Showing posts with label Pfizer. Show all posts
Showing posts with label Pfizer. Show all posts

Children overdosed during Pfizer drug study


In the article titled “Pharmaceutical injury alert: FDA slams Pfizer with warnings for deadly clinical trials,” posted on April 23, 2010, it was incorrectly reported that participants of a drug trial died. Twenty-six pediatric patients received overdoses of a psychiatric drug in 2006, and three more overdoses occurred in 2007; the overdoses did not result in any fatalities.

The U.S. Food and Drug Administration (FDA) issued Pfizer a warning letter, stating they have failed to rectify its testing procedures, which resulted in overdoses in over two-dozen patients during a company trial of Geodon. Several children experienced tremors, restless legs and other complications as a result of the overdoses, as reported by Reuters.

The letter, which was released on Tuesday, April 20, 2010, states that Pfizer was not properly monitoring physicians who were testing the experimental medication. Pfizer said in a statement that only 10 of the overdoses were caused by physician error, and the rest were probably because of patient error.

A new warning letter was prompted after a July 2009 inspection found that the drug maker was still failing to follow its own rules for safely conducting a study. A Pfizer spokeswoman pointed out, “Pfizer has communicated with the FDA about our conduct of clinical trials and, over the next two weeks, will provide an outline of new and existing processes for preventing similar issues with Pfizer clinical trials.”



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Pfizer liver cancer trial halted on safety concern


Pfizer Inc said on Thursday it has discontinued a late stage liver cancer study of its drug Sutent because of high incidence of serious adverse events suffered by patients taking the medicine.
Following a review by the independent Data Monitoring Committee the trial was halted over safety issues, Pfizer said.

Sutent is already approved to treat advanced kidney cancer and gastrointestinal stromal tumors following disease progression and had worldwide sales of $964 million in 2009.

Pfizer is testing Sutent against a wide range of cancers in hopes of significantly expanding sales of the drug.

The liver cancer failure represents the latest in a long list of clinical setbacks for the world's largest drugmaker, including a Sutent failure in a late stage advanced breast cancer study announced last month.

The company has been widely criticized by analysts for its inability to deliver products based on its own research despite the industry's largest research and development budget.

The company last year acquired Wyeth for $67 billion in large part to gain that company's promising portfolio of drugs in development.

The halted open label trial tested Sutent against Nexavar, a liver cancer drug sold by Bayer AG and Onyx Pharmaceuticals Inc .

Safety monitors found higher incidence of serious side effects in patients taking Sutent, known chemically as sunitinib, compared with those who received Nexavar.

Sutent also failed to demonstrate that it was either superior or non-inferior to Nexavar in extending the survival of liver cancer patients, the company said.

"The disappointing outcome of this trial challenges all of us to work harder to understand the complex biology of this disease," Mace Rothenberg, head of clinical development for Pfizer's oncology unit, said in a statement.

Pfizer is still testing the drug against non-small cell lung cancer, prostate cancer and for kidney cancer following surgery.


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Pfizer oral drug may shake up arthritis market

An experimental oral drug from Pfizer could shake up the rheumatoid arthritis market, after impressive results were presented at a medical meeting in Denmark this week.

The drug, known only by the code CP-690,550, is likely to prove a cheaper and more convenient alternative to costly anti-TNF biotech treatments, which have led the field in the past decade, medical experts and industry analysts said.

"The next wave of drugs will be oral. I think what companies are trying to develop are oral agents that can be at least as effective or almost as effective as an anti-TNF," said lead investigator Roy Fleischmann of University of Texas, Dallas.

"Having a compound that is more convenient and cheaper, with a similar risk-benefit ratio to a more expensive biologic, is very important, particularly in these tough economic times," he told Reuters in a telephone interview.

Data presented by Fleischmann at the European League Against Rheumatism meeting in Copenhagen showed that three-quarters of patients had at least a 20 percent improvement in their condition after 12 weeks of treatment with the new drug. A quarter of them experienced a 70 percent improvement.

