November 28, 2008

From The News Wire: Shine a Light on Me - Optical CGM

Newton Photonics wins NSF grant for new glucose meter

The National Science Foundation has awarded a nearly half-million dollar grant to startup Newton Photonics Inc. to create a non-invasive optical sensor capable of
continuously monitoring a patient’s glucose levels.

The NSF made the $480,000 Phase 2 Small Business Innovation Research (SBIR) award on Nov. 3, explained the Newton-based company’s co-founder Shmuel Halevi. The firm specializes in making biophotonic sensors. The NSF cash will fund the company’s effort to create the glucose-monitoring instrument using proprietary Optical Coherence Tomography (OCT) technology.

Currently, no company has released to market a glucose monitor using OCT. Existing technologies from larger companies require the patient’s skin to be broken. “So far, there’s been a lot of talk, but there’s still no instrument like this in the market,” said Halevi. “The market is there waiting for it.”

However, Halevi noted that at least one other startup, GlucoLightCorp. of Bethlehem, Pa., is developing a similar product. He said Newton Photonics’ technology enables prolonged monitoring and eliminates the need for frequent calibration.

Don't get me wrong this could be cool, when it works and is for sale, but speaking as part of the market what we are waiting for is insurance coverage.

November 25, 2008

From The News Wire: Possible New Source of Beta Cell

In animals aka Mice. Who would have guessed it was in mice?

ScienceDaily (Nov. 25, 2008) — Researchers at the Joslin Diabetes Center
have shown that insulin-producing pancreatic beta cells can form after birth or
after injury from progenitor cells within the pancreas that were not beta cells,
a finding that contradicts a widely-cited earlier study that had concluded this
is not possible....

"This means that there is a population of pancreatic cells that can be stimulated, either within the body or outside the body, to become new beta cells, the cells that are lacking in diabetes," said Susan Bonner-Weir, Ph.D., the study's lead researcher and a Senior Investigator in the Section on Islet Transplantation and Cell Biology at Joslin and Associate Professor of Medicine at Harvard Medical School."

November 24, 2008

From the News Wire: Pod People Earnings Call.

Insulet Corp’s (aka Omni Pod) earning call transcript is up at Seeking Alpha.

The interesting news for those of us who’s Diabetes May Vary falls into a couple of little bits. What I found interesting is:

  • CGM is taking longer than they hoped.
  • Production has significantly shifted to China
  • Next Generation goal is 40% smaller 25% cheaper to produce in 2010.
Leading the pack for my interest is GCM and the one question about GCM is on page 9 of a 10 page call transcript. It is taking longer than they thought and the CGM folks are asking Insulet to do the PMA (That is an FDA PreMarket Approval for those who don’t speak Pharma Geek.)

Paul Choi – Merrill Lynch
Just a pipeline question. Can you give us an update on where the CGM development is going right now and when we can expect perhaps a first milestone?
Duane DeSisto
Sure. I think it's taken longer than we thought. Both companies have come back to us. They originally going to submit the PMA. They've asked us now to submit the PMA and we are in the process of evaluating the cost and the timeline if we have to do that. So it's going slower than we thought. Our hope is still that we're into the FDA next year, but it has gone slower than we had anticipated.
CGM also came up in a reply about Podd’s share of the pump market at large centers. The reply was that when the Omni Pod looses a sale in those competitive markets a lot of times it a function of a close loop dream.

Mimi Pham – JMP Securities
And in terms of your top centers, do you get a sense of your market share versus the other pumps, are you getting 10%, 50% of sort of the new pumps sold or used at some of your top
Duane DeSisto
If you take a look – if you just give me some sense, if you take a look at some of the numbers and you can take exception to a couple of these if you like, but from looking at the various reports out there, there is 30,000 to 35,000 new customers, new pumpers a year. You start taking a look at the kind of numbers that we're putting on there as an overall basis, we're getting a very, very large percentage of those new customers. So and in the top centers, look, at the end of the day, for the most part, if we lose out at the top center, it circles around the dream of continuous sensing in a whole closed loop system, because we're not positioned at the moment to take advantage of that. But ultimately we think we have a better solution than what's out there.
For Pod users the big news is a significant shift in production to China. Reportedly the quality of the product from China is slightly better than the US production. Here are a couple of quotes dredged up from the whole.

Duane DeSisto
In the second quarter, approximately 80% of our production came out of Bedford, with the remainder from China. In the most recent quarter, the inverse is the case, with approximately 85% of our production coming from China. This was a swift and impressive transition and I'm proud of our accomplishment.

But apparently most is still in inventory:

Duane DeSisto
So, it's a good question, Mike, but you have to take a look at it. The bottom line is we're carrying four months worth of inventory. So what we produced in the third quarter has not hit the P&L.

