Anemia

EMEA advises against anemia meds

Tracy Staton — Fri, 27 Jun 2008 09:32:17 -0400

European regulators are taking a stand against anemia drugs. The European Medicines Agency says cancer patients with a "reasonably long life-expectancy" should get blood transfusions instead of taking the meds, such as Amgen's Aranesp and Johnson & Johnson's Eprex (sold in the U.S. as Procrit). The EMEA guidance follows an FDA advisory committee's recommendation that the drugs shouldn't be given to cancer patients who might be cured. That's because some studies found a link between the drugs and tumor growth.

Analysts were "somewhat surprised" by the EMEA's "aggressive stance" on the meds, the Wall Street Journal Health Blog notes. No doubt it will further erode sales of the drugs, which already have taken a beating because of safety concerns. In Europe, half of anemia med use is in cancer patients, and some 40 percent of those patients could be affected by the EMEA warning.

- read the Health Blog item

Did FDA counsel save Procrit ads?

Tue, 13 May 2008 06:59:56 -0400

Remember that DTC hearing in Congress last week, when Rep. Bart Stupak alleged that Johnson & Johnson kept pushing its anemia drug Procrit as a fatigue-buster, despite the FDA's admonitions? Testimony on the subject came with a bunch of documents, which The Cancer Letter dug through--to find that the FDA's chief counsel may have intervened on J&J's behalf to keep the ads on the air.

The agency had questioned J&J's advertising, saying its implication that Procrit improved strength and perhaps survival was misleading. Somewhere along the line, the Office of Chief Counsel became involved; notes from a 2002 teleconference show that the OCC asked the staff to "try to find middle ground" and to avoid "yanking" the ad campaign. (The chief counsel at the time of the teleconference is now in private practice.) The ads continued to run through 2005. Experts told The Cancer Letter that they think the episode should be reviewed by agency ethics officials.

Meanwhile, a Government Accountability Office report shows that the FDA drags its heels on issuing warning and untitled letters about DTC ads: Six months on average, and in one case, more than three years. Before 2002, when the FDA decided to submit all draft letters for legal review--by the Office of Chief Counsel--they went out in less than a month.

- find the GAO report here
- see the brief in The Cancer Letter
- get more from Pharmalot
- check out the article at FDA News

NC hospital nixes drug-sample handouts

Tue, 13 May 2008 06:59:55 -0400

While drugmakers and the Massachusetts legislature duke it out over the "no pharma freebies" bill, a major North Carolina hospital system has told its docs not to pass on any freebies to patients. Carolinas Healthcare System's 600 physicians aren't allowed to give out drug samples anymore. Zero. Zilch. Nada.

Some patients and doctors "are violently opposed," the physician network's medical director acknowledged. But, he said, the new rule is designed to protect patients, limit liability, and--drum roll, please--decrease the influence of drug companies on prescribing practices. And some doctors in the group already had banned samples and cut back on drug rep visits. "Knowingly or not, it was affecting our practice... and it probably wasn't good for our patients," one said.

As a teaching hospital, Carolinas Medical Center is hardly in the vanguard in banning drug samples. Several others have done so in recent months. One of the motives: protecting tender medical students from undue pharma influence. In the Charlotte Observer's story on the change, one hospital pharmacy director summed up one train of thought: "Who do you want them to learn from--their (faculty) or the drug company representatives?"

- see the article in the Observer

J&J laying off 400 in marketing overhaul

Wed, 30 Apr 2008 06:59:56 -0400

With Procrit under siege, Johnson & Johnson wants to divert its promotional efforts elsewhere--a strategy that will lead to some 400 job cuts in its sales-and-marketing ranks. The company told employees it would consolidate sales-and-marketing operations of Ortho Biotech and Centocor and shave the payroll accordingly.

With Procrit sales sinking ever since the FDA put new safety warnings on its class of anemia drugs, J&J wants to "free up resources that can be redeployed to opportunities that will make the greatest difference to patients and to our own future success as a business." Translation: Heavily marketing Procrit won't help that drug, so why not concentrate sales efforts somewhere we can see some ROI?

- read the Star-Ledger article

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

Related Articles:
Mircera judge seeks expert guidance
Court sends Mircera case to ITC
Roche accepts judge's deal on Mircera
Mircera gets FDA nod, but blocked by patent case
Amgen wins patent fight with Roche

Grassley: Amgen doc rebates skyrocket

Fri, 04 Apr 2008 07:59:57 -0400

Another day, another Grassley letter. You'll recall that earlier this week, Sen. Chuck Grassley demanded documents from Amgen relating to the company's promotions of its anemia drugs. Now, Grassley is asking the company about rebates doctors may have received on those anemia drugs.

