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Chimerix (CMRX) announced Public Health Agency of Canada awarded Chimerix a contract up to $25.3M agreement to procure TEMBEXA. Execution of this contract will be the responsibility of Chimerix, as it is expected to substantially occur prior to the close of the pending transaction with Emergent BioSolutions (EBS).

Emergent BioSolutions announced that the U.S. Food and Drug Administration accepted for review the Biologics License Application for AV7909. AV7909 is the company's new anthrax vaccine candidate evaluated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The Prescription Drug User Fee Act goal date for a decision by the FDA is in April 2023. The rolling BLA submission, completed in April 2022, is based on data from the pivotal phase 3 clinical study of AV7909 that evaluated the lot consistency, immunogenicity, and safety of the vaccine candidate following a two-dose schedule administered intramuscularly in healthy adults. It also included data from the phase 2 study that evaluated non-interference between AV7909 and antibacterial drugs approved for post-exposure prophylaxis of anthrax disease.

Chimerix announced a $9.3 million agreement to procure TEMBEXA with a third party outside of North America, with authorization from the requisite healthcare authority. Chimerix expects to promptly provide treatment courses of TEMBEXA equivalent to the total value of the procurement contract. Execution of this contract will be the responsibility of Chimerix, as it is expected to occur prior to the close of the pending transaction with Emergent BioSolutions.

SIGA Technologies announced approximately $13M of procurement orders for oral TPOXX, including $11M for initial procurement from two new international jurisdictions and an approximate $2M order from a country in the Asia Pacific region that has an established contract for oral TPOXX. "Procurement orders from new international jurisdictions have occurred as SIGA has received a large and ongoing number of inquiries about accessing oral TPOXX, highlighting the importance of health security preparedness," said Phil Gomez, CEO of SIGA. "We expect a portion of the courses of oral TPOXX delivered under these orders will be used for the treatment of active monkeypox cases and represent a first step in the response to this outbreak by the global public health community. By increasing both the scale and scope of TPOXX stockpiling, countries can be better prepared for the outbreak risks of smallpox, monkeypox, and other viruses in the orthopoxvirus family of viruses and make sure that patients are able to access a proven safe and effective treatment." The orders from the new international jurisdictions represent the first procurements of oral TPOXX directly in response to the evolving global monkeypox outbreak. One of the new jurisdictions is located in Europe and the other is located in the Asia Pacific region. SIGA currently expects to deliver approximately $4M of oral TPOXX under the two new contracts within the next 45 days. The remaining approximately $7M of oral TPOXX is expected to be delivered in 2023. With respect to the order from an existing customer, SIGA recently fulfilled the order by delivering $2M of oral TPOXX. In combination with a delivery of a previously disclosed order of $2.8 million, SIGA has delivered in total approximately $5M of oral TPOXX to this country during this quarter. Meridian Medical Technologies is the counterparty to the international contracts and SIGA will be responsible for the manufacture and delivery of product.

Emergent BioSolutions announced that two-year persistence data from its phase 2 clinical study evaluating the safety and immunogenicity of the company's investigational chikungunya virus virus-like particle vaccine candidate were published in The Lancet Infectious Diseases. The article, Safety and immunogenicity of PXVX0317, an aluminum hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial, is available online. Emergent's CHIKV VLP vaccine candidate was well tolerated and induced a robust and durable serum neutralizing antibody immune response against the Chikungunya virus up to two years. A single dose, 40 undefined injection of adjuvanted CHIKV VLP is being further investigated in phase 3 clinical trials.