[Phranky]

FYI


------------------------------
Drug cos. set sights on diabetes care
Provided by: Associated Press
Written by: ASHLEY M. HEHER, AP Business Writer
Jul. 5, 2006


INDIANAPOLIS - Drug companies are racing to capture the ballooning market in diabetes care. Pfizer Inc. plans to debut Exubera, its new inhaled insulin treatment, in July, and Merck & Co., Novartis AG and Eli Lilly and Co. are awaiting FDA approval for new diabetes products that could generate hundreds of millions of dollars in sales.

"I think it's intensely competitive," said John C. Lechleiter, president and chief operating officer of Indianapolis-based Lilly, which began offering Byetta, an injectable diabetes treatment last year. "Many companies that would not have said they were engaged in diabetes research 10 years ago are squarely there now," he said.


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Albert Rauch, a health care analyst with A.G. Edwards & Sons, said he expects the $10 billion diabetes market to eventually rival the $20 billion cholesterol market.

"We think they could be the next blockbuster class of drugs for the pharmaceutical industry," he said.

But the companies could have trouble getting their newest medications into patients' hands.

Gun-shy physicians -- many of whom are still reeling over fallout from Vioxx, a blockbuster arthritis drug that was pulled from the market after it was linked to increased risk of heart problems -- want more research about potential long-term health problems. And insurers could be slow to add some of the latest diabetes drugs to their preferred drug lists.

"It's safe to assume that unless Exubera is priced comparatively to insulin, it would not be added," said David Beshara, chief pharmacy officer for Tennessee's Medicaid program.

Robert Seidman, vice president and chief pharmacy officer for the Indianapolis-based WellPoint Inc., the nation's largest insurer, said a medication usually is on the market six months before a panel of company experts reviews it to decide whether to add it to its preferred drug list.

"The science needs to drive the decision-making process," he said.

Health advocates say the need for new treatments is clear.

A study released this month by the American Diabetes Association said one in three Americans has diabetes or a precursor to the disease, which causes elevated blood sugar levels. Untreated, diabetes can be fatal or cause blindness and circulation problems.

More than 90 percent of patients are diagnosed with Type 2 diabetes, a condition linked to obesity that occurs when the body cannot effectively use the insulin it produces. Fewer than 10 percent of patients are diagnosed with Type 1 diabetes, a disorder in which the immune system attacks insulin-producing cells in the pancreas.

The disease could yield billions of dollars for pharmaceutical companies.

"Whenever there's a great commercial opportunity, companies devote more resources," said Barbara Ryan, an analyst at Deutsche Bank."

In December, Whitehouse, N.J.-based Merck announced it was retooling its business to focus on nine key growth areas -- including diabetes and obesity.

The company is awaiting FDA approval for Januvia, a new class of oral diabetes drug that enhances the body's ability to lower elevated blood sugar levels. Later this year, Merck also expects to file an application for MK-431A, an unnamed drug that combines Januvia with the common diabetes medication metformin. The combination would allow patients to take fewer pills each day.

"We believe there's a tremendous unmet medical need for patients with Type 2 diabetes," said John Amatruda, vice president of clinical research of metabolic disorders at Merck.

Analysts predict Januvia sales could reach $1 billion in 2009.

Prospects could be even bigger for Galvus, a similar medication being developed by Swiss drug maker Novartis.

New York-based Pfizer is in the midst of a campaign for Exubera targeted at more than 200,000 health professionals -- including doctors, pharmacists and diabetes educators -- before its mid-July launch. Company officials have not announced a date for the drug's U.S. release but have already begun sales in Germany and Ireland.

"The fact that we have put the incredible effort and resources behind Exubera is a key demonstration of the importance of diabetes to Pfizer," said David Simmons, the company's U.S. medical director for the drug.

Analysts said they expect Exubera sales to climb to $1.5 billion by 2010.

Lilly, which introduced the first commercially available insulin in 1923, also is honing its focus on the disease. Lilly's diabetes portfolio already accounts for one-fifth of the company's revenue, a figure analysts predicted could more than double in the next four years. Lilly expects to complete late-stage clinical trials of its own version of inhaled insulin later this decade.

"I think it's safe to say that diabetes, along with cardiovascular disease and obesity, is positioned to be one of Lilly's key growth areas going forward," Lechleiter said.

[duck]

"The science needs to drive the decision-making process," he said.

Well, Exubra would never hit the market, then.

[condensr]

Hmmph. It seems as if they're focusing soo much on stuff for Type 2s, well, what about us Type 1s? If they dont want to look for a cure, devote some of that $$ to making even more rapid acting insulins.. even better long acting insulins, etc etc.

