Business digest

C&I Issue 11, 2023

Read time: 5 mins

UK patients, the healthcare system and the life sciences sector are set to benefit from a new scheme that will see the time taken by the Medicines and Healthcare products Regulatory Agency (MHRA) to approve the lowest-risk clinical trials reduced by more than 50%. The scheme is based on that outlined in the MHRA’s clinical trials consultation, which was endorsed by 74% of those who responded. It forms a significant part of the regulator’s overhaul of the clinical trials regulation, supporting the UK government’s ambition for the UK to be one of the best countries in the world to conduct clinical research for patients and researchers. Initial applications for the lowest-risk Phase 3 and 4 trials will be processed by the MHRA within 14 days instead of the statutory 30 days, provided the sponsor can demonstrate the trial meets the MHRA’s criteria, including by confirming there are no known safety issues with the medicine being investigated. About 20% of UK initial clinical trial applications are expected to be eligible for the scheme.

Thermo Fisher Scientific, a US supplier of analytical instruments, life sciences solutions, diagnostics, laboratory, pharmaceutical and biotechnology services, has added a biologics manufacturing to its facility in St Louis, Missouri, US. The expansion will support biologic therapies for diseases ranging from cancers and autoimmune conditions to rare genetic disorders.

US pharma AbbVie has completed the acquisition of Mitokinin, a discovery-stage biotech developing a potentially first-in-class disease-modifying treatment for Parkinson’s Disease. Mitokinin’s lead compound, a selective PINK1 activator, is designed to address mitochondrial dysfunction that is believed to be a major contributing factor to Parkinson’s disease pathogenesis and progression.

Bio-Sep, a UK-based green technology company, has rebranded to Sonichem, emphasising the company’s focus on its business’s core proprietary technology for the ultrasonic processing of low-value woody biomass to extract high-value green chemicals.

German chemicals and ingredients distributor, Brenntag has expanded its partnership with Dutch starch manufacturer, Coöperatie Koninklijke Avebe. The expanded distribution agreement now offers Avebe potato starch and protein products to Brenntag customers in Belgium, Luxembourg and the Netherlands, in addition to the initial region of Turkey.

US engineering and construction firm, Fluor has been awarded a contract for front-end engineering and design and procurement services by Cormorant Clean Energy, a subsidiary of US clean energy and climate technology company 8 Rivers Capital, for the construction of a low-carbon blue ammonia production facility. Once constructed, the facility will be the first commercial-scale application of 8 Rivers’ 8RH2 ultra-low-carbon hydrogen production technology. The hydrogen produced will be converted into ammonia that can be easily stored and transported until it is ‘cracked’ back into hydrogen after reaching its end user. The facility’s ammonia will be considered ‘blue’ because more than 99% of the carbon dioxide generated will be captured as part of the process.

Danish pharma Novo Nordisk has agreed to acquire ocedurenone from US biotech KBP Biosciences for up to $1.3bn. Ocedurenone is an orally administered, small molecule, non-steroidal mineralocorticoid receptor antagonist (nsMRA) that is currently being examined in the Phase 3 trial CLARION-CKD in patients with uncontrolled hypertension and advanced chronic kidney disease (CKD). Uncontrolled hypertension is when a person’s blood pressure remains high despite taking two or more blood pressure-lowering treatments.

Norwegian renewable energy companies, Aker Horizons and Statkraft are to join forces to develop a large-scale green ammonia project in Narvik, northern Norway. The plant under development at Kvandal in Narvik has a planned capacity of up to 600MW and will be one of the first large-scale plants for green ammonia in Europe, with an expected production of 1000 to 1500t/day. The project aims to reach final investment decision in 2025 and plans to start commercial operations in 2028.

Monte Rosa Therapeutics, a US clinical-stage biotech with additional laboratory facilities in Basel, Switzerland, which is developing novel molecular glue degrader (MGD)-based medicines, has entered into a strategic collaboration and licensing agreement with Swiss healthcare company Roche. The partnership aims to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to drug.

US biopharma, Amgen has announced that it has completed its acquisition of Dublin, Ireland-based Horizon Therapeutics for $116.50/share in cash, representing a transaction equity value of approximately $27.8bn.

The Bill & Melinda Gates Foundation has announced new investments to advance access to mRNA research and vaccine manufacturing technology that will support low- and middle-income countries’ (LMICs) capacity to develop high-quality, lifesaving vaccines at scale. The Institut Pasteur de Dakar and Biovac, research institutes with vaccine manufacturing experience based in Senegal and South Africa, respectively, will receive $5m each. $20m will go to Belgian biotech Quantoom Biosciences, ensuring LMICs can benefit from the next-generation of mRNA health tools. Another $10m will go to other LMIC vaccine manufacturers yet to be named.

UK sustainable technologies company, Johnson Matthey and UK energy company BP have been selected by German energy company EDL Anlagenbau for their co-developed Fischer Tropsch CANS technology to be used at EDL’s HyKero plant located in Böhlen-Lippendorf, Germany. The plant plans to produce 50,000t of sustainable aviation fuel/year when fully operational.

2 mins
British speciality chemicals company, Croda has commercialised a process that uses a novel continuous manufacturing technology from UK process developer NiTech. Croda has cut cycle times to just 2min, compared with 10hr in a batch reactor. Croda has also doubled output of a key personal care product in its existing factory set-up, while also cutting CO2e by 86t/year, equal to charging 9000 electric cars.

