Aranesp

Amgen touts pipeline at investor meeting

Maureen Martino — Mon, 10 Nov 2008 09:22:19 -0500

Amgen's top management touted the company's strategy and pipeline at a meeting of Amgen securities analysts and investors in New York City. "Over the next five years we could have three more drugs achieve blockbuster status: Sensipar, denosumab for osteoporosis and denosumab for cancer-related indications," said Amgen CEO Kevin Sharer (photo). The much-anticipated denosumab for osteoporosis--which could bring in anywhere from $2 billion to $10 billion a year--has been submitted to the FDA. Final approval of that drug is expected late this year or early 2009.

Amgen also said it is anticipating 17 key Phase II and III clinical study results in 2009 and 2010, including for denosumab (oncology), AMG 386 and AMG 655 for various cancer indications, and its Sensipar/Mimpara trial, an outcomes study in dialysis patients. Execs noted the company's pipeline swelled to 50 molecules in 2008 from just 20 in 2001.

It wasn't all good news, however. George Morrow, Amgen's executive vice president for Global Commercial Operations, predicted a further 10 to 20 percent decline in Aranesp sales before they stabilize. Neulasta/Neopogen will also be facing generic competition in Europe.

- see Amgen's release for more
- here's the Seeking Alpha article

ALSO: Amgen is already preparing for the launch of denosumab, even though the med hasn't made its way through the FDA yet. Report

Amgen CEO: "I felt real economic pain"

Thu, 08 May 2008 06:59:58 -0400

What do you do when your biggest therapeutic earners are swooning, your stock price is down and analysts have turned scornful? Look for that silver lining. That was Amgen CEO Kevin Sharer's approach yesterday when he was confronted by an angry horde of shareholders at the company's annual meeting. While conceding that last year was 'awful,' the chief executive of one of the biggest biotechs in the world said Amgen was off to a good start in '08. And those troubles the company is facing aren't really all that different from the woes faced by other big drug companies.

It was a tough sell. Even with his income down by 29 percent compared to 2006, steamed shareholders questioned Sharer's $13.2 million in compensation ($19 million according to SEC filings), his driver and car and use of the company plane.

Hey, responded Sharer, his shares are down too. "I felt real economic pain," he told the group. With Amgen shares down 30 percent from the 52-week high and Aranesp sales off by 20 percent, there was plenty of pain to go around the room.

- check out the article from the Los Angeles Times

ALSO NOTED: Dr. Reddy's buys small molecules biz; Labopharm appeals FDA decision; Avant touts typhoid fever data; and much more

Tue, 01 Apr 2008 07:59:50 -0400

> Dr. Reddy's has struck a deal to buy a portion of Dowharma's small molecules business in the UK. Report

> Labopharm has appealed the FDA's decision on its once-daily formulation of tramadol. Report

> Avant Immunotherapeutics says that an experimental typhoid fever vaccine--Ty800--met all primary endpoints in a mid-stage trial. Release

> Monogram Biosciences has inked a deal with Progenics Pharmaceuticals to provide resistance and tropism testing for Progenics' clinical development program of PRO 140, an investigational CCR5 monoclonal antibody being studied for HIV. Release

> VWR International has acquired the lab equipment supplier Jencons for an undisclosed sum. Report

> Here's a big strike against one strategy for protecting drug prices. A European Union advocate general said GlaxoSmithKline violated antitrust laws when it refused to fill Greek wholesalers' orders in a bid to prevent parallel importation. Report

> 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. Report

> Mylan CEO and Vice Chairman Robert Coury (photo) brought down $10.3 million during fiscal 2007, which ran only nine months because the drugmaker changed its fiscal year. Report

> The Vytorin onslaught continues, with Congressional committees circling and secret emails surfacing. Report

And Finally… The largest survey ever of American physicians' opinions on healthcare financing has found that 59 percent of doctors support government legislation to establish national health insurance while only 32 percent oppose it. Release

Amgen forecast darkens as FDA review looms

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

The FDA couldn't have scheduled today's meeting on the risks posed by Amgen's anemia drugs at a worse time. With the market opening to a new raft of chilly economic reports, analysts covering Amgen were in a particularly dour mood about Amgen's chances. Christopher Raymond at Robert W. Baird predicted more restrictions on the use of its multibillion-dollar drugs, which would further eat into the biotech company's revenue. And FBR Capital's Jim Reddoch wouldn't even rule out a vote to remove Aranesp from the market--a worst-case scenario that would inflict major damage at a company that has been working to build up a pipeline of new therapies needed to rescue its bottom line.

