http://www.nydailynews.com/business/story/433779p-365456c.html

Drug companies
focus on diabetes



By ASHLEY M. HEHER
THE ASSOCIATED PRESS


Bob Russell, a 53-year-old diabetic from Greenwood, Ind., uses the
insulin pump he calls a 'godsend' to regulate blood sugar.

A timy pump injects insulin through a catheter into Bob Russell's
abdomen up to seven times an hour, helping him regulate his blood sugar
level so he can stay healthy.
The 53-year-old diabetic from suburban Indianapolis used needles to
inject himself with insulin until five years ago, when doctors gave him
the pump he calls a "godsend."

"It's really simplified my life," said Russell, who was diagnosed as an
insulin-dependent diabetic 23 years ago.

Now, he's hoping to trade the pump for an inhaler, one of a series of
new drugs aimed at a population of diabetics that experts predict could
double, to 350 million, in the next 20 years.

Drug companies are racing to capture that ballooning market as health
advocates worry the disease will become a public health threat.

Pfizer plans to debut Exubra, its new inhaled insulin treatment, in
July, and Merck, Novartis and Eli Lilly are awaiting FDA approval for
new diabetes products that could generate hundreds of millions of
dollars in sales.

Albert Rauch, a health care analyst with A.G. Edwards, 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 Exubra 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 WellPoint,
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% 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% 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, 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.

New York-based Pfizer is in the midst of a campaign for Exubra 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
Exubra is a key demonstration of the importance of diabetes to Pfizer,"
said David Simmons, the company's U.S. medical director for the drug.

Originally published on July 10, 2006


Yehuda Y. Scheff, Supervising Special Auditor Investigator
NYS AG MFCU
120 Broadway, 13th Floor
New York, NY 10271
Voice: (212) 417-5658
Fax: (212) 417-5410
E-mail address: yehuda.scheff@...