It is gonna get smaller. I think that is a good thing.

Mike Weinstein – JP Morgan
Okay. And then the last item and I'll let some one else jump in here. But could you just update us on the progress of the next generation Pod and when we should start thinking about that coming to market and the profitability profile of that product? Thanks.
Duane DeSisto
Okay. It's very early on. Obviously there's all kinds of engineerings and regulatory hurdles to get through, but it really looks like a – our goal would be the back half of 2010. Our target is 40% smaller and 25% less cost is the target. We still have a ways to go, but we haven't seen anything to-date that would discourage us at the moment
Other stuff you can find in there includes:
  • A lot of financial talk about cost, inventories P&L etc. Apparently the unit cost of a Pod was originally about 70 bucks and is expected to be less than $20 soon. The cost of the silver in the battery is significant.
  • There is a trial under way for a sub set of T2’s who use U500.
  • Analysts ask the same question numerous times. I don’t know if that is because they don’t pay attention to other peoples questions, have the attention spans of three year olds or they are fishing for details, probably a little of all three.

November 21, 2008

From The News Wire: Animas Battery Cap Recall

Animas Corporation Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump
Audience: Consumers, endocrinological healthcare professionals

[Posted 11/20/2008] Animas Corporation and FDA informed consumers and healthcare professionals of a nationwide recall of battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump. The battery caps used with the above infusion pumps were manufactured from June 1, 2008 through July 31, 2008, and were distributed from June 16, 2008 through August 1, 2008.

There may be an intermittent loss of contact between the battery cap and the battery compartment in the pump which may result in the device resetting. This can cause the device to stop administering insulin, which could result in an excess level of glucose in the blood (hyperglycemia). Additionally, this failure may lead to user confusion in the amount of insulin administered, contributing to errors in future doses, which may result in lower than normal level of glucose in the blood (hypoglycemia). Healthcare professionals are advised to ensure that their patients replace the battery cap on their insulin pump.

[November 20, 2008 - Recall Notice - FDA]

November 11, 2008

Scott and hardest earned penny of the face of the earth

Scott Strumello provided some great links in a commented on "From The News Wire: Osiris, Genzyme and JDRF IDDP." So to get those links little more exposure I am bringing them out of the total obscurity of a comment on YDMV, to the relative obscurity of an actual post on YDMV.

Scott said...

Actually, the policy at JDRF's involvement in private companies was featured in The Wall Street Journal back in 2007 (see for details), and was a function of former CEO Arnold Donald's policy to make investments to advance diabetes research. More detail is available on the JDRF website from an interview with him (see Details are also disclosed in the organization's annual report, though this won't be included until the 2008 report comes out next year.

Thanks Scott for providing background to the basic idea of a not for profit (JDRF) funding for-profit pharmaceuticals. Everyone go read the links - I'll wait ....

... Cool idea huh?

I think it is a great idea to try to bridge the academic work to real world of approved therapy. I look at it like this: Lots of mice get cured - maybe this will help move those cures to people.

One of the links Scott provided says:

Every donor or volunteer should feel that they are totally connected to JDRF. They should feel that they are proactively communicated with. That their connection to type I is understood by JDRF. They should be treated with integrity and caring and know that their opinions count. It doesn't mean we are always going to do exactly what a given volunteer's opinion is, but if they understand why we’ve done something, even if they would do it differently, it creates the basis of the possibility of alignment.

Earlier the articles says," My personal analogy again is the single mom barely making ends meet, and she's scraping every penny she can to give to JDRF so that her child can be cured, and we have to honor that penny like it’s the hardest earned penny on the face of the earth."
I agree.

IDDP projects are valuable. As such they must pass the hardest earned penny of the face of the earth test. We all should have the opportunity to find out how each JDRF IDDP investment of hard earned pennies is honorably aliened with a potential cure. The way to do that is transparency.

I am sure JDRF has some real smart people working on the IDDP program. Heck I have even talked with some of them. So OK maybe they weren't so smart to get on phone call with me but anyway.... Smart people still need to explain what they are up to. The sign of a real smart person is their ability to explain complex stuff in simple terms.

To help make my point here is an analogy that will more than likely do little but prove I am not such a smart guy. One of the reason the financial industry crashed and burned this fall was credit risk swaps. These are instruments of spectacular complexity. Congress decided that since they are only available to big smart firms, like say AIG, that they, Congress, didn't need to regulate the market for swaps. The idea was that the super smart guys buying and selling the things would be a balance each other and the market would be self regulating.

That didn't work out real well.

In part because a free market assumes there is information. But nobody was reporting what their position in swaps was. Not knowing AIG was awash in swap risks the market couldn't accurately price AIG. In case you missed it We the People are on the hook for a few hundred billion in loans to the super smart guys at AIG.

