Afinitor, Onbrez news demonstrate Novartis strengths

Novartis has reported double good news about two drugs as it looks to shore up sales in the face of patent expirations of key drugs, including Diovan.

The New England Journal of Medicine has published a study showing Afinitor tablets plus best supportive care more than doubled progression-free survival--from 4.6 to 11 months--compared with placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors. It also reduced the risk of cancer progression by 65 percent.

Afinitor is approved in the EU for the treatment of patients with advanced renal cell carcinoma whose disease has progressed on or after treatment with vascular endothelial growth factor-targeted therapy. It is also approved in the U.S. for the treatment of patients with advanced RCC after failure of treatment with sunitinib or sorafenib. The FDA also has given its thumbs up for the drug to treat patients with subependymal giant cell astrocytoma associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection.

Separately, Novartis also has reported results from two Phase III studies that show patients with chronic obstructive pulmonary disease treated with once-daily Onbrez Breezhaler plus Spiriva, which is sold by Boehringer Ingelheim and co-marketer Pfizer, experienced significantly greater improvements in lung function than those treated with Spiriva alone. Reuters notes the news could boost Novartis' respiratory franchise and underscores the strength of the Swiss drugmaker's pipeline.

The EU approved the Onbrez Breezhaler in November 2009 as a maintenance bronchodilator treatment of airflow obstruction in adult patients with COPD. It is now approved in more than 50 countries and has been launched in 13 European countries. The application for U.S. approval under the trade name Arcapta Neohaler is expected to be reviewed by an FDA advisory committee in March. Dow Jones reports Onbrez Breezhaler had sales of about $33 million in 2010 and is expected to reach several hundred million dollars in peak sales, according to analyst estimates.

- check out the Novartis release on Afinitor
- see the Novartis statement on Onbrez
- get more from Reuters
read the Dow Jones story