Portola's AndexXa Still Approvable, But It Will Take Time

Morgan Stanley’s Matthew Harrison believes regulatory updates regarding AndexXa and betrixaban were key drivers for Portola Pharmaceuticals Inc PTLA, which could offer clarity regarding approval timelines and restore investor confidence.

Harrison maintains an Overweight rating on the company, while lowering the price target from $61 to $28.

Approvable Drug

The analyst stated, “AndexXa remains an approvable drug and that the issues it faces do appear rectifiable and do not center on the product itself but rather around the processes associated with the drug product.”

Portola Pharma has received a complete response letter (CRL) from the FDA for AndexXa. The letter focuses on issues related to manufacturing, clinical data on edoxaban and Lovenox, as well as some recently submitted ANNEXA-4 amendments.

Related Link: Citi Sees "Too Much Risk" In Portola Pharma, Downgrades To Neutral

What The FDA Wants

“Mgt. indicated a few noncritical observations were recorded during their preapproval manufacturing inspection in April, but had little dialogue with FDA on manufacturing after what mgt. indicated was a "good" post-inspection meeting,” Harrison mentioned.

The FDA has asked for additional clinical data, including bolus plus infusion for Lovenox, since there was no Phase III bolus plus infusion and Phase II was only bolus.

With edoxaban, Portola Pharma did not complete additional trials on healthy volunteers, since it was believed that PK/PD modeling was sufficient.

The FDA has also asked for additional data on how thrombin generation was measured, as well as additional work on ANNEXA-4.

“Mgt. indicated it could potentially resubmit by the end of the year, but indicated it would not have precise timelines or views on when a resubmission could occur until it met with the FDA to discuss the CRL,” the analyst added.

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