Micellar Nanoparticle Technology for Transdermal Delivery of Non Hormonal Drugs
May 25, 2005 - 11:37:00 AM
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"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."
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By Novavax, Inc.,
[RxPG] 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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Additional information about the news article
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About Novavax, Inc.
Novavax, Inc. is a fully-integrated specialty biopharmaceutical company focused on the research, development and commercialization of products utilizing its proprietary drug delivery and vaccine technologies for large and growing markets, concentrating on the areas of women's health and infectious diseases. Novavax currently sells, markets, and distributes a line of prescription pharmaceutical products and prenatal vitamins through its national sales force including its MNP-based product, ESTRASORB, the first topical emulsion for estrogen therapy. Novavax's MNP technology involves the use of patented oil and water nanoemulsions that it believes can be used as vehicles for the topical delivery of a wide variety of drugs and other therapeutic products, including hormones. In addition, Novavax conducts research and development on preventative and therapeutic vaccines and proteins for a variety of infectious diseases, including HIV, influenza, and SARS, and E-selectin tolerogen for the prevention of stroke.
Statements made in this press release that state Novavax's or management's intentions, hopes, beliefs, expectations, or predictions of the future are forward-looking statements. Forward-looking statements include but are not limited to statements regarding usage of cash, product sales, future product development and related clinical trials and future research and development, including FDA approval. Novavax's actual results could differ materially from those expressed in such forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements. Such factors include, among other things, the following: general economic and business conditions; ability to enter into future collaborations with industry partners including an ESTRASORB(R) licensing agreement; competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; ability to establish and maintain commercial-scale manufacturing capabilities; results of clinical studies; progress of research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; the ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity financing or otherwise; and other factors referenced herein. Additional information is contained in Novavax's annual report on Form 10K for the year ended December 31, 2004 and Form 10Q for the quarter ended March 31, 2005 incorporated herein by reference. Statements made herein should be read in conjunction with Novavax's Form 10K. Copies of the filing may be obtained by contacting Novavax at 508 Lapp Road, Malvern, PA 19355 Tel 484-913-1200 or the SEC at www.sec.gov.
CONTACT: INVESTOR RELATIONS: Nelson M. Sims, President and CEO, RitaFreedman, Manager Investor Relations, Novavax Inc., Tel: (484) 913-1200,Email: [email protected]
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