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)

According to several recent reports, Pfizer, Inc. (NYSE:PFE) appears to have produced such a huge quantity of Exubera inhaled insulin at its Terre Haute, Indiana production facility that it should have roughly 3 years worth of drug inventory by the end of 2007.

Earlier this month, Brandweek reported that Friedman, Billings, Ramsey healthcare analyst Dr. James Reddoch wrote to the firm’s institutional brokerage clients that Pfizer had built up roughly $800 million in Exubera inventory, and should have 3 years worth of inventory built up the end of 2007:

“With lackluster demand so far, Pfizer has built up nearly $800 million in Exubera inventory this year and, based on guidance, will have over $1.5 billion in inventory by the end of this year (i.e., nearly three years’ worth of demand, based on our estimates). Pfizer will re-launch the product in April; this is probably the last chance to get traction with physicians and stimulate demand.”

Even with Pfizer’s lackluster sales of the insulin, the Vigo County Council in Indiana where the diabetes drug is produced approved a $4.515 million tax increment finance, or ‘TIF’ bond based on Pfizer’s taxes.

According to the Terre Haute Tribune-Star:

Taxes paid by Pfizer will fund the TIF bond payments, with the county’s income tax serving as a backup to secure the 15-year bond through 2021.

In other words,  if Pfizer defaults on the bond payments, the county will use it’s own income tax as security to pay the bond’s obligation.

Competition for introducing inhaled insulin in India is heating up. The country has what could become one of the larger pharmaceutical markets.

A new report from Express Pharma, India’s pharmaceutical industry newspaper, has one Indian doctor suggesting that inhaled insulin may be available in the country as early as 2009.

Eli Lilly & Co. (NYSE: LLY) is currently conducting inhaled insulin trials at Indraprastha Applo Hospital based in New Delhi.

Lilly and Alkermes, Inc. (NASDAQ:ALKS) recently extended extended their agreement covering the development of Alkermes’ AIR inhaled inhaled insulin. AIR is currently undergoing FDA Phase 3 clinical trials.

Dr. A. Ramachandran of MV Diabetes Hospital and Research Centre in Chennai, India ackowledged: “We are currently doing research on insulin inhalers.” He did not cite exactly which drug that the diabetes hospital is testing.

Novo-Nordisk also reportedly plans to introduce inhaled insulin in India by 2009. This blog recently reported on the size of Novo’s AERx inhaled insulin device, with a picture of the device’s large form-factor being tested in the U.S.

Novo is currently engaged in intellectual property litigation with Pfizer over Exubera’s drug patent. Pfizer filed an answer slamming Novo for trying to halt sales of the first FDA-approved inhaled insulin. In December, a federal judge denied Novo’s request for an injunction to Exubera sales pending the outcome of the litigation.

It’s too early to tell, but it seems unlikely that Novo would try to start similar patent litigation in India.

With layoffs in Kalamazoo and Ann Arbor, Mich. just a week old, a Pfizer, Inc. (NYSE:PFE) spokesman for the company’s Midwest operations revealed that the pharmaceutical company has “no plans at this stage to equip our local manufacturing facility to produce protein-based drugs” like Exubera inhaled insulin.

Those comments were made by Pfizer’s Rick Chambers to the Kalamazoo Gazette newspaper.
The company currently makes Exubera at its Terre Haute, Ind. manufacturing facility, then transports the diabetes medication nearly 300 miles to its Portage, Mich. plant for final packaging.

Three months ago this blog reported that investment WR Hamcrecht + Co. — which “maintains a market” (i.e., owns) in shares of the co-developer of the inhaled insulin, Nektar Therapeutics (NASDAQ:NKTR) — may have inadvertently disclosed an production risk:

Nektar makes all the dry powder insulin (the doses that are inhaled) at its headquarters in San Carlos[, Calif.], and Pfizer has been getting all that it has ordered there.

Could having all the Exubera powder made at one facility create a supply-chain risk for Exubera production and sale to diabetic consumers? On a purely practical level, this seems like a rather risky move.

It appears that some Pfizer, Inc. (NYSE:PFE) sales reps are complaining about meeting their Exubera sales quotas. Others, as explained below, are highly critical of the pharmaceutical company’s launch of the diabetes drug.

A recent post on CafePharma’s message board for the Pfizer drug sales team suggests that the company didn’t put enough money into Exubera’s launch and marketing campaign:

The problem with Exubera is that is was launched half-assed, before we had production ramped up to meet expected demand. Then, when we had enough product, we had no promotional money and then everyone was focused on NOT GETTING FIRED. Oh, and they changed the dates of the phases of the launch repeatedly (sometimes twice in the same month), changed the compensation and contests, and then finally they changed the division selling it (to the division that should have had it to begin with).

Exubera is a great product but it has to be launched well, with the $$$ for both education/promotion and DTC (which will drive sales). The launch, to date, has been, without a doubt, the worst in the history of Pfizer… a complete, utter back-alley abortion performed by a retarded monkey with a chain saw.

But just two (2) days after this apparent Pfizer sales rep. made the post above, Pfizer launched a slick new marketing campaign using video news releases (’VNR’) saying that Exubera is “now available in pharmacies.”

The videos (the first one here, and the second here) include comments by paid Pfizer consultant Dr. Jay Skyler.  He is a former president of the American Diabetes Assocation.  Skyler says in the first video that “one of the Holy Grails of diabetes…is the need to overcome the need for insulin injections.” By subtlely trying to suggest that insulin injections may be feared by people with Type 1 or Type 2 diabetes, Pfizer is apparently hoping that fear will be an effective marketing tool.This is part of Pfizer’s new DTC (”direct-to-consumer”) Exubera advertising campaign.  The VNR’s are troubling, however, because of their potential ability for misuse and creation of false impressions.

The effect of the VNRs and Exubera marketing have been examined by this blog before. First, when a San Francisco reporter broke a story charging that a Bay Area T.V. station reporter’s broadcast violated station “policy and…FCC rules.”

Second, the CBC (Canadian Broadcasting Corporation) improperly gave photo credit for a story they did on Exubera, claiming it was a CBC photo when, in fact, it was part of a Pfizer Exubera media release and marketing campaign.