Magazine
#1 Amgen
One Amgen Center Dr.
Thousand Oaks, CA 91320-1799
Tel: (805) 447-1000
Fax: (805) 447-1010
www.amgen.com
| Headcount | 18,000 | |
| Year Established | 1980 | |
| Biopharma Revenues | $12,022 | +20% |
| Total Revenues | $12,430 | +18% |
| Royalty Revenues | $408 | -29% |
| Net Income | $3,670 | +55% |
| R&D Budget | $2,314 | +14% |
| Drugs Approved/Launched |
|
| Drug | Indication |
| aranesp | anemia of chronic renal disease, chemotherapy-induced anemia |
| enbrel | ankylosing spondylitis, moderate-to-severe juvenile rheumatoid arthritis, moderate-to-severe plaque psoriasis |
| epogen | anemia of end-stage renal disease |
| kepivance | severe oral mucositis in patients with hematologic cancers undergoing bone marrow transplant |
| kineret | rheumatoid arthritis |
| neulasta | extend first-cycle protection from infection to cancer patients receiving moderately myelosuppressive chemotherapy |
| neupogen | neutropenia |
| sensipar | hyperparathyroidism in end-stage renal disease, hypercalcemia of parathyroid carcinoma |
| Drugs Pending Approval |
|
| Drug | Indication |
| panitumumab | colorectal cancer |
| aranesp |
extended dosing for chemotherapy-induced anemia |
| Drugs in Phase IIb and Beyond | |
| Drug | Indication |
| amg 531 | immune thrombocytopenic purpura |
| aranesp | anemia of cancer in patients not receiving chemotherapy, cardiovascular disease in patients with chronic kidney disease and type 2 diabetes |
| denosumab | bone loss induced by hormone ablation therapy for breast cancer or prostate cancer, postmenopausal osteoporosis, prolonging bone metastases-free survival |
| kepivance | oral mucositis associated with radiation therapy and chemotherapy for solid tumors |
| sensipar | secondary hyperparathyroidism in chronic renal insufficiency |
| Early Research Projects |
|
| Drug | Indication |
| amg 076 | obesity |
| amg 102 | oncology |
| amg 221 | type 2 diabetes |
| amg 317 | asthma |
| amg 386 | oncology |
| amg 403 | pain |
| amg 479 | oncology |
| amg 517 | pain |
| amg 623 | B-cell chronic lymphocytic leukemia |
| amg 655 | oncology |
| amg 706 | oncology |
| amg 951 | oncology |
| Top Selling Drugs |
|||
| Drug | Indication |
Sales |
(+/-%) |
| aranesp | chemotherapy-induced anemia | $3,273 | +32% |
| enbrel | rheumatoid arthritis, psoriatic arthritis | $2,573 | +35% |
| epogen | anemia | $2,455 | -6% |
| neulasta | chemotherapy-induced neutropenia | $2,288 | +31% |
| neupogen | chemotherapy | $1,216 | +3% |
Account for 98% of total biopharma sales, down from 99% in 2004.
PROFILE
One more year! Last year, I asked if Amgen's days of 20% annual growth were behind it, and the company went off and delivered a 20% bump in biopharma sales in 2005. The increase was fueled by its two main anemia drugs, Aranesp and Neulasta, and rheumatoid arthritis and psoriasis treatment Enbrel, making Amgen the first Biopharma to cross the $10 billion mark (if we combined our Top Companies lists, Amgen would rank #13 overall). In 1Q2006, sales grew "only" 14% to $3.1 billion, led by a 24% jump for Aranesp to $893 million.
While none of those key drugs are long in the tooth, relying on three products is dicey for any company (especially since Enbrel is in a highly competitive class of drugs). Amgen has been conducting trials to broaden Aranesp's label into the cardiac field, trying to establish a connection between anemia and symptomatic heart failure. In a June 2006 announcement, the company indicated that a mid-stage Phase II trial didn't show statistically significant improvements in patients, but that the data (involving 319 people) would be incorporated into the 3,400-person study to see if there is a benefit in treating heart failure with Aranesp.
Of course, with all this talk of Aranesp, Neulasta and Enbrel, I'm overlooking Amgen's first-generation drugs which "only" account for $3.6 billion in 2005 sales, enough to rank #3 on the Top Biopharma list by themselves. Still, Epogen and Neupogen have seen their best days, and will likely decline or post very modest gains next year.
| THE LOWE DOWN Amgen has been living in a different world than the small-molecule pharma companies, and don't they just know it. The company coined money while others glared at it and muttered about how, well, sure, they wished that generic companies couldn't figure out how to make their drugs when they went off patent too (grumble grumble). But that, of course, looks to be changing -- at least over in Europe, where some serious challenges are coming in the EPO business. And Amgen's stock, which for some time has also been living in a different world, seems to be joining the rest of the industry this year. Outside of the generic worries, the fact that Enbrel sales have been huge isn't helping the company, because back when they bought Immunex, Enbrel sales were supposed to be, well, even bigger than huge by now. So Amgen finds itself worrying about generic competition, fighting to keep its patent space, spending a lot of money to extend the indications of its existing drugs . . . this all sounds very familiar, somehow . . . Face it, folks: you're a drug company. Welcome, at long last, to the club. --Derek Lowe |
Fortunately, Amgen has several strong candidates waiting in the wings. In March 2006, Amgen completed the rolling BLA for panitumumab in the treatment of metastatic colorectal cancer in patients who have failed prior chemotherapy. Two months later, the FDA gave it Priority Review status, so a decision will be forthcoming within six months of the filing date. Panitumumab belongs to the same class of drugs as Erbitux and Tarceva, and will also compete with heavy-hitter Avastin in the colorectal cancer indication. Amgen has predicted that its drug will reach the pass the $2 billion mark in annual sales.
