Results tagged “pfizer” from Drugs & Medicaments

LONDON, March 7, 2007-The Medicines and Healthcare products Regulatory Agency (MHRA) has requested Pfizer to withdraw an advertisement making potentially misleading claims about Zyvox (linezolid), an antibiotic used to treat certain types of serious infection.

The MHRA became aware of the advertisement in the British Medical Journal (BMJ) claiming that Zyvox has superior cure rates compared to products containing the active ingredient vancomycin. At the time, Pfizer was in discussion with the MHRA about emerging concerns relating to the efficacy and safety of Zyvox compared to vancomycin in a clinical trial in patients with catheter-related infections.

Pfizer has lost a Beijing court case over the rights to a popular Chinese translation of its drug Viagra.

A court ruled Pfizer can no longer use the name Wei Ge, or mighty brother, to market Viagra as China's Guangzhou Welman had registered the brand.

While Pfizer markets the anti-impotence pill as Wan Ai Ke in China, it is commonly called Wei Ge by the public.

Jan. 4 (Bloomberg) -- U.S. regulators approved 18 new drugs in 2006, close to an eight-year low, as drugmakers struggled to develop products for hard-to-treat disorders.

The number of medicines recommended for sale in 2006 and 2005 dropped from the annual average of 26 drugs recorded in the previous six years, according to U.S. data. Last year's approvals include Pfizer Inc.'s cancer treatment Sutent and Merck & Co.'s diabetes drug Januvia.

Drugmakers are spending more on research and developing fewer drugs, the U.S. reported last month. The failure rate of compounds in testing has increased as companies target intractable diseases, a government study said. London-based AstraZeneca Plc, for example, scuttled three experimental drugs last year, including treatments for diabetes and stroke.

by Paul Howard, The Examiner

WASHINGTON - William Osler, one of the founding faculty members at Johns Hopkins Medical School, once remarked: “If it were not for the great variability among individuals, medicine might as well be a science and not an art.” A century later, medicine is, despite its technical prowess, in many ways still an art — albeit an expensive one.

Pfizer learned that lesson the hard way in early December, when they halted development of their much anticipated “good cholesterol” boosting drug, torcetrapib. A late-stage clinical trial revealed excess deaths and cardiovascular problems in patients taking the drug together with Lipitor, compared to Lipitor alone.

In the 15,000-patient trial, there were 82 deaths for the torcetrapib combo vs. 51 for Lipitor. The failure cost Pfizer $800 million in research costs, $20 billion in market capitalization and 15 years of research.

Pfizer (PFE) is an enormous company with approximately $52B in sales per year, $12B in profit per year, and $180B market cap. The company has a large stable of prescription medications such as Lipitor, Norvasc, Zoloft, Viagra, Celebrex and others.

Lipitor is the number one selling prescription drug worldwide with over $12B in sales. Pfizer also has a gigantic research effort, spending several billion dollars per year to bring out more prescription medicines. Also, as seen by the purchases of Warner-Lambert and Pharmacia, Pfizer is willing to buy other companies to expand its product portfolio. Additionally, PFE often buys the rights to compounds being tested by much smaller companies.

It's a sure bet drug developer Liponex Inc. will be feeling one of those things at the end of February when it reports do-or-die clinical results for a new treatment to raise levels of "good" cholesterol and reduce heart disease.

"This is the Holy Grail of cardiovascular R&D," claims Duncan Emerton, an analyst with British market research firm Datamonitor PLC, referring to the link between raising good cholesterol, or HDL, and melting plaque buildup in arteries that can cause heart attacks and stroke.

On the other hand, statin drugs, of which Lipitor is the best known, have created a $32-billion-a-year (U.S.) market by lowering "bad" cholesterol, or LDL. But they only halt the buildup of additional plaque. Studies have shown that a 1-per-cent drop in LDL can reduce the risk of developing heart disease by 1 per cent, but a 1-per-cent increase in HDL can reduce the risk by 3 per cent.

U.S. regulators cleared six more companies to begin selling generic copies of Merck & Co.'s cholesterol drug Zocor, signaling steeper price reductions.

The approvals posted on the Food and Drug Administration's Web site Wednesday are in addition to those granted Teva Pharmaceutical Industries Ltd. and Ranbaxy Laboratories Ltd. in June when Merck's patents expired. The new versions of the world's second-best-selling cholesterol-lowering pill will drive prices down as much as 70 percent, analysts said. Teva has been selling copies for 8 percent less than Merck.

