FDA cites bleeding risk with experimental J&J drug

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Posted on 17th March 2009 by Gordon Johnson in Uncategorized

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Date: 3/17/2009

By MATTHEW PERRONE
AP Business Writer

WASHINGTON (AP) — Federal health officials say a Johnson & Johnson drug helps prevent deadly blood clots in patients getting hip or knee replacement, but it also carries a risk of serious internal bleeding.

Johnson & Johnson and partner Bayer have asked the Food and Drug Administration to approve their once-daily pill, rivaroxaban, as an anticlotting drug to stop blood clots in legs and those that can travel to the lungs. More than 800,000 U.S. patients receive hip or knee replacements each year, and an estimated 40 to 60 percent are at risk of blood clots.

But FDA regulators said in documents posted online Tuesday that the drug carries nearly twice the risk of bleeding of Sanofi-Aventis’ Lovenox, the top-selling blood thinner used by patients receiving orthopedic implants.

On Thursday the agency will ask a panel of cardiology experts to weigh in on the drug’s risks and benefits. The FDA is not required to follow the advice of its panel, though it usually does.

After reviewing four studies with more than 12,000 patients, the FDA said major bleeding occurred in 0.4 percent of patients on the J&J; drug, compared with 0.2 percent of those taking Sanofi’s drug, known chemically as enoxaparin. The drug was Paris-based Sanofi’s biggest product last year, with sales of $3.5 billion.

“The evidence that administration of rivaroxaban could lead to bleeding events in significantly more patients relative to enoxaparin amplifies this safety concern,” states the FDA’s review, posted online Tuesday.

Regulators also voiced concerns about potential risks of liver injury or toxicity, a common side effect with blood-thinning drugs. Bayer and J&J; have proposed that the drug would be used for only two weeks by knee surgery patients and five weeks by hip surgery patients.

But the FDA is concerned doctors could use it for longer periods. The agency will ask its panelists whether there is enough information to gauge the risks of the drug over the long term.

The agency said it asked the companies to develop a lower-dose version of rivaroxaban that could be used by patients with liver or kidney problems. According to the agency, the companies “regarded this modification as unnecessary.”

But a J&J; spokesman said the company “is actively working with the FDA on this issue to assure the best balance of benefit and risk.”

The FDA also said the companies declined to design a risk minimization strategy for their drug, or a plan to help doctors and patients use the drug safely. But the company said it has submitted a number of plans to reduce the drug’s risks, including education and outreach programs.

The agency will have to weigh rivaroxaban’s risks against its promise as a lifesaving medication.

In four studies of knee and hip replacement patients, rivaroxaban cut the risk of blood clots or death in half, to 0.6 percent, compared with 1.3 percent for patients taking Lovenox.

Rivaroxaban is one of several new anticlotting drugs designed to be safer and more effective than older treatments. One mainstay of anticlotting treatment, Coumadin or warfarin, requires patients to undergo frequent blood tests because a too-high or too-low dose can lead to strokes or dangerous bleeding.

“If we look at our program, we believe we have a very effective drug with a very positive benefit risk profile,” J&J; Vice President Peter Wildgoose said in an interview last week.

J&J; is studying the drug in more than 60,000 patients for additional uses, including stroke prevention and treatment of coronary artery disease.

If the drug is approved, Johnson & Johnson’s Ortho-McNeil business will sell the drug in U.S., while Bayer HealthCare AG will have marketing rights in other countries.

Shares of New Brunswick, N.J.-based J&J; fell $1.18, or 2.3 percent, to $49.56 in morning trading.

Copyright 2009 The Associated Press.

FDA holds safety hearing on 50-year-old painkiller

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Posted on 30th January 2009 by Gordon Johnson in Uncategorized

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Date: 1/30/2009

By RICARDO ALONSO-ZALDIVAR
Associated Press Writer

WASHINGTON (AP) — Call it the cold case file of drug safety.

Federal health officials convened a public hearing Friday on whether to ban Darvon, a painkiller first approved in 1957, when there were few alternatives for treating pain except aspirin and powerful narcotics.

Now mainly marketed as Darvocet, which includes a dose of acetaminophen, the drug remains one of the top 25 most commonly prescribed medications. More than 20 million prescriptions were written in 2007.

The consumer group Public Citizen said the FDA should withdraw Darvon from the market because the drug offers relatively weak pain relief and poses an overdose risk, with the potential to be used in suicides.

“It has unique risks and no unique advantages,” said Dr. Sidney Wolfe, a drug safety expert with Public Citizen who first sought a ban in the 1970s. “It has been a big drug of abuse for quite a long time.”

Two companies that market the drug — Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals— say the medication is safe and effective when used as directed. In documents filed with the FDA, the companies say doctors need a range of options to treat pain, and note that many other painkillers have become drugs of abuse.

Dr. Jerry Avorn, a professor of medicine at Harvard and a critic of the pharmaceutical industry, is glad the FDA is taking a hard look at Darvon.

“I have been astonished at how widely used this drug is,” Avorn said. “It’s no longer the most abusable and most dangerous drug in its class, but the fact that there are worse drugs doesn’t make Darvon a good drug.”

The United Kingdom banned its version of Darvon in 2005. The FDA, however, may take a more cautious approach, such as requiring stiffer warnings, safety studies or special education efforts aimed at doctors and patients.

