Archive for the ‘Pfizer’ Category

Inhaled insulin Exubera may cause lung cancer

Thursday, April 10th, 2008

Exubera insulinUS drugmakers Pfizer Inc and Nektar Therapeutics on Wednesday warned of cases of lung cancer in clinical trials of their inhaled insulin Exubera.

The findings led Nektar to announce it was abandoning its search for a new marketing partner for the troubled drug, effectively signaling Exubera’s demise after entering the market in January 2006.

Pfizer, the world’s largest pharmaceutical company, announced last October it stopped marketing Exubera, saying it did not meet customer needs or the financial expectations of the company.

The rise in lung cancer apparently linked to Exubera led Pfizer to update the medication’s warning label to include information “about lung cancer cases observed in patients who used Exubera,” the company reported in a statement.

It said that over the course of the clinical trial, six out of 4,740 Exubera-treated patients developed lung cancer, versus one of the 4,292 patients not treated with Exubera.

An additional case of lung cancer in an Exubera-treated patient was discovered after the drug’s debut on the market following its approval by the US Food and Drug Administration.

The updated label states that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were “too few cases to determine whether the development of lung cancer is related to the use of Exubera.”

“Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials,” Pfizer chief medical officer Joe Feczko said in the statement.

“We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies,” he added.

Nektar announced it was stopping all spending on the drug, including research and marketing.

“The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners,” said Nektar president Howard Robin on the company’s website.

Diabetes affects 230 million people worldwide, including 21 million in the United States, according to Pfizer. Exubera is a short-acting insulin breathed in through an inhaler that helps control high blood sugar in people with diabetes.

Pfizer warns Exubera patients about risk

Pfizer Inc. said Wednesday it is warning patients using its inhaled insulin product Exubera about the risk of lung cancer, leading Nektar Therapeutics to terminate its inhaled insulin programs.

Nektar had been Pfizer’s partner on Exubera from 1995 until Pfizer discontinued the drug in October 2007 after lackluster sales. Some patients continue to take the drug, however, including some enrolled in extended transition programs or clinical trials.

On Wednesday, Pfizer said it updated the U.S. product labeling for Exubera Inhalation Powder to include a warning about lung cancer cases observed in patients who used the inhaled insulin treatment.

Over the course of Exubera’s clinical trial program, 6 of the 4,740 patients treated with Exubera developed lung cancer, compared with 1 of the 4,292 patients not treated with the drug.

There was also a post-marketing report of lung cancer in one Exubera-treated patient.

The label notes that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were too few cases to determine whether the cancer is related to use of Exubera.

Pfizer said the data was reviewed by the company and the Food and Drug Administration.

Nektar said it will stop all spending associated with its inhaled insulin programs and will not incur any additional charges related to the action.

“The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners,” said Howard W. Robin, president and chief executive of Nektar, in a statement. “Fortunately, over the past year Nektar has significantly transformed its business, moving away from inhaled insulin.”

Exubera

Generic Name: insulin inhalation
Brand Names: Exubera

What is Exubera?

Insulin inhalation (Exubera) was withdrawn from the U.S. market in 2007 due to lack of consumer demand for the product. No drug safety concerns were cited in this withdrawal.

Exubera is a rapid-acting form of human insulin that is inhaled through the mouth. It works by lowering levels of glucose (sugar) in the blood.

(more…)

Viagra’s 10th anniversary

Thursday, March 27th, 2008

Viagra pillsTen years ago this month the lives of millions of men and women were changed almost overnight by the advent of a little blue pill — the first oral treatment for impotence.

Viagra, developed by accident by scientists at Pfizer Laboratories, was first approved for use by the US Food and Drug Administration on March 27, 1998.

“Originally, we were testing sildenafil, the active drug in Viagra, as a cardiovascular drug and for its ability to lower blood pressure,” said Dr Brian Klee, senior medical director at Pfizer.

“But one thing that was found during those trials is that people didn’t want to give the medication back because of the side effect of having erections that were harder, firmer and lasted longer.”

Since Viagra went on the market it has been used by 35 million men around the globe, and it took impotence off the taboo list, making it infinitely easier to treat.

