This blog has continued researching and reporting on potential Exubera inhaled insulin risks for more than two years.

Pfizer’s and Nektar’s announcements this morning that 6 of the 4,740 patients using Exubera in clinical studies developed lung cancer confirms what this blogger has been saying all along:

That it was foolish of the FDA to rush into conditionally approving the inhaled insulin without first completing long-term safety studies of the diabetes drug.

During that time, we’ve examined studies, concerns by endocrinologists and pulmonologists about the drug, and caution by diabetics.
Nektar announced today that it “ceased all negotiations with potential partners for its inhaled insulin programs as a result of new data analysis” citing lung cancer developed by patients in Exubera safety studies.

Pfizer appeared to suggest that any diabetics who developed lung cancer while on Exubera might be at fault, since “all patients who developed lung cancer had a prior history of cigarette smoking.”
Not surprisingly, the drugmaker pooh-poohed the cancer findings, claiming there “were too few cases to determine whether the development of lung cancer is related to the use of Exubera.” Citing financial reasons, Pfizer already opted to yank Exubera from its product line last fall.

Pfizer’s decision to halt Exubera inhaled insulin sales has led the layoff of 660 of the drug company’s workers at its Terre Haute, Indiana manufacturing facility.

The news was announced by Nat Ricciardi, president of Pfizer Global Manufacturing. Workers were informed that they would lose their jobs today, according to the Kalamazoo Gazette.

That will leave more time for MySpace postings by current, former, and soon-to-be terminated Pfizer Exubera manufacturing facility employees who were known to share their personal information with folks on the world wide web!

Folks like young Exubera worker Justin Mattick who, for more than a year, has been happy to let Pfizer, competing drugmakers, and neighbors know that he makes $75,000 - $100,000 a year.

Then there was Adam Gentry who once said that Pfizer’s Terre Haute Exubera production plant “has a slower work pace (mind-numbingly slow at times).” Gentry also disclosed details about Pfizer’s quality control procedures, advising that “[b]ecause they’re regulated by the FDA, EU, UK, ASCAP, UCLA, KFC, etc, we have to be very careful and sign everything.”
Readers shouldn’t forget that another apparent Pfizer insider (”I actually work for Pfizer,” the insider admitted) who publicly alleged that “[t]here are several issues with the manufacturing process that I will not go into, but lets just say it’s not efficient or effective.”

Danish diabetes drugmaker Novo-Nordisk has opted to halt further development of its AERx inhaled insulin.

The pharmaceutical company’s new decision comes shortly after it Pfizer and Novo settled their patent litigation of Pfizer’s Exubera inhaled insulin.

Novo’s AERX inhaled insulin was in Phase III trials when the decision was made. The device previously that was previously shown being used in trials appeared huge (inset, left) — as big as a camcorder.

Bloomberg reports that the decision will result in Novo taking a $260 million (U.S.) charge.
Approximately 300 Novo-Nordisk employees are expected to lose their jobs at the company’s Hayward, Calif. research facility, according to the Contra Costa Times.
(Picture credit: Sacramento Bee)

Novo-Nordisk and Pfizer reportedly settled their patent litigation this week over Pfizer’s failed Exubera inhaled insulin and Novo’s AERx insulin that the Danish drugmaker has been developing with Aradigm Corp.

The litigation started just before Pfizer brought Exubera to market (after considerable delays), and continued for just over a year.

Novo claimed that Exubera infringed on a host of patents that it had for inhaled insulin. In its answer to the lawsuit, Pfizer stressed that the real reason behind Novo’s suit was “to preserve indefinitely the inhaled insulin market for Novo.”

Although the settlement agreement was reported late Monday, terms of the deal were not made public.

Pfizer announced that it was pulling Exubera from the market on October 18, 2007. Given that Pfizer originally paid Sanofi-Aventis $1.3 billion to acquire exclusive worldwide rights to market the first FDA-approved inhaled diabetes drug, yet only generated $4 million in Exubera sales for Q2 2007, it is no surprise that the drugmaker opted to stop spending money on lawyers fees when it no longer had a product to justify the litigation expense.

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.