From the News Wire: Biodel

This out from Biodel:

DANBURY, Conn.--(BUSINESS WIRE)--Biodel Inc. (Nasdaq: BIOD) announced today its plan to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of this year for approval to market VIAject® for the treatment of diabetes. VIAject® is Biodel’s investigational ultra-rapid-acting injectable human insulin intended for meal-time use by people with Type 1 and Type 2 diabetes. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies as well as two completed Phase 3 studies of VIAject® in patients with Type 1 and Type 2 diabetes.

Preliminary results from the Phase 3 studies were reported last year at the 44^th Annual Meeting of the European Association for the Study of Diabetes (EASD). Biodel intends to seek approval for the 100 IU/cc liquid formulation of VIAject®, which is bioequivalent to the two-part 25 IU/cc lyophilized powder formulation of VIAject® that was used in the company's pivotal Phase 3 clinical trials. Biodel believes that results from both Phase 3 studies showed that VIAject® was non-inferior to Humulin® R, the leading recombinant human insulin, in terms of blood glucose control, when measured by the mean change in patients' hemoglobin A1c levels (HbA1c). The results also demonstrated lower incidence of hypoglycemia and less weight gain in patients receiving VIAject® as compared to patients receiving Humulin® R.

At the EASD conference, Biodel reported that preliminary efficacy results from patients with Type 1 diabetes in India were not comparable to results from patients in the United States and Germany. While non-inferiority of VIAject® to Humulin® R was achieved without the data from India, it was not achieved when the data from India was included. Biodel identified probable causes for the variance in the data from India with the assistance of regulatory consultants and presented the results to the FDA in its pre-NDA briefing package. Among the causes noted in the briefing package, an identifiable subset of blood samples from patients in India was found to be compromised due to excessive heat exposure in transit to a central laboratory. When the compromised samples are removed from the efficacy analysis, non-inferiority in both the Type 1 and Type 2 trials is achieved.

After reviewing all of the data from the two pivotal Phase 3 clinical trials with regulatory consultants and meeting with FDA staff, the company has decided to proceed with the submission of its NDA under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act. The FDA will review any submission the company makes to determine whether it meets the requirements for filing. There can be no assurance that the FDA will file the NDA, or that once filed, it will be approved.

Biodel’s chairman and chief executive officer, Dr. Sol Steiner, stated: “After investigating the cause of the anomalous data in India and discussing our findings with the FDA, we are now comfortable proceeding with the preparation and submission of the NDA for VIAject® in the second half of this year. This is based on a compelling package of pharmacodynamic studies demonstrating potential advantages over currently available rapid-acting insulin analogs as well as the results of both pivotal Phase 3 clinical trials, which we believe met the endpoint of non-inferior change in HbA1c over six months. In the meantime, we continue to collect safety data from the open-label extensions of the Phase 3 trials and are proceeding with plans to conduct additional development work this year to further differentiate VIAject® from the rapid-acting insulin analogs.”

I think I have lost money on shares of this too. See my DexCom comments about Jacques Cousteau

I Am NOT Making Fun of Amy Tenderich…

… much.

I always pick up something from Diabetes Mine.

So there I am reading away and wondering why Amy is talking about ugly. Ugly-cemia to be exact.

I am all like - What the heck is that?

…is that when TV’s Betty has diabetes?

…is that what all the holes on you fingers are called?

…is that when the meter number is so bad you have to turn away from the screen for fear of being tuned into an Old Testament pillar of salt, well maybe sugar in this case.

I am a little dyslexic, ok I am a lot dyslexic, and somehow my brain wasn’t coming close to processing the “e” in the beginning of eUGLYcemia.

Through some miraculous process the “e” magically appeared and I was still all – What the heck is that? Amy went on to explain that is blood sugar at the goal. Like all diabetes terms this one falls into the “Did they intentionally make these words up to be confusing?” category. (Yes.)

Are not our live sufficiently messed up with type 1 care that we could just skate by with “goal” and maybe “target” in our vocabulary?