Yes, the market is smaller for T1s, but a lot of T2s end up on insulin anyhow.

[duck]

Originally Posted by condensr

Hmmph. It seems as if they're focusing soo much on stuff for Type 2s, well, what about us Type 1s? If they dont want to look for a cure, devote some of that $$ to making even more rapid acting insulins.. even better long acting insulins, etc etc.

Yes, the market is smaller for T1s, but a lot of T2s end up on insulin anyhow.

The sheer volume of T2's vs T1's will make any money-driven diabetes-related endeavor lean toward creating better treatments for them, it's pure economics.

Now, let me step out of the way as the T2 members here respond to the notion that a lot of them will end up on insulin anyhow...

[condensr]

Originally Posted by duck

The sheer volume of T2's vs T1's will make any money-driven diabetes-related endeavor lean toward creating better treatments for them, it's pure economics.

Now, let me step out of the way as the T2 members here respond to the notion that a lot of them will end up on insulin anyhow...

<disclaimer>
Well, I say that not for the folks here on this forum, most of which obviously think enough about diabetes to be on an internet forum devoted to said topic, but instead for the ones that don't take as good care of themselves. Many of these I know personally. That is for whom I make such a statement.
</disclaimer>

[spike]

Originally Posted by duck

The sheer volume of T2's vs T1's will make any money-driven diabetes-related endeavor lean toward creating better treatments for them, it's pure economics.

Now, let me step out of the way as the T2 members here respond to the notion that a lot of them will end up on insulin anyhow...

The T2's should always consider all their treatment options. My good friend and neighbor of 3+ decades recently died because Kaiser didn't put him on insulin in time to prevent him falling apart from blindness, amputation, 2 heart attacks and failed kidneys. They kept giving him pills...for more than 10 years past the point when it was obvious to me and his family that he should go on insulin. I kept telling him he needed insulin because he wasn't getting on top of the bg's with the pills. Sure enough, the year he retired, all the things I just mentioned occurred to him in rapid succession.

remember folks, you've only got one body to live in, so don't take for granted that your treatment is "working" just because a doctor sees you a couple times a year and declares that "you are doing just fine". keep on top of your random bg's, fasting bgs, and A1c's. If you've any suspicion that your diabetes isn't under control get another opinion, or at least bug the doctor that's treating you. As for my situation, I had to drop an endo I'd had for more than 10 years because REFUSED to prescribe a pump for me, even though I'd had terrible results with MDI. (Trips to the ER, Glucagon, paramedic visits, high A1c's). I got to the point where I was fed up and then I sought out a doctor who was pro pumping. With mere weeks of seeing the new doc, I got my first pump, and regained a nearly normal life. I shudder to think how bad a shape I'd been in by now (assuming I hadn't already succumbed to either fatal drop in bg or complications from persistent high bg's)

I didn't have the luxury of all the online information currently available to anyone with a PC and good eyesight.

Heck, I might as well add to my soap-box ramblings: consider statins for lowering your cholesterol levels too, if they are even borderline high.

[bittersweet]

I think the key statement in that article is that its a billion dollar business. and lets face it their clientel could be potentially purchasing their products for over 30years. from a business standpoint the R&D for a cure will never see returns on investment like a new treatment mechanism. after all they are businesses and money is the bottom line.

[condensr]

Right. Well, I didn't intend to degrade this thread to a cure vs. treat conspiracy thread..

Despite the fact I wish research would be equal between T1 and T2, I am still very pleased that so much money is going to be spent on helping out ANY diabetics, no matter which type. Good news!

[duck]

Originally Posted by condensr

<disclaimer>
Well, I say that not for the folks here on this forum, most of which obviously think enough about diabetes to be on an internet forum devoted to said topic, but instead for the ones that don't take as good care of themselves. Many of these I know personally. That is for whom I make such a statement.
</disclaimer>

Touche`.

It's just been a touchy subject here. I never said a T2 shouldn't consider the option, but I understand why an otherwise under-control T2 would get offended if someone said "You're going to be on insulin soon anyway". BUt, different topic for a different topic.

[jeggeman31]

Originally Posted by Phranky

- The disease could yield billions of dollars for pharmaceutical companies.

That is the very reason I say. There will NEVER be a cure for diabetes.

[JasonJayhawk]

My sister is a pharmacist at a hospital, and her team was recently visited by an Exhubra sales rep. When the rep was telling them about the user's selection of either 2 units or 8 units, my sister asked a simple question: "Is that going to be good enough for meal coverage?"

The rep responded with the answer of, "I don't know."

The drug reps must be out in force to market this new inhalable insulin...