Roche Holdings Ltd. (RHHBY) recently reported positive data on rheumatoid arthritis (RA) treatment RoActemra (tocilizumab; marketed as Actemra outside Europe) from a late-stage trial (ACT-RAY). The data were presented at the European League Against Rheumatism congress.
The study results demonstrated that the clinical efficacy of RoActemra, when given as a monotherapy, was comparable to that of RoActemra in combination with methotrexate (MTX). MTX is widely prescribed for people with RA.
However, up to 40% of the patients who are given MTX, do not show adequate response to the treatment or experience adverse events and need other RA treating drugs to help control the inflammation.
The two-year ACT-RAY study, which enrolled 556 patients, was conducted to evaluate the safety and efficacy of adding RoActemra to MTX compared with switching to RoActemra monotherapy from MTX, in adult patients with moderate-to-severely active RA who responded inadequately to MTX.
We note that Roche’s Actemra faces competition from UCB’s (UCBJF) Cimzia and Abbott Labs’ (ABT) Humira.
Recently, Roche entered into a licensing agreement with TeaRx Ltd., wherein it granted TeaRx development and commercialization rights to treatments for patients at risk of thrombosis in Russia and 12 other countries. TeaRx plans to initiate clinical studies with the candidates in 2012. Roche will make an investment in the form of manufacturing the active pharmaceutical ingredient (API) for early-stage studies.
TeaRx plans to conduct studies for the prevention of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing orthopedic and general surgery. Clinical studies for candidates indicated for the prevention of thrombotic events (stroke) in risk patients with atrial fibrillation (AF) are also planned.
Per the terms of the agreement, Roche will receive royalties on the sales of the drugs in those territories. Additionally, Roche and TeaRx can negotiate rights for other territories as well.
We currently have a Zacks #3 Rank (short-term Hold rating) on Roche.
Be the first to comment