Diabetics suffer from many different ailments, but among them are foot problems. In particular, problems with cuts and sores that don’t heal easily.
Derma Sciences, a pharmaceutical company in West Windsor that has been looking for a successful new product, is banking on the success of foot ulcer medication for diabetics that it believes has potential to appeal to a wide market.
Known only by the letters and numerals DSC127, the drug is in phase-three testing, which is when earlier testing has shown it to have value and tests are carried out on a wider scale in the marketplace. It is the final step before mass marketing.
“It will be about 18 more months until we have the readout of the results, but if it’s approved it will be the first drug of its type approved for healing diabetic foot ulcer,” company CEO Ed Quilty said. Derma Sciences, which specializes in wound care, recently completed an $86 million public offering as it gears up to begin marketing the drug. Nearly one million diabetics suffer foot ulcers each year, Quilty said.
Quilty has been at the helm of the Carnegie Center-based company since 2000, when he stepped down from the top job at Palatin Technologies, a Cranbury-based drug company. Previously he was managing both companies part time.
Derma Sciences, a 30-year-old company, was struggling, and Quilty sought to devote himself full time to turning the company around. Its stock was trading for less than $1, and sales of its wound care products were slumping.
Now, Derma Sciences has many products on the market, and its stock has moved to the Nasdaq exchange, a step up from the small cap market where it used to trade. Last week shares were trading in the $14 range. The company has not turned a profit in at least the past three years, though revenue has been on the rise.
Quilty said the most recent stock issue puts the company on sound footing to take its new foot ulcer product to the next stage.
“Right now the company has over $100 million in cash, so we have a good war chest,” he said.
Quilty said that Derma intends to use the newly raised money to successfully complete the third phase of clinical drug trials for DSC127. The company is also focused on expanding its marketing and sales force and looking for new products through acquisition.
One thing that gives the company confidence is the size of the diabetic care market. In New Jersey there are about 600,000 adults who have been diagnosed with diabetes, while 26 million adults across the nation are afflicted by the same disease. Another 79 million adults are prediabetic, according to the American Diabetes Association.
In the U.S. more than 10 percent of money spent on health care goes to treating diabetes and its complications.
While Quilty said he was optimistic that the foot ulcer drug will be approved, there are long odds for drug development in the U.S. Only about 25 to 30 percent of drugs make it through the third phase of clinical trials, according to the FDA.
Diabetic foot ulcers can develop because of poor circulation and lack of nerve sensitivity in the feet, Quilty said. These ulcers can be difficult to treat because they often go unnoticed and are located in areas that people have difficulty keeping pressure from.
“The problem is someone who’s got diabetes has a hole in the bottom of their foot, chances are they’ve got neuropathy, they don’t feel anything,” Quilty said.
The final approval of the ulcer application drug would broaden Derma’s array of treatments for diabetic foot injuries, Quilty said.
“We’re in three businesses, pharmaceutical development, advanced wound care and traditional wound care,” Quilty said.
Derma recently introduced a new product, AmnioMatrix, which serves as a scaffold for regenerating skin tissue over a wounded area, Quilty said. The product is derived from placenta and brings many nutrients into the cell regeneration equation, he said, which helps new tissue to form.
“Where we’re focusing — where the biggest need is — is in areas where tissue needs to be regenerated,” Quilty said.
The company also sells the TCC-EZ cast, which is designed to prevent a person from putting pressure on their foot by pushing it up to their calves, he said. This prevents diabetics and others already suffering from foot ulcers from re-injuring themselves, without relegating them to their bed for months, he said.
People with severe wounds can use Medihoney, a honey-based gel product, to get relief and aid the healing process, he said. Then, if the wound persists, the AmnioMatrix can be applied to support skin growth, he said. If the wound is on the foot, as many diabetic wounds are, the TCC-EZ cast can be used to keep pressure off the affected area and prevent re-injury.
While Derma’s corporate headquarters is in West Windsor, the company manufactures much of its product in a facility outside Toronto, and has distribution centers in Houston, St. Louis and the United Kingdom.
Derma is also the world’s second largest producer of private label bandages, such as store brands and the cartoon prints that pediatricians use, Quilty said.
While different goods produced by Derma can be found on the shelves of local pharmacies and grocery markets, it mainly supplies its advanced wound care products to many of the 1200 wound clinics around the country, Quilty said.
Still, while there is a significant market for Derma’s products, the company faces stiff competition from a variety of producers, many with larger more well-known names such as 3M and Smith & Nephew.
2 trchristie HINDASH.JPG
CONNECT WITH US:
On mobile or desktop:
• Like Times of Trenton on Facebook
• Follow @TimesofTrenton on Twitter