Drug War '07: drug giants Novo Nordisk and Sanofi-Aventis have been sparring recently over their insulin pen designs. Novo alleges Sanofi has stolen its design ideas, basically. Check out Bev's post on this to learn more.

The reason it's such a big deal to them is money. The insulin pen could be super-lucrative for investors. Meanwhile, here's some news that's bound to get big pharma even more excited: a new study reports that insulin pens are cheaper and more effective than insulin shots.

Why so good? Fewer trips to the emergency room and fewer visits to the doctor. Insulin pens boast a pre-measured dosing system, with each dose of insulin contained in a single, disposable cartridge. This eliminates the risk of over- or under-dosing, says senior author of the study, Dr. Rajesh Balkrishnan of Ohio State University in Columbus. The researchers say that study participants who used an insulin pen instead of a regular syringe ended up reducing their annual healthcare costs by nearly $17,000. Wow.

What I'm not clear on here is whether or not they factored in the added expense of upgrading from syringes to insulin pens.

Want to know more? The study has been published in the latest issue of Clinical Therapeutics, but you can click here to read a summary.

Novo Nordisk, one of the Big Three insulin manufacturers (Eli Lilly and Sanofi-Aventis round out the group), has started legal action in the United States to block the launch of rival Sanofi-Aventis' new SoloSTAR injection pen. Novo claims Sanofi's SoloSTAR infringes on the patents of its NovoPen 4. Sanofi is ramping up for a U.S. launch in the next few months -- they contest Novo's claims and will defend their rights in court.

According to a March 2007 post in Scott Strumello's blog, the SoloSTAR is a disposable insulin pen aimed at the vast type 2 market, and Sanofi's Lantus will be the first insulin used in the new pen. SoloSTAR reduces the injection force by 30 percent or more compared to other leading disposable pens, good for people with poor grip or limited hand mobility. Different pen colors will be offered for different insulins, a nice feature to aid in correct insulin identification.

From my internet and blogosphere research, the SoloSTAR was introduced in Europe last April, and it was recently approved by the Food and Drug Administration.

This isn't the first Novo/Sanofi patent scuffle. Novo has alleged Sanofi's OptiClik pen deliberately infringed patent protections on Novo's Flexpen (post image from www.novonordisk.com). The Insulin Dependent Diabetes Trust's April newsletter stated the case should go to court sometime this year.

Scientists in Germany are reporting development of a urine test that finally can identify athletes who misuse certain kinds of insulin in an illicit attempt to enhance performance.

An article scheduled to appear in an April edition of Analytical Chemistry says it is possible to detect the misuse of insulin in a urine sample. Scientists had not attempted to develop a test in the past because of the presumption that it was impossible to detect misuses of insulin. Because insulin is rationed and used efficiently by the body, a byproduct of insulin would be theoretically undetectable. However, with the advent of the newer long-acting insulin analogues, scientists are now able to identify degradation product in the urine.

The test does not identify residue from the use of two other forms of long-duration insulin. However, the test does identify the misuse of Lantus, manufactured by Sanofi-aventis. Determination of long-acting insulin analogues in urine is especially helpful for doping control purposes. The procedure provides a fast and reliable way to identify the misuse of the long-acting insulin analogue LAN in regular doping control specimens.

So the price of drugs just seems to keep on climbing. And sometimes I wonder if the sky really is the limit in terms of the prices we are expected to pay. I, for example, just filled a prescription and received a tiny bottle the size of a purse-pack-sized bottle of eye drops. And how much did I pay? $25. Yes, and that's with insurance. It's insane. But it's not happening everywhere. In western Europe, where publicly-owned, government-run health care systems are the norm, people are putting the squeeze on the big pharmaceutical companies.

