Alder BioPharmaceuticals has extended a supply agreement with Novartis subsidiary Sandoz to provide the drug substance for eptinezumab, its migraine candidate anticipated to launch next year.
Last Friday, Alder BioPharmaceuticals submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its investigational monoclonal antibody (MAb) targeting the calcitonin gene-related peptide (CGRP), eptinezumab.
If approved, the firm expects the migraine prevention candidate to be launched in the first quarter 2020. As such, the firm has secured an amendment to its existing deal with Novartis subsidiary Sandoz for the supply of eptinezumab drug substance.
“We recently entered into an amendment through which Sandoz will manufacture quantities of eptinezumab drug substance for a five-year term, running through 2023,” an Alder spokesperson told BioProcess Insider.
“Alder has had a long-standing relationship with Sandoz, going back over a decade. Our supply agreement for eptinezumab with Sandoz dates back to 2015. In fact, Sandoz was the supplier of product tested in our PK study.”
30 million and more
During the firm’s recent Q4 conference call, Alder management said the potential patient population for eptinezumab numbers 30 million people in the US alone. With Sandoz’ supply, the firm is confident it will have enough product to cope with the demand.
“We are very happy with how we are positioned for launch and are confident that this supply agreement and its amendments will allow us to meet our forecasted supply needs and compete globally at launch and beyond,” we were told.
The Sandoz amendment, dated January 1 2019, is published as part of a Form 10-K filed with the SEC. The filing also states that Alder “historically relied on a single smaller scale CMO” to manufacture clinical supplies of eptinezumab, but the agreement with Sandoz will supply a certain guaranteed quantity of eptinezumab drug substance for commercialization.
However, the filing adds: “We expect to enter into additional CMO relationships for our eptinezumab commercial supply needs as well as for our other product candidates.”
When questioned on other contract manufacturing organizations (CMOs), the spokesperson was unable to “speculate about alternative suppliers” due to competitive reasons. “However, we do have a long-term supply strategy in place.”