The price drop may hurt sales of Pfizer Inc.'s Lipitor, the world's top-selling drug, with revenue last year of $12.2 billion, and the source of almost half of the New York-based drugmaker's profits. Lipitor prescriptions declined 6 percent in the fourth quarter as health plans encouraged patients to switch to generic copies of Zocor, Bear Stearns analyst John Boris said in a Dec. 21 research report.

Those already in Washington, and those newly elected to Congress, who want to artificially control drug prices got an important lesson in economics last week. They also got a tutorial on why new lifesaving drugs are so expensive.

The lesson came as Pfizer, a leading pharmaceutical maker, canceled trials of a new cholesterol-controlling drug — torcetrapib.

As the stock market opened on Monday, Pfizer's announcement over the weekend sent its stock tumbling 14 percent, kicking the stuffing out of the company's estimated worth by more than $20 billion.

WASHINGTON — Federal prosecutors on Monday charged a senior scientist at the National Institutes of Health with conflict of interest for taking $285,000 in fees from a drug company that was involved with his government research.

Dr. P. Trey Sunderland III is the first official in 14 years to be prosecuted for conflict of interest at the NIH, an agency rocked in recent years by revelations of widespread financial ties to the drug industry. Sunderland accepted the fees from 1998 to 2003 from Pfizer Inc.

Sunderland, who has headed the NIH's geriatric psychiatry branch, is scheduled to appear Friday in a federal courtroom in Baltimore, according to the office of U.S. Atty. Rod J. Rosenstein.

Pfizer Inc.'s new experimental heart drug is dead, but the dual approach the company was testing -- boosting good cholesterol while lowering the bad -- is very much alive, specialists said Monday.

A drug already on the market, Niaspan, raises good cholesterol without serious risks, and a large federal study is testing it with statin medications -- the very thing Pfizer was trying to do before being forced to abandon research on its drug, torcetrapib, over the weekend because of safety problems.

For consumers, the main fallout may be a delay in getting a new medicine that avoids Niaspan's chief side effect, a hot prickly sensation called flushing that patients hate but that can be minimized, doctors said.

Pfizer Inc. said Saturday it has cut off all clinical trials and development for a cholesterol drug that was supposed to be the star of its pipeline because of an unexpected number of deaths and cardiovascular problems in patients who used it.

The world's largest drugmaker said it was told Saturday that an independent board monitoring a study for torcetrapib, a drug that raises levels of HDL, or what's commonly known as good cholesterol, recommended that the work end because of "an imbalance of mortality and cardiovascular events."

The news is devastating to Pfizer, which had been counting on the drug to revitalize stagnant sales that have been hurt by numerous patent expirations on key products. It has said it was spending around $800 million to develop Torcetrapib.

While hopes remain high for Pfizer's new cholesterol drug, the pharma giant is ready to run a leaner operation and look beyond its own labs

At the start of Pfizer's (PFE) Nov. 30 meeting for Wall Street analysts, a crowd gathered around a poster about torcetrapib, the drug giant's experimental product to treat high cholesterol. Torcetrapib could be the crown jewel in Pfizer's pipeline—a newfangled treatment that simultaneously raises "good" cholesterol while lowering the "bad."

But recent trial results suggest it raises blood pressure in some patients, a side effect that could stifle the market potential of what was to be a blockbuster replacement for Pfizer's Lipitor, the world's top-selling drug, which is facing generic competition. "Have you identified what causes the increase in blood pressure?" asked an analyst of a Pfizer scientist. "No," came the simple reply.

Pfizer Inc. raised its 2006 earnings estimate and said the number of experimental products it has under development, including drugs for AIDS, obesity and cancer, jumped 60 percent since early this year.

Pfizer, the world's biggest drugmaker, increased its adjusted earnings estimate to at least $2.05 a share from a previous forecast of $2 a share, the New York-based company said today in a statement. There are 242 drugs in the pipeline, the statement said, an increase of 90 since February 2006.

Pfizer needs new products to replace revenue it will lose as patent protection runs out by 2011 on drugs that generated almost half of the company's $51 billion in sales last year. The best-selling Lipitor cholesterol drug, which accounts for $13 billion a year, will face generic competition in four years. New Chief Executive Officer Jeffrey Kindler is also expanding a plan to cut $4 billion in costs by 2008.

Two pharmaceutical drug distributors pleaded guilty Thursday to taking part in a $42 million conspiracy to illegally import and sell the cholesterol reduction drug Lipitor and other medicines.

Richard K. Rounsborg, 48, of Kearney, Neb., and Albert David Nassar, 51, of New York, each pleaded guilty to conspiracy.

