Vyteris Announces First Successful Non-Invasive Delivery of Peptide Using Smart Patch TechnologyFAIR LAWN, N.J.--(BUSINESS WIRE)--Jan 22, 2008 - Citing a significant advance in drug delivery, Vyteris, Inc. (OTC BB: VYHN) and Ferring Pharmaceuticals today announced results from a completed Phase 1 clinical trial demonstrating that Vyteris' patented Smart Patch transdermal technology successfully delivered a peptide molecule in humans (multiple pulse) without the use of needles (non invasively) in therapeutic levels aimed at the treatment of female infertility.
"These trial results represent a significant accomplishment for Vyteris in demonstrating that our delivery system are capable of achieving therapeutic levels of a peptide without using any needles," said Timothy J. McIntyre, chief executive officer of Vyteris. "This is the initial step in potentially clearing the pathway to pursue eventual commercialization of this technology and its broader applications to other peptides, which as a class of biotechnology drugs, are severely limited to delivery by subcutaneous (subQ) / intramuscular (IM) injections or intravenous (IV) infusions."
As part of the trial agreement between Vyteris and Ferring Pharmaceuticals, the study results showed that therapeutic levels of the peptide in humans are achievable without the use of injections or infusion pumps. The clinical trial was conducted in the U.S. with 30 healthy volunteers under an investigational new drug application (IND). Specific technical data will undergo peer review for future disclosure.
Kenneth Kashkin, Chief Medical Officer and Senior Vice President Global Clinical Research and Development of Ferring Pharmaceuticals, provided an assessment on the importance of this clinical advance: "Significant technological advances, not previously achieved in peptide delivery, have been accomplished by the Ferring/Vyteris team, and we look forward to successfully completing Phase I."
In the Phase I clinical trial, a pulse profile controlled the transdermal delivery of the peptide from patches loaded with different concentrations of the peptide. The amounts of peptide delivered using the patch were comparable or higher than with subcutaneous (subQ) injection. The study used different formulations within the Vyteris patch that were compared with subQ delivery of the peptide. No unexpected adverse side effects were observed in any of the trial participants.
"We will continue our development efforts with the current peptide in our partnership effort with Ferring ," McIntyre added. "On a broader commercial front, we believe this can have a tremendous impact on the lives of patients who are currently limited to less convenient and more costly subcutaneous (subQ) / intramuscular (IM) injections or intravenous (IV) infusions. Further, this represents a significant opportunity for Vyteris to provide innovative solutions to the biotechnology industry in utilizing a brand new delivery channel for peptides previously limited to injection methods."
The product under development by Vyteris and Ferring would employ Vyteris' patented Smart Patch drug delivery technology, which is positioned to provide a safe and effective method of delivering drugs via a pre-programmed regulating system, a characteristic important in the delivery of therapeutics for the treatment of female infertility while offering the possibility of administering the peptide without needles and is being designed to deliver multiple transdermal pulses automatically, around the clock, in a painless, convenient and cost-effective manner.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals is an international pharmaceutical company that manufactures and markets the largest family of fertility treatments of any manufacturer in the U.S. The Company markets BRAVELLE, MENOPUR, REPRONEX(R) (menotropins for injection, USP), NOVAREL and ENDOMETRIN in the U.S. to infertility specialists and their patients. Ferring also offers the Q--CAP(TM), the first and only needle-free reconstitution device, for use with its fertility treatments. Ferring's line of orthopaedic and urology products includes EUFLEXXA(TM), hyaluronic acid for pain from osteoarthritis in the knee. Other products include ACTHREL(R) (corticorelin ovine triflutate for injection) for the differential diagnosis of Cushing's syndrome and DESMOPRESSIN ACETATE in injectable and rhinal tube forms for the treatment of diabetes insipidus and primary nocturnal enuresis. The Ferring Group specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, gastroenterology, obstetrics/gynecology and infertility. For more information, call (888) 337-7464 or visit www.ferringusa.com or www.ferringfertility.com
About Vyteris, Inc.
Vyteris, Inc is the maker of the first active drug delivery patch to receive marketing clearance from the U.S. Food and Drug Administration (FDA). Vyteris' proprietary active transdermal drug delivery (iontophoresis) technology delivers drugs comfortably through the skin using low-level electrical energy. This active patch technology allows precise dosing, giving physicians and patients control in the rate, dosage and pattern of drug delivery that can result in considerable therapeutic, economical, and lifestyle advantages over existing methods of drug administration. Vyteris' first product, LidoSite(R), which provides dermal analgesia prior to venipuncture (IV catheter insertions, blood draws, etc.) and superficial dermatological procedures, was the first FDA approved active patch. For more information, please visit our website at www.vyteris.com.
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Posted: January 2008