India's Natco challenges Celgene's Revlimid patent in USA; new CFO named

US biotechnology firm Celgene Corporation (Nasdaq: CELG) said on Friday it has received a Paragraph IV Certification Letter advising that Natco Pharma of Hyderabad, India, had submitted an Abbreviated New Drug Application to the US Food and Drug Administration requesting authorization to manufacture and market generic versions of its cancer drug Revlimid (lenalidomide) 5mg, 10mg, 15 mg and 25mg capsules in the USA.

The drug is a major and growing product for Celgene, which reported net global Revlimid sales of $1.76 billion in 2009, up 28.8% 2008 and $587 million in the second quarter of this year. Although the firm's stock reacted negatively at first, by afternoon trading on August 3 it rebounded and was up 2.8% at $52.06, as analysts expressed confidence in the intellectual property surrounding the product.

The drug is approved in combination with dexamethasone for the second-line treatment of multiple myeloma in over 50 countries across Europe, the Americas, the Middle East, and Asia. In Australia and New Zealand, Revlimid is sanctioned as combination therapy for the treatment of patients whose disease has progressed after one therapy.