Sales of Amgen Inc.'s second-generation anemia-fighting drug Aranesp took off, too: Approved in September 2001, the product brought in $42 million by the end of the year.

And, though initial product sales can be misleading (because distributors and hospital formularies are stocking their shelves), it's clear from the sales figures in the above table that the newly approved therapeutics are off to a strong start. Given the size of the markets, and the conditions they address -- AIDS (Viread), rheumatoid arthritis (Kineret), congestive heart failure (Natrecor), septic shock (Xigris) and chronic lymphocytic leukemia (Campath) -- product sales should soar in 2002.



It can take a number of years for a biotherapeutic to reach its full market potential, of course. Consider Biogen Inc.'s multiple sclerosis drug Avonex: Approved by the FDA in May 1996, sales of this product are still growing. Sales have more than quadrupled in five years -- from $240 million in 1997 (the first full year on the market) to $972 million in 2001. And Genentech Inc.'s breast cancer therapy Herceptin has nearly doubled its sales in three years -- from $188 million in 1999 (the first full year on the market) to $347 million in 2001.


Products On The Rise: First Full-Year Sales vs. Year 2001 Sales

As well, sales can grow substantially once a product's been approved for additional indications. Centocor Inc.'s Remicade, which was first cleared for treating Crohn's disease in August 1998, went on to gain approval for use in rheumatoid arthritis (RA). And Immunex Corp.'s Enbrel, which was approved in November 1998 as a second-line therapy for RA, is now prescribed as a first-line therapy for adults with RA, as a treatment for juveniles with RA and as a therapy for patients with psoriatic arthritis.

Soon, each could garner yet one more approval: According to data now being presented at the American Academy of Dermatology's annual meeting in New Orleans, both Enbrel and Remicade work remarkably well in psoriasis, a very difficult disease. (For a discussion of psoriasis, and the many therapies now in development, see the Signals article, "The Heartbreak Of Psoriasis.")


An expanding patient base can guarantee strong sales for years -- if not decades. There's no better example of this than Eli Lilly and Co.'s recombinant human insulin drug, Humulin. It was approved for marketing in October 1982 -- 20 years ago -- and today it's racking up annual sales of more than $1 billion. In the last few years, sales have started to plateau, but Lilly's more than making up for that with Humalog, a recombinant insulin analog that garnered $628 million in 2001.


Established Products: Year 2000 Sales vs. Year 2001 Sales

And there's no stopping the red blood cell booster recombinant erythropoietin. Johnson & Johnson's version, Procrit, was first approved in December 1990. In 2001, it reaped $3.4 billion in worldwide sales. Amgen's drug, Epogen, has been on the market since mid-1989. By the end of 1996, annual sales had broken the $1 billion barrier; in 2001, they topped $2.1 billion.

Amgen's restricted to selling Epogen as an anemia therapy in the U.S. dialysis market. However, now that its second-generation product Aranesp has been approved, the company's ready to expand its franchise. Aranesp, which requires less frequent dosing that Epogen, is prescribed for treating anemia associated with chronic renal failure -- whether or not those patients are on dialysis. Moreover, Amgen's already submitted supplemental applications in the U.S. and Europe for Aranesp's use in treating patients suffering from anemia associated with chemotherapy.

For a biotech company, or a pharmaceutical concern, the ability to bring new products to market year after year is a critical component of the organization's continuing financial health. But garnering new indications for established drugs, and developing second-generation products with enhanced efficacy or longer half-life, can also result in solid gold sales, year after year.