Mircera

Roche helps catch cheating athletes

Tracy Staton — Thu, 09 Oct 2008 10:26:28 -0400

The campaign against sports cheats has found a new ally in Big Pharma. Roche says it collaborated with anti-doping experts to help catch Tour de France athletes who used its anemia drug Mircera--known as CERA in sports circles--to boost their cycling performance. And now, drug watchdogs will be using that assistance to check the stored blood samples of Olympians, double-checking the honesty of medal-winning athletes.

Roche teamed up with the World Anti-Doping agency in 2004, when clinical trials showed that CERA could help athletes perform better. Together they developed a test to detect athletes' use of the drug. That lab screen found that three stage winners in the 2008 Tour used CERA to boost their ability to compete.

"We were very pleased that this collaboration with WADA has been productive," Roche spokeswoman Claudia Schmitt told the Associated Press. "We are really not happy to see Mircera misused for doping, or to see it in the sports world."

- read the story in the International Herald Tribune

Amgen prevails against Roche's Mircera

Tracy Staton — Fri, 03 Oct 2008 12:08:49 -0400

In its ongoing fight with Roche, Amgen now has stronger backing from a federal court. The U.S. District Court in Boston ruled yesterday that Amgen should get a permanent injunction against Roche's anemia med Mircera. This decision cements a previous jury's conclusion that Mircera violates Amgen's patents.

The court's ruling contains just the kind of language drugmakers like to see: "Failure to enter a permanent injunction...would risk undermining the incentives for innovation that have produced, and hopefully will continue to produce, medical advances that extend and enhance the value of life."

You'll recall that Amgen's earlier request for a permanent injunction was tabled by a Massachusetts judge, who wanted to consider granting Roche a license to sell Mircera in the U.S. The judge said that if the Swiss drugmaker met certain conditions--such as paying royalties to Amgen--he might deny the injunction request. Roche agreed to those conditions, but the judge realized he didn't have the technical expertise to determine fair pricing for Mircera, and so brought in an independent expert to take a look.

Now, though, that's not an option. Though the permanent injunction can't be granted until an appeal of the preliminary injunction is resolved, Amgen, of course, is pleased. The ruling "reaffirms the infringement and validity of our patents," general counsel David Scott said in a statement.

- see the Amgen release
- read the Wall Street Journal story
- check out the CNBC coverage

Roche appeals Mircera injunction

Thu, 10 Apr 2008 06:59:56 -0400

Roche is appealing to a higher power on Mircera. The Swiss drugmaker is appealing a lower court ruling barring U.S. sales of the anemia med, claiming that Mircera doesn't infringe on Amgen's patents after all. Saying that a judge in federal court encouraged the appeal, Roche said it "maintains its position that all of Amgen's patents...asserted against Roche are invalid and not infringed."

Apparently, Roche got tired of waiting for Judge William Young to decide whether to let it sell Mircera in the States. You'll recall that, in giving Amgen its injunction against Mircera, Young said he might let the drug onto the market under certain conditions, including price controls and royalty payments. Roche agreed to the conditions, but Amgen balked--and so Young is appointing a special master to help sift through the technical issues.

Then--as now--Amgen simply said it thinks a permanent injunction against Mircera is the only correct answer. We'll see what the various judges decide.

- check out the item at Pharmalot

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Mircera judge seeks expert guidance

Thu, 27 Mar 2008 07:59:54 -0400

The judge refereeing the turf battle between Roche and Amgen over anemia meds has taken a time-out to consult the experts. Judge William Young said he's grappling "with complex issues" in the patent fight and ordered the appointment of a special master to make recommendations on price and dosing.

Here's the action so far: A court ruled that Roche's anemia drug Mircera infringes on Amgen's patents on Epogen. But though Young granted Amgen's request for a temporary injunction against Roche's med, he also said that--because it's given to patients less often than Amgen's version--it might be in patients' best interests for the two companies to make a deal. He set out five conditions for Mircera sales, including a 22.5 percent royalty payment to Amgen and a stipulation that Mircera would sell for no more than Epogen did. Roche accepted those conditions; Amgen asked for a permanent injunction.

Now, Young is giving Amgen and Roche 15 days to suggest candidates for the special master job and allotted 60 days for that master to make his or her recommendations. At issue: pricing parity. Given the different dosing schedules for the drugs, how can Roche be sure to keep Mircera's price at a level no higher than Epogen's? We'll have to wait and see. And that might be a long wait: Amgen has now asked for a trial to determine compensation if Roche gets to sell Mircera in the U.S.

