Following swift approval from the FDA, Amgen Inc. expects its next blockbuster drug for chemotherapy patients to enter the market April 1.
Neulasta (pegfilgrastim), the second generation of Neupogen, was granted clearance for sale after only 10 months under FDA review. Ken Keller, senior director of marketing for Thousand Oaks, Calif.-based Amgen, told BioWorld Today that even though Amgen didn’t expect approval until 2003, the early decision will not hamper the company’s ability to get the drug to customers.
Elise Wang, biotechnology analyst for Salomon Smith Barney Inc. in New York, told BioWorld Today that Neulasta likely will cannibalize Neupogen sales, but also should help expand the market. “We are anticipating that when it gets priced, it will be priced at somewhat of a premium to the current product and because it is so much more convenient, you will see expanded use,” she said. “Neulasta provides a sustained duration and clearly is a much more convenient dosing regimen than Neupogen.”
Wang said Neulasta is expected to generate about $2 billion in (U.S.) sales by 2005. Neupogen currently commands about $1.3 billion annually. “We think Neulasta will drive the franchise that Amgen has, which today is a high-single-digit growth year over year, to a double-digit growth level,” she said.
Amgen’s stock (NASDAQ:AMGN) closed Friday at $57.88, up $2.38.
Neulasta, injected once per chemotherapy cycle, works by stimulating the body to produce white blood cells quickly, therefore reducing the risk of infection. Chemotherapy kills normal cells as well as cancer cells, including the ones that protect against infection. Neulasta, formerly known as SD01, is approved for decreasing the incidence of infection, as manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs.
Neupogen, Amgen’s white blood cell stimulator, is administered subcutaneously seven to 10 days during the chemotherapy cycle.
“Patients can use Neulasta and go through chemotherapy safely,” Keller said. “Right now there are about 1.5 million patients [in the United States] getting chemotherapy and only about 10 percent of those patients are receiving protection up front from infection. The biggest reason is the burden of daily dosing. We think Neulasta will allow us to protect a lot more patients. There’s a huge untapped market.
“Most patients get chemotherapy on an outpatient basis and the last thing they want to do is end up in the hospital,” Keller said. “Every year there are thousands and thousands of patients who end up in the hospital because of infection when they receive chemotherapy.”
According to the company, Neulasta was safe and well tolerated in clinical trials. The most common adverse event was mild to moderate bone pain, in 26 percent of the patients.
Neulasta joins the list of other successful products made by Amgen. Epogen (epoetin alfa), an anemia therapy for dialysis patients, and Aranesp (darbepoetin alpha), the second generation of Epogen and an anemia treatment for dialysis and non-dialysis patients, reached $2.2 billion in sales last year. Amgen in the fourth quarter launched Kineret, a rheumatoid arthritis drug, which managed $12 million in sales. Also at the end of the year, Amgen entered a $16 billion deal to buy Immunex Corp., of Seattle. Through the purchase, Amgen gains rights to Enbrel, an approved drug for arthritis that generated $762 million in 2001 sales despite supply limitations, sales expected to rise significantly in the coming years. (See BioWorld Today, Dec. 18, 2001, and Jan. 25, 2002.)