The moral of the story is that information is critical.

I am all for IDDP projects. In the interest of respecting hardest earned penny of the face of the earth the single mom as well as the rest of us should have some idea of how many pennies are involved, what the the pennies are trying to achieve and if it is wildly successful how will JDRF get the pennies back.

In the specific case in point, I don't think it is asking too much to know if Osiris signing a potentially billion dollar deal for a product an IDDP investment was helping into trials counts at a milestone for repayment. If so, then JDRF can do another similar deal with someone else as another step on the path to a cure.

From The News Wire: DexCom on Animas and Edwards

DexCom is in the news today.

The stock is getting whacked, we hold these truths to be self evident since everything is getting whacked. Some press is about DexCom and not making earnings this quarter. That is par for financial press.

I find more interesting the news that they are entering into an agreement with Edwards Lifesciences Corporation, "to develop products for continuously monitoring blood glucose levels in patients hospitalized for a variety of conditions." The deal brings cash to DexCom and helps get the product into institutional markets. I would think that a wider market for DexCom products is a good thing. Of course your interpetation of how this all shakes out is up to you. I like the idea of a vote of confidence and capital in the CGM feild.

More interesting persoanlly, since we use Animas pumps, are the comments about DexCom and Animas. They are still expecting a product out in the summer of '09. See Seeking Alpha for the full call transcript
"A quick update on our insulin pump partnership with Animas Corporation. We continue to make substantial progress on the joint development of an integrated insulin pump CGM System with Animas Corporation. Our continued goal is to complete all development, clinical and regulatory efforts with Animas and be positioned to launch our first product during the summer of 2009. But, as you are well aware, the timing of regulatory process is uncertain."

There is other good stuff like talking about working with insurance for reimbursement, demand for the product, the JDRF study and lots of geeky finance talk. If that stuff floats you boat enjoy the call transcript.

Your Diabetes May Vary and so does the value of stocks I own including DexCom. Hopefully your A1C is more stable than portfolio. LOL.

November 7, 2008

From The News Wire: Reports on Effects of DiabeCell(R)

Living Cell Technologies Reports on 12-Month Clinical Effects of DiabeCell(R) at Annual General Meeting

SYDNEY, Australia & AUCKLAND, New Zealand & BOULDER, Colo., Nov 06, 2008 (BUSINESS WIRE) -- Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY) today updated shareholders at their Annual General Meeting in Adelaide, Australia on the Phase I/IIa clinical trial of DiabeCell(R), LCT's lead product candidate for the treatment of insulin dependent (Type 1) diabetes.

A total of six patients have been implanted with DiabeCell(R) to date; five patients received the lowest dose of 5,000 islet equivalents (IEQ/kg), and one patient was dosed with 10,000 IEQ/kg. Of the initial five patients, four have had a second dose and two patients have been observed for more than 12 months. Of the two patients followed for more than a year, observations include:

Patient one has maintained HbA1c at the ideal level of 6.7 percent with less insulin. His daily insulin dose requirement varies and has been reduced by 25 percent to 46 percent compared to his pre-treatment insulin usage.

Patient two did not require insulin for five months after the first implant and now uses 36 percent less insulin daily than before the DiabeCell(R) implant.

To date there have been no remarkable adverse events.

Click here for more

November 6, 2008

From The News Wire: Osiris, Genzyme and JDRF IDDP

JDRF made a two million dollar payment to Osiris in June as part of an IDDP program. This was for trials of Prochymal.

Today (11/6/08)

Genzyme Corp. and Osiris Therapeutics announced today that they have entered a strategic alliance for the development and commercialization of Prochymal and Chondrogen, two novel, late-stage adult stem cell treatments that hold significant potential to treat a wide range of diseases. These stem-cell products are designed to provide therapeutic benefit by controlling inflammation, promoting tissue regeneration, and preventing scar formation.


The Wall Street Journal has more:

Genzyme Corp. and Osiris Therapeutics Inc. have reached a deal, valued at as much as $1.4 billion for Osiris, to jointly develop and sell Osiris stem-cell-based treatments that are aimed at several diseases.

Under the deal, Genzyme will pay Osiris $130 million upfront in two guaranteed payments, the second of which is due on July 1, while it helps develop and market Osiris's Prochymal and Chondrogen products. The deal then calls for as much as $1.25 billion in potential payments over several years as regulatory and sales milestones are hit.

Prochymal and Chondrogen are made from a type of stem cell that is taken from the bone marrow of adult donors. Prochymal is an injectable drug aimed at a number of diseases, including a rare immune-system problem that can hit marrow-transplant patients, while Chondrogen is being developed as a potential injectable treatment for severe knee arthritis.

So how does the JDRF thing factor in? I wish JDRF was transparent about this stuff. They aren't. Well off to see what I can find out.