Royalty monetization is a financing tactic that is becoming increasingly popular during challenging times, and PTC Therapeutics Inc. is the latest firm to leverage a marketed drug to pay off debt and fuel its development pipeline. The company agreed to sell up to $1.5 billion of its Evrysdi (risdiplam) royalty stream to Royalty Pharma plc. Evrysdi is a survival motor neuron 2 RNA splicing modifier approved by the U.S. FDA in 2020 to treat spinal muscular atrophy. “We believe this takes away one of the key bear cases on the company’s cash balances, having to stay above $100 [million] for debt covenant in light of Emflaza [loss of exclusivity] and potential Translarna withdrawal from the EU market (which we continue to see a 75% chance of),” said RBC Capital Markets analyst Brian Abrahams. Following the news, PTC’s shares (NASDAQ:PTCT) surged $18.5% to $24.27 in midday trading Oct. 19.

ADC deals humming along with Hummingbird-Endeavor agreement 

The new deal between privately held Hummingbird Bioscience Pte. Ltd. and Endeavor Biomedicines Inc. is just one of three antibody-drug conjugate (ADC) agreements reached in the past week, marking a fourth-quarter surge for the therapy. Endeavor has acquired the exclusive, worldwide rights to Hummingbird’s HMBD-501, HER3-targeted ADC with an exatecan payload. Hummingbird could receive up-front and milestone payments of up to $430 million. On Oct. 16, Sotio Biotech Inc. acquired the rights to Synaffix BV’s ADC technologies, with Synaffix eligible for up to $740 million. Last week, on Oct. 12, Medilink Therapeutics Co. Ltd. licensed the exclusive global rights to an ADC targeting HER3 to Biontech SE for an up-front $70 million, with the possibility of development, regulatory and commercial milestones that could exceed $1 billion. In 2023, there have been 42 ADC deals worth about $13.83 billion, compared to 37 deals worth $21.1 billion.

Elevar shells out $600M for rights to Hengrui’s anti-PD-1 antibody outside China, Korea

Elevar Therapeutics Inc. and Hengrui Pharmaceuticals Co. Ltd.’s licensing deal for camrelizumab (SHR-1210; Airuika in China) will add the PD-1 antibody to Elevar’s liver cancer armory for pairing with rivoceranib, its tyrosine kinase inhibitor on the brink of U.S. FDA review. Amassing “both camrelizumab and rivoceranib under one portfolio will significantly streamline commercialization,” Elevar said.

ALK, ROS1 bustling as multiple players advance prospects

This summer’s phase III news from Qilu Pharmaceutical Co. Ltd. with iruplinalkib – an oral inhibitor of ALK and ROS1 tyrosine kinase – reinforced the ongoing interest in the pair of oncology targets, where a handful of developers remain busy. In the queue are such players as Ascentage Pharma Inc., Bristol Myers Squibb Co. and Nuvalent Inc.

Holy grail? Paradigm’s injectable Zilosul shows disease-modifying attributes in osteoarthritis

A six-week treatment regimen of Paradigm Biopharmaceuticals Ltd.’s Zilosul (injectable pentosan polysulfate) resulted in improvement of both the symptoms of osteoarthritis and preserved or regenerated joint tissues in the knee, according to phase II trial results. “What we see with twice-weekly injections given for six weeks is that we've seen a consistent pattern across the regions of cartilage thickening over the six months of follow-up,” Paradigm Chief Medical Officer Donna Skerrett said during an Oct. 18 conference call. The six-week treatment at 2mg/kg twice weekly resulted in an increase in overall cartilage thickness across all compartments of the knee of 0.17mm compared to an overall decrease of -0.09mm in the placebo group.

Limited semaglutide supply keeps window open for counterfeits

Fake versions of Novo Nordisk A/S’ 1-mg Ozempic prefilled pens are sounding alarms in Europe amid an ongoing shortage of the company’s semaglutide products resulting from demand in the weight-loss space. The EMA this week reported that counterfeits, labeled in German and originating from wholesalers in Austria and Germany, have been identified at wholesalers in the EU and the U.K. The outer packaging of the fakes is difficult or impossible to distinguish from Novo Nordisk’s packaging, but the pens themselves are quite different from the authentic product, according to German regulators who first raised the alarm.

Final guidance explains US FDA’s benefit-risk assessments

Responding to industry’s need for a clearer understanding of the U.S. FDA’s benefit-risk considerations for drugs and biologics, the agency finalized a 2021 guidance that details the factors reviewers at its drug and biologics centers use in their benefit-risk assessments. The guidance also discusses how sponsors can inform that assessment throughout the lifecycle of their products, according to a notice to be published in tomorrow’s Federal Register.

Also in the news

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