Magazine
#8 F. Hoffman-La Roche
4070 Basel
Switzerland
Tel: (41) 61 688 1111
Fax: (41) 61 691 9391
www.roche.com
| Headcount | 68,218 | |
| Year Established | 1896 | |
| Pharma Revenues | $16,613 | +20% |
| Total Revenues | $28,654 | +20% |
| Net Income | $5,413 | -5% |
| R&D Budget | $4,589 | +10% |
| Drugs Approved/Launched | |
| Drug | Indication |
| avastin | colorectal cancer |
| bonviva/boniva | osteoporosis, monthly oral formulation |
| invirase | HIV, 500 mg formulation |
| pegasys | chronic hepatitis B |
| xeloda | adjuvant colon cancer |
| rituxan | rheumatoid arthritis |
| tarceva | pancreatic cancer |
| herceptin | early-stage HER2-positive breast cancer |
| Drugs Pending approval | |
| Drug | Indication |
| cera | renal anemia |
| avastin* | NSCLC, colorectal cancer |
| lucentis | age-related macular degeneration |
| * in Japan | |
| Drugs in Phase IIb and Beyond | |
| Drug | Indication |
| r744 | renal anemia |
| rituxan | rheumatoid arthritis, DMArD inadequate responders, chronic lymphocytic leukemia (CHL) |
| actemra | rheumatoid athritis, systemic onset of juvenile idiopathic arthritis |
| cellcept | lupus nephritis, myasthenia gravis |
| tarceva | NSCLC |
| xeloda | metastatic colorectal cancer, gastric cancer |
| avastin | pancreatic cancer, colorectal cancer, breast cancer NSCLC, ovarian cancer, prostate cancer, renal cell carcinoma |
| herceptin | metastatic breast cancer, advanced gastric cancer |
| bondronat | metastatic bone pain |
| valcyte | CMV in transplantation |
| ed-71 | osteoporosis |
| xolair | pediatric asthma, peanut allergy |
| avant | adjuvant colon cancer |
| Early Research Projects | |
| Drug | Indication |
| r1646 | overactive bladder |
| r1599 | osteoarthritis |
| r1511 | type II diabetes |
| r1663 | anticoagulant |
| r1450 | Alzheimer’s disease |
| r1551 | schizophrenia |
| r1647 | depression |
| r1507 | solid tumors |
| r1206 | HIV |
| r7025 | HCV |
| Drugs coming off patent | |
| Drug | Indication |
| rocephin | antibiotic |
| Top Selling Drugs | |||
| Drug | Indication | Sales | (+/- %) |
| mabthera/rituxan | non-Hodgkin's lymphoma | $3,341 | 23% |
| neorecormon/epogin | anemia | $1,811 | 8% |
| herceptin | breast cancer | $1,726 | 49% |
| pegasys/copegus | hepatitis C | $1,456 | 16% |
| cellcept | transplantation | $1,371 | 21% |
| avastin | oncology | $1,339 | 141% |
| tamiflu | influenza | $1,253 | 371% |
| rocephin | antibiotic | $746 | -29% |
| xeloda | oncology | $640 | 49% |
| xenical | weight loss/management | $511 | 7% |
Account for 85% of total pharma sales, up from 78% in 2004.
PROFILE
Two years ago, Roche had three drugs in the billion-dollar category, and one of them was about to go generic. This year, the company posted seven blockbusters and a few more of its up-and-comers look like they’ll strike gold, too.
(NOTE: Roche doesn’t break out drug sales of its own Pharmaceuticals division with those of its Chugai and Genentech subsidiaries. It does, however, break out the three units’ total sales. The Roche numbers listed at the beginning of this report reflect sales from its Pharmaceutical division and Chugai, while Genentech’s are cut out. Since Genentech is treated as a standalone company for our Top 10 Biopharma report, some of the drug sales figures listed here can be misleading. For example, if we subtract Genentech’s 2005 Rituxan sales from Roche’s 2005 MabThera sales, Roche’s share drops to $1.5 billion, not the $3.3 billion listed in our Top-Selling Drugs chart. The Swiss have always had a penchant for secrecy when it comes to money.)
| THE LOWE DOWN Roche, like its Swiss buddies over at Novartis, has the big money and isn’t afraid to spend it. Witness deals like its partnership with Trimeris, which led to the construction of a whole new protein-synthesis factory just to produce a single drug. Mind you, Fuzeon might or might not ever earn back the investment, but at least Roche was ready to put its money down. Roche famously put a little bit down on Tamiflu a few years back, which (at last) looks like it’ll earn out pretty well. And its investments in oncology (along with Genentech) are turning into the sort of story that many companies never get to tell. The problem is, I wish that Roche would stop telling some parts of that story, specifically the part about how everyone should be glad to pay the (rather steep) costs of those drugs because they’re just so darn great. From some angles, they are great, but that term’s more loosely defined in oncology than it is in some better-served areas. Our industry has a problem with pricing and the public perception of it, and we have a problem with over-hyping of new drugs. Combining those two seems ill-advised. —Derek Lowe |
In June, Roche released findings that MabThera can inhibit structural damage in the joints of RA sufferers. Supplementing MabThera/Rituxan’s entry into the RA market, Roche’s Chugai unit in Japan filed Actemra, another new biologic, to treat RA. Roche and Chugai are in international Phase III trials with Actemra.
Roche is also going after Amgen and J&J’s anemia franchise with CERA (continuous erythropoietin receptor activator), a pegylated recombinant human erythropoietin. Roche finished four Phase III trials of CERA in December 2005 and determined treatment dosing can be effective in monthly intervals.
Unfortunately, Amgen hasn’t taken the threat to its main moneymakers lying down. The Big Biopharma launched a patent infringement lawsuit against Roche, contending that pegylation of a protein isn’t enough to make it non-infringing. Amgen makes approximately $6 billion annually from its anemia drugs, and some analysts predict CERA could hit $3.5 billion at its peak.
Pan(dem)ic
For just about any company, firing-on-all-cylinders results like these would make for a great public image. However, Roche found itself vilified in 2005. The company’s antiviral treatment for influenza, Tamiflu (co-developed with Gilead Sciences), turned out to be effective at treating some strains of avian flu. When governments ordered stockpiles of the drug to prepare against a flu pandemic, Roche contended that it didn’t have the manufacturing capacity to meet all demand. When it was suggested that Roche license out production to generic manufacturers, the company balked. Suggestion rapidly segued into threats of mandatory licensing, which ignored the fact that Tamiflu isn’t the easiest compound in the world to make.
Eventually, Roche began outsourcing production of Tamiflu. In December 2005, the company said that it evaluated 200 third-party manufacturers in less than two months, and settled on a dozen potential partners. In March 2006, the company announced that the global network for Tamiflu will include 15 external contractors in nine countries.
In December 2005, Roche granted a sub-license in China to Shanghai Pharmaceutical Group, and one in India to Hetero Drugs. An African sub-license was granted to Aspen Pharma in May 2006, with others to follow. The company contends that it can now get 400 million treatment-courses produced per year by the end of 2006. Roche has donated millions of Tamiflu courses to the World Health Organization.
What was the “upshot” of this pandemic panic? Tamiflu sales were up nearly $1 billion in 2005, and hit $464 million in 1Q2006 (+28%). I’m assuming they’ll slip back down now that we’re out of flu/panic season, but it’s possible that the back-orders for national stockpiles will keep the revenues skyrocketing for quarter after quarter. Let’s hope we never have to find out if it works.
