REDWOOD CITY, Calif., June 21 Incline Therapeutics, Inc., a privately-held, hospital-focused specialty pharmaceutical company, announced today that it has entered into an agreement to acquire the rights to IONSYS(TM) (fentanyl iontophoretic transdermal system) from ALZA Corporation and completed a $43 million Series A financing.
Under the terms of the agreement, Incline will receive an exclusive, worldwide license to IONSYS and will acquire certain other assets related to IONSYS.
IONSYS(TM) (fentanyl iontophoretic transdermal system) is an investigational product candidate intended to provide patient-controlled analgesia for adult inpatients requiring opioids following surgery. IONSYS is a compact, needle-free, self-contained, pre-programmed system designed to be applied to the skin on the upper arm or chest and activated by patients double clicking a button on the system. A generally imperceptible electrical current then actively delivers a small dose of the short-acting opioid analgesic fentanyl directly through the skin and into the systemic circulation.
IONSYS was approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2006; however, IONSYS is not currently marketed anywhere in the world. Before marketing IONSYS, regulatory approval must be sought from both the FDA and EMA for new patient safety features being developed into the system. Additionally, FDA approval will require an acceptable Risk Evaluation and Mitigation Strategy (REMS) to manage risks associated with fentanyl contained in IONSYS, which is subject to potential abuse and misuse.
"We believe IONSYS is an exceptional asset around which to form Incline Therapeutics," said Alan Levy, Ph.D., Chief Executive Officer and Director of Incline. "We look forward to building upon the product to accelerate the development of IONSYS toward potential approval and launch."
Series A Financing
The $43 million Series A equity financing was led by Frazier Healthcare Ventures. The venture syndicate also includes 5AM Ventures, Technology Partners, Adams Street Partners, Saints Capital Partners, and Emergent Medical Partners. In connection with the financing, James Topper, M.D., Ph.D., General Partner of Frazier Healthcare Ventures, James Young, Ph.D., Venture Partner of 5AM Ventures, Jim Glasheen, Ph.D., General Partner of Technology Partners, and Terry Gould, Partner and Head of Direct Investments of Adams Street Partners, have joined the Incline board of directors.
"Incline represents a unique investment opportunity around a late-stage product candidate with seven completed Phase III clinical trials, prior regulatory approvals, and substantial manufacturing capacity," said Dr. Topper of Frazier Healthcare Ventures. "Further, we are pleased to join such an experienced management team, several of whom we have worked closely with in previous ventures."
Cadence Option Agreement
Separately, Cadence Pharmaceuticals, Inc. announced today that Incline has granted Cadence an option to acquire the company. In connection with the transaction, Ted Schroeder, President and CEO of Cadence, has been appointed as Cadence's representative on the Incline board of directors.
About Inpatient Post-Operative Pain Management
More than 20 million inpatient surgical procedures requiring pain management are estimated to occur in the United States each year. Current treatment methods include bolus injections, regional nerve blockade, epidural infusions, and intravenous patient-controlled analgesia (IV PCA). IV PCA systems are controlled infusions pumps that deliver a prescribed amount of an intravenous opioid when a patient activates a button connected to the pump. Although it is estimated that approximately 50% of patients receive IV PCA after surgery, IV PCA has been associated with programming, medication, and pump errors, IV line infections, needlestick injuries, and limited patient mobility.
About Incline Therapeutics, Inc.
Incline Therapeutics is a hospital-focused specialty pharmaceutical company focused on the development of IONSYS (fentanyl iontophoretic transdermal system). Incline is financed by leading life science venture capital firms and led by a management team with significant pharmaceutical and medical device industry experience. The company is based in Redwood City, California.
Incline(TM) is a trademark of Incline Therapeutics, Inc.
Cadence(TM) is a trademark of Cadence Pharmaceuticals, Inc.
Contact: David Socks President and Chief Operating Officer Incline Therapeutics, Inc. Phone: 858-436-1414
SOURCE Incline Therapeutics, Inc.