Novartis AG (ADR) (NYSE:NVS) oncology portfolio has received a major boost, the European Medicines Agency panel having recommended the approval of Kisqali. The drug in combination with an aromatase inhibitor is a novel treatment for postmenopausal women with hormone receptor positive breast cancer.
The positive opinion puts the Swiss drug maker on course to rival Pfizer Inc. (NYSE:PFE) Ibrance, which is also being used to treat breast cancer. Attention now turns to the European Commission which is tasked with the responsibility of approving drugs in the block.
Approval in Europe would add to approval in the US by the Food and Drug Administration in March.
“This positive CHMP opinion brings us one step closer to improving the lives of women diagnosed with advanced or metastatic breast cancer throughout Europe. There is currently no cure for advanced breast cancer […],” said Bruno Strigini, CEO, and Novartis Oncology.
Kisqali is one of the drugs that observers believe will help drive the company’s earnings with annual sales of up to $1.5 billion by 2022. However, to achieve such a feat, it will have to steal some market share from Ibrance approved in 2015 and with sales of $2.1 billion in 2016.
Biosimilar and Generic Competition Threat
Regulatory approval for the breast cancer drug in Europe is highly needed as Novartis continues to explore ways of strengthening its oncology portfolio. The portfolio has come under pressure in recent years on the expiry of patents for key cancer drugs such as Gleevec. The company’s once top-selling drugs are now struggling to generate desired sales at the back of growing generic competition.
In addition to the positive response in Europe, Novartis has also reported positive trial results on its cancer cell therapy CTL019. The company is also working on eye drug RTH258 having also reported successful trials on the anti-inflammatory canakinumab on heart attack survivors.
Novartis is also working on a number of biosimilar treatments as it looks to win back some business from brand names already in the market.
Novartis stock was unchanged in Friday’s trading session ending the week at $86.34 a share.
