Exubera Inhaled Insulin: Reported & Suspected Risks for Diabetics

November 11, 2008

Pfizer Selling Terre Haute, Ind. Exubera Inhaled Insulin Plant

Filed under: Uncategorized, Exubera News, Exubera: Type 1 Diabetes, Exubera: Type 2 Diabetes, Exubera - Pfizer, Exubera Layoffs, Exubera - Terre Haute — exuberar @ 10:45 pm

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January 15, 2008

Novo-Nordisk Opts to Stop Inhaled Insulin Development

Filed under: Uncategorized, Exubera News, Exubera - Pfizer, Diabetes Research, Drug Litigation, Novo-Nordisk — exuberar @ 7:39 pm

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 Nordisk AERx inhaled insulin device in FDA clinical trial 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)

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March 23, 2007

Pfizer Exubera Inhaled Insulin Supply Far Exceeds Demand

Filed under: Uncategorized, Exubera News, Exubera: Diabetes Treatment, Exubera - Pfizer, Exubera: Insulin & Drug Sales, Exubera - Sales — exuberar @ 10:28 pm

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.

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February 11, 2007

India May Get Inhaled Insulin Approval Within 2 Years

Filed under: Uncategorized, Exubera News, Exubera - Sales, Drug Litigation, Novo-Nordisk, Eli Lilly & Co., Alkermes — exuberar @ 2:35 pm

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.

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January 30, 2007

Pfizer Spokesman: No Plans to Make Protein-Based Drugs Like Exubera in Mich. Plants

Filed under: Uncategorized, Exubera News, Exubera - Pfizer, Diabetes Research — exuberar @ 11:51 am

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.

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Recently Posted

November 11, 2008

Pfizer Selling Terre Haute, Ind. Exubera Inhaled Insulin Plant

January 15, 2008

Novo-Nordisk Opts to Stop Inhaled Insulin Development

March 23, 2007

Pfizer Exubera Inhaled Insulin Supply Far Exceeds Demand

February 11, 2007

India May Get Inhaled Insulin Approval Within 2 Years

January 30, 2007

Pfizer Spokesman: No Plans to Make Protein-Based Drugs Like Exubera in Mich. Plants