- read the item in the WSJ Health Blog
- check out Pharmalot's coverage
- see Amgen's new motion

Related Articles:
Court sends Mircera case to ITC. Report
Amgen: Mircera deal would set precedent. Report
Roche accepts judge's deal on Mircera. Report
Mircera gets FDA nod, but blocked by patent case. Report
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Roche: Patent ruling won't stop Mircera. Report

Court sends Mircera case to ITC

Thu, 20 Mar 2008 07:59:55 -0400

Another chapter in what's becoming a long Mircera saga: A federal appeals court ruled that Roche could import the anemia drug so long as it wasn't for sale--but sent the case back to the International Trade Commission for its opinion. Previously, the ITC had said that it couldn't rule on whether importing the med in itself would infringe on Amgen's patents. The appeals court says it can.

Meanwhile, a federal judge is still weighing his opinion in the case. Last month, he told Roche he might let Mircera onto the market in spite of the patent infringement if Roche would meet five conditions. Roche said yes. Amgen said, Not fair. How the judge will respond now is anyone's guess.

- read the update in the Wall Street Journal

ALSO: The shoe's on the other foot for Roche in India. The Delhi High Court ruled that domestic drug maker Cipla could market its copycat version of Roche's lung cancer med Tarceva, pending another hearing in August. The court also accepted a patent challenge to Tarceva from Cipla; Roche has four weeks to respond. Report

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Roche to Launch Mircera in U.K. and Germany. Report

Amgen: Mircera deal would set precedent

Wed, 19 Mar 2008 07:59:57 -0400

Should he or shouldn't he? The judge weighing the case of Amgen v. Roche is getting a lot of unsolicited advice on whether to allow Roche's anemia med Mircera onto the market. Last year, a jury ruled that Mircera stepped on Amgen's patents on Aranesp and Epogen; last month, the judge gave Amgen a preliminary injunction against Mircera, but said he might let Roche sell the med under five conditions.

Well, yesterday, Roche said OK to all those conditions. It would pay Amgen a 22.5 percent royalty, set prices at or below Epogen's until Amgen's patents expire, and so on. Amgen quickly countered in defense of its patents, saying that letting Roche sell the drug would set a precedent weakening patent protection--and weakening patent protection would squeeze R&D. Amgen wants the judge to block Mircera permanently. Or at least until its patents expire.

It's not clear when the judge will rule, but as In Vivo notes, he appears to be concerned about patients as much as patents. And Roche says that its anemia remedy could be administered only once every two weeks or even once every four weeks, so it's a good option that's not now available. Amgen disputes that, of course, saying that Mircera offers no additional benefits.

Meanwhile, the market for anemia drugs has already been shrinking on safety concerns. Dosing limits have been recommended or imposed by various regulators, and last week an FDA advisory panel said they should be further restricted in some cancer patients.

- read the Wall Street Journal story
- get the article from the Associated Press
- see the In Vivo piece
- check out the item at the WSJ Health Blog

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Roche accepts judge's deal on Mircera. Report
Mircera gets FDA nod, but blocked by patent case. Report
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Judge blocks Roche's Mircera--for now

Fri, 29 Feb 2008 06:59:56 -0500

Victory for Amgen--and maybe for Roche, too. The California drug maker persuaded a judge to temporarily ban Roche's competing anemia drug Mircera in the U.S. But the judge also said he'd consider letting Roche sell the med under certain conditions.

You'll recall that Roche got approval late last year for the anemia fighter, which would compete with Amgen's Epogen and Aranesp and Johnson & Johnson's Procrit. But Roche was enjoined from launching the drug because of patent-infringement questions. Later, Roche offered Amgen 20 percent royalties on Mircera, but Amgen rejected the figure.

Apparently the judge agreed that 20 percent was too low: He suggested 22.5 percent. And he said that Roche would have to agree to set prices no higher than those for existing anemia drugs. Predictably, both sides balked. Amgen said making a deal would amount to "rewarding theft of intellectual property." And Roche said its original offer was "fair and aggressive;" it may appeal the ruling. In any case, the judge gave Roche three months to think over his offer.

- check out the coverage in Business Week
- read the story at CNN Money

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Amgen calls Roche 'snake-oil salesman'

Wed, 20 Feb 2008 06:59:56 -0500

No way, Roche. Amgen rejected a royalty offer from the Swiss drugmaker, which wants to sell an anemia drug that would compete against Amgen's signature blockbusters. Mircera, Roche's version, was approved by the FDA in November, but a jury ruled that the drug would infringe on Amgen's patents. Despite a juicy royalty offer of some 20 percent--twice that paid by Johnson & Johnson for its Procrit med--Amgen is holding fast.

