CELG seeks Label Expansion - Analyst Blog

Celgene Corporation (CELG) announced that it has filed for approval of cancer drugs Revlimid (lenalidomide) and Istodax (romidepsin) for additional indications. While European approval was sought for Revlimid as a first-line maintenance therapy in patients suffering from multiple myeloma (MM), US approval was sought for Istodax for treating patients suffering from peripheral t-cell lymphoma (PTCL). The patients have been treated at least once for PTCL.

Results from late-stage studies formed the basis of the Marketing Authorisation Application (MAA) submitted to the European Medicines Agency (EMA) on the last day of 2010. Approval was sought for Revlimid in MM patients whose disease has not progressed following initial treatment with drugs such as melphalan, prednisone and Revlimid or autologous stem cell transplantation.

Apart from seeking to expand the label of Revlimid, which is already approved for myelodysplastic syndrome (MDS) and second-line multiple myeloma (MM), Celgene also asked for label expansion for another cancer drug, Istodax, for treating PTCL patients, last month. The company filed a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) for the drug, already cleared by the FDA in 2009 for treating patients suffering from T-cell lymphoma who have received at least one systemic therapy.  If Istodax is approved for the PTCL indication, it would be competing with Allos Therapeutics' (ALTH) injectable treatment for PTCL − Folotyn − which was launched in 2009.

We remind investors that Istodax was added to Celgene's already established cancer portfolio through the acquisition of privately-held Gloucester Pharmaceuticals early last year. The endaveour of Celgene to expand the labels of two of its cancer drugs is encouraging which will boost the company's top line significantly on approval.

Apart from the Gloucester acquisition, Celgene also took over Abraxis BioScience last year. The acquisition has further bolstered Celgene's cancer portfolio by adding cancer injection Abraxane. Abraxane is already available in the US and European markets as a second-line therapy for metastatic breast cancer. The drug is being developed for other indications such as skin, lung and pancreatic cancer. Vidaza is another drug in Celgene's oncology portfolio, which should drive growth going forward.

 
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