Recently, Celgene Corporation (CELG) announced that the US Food and Drug Administration (FDA) will review the supplemental New Drug Application (sNDA) for cancer drug Istodax (romidepsin) on a priority basis.

Istodax is already approved for treating patients suffering from T-cell lymphoma who have received at least one systemic therapy.  Celgene is now looking to get the drug approved for treating patients suffering from peripheral T-cell lymphoma (PTCL), who have received at least one prior therapy.  A response from the FDA is expected to be out by June 17, 2011 (target date).

 The sNDA was filed by Celgene in December 2010 based on  safety and efficacy data from a mid-stage study of Istodax in PTCL patients.

We note that the US regulatory authority generally reviews those drugs on a priority basis which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission as against the usual ten months.

We note that 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.

Apart from the Gloucester acquisition, Celgene also took over Abraxis BioScience last year. The Abraxis 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.

Our Recommendation

We have a ‘Neutral’ stance on Celgene which is supported by the Zacks #3 Rank (Hold rating) carried by the stock in the short run.

 
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