Pfizer Inc said on Monday it has suspended chronic pain studies of its experimental drug tanezumab at the request of the U.S. Food and Drug Administration over safety concerns.

The move, which put the breaks on studies of the drug for low back pain and diabetic nerve pain, follows last month’s halt of tanezumab trials as a treatment for osteoarthritis after some patients taking the medicine experienced a worsening of their condition that required joint replacement surgery.

The FDA asked for a halt to the chronic pain trials over concern that other patients being studied for the different conditions could suffer similar adverse events, Pfizer said.

Testing of the drug that was once considered a highly promising addition to Pfizer’s developmental pipeline continues in some areas of high unmet medical need, including cancer pain, the world’s largest drugmaker said.

For studies on clinical hold, recruitment of new patients and dosing of existing patients are suspended, Pfizer said, adding that it will work with the FDA to determine “the appropriate scope of continued clinical investigation of tanezumab.

Tanezumab, which is administered by infusion every eight weeks and works by blocking a protein called nerve growth factor that is associated with pain, had the potential to become the first biotechnology drug specifically for pain. But its future is now clearly in doubt.

Prior to last month’s osteoarthritis trials halt, Pfizer had presented positive tanezumab data at a European medical meeting showing it significantly reduced knee pain better than a placebo.

Pfizer is trying to produce lucrative new drugs that can help replace lost revenue when its $12 billion a year cholesterol fighter Lipitor goes off patent late next year, but it has experienced numerous setbacks in those efforts.

Source: Reuters

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Firm aims to apply for six-month patent extension to existing SPC in relevant European countries.

The European regulatory authorities have approved a chewable formulation of Pfizer’s Lipitor for the treatment of familial hypercholesterolemia in children aged 10-17 years. The pediatric indication has also been sanctioned for the currently available tablet form of Lipitor. Approval of the drug for this younger patient population is based on data from a pediatric investigation plan Pfizer filed with the European Medicines Agency in November 2009.

The firm says the EU has created a number of incentives to help persuade companies to invest in clinical development of drugs for use in children. These incentives include the potential to prolong patent life by another six months by applying for an extension to an existing supplementary protection certificate (SPC). Pfizer confirmed it plans to apply for the six month patent extension in European countries where it has an SPC.

Lipitor has been approved in the U.S. for treating heterozygous familial hypercholesterolemia in 10-17-year-old children since 2002.

Source: GEN

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Yet another experimental drug heavily touted by Pfizer Inc. has foundered in advanced testing, raising worries about productivity problems at the world’s biggest drugmaker.

Safety problems with potential osteoarthritis treatment tanezumab, quietly disclosed Wednesday evening, on Thursday triggered a drop in Pfizer shares and a burst of notes to investors from analysts concerned about the trend.

“This is the second negative for (Pfizer) this week,” after the company pulled a cancer drug off the market, Miller Tabak & Co. analyst Les Funtleyder wrote. “We continue to have reservations about (the company’s) R&D capabilities and this announcement only confirms those.”

That’s after a highly anticipated Alzheimer’s drug flamed out in March, a failure doctors called a big setback because many hoped it might be the first treatment to stop or reverse the mind-robbing disease.

This Monday, New-York Pfizer said it was pulling bone cancer drug Mylotarg off the market 10 years after it got accelerated U.S. approval, because recent research found the drug increased chances of dying in patients also getting chemotherapy.

Late Wednesday _ at the urging of the Food and Drug Administration _ Pfizer said it was immediately suspending worldwide testing of tanezumab in patients with osteoarthritis, a common condition in which the cartilage lining joints deteriorates. Pfizer cited “a small number of reports” of patients who received the injected pain treatment having their osteoarthritis worsen, leading to joint replacement.

Just last week, two small companies developing other pain drugs in collaboration with Pfizer announced a total of three drugs, for osteoarthritis or rheumatoid arthritis, weren’t reducing pain as much as expected.

