PTC faces new Duchenne drug rejection; Coherus sells Humira biosimilar

In recent news, several key developments have emerged from companies like PTC Therapeutics, Esperion Therapeutics, and Coherus BioSciences, along with significant updates from Sanofi, Lantheus Holdings, and Forbion.

Drug regulators in Europe have once again advised against renewing the approval for PTC Therapeutics' Duchenne muscular dystrophy drug, Translarna. This marks the third time the European Medicines Agency (EMA) panel has recommended against the renewal. The European Commission had asked the panel to re-evaluate the application, an unusual move, suggesting they consider data from patient registries and real-world use. Despite this additional evidence, the panel concluded that it still doesn’t sufficiently prove the drug’s effectiveness. PTC Therapeutics plans to seek another opinion, during which Translarna will continue to be available in Europe.

Esperion Therapeutics has made a strategic decision to sell rights to sales royalties in Europe for its cholesterol-lowering pill, bempedoic acid. The buyer, Omers Life Sciences, has agreed to pay $305 million for these rights. Omers will hold these royalties until they have received 1.7 times their initial investment, after which Esperion will regain the rights. The proceeds from this deal will be partially used to settle a loan from Oberland Capital. Additionally, Esperion is still in line to receive up to $300 million in sales-based milestone payments under a licensing arrangement with Daiichi Sankyo.

In a bid to refocus its business on branded cancer drugs, Coherus BioSciences is divesting rights to Yusimry, a biosimilar of Humira, to Hong Kong King-Friend Industrial for $40 million in cash. This marks the second biosimilar Coherus has divested this year. The company recently received U.S. approval for Loqtorzi, a cancer immunotherapy, in 2023.

Sanofi is making a significant investment of $40 million in Vigil Neuroscience, a biotech firm developing treatments for neurodegenerative diseases. Through this deal, Sanofi secures an exclusive right of first negotiation to license an experimental antibody targeting the TREM2 protein. Vigil is currently testing a medicine aimed at treating Alzheimer's disease, and the investment will extend the company's financial runway into 2026.

Lantheus Holdings, a company specializing in radiopharmaceuticals and diagnostics, has acquired rights to a radiotheranostic pair for prostate cancer from Life Molecular Imaging for $35 million. The pair consists of a lutetium-based treatment and a gallium-based diagnostic, both targeting the gastrin-releasing peptide receptor. Initially developed by Bayer and discovered at the Universities of Bern and Basel, the pair was later licensed to Life Molecular. Lantheus plans to initiate a Phase 1/2a study next year, using the gallium-based diagnostic as a companion to the lutetium treatment.

Lastly, European venture capital firm Forbion has appointed former Dyne Therapeutics CEO Josh Brumm as a general partner to bolster its U.S. presence. Brumm will support Forbion's current portfolio companies and help identify new opportunities in both the U.S. and Europe. Although Forbion is based in the Netherlands, approximately 30% of its investments are in North America.

These developments highlight the dynamic nature of the biotech and pharmaceutical industries, with companies making strategic moves to optimize their portfolios, secure funding, and expand their global footprints.