Innocoll stock jumps on drug trial results
Innocoll Holdings in Newtown Square said Wednesday that its non-opioid implant for postoperative pain relief met "statistical significance" in patients without the need for other pain medicines, such as opioids.
Innocoll Holdings in Newtown Square said Wednesday that its non-opioid implant for postoperative pain relief met "statistical significance" in patients without the need for other pain medicines, such as opioids.
The company's stock jumped 47.8 percent to close at $10.51 on the news, which comes at a time when regulators are pushing drug companies to come up with alternatives to opioids.
Innocoll's spongelike implant to relieve pain after abdominal hernia surgery is inserted into an incision site during the operation.
Infused with an anesthetic bupivacaine, the medicine, Xaracoll, slowly disperses in the surgery site, providing pain relief for up to 48 hours, and in some cases 72 hours.
The product is biodegradable collagen - a protein found in bones, muscles, skin, and tendons - and dissolves on its own. Xaracoll is made from the Achilles tendon of cows in New Zealand, said Innocoll's chief commercial officer, Rich Fante.
The company said that results from two late-stage trials in a total of 600 patients showed "highly statistical significance" in relieving pain at 24 hours after surgery.
At 48 hours, the next time point researchers examined, one 300-patient study showed statistical significance, and the other 300-patient study "showed what we call a trend toward statistical significance - and almost made it," said Innocoll's chief medical officer, Lesley Russell.
"When you add the two studies together, you get statistical significance at both 24 hours and at 48 hours, and you see statistical significance at 72 hours," Russell said.
The company, which has a manufacturing facility in Germany and a tax domicile in Ireland, plans to file a new-drug application for this treatment with the Food and Drug Administration this year.
Innocoll established commercial operations in Newtown Square in December 2014, and currently has 15 employees there. "Our plans are to have 20 to 25 by the end of the year," Fante said.
"We feel very strongly that there's a huge talent base in the Philadelphia area from large pharmaceutical companies like Merck, GlaxoSmithKline, AstraZeneca, Teva, Bristol-Myers Squibb, etc.," Fante said. "We felt it was important to be in this area." Several Innocoll executives and board members are former AstraZeneca employees.
Janney Montgomery Scott analyst Ken Trbovich said in a client note that the studies "showed Xaracoll use was associated with significant delay in time to first use of opioids and total opioid use."
The drug was "well-tolerated," with adverse events "similar to placebo," he said.
The company's management said on a conference call that surveys of more than 100 surgeons found that the doctors were most concerned with the effectiveness of a long-acting pain product in the first 24 hours following surgery.
"At 24 hours, which is the primary endpoint, both studies were statistically significant," Trbovich said. "That's the most important takeaway. The 24-hour time point is the one the company needs to file and seek approval from the FDA."
Innocoll is also developing a collagen-based medicine, Cogenzia, to treat diabetic foot infections. Results from Phase 3 patient trials are expected in the third quarter.
Innocoll sells several collagen products in Europe, Asia, the Middle East, and Africa. Xaracoll would be the company's first U.S. product.
"That's one of the reasons the data is so exciting for us," Fante said. "This is an opportunity for the U.S. market, where Innocoll doesn't have a product yet."
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