I don't mind high sugars as much as I loathe lows. Personally I'm not so ruffled by shots either (but my liver begs to differ). However, in a message posted on The Islet Foundation, Pfizer reported that insulin-dependent diabetics declared they most hate taking shots. Was this the warm-up for the Exubera campaign? Here's a fact I support! A close second to this hatred is the hypos. Any diabetic will confess -- hypos are unforgiving. So what if you could catch two birds with one capsule?

I must reiterate the scientific genius behind the Oramed gel caps. The encapsulated insulin bypasses destruction in the stomach cavity. It reaches an entry point in the intestines where it reports for duty to the liver. This allows the liver to resume command of the glucose metabolism, just like Mother Nature intended. Whey you inject insulin - you are overriding the livers ability to monitor blood sugar and putting yourself in the line of fire for the dangerous lows. We all know this state of derangement too well. You won't find my lows picture on a milk carton if I happen to lose it, either.

Frequent episodes of hypoglycemia (even mild ones) force the brain to become accustomed to the low glucose. Unfortunately this also causes suppressed signaling of adrenaline, the livers last resort before dangerous lows. More specifically, the glucose transporters located in the brain cells are damaged from frequent episodes of hypoglycemia. So what was once the hypo threshold for the brain to signal adrenalin release becomes lower. Clinically, the result is hypoglycemic unawareness. Down with the shots, down with the lows and big ups with the future of diabetes control! Now we're getting somewhere.

Oramed is developing a soft gel insulin capsule for the treatment of diabetes. The company has recently announced it the successful completion of its clinical trial demonstrating the safety and efficacy of the oral insulin gel capsule.

The pills were shown to reduce blood sugar, with no significant adverse effects. The insulin used in the gel caps is a generic brand of human insulin. The duration of the insulin is similar to Regular. But the most beautiful thing about these gel caps is that they reintroduce the liver into glucose metabolism, thereby reducing the likelihood of dangerous lows associated with injected insulin and oral medications. This could blow away the necessity of blood sugar testing because you are regulating glucose metabolism in the liver, like a person without diabetes.

Up until now, the idea of insulin pills or tablets was inconceivable due to the fact that insulin, when swallowed, breaks down in the digestive system. Oramed's patented technology overcame the problem of digestion as well as permeability to the intestine. The company's goal is for the completion of formal Phase 1 studies in the US by mid-2008. Sign me up!

Imagine taking insulin was as easy as applying skin cream. Guess what - it's not so far fetched an idea, thanks to Phosphagenics and it may be coming soon!

Phosphagenics' has patented a transdermal carrier technology (TPM) that rapidly transports insulin across the skin without disrupting or damaging its surface. The company has recently announced successful results from clinical trials in Australia. This confirmes the TPM technology is safe and effective at delivering insulin into the bloodstream, without adverse events. The trial showed that the insulin safely penetrated through the human skin and delivered insulin into the bloodstream over a sustained period of time. Could this be the next generation of basal insulin? Adios Lantus. Arrivederci Levemir! Almost -- TPM/Insulin, applied topically, delivered insulin through the skin and into the bloodstream for up to 8 hours. So like sunblock -- you'll probably have to reapply.

Weep not, fellow Americans. Although Phosphagenics is based in Australia, they are in the process of applying for Phase 2 clinical trials in the U.S. Big ups to the Muffin Man for keeping me abreast of his leading-edge news from the diabetes-friendly forefront!

A year ago, competitors were out to produce their own versions of Pfizer's Exubera, the inhalable insulin. However, now it's clear that Exubera is a bomb. Yes, a slick new ad campaign might revive its fortunes, so don't count Exubera out of the race quite yet. But it's not likely to be the blockbuster product many thought it could be.

Now the fallout is hurting those companies that were scrambling to compete/cash in by producing their own inhalable insulins. According to a report in Forbes, those same companies are ready to beat a smart retreat. Meanwhile, they're trying to reassure nervous investors. Case in point: MannKind Corp. shares fell nearly ten percent on Monday after it was announced the company could take longer to line up a partner for its inhalable insulin, the Technosphere Insulin System.

