GTC Biotherapeutics (fka GTCB)

[DewDiligence]

NovoSeven Update

Annualized NovoSeven sales during 4Q07 were $1.2B (DKK 6,076), the highest rate ever, but growth was only +3% vs 4Q06 in DKK (+9% in local currencies).

In other words, NovoSeven has reached blockbuster status but continued growth is problematic due to the colossal cost per dose. (Lowering production cost is, of course, the impetus for GTC’s rFVIIa program with LFB.)

Other notables from NVO’s 4Q07 PR:

http://www.novonordisk.com/include/asp/exe_news_attachment.pdf?sAttachmentGUID=08ed30ae-5bd6-4fb6-a2ef-ec14e68be632

>>
Novo Nordisk has finalised the phase 2 safety study for the use of NovoSeven® in cardiac surgery. A total of 172 cardiac surgery patients were included in the study. Preliminary results from the study confirm the safety profile known from the cardiac surgery setting and from previous studies of NovoSeven® outside of haemophilia with inhibitors. While the primary endpoint of this trial was safety, the trial also demonstrated the biologic haemostatic effect of NovoSeven®. Novo Nordisk expects to communicate next steps for NovoSeven® in cardiac surgery during the first half of 2008, following consultations with regulatory authorities and external experts.

A subcutaneously administered formulation of rFVIIa has entered phase 1 clinical development. The possibility of administering rFVIIa by means of subcutaneous injection is expected to significantly improve convenience for haemophilia patients with inhibitors.

The heat-stable version of NovoSeven® was submitted in December 2007 for regulatory approval in Japan. Regulatory submissions of the heat-stable version of NovoSeven® in Europe and the US took place in mid-2007.

Driven by a higher aspiration level within the haemophilia portfolio of Novo Nordisk, the company is now actively pursuing the development of new molecules for the treatment of haemophilia with and without inhibitors. The portfolio includes clotting factors targeting different parts of the coagulation pathway and aim at on-demand as well as prophylactic therapy. Among the preclinical projects, the most advanced of these are expected to enter clinical development within the next couple of years.
<<