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  • Pfizer (PFE) Names First Halozyme (HALO) Target- RN316 Its Anti-PCSK9 Candidate Will Use Once A Month Convenience To Get Leg Up On Competition 0 comments
    Oct 30, 2013 3:44 PM

    The anti-PCSK9 market is an LDL lowering multi Billion dollar prize being fought over by most of Big Pharma. The partnership of Sanofi/Regeneron is In the lead with alirocumab (REGN727/SAR236553) ; phase III trials will begin to show results later this year. It is given every two weeks and is scheduled to be launched in 2015, with sales forecasts of $621m by 2018.

    In second place is Amgen's AMG145, which is in phase III and recruiting patients. Deutsch Bank notes that this could be launched a year later than alirocumab with forecasts 2018 sales of $140m. AMG145 is trying once-monthly and every two week dosing. However, their once-monthly dosing results in a modest loss of efficacy and requires two separate injections. This is an opening for Pfizer.

    Pfizer's RN316 (PF-04950615) in third place, with an expected launch in 2017. Roche is, however is a close fourth with phase II data on its subcutaneous project RG7652 coming later in 2013.

    This was the well known story up until Pfizer's Q3 conference call held on 10/29/13. The following is the first announcement of Pfizer's first partnered target with Halozyme:

    Ian Read - Chairman and CEO: That being said, Mikael, do you want to add on something about - some of the technology that we're excited about there?

    Mikael Dolsten - President, Worldwide Research & Development: Yes, to build on the excellent way in which John described, our PCSK9 clinical strategy, it's a really well behaving antibody. This twice monthly administration schedule is the logical next step as John described. However, we think that as part of the potential lifecycle management strategy, there are opportunities that all explore once-monthly schedule. That may include the use of technologies such as the Halozyme technology for which we have exclusive license within the PCSK9 class and we are now performing early test on the suitability of that technology to extend half-life and also lower the volume that you need to inject. The antibody itself at high dose has the potential for once-a-month, but we would rather see a technology like this to give really convenient opportunity. So, as you can see, as we go forward with twice monthly, we have a lifecycle management potential to offer additional regimens.

    By naming RN316 as a Halozyme target, Pfizer maintains the exclusive use of its Enhanze technology to spread its monoclonal antibody in the subcutaneous space. The greater the spread, the better and more long lasting the effect of the active molecule. This same technique has been approved recently by the EMA in Herceptin SC.

    By developing the most effective once a month formulation, Pfizer-Halozyme may overcome any advantage being earlier to market affords its competition. Certainly, Pfizer, like Roche and Baxter before it, is demonstrating to its Big Pharma competitors the potential value of partnering with Halozyme. Lately, Pfizer is adopting a biosimilar strategy One may be certain that more large molecule target Halozyme partnerships are on the horizon- perhaps with the Humira Biosimilar currently in Ph1.

    Disclosure: I am long HALO. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

    Themes: long-ideas
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