Novo Nordisk scuttles late-stage hemophilia drug over patient risk

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Danish drugmaker Novo Nordisk ($NVO) has killed development of a hemophilia med once hailed as a successor to its blockbuster product for the bleeding disorder, after the company discovered anti-drug antibodies to the experimental factor VIIa therapy in some study patients, Reuters reported. The setback hampers the company's work on building its hemophilia franchise as competitors such as Biogen Idec ($BIIB) seek entry to or growth in the market.

Anti-drug antibodies present a risk to patients with hemophilia who count on injected clotting factors to arrest bleeding. Novo Nordisk says that it first revealed Aug. 9 that a few patients in its late-stage study developed antibodies against its fast-acting factor VIIa, called vatreptacog alfa, with the antibodies having a neutralizing effect in one patient. The company was quick to note in its release Friday that no such antibodies have been reported in patients on marketed hemophilia drug, NovoSeven, while taking inhibitors to factor VIII and factor IV.

"The observation of anti-drug antibodies and the potential risks hereof for haemophilia patients with inhibitors has led Novo Nordisk to discontinue further development of vatreptacog alfa," Novo said in its statement today.

The decision to end development of vatreptacog dashes hopes that the drug could help replace sales of aging blockbuster NovoSeven, which Reuters says brings in more than $1.4 billion in annual sales to Novo Nordisk.

Novo Nordisk, the world's top insulin maker, faces growing competition in the hemophilia market. Weston, MA-based biotech giant Biogen Idec made progress in entering the market with positive data from its late-stage LONG-B trial for its long-acting clotting factor for hemophilia B patients, noting that there were no anti-drug antibodies discovered in patients who took part in the study.

- here's the company's statement
- and Reuters' report

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