On December 16, 2021 Alpine Immune Sciences, Inc. (Nasdaq: ALPN) and Horizon Therapeutics plc (Nasdaq: HZNP) reported an exclusive license and collaboration agreement for the development and commercialization of up to four preclinical candidates generated from Alpine’s unique discovery platform (Press release, Alpine Immune Sciences, DEC 16, 2021, View Source [SID1234597286]). The overall agreement includes licensing of a lead, potential first-in-class preclinical candidate, as well as a research collaboration to jointly generate additional novel candidates. These candidates include previously undisclosed multi-specific fusion protein-based therapeutic candidates for autoimmune and inflammatory diseases.
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"We are extremely pleased to enter into this collaboration with Horizon, and look forward to working with its talented research and development team," said Stanford Peng, M.D., Ph.D., Alpine’s President and Head of R&D. "With our combined expertise, we hope to accelerate and expand the potential clinical impact of our discovery platform on autoimmune and inflammatory diseases."
"This partnership represents an opportunity to advance our research efforts, moving our mechanistic insights into innovative molecules utilizing Alpine’s expertise and proven ability to design multi-specific protein-based immunotherapies," said Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. "This collaboration will expand Horizon’s early pre-clinical pipeline with complementary mechanisms of action to our current clinical stage therapeutics and provide our first pre-clinical, multi-specific development candidate."
Under the terms of the agreement, Horizon will make an upfront payment to Alpine of $25 million as well as an equity investment in Alpine of $15 million at a 25 percent premium to the 30-day volume-weighted average share price. In addition, Alpine is eligible to receive up to $381 million per program, or approximately $1.52 billion in total, in future success-based payments related to development, regulatory and commercial milestones as well as tiered royalties on global net sales. Under the agreement, Alpine will advance candidate molecules to pre-defined preclinical milestones. Horizon will then assume responsibility for development and commercialization activities and costs.
Similar to changes at other peer companies, beginning in the fourth-quarter 2021, Horizon will no longer exclude upfront and milestone payments related to collaboration and license agreements from non-GAAP R&D expense, adjusted EBITDA and other non-GAAP financial measures and has filed a Form 8-K today with additional details.