Nanotherapeutics, Inc. announced today that on November 20, 2013, the Company held a Type C meeting with the U.S. Food and Drug Administration (“FDA”), providing an opportunity for the FDA to review and provide feedback on Nanotherapeutics’ plans for its Advanced Development and Manufacturing (NANO-ADM) Center facility to be located in Copeland Park, Alachua, FL.
The review and subsequent discussions with the FDA focused on its cGMP manufacturing space, which will provide Nanotherapeutics with capabilities to develop and produce bulk vaccines and biologics for the Department of Defense (DOD), other government agencies and industry. The Company expressed its appreciation to the FDA for granting the meeting, which represents the achievement of a major milestone in the ongoing design of a successful NANO-ADM Center.
On March 20, 2013, the DOD awarded Nanotherapeutics, as prime contractor, a contract to provide all the core services necessary to establish a Medical Countermeasures Advanced Development and Manufacturing (MCM ADM) capability. Nanotherapeutics subsequently secured private financing to buy 30 acres of land and construct a 165,000 square foot NANO-ADM Center as its operational and manufacturing hub in Alachua. The goal of the contract is to enable a flexible, multi-product, multi-purpose facility based on single use technology (SUT) for faster and more effective development and manufacturing of medical countermeasures designed to protect and treat military populations against chemical, biological, radiological and nuclear attacks and outbreaks of naturally occurring, emerging and genetically engineered infectious diseases.
A groundbreaking ceremony for the NANO-ADM Center was held on October 23, 2013. Construction of the NANO-ADM Center is scheduled for completion in early 2015, with commissioning, qualification and full occupancy expected by mid-March 2015.
Nanotherapeutics, Inc. is a privately held biopharmaceutical company with a major focus on developing a diversified proprietary pipeline of products having both biodefense and medical applications. Products under development include biodefense medical countermeasures, CNS, wound healing, addiction and pain, oncology, anti-infectives, vaccines and orthopedics. The Company has one FDA cleared injectable biologic, NanoFUSE® DBM used by orthopedic surgeons as bone graft filler. Nanotherapeutics has in-house cGMP manufacturing, formulation, and expertise in pre-clinical and clinical product development as well as clinical trial management to support its products. Established in 1999, the Company employs several proprietary platform technologies to manipulate and enhance the properties of drug candidates. For more information, visit the Company website at www.nanotherapeutics.com.