heartburn

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: 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

AstraZeneca, Ranbaxy settle Nexium fight

Tue, 15 Apr 2008 06:59:58 -0400

AstraZeneca investors were jumping for joy this morning when the drugmaker announced it had played Let's Make a Deal with Indian generics maker Ranbaxy. The copycat company agreed to wait till 2014 to sell its version of the heartburn med Nexium, AstraZeneca's top selling drug with $5.22 billion in revenues.

That's a huge coup for AstraZeneca, which has been fighting off the generic challenge since 2005. But it's also a good deal for Ranbaxy: the Indian drugmaker gets U.S. distribution rights to two off-patent AstraZeneca meds, Prilosec and Plendil, and will start supplying the active ingredient in Nexium to AstraZeneca beginning in 2009.

AstraZeneca still faces patent challenges on Nexium from Teva Pharmaceutical Industries and India's Dr Reddy's, but analysts said that Ranbaxy's willingness to settle may signal the strength of AstraZeneca's case. Market watchers also upped AstraZeneca's target share price.

- check out the press release from AstraZeneca
- read the piece in the Financial Times
- see the Wall Street Journal story
- find out how the market reacted at CNN Money

Related Articles:
AstraZeneca rivals could launch any day. Nexium report
FDA to review Nexium, Prilosec. Nexium report
Canada questions safety of Nexium, Prilosec. Nexium report
Nexium formulation wins FDA approval. Nexium 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

Dexcel gets right to sell copycat Prilosec

Mon, 05 Nov 2007 06:59:54 -0500

The fight is over. Over-the-counter drug distributor Perrigo said its partner Dexcel Pharma Technologies has settled patent litigation with AstraZeneca over the heartburn med Prilosec OTC. The settlement deal will allow Dexcel to sell a store-brand version of the drug as soon as it gets FDA's approval.

The patent fight has been going on since May 2006, when AZ sued to block Dexcel's new drug application. Now, AZ has waived its patent claims on Dexcel's product. Perrigo, which will be the exclusive distributor for the drug, expecting sales of $150 million to $200 million. Overall, Prilosec OTC sells at the rate of $750 million annually.

- see this release from Perrigo (.pdf)
- read the report from the Houston Chronicle

Related Articles:
Canada questions safety of Nexium, Prilosec. Report
FDA to review Nexium, Prilosec. Report

Heartburn drug use in kids skyrockets

Thu, 04 Oct 2007 06:59:54 -0400

First diabetes, then high blood pressure, and now heartburn? Kids are turning up with more and more adult ailments these days; consider a new surge in use of heartburn drugs among the 18-and-under set. The most dramatic increase was in kids up to 4 years old; more than half a million children that age were taking heartburn remedies last year, a hike of about 56 percent over 2002 numbers.

Experts theorized a few reasons for the increase. One, growth in obesity, which tends to exacerbate heartburn. Two, heartburn drugs like Prevacid were approved for kids during the time period covered by the study--leading some to speculate that small children are taking these drugs unnecessarily. Though little kids often experience gastric reflux, many outgrow it on their own, they said.

- check out the article in the Washington Post