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Rendering courtesyof Schick Goldstein ArchitectsUnited Therapeutics dedicated its new $32 million, 50,000-square-foot, four-story research and production facility in Silver Spring this week. The building is the first phase of the drugmaker’s expansion project.
Rothblatt presented the meters — on half poles and mounted on pedestals — as trophies to county and state officials, a regulatory lawyer, company researchers and others who had ‘‘brought the new building concept to life” on budget and in time, she said, for the drug company’s 10th anniversary.
Several hundred invited guests, including Dr. Louis W. Sullivan, former secretary of the U.S. Department of Health and Human Services, braved torrential rain to attend the ceremony under a tent outside the new research and manufacturing facility.
The 50,000-square-foot, four-story facility is phase 1 of United’s proposed expanded campus and headquarters in Silver Spring, Rothblatt said. It was designed by Schick Goldstein Architects PC of Washington. D.C. United has other facilities or offices in Chicago; Boston; Melbourne, Fla.; Triangle Research Park, N.C.; Washington, D.C.; and England.
Rothblatt founded the company in June 1996 under the name Lung Rx to find a cure for pulmonary arterial hypertension, a debilitating lung disease that her daughter had contracted. The company licensed the drug Remodulin for the condition and commercialized it in an injected form. United is also working on inhaled and pill versions of Remodulin.
United reported sales of $115.9 million and a profit of $65 million in 2005.
The medical building will allow the company to manufacture the active ingredient for Remodulin and its newest drug candidate for ovarian cancer: OvaRex Mab, which is in phase 3 clinical trials.
Building a manufacturing plant for the two drugs in downtown Silver Spring, Sullivan said, ‘‘is a wonderful story. You find a possible treatment, take it to the lab, then to the patients and eventually put that science to work for the health of those patients in a very rapid time.” Sullivan is president emeritus of the Morehouse School of Medicine in Atlanta.
Rino Aldrighetti, president and CEO of the Pulmonary Hypertension Association, also in Silver Spring, said that of the estimated 100,000 patients with the disease, only 20,000 are in treatment. When the first registry of patients was published at the National Institutes of Health in 1985, he said, ‘‘there were only 187 listed with the disease. But the reality is that it is not that rare.” Only 50 percent of the patients, usually women of child-bearing age women, survive, and for only five years, he said.
Frank J. Sasinowski, a former regulatory lawyer with the Food and Drug Administration, said Remodulin and the large, new manufacturing plant to produce it are ‘‘a story of orphan drug work that needs to be told.” Orphan drugs, as designated by the FDA, are used to treat diseases that affect fewer than 200,000 Americans or are drugs ‘‘for which there is no reasonable expectation” that their developer and manufacturer can recover their costs from U.S. sales.
Lugging his 50-pound parking meter, Sasinowski said that ‘‘when President Reagan signed the Orphan Drug Act in 1983, I couldn’t have dreamed that today there would be 2,880 orphan drugs approved. And almost all of the orphan drug developments have been driven by someone like Martine, with a mission.”