Childbirth complications may be relatively uncommon in the U.S., but they’re affecting American women who give birth more than twice as often as they did a decade ago.
That kind of data is what moves maternal-fetal medicine specialist Dr. C. David Adair, a founder and chairman of Glenveigh Medical, to action.
Adair formed Glenveigh Pharmaceuticals in 2004 based on research he’d been doing for over a decade on preeclampsia, a condition in which a pregnant woman develops high blood pressure and protein in the urine in her second or third trimester. It occurs in 6 to 8 percent of pregnancies, is a leading cause of death for mothers and babies, and leads to thousands of premature births annually.
Women with severe preeclampsia and eclampsia can suffer from seizures and organ failure that can reduce bloodflow to the uterus. Early delivery is the most effective treatment, but that can cause complications for the baby. Other drug treatments address the symptoms but not the underlying cause of the condition, as there are many unanswered questions around the etiology of the condition.
The company paired up with Glaxosmithkline to test the big pharma’s drug Digibind (digoxin immune fab), which was already approved for complications associated with too much of the cardiac drug digoxin, in treating women with preeclampsia. Results from a Phase 2b study indicated that the drug neutralized a key factor associated with preeclampsia-related high blood pressure in pregnant women and lowered the incidence of intraventricular hemorrhage in infants.
“We don’t have any cure except stabilization with magnesium to prevent seizures,” Adair said. “(DIF) appears to stabilize maternal condition, potentially reverse it, and improve neo-natal outcome.”
Two phase 2 studies of the drug have now been completed, and it’s been granted orphan drug designation and fast-track designation from the FDA.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Now, the small firm is looking for a big partner to help it move forward. “It’s a little bigger development pathway than we can do,” said Adair, who is still a practicing physician. “I’ve carried this as far as I can, and now it needs to go to somebody who can do it right from here on out.”
In the meantime, Glenveigh has been making use of its talent, including its CEO who previously led commercialization of Digibind for GSK, by adding to its family of companies. “I still saw so many ill things going on for women,” Adair explained in an interview. “I thought that my life calling was to attack those problems.”
It’s taking the “own the disease” approach with a portfolio of companies comprising Glenveigh Surgical, which commercializes instruments and medical devices, and Glenveigh Research, which conducts basic science research. Its device offerings include the Ebb for postpartum hemorrhage (which usually occurs together with preeclampsia, Adair said) and the Jetty to prevent postpartum discharge of fluids from the vagina during episiotomies and laceration repair procedures. It also markets the Beacon, an abdominatal fetal heart rate monitor
Adair said there are two more devices in development – one that’s a dilation meter to help avoid unnecessary C-sections, and another is a solution to address the 40,000 to 50,000 babies terminated each year because the mother’s water breaks too early.
The Chatanooga, Tennessee-based company is also looking at some other pharmaceutical candidates and diagnostics for women’s healthcare.
“We’re not looking to be a me-too,” Adair said about the company’s innovation strategy. “We just wanted to do what’s good and right with women.”
It’s done that so far with backing from private investors and without venture capital. “People have looked at obstetrics as a high-risk area,” he added. “Typically big pharma never wanted to be part of the space.”
There’s been more interest lately, as Merck launched its Merck for Mothers campaign to address complications during pregnancy and childbirth, and new ways to prevent, predict and identify preeclampsia are being tried in clinical trials. A company called Utah Medical even has a postpartum hemorrhage device similar to Glenveigh’s.
But Adair said he doesn’t really see any of them as competitors or potential acquirers. Rather, he said he congratulates and thanks anyone making strides in obstetrics. “I give advice freely, I help other entrepreneurs,” he said. “I never see anybody who’s helping women and babies as competition.”
