Saturday, June 23, 2007

ADA Scientific Sessions: Biodel Announces Regular Insulin Beats Analogs

I'll admit it, the headline may be a slight exaggeration, but let me explain. As my readers may recall, when I gave my 2006 Wrap-Up and Outlook for 2007 and Beyond, I made a point of highlighting that insulin analogs could become dinosaurs in the not-to-distant future, but we should not look to these to come from Novo Nordisk, Eli Lilly and Company or Sanofi Aventis. Specifically, I cited two developments, one by a France-based company called Flamel Technologies, S.A. in developing a product called Basulin (an ultra long-acting regular insulin) which, if it makes it beyond clinical trials, will be marketed by Bristol-Myers Squibb. At the other end of the extreme, another company called Biodel Inc., a privately-held biopharmaceutical drug delivery company based in Danbury, CT that develops drug delivery technologies which increase drug efficacy, enhance drug performance, and make drugs easier for patients to take is working on a potentially even more rapid insulin (called Viaject) than today's analogs.

The issue of repetition in diabetes-related research is a major reason that I have decided not to attend the American Diabetes Association 67th Annual Scientific Sessions which just began in Chicago. I just could not stand to sit through 4 more days of more research into the virtues of glycemic "control" rather than a more serious investigation into the severe limitations of current treatment modalities. One issue I have with the The American Diabetes Association is that they fail to even require a meta-analysis of previous research into the subject before giving researchers a venue or publishing repetitive studies, and the fact that the ADA does not require its authors to conduct a meta-analysis seriously damages their credibility.

I should note that in recent years, some respected scientific journals have attempted to address the issue of wasteful research by placing more burden on researchers and authors to prove that their work is unique. I am thinking, for example, of The Lancet, which announced in the summer of 2005 that it now requires all authors submitting papers to show they performed a meta-analysis of previous research or consulted an existing one. The ADA needs to adopt a similar policy, but has its collective head so firmly pushed up its own arse that they fail to see anything wrong with their business-as-usual approach.

That is not to say that there will not be useful take-aways, but it consumes a lot of time to sift through all of the junk that will be presented. However, back to the theme of this post, one of the first presentations at the ADA Scientific Sessions in Chicago pertained to Biodel's Viaject insulin, and the results indeed looked promising. Specifically, Viaject required less insulin, and the authors also believe that alone was responsible for fewer incidents of hypoglycemia, and less weight gain!

I am including the abstract of that presentation here, followed by a news story on the same subject:

"Management of Insulin Treatment -- New Technologies and Beyond," abstract number: 0034-OR. SOLOMON S. STEINER, MARCUS HOMPESCH, RODERIKE POHL, FRANK FLACKE, ANDREAS PFUETZNER, PATRICK V. SIMM...


Biodel Inc. Announces VIAject(TM) Data At Oral Presentation At The American Diabetes Association Meeting

Jun 23, 2007

Biodel Inc. (Nasdaq: BIOD) today announced the presentation of additional clinical data from its VIAject(TM) program at the 67th Scientific Sessions of the American Diabetes Association (ADA). As disclosed in an oral presentation entitled, "Management of Insulin Treatment -- New Technologies and Beyond," abstract number 34-OR.

Interim results of Biodel's Phase III clinical trials demonstrated statistically significant daily meal-time (prandial) dose reductions in patients with Type 1 and Type 2 diabetes using VIAject(TM). Type 1 patients receiving VIAject(TM) showed a 28% reduction in daily prandial dose while control patients receiving Humulin(R) R showed a non-significant increase of less than 1%. Type 2 patients receiving VIAject(TM) showed a 49% reduction in daily prandial dose while control patients receiving Humulin(R) R showed a non-significant increase of 2.3%. VIAject(TM) is a very rapid-acting form of injectable human insulin for meal-time use by patients with Type 1 or Type 2 diabetes and is comprised of commercially available recombinant human insulin and our proprietary formulation of ingredients, all of which are Generally Regarded As Safe (GRAS) by the Food and Drug Administration (FDA). Biodel is currently evaluating VIAject(TM) in ongoing Phase III clinical trials.

"We are encouraged that the VIAject(TM) Phase III data continues to meet our expectations and are pleased to share our interim findings in the context of a respected scientific forum provided by the ADA," stated Solomon Steiner, CEO of Biodel. "We plan to advance VIAject(TM) and other product candidates utilizing our proprietary VIAdel(TM) technology and look forward to bringing much needed therapies to the patient population."

