It all seemed as if Portola Pharmaceuticals Inc. (NASDAQ: PTLA) and the FDA were reading from the same script until the regulator did the unexpected: issuing a complete response letter (CRL) with regards to application for approval of AndexXa, Portola’s most advanced product candidate.
Why did the FDA behave like that?
The FDA cited at least three major reasons for rejecting the new drug application for AndexXa.
The agency told Portola Pharmaceuticals Inc. (NASDAQ: PTLA) that it would only review the application if it was furnished with additional information relating to the manufacturing of the drug. The FDA also requested additional data relating to inclusion of Sanofi SA (ADR) (NYSE:SNY)’s Lovenox (enoxaparin) and Daiichi Sankyo’s Savaysa (edoxaban) in the label of AndexXa.
Third, the FDA told Portola that it will require more time to complete the review of post-marketing clinical amendment commitments made by the company. Keep in mind that Portola only recently submitted the commitment.
What’s Portola thinking?
There is no doubt that FDA’s rejection of approval request for AndexXa comes as a setback for Portola. However, the company’s CEO Bill Lis appeared to be trying to put out the fire after investors seemed to be heading for the exit on the disappointing news.
CEO Lis said that Portola Pharmaceuticals Inc (NASDAQ: PTLA) intends to move quickly to address the issues raised by the FDA. He further talked of plans to meet the FDA soon without specifying when.
Until the FDA issued CRL on AndexXa, there was nothing to indicate that approval request for the drug would be rejected. Remember AndexXa carries both FDA’s Orphan Drug and Breakthrough Therapy designations.
The FDA also agreed to accelerate review of AndexXa, which should theoretically shorten the time it takes to bring a drug to market. Perhaps the fact that AndexXa is promising to address unmet medical needs suggest that also is not lost for Portola Pharmaceuticals Inc. (NASDAQ: PTLA) and its most advanced drug compound.
Nevertheless, there will be more costs for Portola to incur in bringing AndexXa to market that it intended. Furthermore, launching AndexXa on the market could be delayed further.
2Q2016 results – Portola Pharmaceuticals Inc (NASDAQ: PTLA)
Portola Pharmaceuticals Inc (NASDAQ: PTLA) posted EPS loss of $1.02, which was better than the consensus estimate by $0.18. Revenue of $4.2 million rose 76.5% YoY, but slightly fell short of the consensus estimate.