Amgen

Safety fears derail late-stage Amgen cancer trial

John Carroll — Thu, 20 Nov 2008 10:30:10 -0500

Amgen has been dealt a serious blow to its hopes to develop new cancer therapies. Researchers for Amgen and Takeda suspended enrollment in a late-stage trial for motesanib after tracking a higher death rate among patients taking the oncology drug compared to the control group. The data monitoring committee also recommended that patients with squamous non-small-cell lung cancer stop taking the drug. They did not suggest halting treatment of the non-squamous cancer type.

Analysts have been closely tracking the motesanib trial. Amgen ranked it as one of three cancer trials that were expected to deliver key data in 2009 and 2010. Motesanib works by halting angiogenesis, starving cancer tumors of their blood supply.

"While we are disappointed in this outcome, it is consistent with data seen with some other anti-VEGF therapies and appears to constitute a class effect of these types of agents," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Patient safety is our top priority, hence we have acted quickly to implement the recommendations of the DMC. Working with our development partner, Takeda, we will continue to evaluate the therapeutic potential of motesanib in non-squamous NSCLC and metastatic breast cancer, as well as in other solid tumors."

- read the Amgen release
- read the AP story

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's Sharer sees light at end of tunnel

Maureen Martino — Fri, 07 Nov 2008 10:04:42 -0500

Amgen has had a rough couple of years. The world's biggest biotech saw sales of its blockbuster anemia drugs Aranesp and Epogen take a major hit last year when they garnered black box warnings for heart and vascular problems at high doses. And when Medicare--the drugs' biggest buyer--cut reimbursement rates for the drugs, Amgen suffered. The biotech cut 2,600 jobs in 2007 as part of a widespread restructuring aimed at slicing out a billion dollars in expenses.

But in an interview with the Wall Street Journal, CEO Kevin Sharer (photo) says the company's tough times are in the past. "...Amgen is poised to be 'among the top three in revenue growth and earnings growth' in the biopharmaceutical industry over the next five years, a period when many large drug companies will face added pressure because of patent expirations," the WSJ reports.

Key to Amgen's turn-around is the osteoporosis treatment Denosumab. The drug has already been submitted for FDA review and, if approved, could bring in $2 billion to $3 billion in sales a year.

- read the Wall Street Journal article

Amgen, IBM ink $800M contract

Maureen Martino — Fri, 24 Oct 2008 11:36:05 -0400

IBM has signed a five-year, $500 million deal with Amgen to provide provide IT services to the biotech company, including computer networks, software, messaging systems and help desk support. IBM could get an additional $300 million if three extension contracts are exercised. David Polk, a spokesman for Amgen, told Bolder County Business Report that the services will extend to "all 60-plus global facilities."

- see this report

Amgen - Biotech Market Share Report

Maureen Martino — Sun, 28 Sep 2008 20:50:58 -0400

Company: Amgen
2007 Sales: $15.9 billion
Market share: 21.3$
CAGR: 27%

What Amgen has: Amgen has five of the 22 biotech blockbusters currently on the market--tied only with Roche. Marketed by Amgen and Wyeth, Enbrel tops this list as the world's bestselling biologic. The drug is indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and moderate to severe plaque psoriasis. Enbrel, which competes with Remicade and Humira, brought in $5.2 billion in sales in 2007.

Amgen saw sales of anemia drugs Arenesp and Epogen take a hit last year when the two garnered black box warnings for heart and vascular problems at high doses. Still, the second and eighth ranked blockbusters racked up $4.4 billion and $2.9 billion, respectively. Neulasta and Neupogen (which treat a lack of certain white blood cells caused by cancer and chemo) round out the company's blockbusters.

What to watch for: Amgen's next big up-and-coming drug is, of course, the osteoporosis treatment Denosumab. The drug has already been submitted for FDA review and, if approved, could bring in $2 billion to $3 billion in sales a year.

Cytokinetics touts data from heart failure trial

John Carroll — Wed, 24 Sep 2008 11:40:34 -0400

A small mid-stage study has produced positive interim data for Cytokinetics' experimental drug CK-1827452. A full set of data will be delivered to Amgen--which has an option to co-develop the drug--by the end of the year. The developer is pursuing clinical research of the drug's effect on stable heart failure patients, evaluating CK-1827452 for the potential treatment of patients with either acutely decompensated or chronic heart failure. Cytokinetocs announced just a week ago that it was axing a third of its staff so it could concentrate more of its resources to advance CK-1827452.

"The unique mechanism of action of CK-1827452 increases stroke volume without an increase in energy expenditure and holds great promise for the treatment of heart failure," said Dr. John Cleland, professor of cardiology at the UK's Castle Hill Hospital, University.

The interim analyses demonstrated statistically significant correlations between CK-1827452 plasma concentration and increases in systolic ejection time, stroke volume, fractional shortening (each p < 0.0001), cardiac output (p < 0.01), and ejection fraction (p < 0.05).

