Glaukos Corp.

Clesrovimab is a single dose extended half-life monoclonal antibody developed as a passive immunisation for the prevention of RSV. Image credit: Sergiy Palamarchuk / Shutterstock. MSD ( Merck & Co) is planning to get its respiratory syncytial virus (RSV) vaccine, clesrovimab, approved and launched before the next RSV season in 2025-26, after reporting positive results from a Phase IIb/III trial. The company first reported that the Phase IIb/III MK-1654-004 trial (NCT04767373) evaluating clesrovimab as a preventative treatment for RSV in infants met its primary endpoint in July. MSD has now presented data showing that the therapy met the primary endpoint by reducing the incidence of RSV-associated medically attended lower respiratory infections (MALRI) requiring at least one indicator of lower respiratory infections by 60% through the first five months after dosing compared to the placebo. The results were presented at IDWeek 2024 taking place from 16-19 October in Los Angeles. MSD noted that the company is “continuing to discuss these data with health authorities around the world with the goal of making clesrovimab available for infants as early as the 2025-26 RSV season”. If approved, clesrovimab’s main competitor will be AstraZeneca and Sanofi ’s Beyfortus (nirsevimab), which is approved in the US for preventing RSV lower respiratory tract disease (LRTD) in newborns and infants. GlobalData estimates that Beyfortus will eclipse clesrovimab sales due to its first-to-market advantage, with the former raking in $2.5bn in 2030 compared to $408m for the latter over the same period. GlobalData is the parent company of Pharmaceutical Technology . See Also: FDA approves AbbVie’s VYALEV for advanced Parkinson’s treatment Glaukos eyes FDA approval for ocular therapy after Phase III win Clesrovimab is a single dose extended half-life monoclonal antibody developed as a passive immunisation for the prevention of RSV. The placebo-controlled Phase IIb/III MK-1654-004 trial enrolled 3,632 infants under one year. Clesrovimab met its secondary endpoint by reducing RSV-associated hospitalisations over five months by 84.2%, compared to placebo. The therapy also met its tertiary endpoint of reducing RSV-associated LRTD hospitalisations by 90.9% versus placebo through five months. MSD also presented data from an interim analysis from the Phase III MK-1654-007 trial (NCT04938830) that compared clesrovimab to Sobi’s RSV monoclonal antibody vaccine Synagis (palivizumab). The study is evaluated the vaccines in infants and children at increased risk for severe RSV disease. At the time of interim analysis, 901 participants were enrolled in the trial. The results showed that clesrovimab had a comparable safety profile to Synagis. Additionally, the incidence rates of RSV-associated MALRI requiring at least one indicator of lower respiratory infections and RSV-associated hospitalisations were comparable between the two groups, 3.6% and 1.3% in clesrovimab and 3% and 1.5% in Synagis groups, respectively.

Children with narcolepsy cannot choose when to wake or sleep. Image credit: Shutterstock/Roman Samborskyi. Paediatric patients with narcolepsy will now have access to Avadel’s Lumryz (sodium oxybate) after the US Food and Drug Administration (FDA) approved a supplemental new drug application. The expanded approval for the oral suspension is for the treatment of sudden muscle weakness, called cataplexy, or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy, as per a 17 October press release. Lumryz, which was approved in adults in the US in May last year, was also granted seven years of orphan drug exclusivity. This means the FDA will not approve another marketing application for a competing product until October 2031. Narcolepsy is a chronic neurological disorder that impacts the brain’s ability to regulate sleep and wake cycles, meaning people cannot choose when to wake or sleep. EDS and cataplexy are common symptoms in those with the disorder, with the latter occurring in 70% of patients. Whilst narcolepsy itself does not cause serious health problems; it has a significant impact on day-to-day life. It is thought Lumryz works by binding to gamma-aminobutyric acid B receptors in noradrenergic and dopaminergic neurons, increasing the time a person spends in deeper sleep. The treatment has a boxed warning as a central nervous system depressant, and for its potential for abuse and misuse. See Also: FDA approves AbbVie’s VYALEV for advanced Parkinson’s treatment Glaukos eyes FDA approval for ocular therapy after Phase III win The widened use of Lumryz intensifies the competition with Jazz Pharmaceutical’s rival compounds Xyrem (sodium oxybate) and blockbuster Xywav, a mixture of calcium, magnesium, potassium, and sodium oxybates. Unlike Lumryz, Jazz’s twice-nightly drugs require patients to wake up in the middle of sleep to take the second dose. The FDA highlighted this when granting the exclusive market period to Lumryz, ruling it was superior to Xyrem and Xywav due to the dosing regimen, according to Avadel. Avadel’s CEO Greg Divis said the approval is important for younger narcolepsy patients and their caregivers who “face significant challenges associated with waking up in the middle of the night to complete treatment regimens”. “With this label expansion, paediatric patients seven years and older living with narcolepsy now have the same option that adult patients with narcolepsy have – to choose a once-nightly treatment option that does not disrupt sleep for a middle of the night dose,” he added. Xyrem saw peak sales in 2020, bringing in annual revenue of $1.7bn. Xyrem sales decreased after the approval of Xywav, with the latter having more flexible dosing. Xywav passed the $1bn revenue mark last year and is forecast to generate more than $1.8bn by 2030, according to GlobalData’s Pharma Intelligence Centre. Lumryz is forecast to make $639m in the same year. GlobalData is the parent company of Pharmaceutical Technology . Jazz Pharmaceuticals has initiated multidistrict patent infringement lawsuits against Avadel over the past few years to block Lumryz’s entry to market, in addition to suing the FDA itself. A jury from the United States District Court for the District of Delaware gave its verdict in March this year, siding with Avadel for one patent whilst ruling against the company in relation to another. Avadel said it would appeal the decision and added legal proceedings would not impact the ongoing commercial launch of Lumryz, as per a statement at the time. Jazz was in court another time this year relating to a separate matter of misleading promotion relating to Xyrem. The company agreed to pay $20m in civil and criminal penalties over a period of five years.

