rEVO Biologics, Inc. Provides Grant to Yale University to Establish a Center of Advancement for Preeclampsia

rEVO Biologics, Inc., a subsidiary of LFB Biotechnologies, today announced that it has provided a multi-year grant of up to $1M to Yale University to establish a Center of Advancement to further research and education in preeclampsia, and to uncover and define the best models of clinical care for the condition. rEVO is a biopharmaceutical company focused on the development of treatments for rare diseases, including early onset preeclampsia.

Preeclampsia is a life-threatening progressive condition that occurs in approximately five to eight percent of all pregnancies and typically occurs after the twentieth week of pregnancy. Early onset preeclampsia is a severe form that arises between 24 and 28 weeks gestation. The cause of preeclampsia is unknown, but the number of cases is growing rapidly. At present, delivery of the baby is the only known way to stop the progression of preeclampsia, which without intervention, can escalate to multiorgan failure, seizures, coma or death for the mother and baby.

“We are honored to partner with Yale University to make the Center of Advancement a reality,” said Yann Echelard, Ph.D., President and CEO, rEVO Biologics. “Preeclampsia is a serious disorder that can be devastating to both mother and baby, especially when it occurs prior to 34 weeks gestation. rEVO is committed to advancing research in early onset preeclampsia with the goal of speeding much-needed treatment to patients.”

Research at the Center will focus on the short- and long-term burden of preeclampsia for mother and baby with a specific focus on evaluating potential treatment options for the condition and related disorders. Researchers will also establish a robust database of genomic, proteomic and other biomarkers to help predict, diagnose and monitor the progression of preeclampsia. This research is an important step in helping to identify and better understand the cause of preeclampsia, which is currently unknown. The grant will be provided over the course of three years.

“The Center of Advancement will be fully dedicated to providing support, education and research to better understand, diagnose and treat preeclampsia,” said Michael J. Paidas, M.D., professor, vice chair of obstetrics, and director of the Yale Women and Children’s Center for Blood Disorders and Preeclampsia Advancement. “Despite significant advances made in preeclampsia, there has been little progress in identifying effective treatment options. Our hope is to improve scientific understanding of the disease that will ultimately lead to better care for women with preeclampsia and their babies.”

In addition to research, the Center will also provide resources to educate pregnant women and their healthcare providers about preeclampsia and related conditions.

rEVO has initiated PRESERVE-1, a Phase 3 clinical program for ATryn® [antithrombin (Recombinant)] for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy.

About rEVO Biologics

rEVO Biologics, Inc. (www.revobiologics.com) is a commercial-stage biopharmaceutical company focused on the development and commercialization of specialty therapeutics to address unmet medical needs in patients with rare, life-threatening conditions. The company’s lead product, ATryn, is the first and only plasma-free antithrombin concentrate. ATryn received FDA approval in 2009 for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. The company has a number of products in its pipeline and is actively seeking additional indications for its lead product.

About LFB Group

The LFB Group is a biopharmaceutical group that develops, manufactures and markets medicinal products for the treatment of serious and often rare diseases in several major therapeutic fields, including hemostasis, immunology and intensive care. The LFB Group is the leading manufacturer of plasma-derived medicinal products in France and sixth worldwide and is also among the leading European companies for the development of new-generation medicinal products or treatments based on biotechnologies. The LFB Group is pursuing a growth strategy that seeks to extend its activities at the international level and develop innovative therapies. To that end, the LFB Group currently markets its products in 30 countries around the world with a global turnover of €477 million in 2013.

About Preeclampsia

Preeclampsia is a condition that only occurs in pregnancy and affects the placenta. Abnormal development of blood vessels from the uterus to the placenta may lead to decreased blood flow, nutrients and oxygen from mother to baby, placing the baby at risk for prematurity and abnormal fetal growth. The lining of the blood vessels (endothelium) also becomes damaged causing inflammation that extends from the placenta throughout the mother’s blood vessels and internal organs. As a result, high blood pressure, stroke, seizures and liver and kidney problems can occur or even death for mother or baby.

According to the American Congress of Obstetricians and Gynecologists (ACOG), in the United States, the incidence of the disorder has increased by approximately 25 percent from 1987 to 2004.

Preeclampsia and related conditions like HELLP syndrome (hemolysis, elevated liver enzymes and low platelet count) and eclampsia are characterized by a rapid rise in blood pressure for the mother that may lead to seizure, stroke, multiple organ failure or even death for mother or baby. The Preeclampsia Foundation estimates the annual cost of preeclampsia is more than $7.0 billion in the United States, including approximately $3.0 billion relating to maternal disabilities and approximately $4.0 billion relating to infant morbidity.

About the PRESERVE-1 Clinical Trial

PRESERVE-1 (Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia) is a Phase 3, randomized, double-blind, placebo-controlled trial of 120 patients assessing the safety, efficacy and pharmacokinetics of ATryn, in patients who are being expectantly managed for early onset preeclampsia.

Efficacy will be assessed by comparing the difference in gestational age from the time of randomization into the trial until delivery of the baby for women given ATryn to those given placebo. The effect of ATryn on neonatal clinical outcomes will also be assessed.

About ATryn

Indications and Usage

ATryn is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.

It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.

Important Safety Information

ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. Allergic-type hypersensitivity reactions, including anaphylaxis, are possible. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur during administration, treatment must be discontinued immediately and emergency treatment should be administered.

The anticoagulant effect of drugs that use antithrombin to exert their anticoagulation may be altered when ATryn is added or withdrawn. To avoid excessive or insufficient anticoagulation, coagulation tests suitable for the anticoagulant used (e.g., aPTT and anti-Factor Xa activity) are to be performed regularly at close intervals and in particular in the first hours following the start or withdrawal of ATryn. Additionally, patients should be monitored for the occurrence of bleeding or thrombosis in such situations.

The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis and post procedural). The most common adverse events reported in clinical trials at a frequency of ≥5% are hemorrhage and infusion site reaction.

For more information, please view full Prescribing Information for ATryn, visit www.atryn.com or call 1-800-610-3776.

To report suspected adverse reactions contact rEVO Biologics, Inc.at 1-800-610-3776 or the FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.