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I dont know if this was ever posted here, but I couldnt find it. After reading this, I think I know why Iressa is so expensive. The company lost mega bucks due to deaths in Japan from the drug. I know it is helping many people, but I just wanted everyone to be aware of this if you aren not already.


U.S. to decide on AstraZeneca drug as deaths rise

Last Updated: 2003-05-02 17:01:23 -0400 (Reuters Health)

By Mark Potter

LONDON (Reuters) - Europe's second-biggest drugmaker, AstraZeneca Plc, said on Friday its lung cancer drug Iressa had been linked to 69 new deaths in Japan, just days before it hopes to win U.S. approval for the medicine.

Most analysts think the U.S. Food and Drug Administration (FDA) will give a green light for Iressa to go on sale in the world's biggest drug market, noting the medicine is given only to seriously ill people for whom other therapies have failed.

"I think probability is on its (Iressa's) side, but it's going to be for a limited indication," said Howard Miller, an industry analyst at stockbroker Teather & Greenwood. He forecasts peak annual sales of $550 million for Iressa.

Iressa (gefitnib) is one of a number of new medicines that AstraZeneca hopes will make up for declining sales of ulcer pill Losec, sold as Prilosec in the United States, which is now facing cheap, copycat competition.

Its prospects have been clouded by the series of deaths in Japan and revenues from the drug in that country fell to $19 million in the first quarter of this year from $41 million in the last three months of 2002.

AstraZeneca said on Friday that, according to the Japanese health ministry, the number of people who had died after taking Iressa had risen to 246, and that some 616 patients had suffered side effects since the drug's launch in July 2002.

However, a spokesman also said the proportion of patients developing interstitial lung disease -- a potentially deadly condition linked to Iressa -- had "plateaued" and that the Japanese health ministry continued to back the medicine.

"The ministry has no problems with the benefits versus risks (of the drug)," the spokesman told Reuters.


An FDA advisory panel backed Iressa in September as a last resort treatment for advanced lung cancer, and the regulator is expected to make a final ruling by Monday.

"I think it will just about make it," said Paul Diggle, an industry analyst at WestLB Panmure, though he is forecasting peak annual sales of just $250-300 million.

AstraZeneca received a boost on Thursday when Australia became the second country to back the sale of the drug.

But on the same day a U.S. consumer group, Public Citizen, said Iressa was "likely ineffective and dangerous" and should not be approved in the world's biggest market for medicines.

Iressa is a pill designed to shrink tumors without the side effects of chemotherapy and belongs to a new family of drugs known as epidermal growth factor receptor inhibitors, which caused great excitement among cancer specialists when they were first discovered.

Sales prospects suffered a setback last year, however, when Iressa failed to work in trials combining it with other drugs.

Iressa's initial use is for patients with advanced non-small cell lung cancer who have previously received chemotherapy. Lung cancer is the leading cause of cancer deaths worldwide, and about 80 percent of cases are non-small cell lung cancer.

Longer-term, AstraZeneca also hopes the drug will have a role in the treatment of other cancers.

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Iressa induced bilateral pneumonia in my wife, much like many cases in Japan. Luckily, she has healthy lungs, so she survived. This only happens in less than 1% of the cases, but if you are in that group, as she was, it doesn't matter how many didn't get it. I am happy for those who are taking it and it is working. All drugs have risks. We just need to educate ourselves contstantly on what those risks are and make decisions based on the knowledge. Don

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  • 4 weeks later...

I have read more than once that Iressa is prescribed when the use of ALL other cancer drugs has been exhausted. My oncologist is planning on putting me on Iressa when (hopefully!) he sees further tumor shrinkage from Carbo/Taxol. Those are the only chemos I've been on and he's told me I have other chemo options. I figure he must be fairly sold on Iressa because he's not the world's greatest optimist!


Diagnosed Stage IV nsclc August 2003

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