Amgen officials, though, will fight this battle over the $6 billion market to the bitter finish.

"ESAs provide an unequivocal treatment benefit for cancer patients undergoing chemotherapy by reducing the need for blood transfusions," said Roger M. Perlmutter, Amgen's executive vice president of research and development.

- see Amgen's release
- read the story from CNN
- and check out the Dow Jones report

Related Articles:
Epogen/Aranesp--Top 10 Warnings and Recalls. Report
FDA's worst-case anemia scenario. Report
Do anemia warnings signal new limits? Report
Study: Anemia meds hike death risk 10%. Report
FDA: More risks from anemia drugs. Report

ALSO NOTED: Light Sciences withdraws IPO; Medicare to restrict anemia meds?; and much more...

Mon, 11 Feb 2008 06:59:50 -0500

> Light Sciences Oncology has withdrawn its IPO registration, citing "unfavorable market conditions." Report

> 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, 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. Report

> Back off, Seroquel imitators. So says AstraZeneca, which is pursuing a summary judgment in its patent fight with Teva Pharmaceutical Industries. Teva has threatened to launch a copycat version of the antipsychotic med as early as next month. Report

> The watchdogs are circling DTC drug commercials. Report

> Check out this list of the most-visited drug websites. Report

And Finally... Even de-fanged botulinum toxin may still be toxic to some people. The FDA says Botox and its sister med Myobloc have been linked to serious reactions, including death. Report

ALSO NOTED: Anemia drugs back in the spotlight; Biodel completes VIAject enrollment; and much more...

Fri, 04 Jan 2008 06:59:50 -0500

> The FDA has 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). Report

> Biodel has completed enrollment of its two Phase III clinical trials of VIAject, an injectable meal-time insulin for use by patients with Type 1 and Type 2 diabetes. Release

> Chutes & Ladders: Pharmos has made a number of changes to its board of directors and management. Release

> Chutes & Ladders: ViroPharma has appointed Thomas F. Doyle as vice president, strategic initiatives. J. Peter Wolf has been promoted to vice president, general counsel and secretary of the Board of Directors. Release

> So far, personalized medicine isn't perfectly personalized. New data shows that diagnostic tests to determine whether women should take certain breast cancer drugs have a failure rate of up to one-quarter. Report

> At a Morgan Stanley pharma conference yesterday, Schering-Plough CEO Fred Hassan was quizzed and requizzed by investors about the Vytorin-Zetia controversy. Report

> It's increasingly apparent that some of our most-lauded new oncology agents carry pretty serious baggage: they can cause heart attacks. Report

And Finally... The pharmaceutical industry spends twice as much on marketing and promotion of drugs as it does on R&D. Report

Amgen platelet therapy hits endpoint in Phase III

Mon, 10 Dec 2007 06:59:54 -0500

A day after seeing its stock take a nasty dive on more bad news related to Aranesp, Amgen reported on Saturday that a late-stage study of romiplostim for increasing platelet levels in patients with Immune Thrombocytopenic Purpura hit its primary endpoint. In data revealed at the American Society of Hematology's annual meeting, researchers said that 38 percent of patients taking the drug had a sustained platelet response and patients were able to reduce or stop taking other drugs for the condition. More romiplostim data will be released today on another group of patients. Out of the 42 patients taking the therapy 26 percent needed other ITP meds to increase their platelet count compared to 57 percent of the patients taking a placebo.

- see this release on the data
- check out the report from TheStreet

ALSO: Take a look at Amgen's pipeline. Report

Related Articles:
Amgen in new talks over ESA safety. Report
Amgen discusses the future with analysts. Report
Amgen in crisis? Not us, says CEO Sharer. Report
Amgen stock slips as anemia drug concerns rise. Report

Aranesp flunks late-stage trial for breast cancer

Mon, 03 Dec 2007 06:59:55 -0500

Good news is hard to come by at Amgen. The company's slipped on Friday after the biotech giant announced that its fading anemia blockbuster Aranesp failed a late-stage study for breast cancer. Combined with chemotherapy, there was no indication that the combinatorial approach helped shrink tumor sizes in early-stage breast cancer victims. And in the long-term follow-up, researchers said that there were more deaths and tumor progression in the Aranesp group than in the control group. Amgen has been restructuring as it deals with a cutback in the use of anemia drugs.