The FDA awaited recommendations Friday from a panel of independent advisers.

In an analysis prepared for the hearing, the FDA’s safety office said it had searched the agency’s database of reported drug problems, but the result was “insufficient” to allow reviewers to make a clear-cut recommendation. The safety office found more than 3,000 reports of serious problems. The top three were suicide, drug dependence and overdoses.

In a separate analysis, the FDA office that handles painkillers said Darvon is a weak pain reliever. Most studies show that in Darvocet, the widely used combination drug, the Darvon component appears to contribute “little or no” additional pain relief beyond that provided by the acetaminophen component, reviewers said.

Wolfe presented the advisory panel with new data from the government’s Drug Abuse Warning Network, which tracks emergency room visits and deaths. It showed that Darvon-related deaths rose to 503 in 2007, from 446 in 2006. In both years, about 20 percent were suicides. The network covers only about one-third of the U.S. population.

Data from the Florida’s medical examiner reporting system showed that in 2007 Darvon was present in the bodies of 341 people who died from drug-related causes. Medical examiners identified it as the cause of death in 85 of the cases, or 25 percent.

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On the Net:

FDA meeting agenda: http://tinyurl.com/cg5k5a

Copyright 2009 The Associated Press.

AstraZeneca 3Q profits up 29 percent

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Posted on 30th October 2008 by Gordon Johnson in Uncategorized

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10/30/2008

By JANE WARDELL
AP Business Writer

LONDON (AP) _ Pharmaceutical company AstraZeneca PLC posted a 29 percent rise in third quarter net profit on Thursday as strong sales in emerging markets like China helped offset flat demand for its products in the United States.

London-based AstraZeneca also lifted its full-year earnings forecast as it banked on the pharmaceutical industry being more resilient than other businesses to the global economic downturn — adding that it is on the lookout for acquisitions arising from the crisis.

Net profit was up to $1.73 billion in three months ended Sept. 30, from $1.34 billion in the same quarter a year ago.

Revenue rose 9 percent to $7.78 billion over the quarter, from $7.15 billion, despite what chief executive officer David Brennan termed an “increasingly challenging environment.”

Chief financial officer Simon Lowth said AstraZeneca had so far seen no impact on its business from the global financial turmoil.

“The pharmaceutical sector, we believe, will be more resilient to the downturn than other sectors,” Lowth told reporters on a conference call.

The company raised its full-year earnings per share target to between $4.90 and $5.05, citing improved gross margin and lower expenditures in research & development arising from efficiency improvements. It had previously forecast EPS of between $4.60 and $4.90 when it released its second quarter earnings in July.

The company said the new guidance is based on its original assumptions for currency values, which were average exchange rates during the fourth quarter 2007.

The company’s stock rose 5.2 percent to 2,550 pence ($41.08).

Lowth said the company had decided not to make further share repurchases this year — after total repurchases so far worth $603 million — to reserve firepower for potential acquisitions.

“We want to be ready if the flow of products … to bring into our pipeline and to market increases,” he said.

Lowth said the company was looking to acquire new compounds via product licensing and acquisitions, with a focus on core therapeutic areas.

He added that the company was in a good position to take advantage of opportunities, with its cash flow boosted to $5.95 billion in the nine months to Sept. 30, compared with $4.51 billion in 2007.

Outstanding debt, including loans, short-term borrowing and overdrafts, were at $13.37 billion at Sept. 30, of which $2.55 billion is due within one year. Lowth said the company would be able to pay that debt from its current cash balances and business cash flows, without the need to refinance.

He declined to elaborate on the size of a potential acquisition but said that AstraZeneca was committed to maintaining its credit ratings of AA-/A1.

Over the quarter, sales in the United States, where the company is facing tough generic competition to its products were unchanged as a $141 million decline in sales of Toprol-XL overshadowed 5 percent growth in the rest of the U.S. business. Lowth declined to make a prediction for U.S. sales in 2009.

Sales in the “Rest of the World” were up 6 percent, with a rise of 2 percent in established markets outshone by an 18 percent jump in emerging market sales. Sales in China alone soared 35 percent.

In terms of products, cholesterol drug Crestor was the top performer for the quarter, with sales worldwide up 28 percent to $922 million. U.S. sales of the drug were up 23 percent, fueled by its artherosclerosis label — the U.S. Food and Drug Association in November approved Crestor for a new use against an artery disease that can lead to heart attack and stroke.

Overall sales of Nexium, its heartburn drug, dropped 2 percent to $1.32 billion, while sales of Seroquel, its anti-psychotic drug, were up 4 percent at $1.13 billion.

AstraZeneca has had key wins this year against generic competition for both drugs. In April, it settled a patent lawsuit against Ranbaxy Laboratories Ltd., agreeing a deal that will delay the Indian company’s release of a generic version of Nexium. In July, a decision by a U.S. court to award a summary judgment in AstraZeneca’s favor avoided the need for a full trial and meant that generic copies of Seroquel will not be launched any time soon.

Among the company’s other top drugs, sales of asthma treatment Symbicort jumped 25 percent to $501 million, while sales of breast cancer treatment Arimidex rose 9 percent to $486 million.

Copyright 2008 The Associated Press.