Halozyme Therapeutics Inc (HALO)

[DFRAI]

Rod

It seems that Pfizer - bococizumab is not slated for fda approval until 2017/2018...and they may have competitors ahead of them as of now unless FDA changes goal post based on Merck's Vytorin trial - Improve-it.
http://www.fool.com/investing/gene
ral/2014/01/15/pfizer-enters-a-10k-race-ready-for-a-marathon.aspx

In November 2013, the American College of Cardiology and the American Heart Association updated their cholesterol therapy guidelines. The groups recommend physicians continue prescribing standard therapies like statins over fancy new drugs. The sole reason, it seems, boils down to long-term familiarity.

This was great news for Pfizer, but terrifying to its competitors. Luckily for Amgen and Sanofi, a deputy director in the drug and research branch of the FDA, Eric Colman, soothed their nerves. Apparently, PCSK9 approval decisions will remain based largely on the reduction of LDL-C and blood pressure.

That isn't a promise that's etched in stone, however. Coleman also mentioned Merck's Vytorin trial. The FDA might change its mind, depending on results from the IMPROVE-IT trial. This is a two-and-a half year trial of non-statin therapy Vytorin combined with Simvastatin, comparing it against Simvastatin alone to measure the rate of heart attack and stroke. If the statin plus non-statin therapy doesn't significantly decrease the rate of cardiovascular events, the FDA will probably change its mind. This would force Pfizer's competitors to also include cardiovascular outcomes trials before filing their new drug applications. As a result, Pfizer could find itself in the lead.

Fortune favors the bold
Pfizer might be late to the party, but I can't help but be impressed by its bold move to differentiate itself from the competition. The company's full cardiovascular outcomes trials are likely to be far more expensive than its competitors' Phase 3 programs. Given the reluctance of doctors and payers to adopt new expensive therapies without long term proof safety and efficacy, however, it has a good chance of paying off in the long run. On top of that, if regulators change their minds then Pfizer and its investors will be laughing all the way to the bank.