A new article in today’s New York Times suggests that there is a “New Sense of Caution at the F.D.A.” But is the caution based on prudence, new drug evaluation policies, or a curious combination of factors?

Looking back at the FDA’s drug approval of Exubera, the inhaled insulin developed by Pfizer, Inc. (NYSE:PFE), Nektar Therapeutics (NASDAQ:NKTR), and sanofi-aventis (ADR) (NYSE:SNY), there are still questions about the FDA’s rush to give what appears to be conditional approval of the inhaled insulin.

According to the NYT, the FDA delayed drug approval for Exubera for 90 days:

…whether from caution or a lack of manpower, it has also become common for the agency simply to postpone decisions by 90 days. About half a dozen drugs, including Pfizer’s inhaled insulin, Exubera, that have been approved in the last several months were first subjected to 90-day delays.

There was not only a delay for Exubera, but also a host of studies that the FDA insisted must be peformed over the next decade.

These studies include:

• Exubera safety for children with diabetes
• Decreases in lung function and capacity
• Autoimmune responses
• Exubera use by smokers
• Affect upon diabetics with pulmonary issues
• Hypoglycemia

Given that the inhaled insulin was examined for only two (2) years, it is this blog’s opinion that there is still insufficient long-term data on the drug’s safety.  Type 1 and Type 2 diabetics on insulin therapy will be using it for far longer than 2 years.

While considerable concern is justified over a glowing global population of diabetics who are diagnosed at younger ages than was previously common, Exubera’s safety should be at the forefront of diabetics and their doctors considering inhaled insulin therapy.  More research needs to be done.

Yesterday Nektar Therapeutics (NASDAQ:NKTR) Chairment and Acting CEO Rob Chess announced at the UBS AG (NYSE:UBS) Global Life Sciences Conference in New York City yesterday, that he went to his local pharmacy and filled a prescription for Exubera inhaled insulin. “It was Tier 2,” he explained, costing him a $20 health insurance co-pay.

That raises several interesting questions:

1. Is Nektar’s Acting CEO Really Diabetic?If not, did Chess get a physician to write a prescription for insulin so that he could buy it with using Nektar’s company’s health insurance, even though it was for a disease he doesn’t have?If he’s not diabetic, doesn’t that drive up Nektar’s health insurance rates by buying medicine for which he’s got no medical necessity?
2. Do Drug Company’s Routinely Have Employees Go Out to Buy Their Own FDA-Approved Drugs For Marketing Purposes, But For Which They Have No Medical Need?If Chess isn’t diabetic, e would have no medical necessity to buy it using his company’s health insurance. Did he buy it in advance of the UBS AG (NYSE:UBS) Global Life Sciences Conference as nothing more than a marketing ploy so that he could talk about it in front of analysts, investors, shareholders, physicians, and diabetics, just to try and convince them that some payors are making Exubera an affordable insulin?
3. Are Pfizer, Inc. and Nektar Therapeutics Have A Tough Time Getting Exubera onto Health Insurance Drug Formulary Lists? This blog has been following how health insurance companies have been dealing with the increased cost of Exubera inhaled insulin. Marketed by Pfizer, Inc. (NYSE:PFE) with a sales team of 2300 reps, the diabetes drug appears to be having a rough time getting onto drug formulary lists:
   

   A. An HMO consultant whose company has evaluation input for some 90 million insured people recently criticized Pfizer for being slow to provide essential Exubera product information to insurance companies’ pharmacy and therapeutics committees so that they could evaluate whether or not to add it to their formulary list;

   B. Some insurance companies like Blue Cross and Blue Shield of Rhode Island aren’t putting it on their formulary right now. Others like Kaiser Permanente don’t appear to be listing it as an option at all. The non-profit Harvard Pilgrim Health Care has already tagged Exubera as a non-preferred drug.

   C. One general practitioner has written about the problems of Exubera’s cost being a factor in prescribing it to diabetic patients:

   If the patient can’t afford the medication, the clinical advantages of the brand don’t matter.

   For him, Exubera won’t be the right diabetes medication for some patients if the financial burden they’ll face is much greater than the cost of injectable insulin.