That all adds up to significant potential pain for Pfizer shareholders, who also have seen five late-stage studies of different cancer drugs fail in the last 18 months. In addition, Pfizer has sharply reduced its prized dividend, to help pay for its $68 billion acquisition of Wyeth last October.

On Thursday, Pfizer shares fell more than 3 percent, closing down 40 cents at $14.48, a big swing for a company with $68 billion in revenue.

“Biomedical R&D is one of the riskiest and most challenging businesses in the world,” said Pfizer spokesman Ray Kerins. “While our latest announcements demonstrate the risks and difficulties inherent in working with complex diseases, our pipeline demonstrates our ongoing commitment to focus on high-priority disease areas where there is significant unmet medical need.”

In this year’s biggest disappointment, Alzheimer’s treatment Dimebon, which Pfizer and partner Medivation Inc. were developing, failed to work in a late-stage study. That was after it had kept patient symptoms such as trouble with thinking and daily function from worsening for a year in a prior study.

Pfizer is continuing two other studies of Dimebon, one in combination with other Alzheimer’s drugs and taken for a longer period, and one in patients with Huntington’s disease, so it might still salvage the drug.

Likewise, Pfizer said it is still testing tanezumab in 17 studies for pain due to conditions other than osteoarthritis, including cancer and lower back pain, nerve pain related to diabetes and interstitial cystitis, a chronic bladder inflammation. The company is to discuss the future of those studies soon with FDA officials.

UBS Securities analyst Marc Goodman said he was reducing his sales forecast for tanezumab from $325 million to $200 million in 2015.

“We wouldn’t be surprised if we eventually have to remove all sales,” Goodman wrote.

Leerink Swann analyst Seamus Fernandez did exactly that, eliminating the $525 million in sales he expected in 2016.

He called the tanezumab news “yet another” late-stage pipeline failure and further evidence of Pfizer’s “R&D productivity challenges.”

Since acquiring Wyeth, Pfizer has significantly pruned their combined research portfolio, eliminating many programs no longer considered priority areas or where early results didn’t justify large, very expensive studies in patients.

Now Pfizer desperately needs some research successes, given that its $11.5 billion a year cholesterol blockbuster Lipitor will see sales plummet when it starts getting generic competition at the end of 2011. Sales are already down from Lipitor’s $13 billion peak because insurers and cash-strapped patients are turning to generic versions of similar drugs.

Meanwhile, at least eight other Pfizer drugs that are big sellers with high profit margins also will face generic competition in the next few years, BernsteinResearch analyst Tim Anderson notes.

Pfizer has just over 25 prescription drugs with enough revenue to report their individual sales. The company also gets well over $11 billion a year in revenue from many drugs with lower sales and from partnerships with other companies, plus several billion a year from sales of animal health, consumer health and other products.

Pfizer now spends roughly $9 billion a year on research and development, according to Anderson. That’s about 13 percent of its annual revenue.

“Investors should expect _ and demand _ that a certain level of pipeline progress will be made,” he wrote.

Updates 20th paragraph to add detail on number of prescription drugs and other revenue sources.

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Pfizer is in trouble today with the announcement that the FDA has sent it warning letter citing the pharma giant for dragging its heels on reporting side effects associated with several currently marketed drugs.

In a scathing, 12-page letter, the agency says Pfizer has sat on side effect data going back as far as 2004 on several of products, including Viagra, Lipitor and Lyrica. It also scolds the company for neglecting to tell the agency about missing samples, some of which may have been stolen. The May 26 warning was issued in response to a six-week audit of Pfizer’s New York headquarters last summer, Pharmalot reports.

In one instance, Pfizer failed to report cases of visual problems within the required deadline that might have been related to Viagra “by misclassifying and/or downgrading reports to non-serious without reasonable justification,” the agency says. Pfizer faces litigation over Viagra and visual side effects, as Pharmalot notes.

