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.

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.

A new picture of Novo Nordisk A/S (NYSE:NVO) AERx inhaled insulin was shown being used in clinical trials in Fresno, California. The form factor of the device in the photo is quite large — like Pfizer’s Exubera inhaler, although it is in a different shape.

The Fresno Bee article shows an asthmatic insulin-dependent diabetic participating in an FDA-pproved clinical trial of Novo’s AERx inhaled insulin (Photo Credit: Kurt Hegre, Fresno Bee):

The 52 year-old patient, Dale Anne Payne, has had Type 1 diabetes for 26 years.

This blog recently compared the size of the Exubera inhaler with Mannkind’s Technosphere insulin inhaler that is still in clinical trials. Examining just the size of the inhaler devices, the proposed form factor of the Technosphere unit is palm-sized, Novo’s AERx device being studied is like inhaling from a camcorder, and Pfizer’s Exubera device still elicits comparisons to a bong.
What appears notable is that unlike the Pfizer and Sanofi-Aventis studies conducted before Exubera’s FDA approval, the Novo studies do not exclude asthmatics from participating in trials to examine the “investigate [s]afety and [e]fficacy” of AERx.

The FDA’s approval of Pfizer’s Exubera was conditioned, however, upon Pfizer doing long-term safety studies over a decade to further examine known and potential risks to asthamtics, smokers, and children.
Novo’s FDA trials of AERx are being conducted in the U.S. and around the world on:

• Type 1 diabetics
• Type 2 diabetics, including both:

• Safety and Efficacy Trials
• Trials with and without the pioglitazone oral diabetic drug Actos marketed jointly by Tokyo-based Takeda Pharmaceutical Company Limited (Public,TYO:4502) and Eli Lilly & Co. (NYSE:LLY)

Novo Nordisk and Pfizer are currently litigating a patent lawsuit filed by Novo in August claiming that Pfizer’s Exubera infringes Novo’s patent rights of its AERx inhaled insulin that is still in FDA trials. Pfizer’s answer to the lawsuit alleged, in part, that:

• Novo and its counsel seek, without justification, to preserve indefinitely the inhaled insulin market for Novo.
• …Novo and its counsel seek to deny diabetic patients access to the only FDA-approved system for the delivery of insulin through inhalation.

Last month a federal judge rejected, in a 17-page court opinion, Novo’s attempt to halt Pfizer’s Exubera sales pending the outcome of the parties’ patent litigation.