That was a better result than for patients given Abbott Laboratories's anti-TNF drug Humira, known chemically as adalimumab, although the nature of the mid-stage clinical trial meant it was not possible to make a direct comparison.

In the 384-patient Phase II study, the drugs were given as monotherapy and Humira is known to produce better results when combined with the older drug methotrexate, Fleischmann noted.

"Adalimumab obviously works better with methorexate. JAK (Pfizer's drug) may not need methotrexate," he said.

Some results with the new drug were released on June 9, with more details outlined at the conference on Thursday.

Pfizer's new drug is a potential competitor not only for Humira, which sold $4.5 billion last year, but also Johnson & Johnson and Schering-Plough's Remicade, Amgen and Wyeth's Enbrel, and UCB's Cimzia.

Richard Parkes, a research analyst at Piper Jaffray, said the threat from orally administered medicines was increasing and their profile had been raised by the "compelling" Pfizer data.

"This and other oral RA (rheumatoid arthritis) drugs currently in Phase II development from Incyte and Rigel represent an increasing long-term threat," he said.

CP-690,550, which is given twice daily, is a so-called JAK-3 inhibitor that works by blocking enzymes involved in inflammatory and autoimmune diseases.

The most common adverse events were mild to moderate urinary tract infection, diarrhoea, bronchitis and headaches. There were also significant dose-dependent decreases in white blood cells and increases cholesterol, which Fleischmann said were "manageable".

Pfizer started a large final-stage Phase III clinical programme with CP-690,550 February. It is also studying the drug as a potential treatment for other autoimmune diseases, including psoriasis and inflammatory bowel disease, and for the prevention of organ rejection following transplant.

Source : www.reuters.com


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Pfizer drug effective in rheumatoid arthritis study

An experimental oral rheumatoid arthritis drug being developed by Pfizer Inc was significantly more effective than a placebo in a mid-stage clinical trial, according to data to be presented at a medical meeting in Denmark on Thursday.

The drug, given twice daily, was tested at strengths of 3 milligrams, 5 mg, 10 mg and 15 mg and demonstrated a statistically significant response at all doses compared with a placebo, the company said.

Data from a 12-week interim analysis of the six-month study of the drug, CP-690,550, has been used to help select the 5 mg and 10 mg doses for larger Phase III clinical trials, Pfizer said. Phase III is typically the final stage of testing before a new drug is submitted to the U.S. Food and Drug Administration for an approval decision.

The primary goal of the study was an ACR 20 response rate, defined as 20 percent improvement in tender and swollen joints.

At the two highest doses, 75.4 percent of patients achieved ACR 20 response rates compared with 28.8 percent of those in the placebo group. The ACR 20 response was 49 percent at 3 mg and 63.3 percent at 5 mg, according to data to be presented at the European League Against Rheumatism meeting in Copenhagen.

The differences in response rates were seen as early as two weeks into the study, researchers said.

The study involved 384 patients with active rheumatoid arthritis, who had not responded to treatment with another anti-rheumatic drug, such as methotrexate.

CP-690,550 is a so-called JAK-3 inhibitor that works by blocking enzymes involved in inflammatory and autoimmune diseases.

In addition to the ACR 20 primary goal, there were statistically significant ACR 50 responses -- 50 percent improvement -- for the drug at 5 mg, 10 mg and 15 mg, and ACR 70 responses at the two highest doses, compared with placebo, researchers said.

The most common adverse events were mild to moderate urinary tract infection, diarrhea, bronchitis and headaches.

Significant dose-dependent decreases in white blood cells and increases in both good and bad cholesterol were consistent with previous studies of CP-690,550, Pfizer said.

Source : www.reuters.com


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Fablyn Approved in Europe for the Treatment of Osteoporosis

Ligand Pharmaceuticals Incorporated today announced that its partner, Pfizer, Inc. has received approval from the European Commission(EC) for FABLYN® (lasofoxifene) Tablets, a selective estrogen receptor modulator (SERM) for the treatment of osteoporosis in post-menopausal women at increased risk of fracture. FABLYN was submitted for approval in Europe in January 2008. This is the first regulatory approval for FABLYN, a product that stems from a 1991 research collaboration with Ligand.

