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One Amgen Center Dr.
Thousand Oaks, CA 91320-1799
Tel: (805) 447-1000
www.amgen.com
| Headcount | 7,682 | |
| Year Established | 1980 | |
| Biopharmaceutical Revenues | $3,511 | 10% |
| Total Revenues | $4,016 | 11% |
| Royalty Revenues | $252 | 40% |
| Net Income | $1,120 | -2% |
| R&D Budget | $865 | 2% |
Drugs Approved/Launched
| Drug | Indication |
| Kineret | inflammation/rheumatoid arthritis |
| Aranesp | anemia |
| Neulasta | infection |
| Stemgen | PBPC mobilization* |
| * Australia, Canada, New Zealand approval | |
Drugs in Phase IIb and Beyond
| Drug | Indication |
| AMG 073 | secondary hyperparathyroidism |
| PEG-sTNF-RI | rheumatoid arthritis |
| Epratuzumab | non-Hodgkin's lymphoma |
Early Research Projects
| Drug | Indication |
| Alfimeprase | blood clots |
| osteoprotegerin | bone density |
Top Selling Drugs
| Drug | Indication | $ | (+/- %) |
| Epogen | anemia | $2,150 | 10% |
| Neupogen | chemotherapy | $1,346 | 10% |
| Account for nearly 100% of total biopharma sales, same as in 2000. | |||
Key Personnel
Kevin W. Sharer
chairman, chief executive officer, president
Fabrizio Bonanni
senior vice president, quality and compliance
George J. Morrow
executive vice president, worldwide sales and marketing
Richard D. Nanula
executive vice president, finance, strategy and communications, chief financial officer
Roger M. Perlumtter
executive vice president, R&D
Beth C. Seidenberg
senior vice president, development
Highlights
In 2001, the world's biggest biopharma company took steps to get even bigger, crossing over into Big Pharma status. Amgen's revenues, at $4.0 billion last year, would place it at #19 in the Contract Pharma's Top Pharmaceutical Companies, and if a proposed merger goes through, it could take a bigger jump in 2002.
In December 2001, as a successful year was winding down, Amgen made an offer to buy Immunex, #5 on our Top Biopharma list. The estimated purchase price for the company was $17.6 billion, which seems like an awful lot of money for a company with $960 million in sales in 2001 and production problems limiting the growth of its main product (for more information, see Immunex on p. 104). However, Amgen's management is confident in the acquisition, even with its premium price. The company predicts that its combined 2002 revenues could add up to $5.5 billion, which would move it up to #17 on the Top Pharma list, and may also spark a wave of consolidation in the biopharma industry.
Discussing the proposed acquisition (still unapproved at press time), Amgen chairman and chief executive officer Kevin Sharer said, "This is a compelling strategic transaction and an excellent opportunity for the shareholders, employees and partners of both companies, and we expect it will generate significant benefits for hundreds of thousands of patients around the world. We firmly believe that, as a result of this combination, Enbrel—the fastest-growing biologic drug ever—will reach its peak of $3 billion or more in annual sales. This acquisition will make Amgen a leader in the $10 billion-plus potential inflammation market in biologics. The balance of safety, efficacy and dosing of Enbrel, as well as the extension of applications for the treatment of psoriasis and psoriatic arthritis, have potential to lead to even further commercial success. Overall, the combination will increase our financial strength, further diversify our product portfolio and accelerate our long-term growth."
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Amgen is no WorldCom, relying on mergers to accelerate its market position. The company, already with a top-selling biodrug in the $2.1 billion Epogen, and a second billion-dollar product in Neupogen ($1.3 billion), received approvals for three more biologics license applications (BLAs) last year. Aranesp, for the treatment of anemia in chronic renal failure, helps the company solidify its position in the anemia market that it first staked out with Epogen. Neulasta, for the treatment of infection related to chemotherapy offers a less-frequent dosage than Neupogen. Kineret, the first drug delivered from Amgen's inflammation development program, treats rheumatoid arthritis and may complement Enbrel, once the Immunex merger closes. Certainly, the addition of Immunex's sales force, which targets the rheumatoid arthritis market, will be a boon to Amgen.
