Science in the Triangle

Eisai’s new production plant in Research Triangle Park is fully equipped to make Halaven, a new treatment for advanced breast cancer, but the 66,700-square-foot building is still empty of people except for the occasional employee mopping floors. It will stay that way until the Food and Drug Administration inspects the plant and clears it for production.

Stephen Errico

The FDA approval, which Stephen Errico, director of Eisai’s parenteral operations, expects in September, will usher in a new era for Eisai and its main U.S. manufacturing site in RTP.

The Japanese drugmaker is switching its attention to injectable drugs after focusing on pills for many years. Injectable cancer treatments such as Halaven are on top of Eisai’s priority list and no matter whether these cancer treatments will come out of Eisai’s own research and development labs or the labs of partners, the new RTP plant will make and package them and ship them, first to the U.S. market and later the rest of the world.

Plans to seek regulatory approval for the RTP plant to produce for the European market are next.

“This facility is very unique and important to Eisai,” Errico said during a recent tour of the plant.

For the past 13 years, Eisai has made and packaged pills in RTP - Aricept, the leading Alzheimer’s treatment, and Aciphex, an acid reflux treatment. Aricept, Eisai’s biggest seller, generated about $2 billion in annual sales in the U.S. But in November, Aricept lost patent protection and Eisai expects to lose about 60 percent of its blockbuster’s sales to cheaper generic competitors over the next two years. In March, Eisai cut 70 jobs at its RTP operations, all of them in the pill part of its business.

Future growth sees the company in the injectables and oncology market.

So do most pharmaceutical companies.

Cancer is the second most common cause of death in the U.S., according to the American Cancer Society. In 2010, more than 500,000 Americans died from the disease and more than 1.5 million Americans were newly diagnosed with cancer. With more than 200,000 new cases every year, breast cancer is the most common cancer in women.

The active ingredient in Havalen is eribulin mesylate, a synthetic version of a chemical made by a black sea sponge. It was first isolated in 1985 by a Japanese scientist and has shown to prevent cell division. Eisai found it screening chemicals made by plants and animals living under water and in the tropical rain forest.

Eisai's operations in RTP include a new plant to make injectable oncology drugs. The new plant, in the foreground, could be expanded where the parking lot is now.

Eisai makes the eribulin mesylate in Japan. The active ingredient arrives in RTP as a powder, is then mixed with alcohol and water, filled in vials, labeled and packaged. All of the employees who will work on the line making Havalen will have to wear special clothing - from scrubs, hairnet, booties and gloves to two layers including a whole-body suit - for protection and to ensure the liquid isn’t contaminated.

Havalen faces competition from two other recently approved treatments for advanced breast cancer, but Eisai projects Havalen will become a blockbuster seller, generating about $1 billion per year. Up to 40 production workers could crank out as many as 4 million vials of Havalen on the RTP plant’s commercial production line per shift, Errico said. A second shift could be added.

A second production line is reserved for smaller batches of injectables used in clinical trials.

Errico estimated that initial demand for Halaven will keep about 25 percent of a shift busy. About 30 people have been hired and trained to work in the new plant. Errico said Eisai is looking for contracts to make other injectible products. “Our goal is to be a multi-product facility,” he said.

A framed architectural drawing on the wall shows three production lines Eisai could add on the southside of the building. But those are long-term plans. “I’ll probably be retired before we fill that,”Errico said.