- check out the Cytokinetics release

RelaCytokineticsted Articles:
Cytokinetics slashes workforce, drops oncology work
Cytokinetics extends GSK collaboration
Cytokinetics forges $75M financing deal

Amgen shares surge on positive D-mab data

John Carroll — Tue, 16 Sep 2008 11:57:40 -0400

Amgen investors had plenty to cheer about this morning after seeing some impressive data on D-mab's ability to reduce fractures among post-menopausal women with osteoporosis. The therapy reduced new spine fractures by 68 percent compared to placebo and reduced hip fractures by 40 percent. The news triggered a 5 percent surge in Amgen stock.

Researchers had already alerted the industry that the study had been a success, but held back the details for this week. Analysts say that an approved denosumab--a twice yearly injection--could be worth two to three billion dollars a year. But observers also note that D-mab is going to have to prove itself against standard therapies in order to reach mega blockbuster status.

On Monday Amgen released data from a study illustrating that patients preferred D-mab to Fosamax and also demonstrated greater increases of bone density.

- read Amgen's release
- check out the report from TheStreet

Amgen putting D-mab data on display this week

John Carroll — Mon, 15 Sep 2008 11:57:51 -0400

After seeing its fortunes rise and fall on the fate of its anemia drugs, Amgen will attempt to turn to a new page with the release of data from 25 studies devoted to its promising osteoporosis drug denosumab. The data blitz will take place at the annual meeting of the American Society for Bone Mineral Research in Montreal. At stake is denosumab's position in a $7 billion market.

Investors clearly believe that Amgen has a blockbuster on its hands. Its shares have risen from less than $40 to more than $60 on the drug's prospects. About 10 million people suffer from osteoporosis and the majority of them are women. Standard therapies have some harsh side effect for many patients, leaving the market open to a new therapy. Long-term safety has yet to be established, of course. Analysts have been looking for a marketing application later this year with an approval likely in 2009.

- check out the report from the Wall Street Journal

FDA approves Amgen's Nplate

Maureen Martino — Mon, 25 Aug 2008 09:38:13 -0400

Amgen has received FDA approval for Nplate for the treatment of immune thrombocytopenic purpura (ITP). ITP is a bleeding condition--which affects about 60,000 people in the U.S.-- that causes the body to attack its own blood clotting cells. The injectable drug stimulates the body's bone marrow, which raises platelet count.

Back in March an expert panel unanimously recommended the drug and Amgen as been waiting for an approval since July. Analysts say the drug could earn between $66 million and $117 million in 2009.

- see Amgen's release
- here's the WSJ report

Wall Street swoons over Amgen's D-mab future

John Carroll — Tue, 29 Jul 2008 12:16:12 -0400

It's been a long time since I've heard the words "love" and "Amgen" in one sentence, but that's the approach the Los Angeles Times took in covering Wall Street's enthusiastic response to D-mab's performance in a recent clinical trial. Oppenheimer's Bret Holley says the drug is on track to break the billion-dollar mark in 2010 with an approval possible in 2009. And that helped send shares of Amgen surging to a 14-month high.

- reaad the story from the Los Angeles Times

Amgen shares buoyed by late-stage D-mab data

John Carroll — Mon, 28 Jul 2008 10:42:31 -0400

Amgen issued some eagerly awaited late-stage data on its bone drug denosumab, which demonstrated a lower risk of spine and hip fractures among women with osteoporosis. Investors rallied behind the company, raising the value of its battered shares by 15 percent after the data hit following Friday's market close.

Amgen badly needs an approval for denosumab to help alleviate an 18-month sinking spell brought on by worse and worse news regarding its anemia drug franchise. And the fresh spate of data is promising to lead the company back to what TheStreet calls the "biotech growth club." The crucial test, says Dow Jones, will come when the full set of data is released in September and analysts can better determine if the therapy can compete effectively with cheaper drugs already on the market.

- check out the report from TheStreet
- read the report from Dow Jones

Amgen and Takeda - Billion-dollar deals

Maureen Martino — Wed, 23 Jul 2008 08:35:21 -0400

Who: Amgen
With: Takeda
What: $1 billion licensing deal

Scoop: 2007 was a rough year for Amgen. Safety problems plagued the company's bestselling anemia drugs Aranesp and Epogen, causing sales of the drugs to plummet. Amgen restructured and cut jobs in an effort to cut expenses in the wake of falling profits. Amgen also said it had more drug candidates in its pipeline than it could develop, and Takeda was willing to take the targets off Amgen's hands. Takeda gained 13 experimental therapies in a deal that may be worth more than $1 billion. The move marks Takeda's entry into the biologics market.

FDA expected to act soon on Amgen’s Nplate

John Carroll — Tue, 22 Jul 2008 11:46:53 -0400

It's down to the nail-biting stage of drug discovery for Amgen's Nplate team. Analysts say they expect a formal decision from the FDA on the blood-clotting drug by tomorrow. And with the endorsement of an expert FDA committee, the betting is going in Amgen's favor. That would be good news for a big biotech player which has been dealt some sharp blows recently.

An approval may well set the stage for some direct competition with Promacta, an experimental therapy from GlaxoSmithKline and Ligand which is also awaiting FDA action. Nplate is an injectable drug intended for long-term use while Promacta is a pill designed for short-term therapy.

