Retractable syringes maker Unilife Corporation (UNIS) has begun the initial supply of its Unifill ready-to-fill (prefilled) syringe to Sanofi (SNY). This follows the company’s recent completion of all the required validation tests for the product.
Under the terms of the exclusive agreement, inked in July 2008, Sanofi paid Unilife roughly $40 million, consisting of $16 million for the exclusive right to negotiate the purchase of Unifill and up to $24 million to help fund the industrialization program for the device. The deal provides Sanofi with the exclusive rights to the Unifil syringe for use in the complete therapeutic classes of antithrombotic agents and vaccines as well as four smaller sub-groups, until June 30, 2014.
The initial sales to Sanofi represent a major landmark in the commercialization process of the Unifill syringe. With this milestone, Unilife is now well placed to market this unique device to other pharmaceutical companies.
Unilife is currently in the process of negotiation with more than 20 pharmaceutical companies who have shown interest in its syringe. The product has drawn interest from an increasing number of companies for use in therapeutic classes other than those retained by Sanofi.
It is anticipated that these pharmaceutical makers will conduct their own formal appraisal of Unifill syringe in combination with their injectable drugs or vaccines. Submission of the study data will be the final step in completing the regulatory process for the drug-device combination product.
Prefilled syringes act as the main drug container for about 50 injectable vaccines and drugs that are marketed by over 20 pharmaceutical companies. Unilife is of the opinion that the pharma market for prefilled syringes is the most rapidly growing, relatively uncongested and most lucrative segment of the global syringe industry.
The first-of-its-kind Unifill syringe is expected to revolutionize the $2.7 billion devices market for prefilled syringes as it is way advanced vis-à-vis the currently available prefilled syringes.
Pennsylvania-based Unilife develops and markets advanced drug delivery systems. It collaborates with biotech and pharmaceutical companies and explores new devices that could be used with their drugs. The company has developed a wide array of its own injectable drug delivery products, including retractable syringes.
Unilife markets its prefilled syringes to pharmaceutical manufacturers, suppliers of medical products to healthcare facilities and patients who self-administer prescription drugs. Its patented syringes provide integrated safety, which is designed to protect patients from needle stick injuries. Unilife competes with Becton, Dickinson and Company (BDX) among others.
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