U.S. Attorney Bradley Schlozman said they bought Lipitor intended for distribution in South America, then illegally imported it into the U.S. to sell at a lower cost than Lipitor made for the U.S.

The Lipitor bought and sold by the conspirators was not manufactured by Pfizer, which makes Lipitor for distribution in the U.S.

source - STL Today 

Pfizer Inc. may fall short in convincing federal regulators that its painkiller Celebrex should receive expanded approval to treat children with a devastating form of arthritis, according to documents released Tuesday.

Pfizer wants Food and Drug Administration approval to sell Celebrex as a treatment for juvenile rheumatoid arthritis, or JRA, which affects as many as 60,000 U.S. children. The disease causes painful joint swelling and can affect growth and development.

However, an FDA review of the New York company's application questions whether the drug works for the pediatric disease. The FDA approved the drug for use in adults with osteoarthritis and rheumatoid arthritis in 1998.

NEW YORK (CNNMoney.com) -- Pfizer said it would cut its U.S. sales force by 20 percent as part of an ongoing effort to reduce costs.

Pfizer (up $0.08 to $27.05, Charts), the world's biggest drug company, announced the impending job cuts in the form of a press release but did not say when the reductions would take place.

The job cuts, which will affect some 2,200 workers, are coming from all levels of Pfizer's sales organization - from senior management to field representatives, Pfizer spokesman Paul Fitzhenry told Reuters.

VANCOUVER, BRITISH COLUMBIA--(CCNMatthews - Nov. 28, 2006) - A major national research project, co-led by Drs. Bruce Carleton and Michael Hayden, to improve drug safety for children, today received a major contribution of $500,000 from Pfizer Canada Inc. The project, named Genotype-Specific Approaches to Therapy in Childhood (GATC), receives major funding from a Genome Canada/Genome BC-sponsored research program and is led from two research centres within the Child & Family Research Institute (CFRI) at BC Children's Hospital.

A failure of modern medicine is the debilitating and lethal consequences of adverse drug reactions (ADRs) which rank as one of the leading causes of death and illness in North America. Children are at a greater risk for severe ADRs, yet there remains a lack of understanding of their causes due in part to an inability to conduct pediatric patient studies of similar rigour and scope as in adult populations. The goal of GATC is to promote the health and well-being of Canadian children and of the global pediatric community by developing cost-effective interventions to reduce life-long disabilities and deaths caused by severe ADRs. The project will identify pediatric patients experiencing ADRs, collect DNA samples, apply genomics-based technologies to identify ADR-associated genetic markers and help predict and prevent drug toxicity.

WASHINGTON -- Despite Celebrex's well-documented link to higher heart risks, Pfizer Inc. wants permission to sell its painkiller to treat children as young as 2 who have arthritis.

Even as critics call for the drug to be removed from the market, Food and Drug Administration advisers will meet Wednesday to consider the company's request to expand Celebrex use.

Celebrex was the first of a class of new-style painkillers, called cox-2 inhibitors , approved in December 1998, and it is the last one to remain on the market. The drugs were designed to relieve pain without causing the stomach distress associated with other treatments, but they have been plagued by safety concerns. Merck & Co. pulled Vioxx from the market in 2004 after its studies showed the painkiller doubled the risk of heart attacks and strokes. Merck now faces more than 20,000 Vioxx lawsuits. Pfizer, under pressure from the FDA, last year halted sales of another cox-2 inhibitor, Bextra , because of heart risks and potentially fatal skin reactions.

The Government's health watchdog faces court action over its decision to deny tens of thousands of patients access to dementia drugs.

Companies involved in the marketing of one of the drugs said they had no option but to seek a judicial review of how the National Institute for Health and Clinical Excellence (Nice) reached its conclusions.

Nice rejected an appeal last month over its guidance that states that sufferers with early or late-stage Alzheimer's disease should not have access to Aricept (donepezil), Reminyl (galantamine) or Exelon (rivastigmine).

Celebrex - the only Vioxx-like drug still on drugstore shelves - could soon be sold specifically as a treatment for rheumatoid arthritis in children if the Food and Drug Administration approves a Pfizer request to do so.

The FDA has already approved Celebrex (celecoxib) to fight pain and inflammation but not specifically for use in children. Only 20 percent to 30 percent of FDA-approved drugs are specifically labeled for pediatric use.

But now Manhattan-based Pfizer is seeking FDA approval to market Celebrex specifically in children 2 years and older who have rheumatoid arthritis.