4. May 2012 14:42
Results from Roche’s SUMMACTA study have shown the subcutaneous (SC) formulation of Actemra (tocilizumab) met its primary endpoint when compared with an intravenous (IV) version.
The two-year study included 1,262 patients and found that the weekly convenient SC formulation showed comparable efficacy and safety to the IV monthly formulation.
Dr Hal Barron, Chief Medical Officer and Head Global Product Development, said the results may provide patients and their doctors in the future with an “important additional treatment option.”
Roche will now complete a further clinical trial, the BREVACTA study, and plans to submit data from both to the US FDA ahead of obtaining a license for the SC formulation.
Actemra is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumour necrosis factor (TNF) antagonist therapies. It is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in youngsters aged two years or older.
Also in the SUMMACTA study, a similar number of patients with RA achieved an ACR20 response after 24 weeks – a measurement indicating improvement in the number of tender and swollen joints, pain scale and patients’ and physicians’ assessment of improvement, and certain laboratory markers.
“We are very pleased with these data showing that subcutaneous administration of Actemra provides clinically meaningful and comparable results to the IV infusion,” said Dr Barron.
The results of the BREVACTA study are expected later in the year.
13. October 2011 14:57
Roche has posted solid sales performance in the first nine months of 2011 with overall group activity up 2% to 31.5bn Swiss francs.
Sales in the pharmaceutical division grew 1% after growth of key medicines and markets, particularly in the international region where a 6% increase was recorded.
Severin Schwan, Roche CEO, says the Group is “on track to achieve our targets for 2011” after recording results in line with expectations.
The Group confirmed it is expecting low single digit growth this year and is still targeting Core EPS growth of approximately 10% despite a challenging environment and global health reforms.
US pharmaceutical sales were up 1% and driven mainly by demand for Lucentis, Rituxan and Actemra. But the company suffered an expected negative impact in sales of Avastin (pictured) after the uncertainty around the metastatic breast cancer indication in the US.
Sales were down 4% in West Europe, primarily due to government austerity measures, and 2% in Japan after the affects of the earthquake in the country in March, the company said. Although an increasing demand for products in China (+28%), Venezuela (+88%) and Brazil (+16%) helped boost figures internationally.
In the same period, Roche also reported positive data from seven clinical studies, a number of which have already formed the basis for regulatory filings and approval in Q3; including the launch of skin cancer medication Zelboraf and companion diagnostic cobas BRAF Mutation Test following FDA approvals in August and Tarceva (pictured) in the EU for EGFR-mutated non-small cell lung cancer.
“The successful US launch of our new melanoma medicine Zelboraf and the diagnostic cobas BRAF test has strengthened our leading position in personalised healthcare,” said Severin Schwan. “The good results we have achieved with new medicines in seven late-stage clinical trials so far this year further enhance our prospects for future growth.”
3. August 2011 13:37
Roche’s RoActemra has been approved in Europe for the treatment of Systemic Juvenile Idiopathic Arthritis (sJIA).
The medicine is intended to treat patients two years of age and older who have responded inadequately to previous therapy with NSAIDS and systemic corticosteroids.
RoActemra is known as Actemra outside of Europe can be prescribed alone or in combination with methotrexate.
Hal Barron, Chief Medical Officer and Head of Global Product Development at Roche, stated: “RoACTEMRA is the first and only biological treatment to demonstrate significant efficacy in this patient population and offers physicians a new option for this extremely difficult to treat disease.”
sJIA is the rarest form of Juvenile Idiopathic Arthritis (JIA), also known as Juvenile Rheumatoid Arthritis (JRA). The disease affects about 10-20% of children with JIA, with the peak age of developing sJIA being between 18 months and two years of age, although the disease can persist into adulthood.
Roche is a biotechnology company with focus on pharmaceuticals and diagnostics. The organisation manufactures medicines to be used in areas of oncology, virology, inflammation, metabolism and CNS.