Amgen also moved several products into Phase III in 2001: AMG 073, a small molecule treatment (a first for Amgen) for hyperparathyroidism, licensed in from NPS Pharmaceuticals; keratinocyte growth factor (KGF) for the treatment of mucositis; and epratuzumab, a non-Hodgkin's lymphoma treatment licensed in from Immunomedics, Inc.
During the year, Amgen cancelled several of its collaborations. Its development and commercialization agreement with Praecis Pharmaceuticals ended in September 2001, several months after Praecis received a not-approvable letter from the FDA for Plenaxis, which was intended initially to treat hormonally responsive prostate cancer. Amgen and Guilford Pharmaceuticals also parted ways, after a Phase II trial of a neuroimmunophilin ligand failed to show significant improvement in the motor skills of people with Parkinson's disease.
At the end of 2001, Amgen entered several of collaborations. The company began a three-year collaboration with Isis Pharmaceuticals to discover new antisense drugs. The companies will collaborate on antisense drugs utilizing Isis' proprietary second-generation chemistry, called 2'-O-methoxyethyl, to inhibit several gene targets. Also, Isis' GeneTrove division entered into a functional genomics alliance with Amgen, giving Amgen access to antisense gene functionalization and target validation expertise, as well as to certain patents within Isis' functional genomics suite of patents.
Amgen also started a collaboration with Hyseq Pharmaceuticals to develop and commercialize alfimeprase, a thrombolytic, for the treatment of peripheral arterial occlusions and other cardiovascular indications. Hyseq will lead development and be responsible for all clinical development activities, while Amgen will be responsible for manufacturing activities. Amgen will have the option to lead commercialization efforts, and has warrants to buy Hyseq common stock at a premium to the current market price. Alfimeprase was identified through Amgen's research program.
In May 2002, Amgen solidified its neutropenia franchise by buying European rights to Neupogen and Neulasta from Roche. Amgen paid $137.5 million for the rights. Roche will continue as the licensee for filgrastim and pegfilgrastim in certain countries in Eastern Europe, the Middle East, Africa, Asia and Latin America.
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1 DNA Way
South San Francisco, CA 94080
Tel: (650) 225-1000
www.gene.com
| Headcount | 4,850 | |
| Year Established | 1976 | |
| Biopharmaceutical Revenues | $1,743 | 36% |
| Total Revenues | $2,212 | 25% |
| Royalty Revenues | $265 | 28% |
| Net Income | $150 * | |
| R&D Budget | $526 | 7% |
| * posted $74 mil. loss in 2000 | ||
Drugs Approved/Launched
| Drug | Indication |
| Cathflo | Activase catheter occlusion |
Drugs Pending
| Drug | Indication |
| Nutropin AQ Pen | growth hormone deficiency chronic renal insufficiency Turner syndrome Xolair allergic asthma |
Drugs in Phase IIb and Beyond
| Drug | Indication |
| Anti-CD11a antibody | rheumatoid arthritis |
| LDP-02 antibody | inflammatory bowel diseases |
| Avastin | colon cancer/refractory breast cancer |
| Herceptin | adjuvant breast cancer |
| Nutropin Depot | adult growth hormone deficiency |
| Rituxan | immune thrombocytopenic purpura intermediate/high-grade non-hodgkin's lymphoma |
| Tarceva | pancreatic cancer/lung cancer |
| Xanelim | psoriasis |
Early Research Projects
| Drug | Indication |
| Anti-CD40 antibody | hematologic malignancies |
| Anti-tissue factor | acute coronary syndrome |
| Trastuzumab-DM1 | solid tumors |
| 2C4 antibody | solid tumors |
| AMD-Fab | age-related macular degeneration |
| Anti-CD11a antibody | kidney transplantation |
Top Selling Drugs
| Drug | Indication | $ | (+/- %) |
| Rituxan | non-Hodgkin's lymphoma | $819 | 84% |
| Herceptin | breast cancer | $347 | 26% |
| Account for 67% of total biopharma sales, up from 56% in 2000. | |||
Key Personnel
Arthur D. Levinson, Ph.D.
chairman and chief executive officer
Louis J. Lavigne, Jr.
executive vice president, chief financial officer
Susan Desmond-Hellmann, M.D., M.P.H.
executive vice president, development and product operations, chief medical officer
Richard H. Scheller, Ph.D.
senior vice president research
Stephen G. Juelsgaard
senior vice president, general counsel and secretary
Myrtle S. Potter
executive vice president commercial operations,
chief operating officer
Highlights
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Genentech's bid for a mistrial was denied. In the second phase of the case, City of Hope Lawyers said Genentech should be punished by paying at least the same amount as compensatory damages and as much as 10% of what the hospital argued was the company's $5.8 billion net worth. At the end of June, Los Angeles County Superior Court jury voted to award COH $200 million in punitive damages, brining Genentech's total payment to $500 million. Genentech plans to appeal the punitive damages award.
