Novartis has given a pipeline update which reveals plans to launch combinination drugs incorporating its antihypertensive Tekturna and a delay to a possible launch of the kidney cancer therapy Afinitor.
The Swiss healthcare major hosted an investor event in Cambridge, Massachusetts and stated that it currently has 139 projects in clinical development, including 14 biologics. However for the near future, the firm has high hopes for Tekturna/Rasilez (aliskiren) which it claims “forms the foundation for single-pill combination therapies that provide new options to treat cardiovascular disease”.
These include a combination with Novartis’ own blockbuster Diovan (valsartan) which is set for submission in the USA by the end of this year and in the European Union in 2009. Also in the pipeline is a single-pill combination with Pfizer’s off-patent calcium channel blocker Norvasc (amlodipine), as well as a triple-combination therapy with Tekturna, amlodipine and a diuretic.
Importantly, Novartis said that it expects all these treatments to be approved before the expiration of the patent on Diovan in the USA in 2012.Third-quarter global sales of the latter rose 14% to $1.44 billion.
More worrying was the news that the US Food and Drug Administration has requested additional data regarding the experimental kidney cancer treatment Afinitor (everolimus), formerly known as RAD001. This means that the agency’s action date has been extended by three months to sometime in the first quarter of 2009.
Novartis noted that the FDA did not want additional studies of Afinitor but has requested “some data clarification and reformatting related to previously submitted oncology studies as well as additional data from the ongoing trial in pancreatic neuroendocrine tumours”. Everolimus, a once-daily, oral therapy that inhibits the mTOR protein, was granted priority review status by the FDA in September.
Other compounds that Novartis highlighted included ACZ885(canakinumab) a treatment for a group of rare but potentially life-threatening autoinflammatory diseases called cryopyrin-associated periodic syndromes. The first submissions were previously planned for 2009, but are being moved forward to the end of 2008 after data from two clinical studies showed adults and children achieved rapid and long-lasting clinical remission of these diseases.
Also meriting special mention was the investigational chronic obstructive pulmonary disease drug QAB149 (indacaterol) which will be submitted for its first regulatory approvals by the end of the year.