Not only that, MannKind postponed the release of its second quarter financial report. Wall Street analysts downgraded the stock, saying its short-term outlook is "challenged" and cited disappointing sales of Exubera as a factor. The outlook could be even worse if it looks like insulin caps will make it to market. As I said in a previous blog on that topic, who wants to tote a bulky inhaler around if you can pop some capsules instead?

There's a story running on CNN Money about the progress of Oramed Pharmaceuticals' insulin capsule, which is currently under development. The capsule, taken orally, could provide a more convenient way for diabetics to get insulin than through shots. And popping a gel cap would, needless to say, also be more convenient than toting and blowing on one of those big old clunky Exubera inhalers.

In the quest to get its product to market, Oramed needs cash, and lots of it. Answering the call, a combination of private investors are putting up more than two million dollars in financing for the Israel-based company.

It's hoped the money will help to propel the insulin capsule through completion of Phase 1 (drug safety) trials by the middle of next year. Said Oramed CEO Nadav Kidron, "This investment marks a milestone for Oramed's stability, allowing the company to fully focus on its research and development efforts and complete its phase 1 product trials."

Stay tuned.

Remember back in 2006 all the buzz surrounding Exubera, Pfizer's inhalable insulin product? It was much-hyped by Pfizer and, let's face, the media happily joined in too, spreading the word that (as Pfizer would have it) Exubera would be wildly successful and make squillions of dollars for investors.

It didn't work out that way at all. Sales so far have topped out at around four million dollars per quarter, far short of the two billion projected before the product was released. Now, in a bid to lift lackluster sales, Pfizer is launching a major ad campaign for Exubera. Yes, the inhaler device is extremely indiscreet. Yes, long-term use of the drug itself could cause lung damage. Oh, and health insurers may not cover prescriptions for Exubera for those diabetics who want to try it. But I guess where there's a slick selling strategy there's a way...into the pockets of consumers, that is.

Which is not to say I blame Pfizer. The company has poured so much money into this product, does it really have a choice at this point? No. Also, it's entirely possible Pfizer could turn things around. This article by Arlene Weintraub for Business Week reminds readers that the drug giant had enormous success with its clever ad campaigns for Viagra and for the incontinence drug Detrol. Writes Weintraub, this new campaign will probably cost Pfizer big-time: we're talking tens of millions of dollars, but it will be worth it for Pfizer if it can reproduce that kind of success.

If at first you don't succeed - go straight to the patient's home. After a lackluster attempt to sell doctor's on prescribing Phizer's inhalable insulin, Exubera, the company has decided to begin running television and print campaigns to advertise directly to patients.

The ads will start appearing the second half of 2007. However the main contention from Congress and medical groups is that mass marketing to patients encourages excessive use of costly therapies. Exubera gained a reputation for being an over priced and not-so-discreet way to administer insulin. Doctors say the inhaler is unwieldy. Depending on a patient's health care plan, they can pay about $600 a year more for Exubera than injectable forms of insulin. Clinical trials have found the product can reduce lung function for some patients. Pfizer says the condition is reversible and is conducting a five-year study among users to monitor it.

Why the push, Pfizer? You seem hell-bent on making this one stick. The president of Pfizer's worldwide pharmaceutical operations says the television ads will target newly diagnosed diabetics who may not want to inject themselves daily. Patients who develop diabetes later in life may put off using insulin because of needle phobia. Fair tradeoff: I see your fear of needles and raise you $600 a year, a license to toke (in public), and maybe a little bruising on your alveoli. Puff, puff...give it a shot.

