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.

Danish diabetes drugmaker Novo Nordisk A/S (NYSE:NVO) is reducing the number of its inhaled insulin patent infringement lawsuit claims against Pfizer, Inc. (NYSE:PFE) from five to two.

Novo’s General Counsel Jim Shehan told the Danish financial news agency RB Borsen that the company believes it still has “a very strong case” against Pfizer.

The two pharmaceutical giants are battling over their respective pulmonary drug delivery technologies to deliver inhaled insulin to diabetics.  Pfizer’s Exuber received FDA approval in January 2006. Novo’s AERx inhaled insulin is currently in clinical trials, but submission for FDA approval is not expected for several years.
On December 14, 2006 a federal judge denied Novo Nordisk’s request for a preliminary injunction to halt sales of Pfizer’s Exubera inhaled insulin.

The patent infringement lawsuit was filed in the beginning of August 2006, shortly after Pfizer’s July announcement that it was delaying the Exubera product launch until September 2006.  The launch was delayed again when Pfizer announced on October 20, 2006 that it was putting off the launch until January 2007.
Pfizer’s legal answer to Novo’s claims alleged, in part, that its competitor wanted to delay sales of its insulin to diabetics because it was the first and only pharmaceutical company to receive FDA approval for inhaled insulin to treat Type 1 and Type 2 diabetics.

Update: Diabetic reporter Meredith Cummings has grown so frustrated with the erratic blood sugar levels that she experienced using Pfizer’s Exubera inhaled insulin, she’s going back to taking insulin shots.

In her latest report, Cummings says:

my blood sugars fluctuated wildly. A few days of this would make the most determined person physically, mentally and emotionally exhausted.

That’s not good news for Pfizer.

Just the other week, Cummings was complaining that her Exubera “inhaler was large and awkward.”

Yet what’s encouraging is that she still remains a diabetic who see’s her glass of Diet Coke half-full, not half-empty. Her decision to drop Exubera was made only after doing what Pfizer recommended: getting a spirometry (lung function) test to determine if she had any impediments to using the pulmonary drug delivery system; meeting with her endocrinologist; getting proper training on how to use the inhaler; and giving herself a chance to try using it.

Even though Exubera still didn’t work well for Cummings  (”I will gladly take insulin shots if it helps me to maintain that, as well as keeps me feeling good,” she says), that won’t trying another drugmaker’s inhaled insulin once it gets FDA approval.  “As soon as another company comes out with an inhaled insulin that is more fine-tuned, I know I will give it a try,” she says.

That could be good news for Alkermes, Inc. (NASDAQ:ALKS), Novo Nordisk (NYSE:NVO), and Eli Lilly & Co. (NYSE:LLY), and Mannkind Corporation (NASDAQ:MNKD).  Each of them are working on alternative inhaled insulin drug delivery systems.

In what appears to be the longest inhaled insulin trial to date, a Scottish hospital is currently recruiting Type 2 diabetics for a two-year study of inhaled insulin.

The Edinburgh Evening News reports that the study at the Edinburgh Royal Infirmary teaching hospital is seeking Type 2’s for the study.

Scotland Currently Rejected Inhaled Insulin For Nat’l Health Service Drug Formulary List

A Scottish drug forumlary committee listed inhaled insulin in an October-November 2006 report on new drugs that included inhaled insulin.  Evaluations by both the Scottish Medical Consortium (’SMC’) and the Lothian Recommendation and Forumarly Committee (from Scotland’s National Health Service) concluded, at that time, that inhaled insulin was not recommended for use by diabetics.

Only 8 Diabetics Currently Enrolled in the Drug Trial

Very few diabetics are currently enrolled in the trial.  At present there are only eight (8): four who are using inhaled insulin, and four taking subcutaneous insulin injections.
‘Needle Phobia’ Emphasized

It appears that a big push is being made by the head of the Scottish study to emphasize ‘needle phobia’ as a reason for enrolling in the study. The Infirmary’s Dr. Nicola Zammitt believes that “inhaled insulin could represent a major breakthrough in the treatment of diabetes for those with bad needle phobias.”

This has been a major emphasis by pharmaceutical companies like Pfizer when trying to get regulatory approval for inhaled insulin, and seems a likely component of any future Exubera Direct to Consumer (’DTC’) marketing and advertising campaigns.

Unclear Which Drugmaker is Conducted the Inhaled Insulin Trial

It is currently unclear exactly which pharmaceutical company is participating in the Scottish inhaled insulin trial.  It could be Pfizer, Inc.’s Exubera, Novo-Nordisk’s AERx inhaler, Mannkind’s Technosphere inhaled insulin, or AIR inhaled insulin which is being jointly developed by Alkermes & Eli Lilly & Co.