South San Francisco-based Portola Pharmaceuticals has snagged $50 million in loans from partners Pfizer and Bristol-Myers Squibb to help cover the additional costs of readying its breakthrough anticoagulant reversal agent for approval. Approval was sidelined in August when instead Portola was delivered an FDA complete response letter (CRL) tied to manufacturing and other issues.
Portola said on Monday that it will get $25 million in unsecured loans from both Pfizer and Bristol-Myers to help cover the costs of additional development and clinical studies of AndexXa. Pfizer and BMS market the anticoagulant Eliquis for which AndexXa would serve as a bleeding antidote. The three already have development and marketing arrangements for the agent.
“This agreement reflects the commitment and support of the andexanet alfa program by our long-standing partners BMS and Pfizer and helps Portola to continue moving rapidly toward our goal of gaining regulatory approval in 2017,” Tao Fu, chief commercial and business officer of Portola, said in a statement. “We are committed to working with the FDA to bring AndexXa to market as patients currently have no approved antidote available to reverse Factor Xa inhibitors.”
A spokesperson said Monday the money would cover "general development of andexanet alfa in the U.S. and EU, including manufacturing and clinical studies."
In the CRL, the FDA requested more information about Portola’s manufacturing, as well as additional data for inclusion of the anticoagulants edoxaban and enoxaparin in the label.
At the time the CRL was announced, Portola execs said they were surprised by the issues over manufacturing, saying that there had been a handful of observations during a preapproval inspection but that they did not appear critical and the FDA has provided little feedback that would suggest serious concerns. Given the breakthrough nature, they said, they had expected to deal with some validation issues after approval, but the CRL made it clear the FDA wants those nailed down in advance.
Portola was one of five drugmakers that received CRLs this year tied primarily to manufacturing issues. That was more than 40% of the 12 CRLs the FDA has issued so far this year. AstraZeneca received a CRL for the hyperkalemia drug that was the target of its $2.7 billion deal for ZS Pharma. Others included Valeant Pharmaceuticals and Ocular Therapeutix, which each had eye drugs hit with CRLs, and OPKO, the one drugmaker which was able to get its issues resolved and its drug approved within weeks of receiving the CRL.
In October, the FDA issued a CRL for sarilumab, an experimental IL-6 inhibitor being developed by Sanofi and Regeneron. The drug, which will compete with AbbVie’s Humira, is expected to be a blockbuster.