Filed by Alvotech Lux Holdings S.A.S. (Commission File No. 333-261773)
Pursuant to Rule 425 under the Securities Act of 1933
And Deemed Filed und Rule 14a-12 under the Securities Exchange Act of 1934
Subject Company: Oaktree Acquisition Corp. II
JAMP and Alvotech Announce Canadian Approval of SIMLANDI™,
a High-Concentration Biosimilar to Humira®, Providing Access
to Previously Unavailable Versions in Canada
Health Canada rules that 40 mg/0.4 mL and 80 mg/0.8 mL presentations of SIMLANDI™ are not subject to the statutory stay, clearing the way for the launch in the Canadian market
High-concentration formulations, previously unavailable in Canada, reflect over 80% of use in the US Market
SIMLANDI is the first biosimilar candidate to be approved under the Alvotech/JAMP collaboration
REYKJAVIK, ICELAND & BOUCHERVILLE, QC (January 10, 2022) – Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, and JAMP Pharma Group (“JAMP Pharma”), a Canadian owned pharmaceutical company headquartered in the Montreal area, announced today that Health Canada has granted marketing authorization to JAMP Pharma for a high-concentration biosimilar to Humira® (adalimumab), developed by Alvotech. The biosimilar medicine, AVT02 (100 mg/mL adalimumab, in 40 mg/0.4 mL and 80 mg/0.8 mL presentations), will be marketed as SIMLANDI in Canada through an exclusive commercialization agreement with JAMP Pharma.
Health Canada also informed JAMP Pharma that the 40 mg/0.4 mL and 80 mg/0.8 mL presentations of SIMLANDI are not subject to the 24-month statutory stay pursuant to the Patented Medicines (Notice of Compliance) Regulations because AbbVie Corporation, the marketer of Humira, elected to not market the equivalent high-concentration versions to Canadian patients. JAMP has accordingly been issued notices of compliance for these presentations of SIMLANDI and can launch them in Canada.
“We are extremely proud to be the first Canadian company to offer this value-added option at a considerably lower cost than Humira,” said Louis Pilon, CEO of JAMP Pharma Group. “SIMLANDI will give Canadians access to a high-concentration, citrate-free form of adalimumab, which is widely used across both Europe and the U.S.”
“We will also offer a unique 80 mg/0.8 mL dose to Canadian patients that will reduce the number of starting injections by 50% for the patients that require it,” said Bruno Mäder, President & Chief Operating Officer of JAMP Pharma Group.
“The combination of Alvotech’s biosimilar development and manufacturing capabilities and JAMP’s market expertise strongly positions the two companies to help Canadian patients,” said Robert Wessman, Founder and Chairman of Alvotech.