Lyrica

FDA finalizing epilepsy black-box warnings

Christe Bruderlin-Nelson — Wed, 09 Jul 2008 10:23:56 -0400

Stringent epilepsy drug black-box labeling is likely to worry consumers and drug manufacturers alike, and will bring the total of drugs with a suicide risk warning up to about 35. The new warnings will be on the labels of 11 epilepsy drugs as soon as tomorrow, as FDA is very near finalization. Sales of the widely used drugs--which physicians also prescribe to treat migraines, certain types of pain and some psychiatric disorders--were over $8 billion last year.

The FDA made the decision to issue the warnings after analyzing data for nearly 200 trials of over 40,000 patients in a medication safety evaluation it initiated in 2005. They found that patients taking the epilepsy medications had almost double the risk of suicidal ideation or behavior compared to patients taking placebos. Additionally, while none of the individuals taking placebo medications committed suicide, four of those taking the epilepsy medications did.

The risk of suicidal thought and behavior increases after only a week of taking one of the medications and can last at least six months into it. The results were consistent regardless of the particular drug.

The medications affected include some neurology dinosaurs and include carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), pregabalin (Lyrica), tiagabine (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote, Depakene, Depacon) and zonisamide (Zonegran).

Pfizer argued against inclusion on the list, saying that its drug, Lyrica, was different from others in the class. Lyrica is relatively new and might feel the black-box pain more than other drugs.

- here's the Wall Street Journal story
- see eFlux Media's take

Under pressure, pharma collects new indications

Tracy Staton — Mon, 30 Jun 2008 09:32:24 -0400

If the pharma industry were in need of a poster child for indication-happy drug marketing, Cymbalta could be it. The Eli Lilly med is now "the Swiss army knife of drugs," the Indianapolis Star says. It has a half-dozen approved uses: depression, anxiety, maintenance treatment for depression, diabetic nerve pain, fibromyalgia, and in Europe, stress urinary incontinence.

There's reason behind this strategy. It works. On the market for just four years, Cymbalta racks up billions in sales for Lilly; in fact, it's Lilly's second-biggest seller. Given the fact that Lilly hasn't launched a new drug for humans in three years, growing existing meds has been crucial.

Lilly, of course, is far from alone. Dispirited by their limping pipelines and increasingly rigorous regulators, drug companies across the board have been looking for new uses for their already-approved drugs. Think Pfizer's Lyrica, for instance; it's approved for three different nervous system complaints, and the company plans to seek the OK for epilepsy treatment.

Understandably. But is this search for new indications eroding new-compound R&D? Some experts think so. Others say drugmakers would be remiss if they didn't look for new uses for old meds. One thing is certain: It's not about to stop anytime soon.

- read the story in the Indy Star

Pfizer got tax break but didn't deliver jobs

Wed, 05 Mar 2008 06:59:57 -0500

As Pfizer held its big conference call with analysts this morning, the New York Daily News was reporting on the company's job cuts and plant closure in Manhattan and Brooklyn. At issue: a $10 million tax-break package the drug maker got in return for creating new jobs in New York. Pfizer was supposed to be on the hook for boosting employment to 8,659 from 5,735.

In 2004, the first year of the agreement, Pfizer was supposed to create 1,000 jobs. Tally: 199. And that was the net after Pfizer moved 1,000 jobs in from out of state and then cut other workers. Of course we all know that more job cuts have followed. The company is shutting down its historic Brooklyn plant; by the time the last workers there are laid off, the company may even have fewer employees than when the tax deal began.

Pfizer did notify the city last September that it wouldn't be meeting its job-growth goals. The city suspended the tax deal. But too late--Pfizer had already received almost all the tax breaks.

Meanwhile, about that conference call: As expected, the company didn't reveal any earth-shatteringly new strategies. It's eyeing global markets for growth and concentrating on cutting more costs via outsourced manufacturing and real estate cutbacks. It will also continue leaning hard on its fastest-growing meds such as Geodon and Lyrica. We'll have more tomorrow.

- see Pfizer's release
- read the story in the Daily News
- check out the Pharmalot item

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FDA: Epilepsy drugs boost suicial thoughts

Fri, 01 Feb 2008 06:59:57 -0500

The FDA issued a sobering warning yesterday: the risk of suicide and suicidal behavior doubles for patients taking epilepsy drugs. Millions are--they're prescribed not only for the seizure disorder but for pain and psychiatric illnesses. The 11 drugs affected include such big-name meds as Pfizer's Lyrica, Abbott Laboratories' Depakote and OrthoMacNeil's Topamax.

Before issuing the warning, the FDA reviewed 199 studies on the meds, finding that the risk of suicide-related events in patients taking the drugs, while low, were still significantly higher than those taking placebo. Patients starting therapy with one of the meds should be watched carefully for signs of suicidal behavior, the agency said. Warnings about the risks will be included in the drugs' labels.

