Originally created 05/28/98

New drug awaits approval



Searle pharmaceutical plant in Augusta is gearing up to start production next month on a new generation of arthritis drugs.

Company officials say bulk quantities of Celecoxib will be rolling off the assembly line within four weeks in anticipation of the federal Food and Drug Administration's approval of the drug in 1999.

Celecoxib, which will be marketed under the brand name Celebra, is said to treat osteoarthritis and rheumatoid arthritis without causing ulcers and other side effects found in current remedies.

"Obviously, we're scrambling to put all the resources together to make it as soon as we can," said Bill DeFer, Augusta plant manager.

The Searle plant has already produced the drug in test quantities, he said. Celebra is in phase three of human testing.

Searle is one of several companies in Monsanto Life Sciences Co., a division of St. Louis-based Monsanto Co. Monsanto, the nation's fourth-largest chemical company, is also parent company of NutraSweet Keico Co., a maker of artificial sweetener.

Augusta will be the primary manufacturer of Celebra, but will be aided by the company's new plant in Barceloneta, Puerto Rico, which it acquired earlier this month from New Jersey-based Nycomed for $66 million.

The Barceloneta facility would replace Augusta as the primary producer of Searle's cardiovascular drug, Orbofiban, once it comes on line in two years, Mr. DeFer said.

Other companies, including Merck & Co. and Glaxo Wellcome PLC, are working on similar arthritis drugs collectively known as "COX-2 blockers" for their ability to block a specific cyclooxygenase protein believed to cause inflammation and pain in joints.

Once tests are complete and Celebra is ready for sale, analysts say it could render existing arthritis medications obsolete, including Searle's Daypro, the No. 2 selling non-steroidal, anti-inflammatory arthritis drug on the market.

"The benefits from Celebra seem to be overwhelmingly positive and could, in effect, replace the non-steroid, anti-inflammatory drug market," said Doug Groh, an analyst with Merril Lynch.

Celebra production in Augusta created 10 new positions which have already been filled, Mr. DeFer said.

The retrofit contract for the Puerto Rican facility has been awarded to Two-State Construction Co., a 300-employee industrial contractor based in Thomson, Ga. Company President Cliff Poston said his management team plans to spend 18 months in Puerto Rico working on the project.

"It's going to be a real fast-track type project," said Mr. Poston, who declined to disclose the dollar amount of the project.

Two-State was also the contractor for Augusta's Celecoxib plant, which is being used as the pattern for the Puerto Rico facility.

Monsanto has been busy in other areas of its diversified operations, most recently in March when it broke ground on its $100 million facility to produce somatotropin, a synthetic hormone marketed under the brand name Posilac, which increases milk production in dairy cows.

Through its various divisions, Monsanto's Augusta operation is the world's largest producer of aspartame, the substance used to make NutraSweet, and L-Phenylalanine, an amino acid used in aspartame and pharmaceutical products.

In addition to Daypro, Augusta also produces pharmaceutical products such as Ambien, an insomnia drug; Norpace, a heart arrhythmia drug; and Aldactone, a hypertension medication.