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Landmark Rh Vaccine Celebrates 35 Years of Saving Babies’ Lives

RhoGAM® Hailed as One of the Top Achievements in 50 Years of Women’s Health

RARITAN, NJ (July 14, 2003) — On May 29, 1968, a new mother at Holy Name Hospital in Teaneck, N.J., helped make history as the initial recipient of the world’s first injectable treatment to prevent life-threatening Hemolytic Disease of the Newborn. The event marked the launch of one of the most significant ob-gyn breakthroughs of the 20th century and virtually guaranteed the lives of thousands of babies a year. In the 35 years since that first injection, RhoGAM® Rho(D) Immune Globulin (Human) has protected millions of babies and has been trusted by more than a generation of mothers. The product, which is manufactured by Ortho-Clinical Diagnostics, a Johnson & Johnson company, remains the gold standard of protection for Rh-negative women and their babies.

“Before RhoGAM® was available, Hemolytic Disease of the Newborn claimed the lives of roughly 10,000 babies in the U.S. every year. That alarming statistic translated to more than 27 babies lost each day,” said Catherine Burzik, president, Ortho-Clinical Diagnostics, Inc. “Desperate for an effective treatment to overcome the disease, physicians resorted to such risky measures as administering blood transfusions by needle to babies still in the womb. Today, RhoGAM® is administered as a routine part of an at-risk pregnant woman’s pre- and postnatal care, and thankfully, Hemolytic Disease of the Newborn has been virtually eliminated.”

The discovery of RhoGAM®, a simple and safe Rh “injection” that prevents the Rh disease from developing, was the result of years of pioneering collaborative work by researchers at Columbia University in New York and the Ortho Research Foundation (now Ortho-Clinical Diagnostics) in Raritan. When it was launched, RhoGAM® was heralded by medical journals and publications such as The New York Times as an obstetrical milestone. The American College of Obstetrics and Gynecology has hailed RhoGAM as one of the top achievements in 50 years of women’s health.

"For more than a generation, RhoGAM® has had a record of proven safety and efficacy,” stated Scott MacPherson, Marketing Director for the Ortho-Clinical Diagnostics Immunohematology and RhoGAM® franchises in the U.S. “More than 18 million doses have been administered since its development. And we have provided 35 years of uninterrupted supply, continuing to be the market leader.”

Throughout the past 35 years, Ortho-Clinical Diagnostics has spearheaded significant advances in the production of RhoGAM®. In 1997, in order to provide an extra layer of assurance for safety, the company launched RhoGAM® Ultra-Filtered, which is produced with an additional ultrafiltration process that removes viruses such as HIV, hepatitis C and hepatitis A. In 2001, RhoGAM became available free of preservatives in a latex-free delivery system, and it now has a safety shield on the syringe.

Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading provider of high-value diagnostic solutions for the global health care community. Committed to developing the most advanced tests for early detection or diagnosis of disease, the Company brings products to market that provide timely information and help to facilitate better medical decisions. Ortho-Clinical Diagnostics also provides blood screening and typing products that help ensure the safety of the world’s blood supply. In addition, through its patented micro slide and enhanced chemiluminescence technologies, the Company transformed the way clinical laboratories perform testing. Worldwide, health care professionals rely on Ortho-Clinical Diagnostics for innovative diagnostic solutions that promote effective diagnoses and enhanced patient care.




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