As we bring 2012 to a close, we’re looking back at a few of the interesting events that took place. It was a challenge to whittle this down to a manageable number. So we decided to go with three.
So, without further ado:
Pfizer acquires NextWave – This one really surprised a lot of the pundits. But in our view, it demonstrates what can be done through reformulation. Will all reformulation-based products command a premium like this? Absolutely not. However, taking an old molecule and recasting it in such a way that improves safety, compliance, and even efficacy is innovative, in our view. Will this make up for Lipitor sales? No, but it can cushion the blow a little.
BioSimilars – We thought it would be easy, right? Just grab a CMO, hand them some clones, and we’re off an running selling alemtuzumab for pennies a day.
Well, we all learned that reality is actually quite different. First, making stable clones that produce bioequivalent proteins, especially monoclonals, is not as easy at it sounds. Nor is the manufacturing, for that matter. Oh, and the commercialization is also challenge.
This all means that the biosimilars market, especially in the US (if we ever get our act together) will be limited to the major biotech companies who have the resources and the expertise to do all this.
So much for those pennies…
Globalization – All companies should be thinking globally from Day 1. We all know this. But do companies really do think globally? Do early-stage business plans consider developing a product outside the US first, before bringing it into the US? We’re a little surprised that more companies aren’t thinking along these lines. As Burrill commented earlier this year, this mindset can make a huge difference for some companies.
However, there are many exceptions. Interestingly, it’s many of the generic companies, especially the small ones, who are thinking in global terms right from the beginning. They seem to be much more willing to look at development and licensing opportunities from outside the US. Now we know that it’s “easier” to bring a generic formulation / candidate in from overseas compared to an NCE. But the mindset is what we find interesting.
For a broader overview of the year, check out Patricia Van Arnum’s 2012: The Year in Review.