Data was also presented from a Phase II study of 16 subjects with Type 1 diabetes. Subjects received either VIAject(TM) or regular human insulin (Humulin(R) R) after a standardized meal and postprandial blood glucose (BG) was monitored. Plasma insulin and blood glucose levels were determined throughout the study. Administration of VIAject(TM) resulted in statistically significantly faster insulin absorption than regular human insulin and lower insulin levels after three hours. The baseline corrected BG profile following the meal was significantly lower during the early time periods of 0-120 and 0-180 minutes, indicative of less hyperglycemia. The mean total glucose infused to maintain normal blood glucose levels was 5 times lower with VIAject(TM) than with regular human insulin, indicative of less hypoglycemia. This data showed that VIAject(TM) provides better postprandial blood glucose control with less hyperglycemia in the first three hours after the meal and less risk of hypoglycemia in the next five hours as compared to regular human insulin.

Biodel noted that its clinical trials are continuing, and that the final results of the trials may be different than those suggested by the interim data presented.

About VIAject(TM)

Our lead clinical candidate is VIAject(TM), a very rapid-acting form of injectable human insulin for meal-time use by patients with Type 1 or Type 2 diabetes. VIAjet(TM) is comprised of commercially available recombinant human insulin and our proprietary formulation of ingredients, all of which are GRAS by the FDA. Our proprietary formulation delivers insulin in a form which closely resembles the way a normal body uses insulin to help glucose enter the body's cells, providing energy that allows the body to function. Current insulin therapies are not delivered quickly enough to simulate the desired meal-time insulin spike. In tests to date, the VIAject(TM) formulation of insulin promotes a more rapid absorption, which more closely mirrors the effects of naturally produced insulin in non-diabetics thereby providing more effective blood glucose control. This novel therapy is currently undergoing two pivotal Phase III clinical studies. The two studies, one involving 400 patients with Type 1 diabetes and the other involving 400 patients with Type 2 diabetes, are comparing the effects of VIAject(TM) to Humulin(R) R, the leading recombinant human insulin.

Biodel believes the potential advantages of VIAject(TM) are:

-- VIAject(TM) may provide a safer therapy than the currently marketed meal-time insulin treatments;

-- VIAject(TM) more closely mimics the natural spike of first-phase insulin release in non-diabetics, possibly reducing the risk of hyperglycemia;

-- VIAject(TM) may allow for a lower dose of insulin required to adequately cover a meal compared to Humulin(R) R and Humalog(R), the market-leading insulin products;

-- VIAject(TM) may reduce the amount of insulin that remains in the bloodstream several hours after a meal, reducing the risk of hypoglycemia; and

-- VIAject(TM) may prevent weight gain.

About Biodel Inc.

Biodel Inc. is a development stage specialty biopharmaceutical company located in Danbury, Connecticut. The Company is focused on the development and commercialization of innovative treatments for endocrine disorders, such as diabetes and osteoporosis. Biodel develops product candidates by applying proprietary formulation technologies to existing drugs in order to improve their therapeutic results. The Company has two insulin product candidates currently in clinical trials for the treatment of diabetes. Additionally, the Company has two preclinical product candidates for the treatment of osteoporosis.

Safe Harbor

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward- looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, our ability to secure FDA approval for our product candidates under Section 505(b)(2) of the Federal Food, Drugs and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel(TM) technology; the progress or success of our research, development and clinical programs, the initiation and completion of our clinical trials, the timing of the interim analyses and the timing or success of our product candidates, particularly VIAject(TM) and VIAtab(TM); our ability to secure patents for VIAject(TM) and our other product candidates; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2007. The Company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.

Biodel Inc.
http://www.biodel.com

URL for this article:
http://www.medicalnewstoday.com/medicalnews.php?newsid=75038&nfid=crss

8 comments:

Jenny said...

Scott,

Excellent point about the ADA's failure to consider previous research.

Even worse, in my opinion, is the way that in its journals the ADA funds the publication of well-conducted research that makes it very clear how bad the advice they are giving patient really is, but they ignore it and keep on giving out the "carbs are good for you", "tight control means blood sugars of 180 mg/dl 2 hours after a meal" advice that is causing blindness, nerve damage and kidney failure.

