Global Briefs: Sanofi, J&J, Dr Reddy’s & More
A roundup of news from Johnson & Johnson, Sanofi, Dr Reddy’s Laboratories, and SK biosciences, Highlights below.
* Sanofi Gains Favorable Ruling Over BI in Zantac Arbitration
* J&J Reaches Settlement Over Biosimilar of its Blockbuster Drug Stelara
* Sanofi Provides Update on its AI Usage
* FDA Issues Form 483 to Dr Reddy’s Formulation Facility
* FDA Advisory Committee Recommends Monovalent XBB Omicron Variant as Strain for COVID Vaccines
* WHO Grants Emergency Use OK for SK biosciences’ COVID-19 Vaccine
Sanofi Gains Favorable Ruling Over BI in Zantac Arbitration
Sanofi reports that an indemnification claim by Boehringer Ingelheim (BI) against Sanofi regarding ongoing litigation of Zantac (ranitidine), an antacid, has been dismissed by an international tribunal in an arbitration ruling. The litigation, which began in 2019/2020, involves claims surrounding nitrosamine impurities as potential cancer-causing agents in ranitidine, which is no longer marketed.
Zantac was launched in the US as a prescription medication by GlaxoSmithKline (GSK) in 1983, and GSK continued to market the prescription version until 2017. In 1995, GSK launched an over-the-counter (OTC) version of Zantac (75 mg). In 1997, generic ranitidine entered the market. In 1998, Pfizer acquired the OTC rights, and in 2004, it launched a 150-mg version of the product as well. In 2006, BI acquired the US OTC rights for Zantac, and in January 2017, Sanofi acquired those OTC rights.
Under the ruling, the tribunal dismissed BI’s indemnification claim, a claim for compensation against Sanofi, and confirmed that Sanofi is not liable to compensate BI for any potential losses in relation to the ongoing Zantac litigation in the US. Sanofi says this decision is final and non-appealable. The arbitration dispute arose from contractual indemnification obligations agreed between Sanofi and BI as part of the January 2017 swap of Sanofi’s Animal Health business for BI’s Consumer Health Care business.
J&J Reaches Settlement Over Biosimilar of its Blockbuster Drug Stelara
Johnson & Johnson (J&J) has reached a settlement and licensing agreement in the US with Teva Pharmaceuticals and Alvotech, a Reykjavik, Iceland-based biosimilars company, concerning AVT04, Alvotech’s proposed biosimilar to J&J’s Stelara (ustekinumab), a drug for treating plaque psoriasis and psoriatic arthritis. The settlement grants a license entry date for AVT04 in the US no later than February 21, 2025. Stelara posted 2022 global revenues of $9.7 billion.
In 2020, Teva and Alvotech formed an exclusive strategic partnership for the commercialization in the US of five biosimilar product candidates.
Sanofi Provides Update for its AI Usage; Rolls Out AI App
Sanofi has provided an update regarding its use of artificial intelligence (AI) through the launch of its AI application (app), plai. Sanofi developed the app with Aily Labs, an AI platform company, for delivering real-time, reactive data interactions and a 360° view across all Sanofi activities. The app aggregates available company internal data across functions and uses AI to provide insights and personalized “what-if” scenarios to support decision-making in the company.
In manufacturing and supply, Sanofi is applying digitalization in its quality assessment processes by moving from paper to electronic batch records, using digital approaches and data to improve asset utilization, and increasing productivity by implementing new manufacturing 4.0 capabilities. Sanofi has also developed an in-house AI-enabled yield optimization solution that learns from past and current batch performance for yield improvements. This helps to optimize usage of raw materials, contribute to the company’s environmental objectives, and support improved cost efficiency. Also, recent plai adoption within Sanofi’s bio/pharma supply chain has enabled predicting 80% of low inventory positions to allow the company to take mitigating actions to secure supply faster.
In clinical operations, Sanofi is using plai to run better clinical trials. For example, R&D teams can find and set up new, more convenient trial sites for their target groups, thereby broadening opportunities for those from historically underrepresented communities to participate in clinical research and increasing diversity in clinical trials.
In research, Sanofi has built multiple AI programs to reduce research times through improved predictive modelling and to automate time-sink activities. Sanofi reports that AI enables R&D teams to scale and accelerate research processes and improve potential target identification in therapeutic areas, such as immunology, oncology or neurology, by 20% to 30%. AI also is facilitating work on mRNA research. While Sanofi owns a large library of lipid nanoparticles, R&D teams now use AI to create digital models to predict the strongest selection of lipid nanoparticles.
FDA Issues Form 483 to Dr Reddy’s Formulation Facility
The US Food and Drug Administration (FDA) has issued a Form 483 with four observations to Dr. Reddy’s Laboratories following a pre-approval and routine GMP inspection of the company’s formulation facility in Srikakulam, Andhra Pradesh, India. FDA conducted the inspection of the facility from May 8, 2023, to May 12, 2023. The company said it will address the observations within the stipulated time frame.
Source: Dr. Reddy’s
FDA Advisory Committee Recommends Monovalent XBB Omicron Variant as Strain for COVID Vaccines
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on June 15, 2023, to discuss and make recommendations for SARS-CoV-2 strain(s) for updated COVID-19 vaccines for use in the US beginning in the fall of 2023.
For the 2023-2024 formulation of the COVID-19 vaccines for use in the US beginning in the fall of 2023, the committee unanimously voted that the vaccine composition be updated to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant. Following discussion of the evidence, the committee expressed a preference for the XBB.1.5 variant.
Based on the evidence, the FDA has advised manufacturers that will be updating their COVID-19 vaccines, that they should develop vaccines with a monovalent XBB 1.5 composition.
WHO Grants Emergency Use OK for SK biosciences’ COVID-19 Vaccine
The World Health Organization (WHO) has granted SK bioscience, a Gyeonggi, South Korea-based bio/pharmaceutical company, Emergency Use Listing of its COVID-19 vaccine, SKYCovione.
Source: SK biosciences