A few weeks ago, when an FDA advisory panel met to discuss those anemia drugs and their safety in cancer patients, some of the expert panelists questioned whether Amgen's discounted prices might have encouraged overuse of the meds. Grassley writes in today's letter that a review of some documents previously collected from Amgen found that doctor rebates on Aranesp, one of the anemia drugs, increased markedly from 2004 to 2006. One Alabama cancer center, for instance, got more than $3 million in 2006 compared with $1.3 million in 2004.

The senator is asking for more information on those rebates: how are the amounts determined, for instance? "Some oncology practices in some states are receiving unusually high rebates for purchasing Aranesp," Grassley stated in a press release. "These trends underscore the need for greater transparency in the financial relationships between drug makers and doctors."

- read Grassley's press release (.pdf)
- see the item at Pharmalot

ALSO: Amgen shares dropped yesterday on news of possibly troublesome safety data from a late-stage trial of the osteoporosis remedy denosumab. Report

Related Articles:
Congress probes Amgen, J&J promos. Report
FDA's worst-case anemia scenario. Report
Do anemia warnings signal new limits? Report
Study: Anemia meds hike death risk 10%. Report

Congress probes Amgen, J&J promos

Tue, 01 Apr 2008 07:59:55 -0400

Did Amgen and Johnson & Johnson over-promote their anemia drugs? Congress is asking the companies for documents detailing their advertising and promotions, including a "bundling" discount Amgen allegedly offered to doctors on Neupogen and Neulasta in return for Aranesp scrips. "We are concerned that such 'bundling' practices may have helped fuel excessive and dangerous off-label use of Aranesp," Rep. John Dingell wrote to Amgen in a letter demanding the documents.

Meanwhile, Dingell's Energy and Commerce Committee is also asking J&J for records on its DTC ads for Procrit, which claimed the med could offer "strength for living."

The ad/promo investigation comes at a time when the anemia drugs have been under scrutiny for safety risks. The meds have been linked to increased risk of death at high doses, and have been linked to tumor growth and death risk in certain cancer patients.

- see Dingell's letter to J&J (.pdf)
- check out Dingell's Amgen letter (.pdf)
- read the Boston Globe article

Related Articles:
Amgen--Big Biotech's Stock Report. Report
FDA's worst-case anemia scenario. Report
Do anemia warnings signal new limits? Report
Study: Anemia meds hike death risk 10%. Report
New Medicare cap on anemia drugs could hammer Amgen. Report
FDA: More risks from anemia drugs. 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

Related Articles:
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
Amgen wins patent fight with Roche. Report
Roche: Patent ruling won't stop Mircera. Report
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

Related Articles:
Roche accepts judge's deal on Mircera. Report
Mircera gets FDA nod, but blocked by patent case. Report
Amgen wins patent fight with Roche. Report
Roche: Patent ruling won't stop Mircera. Report
Roche to Launch Mircera in U.K. and Germany. Report

ALSO NOTED: Roche accepts judge's deal on Mircera; Pharma stocks weathered yesterday's craziness;

Tue, 18 Mar 2008 07:59:50 -0400

> Breaking news: Roche said it agreed to a judge's conditions for its launch of the anemia drug Mircera, which Amgen had attacked for patent infringement; the conditions include a higher royalty for Amgen. Report

> How did drug stocks fare in yesterday's crazy market? Erratically, just like most others, but the pharma index ended the day up by 1.25 percent. Report

> EastPharma is buying marketing rights to eight Roche products registered in Turkey, including cardio and central nervous system meds. Report

> Denmark's Lifecycle Pharma is commencing a rights offering of 24 million new shares, with preemptive rights for current shareholders, in hopes of raising $86.5 million. Report

> Glenmark Pharmaceuticals launched five dermatology products designed to treat eczema and psoriasis. Report

> A new computer model developed at the University of California at Los Angeles can identify effective drug combinations and their recommended doses. Report

And Finally... What do you get when you mix 20 drug developers active in the diabetes field with a room full of geneticists? Hopefully, a new generation of therapies that pinpoint subsets of the disease. Report

J&J hikes CEO's pay to $25.1M

Thu, 13 Mar 2008 07:59:58 -0400

Another day, another CEO pay raise. Johnson & Johnson honcho Bill Weldon (photo) nabbed a 22 percent hike in compensation in 2007. Between base salary of $1.73 million, incentive pay of $9.19 million, plus stock awards and options and various miscellaneous perks, he raked in $25.1 million in compensation. In 2006, his package amounted to $20.6 million.

