FDA approval

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. Plus, it's submitted for FDA approval of chronic knee and low back pain, and researchers are studying it as a chronic fatigue treatment.

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

FDA panel blesses new Enbrel use

Tracy Staton — Thu, 19 Jun 2008 08:36:06 -0400

The safety concerns recently raised about TNF blockers in general and Enbrel in particular weren't enough to keep the Amgen drug down. An FDA advisory panel voted 7-5 in favor of using Enbrel in children with moderate-to-severe psoriasis. As you know, it's already approved for use against rheumatoid arthritis in children and adults, and against psoriasis in adults. It pulled in $3.2 billion in 2007 revenues.

The vote follows an announcement earlier this week that the FDA aims to strengthen the warning labels on Enbrel. The agency wants to flag the risk of death among children and of moderate-to-severe infections in adults. That's because the agency found in its database a series of serious malignancies, infections, and neurological problems in pediatric patients who took Enbrel (a.k.a. etanercept).

Meanwhile, the agency is studying the entire class of drugs--the tumor necrosis factor blockers--for possible links to childhood cancers, especially lymphoma, in kids treated for RA or Crohn's disease. Enbrel is one of those drugs; the others approved in the U.S. are Humira (Abbott Laboratories), Remicade (Johnson & Johnson), and Cimzia (UCB).

- here's re release
- read the Washington Post story
- see the piece at CNN Money

FDA drags feet on generic approvals

Tracy Staton — Mon, 16 Jun 2008 07:20:47 -0400

And you thought the odds on new-drug approvals at the FDA were bad. Generics get the thumbs-down 96 percent of the time, according to a new report from the Inspector General. And agency review of new generics is slow, too--rather than the 180 days required by law, it's 217 days on average, more for those meds that aren't rejected outright. Those that won tentative approval saw their apps languish for an average of 300 days.

Not surprising, really, given the recent spotlight on FDA's lack of resources and staff. And going slow on the generic uptake isn't nearly so worrisome as the other problems FDA has faced because of that lack. But in any case, the IG suggested the FDA give generics makers more guidance up front so that their applications are more worthy of review the first time out.

- see the Wall Street Journal Health Blog item

FDA finally gives thumbs-up to Entereg

Tracy Staton — Wed, 21 May 2008 10:53:32 -0400

GlaxoSmithKline and Adolor reached the Entereg summit. After a four-year climb, the two companies finally got FDA approval to sell the anti-constipation drug Entereg. It's OK'd for use after abdominal surgery, and will be available under a risk-management program designed to prevent long-term outpatient use. The approval was delayed several times when the agency asked for more data, concerned about side effects such as heart problems that might arise with long-term use.

- here's the release on the approval
- see the story in Forbes
- check out the Philadelphia Inquirer article

Wyeth pounces on Sandoz's copycat Protonix

Tracy Staton — Wed, 21 May 2008 10:46:11 -0400

Wyeth is going toe-to-toe with Novartis. The Protonix maker--and its partner, Nycomed--filed suit against Novartis' generics arm, saying its copycat drug violates the heartburn med's U.S. patent. Sandoz, you'll recall, filed last month for FDA approval of an injectable form of the drug.

It's just the latest twist in the rapidly lengthening story of copycat Protonix. Last year, Teva Pharmaceuticals launched its version, but stopped shipping to sit down with Wyeth at the negotiating table. No settlement of the companies' patent fight has yet been reached, but in the meantime, Wyeth teamed up with Prasco Laboratories to sell an authorized generic. Soon after, a division of India's Sun Pharmaceuticals released its own version.

Wyeth's sales--both branded and generic--dropped by 66 percent during the first quarter--a painful loss, considering the fact that Protonix once was the drugmaker's biggest seller. It's still defending its Protonix patent, though, and plans to ask for lost profits and damages from both Teva and Sun when the patent case goes to trial.

- see the Wall Street Journal story

SPOTLIGHT: FDA forces contract manufacturer to reform

Tracy Staton — Mon, 19 May 2008 11:07:14 -0400

Contract manufacturer Scientific Laboratories is in a world of hurt today, as FDA has barred it from manufacturing or distributing drug products until it brings its operations up to par. The company, which makes various prescription cough-and-cold meds, didn't ask FDA for approval for some of its drugs--a dozen of them--and didn't comply with required manufacturing protocols. The consent decree Scientific Labs signed requires it to get the FDA's blessing for any product it sells and to conform to good manufacturing practices. The drugs it's already made all have to be destroyed. And the agreement comes with a big or-else: If Scientific Labs doesn't comply, FDA can shut it down completely. Story | Item

ALSO NOTED: Pfizer gets new cancer team to advance key drugs; Bayer clearing Trasylol off U.S. market;

Fri, 16 May 2008 06:59:50 -0400

> With the clock ticking on its patent for Lipitor, Pfizer has turned to a group of new executives to lead the company to the promised land of new cancer therapies. Report

> Bayer is pulling its remaining stocks of the anti-bleeding drug Trasylol, leaving the drug on the market only under an investigational program, the FDA announced. Release | Report

> Sanofi-Aventis has instituted a precautionary recall of 11 batches of the anti-clotting drug Lovenox after some were found contaminated with low levels of oversulfated chondroitin, the same chemical found in tainted heparin recalled by Baxter earlier this year. Report | Report