==
I'd read the PR release about VIAJect yesterday, too--that's what you copied in your blog. I hope this stuff is real. PRnewswire releases aren't entirely credible as they are written by the company's marketing department and may just be an attempt to manipulate the company's stock.

But I am a big fan of R because the strange responses I've had to two different analogs make me concerned that they aren't good for my body.

My concern is that this R+GRAS stuff will be as expensive or even more expensive than the analogs and that, worst case, this kind of formulation may cause the cheap R to go the way of UL (which worked very well for me.)

It would be nice if it worked, though. OTOH, I can see some problems with a much too fast insulin too. What I like about R is that it lasts over enough time that it eventually meets up with my food rather than hitting all at once with the potential of missing it.

BetterCell said...

The ADA is a Top-Heavy organization loaded with too much Politics and Buracracy.
What kind of good can develop from such a place?

Chrissie in Belgium said...

YES, sifting through all the junk is enough to finish you off! About the new insulins - don't get me wrong, I like progress, but I also prefer an older medicine over a newer medicine so that it has proven itself over time. So often one hears, "ooops this medicine wasn't quite as safe as we thought!"

Anonymous said...

When the ADA "morphed" from a patient-focused charitable organization to a charitable CORPORATION, the mission changed. To remain "a player," the ADA had to please it "shareholders" (contributors and advertisers) rather than diabetic patients.
The "new mission" has become perpetuating the organization rather than serving and advocating for patients.

Melody

Scott said...

Thank you all for your feedback. To Jenny, I wholeheartedly agree with you on regular insulin, and the best logic is there's a reason that's what is in the body to begin with! You're right about press releases, however, to comment on Viaject, I should note that it is not dramatically faster than rapid-acting analogs (in fact, its only minutes faster, but as one analyst said, in this business, time is money). However, the fact that it is from a structural standpoint, identical to regular human insulin gives it a big advantage over analogs which are neither human, nor insulin. It will be interesting to see how this plays out!

Barry, I certainly agree with you re: the ADA, and that also applies to Melody's comment as well. The ADA's credibility among patients is pretty low to begin with (except newly diagnosed patients, unfortunately), but I think the issue of duplicative research is harming their reputation within the scientific community as well. I just take issue with them when they refer to themselves as the diabetes authority, yet they cannot even police the articles that appear in their own publications! I have traditionally supported JDRF over the ADA anyway (their current leadership has made me rethink that), but its really unfortunate when so many patients and doctors alike look to that organization for leadership. Oh well!

Chrissie, I completely agree re: older medicines over newer medicines that have proven themselves. Personally, I believe I attained control that was comparable (if not better) using animal-derived, purified insulins, and did not suffer from issues with hypoglycemia unawareness at any point when I used them, but have had continued problems with synthetic "human" insulin which is blamed on the patient for not correctly counting carbs or some other issue. The reason I find Biodel's Viaject attractive is that it is structurally identical to regular human insulin. The big deal is that none of the ingredients are new invention, rather they are already approved by the FDA for use in other applications, so we're not talking about untested substances here! Biodel is about to go public, and I would consider an investment in this company ... although they could ultimately be acquired, shareholders will likely get a rich premium for their shares!

Wingman said...

Wow this post was really eye opening. For my master's in political economy I had to write full academic reviews before any term paper - I can't believe the ADA doesn't have as tight controls.

As a newly diagnosed Type I, I agree that the information on the ADA's website is awful. It gives you just the bare minimum of what you need to know and it seems that in the medical community doctor's/ researchs are too affraid to make the patient "feel bad". It's like there is something wrong with those of us who want the tightest control possible.

Amalas said...

I find that study to be mostly worthless. Why compare VIAject(TM) to Humulin(R) R? I would much rather see a study that compares VIAject to say, Humalog or Novolog.

Scott said...

Amalas, the fact of the matter is that its REQUIRED by the U.S. Food and Drug Administration for approval, AND the study must be done in comparison to Regular insulin, not an insulin analog. There was some debate at the ADA Scientific Sessions in Chicago this year about whether Regular should be considered the current "gold standard" of treatment, but for the time being, that remains the case.

The company may choose to conduct additional testing in comparison to Humalog or Novolog, but that is optional, not required by the FDA.