Palbociclib itself targets ER+, HER2-positive breast cancer (the most common form of breast cancer) and works by inhibiting two cyclin dependent kinases, or CDKs, 4 and 6. These CDKs are essential for cell replication and their suppression has been demonstrated to interfere with tumor cell progression in advanced stages of the disease. Analysts at both Leerink Swan and JPMorgan estimate that, if approved for multiple indications, Palbociclib could have sales of $5 billion, annually.
A moat of competition, but plenty of upside
However, investors would probably be wise not to get too carried away with yesterday’s news given that another therapy — which I would certainly call revolutionary — known as Kadcyla for HER2-positive breast cancer was just approved in February. Kadcyla, developed by Roche Holding Ltd. (VTX:ROG) and ImmunoGen, Inc. (NASDAQ:IMGN) piggybacks a toxin on an antibody and, using ImmunoGen’s proprietary targeted antibody payload technology, delivers a higher dose of toxin directly to the targeted cancer, which has a signature protein that causes the release of the toxin from the antibody. In late-stage trials, Kadcyla improved PFS by 50% over the placebo to 9.6 months.
Where Palbociclib will have a major one-up on the competition is in ease of use. It’s an oral medication compared to Roche’s Herceptin, Perjeta, or combo drug Kadcyla, which are all administered intravenously. Only the combination of Roche’s Xeloda and GlaxoSmithKline plc (ADR) (NYSE:GSK)‘s Tykerb is currently administered in pill form, but many newly approved drugs and pipeline products have shown PFS advantages over that combination. Even Palbociclib (going strictly off phase 3 results) whooped Kadcyla on a numerical PFS basis, but I’d like to see a head-to-head trial before I’d go making any definitive “one’s better than the other” statements.
If Pfizer Inc. (NYSE:PFE) and Novartis can demonstrate that its combination is safe, I don’t think there’s a thing that’ll hold back an accelerated approval within the next two years. Breast cancer patients definitely have a reason to celebrate if Palbociclib’s 248% PFS improvement over the placebo holds true in further studies.
The article A “Breakthrough” May Be on the Way for Breast Cancer Patients originally appeared on Fool.com 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 recommends ImmunoGen and Vertex Pharmaceuticals.
Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.