US biopharma Gilead Sciences and Assembly Biosciences, a US biotech developing antiviral therapeutics targeting serious viral diseases, have entered into a 12-year partnership to advance the research and development of novel antiviral therapies, with an initial focus on Assembly Bio’s established areas of herpes viruses, hepatitis B virus (HBV) and hepatitis D virus (HDV).

Cessation Therapeutics, a US clinical-stage biotech researching biologics that target substances of abuse, has been awarded a grant from the US National Institute on Drug Abuse (NIDA, a division of the US National Institutes of Health) to support development of a subcutaneous formulation of its anti-fentanyl mAb, CSX-1004 SQ. It is part of a multi-year award expected to total $14.8m. CSX-1004 is a human IgG1 monoclonal antibody specific for fentanyl and fentanyl analogues and works by sequestering fentanyl molecules as they enter the bloodstream, effectively neutralising them in the blood before they reach the brain preventing them from exerting their harmful effects. Through different delivery methods, the platform can be optimised to potentially protect against overdose, reverse overdose, and treat fentanyl-related opioid use.

US clinical-stage biopharma, AN2 Therapeutics, which works on developing treatments for rare, chronic and serious infectious diseases with high unmet needs, has received an exclusive license from the University of Georgia Research Foundation to advance the development of a boron-containing small molecule for Chagas disease. These boron-based molecules were originally discovered by researchers at US biopharma Anacor Pharmaceuticals (a wholly owned subsidiary of US pharma and biopharma, Pfizer) and the University of Georgia, with grant funding from UK health research charitable foundation Wellcome.

NatureWorks, a US company that manufactures bioplastics (polymers derived entirely from plant resources as an alternative to conventional plastic made from petroleum) has made significant progress on the construction of its new fully integrated Ingeo PLA biopolymer manufacturing facility in Nakhon Sawan Province, Thailand. As a fully integrated PLA complex, the plant will include three manufacturing facilities: lactic acid fermentation, lactide monomer production, and polymerisation. The facility will have an annual capacity of 75,000t of biopolymer.

Indian CDMO, Aragen, which provides services for the pharmaceutical, biotechnology, agrochemicals and animal health industries, has commissioned its new formulations manufacturing facility in Hyderabad, India. Located at the Mallapur Campus it is equipped to support the clinical manufacturing of a wide range of dosage forms, including oral solids, liquids, topicals and films.

UK biotech Ingenza and US biofuel company Phibro Ethanol have joined forces to engineer a novel yeast strain that will increase yield in the commercial production of bioethanol under both challenging and conventional environmental conditions. This innovation will help to make this natural resource more widely available for processing into sustainable fuels across a range of industries.

Antiverse, a UK biotech developing a computational antibody drug discovery platform, and GlobalBio, a US antibody engineering company working to improve and develop therapeutic antibodies, have announced they will be extending their collaboration to advance immune checkpoint inhibitors in cancer therapy. The initial collaboration successfully resulted in the generation of a panel of anti-PD-1 antibodies with diverse binding and functional profiles, with two candidates from this panel now entering preclinical development.

German chemicals company BASF is investing in a new fermentation plant for biological and biotechnology-based crop protection products at its Ludwigshafen site. The plant will manufacture products that bring value to farmers including biological fungicides and biological seed treatment. BASF also plans to use the plant to produce the main building block of Inscalis, a novel insecticide derived from a fungal strain. Commissioning is planned for the second half of 2025. The plant will use microorganisms to convert renewable raw materials such as glucose into the desired products.

BASF has also claimed it is the first company to produce metal-organic frameworks (MOFs) on a production scale of several hundred tons/year. MOFs are highly crystalline structures with nanometre-sized pores and a large surface area. This structure offers a high capacity for the storage of carbon dioxide, the dehumidification of air for room climate control, and the adsorption of the greenhouse gas methane.

Finland’s Neste is collaborating with Japan’s Suntory, Eneos and Mitsubishi in the commercial production of PET produced from Neste’s 100% biobased RE feedstock. Eneos will use bio-intermediates based on Neste RE to produce bio-paraxylene (PX) at its Mizushima refinery in Okayama, Japan. The bio-PX will then be converted to purified terephthalic acid (PTA) and then PET resin for Suntory to use to manufacture PET bottles.

Sabic’s 30% glass fibre-reinforced copolymer resin, Stamax 30YH570, is the first polymer used for electric vehicle (EV) battery systems to receive UL Verification for marketing claims of thermal and mechanical performance. The resin is offered under the company’s Bluehero electrification initiative, which is designed to demonstrate the performance advantages of thermoplastics over steel and other metals used for battery packs.

Neste has also collaborated with LyondellBasell, Biofibre and Naftex to utilise its Neste RE renewable feedstock in LyondellBasell’s production of CirculenRenew C14 polypropylene, which is then used by Biofibre to produce natural fibre reinforced plastic granules that Naftex extrudes into construction materials.

Nutraceutical CDMO Sirio Europe launched two softgel products at CPHI Barcelona in October 2023. The new products are designed to meet increasing demand for natural products for both menopause and improved eye health. The menopause plant-based vegan softgel is based on evening primrose oil and gamma linoleic acid and produced using Sirio’s Plantintegrity technology.

UK-based biocontrol developer Bionema Group has launched a range of four biofertiliser products, BioNFix and Rhizosafe, comprising living microbes to enhance plant nutrition by mobilising nutrient availability in soils and substrates. In tests, the products are said to have resulted in yield improvements as well as a 40-50% reduction in synthetic fertiliser use.

Become an SCI Member to receive benefits and discounts

Join SCI