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New Treatment for Patients Needing Immunity Boost of Antibodies

Posted on: Friday, 13 January 2006, 15:00 CST

Patients with rare immune disorders who now receive intravenous infusions of replacement antibodies to boost their immune systems will soon be able to self-administer a therapy at home.

The Food and Drug Administration has approved a new weekly treatment that people can give to themselves manufactured by ZLB Behring, a King of Prussia, Pa., blood-products company.

The company said the FDA granted marketing approval for Vivaglobin, a new formulation of immunoglobulin that is delivered under the skin by using a small, hand-held pump. Until now, patients have received intravenous infusions in a clinic or physician's office.

"This has an advantage for patients who have difficulty with intravenous immunoglobulin injections," said Dennis Jackman, ZLB Behring senior vice president of public affairs. "The product has been sold in Europe, but we wanted to bring it to the United States as a treatment alternative."

About 50,000 Americans suffer from primary immunodeficiency diseases, which are genetic disorders that compromise the immune system and make patients vulnerable to life-threatening infections, the company said.

"It's very good news for patients because there is a choice available to treating physicians," said Fred Modell, president of the New York-based Jeffrey Modell Foundation, started by Modell and his wife, Vicki, in memory of their son, Jeffrey, who died in 1986 at age 15 of a primary immunodeficiency condition.

"It's wonderful in terms of lifestyle _ a child doesn't have to take off from school, or a parent take a day off from work," Modell said. "Intravenous immunoglobulin takes about four hours. Kids and adults go to a clinic or hospital every three weeks."

The company expects to launch the product, which is being manufactured in Germany, at the end of the first quarter, said Paul Perreault, executive vice president of worldwide commercial operations.

"Over the next three or four years, it could grow to be a significant portion of therapy for these patients, but it's going to take time," Perreault said. "This is a niche market. These are rare diseases. It's not like a blockbuster drug," which can generate $1 billion or more in annual sales.

ZLB Behring, a maker of blood-protein therapies to treat rare diseases, has more than 200 employees and produces about 30 plasma-derived medicines worldwide for people with illnesses ranging from hemophilia to immune deficiencies.

Formerly called Aventis Behring, the business was sold in December 2003 by Aventis S.A. to CSL Ltd., a global biopharmaceutical company in Australia. Shares of CSL trade on the Australian stock exchange.

For the fiscal year ended June 30, CSL reported revenue of $2.7 billion Australian dollars, or $1.96 billion U.S. dollars. About 80 percent of that came from ZLB Behring, Perreault said.

Besides manufacturing plants in Switzerland, Germany and Illinois, ZLB Behring also operates 62 blood-plasma collection centers in the United States and eight in Germany.

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(c) 2006, The Philadelphia Inquirer.

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Source: The Philadelphia Inquirer

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