The agency requested an immediate meeting and asked for the problems to be fixed within 15 days, or an explanation provided if it would take longer, Reuters reports. Pfizer also must submit a revised plan to fix the problems.

The drugmaker has issued a statment in its defense, saying it provides “complete and accurate data” to determine the benefits and risks of its drugs, although that’s not the same thing as saying all adverse events are reported on time. The drugmaker then promised to ” assure optimal surveillance and reporting of post-marketing adverse events…We are committed to full compliance and timely and accurate submission of individual adverse event reports.”

Source: FiercePharma

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The U.S. Food and Drug Administration has warned Pfizer Inc for failing to quickly report serious and unexpected potential side effects from its drugs already on the market.

In a 12-page warning letter to Pfizer Chief Executive Jeffrey Kindler, the FDA cited numerous examples involving some of the company’s top-known brands, including impotence drug Viagra, cholesterol pill Lipitor and seizure medicine Lyrica.

The delays in reporting side effects date back as far as 2004 and have grown in recent years, according to the FDA’s letter that was released by Pfizer on Wednesday.

Ronald Pace, director of the FDA’s New York office, told Pfizer in the letter dated May 26 that it had not properly documented or investigated reported problems in patients after the drugs were approved for use.

“FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated,” Pace wrote.

Pace asked Kindler to arrange a meeting between the company and the agency over the violations. Pfizer said it received the letter June 3.

The FDA conducted a 6-week inspection of Pfizer’s New York headquarters in July and August of 2009, where agency inspectors found system-wide lapses at the world’s largest drugmaker.

The patient reports “contained serious and unexpected adverse events… that were not submitted until they were identified during the FDA inspection,” Pace wrote. Efforts to fix the problem “have been shown to be ineffective,” he added.

In a statement, Pfizer said it would work with the FDA to satisfy the agency “and to assure optimal surveillance and reporting of post-marketing adverse events.”

But it also said that such individual reports are just one part of its overall monitoring of the drugs it sells and that it “believes we provide complete and accurate data to determine the benefit and risk profile for all of our medicines, and to enable their safe and appropriate use.”

In its letter, the FDA cited multiple examples of reporting lapses.

For example, while Viagra and similar medications are known to cause serious visual problems, including blindness, Pfizer failed to report cases related to its drug within the agency’s 15-day deadline “by misclassifying and/or downgrading reports to non-serious without reasonable justification.”

And with Pfizer’s now withdrawn painkiller Bextra, FDA granted the company a waiver allowing 60 days to forward any complaints, a window of time the drugmaker still missed.

The FDA said Pfizer initially blamed the problems on a new computerized system to handle the reports, saying staff were not properly trained. In a September 2009 response to the agency, Pfizer told the agency it would update user manuals, better train its staff in the computerized reporting system and take other action.

Despite those steps, the FDA said in its letter that the company’s actions were “inadequate.”

Pfizer told the FDA that its reporting improved after May 2009, but did not include any data backing up that claim, the FDA said. Additionally, the company did not prove to the FDA that it trained all the employees it said it would.

According to the FDA, the company’s delays in telling the agency about reported complaints have only grown. About 4 percent of Pfizer’s 80,560 reports were sent late from March 2006 through December 2008 compared with 9 percent from December 2008 to June 2009, the letter said.

Additionally, the FDA cited Pfizer for not immediately telling the FDA about thefts and significant losses of its medications.

FDA’s Pace requested an immediate meeting and asked for the problems to be fixed within 15 days, or an explanation provided if it would take longer. He also called for Pfizer to submit a revised plan to fix the problems.

Failure to fix the problems could result in legal action without notice and the FDA could delay action in approving the company’s pending drugs, among other penalties, Pace said in the letter.

Source: Reuters

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Top Pfizer Inc research executive Martin Mackay has left the world’s biggest drugmaker to head research at rival AstraZeneca Plc as both companies brace for patent expirations on their top-selling medications.