In July of 2001, Genentech, Inc. and Novartis received a Complete Response letter from the FDA for their Biologics License Application (BLA) for Xolair, a treatment for adults and adolescents with moderate allergic asthma which was filed in June of 2001. The letter requested additional preclinical and clinical data analyses, as well as pharmacokinetic information, pushing back its arrival to market. The drug was not approved in 2001. In November, the two companies said they would submit their revised BLA for Xolair to the FDA in the fourth quarter of 2002.
For fiscal 2001, revenue growth was driven primarily by sales of Genentech's BioOncology products, Rituxan and Herceptin.
Genentech has not had very good luck with BLAs in the last eight months. Genentech and XOMA Ltd.'s pharmacokinetic study conducted on Xanelim, comparing XOMA-produced material and Genentech-produced material, did not achieve the pre-defined statistical definition for comparability. The study suggested that the Genentech material achieved a slightly higher serum concentration than the XOMA material. The companies will work with the FDA to determine the next steps, but this will delay the filing of a BLA beyond summer 2002.
Susan D. Hellmann, M.D., M.P.H., Genentech's executive vice president, development and product operations and chief medical officer, commented, "We continue to enroll patients into ongoing Xanelim clinical trials, including additional studies to expose more patients to the Xanelim material being produced at Genentech for marketing after approval. Genentech now plans to submit data from an additional ongoing efficacy study using Xanelim material produced at Genentech to the FDA and, contingent upon successful discussions with the FDA, expects to be able to submit data from this efficacy study before the end of 2002." The companies had planned to submit a BLA this summer and win approval by mid-2003, but that deadline has been pushed back.
However, not all the news about the company's potential drugs has been bad. Genentech and OSI Pharmaceuticals' Tarceva has been designated by the FDA as a "fast track" product for the treatment of chemotherapy-naïve Stage III/IV non-small cell lung cancer patients. Tarceva is a small molecule EGFR inhibitor being developed by Genentech, OSI and Roche.
Despite a few rumors on Wall Street in the earlier part of this year that Genentech's much anticipated cancer drug was having trouble in Phase II trials, the company announced initial positive results in May from a randomized, double-blind, placebo-controlled Phase II study. Patients enrolled in this three-arm trial had failed previous treatments with Interleukin-2. The study showed that patients with metastatic kidney cancer treated with single-agent Avastin had a statistically significant increase in the primary endpoint, time to disease progression, when compared with patients in the placebo arm of the study. A third arm of the trial studied patients receiving low-dose Avastin therapy.
There was also a trend toward improvement in time to disease progression in the low-dose Avastin arm in comparison to placebo. It had been previously reported that some of the patients that were given Avastin during a Phase II trial apparently had problems with bleeding and blood clots. The drug is currently in Phase III trials, and results were not available at press time. Results are due sometime in July or August of this year.
With the hit Genentech is going to take after paying its settlement to the City of Hope (barring appeal), the company is going to need those pipeline drugs more than ever.
