:

1) On the CWD forums of late, a few people have been citing a failure rate of 20% for pods. Someone even said they were able to verify that with their Omnipod rep and that a manufacturing defect was found, fixed and now they are just waiting for theSay_what_2 bad pods to ‘go through the system.‘”

Wow! That sounded unlikely. So I check with the authorities at Insulet. Here’s what their marketing manager tells me:

“People on the product have some problems sometimes, of course, but the incidence is very low. That 20% figure is just ridiculous!”

Now of course that’s the sort of reply you’d expect from a company’s marketing manager, but I have to agree that if their pod failure was approaching anything near such a high percentage, they’d be under major scrutiny and/or going out of business. My personal experience is that I’ve only had three (yes 3) unexplained pod failures in an entire year of using the product. And when it works, the product rocks, IMHO.

2) “Back in Dec. 2005, you wrote about Oculir, Inc., a company that was developing a device to measure glucose levels by scanning the eye. I’ve always remembered this and personally think it could be HUGE as (for me at least), the glucose testing is the most painful (not the shots!)… The website you noted in your blog does not seem to be working and I hope the company or the research didn’t fold.

I spoke with former CEO John Burd yesterday and found out that the company has indeed been dissolved, as of December 2007. Believe me, he’s as disappointed as we are. The laser technology necessary to obtain glucose readings from the eyes simply isn’t robust enough yet, he says.

“The optics needed to shine on the eye and collect the light was a lot bigger challenge than we anticipated. This turned into more of a research project versus a development project, and the investors weren’t willing to support that.”

Drat! Oculir managed to burn through most of the $7.3 million in company financing obtained in 2005. The rest will be “redistributed,” Burd says. And he personally?

“l’m looking for my next opportunity. One of these days somebody’s going to crack the nut on non-invasive glucose monitoring, and I certainly would like to be part of it.”

3)I hear that Roche is developing a GLP-1 analog that has advantages over Byetta as well as Novo’s liraglutide. My wife (Type 2, controlled nicely using a Medtronic pump) suffered too much nausea from Byetta and Symlin but was looking to try a GLP-1 in hopes of reducing her overall insulin intake. I heard they’re starting Phase III trials on R1538 shortly but I couldn’t find anything for it on Clinicaltrials.gov. Do you know how I might find where they will be doing trials?

Well now, development does seem to be moving forward nicely on Roche’s R1538, another injectable for Type 2 diabetics that will, as noted, will compete with Byetta. This drug was originally licensed from from Ipsen in 2003.

A number of sources report that Phase II testing of R1583 was completed in 2007, and the initial data were very encouraging. Phase III clinical trials are anticipated to begin in the first half of 2008. But so far, all Roche has done is drop some big hints, according to Close Concerns consultancy. Their takeaway from a recent earnings call:

“The company apparently aims for a best-in-class profile for their GLP-1 candidate, R1583 (Ipsen). Phase 3 trials are anticipated to begin in 2H08 –- management made it sound like the decision was made but they also reserved just enough judgment not to push it into phase 3 in case of a surprise.”

In any case, nothing on Phase III for this drug appears yet on the company’s own Clinical Trials Search site. That would be the place to look when it comes time to signing up in your state.

A few product details from APM Health Europe:

“Kepler Equities believes the most important differentiating point for GLP-1 compounds, which must be injected, is dosing duration. Roche is testing once weekly and once every two weeks for R1583.

Amylin/Lilly are likely to launch their once-weekly product (exenatide LAR) at about the same time as Novo Nordisk’s liraglutide, approved for once-daily dosing in 2009.

But Kepler says Roche’s R1583 formulation appears to have advantages over once-weekly exenatide LAR. R1583 is available in a pre-filled syringe and uses a thinner needle, while exenatide LAR needs to be prepared by patients.

If the clinical trials are successful, R1583 could be an important product for Roche.”

Oh, and…

4) I know you’re all dying for an update on Calisto’s Glucoband. All I can tell you is that they have not yet responded to any of my queries via phone or email. Not a good sign.

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9 Responses

  1. Elijah M
    Elijah M February 26, 2008 at 9:14 am | | Reply

    I’ve been on the OmniPod for just over a year as well, and I’ve only had two pod failures in that time.

  2. Kathleen Weaver
    Kathleen Weaver February 26, 2008 at 10:03 am | | Reply

    There is a real easy way to see what the failure rate is on the Omnipod — check the FDA’s Maude database.

    In fact, the Maude database helped me decide which pump to get. I picked the one with the least number of fatal entries.

  3. CALpumper
    CALpumper February 26, 2008 at 12:46 pm | | Reply

    The Glucoband would be a God-send!!!

    The advantages are amazing: to not have to worry about blood (or pieces of tissues with dry blood on it seemingly following me everywhere), no more Test strips My goodness and no more callouses on my fingertips?!?!!

    Where do I sign up?

    Too bad it is not that easy. Not enough PWDs “need/want” this technology, eh?

  4. Lisa
    Lisa February 27, 2008 at 6:22 am | | Reply

    Thank you so much for keeping us up to date regarding these ideas/products. It is great to have you as a resource regarding these issues!

  5. Jana
    Jana February 27, 2008 at 8:12 am | | Reply

    I use the Omnipod for only 4 months, but had only 1 deffective pod and have been more than happy since using the Omnipod. Thanks Amy for your posts, thanks to you I was determined to get the Omnipod even though my first insurance company denied me, so I switched and it worked!

  6. Kevin
    Kevin February 27, 2008 at 11:08 am | | Reply

    I don’t mean to bash the Omnipod, but I’ve been on a non-pod pump for almost 8 years and have had only 2 pump failures and 1 serious cannula problem in that time period.

    The failure rates mentioned here seem much higher, and anecdotally I know of someone on a pod that had 2 failures in a single weekend.

    But then again… “the plural of anecdote is not data.”

  7. Mary
    Mary February 27, 2008 at 11:47 am | | Reply

    I’ve had the OmniPod for about 6 months and have had the PDA replaced 4 times and have had at least 10 defective pods replaced. One time when I had to wait on a replacement PDA, I did go back to my Cozmo pump and was pleasantly surprised how reliable it felt. I do not go anywhere without pod replacements. I didn’t do that with my standard pump. BUT I’m still using the OmniPod because I dislike the tubing. The download software is not the best, but I put up with all these downsides to be rid of the attached tubing. I do believe some day Insulet will get it right.

  8. Rick
    Rick August 11, 2010 at 11:49 pm | | Reply

    Oculir was not dissolved due to technological challenges but rather due to the fact that the patent Mr Hurd claimed was his had already been registered by Dr Marc Abreu at Yale University long before Mr Hurd’s supposed discovery. Whether this was co-incidence or not has not been clarified.

  9. Rick Winkhoff
    Rick Winkhoff August 15, 2010 at 10:28 am | | Reply

    Oculir was forced to fold because the patent was ruled invalid by the USPTO based on diabetes monitoring technology by Dr Marc Abreu, a researcher at Yale University. This technology is currently being worked on by Brain Tunnelgenix Technologies Corp

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