Pfizer will consolidate its research and development under Mikael Dolsten, who had worked with Mackay as co-head of research and development since October in a split of duties created from the company’s $67 billion merger with Wyeth.

Pfizer is betting on drugs from Wyeth, where Dolsten served as research head, to help it endure plunging sales of its Lipitor cholesterol fighter when the world’s top-selling drug faces generic rivals late next year.

Pfizer said Mackay, a soft-spoken and personable native of Scotland, had resigned and left the company “immediately.” He will take on the new role of president of R&D at London-based AstraZeneca on July 1.

Mackay had been the company’s global research chief for two years and, after the Wyeth merger, led PharmaTherapeutics research at Pfizer, involving conventional drugs made from chemicals. Dolsten oversaw research of BioTherapeutics, biotech drugs made from complex proteins grown in living cells.

“That structure was unusual,” Leerink Swann analyst Seamus Fernandez said. “It struck me as potentially a vetting period for Dolsten,” to better assess his leadership skills.

Morningstar analyst Damien Conover said Dolsten is not well known by Wall Street and will be under pressure to galvanize Pfizer’s underperforming laboratories.

Wyeth brought Pfizer currently marketed biotech drugs, such as blockbuster arthritis drug Enbrel, but did not greatly remedy Pfizer’s dearth of drugs in late-stage testing.

“So Dolsten has a pipeline that is not as strong as it needs to be to offset Lipitor’s patent loss,” Conover said. He noted, however, that Pfizer is developing treatments for Alzheimer’s disease, arthritis and blood clots that have blockbuster sales potential should they eventually be approved.

Shares of Pfizer were up 1.5 percent to $15.29, while AstraZeneca fell 0.8 percent, both in afternoon trading on the New York Stock Exchange.

R&D PEDIGREE

Dolsten has a medical degree from the University of Lund in Sweden and led drug research for Germany’s Boehringer Ingelheim before joining Wyeth. He also had senior roles with other drugmakers, including AstraZeneca and Pharmacia & Upjohn.

“Anyone in leadership in R&D at Boerhinger Ingelheim, which has been an incredibly productive R&D organization over the last several years, should probably be viewed reasonably positively,” Fernandez said.

Pfizer itself has produced few big drugs since introducing anti-impotence pill Viagra in 1998, despite its later acquisitions of U.S. rivals Warner-Lambert and Pharmacia and an industry-topping annual $8 billion research budget.

“The Wyeth deal buys Pfizer a little more time after Lipitor’s patent expires, but the company really needs to start kicking out some new drugs,” said Miller Tabak analyst Les Funtleyder. “Otherwise, it will have to change direction, and move deeper into related areas of healthcare such as generics or consumer products.”

For its part, AstraZeneca separated the two stages of R&D by having a head of drug discovery and a head of drug development, leaving some investors uncertain about its focus.

Mackay’s appointment brings the two roles together as the company overhauls R&D to prepare for patent expiries on top drugs like Nexium, for acid reflux, and Seroquel, for schizophrenia.

AstraZeneca spokesman Neil McCrae said a unified head of R&D would speed up decision-making and help allocate resources between different projects at a time of major change.

“We set out our strategy for R&D in January, which calls for some significant changes as we seek to improve the productivity of our pipeline,” he said. “In addition, since the acquisition of MedImmune, it has become clear that we need a single point of accountability to manage the entire R&D portfolio.”

Mackay has extensive experience working on both sides of the Atlantic. Prior to joining Pfizer in 1995, he focused on research into central nervous system diseases at Ciba-Geigy, now part of Novartis AG. (Reporting by Ben Hirschler and Ransdell Pierson; additional reporting by Lewis Krauskopf; editing by Michele Gershberg and Gerald E. McCormick).

Source: FOREXPROS.com

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People using cholesterol-lowering statins have a higher risks of liver dysfunction, kidney failure, muscle weakness and cataracts and such side effects of the drug should be closely tracked, doctors said on Friday.