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Chemin des Mines 5bis
PO Box 54 • 1211 Geneva 20
Switzerland
Tel: (41) 22 739 3000
www.serono.com
| Headcount | 4,559 | 1987 |
| Year Established | $1,249 | 9% |
| Biopharmaceutical Revenues | $1,376 | 11% |
| Total Revenues | $127 | 37% |
| Net Income | $317 | 5% |
| R&D Budget | $309 | 17% |
Drugs Approved/Launched
| Drug | Indication |
| Rebif | relapsing multiple sclerosis |
| Ovidrel | infertility |
| Luveris | infertility |
Drugs Pending
| Drug | Indication |
| Luveris | infertility |
| Serostim | AIDS wasting |
Drugs in Phase IIb and Beyond
| Drug | Indication |
| r-hCG | breast cancer |
| r-GH | short bowel syndrome |
| r-IFNB-1a | Guillain-Barré syndrome |
| r-TBP-1 | Crohn's disease |
Early Research Projects
| Drug | Indication |
| IKK-2 inhibitor | multiple sclerosis |
| TACI | autoimmune conditions |
| GnRH antagonist | prostate cancer |
| r-IL-18 bp | Crohn's disease |
Top Selling Drugs
| Drug | Indication | $ | (+/- %) |
| Gonal-F | infertility | $411 | 12% |
| Rebif | multiple sclerosis | $380 | 50% |
| Serostim | wasting | $125 | -9% |
| Saizen | growth retardation | $107 | 19% |
| Account for 82% of total biopharma sales, up from 74% in 2000. | |||
Key Personnel
Key Personnel
Ernesto Bertarelli
chief executive officer
Silvano Fumero
senior executive vice president, research &
pharmaceutical development
Jacques Theurillat
chief financial officer
Franck Latrille
senior executive vice president, manufacturing operations
Jean-Pierre Verhassel
senior executive vice president, sales and marketing
Stevo Knezevic
senior executive vice president, clinical development
Paola Ricci
senior executive vice president, regulatory affairs
François Naef
senior executive vice president, human Resources
Highlights
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Serono's cool.click, a needle-free device used for the delivery of Saizen, recombinant human growth hormone, has received EU authorization. Cool.click allows physicians and nurses the opportunity to offer patients a convenient, less-painful alternative to traditional needles and syringes. It will be launched in Europe later this year. In August of last year, the drug was approved for use in the treatment of adult growth hormone deficiency as well as for use in children.
Last year, the company launched Gonal-F Multi-Dose, which increases patient convenience by utilizing a multi-dose vial. The successful launch of Ovidrel/Ovitrelle and the launch of Luveris in Europe, Serono is now one of the only companies to offer a portfolio of pure and consistent recombinant hormones for the treatment of fertility.
Also in the news, Serono has settled its lawsuit against Columbia Labora-tories related to the recall of Crinone (progesterone gel), which took place in April 2001, and Columbia's counterclaims against Serono. Columbia Laboratories is the manufacturer of Crin-one. Serono is the worldwide marketer of Crinone and the distributor of Crin-one in the U.S. Crinone is used in the treatment of infertile women and in women experiencing secondary amenorrhea. Under the terms of the settlement, the two companies released claims against each other and Columbia will compensate Serono for a total of $6 million. The settlement comprises both free product shipped to Serono for relaunch of Crinone in the U.S. as well as a promissory note from Columbia to Serono for nearly $4 million to be paid during an 18-month period to cover additional recalled product and out-of-pocket costs related to the recall.
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In May of this year, Jacques Theurillat was named deputy chief executive officer in addition to his responsibilities as chief financial officer. Also, in the summer of last year, Serono's re-searchers at the Serono Pharmaceutical Research Institute developed a new procedure that could improve the sensitivity of current tests used to detect abnormal prion proteins. These are believed to cause fatal neurodegenerative diseases such as bovine spongiform en-cephalopathy in cattle, scrapie in sheep and Creutzfeldt-Jakob disease in humans.
In June 2002, Serono made an offer to acquire Genset for approximately $100 million. "This is a continuation of our strategy of selective R&D investments. This investment will further develop our genomics drug discovery platform and feed our pipeline," said Ernesto Bertarelli, Serono's chief executive officer. "There is an excellent fit between Serono and Genset and I am looking forward to a successful transaction."
The company is poised to reap great revenues from the introduction of Rebif to the MS market, and its fertility treatments will also contribute to the company's growth in the coming year.
