Unilife (NASDAQ:UNIS) develops and supplies innovative safety medical devices for pharmaceutical and healthcare markets that mandate the use of safety needles and sharps. Unilife is progressively launching its patented portfolio of prefilled and clinical syringes under two brands: 1. Unifill, a glass-barreled, prefilled safety syringe; and 2. Unitract, a line of plastic barreled, clinical safety syringes. The uniqueness of Unilife’s products lies in the fact that the needle retraction is both automatic and operator controlled within a fully integrated syringe—a combination of safety features that Unilife does not believe is available in any other technology marketed today.
The Company’s syringes may virtually eliminate the risk of acquiring blood borne infections, such HIV or Hep C, via needlestick injuries or blood spatter. Sanofi-Aventis (NYSE:SNY), thought to be the world’s largest purchaser of prefilled syringes, is funding up to $28.5MM (pre-sales) for industrialization and the exclusive right to buy the Unifill Syringe in therapeutic areas such as vaccines and antithrombotics. (Unilife holds ISO 13485 certifications with FDA registered manufacturing facilities located in Pennsylvania.) Unilife aims to establish agreements with other pharma companies in areas not reserved for Sanofi-Aventis.
Unilife began trading on the NASDAQ on February 16, 2010.
Achieved Milestones for Unilife:
April 2009: Completed transition of Unilife headquarters to the U.S.
June 2009: Entered into an Industrialization Agreement with Sanofi-Aventis.
August 2009: Began production of the Unitract 1ml Syringes.
September 2009: Proposed a redomiciliation to the U.S. with trading on the NASDAQ.
October 2009: Received an $5.2 million package from the Pennsylvania government.
November 2009: Filed an Information Memorandum (Australian Securities and Investments Commission [ASIC] and Form 10 (SEC) documents; Completed a $53.6MM capital raise; Appointed Mikron Group as an assembly line partner for Unifll production; Filed patents for a new pipeline syringe, the Unifill Select
December 2009: Signed agreements for the construction of new global headquarters and commercial production facility in York, Pennsylvania.
January 2010: Completed final stages of redomiciliation in the U.S.
February 2010: Form 10 filed with the SEC declared effective; Commenced trading on NASDAQ stock exchange under ticker “UNIS”; Donated its first shipment of Unitract 1ml syringes to Doctors Without Borders in Haiti.
March 2010: Signed an Exclusivity List with Sanofi-Aventis for the Unifill syringe incorporating therapeutic areas including antithrombotics and vaccines; Entered into an exclusive five-year contract with Stason for the distribution of the Unitract 1ml Syringe within Japan, Taiwan, and China, which included the placement of an order for one million units during the first year and additional one million units for subsequent years of the contract.
April 2010: Received FDA clearance for U.S. manufactured units of the Unitract 1ml Insulin Syringe and subsequent change to four-shift, 24/7 operations at Lewisberry facility.
Potential Milestones for Unilife
- Unilife expects to complete construction of the York, Pennsylvania, facility in late 2010.
- Unilife aims to employ approximately 200 individuals by the end of 2010.
- The industrialization program with Sanofi-Aventis is on track to be completed one year ahead of schedule (late 2010). Supply of the Unifill Syringe to Sanofi-Aventis could begin upon the completion of the industrialization program, with a high-volume automated assembly system expected to be established by the end of 2011.
- During 2010, Unilife expects to begin to formalize additional relationships with a number of other pharmaceutical companies that wish to use the Unifill Syringe in areas not designated as exclusive to Sanofi-Aventis.
- Unilife intends to begin full commercial supply of its Unitract 1ml Syringe during the first half of 2010 and to secure further distribution agreements for this line of syringes in the U.S. and overseas.
Disclosure: No Position