In a study covering more than 2 million people in Britain, researchers from Nottingham University found that adverse side effects of statins, which are prescribed to people with high levels cholesterol to cut the risk of heart disease, were generally worst in the first year of treatment.

The findings, published in the British Medical Journal, are unlikely to affect the use of best-selling medicines like Pfizer’s Lipitor and AstraZeneca’s Crestor, but the study’s authors said patients taking statins should be “proactively monitored” for side effects.

“Our study is likely to be useful for policy and planning purposes,” said Julia Hippisley-Cox and Carol Coupland, the two professors who led the study. They said it may also be useful “for informing guidelines on the type and dose of statins.”

Statins are among the most successful drugs of all time and have been credited with preventing millions of heart attacks and strokes. Heart disease is the biggest killer of men and women in the rich world and is also a growing health problem in developing nations.

In a commentary on the study, senior cardiologists Alawi Alsheikh-Al, of the Sheikh Khalifa Medical City in the United Arab Emirates, and Richard Karas of the Tufts University School of Medicine in the United States, said that, like any medical treatment, statins are not completely risk free, but that when used properly, their benefits outweigh their risks.

“It would be wise to interpret the present observations in the context of the confirmed cardioprotective effects of statins and remind ourselves and our patients that these drugs, although considered safe, are, like any intervention in medicine, not entirely free of adverse events,” they wrote.

Coupland and Hippisley-Cox studied data from 368 general practices on 2,004,692 patients aged 30-84 years including 225,922 patients who were new statin users and had been prescribed a range of statins.

They found that for every 10,000 high risk women treated with statins, the positive impact would be around 271 fewer cases of heart disease and 8 fewer cases of oesophageal cancer.

On the other side, there would also be 74 extra patients with liver dysfunction, 23 extra patients with acute renal failure, 307 with cataracts and 39 with a muscle weakness condition called myopathy.

Similar figures were found for men except rates of myopathy were higher, they said. They noted that some of the effects might be due to better detection rates since patients taking statins are likely to consult their doctors more often.

The adverse effects were similar for all different types of statins, except for liver dysfunction, where the highest risks were found for fluvastatin, which is sold by Novartis under the brand names Lescol and Lochol.

“All of the increased risks persisted during the treatment, but were highest in the first year,” they wrote.

Source: Reuters

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The AARP says that manufacturer prices for brand-name prescription drugs commonly used by people on Medicare rose 9.7% for the year ending in March — the biggest annual jump since the group started tracking prices in 2002. The price of specialty drugs like biologics and injectables rose 9.2%. Generic drug prices, meantime, dropped 9.7%. (All this happened while general inflation hovered around 0.3%.)

The report found that all of the top 25 brand-name prescription drugs had higher prices in the last year. Here’s a list of the top 10, with manufacturer and percent change in manufacturer’s price:

1. Nexium – AstraZeneca – 7.4%
2. Plavix – Bristol-Myers Squibb – 10.5%
3. Prevacid – Takeda – 8.1%
4. Protonix – Wyeth – 9.3%
5. Lipitor (20mg) – Pfizer – 5.5%
6. Lipitor (10mg) – Pfizer – 5.5%
7. Aricept – Eisai – 13.9%
8. Fosamax – Merck – 6.7%
9. Norvasc — Pfizer — 5.0%
10. Advair — GlaxoSmithKline — 7.0%

Industry group PhRMA said in a statement that the report was “misleading” because it doesn’t account for “discounts and rebates generally negotiated between drug manufacturers and payers, which can significantly lower the cost of brand-name medicines, ultimately benefiting patients.” The group also said prescription drugs “represent a small and decreasing share of growth in overall health care costs in the U.S.”