Now, J&J grew sales by nearly 15 percent last year, to $61.1 billion. But profits fell by 4 percent to $10.6 billion, mostly on restructuring charges. And that sales growth came despite falling revenues from the anemia drug Procrit, which attracted safety-related scrutiny during the second half of the year. That med, along with sister products made by Amgen, are on the agenda at an FDA advisory panel today and may see sales limits as a result.

And discussion of J&J's 2007 can't leave out the company's big restructuring plan, which involves cutting up to 4,820 jobs. How, we wonder, do those pink-slipped workers feel about Weldon's raise? We know how shareholders feel: J&J stock jumped by 21 cents to $62.65 yesterday, about a dime of that after the proxy was filed.

- read the article from CNBC

ALSO: A J&J unit warned that some patients using its AIDS drug Prezista developed liver damage and others died; cautionary language about liver injuries was added to the drug's label. Article

Related Articles:
AstraZeneca's CEO sees 19% pay cut. Report
Merck chief got 80% pay hike. Report
J&J CEO talks tech. Report
J&J restructures pharma unit, laying off workers. Report

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

Related Articles:
Mircera--2007 FDA approvals. Report
Amgen calls Roche 'snake-oil salesman.' Report
Mircera gets FDA nod, but blocked by patent case. Report
Roche: Patent ruling won't stop Mircera. Report
Roche to Launch Mircera in UK and Germany. Report

SPOTLIGHT: Analysts bearish on Amgen

Thu, 28 Feb 2008 06:59:52 -0500

Faced with what they see as the likelihood of some significant restrictions on the use of Amgen's anemia drugs--as well as new data on risks associated with the drugs--analysts have been turning distinctly bearish on the biotech giant's stock. Report

Study: Anemia meds hike death risk 10%

Wed, 27 Feb 2008 06:59:58 -0500

The drumbeat of data is getting louder. A new analysis of the blockbuster anemia drugs sold by Amgen and Johnson & Johnson concludes they raise the risk of death among cancer patients by about 10 percent. It's the first meta-analysis to show a statistically significant increase in the risk of death from these drugs, said the lead author of the study, to be published in the Journal of the American Medical Association today.

The FDA is convening an advisory panel March 13 to discuss whether to further restrict the drugs, which already have seen their usage limited by Medicare, the U.S. Department of Veterans Affairs and Canadian regulators. The FDA ordered stronger warnings on the drugs--Amgen's Epogen and Aranesp and J&J's Procrit--last year. Since then, sales have declined by hundreds of millions of dollars.

Monday, the U.K.'s National Institute for Clinical Excellence posted proposed guidelines that advocate their use only in patients with ovarian cancer or in cancer patients whose anemia became life-threatening. The guidance didn't offer changes to the meds' use in kidney patients. NICE is accepting comment on the proposal through March 7.

- see the article in the New York Times
- check out the FDA's advisory meeting announcement
- read the proposed NICE guidelines (.pdf)
- find links to related NICE documents (.pdf)

Related Articles:
Medicare: Right to restrict anemia meds. Report
New Medicare cap on anemia drugs could hammer Amgen. Report
Amgen income hammered as anemia drug use drops. Report
FDA: More risks from anemia drugs. Report
Analyst: Anemia drug warnings 'not bad'. Report

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

Related Articles:
Mircera--2007 FDA approvals. Report
Mircera gets FDA nod, but blocked by patent case. Report
Roche: Patent ruling won't stop Mircera. Report
Roche to Launch Mircera in UK and Germany. Report

Medicare: Right to restrict anemia meds

Mon, 11 Feb 2008 06:59:58 -0500

A Medicare official says there's an even better case now for restricting payments for Amgen and Johnson & Johnson's big anemia drugs. According to the agency's chief medical officer, two more studies have cast doubt on the safety of Aranesp, Epogen, and Procrit, which together generated more than $5 billion in sales in 2007. The drugs are one of the biggest prescription costs for Medicare.

You'll recall that last year, the Centers for Medicare and Medicaid Services restricted its reimbursements for the drugs, after four studies suggested various safety problems, including a higher risk of death for patients using them. Now, the FDA has scheduled a hearing to consider two more studies that suggest the drugs are even more risky for some cancer patients. The companies and the American Society of Clinical Oncology continue to submit evidence for their argument that restricting the anemia drugs will only lead to an increase in blood transfusions.

- read the item at Pharmalot

Related Articles:
New Medicare cap on anemia drugs could hammer Amgen. Report
Amgen income hammered as anemia drug use drops. Report
FDA: More risks from anemia drugs. Report
Analyst: Anemia drug warnings 'not bad'. Report

Amgen reps allege marketing abuse

Mon, 07 Jan 2008 06:59:57 -0500

As if Amgen didn't have enough to worry about with its cash-cow anemia drugs under fire. Now it's not only dealing with document subpoenas from the feds, but defending itself against charges of bull-whipping sales reps into marketing drugs off label and violating patients' privacy.

