ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Brusselsspirit, according to the Cortico Presentation these were the steps.


Steps to Re-Commercialization

Regulatory
?? Meet with FDA to initiate re-activation of NDA(s)
?? CMC – provide documentation to justify any changes to site, suppliers,

DMF
?? Drug substance/drug product – demonstrate similarity to product
manufactured under approved NDA
?? Label – match H.P. Acthar® gel indications, excluding Infantile Spasm
?? Filing type – sNDA as prior approval supplement

Quality
?? Utilize modern methods to characterize active pharmaceutical ingredient (API) - (In progress they have to run sequential batches and test for stability. I Don't know how long this will take to complete)

Supply chain
?? Secure partner for API and sterile manufacture (DONE)

Corti presentation

DMF and Regulatory process they hired:

Dr. Mark J. Ginski, Vice President, Corticotropin Product Development

Dr. Ginski is an experienced pharmaceutical executive with almost 20 years of experience in the development of small molecules, peptides and biologics. Dr. Ginski offers experience in various CMC disciplines such as analytical chemistry, formulation development, drug substance and drug product scale-up and process development, as well as clinical and commercial manufacturing of drug substance and drug product. Dr. Ginski joined ANI in May 2016 from Mallinckrodt Pharmaceuticals where he was responsible for CMC & Operations within the Autoimmune & Rare Diseases business unit. Previously, Dr. Ginski held similar roles at Questcor Pharmaceuticals, Cerecor Pharmaceuticals, Alba Therapeutics, Shire Pharmaceuticals and Guilford Pharmaceuticals. Dr. Ginski holds a B.S. in Biologics Sciences and a Ph.D. in Pharmaceutical Sciences from the University of Maryland.

and

Karen Quinn Ph.D as Vice President Corticotropin Regulatory Affairs, effective January 17, 2017.


Karen Quinn is a professional with over 30 years of leadership experience in Global Regulatory Affairs, specifically with a focus on drug products with biologically-derived active pharmaceutical ingredients. Dr. Quinn worked most recently with Takeda Pharmaceuticals International as Senior Director, Global Regulatory Affairs/CMC and Head of the Biologics Group. Dr. Quinn has also held various global regulatory affairs positions with The Dow Chemical Company, Proctor & Gamble Pharmaceuticals, Solvay Pharmaceuticals, Wyeth Pharmaceuticals and Millennium Pharmaceuticals.

They are apparently ahead of schedule. I don't know how far ahead.

They obviously have experienced people in place so I believe they will have all the ducks properly lined when they meet with the FDA

The sNDA takes on average 6 Months to review vs the 10 month NDA.

I think everything gets completed including FDA approval some time in 2018.

JMHO