Vioxx

Merck wins the 'silver' for worst news week

Mon, 05 May 2008 06:59:58 -0400

WBB Securities analyst Steve Brozak has issued a symbolic "silver medal" to Merck for worst news week. In a triple whammy rarely accomplished in the drug world, Merck had two experimental therapies rejected and earned a black eye for the FDA's rebuke on problems at its main vaccine plant. Merck even had to extend its settlement deal on Vioxx. As the AP notes, Merck earned the gold medal for bad news back in 2004, when it pulled Vioxx off the market and triggered a frenzy of lawsuits alleging the drug giant had cavalierly disregarded signs that the drug presented a real danger to patients.

It was only a few weeks ago that Merck was being applauded for a string of new drug approvals and an aggressive restructuring plan. And analysts are betting that bout of positive breakthroughs will get the company through the current Olympic trials for major corporate pain.

- check out the AP report

ALSO NOTED: US Oncology's CFO retires; Profits rise at Novartis, Merck, Lilly; and much more...

Mon, 21 Apr 2008 06:59:50 -0400

> US Oncology's CFO Rick McCook is resigning to explore opportunities in a retail or manufacturing business. Release

> Good financial results from three Pharma biggies should cheer up those market-watchers who moaned their way through much of last week. Sure, a couple of the profit leaps came at least in part from one-time gains. But increases are always better than the alternative. Report

> Seeking Alpha profiles Synta's metastatic melanoma therapy Elesclomol. Report

> Last week, we reported on Big Pharma's march on the capital in support of new off-label marketing rules. Now, opponents of those rules are drawing on another of last week's news events for support: the Vioxx ghostwriting story. Report

> A Roche distributor tattled to India's Drug Controller General, accusing Cipla of promoting its generic version of a Roche drug for an unapproved use. Report

And Finally... Higher food prices and grain shortages are changing attitudes toward biotech crops. Report

ALSO NOTED: Isotechnika reports psoriasis success; Romark enrolls hep C patients; and much more...

Fri, 18 Apr 2008 06:59:50 -0400

> Isotechnika's ISA247 has demonstrated significant efficacy against psoriasis. Report

> Romark Laboratories has begun enrolling patients in a U.S. clinical trial to evaluate nitazoxanide for the treatment of chronic hepatitis C. Preliminary data from the study is expected in the second half of 2008. Release

> It was inevitable: All the chit-chat about drug safety and the FDA's shortcomings had to result in legislation. Rep. John Dingell's House Energy and Commerce Committee released a "discussion draft" yesterday, planning to convene hearings over the next few weeks and draw up the real bill after that. Report

> Pfizer shares hit a 10-year low yesterday. And who can blame investors who sold, considering the Eeyore tone Wall Street analysts took after the drugmaker announced its falling sales and earnings? Report

> Call it the backlash against the backlash. In the wake of the recent Vytorin and Vioxx marketing scandals, drugmakers are banding together to prevent a Congressional crackdown on their power to promote. Report

And Finally… Researchers at Purdue say they're on to a new bird flu vaccine that offers broader protection over a longer period of time. Article

Risk averse? Not us, says top FDA official

Wed, 26 Mar 2008 07:59:58 -0400

Is a rising tide of risk aversion at a post-Vioxx FDA behind the agency's anemic approval record? No way, say the FDA's Janet Woodcock (photo). It's all about the science. And the science, she insists, is pointing to troubling indicators about some of these new drugs.

"We have a different story from the companies," Woodcock told the Financial Times. "We understand that [they] have productivity issues but [we] stick to the same safe and effective criteria as our bedrock. Pharma is having a difficult time but we are seeing drugs that have a lot of questions."

The length and size of clinical trials are growing, Woodcock acknowledges, but that's because regulators know more about what they need by way of data. And new efforts to standardize trials--à la Henry Ford--should help matters. "We need to learn from Henry Ford. Companies collect too much information because they are worried that the FDA will ask for it."

- check out the article in the Financial Times

Related Articles:
2007 FDA approvals. Report
More mixed messages from the FDA. Report
FDA: Hyper-cautious or simply vigilant? Report

2008 NME approvals no better than last year?

Wed, 12 Mar 2008 07:59:54 -0400

In 2007, there was much ado about the slow pace of new molecular entity (NME) approvals. Though over 200 drugs were approved in 2007, only 19 of them represented groundbreaking advances in medicine.

In 2008, according to a post on Pharmalot, the industry is set to repeat last year's lackluster performance. Thus far the FDA has approved 14 NDAs but only one NME--the same rate of approval as last year. Why so slow? Analyst Jim Kumpel of Friedman Billings Ramsey says the FDA is hard at work implementing initiatives that resulted from PDUFA reauthorization. Others, including industry execs, are likely to blame the slowdown on a skittish post-Vioxx FDA that's suffered serious criticism for approving unsafe drugs.

- here's the Pharmalot item
- see the full list of 2007 FDA approvals

Related Articles:
Dry spell or parched desert for NME approvals? Report
'07's drug approval record raises worries. Report
New drug approval lags in 2007. Report
FDA quick to reject drugs as it gets more cautious. Report
Industry exec says FDA approval process too strict. Report

ALSO NOTED: BMS falls prey to subprime crisis;AZ cuts 200 U.K. workers;much more...

