Teva & Alvotech today disclosed their commitment to broaden their current strategic cooperation relationship. Additionally, Teva will purchase subordinated convertible bonds that Alvotech will be issuing.
The partners continue to collaborate closely on issues pertaining to AVT02, an interchangeable high-concentration biosimilar candidate for Humira® (adalimumab), which is now awaiting approval in the United States. Four other biosimilar candidates are included in the current strategic collaboration agreement, including AVT04, a proposed biosimilar for Stelara® (ustekinumab), which is presently awaiting U.S. Food and Drug Administration (FDA) approval.
The expansion to the existing strategic partnership agreement pertains to exclusive commercialization in the U.S. by Teva of two new biosimilar candidates and line extensions of two current biosimilar candidates in the partnership, to be developed, and manufactured by Alvotech. The agreement includes milestone payments, the majority paid following product approvals and upon achieving significant sales milestones. Teva and Alvotech will share profit from the commercialization of the biosimilars. All other financial terms and product details remain confidential.
The agreement also calls for Teva to play a bigger role in manufacturing and quality control at Alvotech’s production site. To ensure Alvotech is completely prepared for an FDA inspection, Teva is actively assisting the company there in Iceland.
For $40 million, Teva has agreed to purchase subordinated convertible bonds that Alvotech will issue in accordance with a convertible bond instrument dated December 20, 2022. Alvotech will use a portion of the money from Teva’s investment to continue building its pipeline of biosimilars in the foreseeable future.
“We welcome Teva’s continued partnership and this expansion of our partnership agreement,” said Robert Wessman, Chairman and CEO of Alvotech. “We remain focused on preparing for a successful pre-approval inspection and resolving any outstanding issues identified by the FDA to be able to bring our biosimilar candidates to patients in the U.S. with Teva as soon as possible.”
“Teva remains fully committed to its leadership in biosimilars and the partnership with Alvotech,” said Sven Dethlefs, Executive Vice President, North America Commercial. “We remain optimistic about additional compounds in the pipeline and continued progress with AVT02 and AVT04.”
AVT02:
Several nations throughout the world, including the 27 member states of the European Union, Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada, Australia, and Saudi Arabia, have approved AVT02 as a biosimilar to Humira® (adalimumab). It is currently marketed in Canada and other European nations. Additionally, dossiers are being examined globally in many different nations.
AVT04:
AVT04 is a monoclonal antibody that has been proposed as a potential Stelara® (ustekinumab) biosimilar. Two cytokines that are involved in inflammatory and immunological responses include IL-12 and IL-23, which ustekinumab binds to. AVT04 is an experimental product that hasn’t been given regulatory approval anywhere. Regulations bodies have not confirmed biosimilarity, and it is not asserted. Johnson & Johnson is the registered owner of the trademark Stelara.