In fact, according to court documents, the California company is scrapping for the fight. After likening Roche to a "snake-oil salesman," Amgen says in court documents, "The only thing more astonishing than Roche's false assertions of its public interests is it chutzpah now in proposing that the Court order a license at a royalty rate of 20 percent."

Amgen calls that figure "grossly inadequate"--language that should be familiar to Roche, which heard the same about its first offer to buy Ventana. Only after sweetening that deal did Ventana give its OK to the sale. And as of yesterday, it was a done deal.

- see the story in Forbes
- check out the snake oil item at the WSJ Health Blog
- read Roche's press release on the Ventana merger

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Roche gets Mircera nod, but no launch

Thu, 15 Nov 2007 06:59:55 -0500

It's a victory, but there won't be any party. Roche got the FDA's blessing for its anemia drug Mircera--an event long anticipated by the Swiss drug maker. Instead of moving Mircera quickly onto store shelves as Roche had hoped, however, the company is reeling from last month's setback in its patent infringement case against Amgen.

Roche may appeal the recent Amgen ruling. Mircera has already been launched in four European countries and in the U.K., and more overseas launches are on their way. But if Amgen succeeds in getting a permanent injunction against Mircera, Roche won't be able to sell the drug in the U.S. until at least 2012. That would be quite a setback. At least Roche won't have to contend with much suspense. The injunction hearing is scheduled for this afternoon.

- see Roche's release
- read this report
- take a look at this Forbes article

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Amgen wins patent fight with Roche

Wed, 24 Oct 2007 06:59:58 -0400

Roche's siege on Amgen anemia-drugs territory is ending with a whimper. A jury ruled that the Swiss drug maker's Mircera product infringes three Amgen patents. Short of "evaluating its legal options" in hopes of a valid appeal, there's little Roche can do to fight back now.

Roche had hoped to roll out Mircera in the U.S. this year. Roche has already introduced Mircera in several EU countries; it expects FDA approval for the drug next month. But armed with its validated patents, Amgen now plans to seek an injunction to stop the product Stateside. Mircera would compete with Epogen and Aranesp, which remain Amgen's cash-cow drugs even as debates rage over their safety.

- see Amgen's release
- read Roche's statement
- see this story from the Los Angeles Times

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Amgen flexes for Roche showdown

Thu, 18 Oct 2007 06:59:55 -0400

"Did I just meet with the mob?" It's not a question you'd expect to hear after a pharma rep comes to call. But according to the New York Times, Amgen is playing hardball to protect its anemia drugs as Roche prepares to launch a competing product, Mircera, next month.

Already, the companies are embroiled in a patent suit; a judge has ruled that Mircera oversteps the bounds of one Amgen patent, so Roche has lots of persuading to do. Meanwhile, the two companies have been conducting "war games" to prep for an anemia showdown. And Roche has been mulling a pricing strategy that would buy market share by increasing the cut for wholesalers and dialysis centers that choose Mircera.

Whose tactics will win? We'll only find out if Mircera makes it to market. A new patent trial is scheduled to start in December.

- see the article for more

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Read more on: Amgen | Roche | Anemia drugs

SPOTLIGHT: Amgen, Roche square off

Tue, 04 Sep 2007 06:59:52 -0400

Amgen and Roche head into court today to continue their fight over anemia drugs. Roche wants to market Mircera, its treatment for the malady, but Amgen claims the drug violates Amgen patents. Last week, Roche thumbed its nose at Amgen, saying it will sell Mircera as soon as the FDA gives its OK--whether Amgen likes it or not. We'll see whether the court has other ideas. Report

Roche: Patent ruling won't stop Mircera

Wed, 29 Aug 2007 06:59:58 -0400

Roche has lost turf to Amgen in their patent battle over Mircera, an anti-anemia drug now under FDA review. A federal judge says that yes, the Roche remedy does infringe on an Amgen patent. Amgen's other patent claims against Mircera are scheduled to go to trial next week.

Amgen, of course, sells the blockbuster anti-anemia drugs Aranesp and Epogen--and they're both crucial to the company's health. In after-hours trading, Amgen was up 1.8 percent on the news; Roche stock had lost 1.8 percent. For its part, Roche says it plans to defy the ruling and launch Mircera in the U.S. as soon as it gets FDA approval. The judge's ruling doesn't affirm the validity of Amgen's patents, the company said in a statement.

- check out this release
- here's the AP report

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