Postpartum hemorrhage is a serious emergency

Without treatment, postpartum hemorrhage can cause death within 2 hours in a healthy woman.¹ Treatment with uterotonics works in many cases, but when uterotonics fail, continued blood loss may lead to a dangerous situation.

Tamponade may be the only therapeutic measure needed to stop postpartum hemorrhage.⁴ Within minutes, tamponade treatment predicts if the bleeding is likely to stop or requires surgery. An early decision to use tamponade may reduce blood loss and the need for transfusion.⁵

Ebb—the first rapid-response dual-balloon tamponade system

Ebb provides a complete tamponade solution to the emergency of postpartum hemorrhage.^* Designed by world-renowned maternal-fetal medicine specialists Michael A. Belfort and Gary A. Dildy, Ebb provides

• Increased capacity for complete conformation to the uterus, when needed
• Rapid, direct inflation for quick response time
• Dual balloon for secure, complete treatment of both uterine and vaginal bleeding
• Ease of administration that advances the treatment of postpartum hemorrhage

The balloon is made of malleable yet extremely strong polyurethane, allowing Ebb to expand and conform to any uterine shape. Ebb also features a vaginal balloon to control vaginal bleeding and act as an anchor to support the uterine balloon. External ports allow independent control of inflation, deflation, irrigation, and drainage.

^*See Package Insert (PDF) for use instructions, warnings, contraindications, and precautions.

References: 1. World Health Organization. Risking death to give life. Available at: http://www.who.int/whr/2005/chapter4/en/index1.html. Accessed March 31, 2010. 2. Combs CA, Murphy EL, Laros RK Jr. Factors associated with postpartum hemorrhage with vaginal birth. Obstet Gynecol. 1991;77:69-76. 3. Combs CA, Murphy EL, Laros RK Jr. Factors associated with hemorrhage in cesarean deliveries. Obstet Gynecol. 1991;77:77-82. 4. Condous GS, Arulkumaran S, Symonds I, Chapman R, Sinha A, Razvi K. The "tamponade test" in the management of massive postpartum hemorrhage. Obstet Gynecol. 2003;101:767-772. 5. Keriakos R, Mukhopadhyay A. The use of the Rusch balloon for management of severe postpartum haemorrhage. J Obstet Gynaecol. 2006;26:335-338.

Jetty—The Clear Solution for Episiotomy and Vaginal Laceration Repair

Episiotomies and vaginal lacerations are common in childbirth¹

Episiotomy is one of the most frequently performed obstetric surgical procedures.² Even in vaginal deliveries that do not involve episiotomies, vaginal laceration is common due to natural causes and the use of medical instruments during delivery.¹ Postpartum fluids and blood frequently contaminate the area, making timely and effective repair critical.² Effective vaginal laceration repair is essential to reduce likelihood of infection, minimize bleeding, limit post childbirth pain, and prevent unnecessarily poor cosmetic results.¹

Vaginal packing with gauze or sponges may be insufficient

Vaginal packing with gauze or sponges is frequently used to stop bleeding and block the flow of fluids, but this practice has its own complications and risks. Counting sponges before and after surgical procedures is a time-intensive task prone to human error,³ and sponges may be retained after repair, potentially leading to infection.

Jetty—the clear alternative to vaginal packing

Jetty is indicated for use during episiotomy and vaginal laceration repair to temporarily prevent the postpartum discharge of fluids from the vagina in order to assist with the repair procedure.* Jetty provides clarity and cleanliness for a timely, effective repair, and it eliminates the need for vaginal packing with gauze or sponges.

• Balloon fills to a maximum volume of 300 mL with saline solution
• Convenient, rapid filling directly from fluid source or a standard syringe
• Single-piece device simplifies use
• No need for sponge counts

^*See Package Insert (PDF) for use instructions, warnings, contraindications, and precautions.

References: 1. Leeman L, Spearman M, Rogers R. Repair of obstetric perineal lacerations. Am Fam Physician. 2003;68:1585-1590. 2. Hale RW, Ling FW. Episiotomy: procedure and repair techniques. Washington, DC: American College of Obstetricians and Gynecologists; 2007. 3. Gibbs VC, Coakley FD, Reines HD. Preventable errors in the operating room: retained foreign bodies after surgery—part 1. Curr Probl Surg. 2007;44:281-337.

