FORT WORTH, TX, JUNE 20, 2012 – Healthpoint Biotherapeutics today announced the company is planning a significant upgrade to its 80,000 square foot research and manufacturing facility in Ft. Worth. The new, state-of-the-art facilities will comprise 25,000 square feet of manufacturing infrastructure, labs and clean room space for the production of cell-based therapies.
“We are very pleased to be embarking on this important and innovative initiative at our headquarters here in Fort Worth,” noted Travis E. Baugh, President and Chief Operating Officer of Healthpoint Biotherapeutics. “The planned, ultra-modern facility will create an efficient platform to support our lead pipeline candidate, HP802-247, which recently completed a successful phase 2b study in venous leg ulcers. Importantly, the facility will also add critical capabilities as we look toward the promise of regenerative medicine.”
The facility upgrade comes as the company is engaged in developing a pipeline of next generation wound care therapies based on cell and cell-matrix biology. The advanced nature of the facility will provide efficient and scalable manufacturing capabilities to support both development and future commercialization, as well as create a unique environment for novel collaboration and identification of new technologies.
Healthpoint Biotherapeutics is planning to invest approximately $60 million to build out and staff the research and manufacturing facility over the next few years. The company plans to add a total of 51 new employees in research and development (R&D), quality assurance and quality control, operations and information technology (IT), with 31 of these hires planned for 2012.
“We are thrilled to have Healthpoint Biotherapeutics locate their state-of-the-art manufacturing facility in our great city,” said Fort Worth mayor Betsy Price. “This is the latest example of how life science related businesses are becoming a much bigger part of our diversified economy. “
“The establishment of this contemporary cell biology facility represents a significant advance for the Fort Worth life sciences footprint," added David Berzina, Executive Vice President of Economic Development with the Fort Worth Chamber of Commerce. "As such, we would like to emphasize the importance of this investment for the greater Ft. Worth community.”
The project will be built out in two phases to coincide with current pipeline requirements. The first phase will include advanced tissue processing capabilities, master cell banking, production of clinical supplies for phase III trials and process development to support future manufacturing scale-up. Important features of the second, commercialization phase include automated closed system cell culturing, automated vial filling and the use of radio frequency identification (RFID) technology allowing efficient, robotic packaging in -80°C freezers and product traceability in sealed dry ice shippers.
Construction of the new facilities is slated to begin in the second quarter, with the first phase anticipated to be operational by the end of 2012. Full validation and commissioning of the facility to release product for clinical trials is expected in 2013. Completion of the second phase will be timed to meet the requirements for the manufacture and ultimate commercialization of the investigational product HP802-247, following regulatory approvals.
Healthpoint Biotherapeutics already operates advanced, biologic manufacturing facilities worldwide, including its facility in Lausanne, Switzerland––which has received manufacturing authorization from the Swiss Regulatory Agency, Swissmedic, for the production of cell-based therapies––as well as a biologic manufacturing plant in Curacao.
HP802-247 is an investigational allogeneic living human cell suspension that consists of two components that are sprayed sequentially on the wound bed at the time of treatment: a fibrinogen solution and a cell preparation containing a mixture of growth arrested, living, allogeneic epidermal keratinocytes and dermal fibroblasts. Based on in vitro studies, HP802-247 is believed to release various growth factors and cytokines into the micro-environment of the wound.
Positive results for a Phase 2b clinical trial investigating the efficacy of HP802-247 in venous leg ulcers were recently announced. The study was a randomized, double blind, dose-finding study involving 228 subjects enrolled across 35 investigational centers in the United States. Overall, HP802-247 achieved statistical significance, as compared with control plus standard care, in both the primary and secondary endpoints.
About Healthpoint Biotherapeutics
Healthpoint Biotherapeutics is a biopharmaceutical company focused on the development and commercialization of novel, cost-effective solutions for dermal repair and regeneration. The company’s research and development strategy is centered on next-generation bioactive therapies for the treatment of chronic wounds. Currently marketed products include Collagenase SANTYL® Ointment, OASIS® Wound Matrix, OASIS® Ultra Tri-Layer Matrix and REGRANEX® (becaplermin) Gel 0.01%. Healthpoint Biotherapeutics is also committed to advancing the care and treatment of wounds through support of industry leading continuing education from The Wound Institute®. To learn more about this comprehensive and award winning educational resource, please visit www.TheWoundInstitute.com®. Healthpoint Biotherapeutics is a DFB Pharmaceuticals, Inc., affiliate company, and is based in Fort Worth, Texas. For more information, visit the company website at www.Healthpointbio.com.