Aranesp

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

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

Emerging markets drive global growth

Wed, 16 Apr 2008 06:59:56 -0400

Without emerging healthcare markets like China and India, global pharma would be in a world of hurt. The global market for meds reached $712 billion last year, according to a new report from IMS Health, up $178 billion over five years before. But the rate of growth is slowing--6.4 percent compared with 11.8 percent in 2001. And without the big engines in Asia, that figure would be lower still. China, South Korea, and India grew by 25.7 percent, 10.7 percent, and 13 percent respectively. Russia and Turkey, 20.2 percent and 17.2 percent. The U.S.? Just 3.8 percent.

The IMS report also included the top 10 sellers worldwide (drum roll, please):

Lipitor, $13.5 billion, Pfizer
Plavix, $7.3 billion, Sanofi-Aventis
Nexium, $7.2 billion, AstraZeneca
Seretide/Advair, $7.1 billion, GlaxoSmithKline
Enbrel, $5.3 billion, Amgen and Wyeth
Zyprexa, $5 billion, Eli Lilly
Risperdal, $4.9 billion, Johnson & Johnson (Janssen)
Seroquel, $4.6 billion, AstraZeneca
Singulair, $4.5 billion, Merck
Aranesp, $4.4 billion, Amgen

Note that Aranesp made the top 10 despite a 12.9 percent drop in sales on safety worries. And the biggest gainer of the year was Plavix, the anti-clotting med; it racked up a 20.5 percent increase in sales.

- see the item at Pharmalot

ALSO: In response to the growing overseas market, DIA is opening an office in India. Release

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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

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

FDA's worst-case anemia scenario

Wed, 12 Mar 2008 07:59:56 -0400

Here's a peek into the FDA playbook for tomorrow's advisory panel on Amgen and Johnson & Johnson's anemia drugs. According to documents posted on the agency website, those expert advisors will be asked to consider several limitations on the meds, which have been linked to increased tumor growth and reduced survival among some cancer patients. And the options include yanking FDA approval for that use.

Other possible measures include using the meds only in patients with incurable cancer or certain types of tumors, restricting distribution of the drugs, limiting advertising and promotion, and requiring informed consent.

If the panel recommends cutting off the cancer indication, that would be a huge loss for both companies. Amgen's Aranesp alone sold about $3.61 billion last year--and more than $2.1 billion of that was for use in cancer patients. Though the drugs would stay on the market--they're widely used in kidney-failure cases--and could be prescribed off-label to cancer sufferers, the safety concerns might curtail those scrips and the insurance reimbursements for them.

For those of you who'd like to dig deeper into the FDA's briefing documents for tomorrow's meeting, check out In Vivo's analysis: The blog looks at some arcane metrics for risk-management programs, which the FDA is newly empowered to institute. Funnily enough, the metrics all seem to add up to one thing: Risk management should lead to decreased sales.

- find the FDA's briefing documents (.pdf)
- check out the New York Times article
- read the story in the Wall Street Journal
- see In Vivo's analysis

Related Articles:
Do anemia warnings signal new limits? Report
Study: Anemia meds hike death risk 10%. Report
Medicare: Right to restrict anemia meds. Report
New Medicare cap on anemia drugs could hammer Amgen. Report
FDA: More risks from anemia drugs. Report

Do anemia warnings signal new limits?

Mon, 10 Mar 2008 07:59:58 -0400

Is it a pre-emptive strike? Late Friday Amgen added new warnings to the embattled anemia drugs Aranesp (Amgen) and Procrit (Johnson & Johnson). The labeling for those drugs now warns that they sped up tumor growth and increased the risk of death in patients with breast cancer and cervical cancer. The additional "black box" warnings came less than a week before an FDA advisory committee meeting where experts will review safety data for the drugs.

The anemia meds have been under public scrutiny since last March; since then, the FDA, Canadian regulators, the Center for Medicare Services, and the Department of Veterans Affairs all have issued warnings or restrictions on the use of the drugs. Sales of the drugs have fallen off by a quarter, and Amgen's shares have dropped by some 27 percent.

Most analysts are expecting sales to drop further after Thursday's advisory panel meets. The group could recommend halting use of the drugs for certain cancers or in all cancer patients. Even if the FDA cuts off only some cancer indications, Amgen's anemia drug sales could lose between $150 million and $250 million, one analyst said. The effect would be worst if FDA changes led to tougher restrictions from Medicare, which last fall stopped reimbursing docs who administer the drugs unless they're given at low doses.

Amgen scientists are expected to fight against new limits by arguing that any safety problems have arisen in patients given higher-than-recommended doses. Also, the company contends that the drugs' risks don't outweigh the hazards of the alternative treatment: blood transfusions.

- read the report from the Houston Chronicle
- check out the AP article
- see the analysis in Business Week

ALSO: Amgen CEO Kevin Sharer said last year was the most difficult in Amgen's history. "This is the most challenging time," he told The Wall Street Journal in a Q&A published today. Sharer also talked about innovation and new drugs.

- find the Q&A in the WSJ

Related Articles:
Study: Anemia meds hike death risk 10%. Report
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