Pamisel's Exclusive Raw Material Supply for Smallpox Treatment Nears FDA Approval... 'US Government 100 Billion Won Support for New Drug'

U.S. Government Establishes Bioweapon Defense Standards Since 2001 Anthrax Terrorism
FDA Designates Smallpox Treatment as Orphan Drug in June 2018
Anticipates Potential Procurement Contract with BARDA

[Asia Economy Reporter Hyungsoo Park] Pamisil is expected to accelerate the improvement of its performance in the active pharmaceutical ingredient (API) sector. Pamisil anticipated an increase in the supply of HDP-tosylate ahead of the new drug approval for the smallpox treatment.

According to related industries and Pamisil on the 17th, Chimerix in the United States is developing a smallpox treatment Brincidofovir, and has received approval from the U.S. Food and Drug Administration (FDA) for the rolling submission of the new drug application (NDA).

Rolling submission means that the FDA reviews the approval materials in stages rather than receiving all the documents at once to expedite the review process.

Chimerix explained in an official press release that Brincidofovir is a treatment under development with a total support contract of approximately 100 billion KRW (about 81.1 million USD) from the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services, and that it expects to sign a potential procurement contract with BARDA ahead of FDA approval.

Pamisil has been exclusively supplying HDP-tosylate, a key intermediate used in Brincidofovir, to Chimerix since 2007. In particular, in 2014, Pamisil signed a Master Supply Agreement (MSA) with Chimerix for the supply of active pharmaceutical ingredients used in Brincidofovir. Therefore, continuous supply contracts are expected.

The related industry expects the completion of Brincidofovir development and FDA approval to be possible. An industry official explained, "The U.S. government, following the 2001 anthrax terrorist attacks, established criteria of bioweapons defence and recommends the development of smallpox treatments,” adding, “The FDA designated the smallpox treatment as an orphan drug in 2018 and approved the expedited review of Brincidofovir.”

This content was produced with the assistance of AI translation services.