US panel accuses China of subsidizing fentanyl production; Nigeria introduces 5-in-1 meningitis vaccine

By PharmaCompass

2024-04-18

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This week’s news brings a mix of promising advancements and concerning issues. A majority of opioid overdose deaths in America involve fentanyl. This week, a special House committee released a report that said the Chinese government is directly subsidizing the manufacturing and export of illicit fentanyl and other synthetic narcotics through tax rebates.

Nigeria has become the first country to roll out the “revolutionary” new Men5CV vaccine against meningitis that protects against five strains of the bacteria that causes the disease, as opposed to the existing one-strain vaccines. In regulatory news, the US Food and Drug Administration (FDA) issued India’s Natco Pharma a warning letter after it received inadequate response to its Form 483.

In deals, Takeda has signed a potential US$ 1.2 billion deal with Kumquat Biosciences to develop a novel immuno-oncology candidate and AbbVie has partnered with Medincell to develop next-generation long-acting injectable therapies. Meanwhile, reports of a possible takeover of Biogaran, a subsidiary of French pharma giant Servier, has raised concerns over 8,600 production jobs.

There were late-stage wins for Intra-Cellular’s Caplyta in treating major depressive disorder, Roche’s Columvi in improving survival in lymphoma patients, and Novartis’ Fabhalta in treating patients with the kidney disease IgA nephropathy (IgAN).

Eli Lilly’s popular weight-loss drug Zepbound has cut episodes of irregular breathing associated with sleep apnea in two late-stage trials. And in trial losses, Sage Therapeutics said its investigational oral medicine dalzanemdor did not show statistically significant differences as compared to a placebo in Parkinson’s disease. Sage does not plan to develop dalzanemdor any further in treating Parkinson’s.

China subsidizing fentanyl production to fuel US epidemic, says House panel

The Chinese Communist Party (CCP) is directly subsidizing the manufacturing and export of illicit fentanyl materials and other synthetic narcotics through tax rebates, a report by the House’s Select Committee on the CCP revealed. A months-long investigation uncovered a government website that in turn revealed tax rebates to produce specific fentanyl precursors, so long as companies sold them outside of China. The strong synthetic opioid is commonly used to lace drugs, making them extremely dangerous. A majority of overdose deaths in the US involve fentanyl — the committee said it “kills over 200 Americans daily,” on average.

Nigeria makes history by introducing five-in-one meningitis vaccine

Nigeria has become the first country to roll out the “revolutionary” new Men5CV vaccine against meningitis. The World Health Organization called it a historic move. The new shot protects agains t five meningitis strains of the meningococcal bacteria, unlike the existing one-strain vaccines. Nigeria is one of the 26 meningitis hyper-endemic countries situated in the African Meningitis Belt. Last year, there was a 50 percent jump in annual meningitis cases reported across Africa. The rollout, funded by Gavi, the vaccine alliance, aims to reach one million people.

Takeda inks potential US$ 1.2 bn immuno-oncology deal with Kumquat Biosciences

Japanese drugmaker Takeda has agreed to pay Kumquat Biosciences over US$ $1.2 billion in upfront and milestone payments to develop and commercialize a novel immuno-oncology small molecule inhibitor as a mono- and/or combination-therapy. Kumquat will receive up to US$ 130 million in near-term payments after it concludes phase 1 trial activities.

AbbVie partners with Medincell for injectable therapies: French biopharmaceutical company Medincell will use its commercial-stage long-acting injectable technology platform to formulate up to six innovative therapies. It will receive an upfront payment of US$ 35 million and will be eligible for up to US$ 1.9 billion in potential development and commercial milestones, plus royalties on worldwide sales.

Possible takeover of Biogaran by Indian company raises concerns over 8,600 jobs

French publications Les Échos and Franceinfo reported about the possible takeover of Biogaran, a top generic drugmaker in France. Biogaran, a subsidiary of the pharma giant Servier, has a portfolio of about 900 drugs, and employs subcontractors that represent about 8,600 jobs largely in France and Europe. According to the reports, among the four interested buyers are India’s Torrent Pharmaceuticals and Aurobindo Pharma. This has raised concerns about relocation of production jobs. Biogaran reportedly represents about 32 percent of the French generic market.

Intra-Cellular’s Caplyta sees late-stage win for major depressive disorder

Intra-Cellular Therapies said a phase 3 study of Caplyta (lumateperone) in people with major depressive disorder (MDD) met both its primary and key secondary endpoints. Given once daily as an adjunctive therapy to antidepressants, Caplyta 42 mg significantly beat the placebo at improving depression severity. An atypical antipsychotic of the butyrophenone class, Caplyta got the FDA go-ahead as a once-daily oral treatment for schizophrenia in 2019. In 2021, the approval was expanded to include bipolar depression. However, analysts say MDD’s patient population is about three times larger than bipolar depression and an expanded approval could add at least US$ 1 billion to peak sales.

Zepbound reduces sleep apnea severity: Last month, FDA had approved Novo Nordisk’s weight loss drug Wegovy for lowering the risk of a stroke and heart attack in overweight and obese patients who did not have diabetes. And this month, Eli Lilly’s popular weight-loss drug Zepbound (tirzepatide) cut irregular breathing episodes associated with a common sleep-related disorder – obstructive sleep apnea (OSA). Treatment with Zepbound reduced the frequency of irregular breathing episodes by as much as 63 percent in adults with OSA and obesity across two late-stage trials. Lilly plans to submit the findings to FDA to expand Zepbound’s use for OSA.

Roche’s drug improves survival in lymphoma patients: Roche’s Genentech said Columvi (glofitamab-gxbm), in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). A late-stage study pitted the Columvi-chemotherapy combination against a rituximab-chemotherapy combination in patients who received at least one prior line of therapy and are not candidates for autologous stem cell transplant. Patients in the Columvi group lived longer. Genentech plans to submit the data to health authorities. An expanded label for Columvi could see it potentially challenge AbbVie and Genmab’s Epkinly (epcoritamab).

Novartis lands FDA priority review for Fabhalta in IgAN: Novartis said Fabhalta (iptacopan) reduced proteinuria (protein in the urine) in patients with IgA nephropathy by 38.3 percent in a phase 3 trial. The Swiss drugmaker filed for FDA’s accelerated approval using the data, and the agency has granted it priority review.

Sage scraps Parkinson’s dud after mid-stage failure: Sage Therapeutics said its investigational oral medicine dalzanemdor did not show statistically significant differences as compared to a placebo on the primary endpoint in patients with mild cognitive impairment in Parkinson’s disease. Sage does not plan to develop dalzanemdor any further in treating Parkinson’s.

Natco hit with FDA warning letter, shipments to US suspended

India’s Natco Pharma was hit with a warning letter after an inadequate response to a Form 483. Natco has stopped making products for the US market at the facility in the Indian state of Telangana. FDA said equipment wasn’t being cleaned and maintained properly, which could have led to contamination of the medications being manufactured. Additionally, the company wasn't looking into why some batches of medicine differed from what they were supposed to be, and there were even missing records for some batches.

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