ANI Pharmaceuticals Reports First Quarter 2019 Results and Reaffirms Guidance

Thursday, May 9, 2019 General News
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ANI Pharmaceuticals, Inc. and Subsidiaries

Table 5: Cortrophin® Gel Re-Commercialization Milestone Update

Step 

Duration

Status

Additional Details 

Manufacture small-scale batch of corticotropin API 

4 mos. 

Complete

• Initial batch yields similar to historical yields 

• Analytical method development and testing ongoing

Select drug product CMO 

6 mos. 

Complete

• Drug product CMO has been selected

Manufacture intermediate-scale batches of corticotropin API 

4-6 mos.

Complete

• Four intermediate-scale batches successfully completed

• Further refined/modernized analytical methods and process

• Demonstrated lot-to-lot consistency

Type C meeting with FDA 

Complete

• Meeting Request submitted 4Q17; FDA granted as Type C Meeting

• Information provided on ANI's regulatory plan for re-commercialization

• Initial FDA response received March 2018 with additional communications in 2nd Quarter 2018

Manufacture demo batch of Cortrophin® Gel 

1 mo.

Ongoing

• Initiate non-GMP formulation/fill/finish of drug product at commercial scale

Manufacture commercial-scale batches of corticotropin API

2-3 mos. per batch

Ongoing

• Analytical method validation for API release/stability

• Scale-up manufacturing process 5x to projected commercial scale

• Manufacture API under cGMPs

• Finalize API manufacturing process and initiate process validation/registration batches

• Initiate viral clearance studies

Initiate manufacture of registration batches of Cortrophin® Gel 

1 mo. per batch

Q2 2019

• Analytical method validation for drug product release/stability

• Process validation

• Registration/Commercial batches

• Initiate registration-enabling ICH stability studies 

Initiate registration stability for sNDA  

6 mos. 

1H 2019

• Six months of accelerated stability from drug substance and drug product batches at time of submission 

sNDA submission

Q1 2020

• Filing - four month PDUFA date



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