- see this release
- check out the report on the trial

Related articles:
Amgen touts new Aranesp studies. Report
Amgen in crisis? Not us, says CEO Sharer. Report
Amgen stock slips as anemia drug concerns rise. Report
Amgen makes big workforce, budget cuts. Report

Mircera gets FDA nod, but blocked by patent case

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

The FDA has approved Roche's anemia drug Mircera, but don't look for any big new product launches soon. Last month Amgen won a patent infringement case on the therapy. And Roche is studying its options--including a possible appeal of the case. In the meantime, Mircera is already available in a long lineup of countries that include Sweden, Germany and the UK.

- see Roche's release
- read the AFX report on Mircera

Related Articles:
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 wants more data on new Aranesp doses. Report

Amgen income hammered as anemia drug use drops

Fri, 26 Oct 2007 06:59:58 -0400

With sales of Aranesp and Epogen on the decline, biotech giant Amgen is feeling the impact right where it hurts the most: The bottom line. Third quarter profit for the company plunged 82 percent as Amgen accounted for restructuring costs resulting from fading sales. And CEO Kevin Sharer laid the blame at the feet of regulators who are ratcheting back on the use of the blockbuster anemia drugs. Sales of Aranesp plunged 23 percent to $818 million. Notably, Medicare wasn't the only payer to reduce reimbursements. Privately insured patients reduced their use of the drug by 30 percent to 40 percent--a key indicator of just how damaging federal regulations can be. Amgen announced plans to lay off 2,600 workers to account for the sudden change in fortunes in its anemia business. Amgen is paying a high price for years of complacency in relying on its anemia franchise instead of being more aggressive about developing new therapies that could add to the company's revenue stream.

- here's the report from The Wall Street Journal

ALSO NOTED: CHMP issues negative opinion on Zavesca;Wyeth CEO discusses the FDA; and much more...

Fri, 19 Oct 2007 06:59:50 -0400

> The Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion for the extension of indication on the use of Actelion's Zavesca. Actelion said it will request a re-examination of the CHMP opinion. Release

> With the FDA in CYA mode, drug makers are having to leap through more hoops to get their products approved--at least that's the opinion of Wyeth CEO Robert Essner and CEO-to-be Bernard Poussot. Report

> The FDA has issued a new warning for three popular ED drugs. Report

> It's an anemia-drug pile-on: Aetna has tightened up its reimbursement rules for Aranesp, Epogen, and Procrit--and analysts believe it will be the first of many private insurers to make the move. Report

> Inspired by Avandia's woes, UK stock analysts are playing a dirge for GlaxoSmithKline's earnings, which are due out next week. Report

> A new imaging probe has highlighted how the human body's hunger pathways operate, illustrating how new therapies could be developed to tame obesity. Report

And Finally... Researchers at UC San Francisco are focusing on a group of genes that not only influence longevity but also reduce the risk of cancer. Report

ALSO NOTED: Zingo data lifts Anesiva stock; Two chemo drugs win approvals; BrainStorm plans trials; and much more...

Wed, 17 Oct 2007 06:59:50 -0400

> Shares of Anesiva jumped after the company announced positive top-line data from a late-stage study of Zingo, its drug candidate for reducing venous procedural pain. Report

> Bristol-Myers Squibb has won the FDA's approval for the chemo drug Ixempra for breast cancer. Report

> The FDA has approved Abraxis Pharmaceutical's chemotherapy drug Epirubicin hydrochloride injection in four dosage forms. Report

> Israel's BrainStorm Cell Therapeutics says it's likely to do clinical trials of its adult stem cell therapies in New York City. Report

> Sorry, Amgen and Johnson & Johnson. So says the FDA, which is backing up Medicare's new limits on using the companies' anemia drugs Aranesp, Epogen, and Procrit. Report

> You can't accuse pharma companies of failing to think ahead. They begin to forge links with future doctors before they even start med school. Report

And Finally... In what is likely to provide a big push for antibiotic developers, a new study by the CDC shows that almost 19,000 Americans were killed by the MRSA superbug last year, making it more lethal than AIDS. Report

SPOTLIGHT: Amgen touts Aranesp data

Wed, 26 Sep 2007 06:59:53 -0400

Fighting to retain its multibillion-dollar market in anemia drugs, Amgen has released new data that shows Aranesp is safe and effective for treating anemia in cancer patients. Report