Vertex acquires Alpine Immune Sciences for USD 4.9 billion in cash, advancing IgA nephropathy treatment with povetacicept, a dual BAFF/APRIL antagonist, entering Phase 3 development in 2024.

BOSTON & SEATTLE: Vertex Pharmaceuticals Incorporated and Alpine Immune Sciences, Inc. announced a significant agreement, where Vertex will acquire Alpine for $65 per share, totaling approximately $4.9 billion in cash. The Boards of Directors for both companies have unanimously approved this transaction, which is expected to be completed later this quarter.

Alpine Immune Sciences' lead molecule, povetacicept (ALPN-303), is a powerful dual antagonist of BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand). In its Phase 2 development, povetacicept has displayed promising potential for best-in-class efficacy in treating IgA nephropathy (IgAN), a serious autoimmune kidney disease that can progress to end-stage-renal disease. Notably, there are currently no approved therapies addressing the root cause of IgAN, which affects around 130,000 individuals in the U.S. Povetacicept is on track to enter Phase 3 clinical development in the latter half of 2024.

Given its mechanism of action as a dual BAFF/APRIL antagonist, povetacicept also has the potential to benefit patients with other severe autoimmune kidney diseases such as membranous nephropathy and lupus nephritis, as well as autoimmune cytopenias. Ongoing clinical studies are investigating its efficacy in these renal indications and autoimmune cytopenias.

Vertex's acquisition of Alpine involves paying USD 65 per share in cash, amounting to a total equity value of approximately USD 4.9 billion, or approximately USD 4.6 billion after accounting for estimated acquired cash. A subsidiary of Vertex will soon commence a cash tender offer to acquire all outstanding shares of Alpine common stock.

The anticipated closure of this transaction is set for the second quarter of 2024, pending certain conditions such as the tender of a majority of Alpine's outstanding shares and the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, along with other customary conditions.

Alpine Immune Sciences is dedicated to pioneering a new era of immune therapeutics. With top-notch research and development capabilities, a highly efficient scientific platform, and a proven management team, Alpine aims to create first- or best-in-class multifunctional immunotherapies through innovative protein engineering technologies, all aimed at enhancing patients' lives. Alpine has also formed strategic collaborations with prominent global biopharmaceutical companies and maintains a diverse pipeline of clinical and preclinical candidates under development.

IgA nephropathy (IgAN) is a progressive, and potentially life-threatening chronic kidney disease that stands as the most common cause of primary (idiopathic) glomerulonephritis worldwide, impacting individuals globally. IgAN is believed to stem from the deposition of circulating immune complexes comprised of immunoglobulins and galactose-deficient immunoglobulin A (Gd-IgA1) in the renal glomerular mesangium, leading to kidney injury and fibrosis. A substantial percentage of those with IgAN eventually progress to end-stage renal disease, and currently, there are no approved therapies addressing its underlying cause.

Reshma Kewalramani, M.D., FASN, Chief Executive Officer and President of Vertex, said, “Alpine is a compelling strategic fit for Vertex and furthers our ambition of using scientific innovation to create transformative medicines targeting serious diseases with high unmet need in specialty markets. We look forward to welcoming the talented Alpine team to Vertex and believe that together we can bring povetacicept, a potential best-in-class treatment for IgAN to patients faster. We also look forward to fully exploring povetacicept’s potential as a ‘pipeline-in-a-product' and adding Alpine’s protein engineering and immunotherapy capabilities to Vertex’s toolbox.”

Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine, said, “Today’s announcement marks a new chapter for Alpine. It became clear during our discussions with the Vertex team that we share many core values, including a commitment to patients, our employees, and an intense drive for innovation. Povetacicept has demonstrated potential best-in-class attributes in IgA nephropathy and has broad development potential across several other autoimmune and inflammatory conditions with significant unmet need. We look forward to the opportunity, now more than ever, to make a meaningful difference in the lives of patients worldwide as part of Vertex.”

According to TechSci Research, the acquisition of Alpine Immune Sciences by Vertex Pharmaceuticals Incorporated is poised to have a notable impact on the growth trajectory of the healthcare market. This strategic move brings together Vertex's established presence in the pharmaceutical industry with Alpine's innovative approach to protein-based immunotherapies, particularly povetacicept (ALPN-303), targeting serious autoimmune kidney diseases like IgA nephropathy (IgAN).

This acquisition signifies a significant investment in the development of novel therapies for autoimmune diseases, a sector of the healthcare market that has been steadily growing due to increasing prevalence and unmet medical needs. Alpine's focus on dual antagonists of BAFF and APRIL, demonstrated through povetacicept's promising Phase 2 results, aligns with the rising demand for effective treatments in this therapeutic area.

The acquisition expands Vertex's portfolio into renal indications and autoimmune cytopenias, diversifying its offerings beyond its existing therapeutic areas. This diversification could lead to increased market share for Vertex in these specific segments, capturing a larger portion of the market catering to autoimmune kidney diseases.

Furthermore, the acquisition of Alpine at a substantial value of approximately USD 4.9 billion highlights the confidence in the future growth potential of these therapies. This vote of confidence from Vertex could attract more investment into similar biotechnology companies focusing on immunotherapies, fostering a competitive yet innovative environment within the healthcare market.