CHATTANOOGA, Tenn. (February 14, 2012) – Glenveigh Medical announced today that the U.S. Food and Drug Administration (FDA) has granted its request for orphan drug designation for a potential new therapy to treat severe preeclampsia and eclampsia. The compound, digoxin immune fab (ovine), is an existing biologic approved for use in cases of digoxin toxicity. Glenveigh, a nationally renowned life science company, has extensive clinical and in vitro evidence to support continued development of this late-stage opportunity. Preeclampsia occurs in 5-8% of pregnancies in the U.S., and these severe forms are leading causes of maternal and perinatal mortality globally.
“This is a tremendous milestone for our company,” stated C. David Adair, M.D., Founder, Chairman, and Chief Scientific Officer of Glenveigh. “As a physician and scientist, I have personally seen the devastation these conditions have caused to both moms and babies. Our program, which includes two successful Phase II studies, offers hope to patients that there will be a treatment for severe preeclampsia in the near future.”
Preeclampsia is a condition in pregnant women that is characterized by high blood pressure and excess protein in the urine in the second and third trimesters of pregnancy. Severe preeclampsia and eclampsia represent the most advanced stages of the disease in which pregnant women can suffer from seizures and organ failure.
“In addition to our patents, orphan designation gives Glenveigh at least 7 years of marketing exclusivity,” noted Rick Proctor, President and CEO. “We are delighted that the FDA granted orphan drug designation which gives innovators added incentives to pursue treatments for smaller patient populations.”
Eleni Tsigas, Executive Director of the Preeclampsia Foundation, added, “Severe preeclampsia can be life-threatening to mother and baby. Effective interventions for this serious disorder of pregnancy are lacking. We are thrilled that this designation can better enable further research and development that may lead to a potential therapy.”
ATTACHMENT: Headshot of Dr. C. David Adair
ABOUT GLENVEIGH MEDICAL | www.glenveigh.com
Glenveigh Medical is a life science and technology based company focused on advancing the practice of obstetrics. Founded in 2004 by a maternal-fetal medicine specialist, Glenveigh prides itself on bringing innovative solutions to the obstetrics industry, relying upon its scientific and medical advisors to provide guidance on market opportunities that will significantly benefit patients in need. Glenveigh’s marketed products include the following medical devices: ebb® (post partum hemorrhage), jetty® (vaginal repairs), and Beacon™ (wireless fetal monitor). Glenveigh is based in Chattanooga, Tennessee.