> FDA has blessed a new tablet coating ingredient, Kollicoat IR, from the German chemical company BASF. Report

> In more bad news/good news on generics, prices for the copycat meds dropped by 9.6 percent in 2007 as some of the most common drugs had price declines of up to 70 percent. Report

> Canadian regulators may pull the Plan B contraceptive--otherwise known as the "morning-after pill"--out from behind the pharmacy counter. Report

> India's Lupin saw its stock leap on an FDA approval for its version of the Wyeth heart-failure and blood-pressure med Altace, aka ramipril. Report

> Ranbaxy got the FDA nod for its muscle relaxant cyclobenzaprine, a generic form of the Ortho-McNeil drug Flexeril. Report

> Sepracor shares were off 2 percent on news that its CFO was leaving the company. Report

> An older statin, fluvastatin, showed action against the hepatitis C virus in a new study. Report

> Getting an embryonic stem cell therapy through clinical trials in the U.S. is looking like an increasingly tough challenge after Geron announced that the FDA is delaying a study of its experimental therapy for spinal cord injuries. Stem cell reoprt

> Forbes Medi-Tech says it will slash a third of its staff and shelve all in-house drug development work as it focuses its efforts on the nutraceutical business. Report

> Sweden's Biovitrum AB has restructured its R&D operations, winnowing out about 100 people either through layoffs or by reassigning them to other work. Report

> Last year's awful record of new drug approvals by the FDA has been followed by a burst of new activity. Pharmalot reports new analysis indicating 29 new drug approvals through April, the fastest rate of acceptance since 1998 and 2000. Report

And Finally ... Also from the ASCO data dump: Vitamin D may help curb breast cancer. Report

Sanofi's Lovenox patents 'unenforceable'

Thu, 15 May 2008 06:59:56 -0400

Will the way soon be clear for a generic form of Lovenox? Sanofi-Aventis just lost a bid to save its patents on the anticlotting med, as a U.S. appeals court upheld a lower-court ruling that called the patents unenforceable. That court found that Sanofi failed to disclose certain info on its patent applications--"inequitable conduct" that negated their protection.

The ruling is a win for Teva Pharmaceutical Industries and Amphastar Pharmaceuticals, which originally challenged the patents. They both applied for FDA approval for copycat forms of the med back in 2003. Lovenox's key patent was set to expire in 2012; Sanofi says it's "considering its legal options."

- read the Wall Street Journal news

Quaid: Preemption unfair to patients

Thu, 15 May 2008 06:59:54 -0400

Dennis Quaid added some star power--and colorful language--to a dry legal debate yesterday. Testifying before Congress, Quaid backed people's right to sue drugmakers, saying that FDA approval shouldn't automatically negate patient lawsuits. "If preemption of lawsuits is allowed to prevail, it will make all of us--the public--uninformed and uncompensated lab rats," he said.

You'll recall that Quaid and his wife sued Baxter after their twin infants were given an enormous overdose of heparin. The lawsuit alleges Baxter knew other babies had died as a result of improper labeling of the drug, had started making heparin with new labels, but failed to recall the older vials mistakenly given to the Quaid twins. Among Baxter's defenses is the FDA's approval of its product.

The Bush administration has been pushing preemption, saying that approval by FDA, a federal agency, should supersede any state-level claims. This fall the Supreme Court will consider the idea when it hears a case pitting a patient against Wyeth. A Congressional committee met yesterday to hear testimony about preemption; presumably, Congress could circumvent a Supreme Court ruling in favor of it by enacting a law specifically allowing the lawsuits.

- read the Los Angeles Times story
- see the article in the Wall Street Journal

ALSO: Currently the sole supplier of heparin for the U.S. market, APP Pharmaceuticals is increasing its prices because of tightening Chinese stocks of the drug's raw ingredient. Several suppliers there have been shut down in the wake of an investigation of contaminated lots of the drug. Report

Preemption debate heats up

Tue, 13 May 2008 06:59:58 -0400

That little legal argument known as preemption is back in the news. You know the one: That FDA approval, being federal, supersedes any state-court lawsuits over blessed drugs and devices. Pushed by the Bush Administration, it's set for a Supreme test this fall when the U.S.'s highest court hears a case in which Wyeth claims it shouldn't be liable for claims about an FDA-approved med.

The latest? Supreme Court justices have had to recuse themselves from various cases lately because of their pharma-stock holdings. Yesterday, it was Samuel Alito bowing out because of Bristol-Myers stock. (Four of the nine justices had to sit out of that case, which involved a laundry list of big U.S. companies.) Two months ago, it was Chief Justice John Roberts sitting out a case involving Pfizer. Given the fact that ratifying preemption as a legal defense wouldn't simply help Wyeth, but all drugmakers, will the two men recuse themselves from that case, too? Inquiring minds want to know.

Meanwhile, Congress is dipping into the preemption fray with a hearing on the concept tomorrow. The House Committee on Oversight and Government Reform--Rep. Henry Waxman's group--is calling a bunch of preemption opponents to testify. On the roster: Actor Dennis Quaid, who's suing Baxter over a heparin overdose given to his infant twins.

- see the item at Pharmalot
- check out the hearing announcement