Unilife Commences Initial Supply of the Unifill Syringe to Sanofi

Unilife Corporation recently announced it has commenced the initial supply of validated product of the Unifill syringe to Sanofi, as per the terms of the industrialization agreement between both parties.

Since signing the Exclusive Agreement in July 2008, Sanofi has paid Unilife a total of approximately $40 million, comprising a $16 million (euro 10 million) fee in exchange for the exclusive right to negotiate the purchase of the Unifill syringe, and to help fund the Industrialization Program for the device up to a maximum of $24 million (euro 17 million). Sanofi has secured exclusivity for the Unifill syringe within the full therapeutic classes of antithrombotic agents and vaccines, plus an additional four smaller sub-groups, until June 30, 2014.

Unilife is now in a position to also commence initial sales of the Unifill syringe to other pharmaceutical companies. Upon the receipt of the Unifill syringe, these pharmaceutical customers will typically conduct drug compatibility and stability studies that will test the device in combination with their injectable drugs. The resulting data is then filed as the last step in completing the regulatory process for the drug-device combination product.

“The start of initial sales of the Unifill syringe is arguably the most significant achievement in our company’s history,” said Mr. Alan Shortall, CEO of Unilife. “We very much appreciate the support of Sanofi since 2003, when they had the initiative and vision to approach us to develop a new generation of prefilled syringes that can help to improve patient care, while also enhancing and saving the lives of healthcare workers. The Unifill syringe is generating strong interest from an increasing number of pharmaceutical companies for use in therapeutic classes outside of those retained by Sanofi. These pharmaceutical companies recognize the significant potential of the Unifill syringe to help generate powerful brand differentiation for their injectable drugs within competitive therapeutic drug classes.”

“The integration of safety features within the glass barrel of a prefilled syringe was a challenge that many within the device and pharmaceutical industries thought to be impossible,” added Dr. Ramin Mojdeh, COO of Unilife. “Yet, through our operational expertise, core technology platform, and innovative spirit, we have successfully overcome a number of technical obstacles to commercialize a game-changing device that is now poised to revolutionize the $2.7 billion market for prefilled syringes. The Unifill syringe sits at the leading edge of a rich and diverse platform of advanced drug delivery devices that we are now developing in collaboration with a number of pharmaceutical partners. Having recognized our capacity for device innovation with the Unifill syringe, these top tier pharmaceutical companies are selecting Unilife as their partner to develop other innovative, differentiated, and proprietary devices that are customized to address the specific and unmet needs of their biological drugs. These partnerships will enable us to build upon the success of the Unifill syringe and expand our horizons across several additional high-value market sectors for injectable drug delivery devices.”

Unilife Corporation is a US-based developer, manufacturer, and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill and Unitract product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world’s first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs.