After scoring a $1.3 billion deal selling Pfizer all of its rights to market Exubera inhaled insulin, Sanofi-Aventis probably laughed all the way to the bank when Pfizer pulled the ridiculously unprofitable diabetes drug from the market.

That’s why Sanofi’s latest ad campaign for injectable insulin has a timely “I told you so” quality to it. Some of that deal money appears to be well spent on these direct-to-consumer (DTC) pieces.

Sanofi’s Go Insulin campaign is a push for the French drugmaker’s injectable basal insulin Lantus. Although not the subject of this ad campaign, the pharmaceutical companies new FDA-approved Apidra fast-acting insulin may also get a boost from this ad series.

Two Type-2 diabetics tell their stories though video about how using injectable insulin has helped them control their diabetes using recommended Hemoglobin A1C targets as guidelines.

Greg, a 45-year-old delicatessen and real estate owner in Virginia describes how his initial treatment taking pills after being diagnosed with diabetes was not effectively helping him cope with the disease. He’s a husband and father with an attitude that shows he tries to tackle things.
Loretha Huff, a Chicago resident, describes how she dealt with managing her diabetes when she was diagnozed at age 35. Taking pills to manage her blood sugar was not effective, so she worked with her doctor to switch to Lantus injectable insulin.

She says that “injecting yourself wasn’t as bad as I thought it was going to be,” and expalins how her Hemoglobin A1C’s have come under better control. With a positive can-do attitude, Loretha’s story seems likely to strike a chord with folks who have concerns about taking insulin injections and eating right. Loretha’s positive, up-beat approach to managing her diabetes seems likely to help Sanofi with its sales of Lantus.

Significantly, Sanofi created special areas on it’s Go Insulin web site focusing on:

• The Importance of Insulin
• Insulin Myths and Realities

These explainer pieces argue that taking insulin doesn’t mean that you’ve failed at treating your diabetes, and that it’s just what you might need to do to control your Hemoglobin A1C levels.

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 sales for 2006 added up to just $18.9M for Pfizer, new data show.

According to drug sales data from IMS Health, 10,000 prescriptions were written for Pfizer’s inhaled insulin in the U.S. last year.

The sales figures are surprising, given that Pfizer paid Frsanofi-aventis more than $1.3 billion for exclusive worlwide rights to sell the insulin.

A new piece in this week’s Brandweek Magazine has an extensive analysis of Pfizer’s failure to successfully launch Exubera inhaled insulin.

The fascinating article by reporter Jim Edwards looks at Pfizer’s marketing of the inhaled insulin developed with Nektar Therapeutics (NASDAQ:NKTR) and sanofi-aventis (NYSE:SNY).  Last year Pfizer paid sanofi more than $1.3 billion for exclusive worlwide rights to sell the insulin.
His conclusion? That Exubera’s bong-like appearance is hurting, not helping sales of the drug:

What Pfizer got for its cash was a device that looks a lot like a marijuana bong—and a brand that analysts, doctors, drug sales reps and some patients believe is a struggle to sell because it is so inconvenient to use.

David Kliff, the editor and publisher of Diabetic Investor, told Edwards that he thought “Pfizer is on drugs” if it still thought that it could get $2B a year in Exubera sales.

More Poor Exubera Sales Numbers Reported

To add to this blog’s report last week on a tally of poor Exubera drug sales in January, Edwards reports in his Brandweek article that Merrill Lynch is claiming a total of only 1,111 perscriptions have been written for Exubera.

Missing From The Article: Discussion of Known Exubera Safety Risks, Physician Concerns

Interestingly, no mention was made of concerns by physicians and diabetics’ worries over Exubera’s still unclear long-term safety. Nor was any mention made of the FDA’s effective conditional approval of the insulin — requiring that a battery of long-term Exubera safety tests be conducted over the coming decade on diabetics using the drug.

A new ad campaign will be launched by Pfizer, Inc. (NYSE:PFE) aiming to convince diabetics that they should try the drugmaker’s Exubera inhaled insulin.

According to a Bloomberg News report by Shannon Pettypiece, Pfizer hopes to launch its direct-to-consumer (’DTC’) Exubera television ad campaign “in the second half of 2007.”
But Pettypiece warns that:

Pfizer is risking criticism by members of Congress and physician groups who say consumer advertising encourages excessive use of costly therapies.

A related concern is whether the TV ads will gloss-over, or not even mention, the concerns that a number of physicians have about the inhaled insulin’s long-term safety for diabetics using the drug. The FDA is apparently so concerned about Exubera’s long-term safety and potential pulmonary risks that the drug agency effectively conditioned approval of the drug in January of 2006, requiring Pfizer to conduct a wide variety of safety studies over the next decade on diabetics in general, in addition to diabetic children and smokers.

Drug formulary coverage for Exubera is another issue.  The insulin costs diabetics a premium over regular injectable insulin. That’s because many insurer’s don’t see a benefit to subsidizing coverage of a more expensive insulin that has yet proven itself to more effective over the long-term for diabetics.

According to Pettypoint:

Wellpoint Inc., the nation’s second- largest health insurer, charges customers more for Exubera than other insulin products because “no meaningful clinical studies are available to demonstrate that its use will result in earlier treatment, improved compliance, improved quality of life, or better long-term outcomes,” says spokesman Jim Gavin.

According to data from Wolters Kluwer Health, only about 900 prescriptions were written for Exubera by physicians each week in January of 2007.
That’s not a lot of positive cash flow for drug that took a while to develop, and cost Pfizer $1.3 billion in a deal last year with sanofi-aventis.  That deal enabled Pfizer to buy intellectual property and licensing rights from the French drugmaker that gives it exlusive worldwide rights to market the insulin.