- CELG held 2q11 earnings conference call 7/28/11 - click for transcript link.
- CELG has licensed CC-930 JNK inhibitor that is in phase 2 trials from Ligand (more details on LGND page)...CELG website lists this program as in phase 2 trials for idiopathic pulmonary fibrosis (IPF) and discoid lupus...but no mention on CC.
- SEC 10q filing: "No further studies with CC-401 [first generation JNK inhibitor] are planned at this time as we intend to advance our new second generation JNK inhibitors, specifically CC-930, which recently completed a Phase Ib multiple dose study. We are also planning to investigate CC-930 in fibrotic conditions assuming safety and tolerability continue to be acceptable." - and listed ongoing phase 2 trial of CC-930 in IPF
- CELG formerly sold Alkaran (now sold by GSK and CELG residual payments ended 3/31/11)...Ligand is developing a Captisol-enabled improved formulation of the product (see details on LGND page)
- CELG sells VIdaza, the only direct competitor to Dacogen which generates significant royalties for Supergen (details on SUPG page)
- Quotes from CC relevant to Vidaza/Dacogen market dynamics:
- "We expect sales of VIDAZA in the U.S to eventually being negatively impacted upon entry of a generic competitor, the timing for that entry is later than we originally anticipated. Second quarter VIDAZA sales benefitted incrementally from this situation and we're benefitting from it so far in the third quarter"
- "Following the first quarter approval by the health technology assessment agency, NICE VIDAZA sales have grown dramatically in the U.K., increasing 48% quarter-over-quarter"
- "Additionally, our teams in Australia and Canada are producing strong sales in their first few quarters since launch. Despite the loss of orphan drug exclusivity for VIDAZA in the United States, [no] generic has entered the market as Jackie reported and our quarter-over-quarter sales remained steady."
- Question: Update on oral VIDAZA [currently in phase 2 and potential competitor to SGI-110 Dacogen oral follow-on from SUPG]? Robert J. Hugin - President and CEO: "Yeah, I think we're very encouraged by what we're seeing in terms of the activity and the tremendous interest in really having an oral epigenetic therapy that can be dosed on a ongoing basis to really have a positive impact, especially in combination therapy. So, we've made great progress on the formulation and we are accelerating that development program as quickly as we can, because we think in a number of indications, this is going to be a very attractive opportunity for us."
- "Just on your VDIAZA question, we obviously the growth is [mostly] outside of the U.S., so product is doing extremely well and what we start to see is in terms of the overall global sales for VIDAZA it will be shifting closer and closer – more and more in favor of international and that will be significantly accelerated when we see the generic in terms of U.S. and that's quite obvious to everybody, I think. So, if we look at the numbers for Q2, the split is roughly 50-50 and again we say the overall growth of 23% is driven by international."