Last month, a former Amgen rep filed suit against the company, alleging that she'd been fired after refusing to participate in a campaign to boost Enbrel sales by pushing the drug for off-label uses. The company trotted out a list of other reasons why she was let go. Now, another rep has sued, saying he, too, was fired for balking at marketing methods he considered unethical, even illegal.

It started in 2005, as increasing competition for the psoriasis and arthritis drug appeared on the horizon, the suits claim. According to this new complaint, sales reps were told to pull patient files from doctors' offices to identify those who might be steered toward Enbrel--including those with mild psoriasis, for which the drug wasn't FDA-approved. Reps also were told to write letters on doctors' behalf to insurers, to convince them to foot the bill for Enbrel in these patients. Letters about the drug were sent to all psoriasis patients in every cooperating doctors' files. The blog Pharmalot has published an internal Amgen memo about some of these sales practices.

In response to the reps' charges, the company has cited its sales-rep code of behavior, which requires employees to comply with all rules governing drug marketing. The two cases are in arbitration.

- read the item and link to the memo at Pharmalot

Related Articles:
Drug marketing costs double R&D. Report
Too much off-label regulation? Report
MAbs are hottest segment of biotech industry. Report

FDA: More risks from anemia drugs

Fri, 04 Jan 2008 06:59:57 -0500

The FDA dealt another blow to embattled anemia drugs yesterday. The agency revealed two new studies that show cancer patients may be more likely to die while using Amgen's blockbuster drugs Aranesp and Epogen (also sold under the brand name Procrit by Johnson & Johnson).

The drugs, known as erythropoiesis stimulating agents (ESAs), are already under safety review by regulators. In November, new warnings of their cancer risks--that tumors might grow faster and patients may die sooner, according to four other studies--were added to their labels. Other research has shown that ESAs pose increased risk of heart attack, stroke, and heart failure. The risks are greatest with high doses of the drugs, so several months ago, Medicare limited reimbursement to lower doses. Some insurers followed suit.

Now, according to an FDA statement, the agency "may take additional action." If regulators further restrict the drugs, Amgen would be deeply wounded. ESAs account for more than half the company's profits.

- see the FDA release
- get details about the newly released data
- read the article from the Los Angeles Times

Related Articles:
Amgen in new talks over ESA safety. Report
Analyst: Anemia drug warnings 'not bad'. Report
Amgen income hammered as anemia drug use drops. Report
Amgen, J&J win a round in anemia controversy. Report

Pharma noshes at the biotech buffet

Wed, 02 Jan 2008 06:59:55 -0500

If 2007 was the year pharma woke up to biotech, then 2008 will be time for brunch. Drug makers will continue to serve themselves from the biologics buffet, whether by gobbling up entire companies or by snacking on a bit of this candidate and a bit of that one through licensing deals. Plus, back in the R&D kitchen, Big Pharma is working on its own biotech recipes, though none of them are likely to be ready for sampling yet.

There's one potential wrinkle in the tablecloth, though: Reportedly, "momentum is building" for a new FDA pathway for generic biologic drugs (biosimilars). In June, a Senate committee approved legislation that would open that door; now, the House is preparing to consider a similar bill. And biosimilars already are taking hold in Europe. Last week, regulators approved a copycat form of Epogen, the blockbuster anemia drug made by biotech big wheel Amgen.

- here's more about Pharma's anemia-centric love for biotech
- see this article on biosimilar legislation in the U.S.

Related Articles:
Big Pharma makes its big leap into biotech. Report
Lines blur as Big Pharma crosses borders into biotech. Report
Who's next on the biotech buyout hit list? Report
Biotech stocks surge as investors anticipate buyouts. Report

Study finds link from ESAs to leukemia

Tue, 11 Dec 2007 06:59:54 -0500

In another blow to anemia drugs, Mayo Clinic researchers announced today that erythropoiesis-stimulating agents--like Amgen's Aranesp and Epogen, and Johnson & Johnson's Procrit--may cause patients with a bone-marrow disorder to develop leukemia.

The researchers had been studying the risk factors for progression from primary myelofibrosis to leukemia, and in the process uncovered this link to ESAs. Though the lead investigator said the study results need to be validated in other trials, he also said that the findings should be taken into account when doctors and patients are deciding whether to use the drugs.

- check out this release

Related Articles:
Top 10 drug warnings and recalls of 2007. Report
Amgen in new talks over ESA safety. Report
Analyst: Anemia drug warnings 'not bad'. Report
Amgen income hammered as anemia drug use drops. Report