|
NOVEN
PRESENTS PRE-CLINICAL STUDY RESULTS AT |
BackStudies
Support Potential for Transdermal Delivery of
ACE Inhibitors, Anti-histamines and Muscle Relaxants
Full Study Results Available at www.noven.com
- - - - - - - - - - - - - - - - - - - - - -
MIAMI, FL. - December
5, 2000 - Noven Pharmaceuticals, Inc. (Nasdaq:NOVN) announced that it
presented a series of pre-clinical study papers at the recent 2000 American
Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition,
and that the full text of these papers is available on Noven's website
at www.noven.com under the "Research/Scientific Publications"
section. At the meeting, Noven representatives reported research findings
that support the potential for transdermal delivery of enalapril (an ACE
inhibitor), azelastine (an anti-histamine) and cyclobenzaprine (a muscle
relaxant), and advance other Noven products currently under development.
"We are extremely
pleased with the results of our ongoing pre-clinical research efforts,"
said Juan Mantelle, Vice President and Chief Technical Officer of Noven.
"While we have a robust clinical program that includes ongoing human trials
for transdermal therapies for Attention Deficit Hyperactivity Disorder
(ADHD), pain management and female sexual dysfunction, we also maintain
an aggressive pre-clinical program to keep our product pipeline full.
Our pre-clinical programs are focused on evaluating existing drugs that
can be reformulated and effectively delivered transdermally or transmucosally.
Our goal is to bring effective, new products to market at a fraction of
the cost and time typically associated with the development of new drugs."
The 2000 AAPS Annual
Meeting and Exposition, held in Indianapolis, Indiana from October 29
through November 2, 2000, featured the presentation of more than 1,800
scientific research studies and drew over 7,000 attendees. AAPS is a professional,
scientific society of more than 11,000 members employed in academia, industry,
government and other research institutes worldwide.
At the AAPS meeting,
David Houze, Noven Senior Research Scientist, presented the results of
a study entitled "In-Vitro Permeation of Azelastine Transdermal Delivery
Devices," which was designed to determine the feasibility of delivering
the anti-histamine azelastine transdermally. Azelastine is currently marketed
as a nasal spray under the name Astelin® by Wallace Laboratories/ASTA
Medica LLC. The results presented by Mr. Houze support the conclusion
that an azelastine formulation contained in a 10cm2 patch can deliver
a therapeutic amount of the drug for three days.
Noven's Rod Hartwig,
Noven Assistant Research Associate, presented the results of a study entitled
"Permeation of Cyclobenzaprine from Transdermal Delivery Devices." Cyclobenzaprine
is a muscle relaxant marketed by Merck & Company under the brand name
Flexeril®. The study was designed to evaluate the practical
administration of cyclobenzaprine by transdermal delivery devices. The
results of the study indicate that a 36cm2 transdermal patch can deliver
cyclobenzaprine in a dose equivalent to three 10-mg tablets taken orally,
and that adequate drug delivery appears to be maintained for 48 hours.
Chensheng Li, Noven
Senior Research Chemist, presented the results of a study entitled "The
Study of Transdermal Administration of ACE Inhibitors and Improved Absorption
of Their Prodrug." The study was designed to evaluate the feasibility
of sustained controlled delivery of a therapeutically effective amount
of ACE inhibitors using a matrix type transdermal delivery system. ACE
inhibitors are the first-line therapy in treating hypertension. The study
results indicated that, while the parent drug of enalapril showed low
permeation rates due to its poor solubility in the stratum corneum layer
of the skin, transdermal delivery systems containing enalapril prodrug
exhibited a significantly higher transdermal penetration rate. Enalapril
Maleate is the generic version of Merck & Company's Vasotec®.
Other study papers
presented by Noven scientists at the AAPS Annual Meeting and Exposition
included "In-Vitro/In-Vivo Correlation (IVIVC) of Transdermal Estradiol
Sytems," "Utilizing Ethyl Cellulose to Sustain the Delivery of Hormones
Through the Skin over Seven Days," "Photostability Testing of Transdermal
Systems," and "Delivery Optimized Thermodynamics in Methylphenidate Transdermal
Drug-in-Adhesive System."
About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leader
in the development of transdermal and transmucosal drug delivery systems
and technologies. Noven has developed and presently manufactures a series
of leading-edge products, including the world's smallest estrogen transdermal
delivery system, the United States' only combination estrogen/progestin
transdermal delivery system, and the first transmucosal patch approved
for marketing by the U.S. Food and Drug Administration. With a wide range
of additional products in development, Noven is committed to becoming
the world's premier developer, manufacturer, and marketer of transdermal
and transmucosal drug delivery systems. For additional information on
Noven, visit www.noven.com. For information on Noven's Vivelle®
and Vivelle-Dot™ products, visit www.vivelledot.com.
Forward looking statements contained in this release are qualified by and subject to the risks and uncertainties specified below and those specified by Noven in its most recent filings with the Securities and Exchange Commission, including the risks that further research studies may contradict the results of studies described in this release, that referenced development projects may never be commercialized and that Noven's patents may not provide meaningful protection against other patch products that may be developed by competitors.
Contact:
James B. Messiry
Chief Financial Officer
(305) 253-1916
Copyright © 2000 Noven Pharmaceuticals, Inc. All rights reserved.