Urologists’ waiting rooms became busier as news got round that the condition, which was rechristened with a new, scientific name — erectile dysfunction, or ED — could be treated with a triangular blue pill.

Previous treatments had involved surgically inserting a prosthesis into the penis, injecting a substance into the male sex organ or using urethral suppositories.

“Viagra brought a lot more people into the office because of the ease of treatment,” Dr Irwin Shuman, a urologist of 40 years’ experience in Washington, told AFP.

“In the old days, when we didn’t have much in the way of treatment, we would do a lot more evaluation, looking for answers as to why somebody had the problem,” he said.

In one test, men would be observed while sleeping to see if erections occurred.

Men who failed to get the usual five to six erections per night were deemed to have a physical problem, and those who did get nocturnal erections were said to have a psychological problem and were sent to see a sex counsellor.

So Viagra helped move impotence out of the psychological realm and into the world of physical illnesses. “What we have come to understand in the past 10 years is that ED is a vascular disease,” said Klee.

“What happens is veins and arteries that deliver and remove blood from the penis are not working the way they should, and Viagra allows those vessels to dilate and increase blood flow to the penis,” he said.

Dr Abraham Morgentaler, director of Men’s Health Boston, and associate clinical professor of urology at Harvard Medical School, hailed Viagra as a “benefit to medicine.”

But, he added, the drug has not delighted all those who took it.

“There are two truths to Viagra: for those who refill (get a new prescription), it’s wonderful and they’re happy,” Morgentaler told AFP.

“But a lot of people look to Viagra for personal happiness, thinking a hard penis can resolve relationship issues,” and they end up disappointed, added the doctor and author of the book “The Viagra Myth.”

Some patients say taking Viagra “does not correspond to the way they want to have sex,” Morgentaler said.

Viagra works best on an empty stomach or after eating a low-fat meal, the medication’s official website says. It kicks in about 30 minutes after being taken, works for four hours, and only with sexual arousal, the website says.

But it’s not the answer for everyone. Morgentaler said he had a 78-year-old patient in his office who “didn’t like the idea of programming sex. Guys, and often women, too, don’t necessarily want to compromise the ideal of sex as something magical, spontaneous, romantic.”

Morgentaler also spoke of the darker side of Viagra, which has evolved since it and two other ED treatments became easily available over the Internet.

“It’s the use of Viagra by healthy young men who don’t need it,” he said.

“These young men take a pill whenever they go out … Maybe because they are inexperienced or shy and Viagra makes them more confident, or maybe because they have inflated ideas about what sex is supposed to be like from seeing Internet porn, which they also have easy access to, and they want to heighten their feelings of masculinity,” he said.

“I am concerned — not that these young men will get addicted physically, but that they will become psychologically dependent on Viagra,” said Morgentaler.

“Sex is an entree into a relationship, and most often what we want from a relationship is to be loved for what we are.

“But some of these young men feel they have to take a pill to be acceptable, and I fear they are potentially missing the opportunity to have true emotional connections with a partner, based on reality, not mythology.”

Viagra celebrates its 10th birthday

The potency enhancing drug Viagra has been on the market for 10 years. In 1998, pharmaceutical company Pfizer introduced the erection drug that was to change millions of lives at a stroke. A solution to erectile dysfunction had been found, and the taboo surrounding impotence was largely a thing of the past.

The little blue pill that enabled millions of couples to reawaken their sex lives was discovered by accident, says sexologist Vera Steenhart of the Dutch Sexology Association. Pfizer was actually looking for a drug for the heart problem angina pectoris. The pills didn’t appear to be benefiting the test subjects, but they refused to give them back. Ms Steenhart:

“The manufacturers found this strange. On further investigation, they found the drug gave the male patients an erection. They were extremely happy about it.”

Effect
The forerunner to Viagra was developed to make blood vessels relax. The test subjects were given the drug to improve blood circulation to the heart to reduce the chance of heart failure. Viagra has the same effect on the penis. When the man is sexually stimulated, the blood supply is improved and it becomes easier for him to maintain an erection.

It’s a myth that the pill can produce an unwanted erection. The user does actually have to be in the mood, so Viagra has little or no effect if he is unwilling to have sex or feels anxious about it. In that case it would be more appropriate for him to have a good talk with his partner or pay a visit to a psychologist or sexologist.

