AngroGel Testosterone Product (ATRS competitor)
AndroGel sales were $258 million in the quarter, down 6.5% versus the prior year. AndroGel continues to maintain a roughly 60% share of the testosterone replacement market. Sales this quarter reflect the year-over-year impact of rebating actions implemented in mid-2012 and certain account losses. We are now forecasting full-year AndroGel sales to be roughly flat versus 2012 levels.
And last is a question on the testosterone market – you’re obviously big there and may be for some time depending on what you do on biz dev and lifecycle management. What’s going on in that marketplace other than jockeying for contracting positions, formulator positions? What’s up with the growth rate there and when can you get that turned around?
The growth rat has definitely slowed down versus what we saw last year. The growth in the market year-to-date through May is around 9%. We are seeing some account losses due to competitive pricing but that said we’re maintaining over 60% share. There’s a fair amount of churn in the market. We still think AndroGel is a very, very important brand and we’re confident that the sales will remain flat through the year....You know, the 1.62% version of the product now accounts for about two thirds of the overall AndroGel franchise as well.
Biosimilars (MNTA and others)
Secondly, sort of a bigger picture question on long-term growth for HUMIRA: as bio-similar versions of products that will compete with HUMIRA become available around the world I’m curious on your view as to whether we will see more or less therapeutic substitution relative to what we’ve seen in the small molecule world.
On the therapeutic substitution, I mean certainly as we’ve said all along we don’t believe that in the area of biologics we’ll see therapeutic substitution that’s similar to oral solids – that’s for sure. And we still believe that based on the safety track record of a product like HUMIRA, the broad indications and all the other attributes of that product that we would see certainly more modest kinds of erosions compared to anything that you’d see in oral solid deals.
So safe to say you don’t expect bio-similar versions of other products to create a negative growth scenario for HUMIRA, even if the HUMIRA bio-similar is years off?
Yeah, I don’t believe it will have a dramatic impact on HUMIRA as an indirect bio-similar competitor...Especially if it’s a bio-similar to Remicade for instance which is an infused product relative to an injectable. So we think that anything in that space would not have an impact on injectables like HUMIRA and/or Enbrel.
And then the final question coming back to bio-similar Remicade and the recommendation of full label there, were you surprised at all with the full label? And what are the implications of that for HUMIRA as we think about potential bio-similar competitors, the amount of clinical work they’ll need to get a broad label as we look at the European market?
I’ll tell you we were surprised by the recommendation being broad without at least to our knowledge any clinical data to be able to support it. I’d say our position is we don’t think that’s in the best interests of patients. I mean it’s clearly unprecedented to have a biologic that you’re going to get ultimately an indication for that you’ve never studied in humans. And I’d say most of the feedback we get from physicians in Europe, particularly GI physicians I’d say is that they want to see data in here.
So we’ll have to see how it plays out. There’s a lot of time between now and the time HUMIRA will potentially face bio-similar competition so it’s a little early to speculate how that might impact HUMIRA one way or the other. I think we’ll have to see how it plays out.