Nope.

But you have to remember that this "e u" word is brought to you by the people who.. (wow Sesame Street flash back - and what is up with Cookie Monster eating vegetables? Cookie was cool because even little kids got the irony that he was on PBS and wasn't PC.) ...coined hyperglycemia and hypoglycemia. They thought it was funny to try to teach those words to us within the first 36 hours after diagnosis when we were seriously sleep deprived.

I swear the diabetes educator and doctor went back to the break room and laughed hysterically after trying to teach me the words: "Gladis you should have seen this dad when I hit him with hyperglycemia. I thought his head was gonna explode. The timing was perfect he was trying to get a nap in that hard little chair next to his kid's bed. I don't think he has slept in days and let me tell you this one is the most needle phobic guy I have ever seen, so I whip out the needle, watch him turn a nice pasty white and bamb hit'm with the "H" words, Ha ha ha Priceless."

We need another weird word from these so called medical professionals like we need more holes in our fingers.

Delaney calls euglycemia, the Magic number. When the school nurse gave her some little stuffed animal doodad for hitting the Magic Number she, being a resourceful little twerp, diversified the portfolio of Magic numbers so as to provide more opportunities to cash in; 100, 101, 111, 123 and I think she was lobbing for 119 as the opposite of 911 too.

So anyway I nominate UGLYcemia as the word that describes all those numbers out there that aren’t magic. Those numbers that in their May Varry-ness make us need to look at the meter in the first place and wonder if our kids are going to turn into a pillar of sugar.

UGLYcemia is everything that isn’t euglycmia.

From the News Wire: Dexcom Call on Seeking Alpha

Dexcom's earnings call transcript is on Seeking Alpha. Now I don't want to deprive anyone of the fun of reading the financial press but just in case wading though ten pages of CEO and Analyst speak isn't you idea of high times, here are the highlight with regard to CGM pump integration:

Terry Gregg Dex CEO

A quick update on our insulin pump partnerships with Animas and Insulet. In January of this year, we announced an expansion of our Animas relationship to an exclusive agreement to develop and market integrated insulin pump CGM systems in markets outside the US. In return, Animas will pay us $5 million upon receipt of a CE Mark for the first OUS commercial product that is expected either later this year or early in 2010. And in addition Animas will pay DexCom a royalty of $200 per CGM enabled pump sold in any OUS market. As parts of this agreement, Animas will also serve as a nonexclusive distributor of transmitters and sensors to purchasers of the Animas CGM enabled pumps outside the US. This exclusive arrangement has an initial term of three years.

We continue our development work on the integrated insulin pumps CGM systems with our pump partners. Our continued goal is to complete all development, clinical and regulatory efforts on these joint development projects and be positioned to launch a first product with Animas during 2009 and with Insulet sometime the following year. But as you are well aware, the timing of the regulatory process is uncertain.

There is a little more on page 9 including, "Well, I can't speak for them." Hmmm wonder if Terry got his hand slapped for saying more that the partners wanted in previous calls.

So pump fans this just ads to our what do we do about the pump that is up for a new 4 year hitch in April problem. If we re-up now we will more than likely need to pay a big fat upgrade fee in just a few months. Why sign up for a four year deal when it look like significant improvements are literally in for FDA approval?

Just to be on the up and up, I do have shares of Dexcom in my IRA. Jacques Cousteau and the team from the Calypso have sent divers looking but the portfolio is so far underwater they will need the mini sub any artifacts from it. LOL Maybe they will save the day by coming up with that huge diamond from the last scene of Titanic...

Link to the iPhone Presnetation

I was remiss in not posting a link. In case you didn't find it on your own here it is.

The Lifescane presentation starts at about 43 minutes into the presentation.

Looks like they use a wire in the video not Bluetooth. (In fact it looks like the wire has shrink wrap on it.)

http://events.apple.com.edgesuite.net/0903lajkszg/event/index.html

Don't beleive what you read...