Let's look at insulin. A while ago there was a kerfuffle in the UK when government advisers overseeing the National Health Service basically said "no, thanks" to Pfizer's inhalable insulin, Exubera. Too expensive, they said. Now, Germany. This week, the biggies - Eli Lilly, Novo Nordisk and Sanofi-Aventis - decided to slash the cost of their insulin products in Germany. Why? Officials from Germany's health ministry say the new fast-acting versions of insulin just aren't worth the money. That left Big Pharma with little option but to play ball anyway, by cutting prices by up to thirty percent. For Novo Nordisk, this means a projected loss of $14.5 million in sales this year, reports Bloomberg.com. According to this article, the German government is, in this regard, following in the footsteps of the UK and the US. In effect, this means trying to cut spending by carefully weighing the costs of specific drugs against their benefits, rather than just picking up the tab willy-nilly.

Bottom line? Market expert Mark Belsey says the big drug producers will have to adapt as the tide turns, spending a lot more time and money justifying the worth of their products. This new strategy, he says, will come at the expense of what used to be their main focus: creating and marketing fancy new mega-drugs.

In the $20 billion diabetes market, when drugs make their way onto the scene, it's a head-turning event. So far, one drug is gaining ground and two of them are raising interest.

Januvia, manufactured by Merck, was recently approved for the treatment of diabetes. Januvia is used with diet and exercise to lower blood sugar in patients with type 2 diabetes. Januvia lowers blood sugar when blood sugar is high, especially after a meal. It also lowers blood sugar between meals and helps to improve the levels of insulin produced by your own body after a meal. The drug is unlikely to cause your blood sugar to be lowered to a dangerous level because it does not work when your blood sugar is low. Januvia faces potential competition from an experimental drug, Galvus. The drugs are similar in many respects, including their status as once-a-day pills, and their ability to lower blood-sugar levels in diabetics while helping them to lose weight, or at least to avoid gaining it. The FDA delayed its decision on Galvus, so we may be waiting till the first half of 2007 to see it in action.

Acomplia, manufactured by Sanofi-Aventis, is in hot pursuit of FDA approval. Acomplia is primarily a treatment for diabetics, but the drug is unusually multi-faceted. It was created to help people quit smoking and lose fat by blocking circuitry in the brain that gives the body cravings. The drug works by blocking the same circuitry in the brain that gives pot-smokers the munchies. The drug is expected to receive FDA approval in the first half of 2007.

The website Diabetes Self-Management is running a feature about a diabetes mentoring program that has just been launched. The idea behind the initiative is simple: people do better at managing their diabetes when they have the support of other diabetics who can give moral support and helpful tips.

The program is called A1c Champions. Sponsored by insulin manufacturer Sanofi-Aventis, A1c Champions signs up people with diabetes and arranges for them to give presentations to diabetes support groups. The program supplies everything you need for the presentations, including materials and information. It also provides training.

If you're interested, first find out if you qualify. You must have Type 2 diabetes and use insulin. You must also have an HbA1c level of less than seven percent. To apply, call 1-866-741-7047.

Earlier today I posted a blog on the introduction of the long-acting insulin drug Levemir to the US market. A reader has since raised the excellent question of how Levemir differs from Lantus, another long-acting insulin drug already available in the US. I went online looking for an answer to this question and found an old article from the Copenhagen Post published back in 2004. Although it's old news (excuse the pun!) by now, it is interesting because it discusses the fierce competition for dominance of the European market by the manufacturers of the two drugs: the French-German company Sanofi-Aventis (Lantus) and Danish insulin producer Novo Nordis (Levemir). Lantus and Levemir are both long-acting insulin products, right? Well, the main difference between them seems to be that Lantus only has to be injected once a day, compared with once or twice a day for Levemir. On the other hand, Levemir is less likely to cause weight gain. So it comes down to convenience versus weight control, at least according to this article. Interestingly, the market analyst quoted here basically concludes that Lantus has the competitive edge for its convenience. I would be willing to bet this logic will not apply in the US market: let's not underestimate the importance many American diabetics attach to avoiding (additional) weight gain.