Global Pharma Briefs: News from Novartis, GSK, J&J, Pfizer, Amgen, BIBy
A roundup of news from Africa (Novartis, GSK), Germany (J&J), South Korea (Samsung Bioepis), and the US (Amgen, Pfizer, Moderna, Biogen, BI, AbbVie, and the FDA).
Novartis, GSK in $3.8-M Pact for Genetic Diversity Research
Novartis and GlaxoSmithKline (GSK) have launched a £2.8 million ($3.8 million) collaboration to support scientific research investigating the link between genetic diversity across different regions in Africa and its potential impact on response to drug therapeutics.
The Project Africa Genomic Research Approach for Diversity and Optimizing Therapeutics (GRADIENT), with a combined funding commitment of £2.8 million ($3.8 million) over five years, calls on African researchers to submit research proposals on the relevance of African genetic diversity to the treatment of malaria and tuberculosis.
The project comprises three funding mechanisms: fellowships, investigator-sponsored research and seed-funds. The South African Medical Research Council will administer the project, and a joint steering committee will oversee the review of submitted proposals. Priority will be given to research aimed at collecting data from currently under-represented regions and improving the scientific robustness of inconsistent data. All datasets collated are planned to be released in a public database to catalyze a positive change in approach to understanding variations in treatment efficacy and safety for patients across the continent.
Source: Novartis and GlaxoSmithKline
Janssen, BioMed X Launch Drug Delivery Research Project
Janssen Research & Development, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and BioMed X, a Heidelberg, Germany-based independent research institute, have formed a new research project for oral drug delivery.
The research project aims to discover novel transport mechanisms in the human intestinal tract that could be used for the oral delivery of diverse therapeutic modalities, including potentially biologics.
Source: BioMed X
Korea (South Korea)
Samsung Bioepis Opens New HQ in South Korea
Samsung Bioepis, a biosimilars joint venture between Samsung Biologics, a biologics CDMO, and Biogen, has opened a new headquarters in Incheon, South Korea.
Construction of the new building was completed in December 2020 and will house approximately 1,000 employees, who will be working in 17,300-square-foot laboratory space and 15,200-square-foot office space.
Source: Samsung Bioepis
US (Manufacturing News)
Nostrum Laboratories Expands Recall of Metformin ER Tablets
Nostrum Laboratories, a Kansas City, Missouri-based manufacturer, marketer, and distributor of pharmaceutical products, is voluntarily recalling one lot of metformin hydrochloride extended-release (ER) tablets (USP 750 mg) to the consumer level in the US due to exceeding acceptable daily intake limit levels of a nitrosamine impurity, N-Nitrosodimethylamine (NDMA), a probable human carcinogen. Metformin ER is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with Type 2 diabetes.
This is an additional recall for the company for NDMA impurities in its metformin-ER products. Earlier this month (January 2021), Nostrum voluntarily recalled one lot of metformin-ER tablets (USP 750 mg) in the US due to exceeding acceptable daily intake limit levels of NDMA. Additionally, in November 2020, Nostrum voluntarily recalled two lots of metformin-ER tablets (USP 750 mg) in the US due to exceeding acceptable daily intake limit levels of NDMA.
These recalls are the latest in a series of recalls for NDMA impurities in metformin-ER products and of NDMA impurities in other products. In June 2020, five companies—Teva Pharmaceuticals USA, Lupin, Apotex, Anmeal Pharmaceuticals and Marksans Pharma—voluntarily recalled in the US select lots of metformin ER formulations due to elevated levels of NDMA. In September 2020, Sun Pharma recalled one lot in the US of Riomet ER (metformin hydrochloride for ER oral suspension), 500 mg per 5 mL, to the consumer level. In October 2020, Marksans made an additional recall of 76 lots of metformin hydrochloride ER tablets (USP 500 mg and 750 mg) to the consumer level.
These recalls are part of an ongoing investigation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) into nitrosamine impurities in certain active pharmaceutical ingredients (APIs) with metformin extended-release products being the latest product of inquiry. In 2018, the FDA and the EMA initiated investigations of nitrosamine impurities in certain “sartan”-containing APIs, used in anti-hypertensive and cardiovascular drugs, such as valsartan candesartan, irbesartan, losartan, and olmesartan. They later broadened those investigations into prescription and over-the-counter forms of ranitidine, a H2 (histamine-2) blocker used to decrease the amount of acid created by the stomach.
Source: US Food and Drug Administration
Fresenius Kabi Issues Recall of NSAID Due to Particulate Matter
Fresenius Kabi USA, a Lake Zurich, Illinois-based healthcare company, is voluntarily recalling a single lot of ketorolac tromethamine injection, USP, 30 mg/mL, 1-mL fill in a 2-mL amber vial to the user level due to the presence of particulate matter. Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID).
Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019. The recalled lots were distributed nationwide in the US to wholesalers, distributors, hospitals, and pharmacies between March 28, 2019 and September 3, 2019.
This is the second recall of ketorolac tromethamine injection from Fresenius Kabi USA within the past year. In May 2020, the company recalled 13 lots due to the presence of particulate matter in eight reserve samples vials. The particular matter was composed of carbon, silicon, oxygen and polyamides.