Fri, 01 Feb 2008 06:59:50 -0500

What's a drugmaker doing, investing in securities at least partly backed by subprime mortgages? Ask Bristol-Myers Squibb, which took a $275 million write-down on so-called "auction rate securities" that had fallen in value to $419 million from $811 million. Report

> In the U.K., 200 AstraZeneca workers may lose their jobs as the company restructures its operations. Report

> Vyteris has redirected its business to focus on the development of peptide delivery using its Smart Patch technology. The change will allow for the further development of small molecule delivery using its technology as well. Release

> An in-development vaccine that weans addicts from their substance of choice has shown the most promise against cocaine addiction so far, but its developers are testing it against other substances now. Report

> The FDA has warned Novartis Vaccines and Diagnostics of the "significant deviations" found at its manufacturing plant in Marburg, Germany, accusing the pharma giant of producing contaminated vaccines and failing to come up with a comprehensive response to the problem. Report

> A federal grand jury is investigating Merck's marketing of Vioxx. Report

> As if patient lawsuits and government investigations weren't enough, now Eli Lilly shareholders are suing. Report

> The FDA has issued a sobering warning: the risk of suicide and suicidal behavior doubles for patients taking epilepsy drugs. Report

And Finally... Scientists have created a genetically modified strain of E. coli that produces substantial amounts of hydrogen. They hope the strain can be used for hydrogen-based energy in the future. Release

ALSO NOTED: Cardiome awaits FDA decision; Congress to investigate Vytorin scandal; and much more...

Fri, 18 Jan 2008 06:59:50 -0500

> Cardiome is awaiting a critical FDA decision on its drug vernakalant. Report

> It seems that many black U.S. residents are less likely to participate in clinical studies, possibly due to distrust of physicians and fears that they might be harmed by participation, according to a study published in the journal Medicine. Report

> Amgen, you're being served. The New Jersey Attorney General has sent out a subpoena to the California company, asking for "a comprehensive array of documents and information" related to Enbrel sales and marketing. Report

> The deadline bell has rung. At final count, more than 50,000 Vioxx plaintiffs have registered for the $4.85 billion settlement. Report

> Congress is promising hearings on the Vytorin controversy. Report

And Finally... What's in a name? Drug-naming experts are charging hundreds of thousands for just the right combinations of vowels and consonants. Report

ALSO NOTED: Big Pharma rethinks animal testing; FDA extends telavancin review; and much more...

Fri, 11 Jan 2008 06:59:50 -0500

> In a move that will please animal rights activists, a number of pharmaceutical companies have determined that they will no longer conduct acute toxicity tests. They say that new technology has rendered these animal tests redundant, slowing down the drug development process. Report

> The FDA is calling for more reviews of Theravance's telavancin. Report

> Merck's good news? It looks as if enough plaintiffs will sign on to the $4.85 billion Vioxx settlement. Merck's bad news? Some plaintiffs are opting out, and some lawyers are challenging settlement provisions designed to prevent that. Report

> Just how did Merck and Schering-Plough get themselves into hot water with the ENHANCE trial, which compared Zetia and Vytorin to a generic cholesterol drug? Maybe by excluding their lead investigator from key discussions. Report

> Here's more evidence that the developing world is hot, hot, hot. Teva Pharmaceutical Industries plans to invest a whopping $1 billion in India. The generics giant will spend between a quarter and a third of that on new manufacturing plants. The rest will go into acquisitions. Report

> Will Florida join other states suing makers of atypical antipsychotics? Report

And Finally... Researchers have identified small pieces of ribonucleic acid that suppress the spread of breast cancer to the lungs and bone. Release

FDA more friendly to approvable than approved

Thu, 10 Jan 2008 06:59:57 -0500

You've probably already heard that FDA approvals took a nasty dive last year, with analysts pondering a variety of reasons for the poor performance. Interestingly, Eye on FDA cites new research from Sargient showing that as approvals were sliding, approvable letters from the FDA were spiking--up 40 percent! Michael Hay, senior analyst and product manager for BioMedTracker, says that "The FDA has received a lot of criticism over several high profile adverse events cases including Vioxx, Tysabri and Avandia. This has triggered an overly cautious approach to new drug approvals at the FDA. Other potential reasons for the decline in approval rates cited in our report include an increase in adverse event reports, increased workload for FDA employees, and a high rate of turnover at the FDA."

Meanwhile, investors are less likely to bid up a stock when they see news of an approvable letter, largely because they are less likely to believe that the drug will be approved. Given the fact that some approvable letters contain a lot more bad news for biotechs than good news, it's likely that investors will be increasingly wary of their impact.

- here's the press release
- check out the report from Eye on FDA

Related Articles:
'07 drug approval record raises worries. Report
Dry spell or parched desert for NME approvals? Report
New drug approval lags in 2007. Report
FDA quick to reject drugs as it gets more cautious. Report

'07's drug approval record raises worries

Wed, 09 Jan 2008 06:59:57 -0500

The paucity of NME approvals by the FDA last year--a miserly 16, one of the worst records in decades--is attracting worried comment from all angles in the drug development business. Elliot Sigal, research chief at Bristol-Myers Squibb, tells the Star-Ledger that the low, low figure "is one measure of how hard it is" developing new drugs today. But the story also notes that a lineup of industry analysts and insiders is fingering a new mandate on caution at the FDA as the big culprit in the slowdown. The agency, though, denies that the debacle over Vioxx has made it any more cautious.

It's all been playing out well for biotech, though, which is home to what many see as a new generation of therapeutics as well as a rich source of new indications for existing therapies. That's a safer strategy to follow, but then maybe it's not just the regulators that are trying too hard to play it safe these days. Catering to a major unmet medical need requires a big appetite for risk taking, and the investment crowd has traditionally been leery of risk.

- here's the report from the Star-Ledger

Related Articles:
Dry spell or parched desert for NME approvals? Report
New drug approval lags in 2007. Report
FDA quick to reject drugs as it gets more cautious. Report
Industry exec says FDA approval process too strict. Report