(more…)

Fake Viagra and Cialis anti-impotence drugs

Wednesday, January 9th, 2008

Fake viagra pillsFrench customs officials have intercepted a shipment of 224,000 fake Viagra and Cialis anti-impotence pills worth 2.4 million euros ($3.5 million), the Budget Ministry said on Monday.

The copies of the best-selling drugs were found on December 18 during a search at the French capital’s main air hub at Roissy, in a freight cargo on its way to Brazil from India.

“Branded Powergra and Erectalis, each box contained, in fact, four tablets in the characteristic shape and color of Viagra or Cialis pills,” Budget Minister Eric Werth’s office, which is also in charge of customs, said in a statement.

“The companies Pfizer and Eli Lilly, which respectively own the Viagra and Cialis brands, quickly confirmed the counterfeit nature of these products and the 224,000 pills were seized,” Werth’s office added.

Fake Viagra maker given 10-year prison term

A man has been given a 10-year prison sentence for producing millions of fake anti-impotence pills.

Viagra, the anti-impotence drug, is made by Pfizer. [file photo]

Wang Weiping was also fined 2 million yuan (US$250,000) in a first ruling on Monday at Shaoxing Intermediate People’s Court in East China’s Zhejiang Province.

The 34-year-old, a legal worker at Kangdeli Health Care Co Ltd in Xinchang County of the province, was arrested in November last year on suspicion of producing and selling counterfeit drugs.

A total of 381,000 fake Viagra pills and 1.4 million counterfeit Cialis tablets, worth a combined total of 241 million yuan (US$29 million) on the market, were also seized from workshops at Kangdeli Health Care, according to a release from the court.

Viagra is produced by the New York-based Pfizer Pharmaceuticals, while Cialis is manufactured by Indianapolis-based Lilly Icos LLC. Both are well-known drugs to treat impotence.

Some of the fake pills were found to contain medical starch, which does not have any curative effect and others had too much sildenafil, the main ingredient of Viagra, and is detrimental to health in large doses, said the release.

Workshops to make the fake drugs were also found in Guannan County of Jiangsu Province, Zhejiang’s neighbouring province.

All counterfeit pills, production machines and materials to make the fake drugs were confiscated.

Wang began making the fake pills in Shaoxing in April last year, and established another manufacturing base at Guannan in Jiangsu Province in June.

Local police and drug administration officials uncovered the case during a crackdown on the production of fake pills.

No counterfeit drugs have actually been found in the marketplace, said Zhang Guojing, director of the Shaoxing Food and Drug Administration.

Wang’s operation is the biggest, in terms of the financial worth of the pills, to have been uncovered in Zhejiang Province.

Erectile dysfunction drugs such as Viagra and Cialis were approved by the Ministry of Health and State Food and Drug Administration as prescription drugs in 1999.

In December last year, seven people in Zhengzhou in Central China’s Henan Province were accused of selling 9.7 million fake tablets of Viagra.

Cialis
30 pills x 10mg $94.19 at $3.14 per pill
180 pills x 10mg $401.15 only $2.23 per pill (Save $233)
Ads by CanadianMedsWorld

Police bust online Viagra gang

The leader of a gang selling fake Viagra over the internet has been given a four and a half year jail sentence.

Ashish Halai, 33, ordered fake Viagra tablets from suppliers in China and Mexico for 25p each and sold them for as much as ?20 online to people in the US and Europe who were too embarrassed to go to their doctor.

Three other members of the gang were also found guilty and will be sentenced later.

The case came to light after an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA), which estimated that the gang netted at least ?2m from the scam.

Mick Deats, head of enforcement at the MHRA, said: “The MHRA treats every report of a counterfeit medicine as a serious incident. This successful prosecution should serve as a clear signal to those contemplating the supply of counterfeit medicines.

“The public are strongly advised to avoid buying medicines online, where the risk of being provided with counterfeit medicines is greatly increased.”

Halai is a chemist who sold his practice in Bayswater, London but continued to use the name to sell herbal supplements.

The court heard that Halai began selling fake anti-impotence drugs in 2002 passing them off as Viagra and Cialis. He packaged the drugs so skilfully that experts said it would take a trained eye to spot the difference.

