ApiJect Awarded HHS-DOD Title 3, Defense Production Act (DPA

|May 12|magazine16 min read

STAMFORD, Conn., May 12, 2020 /PRNewswire/ -- ApiJect Systems America, Inc., a public benefit corporation based here, today announced that it has been awarded an HHS-DOD Title 3, DPA contract valued up to $138 million to accelerate the building of a new U.S.-based, high-speed, population-scale emergency drug injection capability with prefilled syringes from its subsidiary RAPID USA Inc. RAPID USA's emergency program, "Project Jumpstart" is being initiated to supply 100 million prefilled syringes by year-end.

RAPID USA's Project Jumpstart will immediately contract with a sufficient number of existing U.S.- based Blow-Fill-Seal (BFS) facilities to install filling lines and technical upgrades to enable production of prefilled syringes before year-end. BFS is a well-established high-speed medical- grade plastics aseptic manufacturing process that specializes in the high-volume production of pharmaceutical products. Jumpstart will also purchase and stockpile 100 million Needle Hubs for ApiJect prefilled syringes. Jumpstart will develop the capability to manufacture a minimum of 30 million prefilled syringes per month once therapeutic drugs and vaccines become available.

In parallel with Project Jumpstart, RAPID USA will build a network of 30 U.S.-based BFS manufacturing lines at three different, geographically dispersed, sites. Once operational, these 30 lines will fill, finish, and package up to 330 million prefilled BFS syringes per month. Initial production will begin in late 2021. RAPID USA will also build a U.S.-based training and prototyping facility capable of supporting 500 U.S.-based jobs at RAPID USA's three manufacturing sites.

ApiJect Systems America CEO Jay Walker commented: "ApiJect's Title 3, DPA funding gives our subsidiary RAPID USA the capability to swiftly create the domestic surge capacity in prefilled syringes that will be needed as therapeutics and vaccines become available. Project Jumpstart is the first stage in RAPID's HHS-DOD supported two-stage effort. Within six months, Project Jumpstart will create a surge capacity to supply 100 million prefilled syringes and more than 500 million in 2021. Stage two, running in parallel with Jumpstart, will have RAPID USA building a network of 30 U.S.-based BFS manufacturing lines, enabling a monthly production of up to 330 million BFS prefilled syringes."

Walker continued: "When discussions with HHS ASPR first began last year ApiJect was then focused on global health, specifically injection safety in low and middle-income countries where needle reuse and contaminated multi-dose vials kill as many as two million people every year and infect 10 million or more with transmissible diseases such as HIV and Hep-C. ASPR's leadership wanted us to turn our attention to building a U.S.-based population-scale surge capacity for flexible biodefense purposes. We started immediately, and when COVID-19 emerged as a pandemic threat, our public-private partnership with HHS, which had been created in January, accelerated to focus on building both an emergency capability as well as longer-term sustainable injection surge capacity."

Walker further commented: "RAPID USA is led by our multi-disciplinary team of experienced engineers, pharmaceutical technology experts, and management leadership. Our team is expending extraordinary efforts to ensure that when drugs are developed and tested all Americans can receive critical injections. We will have done our part by providing the manufacturing capacity to support the necessary volume of ready-to-use prefilled syringes that contain essential medicines, be they therapeutics or vaccines. Our public-private partnership, supported by Jefferies Financial Group, and the HHS-DOD Title 3 contract, demonstrates the vital role that RAPID will play in the war against COVID-19, as well as future national health emergencies."

Rich Handler, CEO and Brian Friedman, President of Jefferies Financial Group, Inc., commented: "Finding a solution to the COVID-19 crisis demands the best from each of us, as companies and as individual citizens. When we learned what ApiJect was doing with the U.S. Government, Health and Human Services and the Department of Defense, we saw a role where Jefferies and our nearly 4,000 global professionals could make a difference. We invested in RAPID USA as we believe it is the right step at the right time, and we will continue to support ApiJect to assure RAPID USA can do their important job of building the surge capacity needed here on U.S. soil to help put this crisis behind us."

ABOUT APIJECT AND RAPID USA

ApiJect Systems America, Inc., is a public benefit corporation dedicated to making injectable medicines safe and available for everyone. By building a network using high-speed, high-volume Blow-Fill-Seal medical grade plastics technology and an interlocking Needle Hub, ApiJect can supply hundreds of millions of ultra-low-cost prefilled syringes with optional RFID tags to enable GPS-based mobile tracking. ApiJect, along with the U.S. Department of Health and Human Services, is a founding member of the RAPID Consortium, a public-private partnership dedicated to giving the U.S. and the world the surge drug packaging it needs for addressing future pandemics and bio-emergencies. Learn more about ApiJect at www.apiject.com.

RAPID USA, Inc., a subsidiary of ApiJect Systems America, Inc., is building and will manage the high-speed, high volume surge capacity for drug fill, finish and packaging that America needs to effectively respond to future pandemics and bio-emergencies. Starting in the second half of 2021, RAPID USA will begin rolling out new U.S.-based BFS drug packaging lines that once completed in 2022, will provide the capacity to fill and finish up to 330 million prefilled syringes per month for the U.S. and the world. The HHS-DOD emergency program, Project Jumpstart, to supply the U.S. with 100 million BFS prefilled syringes by year-end, is a RAPID USA initiative. Learn more at www.rapidconsortium.com.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included in these materials that address activities, events or developments that ApiJect expects, believes or anticipates will or may occur in the future are forward-looking statements. The words "believe", "expect", "may", "estimates", "will", "anticipate", "plan", "intend", "foresee", "should", "would", "could", or other similar expressions are intended to identify forward-looking statements, which are generally not historical in nature. However, the absence of these words does not mean that the statements are not forward looking. Without limiting the generality of the foregoing, forward-looking statement contained in this press release specifically include the expectations of plans, strategies, and objectives of ApiJect. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of ApiJect, which may cause actual results to differ materially from those implied or expressed by the forward-looking statements.

Cision View original content:http://www.prnewswire.com/news-releases/apiject-awarded-hhs-dod-title-3-defense-production-act-dpa-contract-of-138-million-in-support-of-a-joint-federal-agency-accelerated-build-out-of-domestic-surge-capacity-for-a-high-speed-population-scale-emergency-drug-injecti-301058125.html

SOURCE ApiJect Systems Corp.