Celgene Corporation (CELG) yesterday announced that its cancer drug Amrubicin displayed less toxic effects for the heart than traditional treatments in the same class as per two mid-stage studies. The pooled studies analyzed 117 Amrubicin treated patients by evaluating the reduction in left-ventricular ejection fraction (LVEF), which measures the fraction of blood pumped out of the left ventricle with each heart beat.
Results from one of the studies showed that tumors shrank partially or completely in 44% Amrubicin treated patients with relapsed small cell lung cancer (SCLC), compared to 11.5 % in patients treated with GlaxoSmithKline’s (GSK) Topotecan. The safety and efficacy was confirmed by the other study as well.
Celgene expects to submit a New Drug Application (NDA) in the U.S. and a Marketing Authorization Application in the EU for Amrubicin for the treatment of relapsed/refractory SCLC this year. It has been granted orphan drug status. Amrubicin was approved in Japan in 2002.
SCLC constitutes approximately 15% of all lung cancers. Of the estimated 65,000 SCLC diagnosed patients each year in the US and EU, approximately 60 % have extensive disease at diagnosis while the remaining have localized, or limited stage, disease.
Celgene has three lead products- Revlimid, Vidaza and Thalomid, on the market for hematology and oncology. Revlimid, currently approved for myelodysplastic syndrome (MDS) and second-line multiple myeloma (MM) is the principal growth driver of Celgene, whose declining sales growth rate is a matter of concern.
However, we are optimistic about Vidaza, which targets myelodysplastic syndrome (MDS), a market of about 30,000-40,000 patients in the U.S. We believe that the current negative growth of Thalomid sales will continue due to other more safe and effective drugs for the treatment of MM such as Revlimid and Takeda’s (TKPHY) Velcade.
The presence of two Celgene drugs in the MDS market could mean that Thalomid is ultimately taken off its product portfolio to boost Revlimid sales.
Celgene is seeking to expand the Revlimid and Vidaza labels to increase the patient base. We believe these two products will enable Celgene to dominate the MDS market in the next few years. Consequently, we remain optimistic about Celgene in the long run. Additionally it boasts of a deep and diversified pipeline.
We believe the fundamentals of the company remain strong and the name is still a key holding in the biotech industry.
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