Global Insight Perspective | |
Significance | Roche is offering to make Mircera available in the United States at a lower price than rival drugs and to pay Amgen royalties on U.S. sales of the product. The Swiss company has also received broad European approval for Xeloda in colorectal cancer. |
Implications | Roche is not challenging the court decision on Amgen's patents and is attempting to bring Mircera to the U.S. market through a deal with Amgen. In Europe, Xeloda was made available to more patients suffering from colorectal cancer |
Outlook | With multi-billion sales for its two key drugs, Amgen is likely to keep fighting its corner despite Roche's royalties offer. In Europe, sales of Xeloda are expected to be boosted by the extension as the drug offers greater treatment convenience than existing therapies. |
Swiss pharmaceutical heavyweight Roche has offered to pay U.S. biotech firm Amgen Inc. a 20% royalty on U.S. sales of Roche's anaemia drug Mircera (methoxy polyethylene glycol-epoetin beta), in order to resolve an ongoing patent dispute, reports Reuters. The offer comes as part of a motion filing with the U.S. District Court in Boston, in which Roche suggests ways to bring Mircera to the U.S. market. According to the source, the Swiss company made it clear in the proposal that it was considering selling Mircera at a price tag lower than Amgen's anaemia drugs Aranesp (darbepoetin alfa) and Epogen (epoetin alfa). Amgen has deemed the offer "inadequate".
Mircera, which is currently available in Europe, was granted marketing approval by the U.S. FDA in November 2007 (see United States - Switzerland: FDA Approval for Roche's Mircera Creates New Unease for Amgen) for the treatment of anaemia associated with chronic kidney disease (CKD), regardless of the patient's dialysis status. Although Roche has touted the drug as having several major advantages over rival products, including being storable at room temperature and requiring lower dosages, Mircera is yet to hit the U.S. market after a court found that the drug violated patents on Aranesp and Epogen (see United States: 24 October 2007: Door Slams Shut on Roche's Hopes of U.S. Launch for Mircera). Amgen has requested an official injunction against Roche from a Boston judge to prevent the launch of Mircera onto the U.S. market, and Roche is voluntarily staying clear of commercialising the drug for now. At present there are three anaemia drugs commercialised in the United States, with the third being Johnson & Johnson's (J&J, U.S.) Procrit (epoetin alfa).
Meanwhile, Roche has been granted a broad label extension by the European Commission for oral cancer drug Xeloda (capecitabine) in patients with metastatic colorectal cancer. Xeloda can now be prescribed in combination with any chemotherapy in any round of treatment with or without Avastin (bevacizumab) for this patient population. Prior to the decision, which was based on two Phase III clinical trials involving 2,661 patients, Xeloda was indicated as a first line monotherapy for advanced colorectal cancer. In the European Union, Xeloda is also indicated in metastatic breast and gastric cancer, and as an adjuvant treatment for colon cancer.
Outlook and Implications
Roche's proposal for paying Amgen royalties on U.S. sales of Mircera mirrors the biotech's current arrangement with J&J, which pays royalties on revenue generated by Procrit. It suggests that the Swiss firm is looking at ways to settle the issue without resorting to an appeal. If Roche lost such an appeal, Mircera would not be launched in the United States until Aranesp and Epogen lose patent protection in 2012, and this is a chance that the Swiss company does not seem willing to take, as combined global sales of competitor drugs reached US$9.8 billion in 2006. The suggestion that Mircera's price tag would be lower than competitor drugs could appeal to U.S. payers and help Roche promote the drug's uptake in a market where growth is curbed by prescription and reimbursement restrictions (see United States: 9 November 2007: FDA Urges Further Expansion of Anaemia Drugs' Warning Labels and United States: 26 October 2007: Amgen's Q3 Earnings Hit by Acquisition Charges, Continued Decline in EPO Fortunes).
The broad label extension for Xeloda significantly broadens the patient population it can be prescribed to and follows hot on the heels of a similar decision on Avastin in the same therapeutic indication (see Switzerland: 28 January 2008: Roche Secures Broad European Label Extension for Avastin in Colorectal Cancer). Roche estimates that over 400,000 Europeans are diagnosed with colorectal cancer every year. Global sales of Xeloda grew by 19% in 2007 to 1.15 billion Swiss francs (US$1.05 billion), driven by robust market uptake of the drug in the metastatic colorectal cancer indication. The European decision is expected to promote even faster sales growth in this market. Indeed, the oral treatment offers greater convenience and reduces hospital treatment time compared to standard chemotherapy intravenous 5-fluoropyrimidine (IV 5-FU), which could make it a favourite among prescribers. This is an attractive prospect for the Swiss company, which will count on its successful oncology portfolio to offset the sales decline for blockbuster influenza treatment Tamiflu (oseltamivir; see Switzerland: 30 January 2008: Oncology Portfolio Drives 10% Sales Growth for Roche in 2007 and Switzerland: 12 October 2007: Roche Braced for Tamiflu Sales Slowdown as Government Stockpiles Reach Saturation).