Top Biopharma News for 05/23/2024

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Here are the latest stories being discussed in biopharma today:

Talc Claimants File Class Action Suit Accusing J&J of Fraud Over Bankruptcy Moves

As Johnson & Johnson (J&J) continues efforts to settle thousands of talc lawsuits, a group of five plaintiffs has filed a new class action lawsuit accusing the company of intentionally delaying and deceiving claimants through fraudulent maneuvers. The suit targets J&J, its consumer health spinout Kenvue, and several executives for allegedly engaging in repeated bad-faith bankruptcy filings to prevent plaintiffs from getting their day in court. In 2021, J&J controversially shifted its talc liabilities into a separate company, unsuccessfully attempting to settle cases via bankruptcy twice. The company has now proposed a third settlement offering $6.5 billion to resolve ovarian cancer claims, with claimants having three months to vote on the plan.

Merck KGaA Avoids Prosecution After Cooperating with DOJ to Uncover China Export Scheme

Merck KGaA’s subsidiary MilliporeSigma has skirted prosecution by cooperating with the U.S. Department of Justice to uncover an illegal bio-chemical export scheme to China. The scheme involved former MilliporeSigma salesman Gregory Muñoz and his accomplice Peng Yu, who diverted $4.5 million worth of chemicals including cocaine and methamphetamine to China using falsified export documents. Muñoz was dismissed from his position in May 2023. Upon arrival in China, the chemicals were sold to local laboratories for profit. Both men have pleaded guilty to wire fraud conspiracy.

European Commission Finalizes Joint Clinical Assessment Rules for Member Countries

The European Commission has formalized new regulations to streamline the assessment of new drugs across EU member states. These rules aim to pool expertise from across the continent to evaluate the efficacy of new pharmaceuticals against existing market drugs. This initiative is a part of a broader effort to enhance collaboration in evaluating and funding new products. Currently, member states conduct national-level assessments, which are both time-consuming and costly. The newly finalized rules establish clear timelines and steps for conducting joint assessments, with the aim to distribute assessment reports to member countries following a drug’s marketing authorization.

UK Biotech Revives Former Kyowa Kirin Cancer Drug for Epstein-Barr-Driven Diseases

Hornet Therapeutics is resurrecting a medication originally developed by Kyowa Kirin to combat Epstein-Barr virus (EBV)-related diseases. With $5 million in seed funding from 4BIO Capital, the UK-based biotech aims to advance its flagship product targeting EBV-driven post-transplantation lymphoproliferative diseases (PTLD), a condition characterized by uncontrolled lymphocyte growth that can lead to lymphoma. Initially halted during preclinical stages, Hornet acquired the asset, now named HTX-201, and intends to move forward with development.

Cytokinetics CEO Defends Royalty Pharma Deal: ‘That Narrative Was Hijacked’

Cytokinetics CEO Robert Blum has addressed investor frustration over the company’s recent $575 million deal with Royalty Pharma, coupled with a $500 million public offering. Investors were upset, as they believed the company was better off being sold rather than continuing its independent operations. The proposed funds are intended to support the launch of aficamten for rare heart disease and another Phase 3 study for omecamtiv mecarbil, which was previously rejected by the FDA. Despite the backlash and a significant dip in stock prices, Blum maintains that building Cytokinetics into a robust cardiology entity remains the company’s primary objective.

Chinese CDMO Takes Over Pfizer’s UK Facility; Serum Institute Ships Malaria Vaccine to Africa

Asymchem Laboratories has acquired Pfizer’s API facility in Sandwich, UK, marking its first site in Europe dedicated to small molecule clinical development. The location will become operational by June, with plans to incorporate peptide and oligonucleotide manufacturing in the future. Around 100 workers, including some former Pfizer employees, will be employed at the site.

Meanwhile, the Serum Institute of India has begun shipping its co-developed malaria vaccine, known as R21/Matrix-M, to Africa. The initial shipment included 43,200 doses, with a total of 1.6 million doses scheduled for delivery. This vaccine was developed in collaboration with the University of Oxford and Novavax, signifying a significant step in combating malaria on the continent.