Police seized over ?1.5m worth of the fake drugs when they swooped on the gang. The drugs were imported using business courier services and were disguised as pet supplements.

Pfizer is #1 in research spendings. Johnson & Johnson, Microsoft and Ford are left behind

Wednesday, October 3rd, 2007

Pfizer Inc., the world’s largest drugmaker, is the world’s biggest spender on research, the European Commission said Friday.

That means it outranks rival Johnson & Johnson, software giant Microsoft Corp. and auto companies Ford Motor Co. and DaimlerChrysler AG.

Pfizer spent 5.8 billion euros ($8.18 billion) last year to take the top spot from Ford on the EU’s research and development list, which uses figures from the world’s 50 largest companies to chart how much they invest in researching new products.

The four biggest spenders were all from the United States: Pfizer, Ford, J&J, and Microsoft, as pharmaceutical and biotechnology companies sharply increased research spending to overtake technology hardware and equipment.

Major drugmakers are focusing more on research to develop new products that will help them compensate for losing their exclusive rights to sell many of their best-selling drugs.

U.S.-based Merck & Co. raised investment by 24 percent, AstraZeneca PLC by 15 percent, J&J by 13 percent and GlaxoSmithKline PLC by 10 percent, the EU said.

Germany’s DaimlerChrysler, which is changing its name to Daimler AG after the sale of most of its U.S. unit, was Europe’s highest scorer with 5.2 billion euros ($7.34 billion). Britain’s GlaxoSmithKline ranked No. 7, and German engineering giant Siemens AG was at No. 8.

The European Union’s research commissioner, Janez Potocnik, said more European companies needed to invest more of their own money in research.

Worldwide corporate investment in research grew 10 percent last year, riding the wave of global economic growth. Europe-based companies increased their spending at a slower rate, 7.4 percent.

The European Commission looked at spending by 1,000 companies based in Europe and another 1,000 based outside, saying overall these businesses invested 372 billion euros ($525 billion) in research in the last financial year, more than 85 percent of all research investment worldwide.

A few words about Pfizer

Pfizer Incorporated (NYSE: PFE) is a major research-based pharmaceutical company, which ranks number two in sales. The company is based in New York City. It produces the number-one selling drug Lipitor (atorvastatin, used to lower blood cholesterol); the oral antifungal medication Diflucan (fluconazole), the long-acting antibiotic Zithromax (azithromycin), the well-known erectile dysfunction drug Viagra (sildenafil citrate), and the anti inflammatory Celebrex (celecoxib) (also known as Celebra in some countries outside USA and Canada, mainly in South America).

Pfizer’s shares were made a component of the Dow Jones Industrial Average on April 8, 2004.

Pfizer boasts the industry’s largest pharmaceutical R&D organization.

Pfizer is named after German-American cousins Charles Pfizer and Charles Erhardt who launched their chemicals business Charles Pfizer and Company from a building at the intersection of Harrison Avenue and Barlett Street in Williamsburg, Brooklyn in 1849. There, they produced an antiparasitic called santonin. This was an immediate success, although it was the production of citric acid that really kick-started Pfizer’s growth in the 1880s. Pfizer continued to buy property to expand its lab and factory on the block bounded by Bartlett Street; Harrison Avenue; Gerry Street; and Flushing Avenue. That facility is still utilized for Backshop purposes. Pfizer established its original administrative headquarters at 81 Maiden Lane in Manhattan.

By 1910, sales totaled nearly $3 million, and Pfizer became established as an expert in fermentation technology. These skills were applied to the mass production of penicillin during World War II, in response to an appeal from the US government. The antibiotic was urgently needed to treat injured Allied soldiers, and it soon became known as “the miracle drug”. In fact, most of the penicillin that went ashore with the troops on D-Day was made by Pfizer.

By the 1950s, Pfizer was established in Iran, Belgium, Brazil, Canada, Cuba, Mexico, Panama, Puerto Rico and the United Kingdom.

During the 1980s and 1990s Pfizer underwent a period of growth sustained by the discovery and marketing of multiple successful drugs (Zoloft,Lipitor,Norvasc, Zithromax, Aricept, Diflucan, Viagra).