Think that big old Exubera inhaler (pictured) is sorta comical? You're definitely not alone. I was surfing around trying to get a clearer sense of how Pfizer's much-hyped inhalable insulin device is doing. Are users liking it? Is it really easy to use? Etcetera. But I got sidetracked into reading about that inhaler. It's big, it's plastic, it's bulky. The insulin bong. Come on, admit it. You were thinking the same thing! Here are some of the choicest comments I came across:

Spotted on one message board: "As a pharmacist, my biggest problem with Exubera is that the delivery system looks not entirely dissimilar to a bong. I just don't see the conversation starter 'excuse me, I need to take a hit off of my insulin bong' to be a great opener."

On another board, one wag lists off what he/she considers Exubera's shortcomings. In addition to the fact that, yes, it looks like a bong, this reader also observes that diabetics "have to carry around enough bulky s**t as it is." Plus there's the fact that "Type II's can't afford it...unless they cut back on their food budget...but then they will lose weight...and they wouldn't need insulin."

On Diabetes Mine: the device "really is as bad as it looks in pictures. Worse, because the bulky 'white' plastic portions are not white at all, but that hospital-grade beige that reminds you of walkers and bedpans. An aesthetic nightmare, in the age of cool gadgetry...The funny thing was that the happy Exubera user in Pfizer's video must live in a city as tolerant or as jaded as San Francisco or New York, because not one patron even glanced over as he cocked and sucked on his medicinal bong."

Medical humor site QFever pokes fun at the device's arguably limited appeal with a satirical article describing how Exubera will be a practical alternative for "several diabetics." They missed a golden opportunity here by not zooming in on the inhaler for comedic mileage. What were they thinking?!

The final word goes to Drug Nazi (who I believe has now changed his moniker to Drug Monkey), who finds the Exubera inhaler reminds him of, er, something else entirely: "Oh Yeah...gimmie some of that sweet insulin lovin' baby..." (Oh, PS, if you visit this site, you have to read "Why does my prescription take so damn long to fill?) Happy inhaling.

Generex has been awarded the 2006 North American Frost & Sullivan Award for Technology Innovation for its proprietary oral insulin spray product, Generex Oral-lyn.

Frost & Sullivan's Technology Innovation Award is bestowed upon a company (or individual) that has carried out new research, which has resulted in innovation(s) that have or are expected to bring significant contributions to the industry at hand. In this case, Frost & Sullivan is awarding Generex Oral-lyn as a product that is strongly positioned to be the most acceptable form of alternative, needle-free insulin delivery. This award recognizes the quality and depth of Generex's research and development program as well as the vision and risk-taking that enabled it to undertake such an endeavor.

The significance of Oral-lyn is growing in importance because of its ability to control blood sugar rises after meals. There is mounting evidence that post meal glucose control is a key factor in reducing cardiovascular risk associated with diabetes. For those who keep asking - the CFO has informed me that they are looking into other options that will get Oral-lyn into the hands (and mouths) of US diabetics by sometime in 2007.

National Public Radio (NPR) is running a transcript of its latest report on diabetes treatment options. It's top picks: inhalable insulin (of course, given all the hype!), and also a drug derived from lizard saliva. Hang on. Let's backtrack. Lizard saliva? Turns out, they're talking about the popular diabetes drug Byetta. Yes, the drug that's contained in Byetta is known as exanitide. Byetta has been in the news a great deal in the past because of its unintended, but usually much-welcomed side-effect: weight loss. Exanitide, which mimics a naturally-occurring hormone by stimulating insulin release, is taken from the saliva of the Gila monster (pictured), a large lizard found in the southwest of the US and the northern region of Mexico. It is a venomous little critter, although it's bites are rarely fatal to humans. (Although that's what Steve Irwin thought about sting rays...) Don't ask me how they get the saliva from the Gila monster. I'm afraid I don't want to know...

Still, the NPR report also emphasizes the importance of good old-fashioned exercise and other positive lifestyle changes in managing diabetes. There is also a handy summary chart at the end of the feature explaining who can and cannot use inhalable insulin. If you're confused about this issue, check it out!

