Protonix

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

Wyeth to slash another 1,200 jobs

Tue, 29 Apr 2008 06:59:58 -0400

And the ax is falling again. Wyeth notified employees last Friday than another 1,200 jobs will be slashed from the payroll. That's on top of the 1,240 sales jobs slated for elimination last month.

The cutbacks are part of "Project Impact," a restructuring plan Wyeth hopes will help it grapple with impending generic competition and FDA-approval setbacks. Blockbuster heartburn treatment Protonix has already been losing to generic competition, so much so that the company introduced its own generic version. In 2007, the FDA declined to approve Wyeth's osteoporosis candidate bazedoxifene (Viviant) and its schizophrenia med bifeprunox. Though Wyeth finally got its Effexor replacement Pristiq approved for depression, it was sent back to the drawing board on an indication for menopause.

- see the news at Pharmalot

Under pharma earnings, basic problems

Wed, 23 Apr 2008 06:59:55 -0400

You've heard of see-through buildings. How about see-through pharma earnings? Though drug makers have been reporting increases to their bottom lines, investors are looking past the foreign-currency gains and one-time earnings boosts to the fundamental problems the industry faces.

"Each company generally has had somewhat of the same narrative... limited pipeline visibility, patent expirations, and decelerating growth in their main products," one analyst told the Associated Press. Thus Wyeth lost Protonix revenues; Roche suffered from falling Tamiflu sales; Merck's Singulair, Vytorin, and Fosamax dropped off; Pfizer saw Zyrtec and Norvasc decline; and Lilly's top seller Zyprexa deflated.

Of course Big Pharma also confronts a larger problem, just as most other U.S. companies do: the economy. As Steve Brozak of WBB Securities pointed out, the lackluster quarter is just one more sign of an overall market shift. "This proves to us that we're in a recession," he said.

- read the Associated Press story

SPOTLIGHT: Wyeth sales boosted by Enbrel

Tue, 22 Apr 2008 06:59:52 -0400

Despite major erosion in sales of its heartburn blockbuster Protonix, Wyeth managed to beat Wall Street's expectations for first-quarter earnings, posting a $1.2 billion profit on a 6 percent increase in revenues to $5.71 billion. Protonix sales fell 66 percent, but revenues from the arthritis treatment Enbrel skyrocketed by 36 percent. Report

1,200 Wyeth reps out of work

Fri, 28 Mar 2008 07:59:58 -0400

Don't tell these 1,200 Wyeth sales reps to have a nice weekend. They got pink slips on Wednesday, their jobs eliminated in the drugmaker's previously announced restructuring. They won't go away completely empty-handed, though. The reps will get severance and some continuing benefits, a Wyeth spokesman said.

You'll recall that in January, Wyeth told managers that about 10 percent of its 50,000-strong workforce would be cut by 2011. The restructuring, known as "Project Impact," is designed to cut jobs and other costs and reconfigure the business as Wyeth faces generic competition for blockbusters Protonix and Effexor.

Now, the company says the 10 percent estimate could change. "We're still evaluating the composition of our global workforce," the spokesman told the Associated Press. "Our short term-objective is to achieve a reduction in force of 4 to 6 percent by the middle of the year."

- read the story in the Boston Globe
- check out the Dow Jones article at CNN Money

Related Articles:
Ranks of sales reps thinning. Report
Wyeth mulls 5,000 job cuts. Report
Pharma layoffs set new record. Report
Wyeth stumbles badly trying to develop new drugs. Report

Agencies take aim at patent settlements

Wed, 20 Feb 2008 06:59:57 -0500

Are quid pro quo deals between brand-name drug makers and generics firms in real danger? Euro watchdogs are scrutinizing them, the FTC is suing over them, and the U.S. Congress is considering an outright ban on them.

Perhaps that's because Big Pharma has been cutting deals with generics makers right and left. There's the big Cephalon arrangement that's attracted the FTC's ire: That company paid Teva, Barr, Ranbaxy, and Mylan a total of $200 million to say out of the Provigil market until 2012. The FTC counts 100 deals like this since 2004.

The FTC hasn't had much success in the courts so far, but it's hoping for a grand slam in the Cephalon case. The agency would like the issue to go to the Supreme Court so it can be resolved "once and for all." There's no guarantee, though, that the newly conservative court would rule against these deals. The government's best shot may be in Congress. A Senate committee last week approved a bipartisan bill that would prohibit these arrangements; similar legislation is pending in the House.

Meanwhile, the generics market isn't growing at quite the pace it once was. According to preliminary figures from IMS Health, sales increased by 3.8 percent last year--the same rate as the overall drug market. The market research firm was surprised by those results: "I checked this number and checked it twice," an IMS rep told In Vivo. "We have seen generics growing over the last couple of years somewhere between 10 percent and 20 percent. So to come in...at 3.8 percent is quite dramatic."

- read the Fortune article
- check out the market figures at In Vivo

Related Articles:
FTC sues Cephalon for blocking generics. Report
AstraZeneca, Par collaborate on authorized generic. Report
Wyeth makes its own Protonix copy. Report
Analysts get bullish on generics makers. Report

Teva abstains from Protonix fray

Mon, 04 Feb 2008 06:59:55 -0500

Teva Pharmaceuticals' dilemma: A rival generic drugmaker is ready to flood the market with a copycat Protonix, and Wyeth is set on nabbing at least some generic revenue by selling its own copycat. So what does Teva do?

Nothing, at least for now. The company announced Friday that it has no plans to relaunch the generic Protonix that got it to the negotiating table with Wyeth late last year.

Here's the background: Teva and Wyeth had been fighting over Protonix's patent. Seemingly confident of its position, Teva launched its copycat version. Wait a minute, Wyeth said; we'll talk. Then talks broke down, and last week Wyeth said it would sell its own generic Protonix. India's Sun Pharma chimed in, saying it was planning to launch its copycat, too.

