AZTherapies names Ernest Penachio VP of Manufacturing Operations and CMC

 AZTherapies has named Ernest D. Penachio to the newly created position of VP of Manufacturing Operations and CMC to oversee clinical and pre-commercial manufacturing, scale-up, and CMC content development for the company’s ALZT-OP1 inhaled cromolyn/oral ibuprofen combination therapy for the treatment of Alzheimer’s disease, which is in Phase 3 development.

Penachio was most recently VP of Manufacturing Operations & Facilities at Acorda and was previously Senior Director of Manufacturing Operations and Facilities at Civitas Therapeutics which was acquired by Acorda in 2014. In both of those roles, he was responsible for logistics and CMC activities related to Inbrija inhaled levodopa. Prior to Civitas, he worked in engineering roles at Advanced Inhalation Research and Alkermes, where he was part of the team that developed the ARCUS particle engineering and delivery technology used for Inbrija.

AZTherapies CEO and Chairman David R. Elmaleh said, “We are thrilled to welcome Ernie to the AZTherapies team. Ernie’s extensive experience in the manufacturing of pharmaceuticals delivered by inhalation to treat neurodegenerative diseases is impressive and particularly relevant, as our ALZT-OP1 candidate is designed as a combination therapy that includes an optimized formulation of inhaled cromolyn. Ernie’s arrival could not come at a better time; not only are we ramping up our pre-commercial and regulatory activities on ALZT-OP1, but we are also planning the initiation of clinical trials of our next candidate, AZT-101, which also involves an inhaled formulation of cromolyn, in both ALS and post-ischemic stroke cognitive impairment in the first half of 2020.”

In October 2019, AZTherapies announced that it had raised $26.3 million to fund completion of the Phase 3 COGNITE trial of ALZT-OP1 for the treatment of Alzheimer’s disease, which was initiated in 2015.

Read the AZTherapies press release.

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