4. Some Pfizer Drug Sales Reps Appear to Be Complaining About Filling Rx’s For Exubera
   
   If one poster on Cafe Pharma’s message boards is really a Pfizer sales rep., then it seems they’re having a hard time filling an apparent quota of 175 Rx’s per week for Exubera.Another poster complains that “were [sic] not getting paid to sell [E]xubera”

With Nektar’s and Pfizer’s Exubera sales expectations running high, it really makes a diabetic wonder why an insulin maker’s CEO would go out and tout his own $20 purchase of Exubera. Is it reality, a snake oil sales approach?

Nektar Therapeutics (NASDAQ:NKTR) Chairman and Acting CEO Rob Chess gave a presentation on Wednesday, Sept. 27, 2006 at the UBS AG (NYSE:UBS) Global Life Sciences Conference in New York City.

Chess made a number of things clear:

• Nektar is still carrying a heavy debt-load
  Chess said the company “hope[s] to be profitable by” 2010.  While last quarter it had $500 million in cash, “$100 million of that will be for debt repayment.”
• Nektar is counting heavily on Exubera to become profitable
  Chess is “convinced that this will be a long-term, multi-billion dollar product.”  Nektar is predicting $70-$90M in Exubera-related revenue this year. Chess said this estimate was calculated figuring that 10-20% of Pfizer’s revenue is shared with Nektar, and that 8-10% of Exubera sales are gross profit for the company.

  He estimates that Pfizer will have $2B in Exubea sales by 2010.

A new research report on inhaled insulins concludes that new diabetes drugs like Exubera from Pfizer, Inc. (NYSE:PFE) and Nektar Therapeutics (NASDAQ:NKTR) are not likely to become blockbuster drugs anytime soon.

That conclusion comes from Dublin-based Research and Markets in Ireland. Many pharmaceutical and drug delivery companies are likely to be at odds with this conclusion.

Other inhaled insulins in the pipeline that the report examines include:

• ERx-iDMS,  from Novo Nordisk A/S (NYSE:NVO)
• AIR insulin, from Alkermes, Inc. (NASDAQ:ALKS) and Eli Lilly & Co. (NYSE:LLY)
• Technosphere insulin, from MannKind Corp. (NASDAQ:MNKD)
• Alveair inhalable insulin, from Coremed, Inc.
• KI-02212 inhalable insulin, from Kos Pharmaceuticals (NASDAQ:KOSP)
• Intesulin oral insulin, from Coremed, Inc.)
• Oral-lyn, from Generex Biotechnology Corp. (NASDAQ:GNBT)
• Eligen oral insulin, from Emisphere Technologies, Inc. (NASDAQ:EMIS)

A key factor stressed to support the reports conclusion is that the authors believe that:

the diabetes market will not be receptive to inhalable insulins until compelling data is generated that demonstrate compelling clinical benefits of inhalable insulins over injectables. This view is supported by the recent cost-benefit analyses of it by Germany’s IQWiG and UK’s NICE, and the distinct lack of opinion leader enthusiasm about Exubera.

Wow.  That’s a strong critique. The authors maintain that diabetes leaders are not enthusiastic about inhaled insulin. If you review observations by endocrinologists and general practitioners that this blog has tracked about Pfizer’s Exubera,  they appear cautious about using the new inhaled insulin to treat Type 1 and Type 2 diabetes.  It’s more of a wait-and-see approach.
If you’re ready to plunk down 12,198.00 Euros (almost $15,500 U.S.), you can buy a PDF copy of the full report.

Read a summary of the report here: Pipeline Insight: Insulins - Inhalable Insulins Unlikely to Become Blockbusters.

On the second day of the UBS Global Life Sciences Conference from UBS AG (NYSE:UBS), Pfizer, Inc. (NYSE:PFE) Vice Chairman David Shedlarz told attendees that the drug company’s total annual cash flow will be about $34 billion.

The company’s Exubera inhaled insulin, Shedlarz said, is an “important source of revenue growth” for Pfizer.  He pitched the company’s diabetes drug with a big pharma rep’s mantra:

“Exubera provides efficacy comparable to subcutaneous insulin, with clearly enhanced compliance.”

Not surprisingly, no mention was made of recent criticism by managed care consultants about Pfizer’s apparent difficulties getting insurance companies Exubera product information on time so that Pharmacy and Therapeutics Committees could make a decision about the drug’s cost, safety, and efficacy.

Nor was there any mention of the hesitation being expressed by some endocrinologists, general practicioners , and skeptical diabetics about the insulin.
Click here to listen to Shedlarz and Pfizer’s new CEO Jeffrey Kindler at the conference.