There is a need for additional funding towards the development and clinical studies of AndexXa, a new compound that is a prospective antidote for Factor Xa inhibitors. This is according to Portola Pharmaceuticals Inc, which has entered into an agreement with Bristol-Myers Squibb Co (NYSE:BMY) and Pfizer Inc. (NYSE:PFE).
The agreement is worth $50 million and it is expected to facilitate this need. Both Pfizer and Bristol-Myers will contribute $25 million in unsecured loans while the principal and interest will be recovered from royalties on AndexXa commercial sales.
In what can be seen as a justification of the partnership, chief commercial and business officer of Portola, Tao Fu stated, “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.”
Portola was one of five drugmakers that received CRLs this year
Portola is well-known for the development of product candidates that significantly advance the fields of various hematologic diseases and it has expressed its commitment to work with the FDA. Its collaboration will play a big role in bringing AndexXa to market, which currently does not have any approved antidote available to invalidate Factor Xa inhibitors. However, even as Portola receives the funds, the FDA through a complete response letter (CRL) is seeking for additional information on manufacturing and the inclusion of the anticoagulants edoxaban and enoxaparin in the label.
The manufacturing concerns by the FDA are a shocker to Portola execsutives who claim that there was nothing alarming all through the preapproval inspection. Besides, the FDA had not provided any feedback that showcased serious concerns. Nonetheless, the FDA’s CRL had made it clear that the issues must be nailed down before the final endorsement. Portola has a market cap of just over $1 billion.
FDA has so far issued 12 CRLs
Portola is not alone in having to deal with a CRL. Up to this point, the agency has issued 12 CRLs to various drugmakers. AstraZeneca plc (ADR)(NYSE:AZN) received a CRL for the hyperkalemia drug alongside Valeant Pharmaceuticals Intl Inc (NYSE:VRX) and Ocular Therapeutix Inc (NASDAQ:OCUL). However, Opko Health Inc. (NASDAQ:OPK) was able to sail through with its issues leading to the approval of its drug just weeks after receiving the CRL. Meanwhile, Portola’s stock was trading at $20.24 witnessing an increase of $1.42 or 7.55%.