Vertex Pharmaceuticals Inc. is acquiring Alpine Immune Sciences Inc. for $4.9 billion in cash to gain Alpine’s lead product, phase III-ready povetacicept, which demonstrates best-in-class potential in patients with immunoglobulin A nephropathy (IgAN). Povetacicept (ALPN-303), or “pove,” holds potential “as a pipeline in a product in a number of other serious renal diseases and cytopenias,” Vertex CEO Reshma Kewalramani said during an April 10 conference call, noting that the deal was “just the right fit with just the right assets at just the right phase of development where Vertex can add value.”

Novartis pledges up to $1B-plus in Arvinas prostate cancer deal 

Arvinas Inc. scored a licensing deal with Novartis AG for worldwide development and commercialization of ARV-766, Arvinas’ second-generation Protac androgen receptor degrader for patients with prostate cancer. The arrangement, which brings an up-front payment of $150 million, includes potential development, regulatory and commercial milestone payments of up to $1.01 billion, plus tiered royalties for ARV-766. The pair also executed an asset purchase agreement for the sale of Arvinas’ preclinical AR-V7 program to Novartis.

Enlivex faces market headwinds in phase II sepsis study’s wake

Enlivex Therapeutics Ltd. reported the “positive indication of effect and safety” from the phase II study of Allocetra in treating sepsis and sepsis shock, but the market is taking another view of the clinical trial. The cell therapy’s randomized, controlled study of 120 enrolled patients also reported low mortality rates. However, according to Bruno François, who took a primary role in the study’s design, medical support and patient eligibility oversight, “randomization resulted in the Allocetra-treated cohorts having higher frequencies of septic shock and invasive ventilation prior to treatment, as compared with the control group. Because these patient attributes are typically associated with a significantly higher degree of difficulty of treatment and higher mortality rates, the relative effect of Allocetra in some patient subpopulations was challenging to deduce.” The company’s stock (NASDAQ:ENLV) had taken a deep nosedive at midday, with shares trading 49% downward at $2.02 each.

Eliem shifts focus to autoimmunity with Tenet Medicines buyout

Following decisions in 2023 to back away from its lead neurological therapies and conserve cash, Eliem Therapeutics Inc. found a vote of investor confidence and a new direction through its acquisition of privately held Tenet Medicines Inc. and its anti-CD19 antibody for autoimmune disease. The stock-for-stock merger will give Scotch Plains, N.J.-based Tenet 15% of the combined company, with Eliem shareholders owning 85%. The deal also includes a $120 million private placement that will close at the same time as the acquisition, expected mid-2024. The agreement “represents a transformational event” for Seattle and Cambridge, U.K.-based Eliem, said Andrew Levin, the company’s executive chairman, adding that the goal of the combined company will be to create “a leading immunology and inflammation company focused on treating autoantibody-mediated diseases.” Investors were enthused, with Eliem’s stock (NASDAQ:ELYM) climbing 56% to $4.17 in midday trading April 11.

China advances semaglutide biosimilars, Jiuyuan seeks NMPA nod 

Follow-on biologic makers in China have been working to capitalize on looming patent cliffs of blockbuster biologics. Advancing biosimilars of denosumab (Prolia/Xgeva, Amgen Inc.) and semaglutide are the latest examples. Hangzhou Jiuyuan Gene Engineering Co. Ltd. confirmed to BioWorld that it is seeking Chinese approval of Jiyoutai (JY29-2), a biosimilar to Novo Nordisk A/S’ Ozempic (semaglutide), to treat type 2 diabetes. “Our biosimilar application of semaglutide, indicated for diabetes, was accepted by CDE of NMPA on April 3, after successful phase I and III clinical studies performed in China,” Zhou Li, Jiuyuan, Gene Engineering‘s director of overseas marketing, told BioWorld on April 11.

Regeneron hit with fraud claims for credit card subsidies

With credit card fees taking a sizable bite of their billings, many U.S. health care providers are fighting back by offering patients cash discounts. But when a drug company covers those processing fees for its distributors so their provider clients can accept credit card payments from patients without that bite, it might become fraud. So said the U.S. Department of Justice (DoJ) when it announced yesterday that it had filed a complaint under the Federal Claims Act against Regeneron Pharmaceuticals Inc. Born out of a whistleblower suit filed in 2020 by three Regeneron employees, the DoJ’s complaint alleged those subsidies for the company’s eye drug Eylea (aflibercept) constitute fraud because Regeneron didn’t include the price concessions in its Medicare price reporting, “thereby falsely inflating Medicare reimbursements for Eylea and giving Regeneron an unfair competitive advantage.” The DoJ is seeking triple damages, which could be well upwards of $1 billion, and penalties.

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