Source: US Food and Drug Administration and Fresenius Kabi
US (M&A and Partnering News)
Allergan Aesthetics To Acquire Medical Device Company Cypris Medical
Allergan Aesthetics, an AbbVie company, has entered into a warrant agreement with Cypris Medical, a Chicago-based medical device company.
Following the completion of a clinical trial to be initiated in 2021, Allergan Aesthetics will have the right to exercise an option to acquire Cypris Medical, including the company’s Xact device. The planned clinical trial will evaluate the safety and effectiveness of Xact in treating midface descent as well as for neck lifts. Replacing the scalpel, Xact is designed to allow for lifting and suturing of the superficial muscular aponeurotic system, the same tissue mobilized in a facelift.
In May 2020, AbbVie acquired Allergan for $63 billion.
Amgen, Evoq in $240-M Deal for Autoimmune Disorders Drugs
Amgen and Evoq Therapeutics, an Ann Arbor, Michigan-based immunotherapy company, have announced a license and collaboration agreement for the discovery and development of drugs for treating autoimmune disorders, in a $240-million deal.
Under the agreement, Amgen and Evoq will collaborate on preclinical development, and Amgen will be responsible for clinical development and commercialization. In exchange for exclusive rights to selected autoimmune programs, Amgen will make upfront and milestone payments potentially totaling more than $240 million, as well as pay royalties on sales of resulting therapies.
Source: Evoq Therapeutics
Pfizer Invests $120 M in Clinical-Stage Biotech Companies
Pfizer has announced that, during the second half of 2020, it invested a total of $120 million in four clinical-stage biotech companies as part of the Pfizer Breakthrough Growth Initiative (PBGI). Details of Pfizer’s initial PBGI investments can be found here.
Through PBGI, Pfizer is investing up to $500 million in biotechnology companies and providing funding and access to Pfizer’s scientific expertise to support clinical development programs of potential future strategic interest to Pfizer.
Established in June 2020, PBGI focuses on non-controlling equity investments primarily in public companies with small- to medium-sized market capitalizations and mature private companies that are developing clinical-stage assets aligned with Pfizer’s core areas of focus: internal medicine, inflammation & immunology, oncology, rare disease, vaccines and hospital products.
US (Drug Development News)
Moderna Announces New Development Programs in Infectious Disease Vaccines
Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, is expanding its pipeline to include three vaccine candidates against infectious diseases.
The development programs are mRNA vaccine candidates against seasonal flu, HIV, and the Nipah virus, a zoonotic virus transmitted to humans from animals, contaminated food, or through direct human-to-human transmission. Moderna also announced an expansion of its respiratory syncytial virus (RSV) vaccine program into older adults. Moderna currently has 24 mRNA development programs in its portfolio with 13 having entered the clinic.
US (Sustainability News)
Amgen Launches Sustainability Plan To Achieve Carbon Neutrality
Amgen has launched a new seven-year environmental sustainability plan, with plans to invest $200 million, to achieve carbon neutrality by 2027.
The environmental sustainability plan includes a commitment to achieve carbon neutrality while also reducing water use by 40% and waste disposed by 75%.
Amgen will invest more than $200 million to achieve these 2027 environmental commitments. The company says it will focus on the use of technologies to reduce carbon emissions from Amgen-owned operations, as well as on sourcing renewable energy. As an example, Amgen’s newest biomanufacturing plant in Singapore generates 70% less carbon than traditional biomanufacturing facilities. The company has built a second such plant in Rhode Island.
Where carbon emissions cannot be eliminated from its operations, Amgen says it will invest in sustainability projects that sequester or avoid greenhouse gas emissions. In addition, Amgen will engage with its suppliers to assist and encourage carbon reductions throughout its value chain.
US (IT and AI News)
Biogen, Apple To Launch Study To Develop Digital Cognitive Health Monitoring
Biogen has announced a new virtual research study, in collaboration with Apple, to investigate the role Apple Watch and iPhone could play in monitoring cognitive performance and screening for decline in cognitive health, including mild cognitive impairment (MCI).
The multi-year, observational research study will be launched later in 2021 and will enroll participants, including young and aging adults with a range of cognitive performance. The study’s primary objectives are to develop digital biomarkers to help monitor cognitive performance over time and identify early signs of MCI.
BI, Google in Pact for Pharma R&D
Boehringer Ingelheim (BI) has entered into a collaborative agreement with Google Quantum AI, focusing on researching and implementing use cases for quantum computing in pharmaceutical R&D, specifically including molecular dynamics simulations.
The new partnership combines BI’s expertise in the field of computer-aided drug design and in silico modeling with Google’s resources as a developer of quantum computers and algorithms. The partnership is designed for three years and is co-led by the newly established Quantum Lab of BI.
BI says it will invest in the coming years to realize the full potential of quantum computing. The company has already set up a dedicated Quantum Lab and hired experts in the field of quantum computing from academia, industry, and quantum providers.
Source: Boehringer Ingelheim
FDA Releases AI/Machine-Learning Action Plan
The US Food and Drug Administration has released its first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan. This action plan describes a multi-pronged approach to advance the agency’s oversight of AI/ML-based medical software. Full details of the action plan can be found here.
Source: US Food and Drug Administration