GREENWOOD VILLAGE, Colo., Dec. 16, 2013 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced the ten-year lease of a multi-purpose facility located in the Denver Tech Center of Colorado. Renovation, beginning in early 2014, will provide commercial scale, FDA compliant, State-of-the Art, GMP manufacturing of Ampion ™ and an advanced Research and Development Laboratory as well as sufficient office space to consolidate all operations of the company in a single facility. These renovations will require approximately $7 million in capital expenditures previously accounted for.
"This investment demonstrates Ampio's commitment to address the potential demand for Ampion ™ from the approximately twenty million sufferers of osteoarthritis-of-the-knee in the United States," said Michael Macaluso, Chairman and CEO of Ampio. "Ampion ™ is one of the most important drugs in our portfolio, protected by 45 issued patents and 40 pending, covering multiple clinical indications, manufacturing processes, synthetic methods, and composition of matter claims. As it is our goal to establish Ampio as a global leader in the treatment of inflammatory diseases, the full and timely operation of this new facility that will manufacture our lead drug is a necessary step along that path. The facility renovation is scheduled to begin in the first quarter of 2014 and is expected to be completed in the summer of 2014."Dr. Vaughan Clift, Chief Regulatory Officer of Ampio, noted, "The manufacturing facility will initially provide registration batches of Ampion ™ for the Biologic License Application (BLA). Once the manufacturing operation is approved by the FDA for commercial production, the facility will have an annual production capacity of approximately ten million of the 4 mL doses and more than 50% of the raw material, (human serum albumin, HSA) required to meet this capacity has already been secured through a long-term, non-exclusive, supply agreement as previously announced. The pharmaceutical drug manufacturing group that has produced the Ampion™ clinical supplies to date is overseeing this project until the facility is fully operational."