This cracked me up. Look where you end up if you click Read Full Article.

http://www.octnews.org/articles/722004/newton-photonics-wins-a-nsf-sbir-grant-for-oct-glu/

More proof that you can't trust the internet. LOL

iPhone, LifeScan and My Standard Rants

Wow nothing like mentioning iPhone in on your blog to generate some traffic. YDMV had unusually high traffic yesterday. Nice to know it is mention of a cool cell phone that the world wants to hear about and not the regular musings of a dad of T1 kids.

Very humbling. LOL

(But Hey iCan Learn! Look I have put iPhone in the title of this post!)

For those of you who are new to YDMV let me introduce my standard rants about T1 diabetes information. The data needs to be ours, as in the people managing diabetes. It needs to come in industry standard formats so that We the People can choose the data creation devices that promote our Life Liberty and Pursuit of Happiness. We need choices in the tools to analyze our data from the devices we pick and all the tools and data should play nice together.

See Swimming in the Data Stream Looking for the UN and I would Like a Side Oder of Holy Grail

Yesterday’s iPhone and LifeScan news brought these points to mind but I didn’t articulate my them (my rants) well at all. The BG data moving into an iPhone is all well and cool but if it is a proprietary J&J deal it is part of the problem rather than being an expansion of diabetes care options.

Animas used to tout the fact that their ezMannager program could download all the major meter data. While the program was something less than wonderful the idea of open architecture was great. Look at an Animas pump now and it says OneTough right there on the front face where it doesn't say Animas any more. That and there isn’t the down load options there was. Sorry J&J but that is the wrong directions.

We the People Managing Type 1 need applications that play nice with others. To get it we should use the ever popular market forces and choose the suppliers that provide open systems. OK OK there aren’t any. But we can deal with the fact that the vendors will try to tie us to their products by speaking up.

Call your pump rep.
Call your meter company.
Write actual sail mail letters. (File> Print. LOL)
Blog.
Ask for open data architectures.

Now this may mean your pump rep never calls you back, like our, but hey that tells you something doesn’t it?

How about iPod Touch, Bluetooth and Diabetes?

Reading little more on iPhone 3.0 it sounds like iPod iTouch users will be able to upgrade to 3.0 and they get Bluetooth. So then will the BG app from LifeScan work on an iTouch?

Inquiring minds want to know!

I can see that making more dollars and sense than an iPhone for a kid with T1.


CNET Crave:

Stereo Bluetooth audio is coming to the iPod Touch, said Apple's Greg Joswiak at Tuesday's iPhone OS 3.0 preview event. The added Bluetooth functionality will come by way of the OS 3.0 upgrade, due out this summer. While iPod Touch owners clearly win from the addition of Bluetooth support (a $9.95 upgrade fee is required), they may be a little peeved to learn that the second-generation iPod Touch hardware has probably supported Bluetooth all along.

IPhone 3.0 and Life Scan

YDMV Note. This post about Lifescane and the iPhone gets hit a lot. There is no real product at least yet. See
http://www.ydmv.net/2009/08/wavesense-iphone-app-first-impressions.html
for a manual entry log that is worth looking at.
Note II  Sept 21 2010 Sanofi/WaveSense announce iBGStar 

So according to Gizmodo, Apple showed the new iPhone 3.0 software today and showed and app from LifeScan charting BG for a week. Apparently you will be able to Bluetooth in the data or use a cable.

Gizmodo

By far the most manipulative pitch of the afternoon, LifeScan shows how new Bluetooth connection capabilities and accessory functions can help a young girl manage her diabetes. Above is a week-long chart of her glucose levels, which are good to know if you have diabetes and don't want to die. LifeScan can pull these from a test unit via Bluetooth or cable.

for a photo see: http://i.gizmodo.com/5172248/first-iphone-30-apps-show-off-new-functionality

OK that is cute in a geek kind of way but how about a One Touch that uses less blood, doesn't error 5 and is less huge?


