Ampio Pharmaceuticals, Inc. has held a groundbreaking ceremony to announce the start of construction of its new state-of-the-art manufacturing facility for its lead drug candidate, Ampion, for the treatment of patients afflicted with osteoarthritis of the knee. Located in the Denver Metro area, the facility is expected to be ready for production of AmpionT in the summer of 2014 and should generate approximately 40 new jobs in the next two years.
"Bioscience continues to be a key industry in Colorado and an important part of our advanced industry growth," said Ken Lund, Executive Director of the Colorado Office of Economic Development and International Trade. "We are pleased that Ampio Pharmaceuticals has chosen to increase its employee base and capital investment in Colorado." April Giles, President and CEO, Colorado BioScience Association remarked "We congratulate Ampio Pharmaceuticals on their decision to locate their new manufacturing facility in the Denver Tech Center. Ampio Pharmaceutical's decision to grow their company in Colorado and to focus on innovative methods of treating patient's with debilitating medical conditions has served the company and the community well." "The construction of this manufacturing facility will accomplish a major milestone for the commercialization of Ampio's lead drug," said Michael Macaluso, Chairman and CEO of Ampio. "We are excited about the prospect of bringing a safe and effective medicine to patients whose quality of life have suffered due to osteoarthritis of the knee.
Having announced positive trial results for the initial pivotal trial (SPRING STUDY) late last year, and the start of the final pivotal trial (STEP STUDY) this week, we look forward to reaching commercial-scale production of AmpionT that would follow FDA clearance of the drug. The facility will have an annual production capacity of approximately ten million doses of AmpionT. More than 50% of the source material, human serum albumin or HSA, required to meet this capacity has already been secured through a long-term, non-exclusive, supply agreement as previously announced."