A report from Jim Edwards in BrandWeek details that European pharmaceutical company Sanofi-Aventis will launch a huge brand-awareness ad campaign in March 2006 highlighting Lantus, the drugmaker’s long-acting injectable insulin.

Lantus is a recombinant-DNA synthesized insulin used by Type 1 insulin-dependent diabetics.  The drug hangs in the background over a 24 hour period, supplemented by doses of short-acting insulin at meal times.

Sanofi-Aventis had a huge role in developing Exubera, the inhalable insuling given FDA approval on January 27, 2006.  Just two weeks prior to receiving FDA approval, the company sold all of its Exubera rights to Pfizer for $1.3 billion U.S. dollars, net of German taxes.

Given the attention accorded Exubera, the new FDA-approved inhalable insulin, the Lantus ad campaign is sure to be closely watched.  According to Edwards:

The three print ads will appear in magazines geared toward diabetes sufferers, as well as more mainstream titles such as The New York Times Magazine and Readers Digest. Euro RSCG Tonic in New York created the ads. Spending was not disclosed

The injectable insulin marketing campaign is significant given the renewed interest in diabetes care following Exubera’s approval, and perhaps more importantly, the fact that  “[the] five-year-old brand has not previously been advertised.”

Dr. Carol Levy, an endocrinologist specializing in diabetes care at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City, recently noted that Exubera inhaled insulin could be useful for Type 2 diabetics at mealtime.

That was also one of the conclusions drawn by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CMHP) when evaluating Exubera for the European Community.

A report published by Bloomberg / Philadelphia Inquirer pojects that sales of Pfizer’s newly approved Exubera inhaled insulin will be worth $1.8B in annual sales.

At a time when Pfizer and other pharmaceuticals must deal with, according to one estimate, “some of the $18 billion in sales at risk for products losing patent protection in 2006,” it should come as a surprise that a lot of heavy expectations are attached to Exubera’s launch.

One unanswered question, however, is who will pay for added costs of a drug that some analysts estimate will cost “up to 4 times more than injectable insulin.”  Will insurance companies be willing to pick up the extra cost?  Will diabetics — diagnosed and undiagnosed — be willing or able to pick up any extra cost associated with using the prescription drug?

In an interview with the San Jose Mercury News, Nektar Co-Founder and Chief Scientific Officer John Patton explains that his biggest challenge trying to create inhaled insulin was deaing with safety concerns about the drug:

The knee-jerk reaction from the lay scientists or the lay smart person was, “You can’t do that. You’ll get asthma. It won’t be safe. The lungs are supposed to breathe fresh air, you shouldn’t put anything in there.” Actually, the lungs take in literally billions of particles everyday. There’s all these processing mechanisms and self-cleansing mechanisms. And we’re talking about putting something in there that’s very bio-compatible.

Still, safety concerns about Exubera do not appear to be entirely misplaced: the FDA did not approve the inhaled insulin for use by children; people with respiratory-related conditions — according to studies by Pfizer and Aventis — are at risk for using it; and some physicians and diabetics have chosen to take a wait-and-see approach to using non-injectable insulin.

WAKEFIELD, Mass.–(BUSINESS WIRE)–Feb. 15, 2006–At launch, Exubera lacks the necessary profile for success in today’s evidence-based, payer-dominated market, according to “Irrational Exubera-nce for Pfizer,” an article published today in Business Week online. Drawing upon the 2006 Bruckner Group (BGI) Payer Study, BGI’s Outcomes-Based Access (OBA) Index, and BGI’s outcomes-based access database, BGI Partners Michael J. Russo and David Balekdjian have identified a significant discrepancy between Exubera’s clinical and marketing profile, and analysts’ revenue expectations. The authors believe Exubera is not compatible with an environment in which convenience and innovation take a back seat to healthcare value considerations, even though innovation is clearly needed to improve the standard of care for diabetes patients.

Less than five years ago, before managed care payers adopted OBA as the paradigm for formulary decision-making, Exubera would likely have surpassed blockbuster status. Today, payers are neither able nor willing to pay for expensive new drugs failing to offer compelling healthcare value. To receive preferential formulary coverage (critical to maximizing product revenues), new drugs must deliver improved patient health outcomes and be priced at a level that produces overall treatment cost savings to payers relative to the standard of care–for example, by resulting in fewer surgeries or interventions, emergency room visits, and doctor appointments. Attempts by pharma and biotech manufacturers to circumvent adverse payer coverage decisions through masterful use of physician and DTC marketing are increasingly unsuccessful.

“Irrational Exubera-nce for Pfizer” describes how payers make coverage decisions under OBA, and specifically presents an OBA analysis for Exubera as a case study. The authors conclude that payers are likely to find that Exubera lacks the proof required to justify a significant premium to injected insulin. Exubera reimbursement is likely to be plagued by higher co-pays and stringent utilization restrictions.

Here is a link to the article: www.businessweek.com/technology/content/feb2006/tc20060215_664687.htm

About the Authors and The Bruckner Group (BGI):

Michael J. Russo and David Balekdjian are Partners at The Bruckner Group. BGI is the leading expert in value-based strategies, helping pharmaceutical and biotechnology companies design and implement strategic plans and marketing programs that prove the outcomes-based healthcare value and justify the prices of their products and services.