Alvotech raises $137M months after FDA rejected Humira biosimilar
Alvotech has completed a private placement worth $137 million at $11.57 per share directed only into Iceland, a little over a month after announcing a private placement to pay off a loan to Alvogen.
The biosimilar company has been on the hunt for cash in the last few months, completing two private placements as well as a facility loan in November that secured $136 million.
The placement for “professional clients or eligible counterparties” was taken from treasury shares held by Alvotech’s subsidiary, Alvotech Manco, the company announced Monday. The influx of cash will be used for “general corporate purposes.”
In December, Alvotech completed another private placement of $70 million of bonds to pay off a $50 million unsecured subordinated loan from Alvogen.
Alvotech hit a snag in September when the FDA sent along a rejection letter for the company’s Humira biosimilar, citing “certain deficiencies related to the Reykjavik facility and stated that satisfactory resolution of the deficiencies is required before FDA may approve.” Alvotech partnered with Teva for commercialization in the US.
Icelandic billionaire and Alvotech founder Róbert Wessman previously sang the praises of the company’s ability to be the first to get filing acceptance with the FDA in the US with a higher-concentrated biosimilar of AbbVie’s Humira. But competition would be fierce; the FDA has already approved biosimilars to Humira.
The FDA’s 483 for the Reykjavik facility listed several problems after it was inspected in March. The FDA found that the facility had a lack of procedural controls to ensure that incoming materials were properly qualified, and that the facility couldn’t prevent bacteria and mold. The FDA told the company another inspection would be done in the first quarter of 2023 and the date for an approval decision on Alvotech’s license application for AVT02, the Humira biosimilar, is April of this year. An approval of the license is contingent on a positive reinspection.
AVT02 has already received marketing approval in 35 countries with a July 1 license entry date in the US.