Epogen

New drug-spending leader: Diabetes

Thu, 15 May 2008 06:59:58 -0400

New data on pharma sales details some big shifts in spending. Diabetes meds have displaced cholesterol drugs as the leading drivers of spending growth, for one thing; generic competition is reining in cholesterol costs even as usage of the meds is increasing. Meanwhile, there's been growth in overall diabetes-drug use, and a shift toward pricier treatments, boosting 2007 spending by 12 percent. Overall drug spending grew by only 2 percent last year as patients used more generics.

Plus, safety concerns affected spending on antidepressants, hormone replacement therapy, and anemia drugs, Medco Health Solutions reports. Safety warnings on Procrit, Epogen, and Aranesp depressed sales by 15 percent, while hormone replacement therapy usage dropped by 9.2 percent. Suicide-risk warnings (and generic competition) hampered growth in the antidepressant market.

A separate report from IMS Health showed that the global market for cancer meds is advancing by leaps and bounds, twice as fast as the growth in all other pharmaceuticals. As emerging countries spend more on healthcare, they're investing more in cancer treatments; they're expected to power up spending on these meds by 12 to 15 percent a year through 2012. The overall global drug market, by contrast, is expected to grow by 6.4 percent.

- find the news at the Wall Street Journal Health Blog
- see the Pharmalot item
- check out the story from the Associated Press
- read the article at CNN Money

AZ, Amgen earnings flat; Shire sales leap

Fri, 25 Apr 2008 06:59:54 -0400

It's a mixed bag of drugmaker earnings reports today, with two biggies posting flat results and two smaller firms chalking up respectable gains.

AstraZeneca's profits suffered under restructuring costs and falling Nexium sales, reporting a $2.1 billion gain, 5 percent less than the same quarter last year. Sales were 10 percent higher at $7.7 billion, but much of that increase came from the weak dollar. Analysts and shareholders were unimpressed; UBS wrote that the "ramifications of [the first quarter results] could be far reaching."
Amgen's earnings were mostly flat: Net income of $1.14 billion compared with $1.11 billion a year ago, with accounting charges eating into earnings. Revenues, however, slid by 2 percent, to $3.61 billion. No big surprise, considering that sales of its biggest drug, Aranesp, free-fell by 25 percent; it and its sister med Epogen have been hamstrung by safety concerns for months now.
U.K. specialty pharma Shire posted a 33 percent hike in sales to $702 million, slightly ahead of analyst expectations. EPS was up to 22.7 cents from 21.3 cents during last year's first quarter. One sour note: The company estimated that its Vyvanse ADHD drug--which the company hopes will replace its soon-to-go-off-patent Adderall--would generate sales on the "lower end" of its predicted range of $350 million to $400 million.
Ireland's Elan also posted a big increase in sales--22 percent, to $214.7 million--but still reported a loss of $85.5 million. At least the loss is smaller than last year's $93 million. The revenue increase came from surging sales of its lead drug, the MS treatment Tysabri it co-markets with U.S.-based Biogen Idec.

- see the AstraZeneca piece in the Financial Times
- check out MarketWatch's story on Amgen
- read the Shire article at Orange
- find Elan's numbers in Forbes

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

FDA panel votes to restrict anemia drugs

Fri, 14 Mar 2008 07:59:58 -0400

Look on the bright side: It could have been worse. An FDA advisory panel voted to keep Amgen and Johnson & Johnson's anemia remedies on the market for cancer patients. So the drugs appear to have dodged the feared silver bullet, an outright revocation of that indication; FDA generally follows its panels' advice, but isn't required to.

The bad news--and there is bad news--is that the drugs' use could be severely limited. The panelists voted to restrict them to patients with uncurable cancers. Under the recommendations, the drugs wouldn't be approved for patients with breast cancer or with cancers that affect the head-and-neck region; studies show it's those patients that are most at risk for severe side effects, which include accelerated tumor growth and shortened survival.

One analyst estimated that the restrictions could shave off 40 percent of Aranesp's sales. Another said Amgen and J&J each would lose about a third of their market in cancer patients. Amgen, of course, is more dependent on the drugs; Aranesp is its top seller, and together Aranesp and Epogen (marketed mostly for kidney patients) account for $6.3 billion in sales. J&J's Procrit brought in $2.9 billion last year, but that's just a small fraction of the mega-pharma's $63.6 billion in overall revenues. Sales of the drugs had already been dropping because of safety concerns, prompting job cuts at both Amgen and J&J.

What's next? FDA will have to mull the panel's choices and make its own decisions. Then we'll be watching Medicare to see if it sharply restricts reimbursements for the drugs' use in cancer patients.

- check out the Los Angeles Times story
- read the New York Times article
- see the Forbes market report

ALSO: Yesterday, we reported that J&J CEO William Weldon chalked up $25.1 million in pay last year, relying on the Associated Press' calculations. Well, the Wall Street Journal comes up with a different figure, and it's even more eye-popping: $31.9 million. Report

Related Articles:
FDA's worst-case anemia scenario. Report
Study: Anemia meds hike death risk 10% Report
Amgen in new talks over ESA safety. Report
Medicare upholds anemia drug cuts. Report
Epogen/Aranesp-Top 10 Warnings and Recalls. 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

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

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

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

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