Roche says new RoActemra formulation passes clinical hurdle

A new subcutaneous formulation of Roche's rheumatoid arthritis drug RoActemra has shown efficacy in a phase III trial and could be ready for filing by the end of the year.

The new version of RoActemra (tocilizumab) - known as Actemra outside Europe - could provide a more patient-friendly alternative to the current intravenous formulation and open up the possibility of patients self-administering the drug at home.

The 1,262-patient SUMMACTA study showed that subcutaneous RoActemra given every two weeks was as effective as the current intravenous formulation delivered every four weeks, with a similar proportion of patients achieving a clinical response to treatment after 24 weeks.

Preliminary safety analysis also showed that the adverse event profiles of the two treatment groups were comparable, with no new clinically meaningful safety signals identified. 

A second phase III study called BREVACTA is due to generate data later this year, and if positive Roche will move ahead with plans to file for approval of the new version globally.

Roche is in the process of converting a number of its established biologics drugs to subcutaneous administration, thanks to its ongoing collaboration with drug delivery specialist Halozyme. 

Halozyme supplies a recombinant hyaluronidase enzyme that is used in tandem with a new delivery device to improve the delivery of large-molecule drugs, by increasing the volume of material that can be injected comfortably. The new formulations also allow Roche to extend the patent protection for its brand franchises.

In addition to RoActemra, Roche is also developing a subcutaneous formulation of breast cancer blockbuster Herceptin (trastuzumab) using the technology, providing a means of delivering the drug in a five-minute process rather than the 30-90 minutes needed for the current intravenous infusion. The new formulation has already been submitted for approval in Europe and the US.

Meanwhile, another drug getting the Halozyme treatment is cancer treatment Rituxan/MabThera (rituximab), with a new formulation entering phase III testing in February 2011.