Investors have been in love with Novartis (NYSE: NVS ) over the last three months. The major pharmaceutical stock has shot up like a cannon recently, jumping more than 14% since the end of June. To sweeten its gains, Novartis pulled in two pieces of good news in the last few days that'll have investors smiling from ear to ear. Let's see what you can expect from this pharmaceutical giant looking ahead.
Phase 3 feats
In yesterday's company press release, Novartis' drug for acute heart failure, RLX030, significantly achieved one of a phase 3 trial's endpoints in reducing patient mortality from the disease. Novartis had aimed to cut down on shortness of breath with the drug, a common symptom with a disease that records a high mortality rate compared with many other cardiovascular illnesses.
Novartis originally purchased the company that developed RLX030, Corthera, for $120 million three years ago -- with the possibility of paying out $500 million more if the drug hits certain milestones. Any success of the drug for acute heart failure -- which records an estimated 2 million hospitalizations each year in the U.S. and Europe -- will go a long way to recouping that investment.
You shouldn't expect RLX030 to blow away any records in treating such a common disease that already hosts a number of treatment options, but the drug nonetheless adds another solid cog to Novartis' future. While it's still necessary to hold off on any glamorous predictions until the official FDA ruling comes around, you can rest easy knowing RLX030 is on the right path for success.
Considering that Novartis recently suffered the loss of patent protection on its hypertension drug Diovan HCT, optimism surrounding a future branded star like RLX030 couldn't have come at a better time. Pharmaceutical rival Mylan (Nasdaq: MYL ) gained FDA approval for a generic version of Diovan on Friday, leaving Novartis hurting from the loss of a drug that pulled in $400 million in the second quarter of 2012.
That's not all!
But I promised you two pieces of good news, so let's get the rest of the story. On Friday, the European Medicines Agency's Committee for Medicinal products for Human Use (CHMP) recommended Novartis' VotubiaR kidney tumor-treating drug for EU approval. The illness that Votubia would treat -- kidney tumors related with the genetic disorder tuberous sclerosis complex (TSC) -- isn't exactly the same widespread phenomenon as heart failure, but it still affects between 1 million and 2 million people around the globe. It's estimated that up to 80% of said sufferers will develop the tumors, so Novartis has a nice, large patient base to work with.
The drug, under the name Afinitor, already gained approval in the U.S. for TSC, but Europe should provide thousands of new patients for Novartis' revenue streams. Given that the European Commission, which grants approvals for the 27-nation member union, often heeds the CHMP's recommendations, things look good for Novartis and Votubia.
Looks like a keeper
Novartis has hit a few bumps in the road recently that you should keep in mind -- such as the loss of Diovan's exclusivity and the approval of a competing drug from Sanofi (NYSE: SNY ) in the oral MS treatment market that Novartis' Gilenya once owned all by itself -- a market that BioGen (Nasdaq: BIIB ) also is vying for a share of. Still, the promising results from RLX030 and the European recommendation for Votubia's approval shine two more green lights on this steady pharmaceutical titan, and Novartis shareholders should be all smiles.
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