Icelandic billionare's biosimilar company raises $450M, preps for Nasdaq launch with SPAC merger
As Icelandic billionaire Róbert Wessman tries to take down AbbVie’s megablockbuster Humira in court, he’s also taking his biosimilar upstart to the big time with a $2.25 billion SPAC merger, Nasdaq launch and $450 million raise announced early Tuesday.
While Wessman’s Alvotech has not won FDA approval for any of its biosimilar candidates yet, the company was the first to file with the FDA for approval of its high-concentration Humira biosimilar and to have successfully conducted a switching study in support of a highly-coveted interchangeability designation. But other companies like Amgen, Boehringer Ingelheim and Pfizer have since caught up ahead of the launches of their own Humira biosimilar competitors in 2023.
“So when those biosimilar companies enter in 2023, we expect that only 10% of Humira sales in the US – around 15 to 16 billion, only 10% will be [the lower concentration] 50 mg. We, on the other hand, were the first to get filing acceptance [with the FDA] of the higher concentration, so we can focus on 90% of the market when we come out,” Wessman previously told Endpoints News.
But the higher concentration version of a Humira biosimilar may be a moot point, as BI said in a recent citizen petition to FDA that the agency has yet to weigh in on:
In Boehringer Ingelheim’s view, these biosimilar products, including Cyltezo, should be considered to have the same ‘strength’ as the corresponding OC [original concentration] and HC [higher concentration] versions of Humira because they contain the same total drug content per container (e.g., 40 mg), regardless of the volume of excipients.
What’s more, if Alvotech proves to be successful in defeating AbbVie in court, AbbVie CEO Rick Gonzalez said recently in an earnings call that although he thinks such an outcome is doubtful, all of the other FDA-approved Humira biosimilars would come to market too alongside Alvotech’s biosimilar, potentially in late 2022.
Meanwhile, Alvotech’s pipeline also includes biosimilar candidates to Stelara (ustekinumab), Eylea (aflibercept), Prolia/Xgeva (denosumab) and Simponi/Simponi ARIA (golimumab).
And Alvotech’s partners, including Teva in the US and Stada in the EU, have licensed products in exchange for milestone payments and royalties. As of June 30, Alvotech said it had received license fee commitments of up to $1.15 billion under these partnerships, approximately 80% of which are still to be collected.
“Alvotech has built a highly attractive platform with a long-term view to lead the biosimilars market,” said Zaid Pardesi, managing director at Oaktree and CFO of Oaktree Acquisition Corp II, which is working with Alvotech on the SPAC merger. “The Company’s diverse pipeline and unique capabilities, in combination with its world-class distribution partners, set the stage for meaningful value creation and accelerated growth going forward.”
As part of the SPAC, Alvotech is expected to get $450 million in cash — $250 million from the SPAC’s trust, $150 million from a PIPE financing and a $50 million equity commitment. The merger is expected to close in the first half of 2022.