As a result of the first approval of FABLYN in a major market, Ligand has earned a $3 million milestone payment. Pursuant to the 1991 research agreement and 1996 settlement agreement with Pfizer, Pfizer has elected to pay the milestone payment by returning 323,338 shares of stock it owns in Ligand. The shares are valued as of the date of the settlement agreement adjusted for Ligand's 2007 return of capital paid to Ligand shareholders. After the payment of this milestone, Pfizer owns a remaining 674,230 shares in Ligand.

Pfizer is responsible for the registration and worldwide marketing of FABLYN. Ligand is entitled to receive royalty payments on net sales of the product. In January 2009, Pfizer received a complete response letter from the FDA requesting additional information for FABLYN. On September 8, 2008, the FDA's Advisory Committee for Reproductive Health Drugs voted 9-3 (with one abstention) that there is a population of postmenopausal women with osteoporosis in which the benefits of lasofoxifene likely outweigh the risks. FDA is not required to follow the advice of the panel.

“Today's announcement is an exciting development for Ligand as the European approval of FABLYN marks the fourth drug associated with Ligand's research platform that has been approved and the second to be approved in just the past six months. This milestone payment reduces Ligand's outstanding shares and paves the way for potential future royalty payments and cash flow following the launch of the product,” said John L. Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals. “We applaud Pfizer for its commitment and diligence in advancing the product to approval and developing an alternative treatment option for patients in Europe with osteoporosis.”

Osteoporosis Prevalence

The International Osteoporosis Foundation (IOF) reports that more than 75 million people suffer from osteoporosis in Europe, Japan and the U.S. About 30% of all post-menopausal women have osteoporosis in Europe and in the U.S., and at least 40% of them will suffer osteoporotic fractures in their lifetime. In Europe alone, 3.78 million osteoporosis-related fractures were reported in 2000, with an estimated cost of 32 billion euros. In the U.S., the National Osteoporosis Foundation projects an estimated 10 million American women to have osteoporosis in 2010 and almost 26 million to have osteopenia (low-bone mass), placing them at increased risk of osteoporosis.

About Ligand Pharmaceuticals

Ligand discovers and develops new drugs that address critical unmet medical needs of patients with muscle wasting, frailty, hormone-related diseases, osteoporosis, inflammatory diseases, anemia, asthma, rheumatoid arthritis and psoriasis. Ligand's proprietary drug discovery and development programs are based on advanced cell-based assays, gene-expression tools, ultra-high throughput screening and one of the world's largest combinatorial chemical libraries. Ligand has strategic alliances with major pharmaceutical and biotechnology companies, including Bristol-Myers Squibb, Celgene, Cephalon, GlaxoSmithKline, Schering-Plough, Pfizer and Wyeth Pharmaceuticals. With nine pharmaceutical deals and more than twenty different molecules in various stages of development, Ligand utilizes proprietary technologies for identifying drugs with novel receptor and enzyme drug targets.

Caution Regarding Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These statements include those regarding timing and results of clinical data for FABLYN and other drug candidates, data analysis and evaluation of FABLYN, utility or potential benefits to patients, the potential commercial market for FABLYN and plans for continued development and further studies of FABLYN. Actual events or results may differ from Ligand's expectations. For example, there can be no assurance that other trials or evaluations of FABLYN or other SERM-related product candidates will be favorable or that they will confirm results of previous studies, that data evaluation will be completed or demonstrate any hypothesis or endpoint, that FABLYN or other SERM-related product candidates will provide utility or benefits to certain patients, that any presentations will be favorably received, that FABLYN or other SERM-related product candidates will be useful as a single agent or in combination with other drugs, that marketing applications will be filed or, if filed, approved, or that clinical or commercial development of these product candidates will be initiated, completed or successful or that our rights to FABLYN and other SERM-related product candidates will not be successfully challenged. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in public periodic filings with the Securities and Exchange Commission, available via www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Source : http://www.drugs.com/


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