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Replies to post #179320 on Biotech Values
07/02/14 5:17 PM
On July 1, 2014, Portola Pharmaceuticals, Inc. (the “Company”) entered into a Commercial Supply Agreement with CMC ICOS Biologics, Inc. (“CMC”), pursuant to which CMC will manufacture clinical and commercial supply of Andexanet alfa for the Company. In addition, CMC will provide pre-validation and validation work on behalf of the Company.
Under the Agreement, the Company [Portola] is required to purchase an aggregate fixed number of batches of Andexanet alfa from CMC from 2015 through 2021. The number of batches the Company has committed to purchase reach a peak in 2018 and then taper through 2021. Total batch commitments under the Agreement can be increased or decreased based on the achievement of milestones relating to the regulatory approval process for Andexanet alfa, expansion of existing manufacturing capacity and operational qualification of CMC’s manufacturing facilities.
The Company will make an immediate upfront payment to CMC in the amount of $10.0 million, which will be credited against future batch purchases. The Company will also make a reservation payment to CMC of $4.6 million in November 2014, which will also be credited to the purchase of batches under the Agreement.
Total fixed commitments under the Agreement for the purchases of clinical and commercial batches, not taking into account possible price and batch adjustments, are $294 million over the life of the Agreement from 2015 through 2021. The Company has also committed to $15 million worth of pre-validation work pending the execution of applicable work orders.
07/22/14 3:33 PM
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