Biotech Values

[mouton29]

<<Back in 2013/2014 Revance was proposing to produce the complete product in-house. While they built limited capacity I'm guessing they'll only be able to supply clinical trials as needed. They will have Ajinomoto Althea take care of the fill/finish operations instead.>>


Their 10-K makes it sound like their internal capacity goes beyond clincial trials. https://www.sec.gov/ix?doc=/Archives/edgar/data/1479290/000147929019000030/rvnc1231201810k.htm

We have established capabilities for the production of botulinum toxin type A, including bulk drug substance and injectable finished drug product. Botulinum toxin is regulated as a Tier 1 Select Agent under authority of the Centers for Disease Control and Prevention (“CDC”), and as such requires that we obtain a select agent registration and perform our operations in compliance with CDC regulations. We are in good standing under our select agent registration with the CDC. We have assembled a team of experienced individuals in the technical disciplines of chemistry, biology, biosafety, and engineering and have appropriately equipped laboratory space to support ongoing research and development efforts in our botulinum toxin product development platform. We have the ability to manufacture our own botulinum toxin bulk drug substance to support our clinical trial programs and eventually, our commercial production. We believe that having direct control over our manufacturing processes will enable us to develop additional pharmaceutical product configurations effectively and with a competitive cost structure. In March 2017, we entered into a Technology Transfer, Validation and Commercial Fill/Finish Services Agreement (the “Althea Services Agreement”) with Ajinomoto Althea, Inc.(“Althea”), a contract development and manufacturing organization, to provide us with expanded capacity and a second source for drug product manufacturing to support a global launch of DAXI. The Althea Services Agreement also mitigates supply chain risk by giving us a different manufacturing location for drug product manufacturing and reduces future capital and operating expenditures required in our primary manufacturing facility by outsourcing to an experienced partner.

I recall that Momenta's approval of their generic Copaxone was delayed for many months because the Pfizer affiliate performing fill was found deficient (cardboard found in vials or some such) and there was a lot of moaning over why they didn't have a second source lined up.