Re: Pfizer Drug Conditionally Cleared

[Guest guest]

Where's the MSH we so desperately need? Loni

tigerpaw2c <tigerpaw2c@...> wrote: Pfizer Drug Conditionally Cleared

By Steyer

TheStreet.com Staff Reporter

12/6/2005 6:38 PM EST

Click here for more stories by Steyer

http://www.thestreet.com/_googlen/stocks/robertsteyer/10256109.html?

cm_ven=GOOGLEN & cm_cat=FREE & cm_ite=NA

Pfizer (PFE:NYSE - commentary - research - Cramer's Take) has

received conditional approval from the Food and Drug Administration

for a new fungal infection drug, but the company declined to say

what the conditions are or how long it will take to meet those

requirements.

The drug, called anidulafungin, is designed to fight fungal

infections that affect the skin or mucous membrane but that also can

enter the bloodstream and damage the heart. Pfizer initially asked

the FDA to approve the drug for fungal infections of the esophagus.

The FDA was scheduled to act in late November, but the company

didn't announce the agency's response. A Pfizer spokesman on Tuesday

confirmed that his company received an " approvable letter " from the

FDA on Nov. 25, indicating the agency wanted more information. He

declined to comment on the requirements.

Anidulafungin is one of two anti-infectives that were in late-stage

development at Vicuron Pharmaceuticals when Pfizer offered $1.9

billion for the company on June 16. The deal closed Sept.14.

The other Vicuron product, the antibiotic dalbavancin, also received

conditional approval from the FDA. The agency had been scheduled to

act in mid-September. Pfizer confirmed in its third-quarter

financial report issued Oct. 20 that it had received conditional

approval. Dalbavancin treats dangerous hospital-based infections

featuring bacteria that have become resistant to other antibiotics.

At the time, Pfizer declined to provide details about the

requirements or a timetable, saying only that " we anticipate a rapid

and successful resolution of outstanding issues. "

Pfizer acquired Vicuron in order to bolster its collection of

infection-fighting drugs that produced $4.72 billion in sales last

year, or 9% of corporate revenue.

However, the antifungal Diflucan, which had $945 million in sales

last year, lost U.S. patent protection in July 2004 and is being

battered this year. For the first nine months of 2005, Diflucan

produced $370 million in sales vs. $805 million for the same period

last year.

Generic competition is expected to take a greater toll on the

antibiotic Zithromax, which is used primarily for respiratory

infections. That drug lost U.S. patent protection last month. Last

year, its worldwide sales were $1.85 billion.

FAIR USE NOTICE:

[Guest guest]

> However, the antifungal Diflucan, which had $945 million in sales

> last year, lost U.S. patent protection in July 2004 and is being

> battered this year. For the first nine months of 2005, Diflucan

> produced $370 million in sales vs. $805 million for the same period

> last year.

At Costco, they have the generic form dirt cheap. I forget, maybe 30 cents

apiece or

something. Mine are 13.00 a pill, and the generic the pharmacy tried to foist on

me was

11.00 a pill. Since I can't take lactose, I can't take the Costco brand, but

most people

should be able to use it.

I noticed that they only came out with this " new " drug after they lost the

patent protection

on Diflucan.

They really are not interested in helping people, just in the bottom line. It is

disgusting.

There have been allegations for so many years about the corruption in Big Pharm

and the

FDA, I wonder why we put up with it- is it because we are too sick to deal with

it?

The govt should revoke their advertising ability. At the very least, it would be

a start. It is a

huge conflict of interest, and it just puts out there on the surface what has

been going on

for years before they could advertise.

[Guest guest]

The drug, called anidulafungin, is designed to fight fungal

infections that affect the skin or mucous membrane but that also can

enter the bloodstream and damage the heart. Pfizer initially asked

the FDA to approve the drug for fungal infections of the esophagus.

This is great that they are coming out with new antifungal drugs.

Now my question is how do they know it's a fungal infection? Because

it seems like no matter what type of tests that we have done that it

is not FDA approved, it's new research, on the cutting edge

or " quackery " . So which is it? These tests can be performed within

the hospital walls on individuals to determine fungal infection in

the bloodstream that can affect the heart, that are relied on for

further treatment, but yet when we ask for this type of bloodwork

it's not available. Or there is no such thing.

KC

--- In , " tigerpaw2c " <tigerpaw2c@y...>

wrote:

>

> Pfizer Drug Conditionally Cleared

>

> By Steyer

> TheStreet.com Staff Reporter

> 12/6/2005 6:38 PM EST

> Click here for more stories by Steyer

>

>

http://www.thestreet.com/_googlen/stocks/robertsteyer/10256109.html?

> cm_ven=GOOGLEN & cm_cat=FREE & cm_ite=NA

>

>

> Pfizer (PFE:NYSE - commentary - research - Cramer's Take) has

> received conditional approval from the Food and Drug

Administration

> for a new fungal infection drug, but the company declined to say

> what the conditions are or how long it will take to meet those

> requirements.

>

> The drug, called anidulafungin, is designed to fight fungal

> infections that affect the skin or mucous membrane but that also

can

> enter the bloodstream and damage the heart. Pfizer initially asked

> the FDA to approve the drug for fungal infections of the

esophagus.

>

> The FDA was scheduled to act in late November, but the company

> didn't announce the agency's response. A Pfizer spokesman on

Tuesday

> confirmed that his company received an " approvable letter " from

the

> FDA on Nov. 25, indicating the agency wanted more information. He

> declined to comment on the requirements.

>

> Anidulafungin is one of two anti-infectives that were in late-

stage

> development at Vicuron Pharmaceuticals when Pfizer offered $1.9

> billion for the company on June 16. The deal closed Sept.14.

>

> The other Vicuron product, the antibiotic dalbavancin, also

received

> conditional approval from the FDA. The agency had been scheduled

to

> act in mid-September. Pfizer confirmed in its third-quarter

> financial report issued Oct. 20 that it had received conditional

> approval. Dalbavancin treats dangerous hospital-based infections

> featuring bacteria that have become resistant to other

antibiotics.

>

> At the time, Pfizer declined to provide details about the

> requirements or a timetable, saying only that " we anticipate a

rapid

> and successful resolution of outstanding issues. "

>

> Pfizer acquired Vicuron in order to bolster its collection of

> infection-fighting drugs that produced $4.72 billion in sales last

> year, or 9% of corporate revenue.

>

> However, the antifungal Diflucan, which had $945 million in sales

> last year, lost U.S. patent protection in July 2004 and is being

> battered this year. For the first nine months of 2005, Diflucan

> produced $370 million in sales vs. $805 million for the same

period

> last year.

>

> Generic competition is expected to take a greater toll on the

> antibiotic Zithromax, which is used primarily for respiratory

> infections. That drug lost U.S. patent protection last month. Last

> year, its worldwide sales were $1.85 billion.

>