More than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names, and similar medicines to regulate the formation of red blood cells. Worldwide annual sales are estimated at more than USD 7 billion, including USD 600 million in Europe.
Merck & Co., Inc. announced today that the Food and Drug Administration (FDA) has accepted for standard review a supplemental Biologics License Application (sBLA) for GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]. The sBLA includes data on protection against vaginal and vulvar cancer caused by HPV types 16 and 18 and data on immune memory. Under the Prescription Drug User Fee Act (PDUFA), for standard sBLAs filed in 2007, the FDA's goal is to review and act on 90 percent of sBLAs within 10 months of receipt. Merck anticipates action by the FDA in the first quarter of 2008. 
Pfizer Inc announced today that the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom has recommended Champix (varenicline) for use on the National Health Service for adult smokers who have expressed a desire to quit. This gives smokers across England, Wales and Northern Ireland access to another important treatment option to help them quit smoking. JANUVIA™ (sitagliptin1), Merck & Co., Inc.'s once-a-day oral treatment for patients with type 2 diabetes, has been granted a license from the European Commission. JANUVIA now becomes the first and only medication in a new class of drugs known as dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), which enhance the body's own ability to lower blood sugar when it is elevated, to be adopted by the European Commission.