Royalty Products

We receive royalties on three marketed products that successfully utilize our proprietary PEGylation platform, namely PEGINTRON®, Macugen®, and CIMZIA®, with PEGINTRON being the largest source of our royalty income. We also could receive royalties on Hematide, which is currently in Phase III development, if approved.

PEGINTRON is a PEG-enhanced version of Merck's alpha interferon product, INTRON® A, which is used both as a monotherapy and in combination with REBETOL® (ribavirin) capsules for the treatment of chronic hepatitis C. The product has also been submitted for approval for adjuvant treatment of patients with Stage III melanoma. The application was recommended for approval by the FDA Oncology Drugs Advisory Committee in October 5, 2009. However, on October 30, 2009, the FDA issued a complete response letter to the Merck’s supplemental Biologics License Application regarding PEGINTRON for this indication. Merck continues to work closely with the FDA to respond to outstanding concerns related to the PEGINTRON melanoma filing.

Macugen (pegaptanib sodium injection) is currently being marketed through a collaboration between OSI and Pfizer for the treatment of neovascular (wet) age-related macular degeneration, an eye disease associated with aging that destroys central vision.

CIMZIA was approved in April 2008 for the treatment of Crohn’s disease and is marketed by UCB. In May 2009, CIMZIA was approved for adult patients suffering from moderate to severe rheumatoid arthritis.

Hematide is a synthetic peptide-based erythropoiesis-stimulating agent being evaluated by Affymax and Takeda Pharmaceutical in for the treatment of anemia in chronic kidney failure. At the end of Janaury 2010, Affymax announced that the Phase III trial was completed and top line results would be reported in the second quarter of 2010. If results are positive, the Company plans to submit an New Drug Application (NDA) later in 2010.