India to have BMS’ largest R&D facility after US; its drug plants to face increased FDA inspections

By PharmaCompass

2024-02-29

Impressions: 1459

This week’s Phispers has a lot of news from India. First, Bristol Myers Squibb (BMS) inaugurated a US$ 100 million facility in Hyderabad and said it expects to make this facility its largest R&D outfit outside of the US by next year.

Second, the country director of the United States Food and Drug Administration (FDA) Sarah McMullen has said the regulator will increase the number of inspections in India this year. Requests have been made for more drug investigators to be stationed in India.

Third, Japanese drugmaker Takeda has tied up with India’s Biological E to increase access to its dengue vaccine Qdenga. And fourth, in the cough syrup deaths case, a court in Uzbekistan has sentenced 23 people to prison. The cough syrups were made by India’s Marion Biotech.

In other news, New York’s attorney general has urged the FDA to address safety risks associated with the widely used asthma drug Singulair due to its neuropsychiatric side effects, particularly in minors.

In trials, Zealand Pharma and Boehringer Ingelheim’s obesity drug has aced its primary and secondary endpoints in a mid-stage trial in treating a liver disease — metabolic dysfunction-associated steatohepatitis (MASH). And Viking Therapeutics’ experimental obesity drug has helped patients lose 15 percent weight in a mid-stage trial.

BMS to raise reliance on India for R&D, expands drug substance facility in Ireland

Bristol Myers Squibb inaugurated a US$ 100 million facility in the Indian city of Hyderabad this week. It expects to make this facility BMS’ largest R&D presence outside of the US by 2025. The unit will use artificial intelligence (AI) and digital technologies to develop drugs, and accelerate the development of cell therapies for autoimmune diseases like multiple sclerosis. It will employ over 1,500 people.

Meanwhile, the first drug substance facility of BMS outside of the US, located in Dublin, Ireland, is getting a US$ 400 million boost. The investment will be used to build and design a sterile drug product (SDP) facility. It will also serve as a launch excellence facility for pipeline products. The site will tackle manufacturing across BMS’ oncology, immunology and hematology business. Construction is expected to start in March, with completion expected in 2026.

FDA to step up inspections of manufacturing units in India, says Reuters

The country director of the FDA Sarah McMullen told Reuters that the US agency is set to increase the number of inspections of drug manufacturing units in India this year. Requests have been made for more drug investigators to be stationed in the country.

The Indian government has been pushing drug manufacturers to implement good manufacturing practices that are current to global standards. However, McMullen said they need to invest more in automation for better compliance and that the country’s drug regulatory body needs more resources.

Takeda ties up with India’s Biological E to increase access to its dengue vaccine

Japanese drugmaker Takeda has entered into a strategic partnership with Indian drugmaker Biological E to accelerate the access to its dengue vaccine Qdenga. These doses will ultimately be made available for procurement by governments in endemic countries by 2030 to support their national immunization programs. Biological E will ramp up manufacturing capacity to up to 50 million doses a year, in order to accelerate Takeda’s efforts to manufacture 100 million doses a year by 2030. Meanwhile, a Reuters news report said Takeda is in talks with Indian regulators over making Qdenga available in the country.

Uzbekistan court serves prison terms to 23 over cough syrup deaths

A court in Uzbekistan has s entenced 23 people to prison over the deaths of 68 children linked to contaminated cough syrup. The cough syrup in question was made by Marion Biotech in India and distributed by Quramax Medical in the Central Asian nation. Indian national Singh Raghvendra Pratar, a Quramax director, has received the longest prison sentence of 20 years.

The court found the defendants guilty of abuse of office, sale of substandard or counterfeit medicines, forgery, bribery, and tax evasion. The families of the children will receive US$ 80,000 each. The money will be taken from the convicts, the country’s Supreme Court said.

Boehringer’s obesity candidate shows promise in mid-stage trial for MASH

Boehringer Ingelheim has announced promising phase 2 trial data for its experimental obesity drug survodutide in treating metabolic dysfunction-associated steatohepatitis (MASH), a liver disease. The drug is being developed in collaboration with Zealand Pharma. The drug had received a fast-track designation from the FDA in June 2021.

MASH causes histologic liver damage and occurs in patients who are not alcoholics and who are often obese or have type 2 diabetes mellitus.

The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks. Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. The companies said this potentially positions it as a “best-in-class” treatment. The drug belongs to the glucagon-like peptide 1 (GLP-1) class of drugs.

Viking’s obesity drug helps patients lose 15 percent weight in mid-stage trial

Another obesity drug showed promise in a mid-stage trial. Viking Therapeutics’ experimental drug helped obese patients lose nearly 15 percent of their body weight after 13 weeks (on average). Moreover, the reduction in weight didn’t plateau, which suggests more weight loss could be achieved by continuing treatment.

The news grabbed the attention of Wall Street analysts who said Viking could be in possession of a potential best-in-class agent that threatens the “duopoly ” of Novo Nordisk and Eli Lilly.

New York attorney urges FDA for stricter warning on asthma drug Singulair

The attorney general for New York has urged FDA to address safety risks associated with a popular asthma and allergy medicine Singulair (montelukast). The attorney said the current warnings on the drug's packaging are insufficient, particularly for children.

Thousands of parents and patients have linked the drug to psychiatric problems, including hallucinations, anxiety, and rage. After a hearing in 2019, FDA had mandated a boxed warning, the most stringent drug warning, for Singulair. However, the New York Times found that parents were still unaware of its side effects, which include suicide or suicide attempts.

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