Mfg News: Horizon Therapeutics & Chimerix

A roundup of manufacturing news from Horizon Therapeutics and Chimerix. Highlights below.

* Chimerix, US Gov’t in $680-M Pact for Smallpox Drug
* Horizon Therapeutics To Add Biologics Mfg Facility in Ireland

Chimerix, US Gov’t in $680-M Pact for Smallpox Drug
Chimerix, a Durham, North Carolina-based bio/pharmaceutical company, has signed a multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, for the delivery of up to 1.7 million treatment courses of tablet and suspension formulations of Tembexa (brincidofovi), the company’s smallpox oral antiviral, in a deal worth up to $680 million ($115 million upfront, $551 million in options, $13 million in post marketing activities).

The 10-year contract includes an initial product procurement of 319,000 treatment courses for approximately $115 million. The contract, which contains options for future procurements, is valued at approximately $551 million in total if BARDA elects to exercise all options. In addition to product procurement, the contract supports post-marketing activities of approximately $13 million, for a total potential contract value of up to $680 million.

In May (May 2022), Chimerix entered into an agreement with Emergent BioSolutions for the sale of worldwide rights to Tembexa for $225 million upfront and potential additional milestones of up to $100 million (the transaction was subject to adjustment upon finalization of a procurement agreement for Tembexa with BARDA).

Under the final BARDA agreement, Emergent BioSolutions is expected to pay Chimerix the following: (1) an upfront payment of $238 million upon the signing of the pre-novation agreement; (2) potential milestone payments of up to $124 million (up to $31 million for each of the remaining BARDA procurement options due within 30 days of exercise);  (3) 15% royalty on gross profit from sales of Tembexa outside the US; (4) 20% royalty on gross profit from sales of Tembexa in the US that are in excess of 1.7 million treatment courses; and (5) up to an additional $12.5 million upon achievement of certain developmental milestones.

Closing of the transaction remains subject to BARDA’s approval of a pre-novation agreement between Chimerix and Emergent BioSolutions.

Source: Chimerix

Horizon Therapeutics To Add Biologics Mfg Facility in Ireland
Horizon Therapeutics, a Dublin, Ireland-based bio/pharmaceutical company focused on autoimmune and severe inflammatory diseases, has submitted a planning application to expand its development and manufacturing facility in Waterford, Ireland, to add new drug-substance biologics development and manufacturing capabilities.

The planned facility would add approximately 320,000 square feet to its current 44,000-square foot drug-product (fill–finish) biologics facility and would create approximately 350 jobs over time. Horizon says it anticipates providing additional details with respect to potential investment and timeline as the planning application process proceeds.

Horizon purchased its existing facility in June 2021 for $65 million with the understanding that adjacent land was available for further manufacturing and development expansion. Horizon is working to obtain Ireland’s Health Products Regulatory Authority and US Food and Drug Administration licensure for sterile fill–finish manufacturing (as reported on August 29, 2022) and anticipates the first medicine approved for release from the existing facility in 2023. Both facilities are expected to be used for Horizon’s on market rare disease biologics as well as development-stage medicines.

Source: Horizon Therapeutics