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New drug formulations require approval by the FDA. Microfol™ is NanoMedex’s reformulation of Astra Zeneca’s Diprivan®, with propofol as the active pharmaceutical ingredient (API), an approved anesthetic drug that is now a generic product. An advantage of the first NanoMedex product being a generic anesthetic is the limited amount of clinical testing anticipated for regulatory approval. The API and the components of Microfol™ have both been previously approved as safe for use by the FDA. An additional advantage of anesthetic product development is the lack of long term drug side effects and therefore minimal clinical follow up is required, thereby significantly shortening the time necessary for clinical trial performance and subsequent FDA approval.
The 505(b)(2) Pathway to FDA Approval
NanoMedex Pharmaceutical, Inc’s. Microfol™ is a microemulsion formulation containing the generic active pharmaceutical ingredient (API) propofol and two IIG listed excipients- sodium caprylate and poloxamer 188 which replace the macroemulsion components of the reference listed drug Diprivan® and its generic equivalents. Under the 505(b)(2) NDA NanoMedex may submit Microfol™ as a result of these formulation changes. Section 505(b)(2) was intended to encourage innovation without creating duplicate work and reflects the principle: it is wasteful and unnecessary to carry out studies to demonstrate what is already known about a drug. In the case of propofol as the API in Diprivan® acute and chronic toxicity studies, reproductive toxicity, male/ female toxicity study comparison, in vivo mutagenicity, and cardiovascular and respiratory effects have all been thoroughly documented for the RLD and the generic equivalents.
The technology was generated by an interdisciplinary team of anesthesiologists and chemical engineers at the University of Florida and is now protected intellectual property assigned to the University of Florida Research Foundation under United States patents 6,623,765 awarded September 23, 2003 and 6,638,537 awarded October 28, 2003. A third USPTO patent has been approved in November 2008 awaiting issuance. In Japan, India, and European nations, PCT patent applications have been submitted and are under review. Currently, the University of Florida has exclusively licensed this technology to NanoMedex, Inc. for further development.
Potential customers for NMDXs first product, Microfol™ include anesthesiologists and the purchasing departments for hospital surgical suites, intensive care units, and outpatient surgery centers, endoscopy suites, and radiology. The use of propofol in these areas continues to increase with an increasing rate of medical procedures. Patients receiving propofol include those under the care of anesthesiologists, ICU physicians, radiologists, and gastroenterologists. Future non-anesthesia products will focus on additional clinical specialties such as oncology, infectious disease, and cardiology. Since Microfol™ is NMDX’s lead development product there are no current sales or customers.