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14 Cambridge Center
Cambridge, MA 02142
Tel: (617) 679-2000 • Fax: (617) 679-2617
www.biogen.com
| Headcount | 2,000 | 1978 |
| Year Established | $972 | 28% |
| Biopharmaceutical Revenues | $1,043 | 13% |
| Total Revenues | $72 | -57% |
| Net Income | $273 | -18% |
| R&D Budget | $314 | 4% |
Drugs Pending
| Drug | Indication |
| Avonex | other MS indications |
| Amevive | psoriasis |
Drugs in Phase IIb and Beyond
| Drug | Indication |
| Antegren | MS/Crohn's disease |
| Adentri | congestive heart failure |
Early Research Projects
| Drug | Indication |
| LTBR-mAb | solid tumors |
| VLA-4 inhibitor | inflammation |
| VLA-1 mAb | inflammation/fibrosis |
| interferon beta | cancer gene therapy |
| LFA-1 | psoriasis |
Top Selling Drugs
| Drug | Indication | $ | (+/- %) |
| Avonex | multiple sclerosis | $972 | 28% |
| Accounts for 100% of total biopharma sales, same as in 2000. | |||
Key Personnel
James L. Vincent
chairman of the board
James C. Mullen
president and chief executive officer
Burt A. Adelman, M.D.
executive vice president, R&D
Cornelis "Kees" Been
senior vice president, oncology business unit
Thomas J. Bucknum, Esq.
executive vice president, general counsel, secretary
Frank A. Burke, Jr.
executive vice president, human resources
Nadine D. Cohen, Ph.D.
senior vice president, regulatory affairs
Michael Gilman, Ph.D.
senior vice president, research
Sylvie L. Gregoire, Pharm. D.
executive vice president, technical operations
Robert A. Hamm
senior vice president, Europe, Canada, Africa and Middle East
Hans Peter Hasler
executive vice president, commercial operations
Peter N. Kellogg
executive vice president, finance and chief financial officer
Toshio Nakata, D. Sc.
senior vice president, president, Biogen Japan, Ltd.
John W. Palmer
senior vice president, corporate development
Patrick J. Purcell
senior vice president, chief information officer
Craig Schneier
senior vice president, strategic organization, design and effectiveness
Highlights
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A new report by Decision Resources found that Biogen's Avonex, which has been a leading drug therapy for the disease, will see major competition from Ares-Serono's Rebif, which launched into the U.S. market in March 2002. Biogen has aggressively been trying to convince doctors and patients that Avonex is superior to Rebif, but this has sent up a red flag with U.S. regulators, the Wall Street Journal reported. The FDA found Biogen's promotional materials for Avonex "false" and "misleading." The agency also said the materials, which included letters to doctors and patients and information on a company-run Web site, were "lacking in fair balance."
In March 2002, the FDA gave Switzerland's Serono SA the go-ahead to sell Rebif, which is almost identical to Avonex. Avonex had been protected from copycat competition until 2003 under the federal Orphan Drug Act, which seeks to improve returns for companies that develop therapies for rare diseases. However, after clinical trials found Rebif to be superior, the FDA decided to allow it into the U.S. earlier than initially planned. That same month, the FDA informed Biogen that Rebif's labeling does not enable Serono to make a general claim for clinical superiority over Avonex. FDA's chief counsel told Biogen that, if Serono makes such broad claims not supported by the labeling, he will take enforcement action. The approval letter for Rebif specifically prohibits such claims.
In August of 2001, Biogen. was pleased with a favorable ruling by a Geneva court against Serono Inter-national SA. The Swiss court upheld its injunction prohibiting Serono from publicizing misleading claims against Avonex. Biogen has threatened legal action against the FDA and launched its own study to compare Avonex and Rebif in April of this year.
In other legal news, the company reached a settlement in its long-standing litigation with Berlex Laboratories over a claim that the manufacture of Avonex infringes Berlex's "McCor-mick" patents. In the settlement, Biogen will receive a fully paid, royalty-free, non-exclusive license under the patents held by Berlex in return for a payment of $20 million to Berlex.
Stock prices have been up and down for the company in the last few months. Avonex is responsible for almost 95% of the company's revenues, so when Wall Street heard that second quarter sales for the drug were going to be 5% less than expected, stock prices plummeted. However, the volatility in the company's stock was evident when prices jumped back up when an FDA panel recommended approval for the company's psoriasis drug Amevive, but raised some concerns over long-term safety of the drug. A final ruling on the approval is expected later this year.
Amevive should provide Biogen with an alternate source of revenue, and the psoriasis market is large enough to give the company a good chunk of change. The company is going to need it, especially if Avonex loses significant market share. John T. McCamant, editor of The Medical Technology Stock Letter, commented in an online Web chat, "Psoriasis is a large market that [has been underserved by] the pharmaceutical industry. Amevive would be a poster child for what biotech can deliver, which is the ability to address the underlying disease at its source—in this case, T cells. This drug represents why we believe biotech, not Big Pharma—is going to deliver the innovative blockbuster drugs."
