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Micellar Nanoparticle Technology for Transdermal Delivery of Non Hormonal Drugs
By Novavax, Inc.,
May 25, 2005 - 11:36:38 AM
Novavax, Inc. , a specialty biopharmaceutical company, today announced positive results from pre-clinical studies applying its proprietary micellar nanoparticle (MNP) technology to transdermally deliver five drugs. The pre-clinical data represent proof of principle that the Company's MNP technology is capable of transdermally delivering clinically relevant amounts of non-hormone drugs into systemic circulation.
The five drugs include three non-hormone candidates: NX-300, fentanyl for pain management; NX-301, nicotine for smoking cessation; and NX-302, clonidine for hypertension. The two hormone candidates are NX-200, norethindrone for female hormone replacement and NX-201, ethinyl estradiol, which when combined with norethindrone, is used as a contraceptive.
In addition to achieving clinically relevant blood concentrations of each candidate, these results confirmed that MNP delivery technology can establish a drug depot in the application area and thereby provide for an extended drug release.
"These pre-clinical results were obtained from a well validated model for transdermal drug delivery," said Nelson M. Sims, President and CEO of Novavax. "Once we demonstrate MNP drug delivery achieves the targeted blood levels, we believe there is a high probability of clinical success since the candidates we use are FDA-approved compounds. In most cases, we can use a 505(b)(2) filing for FDA approval, which results in a shorter development time horizon and a lower cost than a typical New Drug Application."
The decision to advance one or more of these product candidates to the IND stage will incorporate technical and market analysis. The Company is currently evaluating other candidates, including non-hormonal molecules not currently available in patch form, to determine their suitability for further development. The Company plans to advance two product candidates to the IND stage by the end of the fourth quarter of 2005.
"Prior to these results, MNP technology had only been used to deliver hormonal products systemically, even though we believed that this technology would work for other potent, small molecule drugs," said Rahul Singhvi, Sc.D., Senior Vice-President and COO of Novavax. "We are very encouraged by these new data, which substantially expand the list of potential drug candidates to formulate in our unique delivery system."
About Micellar Nanoparticle (MNP) Technology
Micellar nanoparticles are an oil and water nanoemulsion that allows systemic drug delivery through topical application. MNP is the basis for ESTRASOB(R), marketed as a topical emulsion that delivers estrogen in a lotion-like formulation for the management of moderate to severe vasomotor symptoms in postmenopausal women. MNP technology has also been successfully applied in the development of Androsorb(TM), which has completed Phase I trials as a topical testosterone replacement therapy.
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