IHS Global Insight Perspective | |
Significance | Roche has hit a stumbling block in regulatory filings for new diabetes drug taspoglutide. A late-stage clinical study has shown that RoActemra is effective in the treatment of systematic Juvenile Idiopathic Arthritis (sJIA). |
Implications | A higher incidence of hypersensitivity reactions was reported for taspoglutide, triggering further investigation. sJIA is an orphan indication with no currently marketed treatments. |
Outlook | Roche will now implement a mitigation plan for taspoglutide, and regulatory filings will be delayed by a minimum of 12–18 months. Roche will also seek approval for RoActemra in the treatment of sJIA, based on this positive data. |
Taspoglutide Faces Regulatory Delays
Swiss pharma major Roche's Type 2 diabetes drug, glucagon-like peptide-1 (GLP-1) analogue taspoglutide, has hit a minor stumbling block after analysis of Phase III studies showed a higher-than-expected incidence of hypersensitivity reactions. According to Roche, some of the reported symptoms from these hypersensitivity reactions include skin reactions, respiratory, and cardiovascular gastrointestinal symptoms. Roche said that there is a potential link between the hypersensitivity reactions and anti-drug antibodies.
In response to these findings and in consultation with the U.S. FDA, Roche will implement a risk-mitigation plan in order to identify patients that may be at risk of these side effects. These patients will then be closely monitored. As a result, it is likely regulatory filings that had been tentatively scheduled for 2011 will now face a minimum delay of between 12 and 18 months.
RoActemra Continues to Shine
Meanwhile, Roche has reported positive results from a new clinical study of rheumatoid arthritis drug RoActemra (tocilizumab), commercialised as Actemra outside the European Union (EU), in the treatment of systematic Juvenile Idiopathic Arthritis (sJIA). sJIA is a severe form of arthritis in children aged between 18 and 24 months, and there are currently no licensed treatments. The study, known as TENDER, which compared RoActemra with placebo, showed that after three months of treatment with RoActemra, a 30% improvement (JIA ACR30) in signs and symptoms of sJIA and absence of fever was observed in 85% of patients, in comparison with 24% of patients in the placebo group. Some 70% and 37% of patients in the RoActemra group achieved JIA ACR70 and JIA ACR90, respectively. The full results are being presented at the European League Against Rheumatism Congress.
Outlook and Implications
Taspoglutide was originally licensed from French biotech company Ipsen, and this latest development constitutes a major setback for both parties. Until now, taspoglutide was being touted as a potential major revenue earner, and one of the major drugs being developed by Roche outside of its current oncology comfort zone. Six sets of results from the T-emerge Phase III clinical trial programme (a set of eight trials) have been reported so far, and the drug has seemingly excelled in the trials, with no safety issues being highlighted. The drug has met all primary endpoints, defined as a reduction in blood glucose levels, while displaying a favourable safety profile. The first study compared taspoglutide with placebo in 373 patients, and showed that taspoglutide was more effective at reducing blood glucose levels. This was followed by three head-to-head trials comparing the drug with existing treatments such as French firm Sanofi-Aventis' Lantus (insulin glargine), fellow GLP-1 agonist Byetta (exenatide; Eli Lilly, U.S.), and dipeptidyl peptidase-4 inhibitor Januvia (sitagliptin; Merck & Co, U.S.). Taspoglutide outperformed both Januvia and Byetta, while showing similar effectiveness to Lantus. The fifth set of results showed that taspoglutide is more effective than placebo in reducing blood glucose levels in patients with a high body mass index. The sixth set of results from the T-emerge programme showed that taspoglutide in combination with metformin and Actos (pioglitazone; Takeda, Japan) was more effective in lowering patient blood glucose levels in comparison with placebo (see Switzerland: 12 February 2010: Roche Rounds Up Results of Five Clinical Trials for New Diabetes Drug and Switzerland: 29 April 2010: Roche Obtains Final EU Approval for Tarceva as First-Line Maintenance Treatment for NSCLC, Reports Latest Positive Data for Taspoglutide).
In light of all the positive data that have been reported so far, these latest findings may cast a shadow on the drug, given the high levels of competition in the market for innovative diabetes drugs. Roche had previously said that if regulatory approval is successfully obtained, annual sales could peak at 2 billion francs (US$1.9 billion). A minimum delay of 12–18 months as estimated by Roche will therefore equate to major revenue loss. Furthermore, the company will have to shell out more to implement the new trial's protocols that have been outlined.
The latest data for RoActemra will boost the commercial prospects of the drug; it is possible that Roche may seek an orphan designation for RoActemra in this indication, based on the small patient population. With no licensed treatments for sJIA available on the market, Roche could potentially create a small niche market for RoActemra. However, Roche is not the only company with its eyes on the untapped sJIA market. Compatriot pharma giant Novartis has also already been granted orphan drug status for Ilaris (canakinumab, formerly ACZ885) in the treatment of sJIA in the EU, with regulatory filings already planned for 2011. Roche has said that regulatory filings will be submitted later in the year.