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Catalent Pharma Solutions

Catalent Pharma Solutions, one of the leading providers of advanced dose form and packaging technologies as well as development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies, in partnership with Secure Symbology, Inc., recently announced an agreement to employ Track and Trace serialization technology for the packaging of Biogen Idec products. Successful implementation of the technology will make Biogen Idec fully compliant with mandates outlined in California's ePedigree law.

The ePedigree law was adopted to try to prevent counterfeit drugs from entering the legitimate supply chain. The World Health Organization estimates that one out of every 100 doses of pharmaceutical and biotechnology products in developed countries is counterfeit. The law requires that all medications sold in the state of California as of January 2009 have a unique, serial identifier that can be electronically read for the purposes of authentication. To meet this requirement, manufacturers must add Track and Trace technologies such as 2-D barcodes or Radio Frequency Identification (RFID) to their packaging. Track and Trace technologies allow pharmaceutical, biologic and over-the-counter medications to be electronically traced to their point of origin to ensure that each unit sold is authentic. Packaging for Biogen Idec's drugs, which treat patients with multiple sclerosis, non-Hodgkin's lymphoma and rheumatoid arthritis, will use serialized 2-D barcode technology from Catalent's Philadelphia facility.

"Patient safety is of paramount importance to us and this is one more step we can take to help increase the safety of our products,"said Robert A. Hamm, Biogen Idec's Executive Vice President, Pharmaceutical Operations & Technology. "In addition to meeting California requirements, 2-D barcode technology will prepare us for other states and countries enacting similar laws."

Catalent provides Track and Trace technology via its exclusive partnership with Secure Symbology (SSI). SSI's patented solution provides pharmaceutical and biotechnology manufacturers with a cost-effective and secure Track and Trace system. The partnership allows Catalent to employ SSI's barcode equipment to serialize the packaging while SSI creates and manages a secure, centralized database of the manufacturer's critical data at the start of the e-pedigree chain.

"Through our partnership with Catalent, SSI developed a patent-pending system that meets Catalent's rigorous and challenging standards for Track and Trace technologies," said Graham Sampson, Chairman of SSI. "We're proud to partner with Catalent to help Biogen Idec lead the industry by helping to secure its much-needed therapies and life-saving medications."

Whereas pharmaceutical products can use either 2-D barcode or RFID technology on their packaging, biologics-based products are expected to predominantly use 2-D barcoding as the effects of RFID technology on biologics have not been evaluated. In addition to protecting the drug supply chain, Track and Trace technologies greatly improve the efficiency of the supply chain since, for the first time, pharmaceutical and biotechnology companies can effectively track inventory and returns, thus improving the company's bottom line.

"Catalent is the only contract packaging company that has conducted an end-to-end pilot of RFID from the factory floor to the pharmacy, as well as a factory-focused pilot on Serialized Barcodes," said Renard Jackson, Executive Vice President and General Manager, Packaging Services, Catalent Pharma Solutions. "Helping biotechnology and pharmaceutical companies incorporate a secure and effective Track and Trace technology within a few short months is critical, since the deadline for compliance is less than a year away."

About Catalent
Headquartered in Somerset, New Jersey, Catalent is one of the leading providers of advanced dose form and packaging technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. The company applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes. Catalent employs approximately 10,000 at more than 30 facilities worldwide and generates more than $1.7 billion of annual revenue. For more information, visit www.catalent.com.

About Secure Symbology
Headquartered in Wayne, NJ with technology offices in Sterling, VA and research offices in New York, NY, Secure Symbology, (SSI) Inc provides complete anti-counterfeiting solutions to all industries, including a special focus on the pharmaceutical industry. SSI's product suite leverages its patented bar coding methodologies, patent pending data vault, to provide cost-efficient and obsolescence-proof anti-counterfeiting and Track & Trace solutions that can be seamlessly integrated into any manufacturer's production line. Through the use of advanced engineering, sophisticated database design, pharmaceutical supply chain knowledge, and a series of patents, SSI has established itself as the leader in anti-counterfeiting. For more information, visit www.securesymbology.com.

SOURCE: Catalent Pharma Solutions

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