Though all the drug makers involved could see sales drop, the company that stands to lose most, according to the San Francisco Chronicle, is Pfizer. That company has nearly a thousand lawsuits pending over the suicides or attempted suicides of patients taking Neurontin. Many of the patients were prescribed Neurontin off-label, during a period when a Pfizer unit was promoting it for use in bipolar disorder, migraine headaches, and other ailments--all uses not approved by the FDA. In fact, the FDA's review of the epilepsy drugs was prompted by an attorney's request.

- check out the release from the FDA
- see the San Francisco Chronicle's article

Related Articles:
Top 10 Drug Warnings and Recalls of 2007. Special Report
Court: Pfizer can defend Neurontin patent. Report

Pfizer's Lyrica booms on iffy diagnosis

Mon, 14 Jan 2008 06:59:58 -0500

Is fibromyalgia an ill-gotten label that could only benefit drug companies? Or is it a real disease that needs treatment? Judging by the abrupt rise in prescriptions for the Pfizer drug Lyrica since it was approved for fibromyalgia treatment in June, it's real. But doctors are still arguing. Even the physician who initially identified the problem now say he doesn't think it's a true disorder

Meanwhile, patient advocates are hoping that widespread drug treatment will legitimize the disease rather than vice versa. Just as Prozac brought depression out of the closet, so might Lyrica for fibromyalgia.

That, of course, would only be to Pfizer's benefit. An estimated 10 million American adults suffer from the disorder. That's not quite the 15 million who suffer from depression each year, but it's plenty. Already, worldwide sales of Lyrica grew by 50 percent in 2007, and analysts expect further growth of some 30 percent in 2008--even as Eli Lilly and Forest Laboratories prepare to launch their own fibromyalgia remedies, probably later this year.

- read this article from the New York Times

Related Articles:
Northwestern sells Lyrica rights for $700M. Report
Pfizer touts blockbuster drug for fibromyalgia. Report
Lyrica gains blockbuster status. Report

Suit: Amgen underpaid royalties

Thu, 20 Dec 2007 06:59:55 -0500

While Northwestern swims like Scrooge McDuck in its $700 million Lyrica payment, Sloan-Kettering Institute for cancer research is suing Amgen for underpaying royalties by more than $72 million. The cancer center claims that, when calculating royalties, Amgen deducted Aranesp-related rebates from Neupogen and Neulasta sales. The latter two drugs sold at a rate of $1.1 billion just in the third quarter. Amgen denies the claims.

- check out this report
- read the Pharmalot item

Related Articles:
Northwestern sells Lyrica rights for $700M. Report
Lyrica OK'd for epilepsy. Report

Northwestern sells Lyrica rights for $700M

Wed, 19 Dec 2007 06:59:54 -0500

It's the last big Lyrica bonanza for Northwestern University. The school sold part of its royalty rights to the blockbuster drug for $700 million. That's a big chunk of change--and this after several years of plowing Lyrica royalties into the university nanotech center, recruiting top-name scientists and building new facilities for them. Now, Northwestern will deposit the lump sum in its endowment fund, where it can earn interest. And it will still collect some money off the (unspecified) royalties it still owns.

The buyer? Royalty Pharma, a New York-based company that's made a practice of buying royalty rights from research universities.

- see this release
- read the article from the Chicago Tribune

Related Articles:
Lyrica OK'd for epilepsy. Report
Pfizer touts blockbuster drug for fibromyalgia. Report

ALSO NOTED: Canada nixes Lilly's Parkinson's drug; Company looks to snap up ex-Pfizer workers;

Fri, 17 Aug 2007 06:59:50 -0400

> Eli Lilly's Permax will be persona non grata in Canada as of August 30. After studies showed the Parkinson's treatment can cause serious heart-valve damage, Lilly in March voluntarily pulled Permax from the U.S. market. Now, Health Canada is ordering the company to stop selling the drug there. Report

> Health Canada also becomes the latest regulator to announce it's reviewing safety data on Prexige, the Novartis Cox-2 inhibitor that Australia withdrew from the market earlier this week. Release

> Laid-off Pfizer staffers may have reason to hope: A pharmaceutical services company is opening an Ann Arbor location, and it's eyeing ex-Pfizer types. Report

> The FDA wants more time to review Endo Pharmaceuticals' supplemental new drug app for the pain med Frova. Endo had applied to expand Frova's label to short-term prevention of menstrual migraine. Report

And Finally... Lyrica isn't making hay only for Pfizer. The $1.2 billion nerve-pain and epilepsy med is bestowing plenty of moolah onto its alma mater, Northwestern University, where chemist Richard Silverman laid the groundwork necessary for its development. Blog