The other big winner here, which came as a big surprise to me, is Novartis AG (ADR) (NYSE:NVS). To start with, Novartis has two drugs – LDK378 and serelaxin – with the breakthrough therapy designation. LDK378 demonstrated an incredible overall response rate of 60% in a 78-patient mid-stage study for ALK+ non-small cell lung cancer and should serve as enough of a basis to file for an NDA in early 2014. Serelaxin is equally exciting with the drug reducing mortality rates in a late-stage trial by 37%. If approved, it would become the first new acute heart failure drug to come to market in more than two decades.
But, Novartis AG (ADR) (NYSE:NVS) is also a crucial component to Pfizer Inc. (NYSE:PFE)’s breast cancer drug palbociclib which has been touted as a potential $5 billion per year drug. The reason is that Novartis’ Femara is given in conjunction with palbociclib to produce its desired results. In a mid-stage metastatic breast cancer trial, those patients given just Femara demonstrated 7.5 months of progression-free survival compared to the combination of palbociclib and Femara which delivered a whopping PFS of 26.1 months!
Adding these together — peak sales estimates of $5 billion for palbociclib, anywhere from $1.5 billion to $6 billion for serelaxin, and no published estimates for LDK378 (but I’d venture a guess of around $2 billion) — and you’ll see that Novartis AG (ADR) (NYSE:NVS) offers one of the most intriguing pipelines right now among the companies which have received the breakthrough designation for one of their drugs.
This is working
The breakthrough designation isn’t handed out lightly by the FDA as you can see, but it also can help us identify biopharmaceutical companies which are likely to show long-term gains. Let’s just say that if I was a shareholder Johnson & Johnson (NYSE:JNJ) or Novartis AG (ADR) (NYSE:NVS) right now, I’d be very pleased with the expedited review process that the breakthrough designation offers.
The article These 2 Companies Are the Biggest Winners of the FDA’s Breakthrough Designation originally appeared on Fool.com and is written by Sean Williams.
Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.The Motley Fool owns shares of, and recommends Johnson & Johnson. It also recommends Vertex Pharmaceuticals.
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