For its 9th birthday, the North Carolina biotech Entegrion is giving itself a present: a product on the market.
The Research Triangle Park company has struck a licensing deal with a Boston-based medical device company to manufacture and market Entegrion’s Stasilon bandage: a proprietary weave of glass and bamboo fibers that promotes clotting. Chief Technology Officer Joseph DaCorta wouldn’t name the company’s East Coast partner. But DaCorta did say that the business expects to make an announcement this week.
The milestone for Entegrion comes in the midst of transition. Former CEO Stan Eskridge has left, though DaCorta says he remains “a friend to the company.” A search for a new CEO continues.
The Stasilon bandage itself received Food and Drug Administration clearance in 2007. Entegrion had been trying to commercialize the product on its own. But those efforts were stymied by the financial markets.
Now, though, Entegrion has raised $1.5 million in financing through debt and other options, money that DaCorta said will keep the company going as it evolves from a company focused on research to one with commercialized products.
“To properly launch a product of that kind, it’s a multimillion dollar effort,” DaCorta said. “It was extremely difficult to raise money in ’09 for anything.”
Blood-clotting bandages are an attractive but increasingly competitive field. Stasilon will compete against a product from Oregon company HemCon Medical Technologies, which has developed a bandage incorporating a compound from shellfish that promotes clotting. HemCon also took a partnership route to commercializing its technology in 2007, signing a four-year distribution agreement with Cardinal Health (NYSE:CAH).
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.
Plus, new competitors are on the horizon. Minnesota’s St. Teresa Medical, for example, is raising money to develop its own blood-clotting bandage. Kalorama Information estimated that the global market for wound care products reached $14 billion in 2009. Wound care includes other products besides wound dressings. According to Kalorama, the top four wound care companies are Johnson & Johnson (NYSE:JNJ), Kinetic Concepts (NYSE:KCI), Hill-Rom (NYSE:HRC) and Smith & Nephew (NYSE:SNN).
Stasilon is the first in a series of new, innovative medical technology products for Entegrion. Resusix, dehydrated human plasma, could be the next in the pipeline. It would offer a shelf-stable alternative to fresh frozen plasma, which poses storage issues and is difficult to use in emergency situations because it must first be thawed. Entegrion expects to file an investigational new drug application with the FDA this summer for Resusix. As clinical work progresses, DaCorta said the company could seek a development partner or pursue other financing options in 2012 or 2013 (Talecris Biotherapeutics (NASDAQ:TLCR) – literally down the street from Entegrion’s RTP offices – is a logical match to Entegrion).
Entegrion is also working on Stasix, a biological product derived from blood platelets developed to stop internal bleeding. The freeze-dried hemostatic agent could be quickly rehydrated and in its dry form, would offer a product with greater shelf-life than blood bank platelets stored in liquid form.
Other early-stage technologies would use the blood’s platelets as a drug delivery device. Platelets seek areas of injury and inflammation. Entegrion is developing a way to load drugs onto platelets for targeted drug delivery. An imaging agent could similarly be loaded onto platelets for the purpose of giving clinicians a better view of tumors or vascular conditions.
Entegrion was spun out of the University of North Carolina at Chapel Hill as Hemocellular Therapeutics in 2002 (though UNC shares shares ownership of Stasilon’s intellectual property with East Carolina University).
The company has operated without venture capital backing. Entegrion is financed by individual investors, many of them doctors, and has won more than $10 million in government contracts to develop products including a portable, handheld medical device to quickly assess clotting disorders. The company has avoided venture capital since 2006, when it rejected a $15 million investment from Oxford Bioscience Partners choosing instead to go forward on its own.
The pharmaceutical industry has thousands of drug companies developing new products by managing molecules. Entegrion is one of the specialized few whose work relies on the human body to manufacture the cell-based products that are the foundations for its new treatments.
“There are therapies there, we just have to work with nature,” DaCorta said.
