FDA Issues Guidance for Use of PCIDs for Anti-counterfeiting Applicable to mark On-Dose ID Covert Markers*

ARmark Authentication Technologies, LLC, announced today that the Food and Drug Administration (FDA) issued draft guidance on July 13, 2009 covering the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug.

The company's ®mark® On-Dose ID covert marker technology is a Physical Chemical Identifier (PCID) which has been designed for application to solid oral dose drug products.

The draft guidance outlines regulatory filing requirements (NDA, ANDA and
postapproval) for usage of ®mark On-Dose ID covert markers for unit-level, on-dose
authentication of oral solid dose pharmaceuticals for the prevention of counterfeiting. The on-dose form of the covert marker technology was developed through an alliance
between ARmark Authentication Technologies, LLC, a developer of custom
authentication systems, and Colorcon, Inc., a world leader in the development of
formulated coatings and other excipients for the pharmaceutical industry. The ®mark®
On-Dose ID covert marker technology is formulated from ingredients listed in the FDA's
Inactive Ingredient Guide (IIG) and is applied via incorporation into the tablet film
coating.

®mark On-Dose ID covert markers are custom-developed from approved excipient
materials and are manufactured under cGMP conditions. These markers can contain
multiple levels of security with brand-owner specific, encrypted information such as lot
and batch ID numbers, logos and other text, patterns, shapes and symbols, in a particle
smaller than the diameter of a human hair. Nearly impossible to replicate or reverse
engineer, the markers are compatible with other covert/overt identification technologies
and can also be incorporated as part of labels, bottles, paper and blister packaging.

The covert markers are applied directly to pharmaceutical tablets during existing tablet
coating processes, not as an additional step, which offers manufacturers total reliability
for placement of the markers on each and every tablet. This compatibility with existing
manufacturing processes also allows for no additional process changes and no new
capital equipment or expenses.

According to the World Health Organization, the US-based Center for Medicines in the
Public Interest predicts that counterfeit drug sales will reach $75 billion globally in 2010,an increase of more than 90% from 2005.

“Counterfeit drugs are a multi-billion dollar industry and the problem reaches across the globe,” said Jeff Robertson, Director/GM of ARmark. “®mark covert markers offer pharmaceutical manufacturers a safe method to protect their products from counterfeiters, while also protecting their customers.”

®mark On-Dose ID markers are identified using ARmark's ®vision™ detection
systems, easy-to-use digital micro-imaging systems that are customizable to each brandowner-specific marker. ®vision systems can be portable, handheld devices that offer immediate on-site detection and authentication of the markers without destroying the product.

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