Global Pharma Briefs: News from J&J, Novartis, Sanofi, and BMS
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A roundup of news from Belgium (Legend Biotech, J&J), Canada (AbCellera), China (Frontera Therapeutics), Ireland (Horizon Therapeutics), Switzerland (Novartis), the UK (Exscientia), and the US (Sanofi, BMS, others).

Belgium

Legend Biotech To Build New Cell-Therapy Mfg Facility
Legend Biotech, a Somerset, New Jersey-based company developing cell therapies, has announced plans to build a new cell-therapy manufacturing facility in Belgium as part of a joint investment with Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Legend has a collaboration and license agreement with Janssen Biotech to develop and commercialize cilta-cel, an investigational CAR-T therapy currently under review by several global health authorities, including in the US and Europe, for treating relapsed and refractory multiple myeloma.

The facility is expected to be operational by 2023 and adds to Legend’s existing manufacturing facilities and presence in Nanjing, China, and Raritan and Somerset, New Jersey.

Source: Legend Biotech


Canada

AbCellera To Build New Antibody Mfg Facility
AbCellera, a Vancouver, British Columbia, Canada-based bio/pharmaceutical company, has secured a site in Vancouver for the construction of a manufacturing facility for therapeutic antibodies.

The 130,000-square-foot facility will support production of drug targets to investigational new drug applications for the company and its partners, including for COVID treatments.

The facility is scheduled to be ready for manufacturing in early 2024. AbCellera anticipates adding hundreds of employees to its current workforce of nearly 300 people over the next few years (as reported on June 22, 2021). The development of the new manufacturing facility is funded in part by a $125.6-million grant from the Canadian government’s Strategic Innovation Fund.

In parallel with the construction of the new facility, AbCellera is also building up an internal chemistry manufacturing and controls development organization. These announcements follow the company’s groundbreaking in April (April 2021) on a new global headquarters in Vancouver.

Source: AbCellera


China

Frontera Therapeutics Starts Construction of Gene-Therapy Mfg Facility
Frontera Therapeutics, a Newton, Massachusetts-based bio/pharmaceutical company, has started construction of a new manufacturing facility in Suzhou, China for clinical manufacturing and initial commercial manufacturing of Frontera’s recombinant adeno-associated virus gene-therapy products.

The 4,000-square-meter premises will house manufacturing cleanrooms for drug substances and drug products, quality control testing labs, process development pilot plants, and clinical testing labs. 

Source: Frontera Therapeutics


Ireland

Horizon Therapeutics To Buy Drug-Product Mfg Facility for $65 M
Horizon Therapeutics, a Dublin, Ireland-based bio/pharmaceutical company specializing in rare autoimmune and severe inflammatory diseases, has agreed to purchase a drug-product manufacturing facility from EirGen Pharma, an OPKO Health company, based in Waterford, Ireland for $65 million. T

he 44,000-square-foot facility includes a filling line and lyophilizer that can be used for both Horizon’s commercial medicines and developmental compounds. In addition, there is adjacent land available for further manufacturing and development expansion. The transaction, which is subject to customary closing conditions, is expected to close in the third quarter of 2021.

Horizon will work with Ireland’s Health Products Regulatory Agency (HPRA) and the US Food and Drug Administration (FDA) to obtain HPRA and FDA licensure for sterile fill-finish manufacturing and anticipates the first medicine approved for release in approximately two years (as reported on June 17, 2021). As part of the transaction, approximately 40 EirGen employees will transfer to Horizon following the close of the transaction. Horizon intends to recruit 50 additional staff for the site in 2021 and 2022.

Source: Horizon Therapeutics


Switzerland

Novartis, HP in Digital Global HealthPact
Novartis and Hewlett Packard have formed a collaboration that aims to accelerate the use of data and digital technologies to improve global access to Novartis’ medicines.

The collaboration will focus on three global health enablers: (1) identifying and integrating data sources related to health; (2) advancing the application of artificial intelligence, machine learning, and geo-spatial analytics to these data; and (3) expanding access to technology in remote and underserved locations.

The first use case for the partnership will seek to develop a disease surveillance solution for dengue fever, initially focusing on India.

Source: Novartis


UK

AI Company Exscientia To Acquire AI Medicines Company Allcyte
Exscientia, an Oxford, UK-based artificial intelligence (AI) development company, has agreed to acquire Allcyte, an AI-focused precision medicines company headquartered in Vienna, Austria, for $60 million.

The transaction is under review by Austrian regulatory authorities. Following the close of the transaction, Exscientia plans to expand Allcyte’s Vienna site as its hub in the European Union.

In May (May 2021), Exscientia entered into a collaboration with Bristol-Myers Squibb, worth up to $1.2 billion, to accelerate the discovery of small- molecule therapeutic drug candidates in multiple therapeutic areas, including oncology and immunology. The agreement includes up to $50 million in upfront funding to Exscientia, up to $125 million in near to mid-term potential milestones, and additional clinical, regulatory and commercial payments that take the potential value of the deal up to $1.2 billion.

In April (April 2021), Exscientia raised up to $525 million in a recent financing round ($225 million upon close and access up to an additional $300 million upon company discretion). 

Source: Exscientia (Allcyte), Exscientia (BMS), and Exscientia (funding)


US

FDA OKs Sanofi’s Flu Vaccine Mfg Facility
The US Food and Drug Administration’s Center for Biologics Evaluation and Research has granted approval for an additional influenza manufacturing facility in Swiftwater, Pennsylvania.to Sanofi Pasteur, the vaccines global business unit of Sanofi. 

The newly completed $424-million facility further expands production and distribution of Sanofi’s Fluzone High-Dose Quadrivalent influenza vaccine for the upcoming 2021-2022 influenza season in the US and will create up to 200 additional manufacturing jobs. Commercialization activities for the US market are underway, with plans to support other countries in the future (as reported on June 17, 2021).

Source: Sanofi


BMS, Sun Pharma Settle Patent Litigation for Generic Revlimid
Sun Pharmaceutical Industries, a Mumbai, India-based pharmaceutical company, and its wholly owned subsidiaries have reached an agreement with Celgene, a wholly owned subsidiary of Bristol Myers Squibb, to resolve patent litigation regarding Celgene’s abbreviated new drug application for a generic version of BMS’/Celgene’s Revlimid (lenalidomide), a drug for treating multiple myeloma.

Under the settlement, Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell certain limited quantity of generic lenalidomide capsules in the US beginning on a confidential date that is sometime after March 2022, subject to US Food and Drug Administration approval. In addition, the license will also allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.

Source: Sun Pharmaceutical Industries


Viona Pharmaceuticals Issues Voluntary Recall of Metformin ER Tablets
Viona Pharmaceuticals, a Cranford, New Jersey-based generic-drug company, is voluntarily recalling two lots of metformin hydrochloride extended-release (ER) tablets (USP 750 mg) to the retail 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.

The product was manufactured by Cadila Healthcare, an Ahmedabad, India-based pharmaceutical company, in November 2019, for US distribution by Viona Pharmaceuticals. The recall is the latest in a series of recalls for NDMA impurities in metformin-ER products and of NDMA impurities in other products.

In January 2021, Nostrum Laboratories recalled one lot of metformin ER formulations due to elevated levels of NDMA and then expanded the recall to an additional lot. 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.

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 ongoing investigations 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

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