According to Michael Krensavage, a pharmaceutical equity analyst at Raymond James Financial, Inc. (NYSE:RJF), the launch of Exubera inhaled insulin for diabetics “has been one of the most spectular flops in the pharmaceutical industry.”

Krensavage made this analysis when interviewed about Pfizer, Inc.’s (NYSE:PFE) difficulty in launching and maintaining profitable new drugs in a highly competitive market.  “No matter how you look at it,” Krensavage concluded, Pfizer’s drug research and development efforts have yielded “a disappointing pipeline.”
Pfizer’s 8K report to shareholders disclosed Exubera’s continued market failure. “Sales of Exubera continue to be disappointing, with $4 million of worldwide revenues in the second quarter of 2007.”
Generating only $4 million in revenue on a diabetes drug for which Pfizer paid Sanofi-Aventis $1.3 billion in January 2006 is an abysmal failure, there may still be a silver-lining for diabetics.

By sticking to proven diabetes medications that do not have unknown pulmonary and related risks for diabetics that are the subject of long-term FDA-mandated drug safety studies (as a condition of the drug’s approval), endocrinologists appear likely to give their patients trusted choices for managing their care.

Even given reported the Avandia heart attack risks for Type 2 diabetics, Pfizer doesn’t seem to have convinced endocrinologists that Exubera is a better diabetes drug.

Exubera inhaled insulin drugmaker Pfizer, Inc. (NYSE:PFE) is expected to release the results of 2 scientific studies involving the diabetes drug at the American Diabetes Assocaition’s Scientific Sessions annual conference in Chicago this week.

The company and, researchers that it supports, are expected to present research findings involving ’stop-and-go’ Exubera usage over a 2-year period involving Type 1 and Type 2 diabetics. The findings concern pulmonary risks and safety issues (i.e., lung function) that remain an ongoing concern of many doctors and diabetics regarding the inhaled insulin.

It will be interesting to see how doctors view the results that Pfizer presents at the ADA sessions, particularly when Dr. John Buse, the orginzation’s president-elect, stated that he sees his job as “talk[ing] people out of (using)” Exubera.

Pfizer’s Exubera sales remain lackluster according to news reports and numerous online posts from anonymous drug sales reps from the company.

The ADA Scientific Sessions are supported, in part, by a grant from the embattled maker of Avandia, the diabetes drug from GlaxoSmithKline that the FDA ordered to carr a ‘black-box warning’ due to widely reported excessive risks of heart attacks and related safety and personal injury issues.

An important new article in the New England Journal of Medicine takes a critical look at pharmaceutical companies for their Direct-to-Consumer (’DTC’) advertising of drugs. The piece by Dr. Miriam Schuchman, “Drug Risks and Free Speech — Can Congress Ban Consumer Drug Ads,” offers a fresh perspective on drug safety risks.

This is particularly important at a time when Vioxx was withdrawn from the market for being associated with coronary safety risks, followed by the recent NEJM report and FDA announcement that diabetics using Avandia had a 43-percent greater risks of heart attack risks than those not taking the GlaxoSmithKline drug.
What does this mean for Pfizer’s Exubera? Dr. Shuchman raises a point that this blog has reported on for over a year: that the FDA granted approval to put the inhaled insulin on the market, “despite the fact that safety studies are still under way.” She is a national correspondent for the NEJM.
Does this show greater caution at the FDA, or drug approvals as usual? It would not.

Take the example of Zelnorm, a drug that, until recently, was used to treat women with irritable bowel syndrome (’IBS’).
Dr. Schuchman says that Zelnorm sales benefited from DTC exposure while it was on the market for four (4) years. That was, until “the FDA withdrew it this past March because it didn’t consider the drug’s benefits sufficient to justify exposing patients to even low risks of a cardiac event.”

But Shuchman reports that “although the drug was only 5 to 10% more effective than placebo for women and was not shown to work at all for men, the belly-baring ad seems to have worked wonders: U.S. doctors wrote 2.1 million prescriptions for Zelnorm in 2005.”

That raises even more questions about Exubera when Pfizer launches DTC ads for the drug this summer. Despite poor Exubera sales, the advertising campaign could be a shot in the arm for Pfizer. Whether the drug will have adverse long-term effects on diabetics’ safety, however, is still an open question.