Pfizer Inc. has pushed back the release date for its much-anticipated new diabetes drug, Exubera, an inhalable form of insulin. Exubera was to be released mid-summer - i.e. around about now. However, Pfizer now says it will not be out until September. The reason, says Pfizer, is the complexity of the manufacturing process for Exubera, which I guess has slowed production a little bit.

This is all to the disappointment, I'm sure, of those diabetics eager to try the product and see how it stacks up against regular old-fashioned insulin injections. Not to mention health professionals curious to see how well it works on their patients and how well their patients like it. Finally, it must be a huge disappointment for medical industry analysts whose bread and butter it is to guess and out-guess each other predicting how Exubera will do and who, I'm sure, are dying to see how it actually performs after all these months of speculation!

Six months after Exubera, the new inhalable insulin product by Pfizer Inc., received approval for release in the US, Canadian diabetics and doctors are still waiting. The Canadian government has not yet given the drug the green light for use in that country, and no one seems to know when that permission might come. According to the article I read on the topic, neither the company that markets Exubera nor the government will say when it might be available. When word does come, it will be through Health Canada, the country's healthy care organization.

The article also quotes Dr. Edmond Ryan, an Edmonton diabetes specialist who says of inhalable insulin: "I would say the majority like it. Others just shrug their shoulders and actually find it doesn't give as tight control as with injectable insulin."

Exubera, Exubera. What will become of you? That is the big question. Pfizer's eagerly awaited inhalable insulin device is nearing the market. For anyone following this saga, there is a must-read market analysis piece on Business Week's website. With the great title to boot: "From Pfizer, Irrational Exubera?"

The article looks at the big question everyone is asking about Exubera: will it be the blockbuster drug it's been hyped as? While Pfizer says it expects billions of dollars in sales (and the company is pouring millions into promoting the product), critics say it is an overhyped, overpriced product that could put some diabetics in danger of lung damage. Not to mention the device is the size of a county fair prize-winning squash! Who wants to suck on that in public?! Let alone tote it around. On the other hand, let's not forget it's big selling point: no needles. Yet critics maintain so-called needle phobia is not as widespread as Pfizer would have you believe.

If you check out this article, also take a look at the readers' comments at the end. There seems to be a fairly even split in opinion on this thing.

There's a report in The New York Times today about the growing market for diabetes drugs--and how that market grows as the so-called diabetes epidemic escalates. The article also touches on the positive spin-off in terms of money-making possibilities for the drug companies and their investors. (The market for diabetes drugs is now worth an estimated $15 billion, and that is expected to grow to at least $25 billion worldwide by 2001!)

The article is worth a look because it profiles the four diabetes-fighting drugs that are generating the most excitement these days. They are: 1. Byetta, 2. Exubera, 3. Galvus, and 4. Januvia. Byetta (pictured) is already available and comes in the form of an injection. Exubera is an inhalable insulin delivery device that will be released for sale in the US in July. Galvus and Januvia come in the form of pills and are expected to arrive on the market next year.

The reason there is so much excitement surrounding these drugs is that they are relatively hassle- and pain-free to use and, best of all, they help treat the underlying causes of diabetes. Anyway, this article gives a handy overview of what all the fuss is about - check it out!

Pfizer Inc. renewed positive momentum (some might say, hype?) over its inhalable insulin product Exubera. The company announced two-year data on Exubera showing that the product is as effective as insulin shots.

The results show that not only does Exubera control blood sugar as well as insulin shots, but also that it results in less weight gain amongst users. The weight gain issues is an added bonus that no doubt will help many patients make up their minds whether or not to make the switch to Exubera...if they can afford it, that is, as the product won't come cheap. Co-pays as high as $50 seem likely - eek! How outrageous is that??

On the down side, the data also confirmed that Exubera has a slightly negative effect on lung function--more so than that caused by insulin shots.

Pfizer made its announcement at the American Diabetes Association's conference, now under way in Washington.