Edit

Amy has more over at her site. There is a shock (not) Amy has the inside dish. She sites another source saying:

“The app then lets users send their readings and a message about how they’re feeling to caregivers like their parents, children or physician. The glucose reader app also includes a meal builder and insulin schedule for easy tracking by tagging readings as pre- or post-meals. The iPhone app can even estimate, based on diet, how much insulin is needed after each meal. The app also shows glucose levels in a chart form and lists each previous reading.”

OK now my kids are going to want iPhones even more.

Here is my question is the Bluetooth going to be proprietary to OneTouch or will it allow other Bluetooth meters to talk with it? I am thinking WaveSense, I like their meters.

Another edit.

This One Touch Ap was made strictly for the 3.0 presentation. It isn't really a coming attraction. More like hey here is an neat idea we could make but what the heck if we can get on the iPhone 3.o stage we'll hack something together.

Read more on how it got to the show here. Careful observers of the video will see something that looks a lot like a wire on the wireless connection, and a little shrink wrap on the wire.

Diabetes Too?

I had my every few years annual physical. At my previous annual, three years ago, the good doc said my blood sugar was one-oh-something. He said that was a little high and warrant notice.

I had a pretty good laugh.

With two type 1 kids one-oh-something is the Promised Land, ground for celebration not notice.

This year my BG was officially an issue. I had to go back and get an A1C and have the BG re-checked. (Psst Doc, I can check that at home without much effort but he wanted me to go in anyway.)

I did do some checking at home and my fasting BG was in fact a little high. Here is the deal; I couldn’t be very impressed by the whole thing.

I did the A1C and it was 6.0. I had already made some changes and the fasting BG was half way back to normal.

They wanted me to see an endo and a nutritionist. Sure, I like I don’t know what they are going to say?

I am eating better as much to save money and eat tastier stuff as anything else. I started taking in home made soup or chili instead of buying lunch. I’m a lot better cook than the local sandwich shop so I am getting good eats and as a side benefit I have lost weight.

My fasting BG has come back to the 1-0-x range. I’ll keep check my blood from time to time. I’ll be more active. More time on the tread mill less blogging.

I am going to skip the endo and the nutritionist. I think it is an act of charity to others who would be in the classes they would refer me to. I would be a frighteningly disruptive influence in an intro to type 2 class. I need to keep making a small effort.

I’m still not impresses by the whole thing. It may need doing but it is nothing close what either of my T1 kids does without thinking.

There is no way I'll call what I need to do diabetes too.

Dexcom FDA approval - Question is for What?

So this little gem is all over the wires today:

March 5 - DexCom Inc: Says received approval from FDA for third generation continuous glucose monitoring system on February 13 - SEC filing * Says to begin commercializing product in Q1 2009

Anyone paying close enough attention to know what this is?

**Edited to ad**

(After using Google apparently I know. It was the first hit. LOL I just don't know I know, ya know what that is like?)

http://ydmv.blogspot.com/2008/08/from-news-wire-dexcom-on-animas-and.html

I quoted Trey Gregg - Dex CEO from Seeking alpha:

We are also pleased to report that we have filed a PMA supplement for a third generation continuous glucose monitoring system with the Food and Drug Administration. Data from our approval support trial demonstrated significant improvements in system on time and improved accuracy as compared to our current product. In addition our third generation system will include twin doors to complement our turn graph and event entry capabilities such insulin intake, (inaudible) exercise as well as configurable alarms.

Diatribe put that into actual english
http://www.diatribe.us/issues/7/new-now-next.php

As we understand it, DexCom is close to a third generation sensor - it has completed the necessary clinical trials necessary for FDA approval. Advantages of this system include a 75 percent smaller sensor size - allows for a smaller insertion unit, which is potentially less painful. The other major promised improvement is in the software component of the device; this version of the software will have trend arrows; event markers for food, exercise, and medication dosing; and user-adjustable alerts with different sounds associated with hyperglycemia and hypoglycemia.