So why would Teva abstain? An analyst tells the WSJ Health Blog that if Teva relaunched, it would have to cut the price because of additional generic competition, and the it would have to rebate customers that bought in December. So maybe it's just holding back for now.

- check out Teva's press release
- read the item in the WSJ Health Blog

Related Articles:
Wyeth makes its own Protonix copy. Report
Wyeth loses a round to Protonix knockoffs. Report
Sun copycat to cut $500M off Wyeth sales. Report

Wyeth makes its own Protonix copy

Wed, 30 Jan 2008 06:59:55 -0500

Wyeth decided to beat the copycats to the punch. The drug maker will launch its own generic version of the blockbuster heartburn med Protonix, more than two years ahead of its patent expiration.

You'll recall that Wyeth had been negotiating with generics giant Teva Pharmaceutical, hoping to settle a dispute over Protonix's patent. Late last year, a Canadian judge refused to stop Teva's launch of a copycat drug, even though the two companies' litigation was ongoing. But Teva agreed to a truce; it would stop shipping the generic to sit down with Wyeth for settlement talks.

Apparently, the two companies couldn't come to terms, and Wyeth came out swinging. "We believe the Protonix compound patent is strong and we will vigorously pursue out litigation against Teva and other infringing generics," President and CEO Bernard Poussot said in a statement.

Teva, on the other hand, says Wyeth nullified the truce by launching its own generic. The company's statement doesn't specify whether it would continue to ship the copycat version. Given the fact that Sun Pharma--which shares 180-day marketing exclusivity for the generic with Teva--is now launching its Pantoprazole product, it's hard to imagine Teva holding back. But, of course, any generics maker that sells a copycat form of the drug risks paying triple damages to Wyeth if its patent is upheld.

Wyeth's move is emblematic of the challenges drug makers face as their top-selling products attract generic competition. Copycat drug makers like Teva and Sun are increasingly aggressive in disputing patents; they start early and keep pushing. And Wyeth isn't the only company to launch its own authorized generic to capture at least some of the copycat revenues for itself. Two weeks ago, Merck announced that it would partner with a generics maker on an authorized version of Fosamax, whose patent expires in February. With billions in revenue at stake--Protonix sold $1.43 billion worth in the first nine months of 2007--who can blame them? But even with an authorized generic going out the door, Wyeth sales will take a big hit. Analysts expect flat revenues for all of 2008, and the company is looking to cut jobs to save some bucks over the next three years.

- read the statement from Wyeth
- check out the release from Teva
- see the report about Sun's Pantoprazole launch in the Economic Times
- find this piece in the Wall Street Journal

Related Articles:
Wyeth mulls 5,000 job cuts. Report
Blockbusters on their way to generic-land. Report
Teva plots strategy on high-risk rollout. Report
Wyeth loses a round to Protonix knockoffs. Report

Wyeth mulls 5,000 job cuts

Fri, 25 Jan 2008 06:59:58 -0500

Welcome Wyeth to the layoff parade. The drugmaker is plotting cutbacks, including job cuts that could amount to 10 percent of its 50,000-strong workforce. Because the company is just beginning to hash out the details, no hard numbers are yet available. According to a Wyeth spokesman, the plans will be announced in March.

Wyeth, of course, is facing the same pressures as other pharma companies who've laid off thousands of workers. Take generic competition: The active ingredient in the company's biggest-selling drug, Effexor XR, goes off patent this June, and Sun Pharmaceutical is readying a generic version. Meanwhile, its blockbuster heartburn med Protonix faces a copycat from Teva Pharmaceutical Industries, which is threatening to launch its version even as the companies dispute its patent protection in court. Wyeth and Teva declared a truce till next Thursday while they try to negotiate a settlement.

And in prepping for layoffs, Wyeth joins a veritable roll call of the biggest names in the business. Merck, Pfizer, Bristol-Myers Squibb, Amgen, GlaxoSmithKline--everyone who's anyone is doing it.

- see the Philadelphia Inquirer article
- read about Wyeth and Teva's truce in the Star-Ledger

Related Articles:
Top 8 layoffs of 2007. Report
Pharma layoffs set new record. Report
Wyeth stumbles badly trying to develop new drugs. Report
Wyeth stock down after several setbacks. Report

Blockbusters on their way to generic-land

Wed, 02 Jan 2008 06:59:57 -0500

We're going to quote ourselves here: Some $23 billion in drugs go off patent in 2008, some of them the biggest names in pharma. Which, pray tell? The following blockbuster or almost-blockbuster meds are expected to lose exclusivity in at least one market worldwide this year:

Fosamax, Merck, 2007 sales of $2.9 to $3.1 billion
Risperdal, Johnson & Johnson, 2006 sales of $4.1 billion
Topamax, Johnson & Johnson, first nine months of 2007 sales at $1.8 billion
Lamictal, GlaxoSmithKline, sales of nearly $2 billion in the 12 months ended Sept. 30
Depakote, Abbott Laboratories, over $1 billion in first nine months of 2007
Camptosar, Pfizer, $903 million in 2006 sales

This is nothing compared with the off-the-charts expirations in 2010. But it might not be all the big drugs that fall this year. Several mammoth products face generic challenges--Wyeth's Effexor XR and Protonix, Novartis' Gleevec, and AstraZeneca's Crestor, to name a few. Timber!

- read about Wyeth's Effexor problems
- get more on the challenge to Gleevec's patent
- here's more on the patent challenge to Crestor

Related Articles:
Analysts get bullish on generics makers. Report
The specter of generic competition grows. Report
Patent 'cliff' looms for Big Pharma. Report
Generic competition heats up. Report