Novartis Curbs US Submission For Afinitor Use In Cancer Tumors
19 minutes agoDow Jones
By Katharina Bart
Of DOW JONES NEWSWIRES
ZURICH (Dow Jones)--Novartis AG (NVS) Friday said it will limit its application for cancer drug Afinitor in the U.S. to one type of cancerous tumor only, dealing a potential blow to the Swiss drugmaker's pipeline of new treatments.
The Basel-based firm said it is now asking the U.S. Food and Drug Administration to approve Afinitor only to treat advanced pancreatic neuroendocrine tumors, a rare form of cancer that has recently received broader attention after it became public that Apple Inc. (AAPL) Chief Executive Steve Jobs had the disease.
This means that Novartis is effectively dropping Afinitor to treat advanced neuroendocrine tumors of gastrointestinal and lung origin after feedback from the health regulator.
"Novartis remains committed to patients with advanced neuroendocrine tumors and will continue to conduct studies in patients with advanced carcinoid tumors, where there is a critical unmet need," the company said.
Afinitor is also being studied in late-stage clinical trials for several other cancers, including advanced breast cancer. The drug, which in 2010 more than tripled sales to $243 million, is expected by analysts to become a blockbuster with more than $1 billion in annual sales.
Had Afinitor been able to clinch approval to treat different cancer types it could have--together with multiple-sclerosis pill Gilenya, which could net more than $3 billion in annual peak sales--helped reduce the sales loss impact from the patent expiry of heart drug Diovan.
Diovan, Novartis' best-selling drug, which had annual sales of more than $6 billion in 2010, will start to lose patent protection in some markets this year. Likewise, cancer medicine Femara, which has more than $1 billion in revenue, will face generic competition in 2011, which is likely to result in a steep sales slump. Depending on the number of generic entrants, sales can drop more than 50% after patent rights mature.
Novartis has said that, while it will continue to stick to its strategy of a diversified pharmaceutical company--the firm also owns a large generics, vaccines and eye-care treatment business--the Swiss drugs giant will push for the development of new drugs.
With more than 10% of its sales going into research and development, Novartis wants to boost the ratio of its specialized medicines over the next few years. Currently, Novartis generates around 20% of its drug sales with medicines that have recently been launched.
-By Katharina Bart, Dow Jones Newswires; +41 43 443 8043; katharina.bart@dowjones.com
