Who would have thought at the beginning of 2013 that Novo Nordisk’s biggest positive catalyst for the year might emerge from its haemophilia franchise? Oddly enough, that indeed seems to be the case. Its new factor VIII has just been backed by Europe’s drug advisors and is due a decision from the US very soon.
NovoEight is now on track to become Novo’s first entry into the factor VIII space, dominated now by Baxter International’s Advate. As a biosimilar, NovoEight would not be expected to take a leading position, especially as longer-acting products are nearing the market. But its approval would allow the Danish group to provide earlier treatment in haemophilia A – it already has a presence in this space with the rescue treatment NovoSeven – and the biosimilar could also serve as a placeholder for its own long-acting agent, now in phase III.
|Product||NovoEight (turoctocog alfa)|
|% of market cap||1%|
|Event type||PDUFA date|
Expanding the offering
Novo holds the enviable position as having the product forecast to be the top-seller for haemophilia in 2018, NovoSeven. The factor VIIa benefits from being a product patients use when they develop inhibitors to factor VIIIs and IXs, the proteins lacking in haemophilia A and B respectively. However, so far it does not have a product with early-line indication as Baxter, Pfizer, CSL and Bayer do.
NovoEight, known also as turoctocog alfa, would expand the Danish company’s offering as it seeks to put its stamp on the market. It will be the first factor VIII to launch since Pfizer introduced ReFacto ZF/Xyntha in 2008. As a biosimilar, it does not promise to offer much in the way of benefit in terms of bleeding control, which might raise some questions about whether it would be able to take market share away by encouraging patient switching.
Nevertheless, analysts expect the agent to carve a decent niche in the market, perhaps helped along by the commercial infrastructure that has helped to establish NovoSeven. EvaluatePharma’s consensus forecasts $173m in sales in 2018; some analysts are more bullish, with Bank of America-Merrill Lynch estimating sales of $375m in 2018, rising to $514m in 2018.
Ahead of the market
If approval comes as expected sometime in October, NovoEight will have some time to take market share before the expected entry of longer-acting agents like Baxter’s pegylated factor VIII, BAX-855, or Biogen Idec and Swedish Orphan Biovitrum’s fusion protein candidate Eloctate (rFVIIIFc) – but not much time, as Eloctate could premiere sometime early next year (Therapeutic focus – Long-acting haemophilia agents set to shake things up, July 26, 2011).
Biogen and Swedish had hoped to achieve a dosing interval of five days in prophylactic use, but in phase III the median was 3.5 days; compared with the every-other-day dosing of shorter-acting agents to maintain a factor VIII trough level of 1% or greater, it is not as great an advance as the most bullish investors hoped (Biogen’s blood data prove a little anaemic for some investors, November 1, 2012). Thus, the shorter-acting agents may hold on for a while; Advate sales are not forecast to decline significantly until 2017.
The relatively modest dosing advantage for Eloctate could help NovoEight, especially if the former is priced at a premium. Also assisting should be Novo’s existing commercial infrastructure in selling NovoSeven; establishing a presence in the pre-inhibitor space could also help should Novo’s long-acting factor VIII, a pegylated entry called N8-GP, achieve approval.
Disappointment on the diabetes front has defined Novo’s 2013, making any success in haemophilia seem like small beer. A setback here would not be welcome.