An urgent need

PE is the leading cause of maternal death in the United States. It is a dangerous and rapidly progressive hypertensive disorder of pregnancy that affects up to 200,000 women annually in the United States (between 5% and 8% of all pregnancies). Globally, PE and other hypertensive disorders of pregnancy are a leading cause of maternal and infant morbidity and mortality, and are responsible for 76,000 maternal and 500,000 infant deaths each year. Early delivery is the most effective treatment, but can have dire consequences for the infant and may not stop progression of the disease in the mom.

A company founded to help solve it

It is this urgent and unmet medical need that prompted one of Glenveigh's founders, C. David Adair, MD, a Maternal Fetal Medicine (MFM) specialist, to begin research into PE almost 2 decades ago and establish Glenveigh Pharmaceuticals in 2004.

The accomplishments that make up Glenveigh's success date back to 1996 when Dr. Adair initiated the first clinical study with Digibind^® (digoxin immune FAB ovine or DIF) in post-partum women. In 2002, Glenveigh entered into a research collaboration with GSK to begin the DEEP Study, a Phase IIb clinical trial in pregnant women to test the drug's efficacy for severe preeclampsia. By late 2004, Rick Proctor, who had responsibility for Digibind^® at GSK, was successfully recruited to become the CEO, and Glenveigh began building a high level Scientific Advisory Board (SAB) and adding other industry veterans to the team.

In early 2007, Glenveigh Pharmaceuticals out-licensed its DIF intellectual property to Protherics Plc, now BTG Plc. BTG is a leading antibody company who manufactures Digifab^®, a similar and competing product to Digibind^®. Glenveigh has now reacquired the rights to the DIF patents, secured supply for remaining clinical work, set up the basis for a commercial supply agreement, filed for orphan disease status, and is preparing a new IND and pivotal study for DIF. These accomplishments will allow Glenveigh to advance commercialization in a more aggressive manner and substantially improve the economics of this opportunity.

In addition, Glenveigh Research is funding investigations and basic science research by SAB members at a number of leading institutions. Work at Brigham Young University, led by Dr. Steven Graves, and at LSU Shreveport, under the direction of Dr. Yuping Wang, has produced exciting data exploring the etiology of preeclampsia and the development of diagnostic and theranostic tests for preeclampsia. Additional research with DIF shows promise for its use in diseases of inflammation and forms the basis for additional patent filings held by Glenveigh.

Can a drug originally used as an antidote for digoxin toxicity treat preeclampsia?

Much is unknown about the etiology of preeclampsia. While incomplete trophoblastic invasion by the placenta and alterations in the immune response may be involved in its pathophysiology, a number of biologically active factors have also been implicated in preeclampsia. One factor, endogenous digitalis-like factor (EDLF), occupies the digitalis-binding site and has been found to inhibit the sodium pump, which itself has recently been shown to play an important physiological role in blood pressure regulation ((Kaplan JH, 2005)). In addition, studies show that EDLF is increased in the circulation of women with preeclampsia and its effects, including vasoconstriction and hypertension, may be reversed by anti-digoxin antibodies.

Glenveigh's commitment to PE runs DEEP

Much is unknown about the etiology of preeclampsia. While incomplete trophoblastic invasion by the placenta and alterations in the immune response may be involved in its pathophysiology, a number of biologically active factors have also been implicated in preeclampsia. One factor, endogenous digitalis-like factor (EDLF), occupies the digitalis-binding site and has been found to inhibit the sodium pump, which itself has recently been shown to play an important physiological role in blood pressure regulation (Kaplan JH, 2005). In addition, studies show that EDLF is increased in the circulation of women with preeclampsia and anti-digoxin antibodies may reverse its effects, including vasoconstriction and hypertension.

Glenveigh's commitment to PE runs DEEP

The DEEP study has now been completed with positive results. It confirmed the hypothesis that EDLF plays a role in severe preeclampsia, that DIF is beneficial as a treatment for preeclampsia, and that additional investigation is warranted. Specifically, the study found that DIF:

• Preserved renal function
• Lowered maternal pulmonary edema
• Lowered the incidence of intraventricular hemorrhage in DIF infants
• Neutralized EDLF and reversed sodium pump inhibition
• Had a favorable safety profile with no adverse events related to study medication

These results suggest that continued research and development with DIF is clearly warranted. Glenveigh has filed for Orphan Drug designation and is pursuing an IND for a Phase 3 clinical trial to advance the DIF program.

Glenveigh welcomes inquiries for additional information. Please contact Rick Proctor, President and CEO, David Adair, MD, Chairman and Chief Science Officer or Andy Johnston, Director of Clinical Operations.