Amgen's other blue-chip prospect is denosumab, an osteoporosis treatment not expected to reach the market until 2008/9 (around the time the patent expires on market-leading Fosamax). Denosumab is projected to be a huge moneymaker for Amgen, since it has the potential to replace the weekly pill regimen of existing treatments with a semi-annual injection.
Not every Amgen product is a billion-dollar blockbuster. Some products take time to grow. Sensipar, the small-molecule treatment for lowering of serum calcium, posted $167 million in 2005 sales (its first full year) and $61 million in 1Q2006 (+126%). Nothing to sneeze at, but it's rarely mentioned when people talk about Amgen's roster. (On the other hand, Kepivance (oral mucositis), in a partial year, posted negligible sales. And where's Kineret?)
Room To Grow
Amgen is still catching up with its growth curve, adding new facilities and expanding existing ones. In September 2005, the FDA licensed Amgen's new sites in West Greenwich, RI and Juncos, PR to manufacture Enbrel and bulk Neupogen, respectively. In January 2006, the company announced plans to boost spending in manufacturing and R&D. The investments include $1 billion for new process development, bulk and fill/finish facilities in Cork, Ireland; expansion of R&D sites in Cambridge, MA, San Francisco, Seattle and Cambridge, UK; and a new development site in Uxbridge, UK. Amgen mentioned that it may expand operations into Japan, Australia, Canada and other countries in future. A week after that announcement, Amgen added $1 billion to its expansion plans in Puerto Rico, which includes existing manufacturing facilities in Juncos and a new formulation and fill/finish site.
In June 2006, Amgen made plans to add administrative positions at its site in Longmont, CO in part because headquarters in California is maxed out at 8,000 workers, while new office space in Longmont will open in 2008. The company currently employs 1,000 people at its two Colorado manufacturing sites (Longmont and Boulder), which produce four of Amgen's drugs.
Amgen has also expanded its commercial operations, launching Amgen International in Zug, Switzerland to target emerging markets in Central and Southeast Asia, Africa, and Latin America. In June 2006, Amgen an-nounced plans to build a sales staff in Japan by 2010 to sell the company's cancer drugs in that market. Amgen will continue to partner with local firms for its non-cancer products, but will boost its Japanese workforce from 110 to 350 in order to develop the oncology sales infrastructure.
Abquisition
The biggest investment Amgen made recently was its $2.2 billion acquisition of Abgenix. The companies were co-developing both panitumumab and denosumab, and the acquisition will give Amgen full ownership (read: no royalties to pay out) of both drugs, as well as Abgenix's manufacturing facility in Fremont, CA. Amgen inherited the development partnership when it acquired Immunex in 2002.
An interesting aspect of the Abgenix purchase is that Amgen wasn't the company's only research partner. Abgenix -- with its Xenomouse technology -- has partnerships in place with more than four dozen companies, including Pfizer and AstraZeneca.
I haven't seen word yet on whether any of those development partners have terminated their relationships with Abgenix, but one source said that chief executive officer Kevin Sharer considered the Xenomouse platform a key to the decision to buy Abgenix.
Big and Small
Amgen isn't avoiding the small-molecule field. In February 2006, Amgen expanded its license agreement with Stockholm-based Biovitrum, acquiring exclusive worldwide rights to a series of small molecule 11beta-HSD1 enzyme inhibitors to treat type 2 diabetes and other metabolic diseases. The lead product from this collaboration is in early clinical development, so don't expect to hear anything about it for a while.
In April 2006, Amgen partnered with Alcon to develop ophthalmology therapies. Amgen will provide the molecules, while Alcon will handle the clinical development and commercialization. Alcon will take rights in the ophthalmology market, but Amgen will retain all other rights. No financial terms were disclosed but, on a product-by-product basis, the companies will either share profits on commercial products or Alcon will pay performance milestones and royalties to Amgen.
So this could be the year that Amgen slips below 20% sales growth, but that's no sign that the company is in trouble. The company is diversifying from the anemia market, getting involved in a pair of lucrative fields in oncology and osteoporosis. With an innovative cancer drug awaiting approval, the company is in a position to leverage its experience in the chemotherapy/anemia field. The 2008/9 release of denosumab could come a little too late to establish the drug before a generic version of Fosamax hits the market.
In the long term, Amgen has a strong early pipeline, adding six new molecules in 2005. Of course, they all look good in early phases . . .