This follows a report last month from pharmacy-benefit manager Express Scripts saying brand-name drugs registered a 9.1% price increase last year, with an 11.5% jump for specialty drugs. An Express Scripts exec told the WSJ then that the increases “were exacerbated by the health care reform debate.” Health-care overhaul legislation includes higher rebates manufacturers must pay to Medicaid. Drug makers disputed that notion, the WSJ reported.

Source: The Wall Street Journal

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It’s been nearly three and a half years since Pfizer abruptly pulled the plug on its $800 million effort to develop torcetrapib after the HDL-cholesterol raising drug was linked to a higher risk of death in a 15,000-patient study.

The disastrous outcome contributed to Pfizer’s stunning decision in September 2008 to sharply curtail early-stage research for drugs for cardiovascular disease, a franchise the company has owned for more than a decade with the blockbuster statin Lipitor and the blood pressure pill Norvasc (now generic).

Rival Merck has been bragging ever since about how it’s staying the course to find new heart medicines. Today at its R&D meeting with Wall Street analysts, the company put an exclamation point on that stance, highlighting a cardiovascular pipeline with six molecules in late-stage development. Among them: anacetrapib — a molecular cousin to torcetrapib designed to raise good cholesterol.

Luciano Rossetti, Merck’s senior VP for global scientific strategy, told analysts the company plans to launch a major clinical trial in 2011 to determine whether adding anacetrapib to a statin reduces the risk of death and heart attacks. That’s the same type of study that tripped up torcetrapib.

Rossetti says company research indicates anacetrapib doesn’t affect blood pressure or levels of the hormone aldosterone. Torcetrapib increased both, an effect that some experts believe may have doomed the drug.

The failure of torcetrapib was also a setback to Merck’s anacetrapib effort, requiring additional studies to provide assurance that it was safe to test the drug in thousands of patients. It will take several more years to find the answer. If all goes well, and there’s no assurance that it will, the company projects filing for approval sometime after 2015.

Source: The Wall Street Journal

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A way of fighting heart disease being pioneered by GlaxoSmithKline a boost today from a scientific study that appears in The Lancet stressed the significance of an artery-clogging enzyme. The study suggests that the enzyme, Lp-PLA2, plays as much of a role in the risk of heart disease as high blood pressure and bad cholesterol.

“Lp-PLA2 activity and mass each show continuous associations with risk of coronary heart disease, similar in magnitude to that with non-HDL cholesterol or systolic blood pressure in this population,” according to the study abstract. The researchers evaluated individual records from 79,036 participants in 32 prospective studies and did a meta-analysis of within-study regressions. Alex Thompson and John Danesh of Cambridge University, who conducted the research, said their findings would sharpen focus on an experimental drug called darapladib being developed by GSK and currently being studied in two large-scale clinical trials involving 27,000 patients worldwide, Reuters reports. Results of the trials are expected between 2012 and 2014.

“We’ve demonstrated that there is this positive association between Lp-PLA2 levels and vascular and nonvascular outcomes,” lead researcher Thompson told heartwire, “but what an observational study can’t do is establish causality. Given all the complexities about disentangling the effects of a measured level of an enzyme in the blood, given that it is carried around and is physically bound to apolipoprotein B on LDL, it is extremely difficult to do. To get that level of evidence, we are going to need randomized, clinical trials.”

“This BHF-funded research shows that Lp-PLA2, an enzyme that’s produced by inflammatory cells involved in the development of artery disease, appears to play a significant role in the progression of that disease,” Professor Peter Weissberg, medical director at the British Heart Foundation, says in a statement. “The acid test will then be to find out if such drugs reduce the risk of heart attacks and strokes in large clinical trials. It will be some time yet before we have the answers.”

GSK discovered darapladib through the use of gene technology from Human Genome Sciences. It is the first in a new class of drugs targeting Lp-PLA2 and is designed to offer something beyond the hugely successful class of cholesterol-lowering statin drugs like Pfizer’ Lipitor and AstraZeneca’s Crestor.

Source: FierceBiotech

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