IHS Global Insight Perspective | |
Significance | MabThera/Rituxan has been shown to increase overall survival in follow-up studies, a critical endpoint in clinical studies for oncology drugs. Roche has given notice to biotech company Actelion that it will no longer participate in their S1P1 alliance. |
Implications | These new results will add to the clinical evidence for MabThera/Rituxan in previously untreated Chronic Lymphocytic Leukaemia (CLL), especially in the important U.S. market, where it is currently waiting to secure regulatory approval for this indication. Actelion will now move forward with the development of ACT-128800 on its own, for the treatment of psoriasis and multiple sclerosis. |
Outlook | These results will further cement expectations that MabThera/Rituxan will become the gold standard of treatment for CLL and will also support Roche's case as it seeks to secure reimbursement for the drug in European countries. The termination of the deal with Actelion is part of Roche's attempt to prioritise its pipeline as part of the Roche-Genentech integration process. This is the second such announcement from Roche, and it is likely to create uncertainty about whether any other similar collaborations could potentially face the axe. |
Benefits of MabThera/Rituxan in Previously Untreated CLL Confirmed
Swiss pharma major Roche has announced the latest results of clinical studies for its drug MabThera/Rituxan (rituximab) in combination with fludarabine and cyclophosphamide (FC) for the treatment of previously untreated Chronic Lymphocytic Leukaemia (CLL). The Phase III study, known as CLL8, showed that after 37.7 months of follow up, 87.2% of patients who were treated with the MabThera/Rituxan plus FC combination were still alive, compared with 82.5% of patients treated with FC alone. In addition to increased overall survival, patients in the MabThera/Rituxan group also reported a median progression-free survival of 51.8 months, compared with the 32.8 months reported in the FC group.
The study, which involved 817 patients, was carried out by German researchers, and sponsored by Roche. The results were presented at the Meeting of the American Society of Hematology in New Orleans yesterday.
Roche Ends Another R&D Partnership
Swiss biotech company Actelion has announced that Roche will no longer pursue the clinical development of Actelion's S1P1 receptor agonist, ACT-128800. Roche and Actelion entered the US$105 million S1P1 alliance for the development of drugs for the treatment of autoimmune diseases back in 2006; however, Roche has decided to terminate the agreement following a review of its portfolio and pipeline. ACT-128800 is currently being developed for the treatment of psoriasis and multiple sclerosis, and the drug is in Phase IIb and advanced clinical trials, respectively, for these indications. Actelion has indicated that Roche's decision is not based on any safety concerns, and that it will now be solely responsible for the drug-development programmes.
Outlook and Implications
Based on these results, MabThera/Rituxan is now the only first-line CLL treatment that has been proven to improve overall survival in previously untreated cases, and this will greatly differentiate the drug from its competitors, thereby improving its commercial prospects. This is a major development for the drug, which has suffered setbacks in the United States, where it is currently seeking regulatory approval in this indication. Last month, Roche's U.S. biotech subsidiary Genentech and compatriot partner Biogen Idec—who co-market the drug under the brand name of Rituxan in the United States—were slapped with a complete response letter from the U.S. FDA regarding their supplemental biologics license application for Rituxan in combination with FC for the treatment of previously treated and untreated CLL, due to labelling issues (see Switzerland: 20 November 2009: FDA Issues Complete Response Letter for Rituxan as CLL Treatment, Second Setback to Roche/Biogen Following Earlier RA Indication Rejection). In the European Union, were the drug is currently approved for previously treated and untreated CLL, this latest set of results strengthens Roche's case for reimbursement, an important hurdle that pharma companies are finding increasingly difficult to cross, especially in the expensive oncology-treatment area.
In terms of the termination of the S1P1 alliance, Roche appears to be streamlining and consolidating its research and development (R&D) activities as part of the Roche-Genentech integration process that is currently underway. On Monday, Roche also notified another biotech company, Genmab (Denmark), that it will no longer undertake the development of RG1507, a monoclonal antibody directed against the insulin-like growth factor-1 receptor due to the fact that it now has in its portfolio numerous molecules targeting the same pathway, and it therefore needs to prioritise resources dedicated to this end (see Switzerland: 7 December 2009: Roche and Genmab End RG1507 Development Programme). It is therefore likely that Roche has terminated the S1P1 alliance for the same reasons as both Genmab and Actelion, who have both stressed that the termination of their respective collaborations with Roche is not due to safety issues. These two announcements are likely to cause concerns among other small companies who have entered similar collaborations with Roche about the future of their partnerships. Even though this is a short-term setback for Genmab and Actelion in terms of the loss of financial support from Roche, in the long term they may reap the benefits as they will be the sole recipients of any revenues generated from both drugs, if they are successfully commercialised. According to reports, Actelion has the financial resources to support the development programme; however, it also has the option to outlicense the drug to other big pharma companies. Given the stage of development of the drugs, the number of possible indications for which they are being investigated, and the fact that many big pharma companies are looking to acquire new drugs to boost flagging pipelines, they may be able to shop around for a good deal.