Pharmaceutical Market Europe • May 2023 • 8-9
NEWS
Johnson & Johnson offers
almost $9bn to end talc lawsuits
Johnson & Johnson (J&J) has said it is offering $8.9bn to resolve the tens of thousands of lawsuits it faces in North America that claim its talc-based products cause cancer.
The company continues to maintain that the products are safe, but hopes that the proposed settlement could help bring the litigation to a swift conclusion.
The amount, which will be paid over 25 years, is a huge increase from the original $2bn that J&J previously committed and reportedly has significant support from current claimants.
J&J has been trying to resolve the more than 38,000 lawsuits since 2021, assigning a subsidiary to manage the claims, before filing a bankruptcy petition – a move sometimes referred to as a ‘Texas Two-Step’.
A bankruptcy judge had initially ruled in favour of the move in February 2022, but the strategy faltered earlier this year when the unit’s petition was rejected on the grounds that neither it nor J&J had a legitimate need for bankruptcy protection because they were not in ‘financial distress’.
J&J has previously said it will stop selling talc-based products worldwide this year. The announcement came around two years after the company halted sales in the US and Canada.
Biogen’s Qalsody granted FDA accelerated approval for rare form of ALS
Biogen’s Qalsody (tofersen) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
ALS is a rare and progressive neurodegenerative disease characterised by a progressive degeneration of motor nerve cells in the brain and spinal cord.
Multiple genes have been implicated with ALS, and mutations in the SOD1 gene are responsible for approximately 2% of all cases.
Qalsody works by binding to SOD1 mRNA, allowing for its degradation by RN-ase-H in an effort to reduce synthesis of SOD1 protein production.
The FDA’s decision, which makes Qalsody the first approved treatment to target a specific cause of ALS, was supported by data from the 28-week VALOR study that measured the efficacy of the drug in patients with weakness attributable to ALS and a SOD1 mutation.
Results showed that those treated with Qalsody experienced a 55% reduction in plasma neurofilament light chain (NfL) – a marker of neurodegeneration – compared to a 12% increase in placebo-treated patients.
Similar NfL reductions were observed at a 52-week interim analysis of the open-label extension (OLE) in those previously receiving placebo and who later switched to Qalsody in the OLE.
Janssen’s Akeega receives EC approval for metastatic prostate cancer
The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has announced that the European Commission (EC) has approved Akeega (niraparib and abiraterone acetate) in combination with prednisone or prednisolone to treat certain prostate cancer patients.
The marketing authorisation, which marks the first worldwide approval of the niraparib-based combination, specifically applies to adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations in whom chemotherapy is not clinically indicated.
Patients with mCRPC and homologous recombination repair (HRR) gene alterations, of which BRCA mutations are the most common, are more likely to have aggressive disease, poor outcomes and a shorter survival time, Janssen explained in a statement.
The EC’s decision was based on positive results from the phase 3 MAGNITUDE study, in which the addition of niraparib to abiraterone acetate and prednisone or prednisolone significantly improved radiographic progression-free survival (rPFS) – the primary endpoint of the study – in all HRR-positive patients.
This was most pronounced in those with BRCA1/2 gene mutations, the company said, where a 47% risk reduction for rPFS was observed.
There was also a trend towards improved overall survival and strong improvement in time to symptomatic progression in patients treated with combination, as well as clinically meaningful improvement in time-to-initiation of cytotoxic chemotherapy.
bluebird bio submits US application for sickle cell gene therapy
bluebird bio has submitted a Biologics License Application to the US Food and Drug Administration (FDA) for its sickle cell disease (SCD) gene therapy.
The application, which includes a request for priority review, is specifically for lovotibeglogene autotemcel (lovo-cel) to treat SCD patients aged 12 years and older who have a history of painful complications associated with the disease.
Affecting approximately 100,000 people in the US, SCD is a lifelong, incurable genetic disease causing red blood cells to take a distinct crescent shape, which can block blood vessels and affect the way oxygen is carried around the body.
bluebird bio’s lovo-cel is an investigational one-time treatment designed to add functional copies of a modified form of the beta-globin gene into a patient’s own haematopoietic stem cells.
Following treatment, a patient’s red blood cells can produce anti-sickling haemoglobin that decreases the proportion of sickle haemoglobin, with the goal of reducing sickled red blood cells, haemolysis and other complications.
The company’s submission is backed by efficacy results from 36 patients with 32 months of follow-up data and two patients with 18 months follow-up. Safety data from 50 patients, including six patients with six or more years of follow-up, is also included in the application.
Amgen and TScan Therapeutics partner to identify new Crohn’s disease targets
Amgen and TScan Therapeutics have announced a multiyear collaboration aimed at identifying new targets for Crohn’s disease.
The partnership will utilise TScan’s target discovery platform, TargetScan, to identify the antigens recognised by T cells in patients with Crohn’s disease.
Amgen will then develop therapeutics based on the discovered targets and will retain all global development and commercial rights.
In exchange, TScan will receive an upfront payment of $30m and will be eligible for over $500m in success-based preclinical, clinical, regulatory and commercial milestones as well as tiered single-digit royalties.
Under the terms of the agreement, Amgen has an option to expand the collaboration to ulcerative colitis, with each company responsible for its own research expenses.
Crohn’s disease and ulcerative colitis are both inflammatory bowel diseases, characterised by chronic inflammation of the gastrointestinal tract. Nearly one in every 100 people in the US are diagnosed with IBD.
Despite the availability of a range of treatments for IBD, not every patient achieves long-lasting remission, underscoring the need for new treatment options.
Raymond Deshaies, senior vice president of global research at Amgen, said: “TScan’s platform provides a best-in-class approach to identify non-conventional drug targets to enable the development of potential first-in-class therapeutics to address unmet medical needs.”
WHO and global partners launch new effort to address falling childhood vaccination rates
The World Health Organization (WHO), along with other global and national health partners, has launched a global effort to boost vaccination among children following declines driven by the COVID-19 pandemic.
WHO, UNICEF, Gavi, the Vaccine Alliance, the Bill & Melinda Gates Foundation and others announced ‘The Big Catch-Up’ to reverse the declines and protect populations from vaccine-preventable outbreaks such as measles, polio and yellow fever.
Over 25 million children missed at least one vaccination in 2021 and the effort will focus on the 20 countries where 75% of these children live.
Vaccine coverage took a major hit during the pandemic due to a range of reasons including overburdened health services, closed clinics, and disrupted imports and exports of vials, syringes and other medical supplies.
Ongoing challenges like conflicts, climate crises and vaccine hesitancy are also contributing to the decline in coverage rates.
The partners will work with countries to strengthen their healthcare workforces, improve health service delivery, build trust and demand for vaccines, and address gaps and challenges to restoring immunisation rates.
“Catching up is a top priority,” said WHO director-general, Dr Tedros Adhanom Ghebreyesus. “No child should die of a vaccine-preventable disease.”
Pharmaceutical Market Europe (PME)
Pharmaceutical industry news, articles, jobs, reports, advice and services