Biotech giant banking on new class of drugs.

These are pivotal years for Thousand Oaks-based Amgen, the world's largest biotech company.

As it celebrates its 25th anniversary, the company has established itself as a multiple-product company with treatments for chronic kidney disease, rheumatoid arthritis and other diseases coming in the years following the release of its first two landmark products. During the next few years, Amgen could be releasing even more blockbuster drugs as it finishes a number of late stage trials.

Specializing in a few key areas such as oncology, inflammation and metabolic diseases, Amgen may have, in a molecule it is calling AMG 162, its next success. The drug, currently in late-stage testing with over 10,000 patients, is showing great success in treating diseases in which bone is broken down too fast, like osteoporosis. It's also in late stage testing for a drug called AMG 531, which stimulates the production of platelets.

Each could revolutionize treatment in its field of medicine and neither has a competitor on the market, said Tony Gringeri, senior director of licensing at the Thousand Oaks biotech titan.

"Over the next three to four years you're going to see all of these things coming to fruition," Gringeri said.

In the last 25 years, Amgen has grown from a business with a handful of employees to one of the most important businesses in Southern California.

It's hard to think of Amgen, which now has billions in revenues, as dependent upon venture capital funds like any other startup company, but the company's beginnings were as humble as most.

Looking back at the company's history, Amgen has essentially existed in three different eras. Incorporated in 1980, Amgen spent that entire decade looking for its first success.

"We were living essentially on venture capital. In 1989, Epogen, our first product, was approved which was an amazing breakthrough that change the practice of medicine," said Gringeri.

Epogen is used for the treatment of anemia in patients with chronic kidney disease who are on dialysis. In 1991 the company launched Neupogen, which is used to lower the incidence of infection in some cancer patients.

"Those two drugs were very, very successful and we went almost overnight from a company with nothing on the market to a company that was doing very, very well," Gringeri said.

In 1992 the company's sales surpassed $1 billion for the first time, and since 1994 Amgen has held to a policy of investing at least 20 percent of product sales into research and development. The reinvestment has helped Amgen grow its product pipeline exponentially.

"It's been 25 years of constant development and growth. Amgen has never been the same from one year to the next." said Gringeri. "During the entire decade of the 90s, we took a total of maybe 20 molecules into testing; we're taking 10 into testing this year."

Tim Osslund, who joined the infant company in the fall of 1980, said that watching drugs grow from discovery to approved treatments is one of the benefits of working at a biotechnology firm, Osslund has had the chance to watch half a dozen drugs complete their development process at Amgen. Most scientists working as university researchers may have the chance to participate in a small part of drug development, but don't get the chance to watch the whole process unfold.

Osslund currently teaches a class at California State University Channel Islands in drug development aimed at showing science and business students alike the process a pharmaceutical company goes through to create a commercial drug.

Many academic scientists have an affinity for discovery and research, but aren't as well-versed in manipulating proteins into functioning drugs or navigating through the Federal Drug Administration, said Osslund. Most of them have no idea what that work costs, either.

JONATHAN D. COLBURN Staff Reporter