Amevive should arrive in the nick of time for Biogen.
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51 University St.
Seattle, WA 98101
Tel: (206) 587-0430 • Fax: (206) 587-0606
www.immunex.com
| Headcount | 1,900 | |
| Year Established | 1981 | |
| Biopharmaceutical Revenues | $960 | 16% |
| Total Revenues | $987 | 15% |
| Royalty Revenues | $27 | -18% |
| Net Income | $170 | 10% |
| R&D Budget | $205 | 23% |
Drugs in Phase IIb and Beyond
| Drug | Indication |
| Enbrel | psoriasis Wegener's granulomatosis ankylosing spondylitis |
| IL-1R type 2 | rheumatoid arthritis |
| Leukine | mucositis |
Early Research Projects
| Drug | Indication |
| IL-1R type 2 | inflammation |
| Anti-IL-4R | asthma |
| TEK | cancer |
| RANK | cancer, osteoporosis |
Top Selling Drugs
| Drug | Indication | $ | (+/- %) |
| Enbrel | rheumatoid arthritis | $762 | 17% |
| Leukine | cancer | $108 | 23% |
| Account for 91% of total biopharma sales, down from 89% in 2000. | |||
Key Personnel
Ed Fritzky
chairman, chief executive officer and president
David A. Mann
executive vice president, chief financial officer, treasurer
Carl J. March, Ph.D.
senior vice president, information technology and biochemical sciences
Kenneth B. Seamon, Ph.D.
senior vice president, drug development
Barry A. Labinger
senior vice president &general manager, commercial operations
Leslie Garrison, M.D., MPH
senior vice president, clinical R&D
Thomas O. Daniel, M.D.
senior vice president, discovery research
Efi Cohen-Arazi
senior vice president, supply operations
Highlights
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Contingent on FTC approval of the Amgen merger, Immunex has agreed to sell its Leukine business to Schering AG Germany. Leukine, which increases the production of infection-fighting white blood cells in patients undergoing certain chemotherapy, treats similar indications as Amgen's Neupogen and Neulasta products. Leukine passed the $100 million mark for the first time in 2001. Schering AG will pay approximately $380 million in cash, plus the payment of additional cash consideration upon achievement of certain milestones.
Leukine's success was a nice boost for Immunex last year, but the company's future is tied mainly to the market for Enbrel. Last year, we wrote about how Enbrel's sales were limited by Immunex's inability to produce enough of the product. That condition held true for 2001, as sales of the drug maxed out up 17% to $762 million. The company plans to reach $1 billion in Enbrel sales this year, as it prepares to bring more production capacity online.
In the second half of 2002, Immunex plans to begin Enbrel production at a $450 million, 250,000-sq.-ft. facility in West Greenwich, RI. Immunex is also building a new facility beside the existing one, called the BioNext Project. The $500 million project will be one of the most advanced cell culture manufacturing centers in the world and employ up to 700 workers.
In April 2002, Immunex signed a manufacturing agreement with Genentech to produce Enbrel at its manufacturing facility in South San Francisco, CA. The site is expected to add supply capacity for Enbrel beginning in 2004. "We're working hard to help assure that the growing demand for Enbrel is met," said Peggy Phillips, Immunex's executive vice president and chief operating officer. "This agreement adds flexibility and depth to our plans to expand the production capacity of Enbrel to the multi-billion dollar level," said Ms. Phillips. Genentech will produce Enbrel through 2005, and the parties can by mutual agreement extend production through 2006.
In order to reach that billion-dollar goal (and the eventual $3 billion in annual sales that Amgen projects), Immunex continues to test Enbrel (initially approved for rheumatoid arthritis) against a number of indications. In January 2002, the drug was approved as the first treatment the signs and symptoms psoriatic arthritis, either as a monotherapy or in combination with methotrexate. Additionally, Immunex is studying Enbrel in a Phase II/III study for psoriasis, and Phase III studies for ankylosing spondylitis and Wegener's granulomatosis.