- read the AP report

Amgen releases positive denosumab results

John Carroll — Mon, 14 Jul 2008 11:22:18 -0400

Amgen is publishing positive data today for its closely watched Phase III trial of denosumab for the treatment of bone loss in men undergoing androgen deprivation therapy for non-metastatic prostate cancer. Researchers say that in the study of 1,400 men, denosumab "produced statistically significantly greater increases in bone mineral density at the lumbar spine (primary endpoint) and non-vertebral sites compared with placebo at multiple time points. These improvements in BMD were consistent with those seen in other denosumab studies evaluating BMD in women with breast cancer receiving aromatase inhibitor therapy, and in post-menopausal women with low bone mass."

"We are also excited by the reduction in vertebral fractures, which permits the conclusion that the increased BMD seen in patients receiving denosumab is associated with improved bone strength," said Roger Perlmutter, M.D., Ph.D., executive vice president of R&D at Amgen. "We are encouraged by the potential benefit this may represent to prostate cancer patients undergoing ADT for whom bone loss and fractures are serious and under-recognized complications of cancer treatment."

- read Amgen's release

ALSO: India's Jubilant Organosys has forged a drug discovery partnership with Amgen. Story

Denosumab - Next gen biotech blockbusters

Maureen Martino — Tue, 08 Jul 2008 15:56:29 -0400

Drug: Denosumab
Company: Amgen

Scoop: Denosumab is a fully-human monoclonal antibody which Amgen is studying for a number of indications, including osteoporosis, treatment-induced bone loss, bone metastases, rheumatoid arthritis, multiple myeloma and breast cancer. The company has reported results from several Phase III studies, including one in which denosumab performed better than Fosomax in a head-to-head trial.

Amgen hopes to get a cut of the $7 billion osteoporosis market with the drug's approval, and according to one analyst, the drug "could achieve sales topping $2 billion a year if and when approved for both osteoporosis and cancer patients." That would go a long way in turning around the company's fortunes after anemia drug sales took a hit last year. And denosumab is even more important to the company, as it's the only potential blockbuster nearing FDA approval.

Amgen drug positive in cancer trial

John Carroll — Thu, 03 Jul 2008 10:30:36 -0400

Amgen was buoyed by the news that new data demonstrates that motesanib slowed the progression of metastatic thyroid cancer. Out of 93 patients in the study, 49 had a positive response. Volunteers with a BRAF V600E mutation did better than those without the mutation. Report

Amgen's D-mab beats Fosamax in trial

Wed, 28 May 2008 06:59:55 -0400

In a head-to-head trial, Amgen's twice-yearly osteoporosis drug denosumab outperformed weekly oral doses of Merck's Fosamax. D-mab, as it's known, showed greater improvement in bone mineral density in the hip and spine compared to Fosamax. "The novel means by which denosumab inhibits osteoclast-mediated bone breakdown shows the promise of RANK Ligand inhibition," said Javier San Martin, Global Development Lead for the denosumab osteoporosis program.

- see Amgen's release
- read the report for more

A deluge of pre-ASCO data hits the market

Fri, 16 May 2008 06:59:57 -0400

As we mentioned earlier this week, data from almost 5,000 clinical studies was released last night in preparation for next week's ASCO meeting. And some of the most interesting data won't be released until the conference. In the meantime, here's a sampling of the trial results that are making waves today.

Kidney cancer patients taking Novartis' RAD001 (everolimus) had progression of their disease delayed by a year, a significantly better result than in those taking placebo. Release
Amgen's brain tumor drug AMG-102 may only work on a subset of patients. The data is from a small Phase II study of the drug. On a better note, Amgen said denosumab cut the risk of bone fractures in cancer patients, outperforming Novartis' Zometa in an early stage trial. Release
A Phase III trial of Avastin for early-stage colon cancer will be available sooner than previously thought, said Genentech, because of faster data collection and more patients with the disease. Data will be available in 2008--a full year earlier than previously planned. Release
BioVex said data from a Phase II trial of OncoVEX demonstrated an impressive rate and durability of response in patients with advanced metastatic melanoma. Release
Nektar Therapeutics announced results form a Phase I study of NKTR-102. The data shows significant anti-tumor activity in patients with refractory solid tumors. Release

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

Pfizer builds plant, creates jobs in Ireland

Fri, 02 May 2008 06:59:58 -0400

Pfizer has finally confirmed earlier reports about its plan to build a biologics manufacturing facility in County Cork, Ireland. The company is investing €190 million ($297 million) in the new facility and anticipates creating 100 jobs. The plant will manufacture small amounts of biologic treatments for use in Phase II and III cancer and diabetes clinical trials. It will be situated next to Pfizer's other Cork facility and is expected to be completed in 2009.

"Our aim is to gain access to the best science inside and outside our walls, and the new Shanbally facility will ensure that we can produce the product for clinical trials which could ultimately impact the lives of millions of patients," said Nat Ricciardi of Pfizer Global Manufacturing.

Pfizer's investment is good news for Ireland. Late last year Amgen said it would "postpone indefinitely" a planned €800 million manufacturing facility in Cork, much to country's disappointment.

- here's the report for more