Vyteris Holdings, Inc.

COMPANY OVERVIEW

Vyteris, Inc. (OTCBB:VYHN.OB), is the maker of the first active drug delivery patch to receive marketing clearance from the U.S. Food and Drug Administration (FDA). Vyteris was organized in November 2000 as a spinout of the Transdermal Systems unit of Becton Dickinson and Company (“BD”), to develop, manufacture and commercialize pharmaceutical products based upon this unique, advanced drug delivery technology. BD created Transdermal Systems just prior to 1990 and invested 10 years and close to $80 million in developing the basis of the Vyteris transdermal drug delivery system.

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’ lead product, LidoSite®, which provides dermal analgesia prior to venipuncture (IV catheter insertions, blood draws, etc.) and superficial dermatological procedures, was the first FDA-approved active patch. Vyteris has entered into several agreements to market LidoSite and develop new products from its transdermal technology, including: Laboratory Corporation of America® Holdings (LabCorp®), one of the world’s largest clinical laboratories, to market LidoSite in the physician office and patient service center segments of the venipuncture market; B. Braun Medical, a leading medical products company, for distribution in the hospital segment; and Ferring Pharmaceuticals, Inc., a leading innovator in the field of naturally-occurring human peptides, for the licensing and marketing of a female infertility therapy product.

Vyteris has also successfully demonstrated in-vivo, either in animals or in humans, the ability of its active patch technology to deliver drugs transdermally for the following applications: smoking cessation, anti-aging cosmeceuticals, treatments for Parkinson’s disease, and peptides for various indications.

ENTERPRISE PROFILE

Highlights

• Highly versatile, FDA-approved and patented platform technology with exciting potential applications in multiple high-growth markets

– First FDA-approved product, LidoSite®, on market with high potential for increased near-term sales, with agreements in place with Laboratory Corporation of America® Holdings (LabCorp®) and B. Braun Medical Inc. for marketing and distribution in physician offices, patient service centers and hospitals

– Strategic partnership agreements in place to accelerate entry into significant high-growth markets with unmet medical needs, including a program with Ferring Pharmaceuticals for revolutionary active transdermal delivery of a fertility enhancement peptide

– Commitment to establish at least two new major drug development projects in each of the next everal years, including the development and marketing of a Vyteris-branded migraine treatment. Vyteris has demonstrated in a Phase I study that their proprietary active patch technology can be used to provide controlled delivery of zolmitriptan in humans.

• New management team with extensive experience in the medical products and pharmaceutical industries across all essential managerial functions


• Specific experience bringing products through development, scaling-up manufacturing, and managing large medical product manufacturing and sales operations


• Portfolio of over 60 U.S. patents and over 120 international patents issued, with an additional 51 patents filed S OF FOCUS


• Vyteris has begun expanding the market for LidoSite®, a needle-free system that quickly numbs the skin prior to venipuncture, through

– Entering into a marketing agreement with Laboratory Corporation of America® Holdings (LabCorp®), a national leader in clinical laboratory testing with over $3.6 billion in revenue and over 220,000 clients worldwide, to market LidoSite directly to office-based physicians and patient service centers

– 400,000 office based physicians who routinely take blood samples in their offices

– 2,164,000 blood samples drawn each day in the U.S.

Areas of Focus

• Vyteris intends to build upon the positive Phase I results of their program with Ferring Pharmaceuticals for active transdermal delivery of a fertility enhancement peptide

– 25 million women worldwide have fertility problems

• Vyteris is developing new opportunities by accelerating clinical trials in

– The treatment of migraine headaches, a $3 billion dollar market, where their technology may have an advantage in delivering rapid onset, bolus medication on demand

– The transdermal delivery of non-steroidal anti-inflammatory drugs (NSAIDs), a $6 billion dollar market, where the complete bypass of the gastrointestinal (GI) tract may eliminate discomfort and more serious issues in the upper GI tract caused by oral NSAIDs.