COVID-19 mRNA vaccines have sparked interest in the potential of mRNA technology, but they have also put producers at the centre of licensing lawsuits. Credit: wacomka / Shutterstock. mRNA-based innovator pharmaceuticals have experienced a massive increase in licensing agreement deal values following success with the technology in Covid-19 vaccines, which helped to curtail the pandemic. Data and analytics provider GlobalData identified an 800% increase in deal values between 2019 and 2024 so far and has noted that key companies are continuing to invest heavily in the development of mRNA-based pharmaceuticals. GlobalData is Pharamceutical Technology’s parent company. However, recent lawsuits filed by GSK against mRNA vaccine producers Pfizer , BioNTech and most recently (15 October) Moderna , have put the licensing of mRNA-based pharmaceuticals in the spotlight. In its lawsuit, GSK has alleged the use of its technology without proper licenses. GSK is suing Moderna in two lawsuits regarding its mRNA vaccines: Spikevax for Covid-19 and mResvia for RSV. The British pharma giant alleges that Moderna ignored patents relating to lipid nanoparticles used in mRNA vaccine formulation technology. See Also: FDA approves AbbVie’s VYALEV for advanced Parkinson’s treatment Glaukos eyes FDA approval for ocular therapy after Phase III win It follows a similar lawsuit against Pfizer and BioNTech filed in April in which GSK alleges the companies were in violation of five patents relating to mRNA vaccine technology. Pfizer/BioNTech’s Covid-19 vaccine, known as Comirnaty, was approved by the FDA in August 2021 and was the first mRNA vaccine to enter the global market. It was followed by the approval of Moderna’s Spikevax in January 2022, although an emergency use authorization (EUA) had made Moderna’s vaccine available earlier. Ophelia Chan, business fundamentals senior analyst at GlobalData, has pointed to Covid-19 vaccines as a turning point for the mRNA sector. “The Covid-19 pandemic highlighted the key advantages of mRNA technology in vaccine development, including rapid production, precise immune targeting and streamlined manufacturing factors that drove the success of mRNA-based Covid-19 vaccines,” she said. mRNA Covid-19 vaccine sales declined significantly in 2023 compared to 2022. However, GlobalData reported that 2023 still saw Moderna’s Spikevax generate around $18.4bn in global revenue , while Pfizer and BioNTech’s Comirnaty generated around $42.4bn. Considering the reasons behind the jump in licensing deal values, Chan added: “Licensing agreement deal values for mRNA-based pharmaceuticals have doubled since 2023 , reaching $3.8bn as major players like GSK and Bristol Myers Squibb invest in mRNA therapeutics to address unmet medical needs.” In April, Bristol Myers Squibb entered into a multi-year, $1.87bn strategic collaboration with Repertoire Immune Medicines looking to develop mRNA-based tolerising vaccines. Meanwhile, GSK and Curevac contributed to the jump in licensing value in July, with a new licensing agreement worth up to $1.57bn. Beyond licensing, GlobalData also expects the sector to see growth across mRNA sales, predicting that the global sales of innovator mRNA-based drugs will rise from $22bn in 2023 to $26.2bn in 2030.