Global Briefs: Lilly, Gilead, AstraZeneca, Astellas & More
A roundup of news from Bavarian Nordic, Eli Lilly and Company/Sigilon Therapeutics, Astellas, AstraZeneca/Statkraft, Gliead Sciences/Tentatrix,, Biocon, UBS Asset Management/Reef Group and. Highlights below.
* FDA Issues Form 483 to Biocon’s Insulin Mfg Facility in Malaysia
* US Gov’t, Bavarian Nordic In $120-M Mfg Pact for Smallpox/Mpox Vaccine
* Lilly Acquires in Sigilon Therapeutics $310-M Deal
* Gilead Takes Equity Stake and in Pact with Bio/Pharma Company Tentrarix
* UBS Asset Management, Reef Group Get OK To Create $1.1-Bn Life-Science Campus in UK
* Astellas To Open Life-Science Facility in Cambridge, Massachusetts
* AstraZeneca in 10-Year Renewables Energy Pact for Sweden-Based Ops
FDA Issues Form 483 to Biocon’s Insulin Mfg Facility in Malaysia
The US Food and Drug Administration (FDA) has issued Biocon Biologics a Form 483 at the company’s insulin-manufacturing facility in Malaysia. FDA issued six observations involving the company’s drug-substance and drug-product units and quality control laboratories as well as two observations for the company’s delivery-devices unit. The observations were issued after two inspections conducted between July 10 and July 20, 2023.
The company said the observations primarily relate to enhancing operational procedures and strengthening training programs. The inspections did not identify any data integrity breaches or systemic non-compliance.
The company stated that it will submit a Corrective and Preventive Action (CAPA) plan to the FDA in a timely manner.
US Gov’t, Bavarian Nordic In $120-M Mfg Pact for Smallpox/Mpox Vaccine
The US Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the US Department of Health and Human Services has entered into a pact with Bavarian Nordic, a Hellerup (near Copenhagen), Denmark-based vaccine company, valued at $120 million, primarily covering the manufacturing of new bulk product for the company’s smallpox/mpox vaccine.
The bulk product, representing $96 million of the contract value, will be manufactured and invoiced in 2023 and will only partly restore the inventory, which was used to manufacture vaccines in response to the mpox outbreak in 2022. In addition, Bavarian Nordic will manufacture and supply additional liquid-frozen doses of the vaccine in 2023, valued at $3 million. The agreement includes additional services totaling $21 million, of which the majority will be received in 2024 and 2025.
Source: Bavarian Nordic
Lilly Acquires Sigilon Therapeutics in $310-M Deal
Eli Lilly and Company has acquired Sigilon Therapeutics, a Cambridge, Massachusetts-based bio/pharmaceutical company, in a deal worth up to to $310 million ($34.6 million upfront and one contingent value right per share for a total deal value of up to $309.6 million).
Sigilon’s product candidates are non-viral engineered cell-based therapies designed to produce functions or therapeutic molecules that may be missing or deficient in patients living with diseases such as diabetes. Since 2018, Lilly and Sigilon have worked together to develop encapsulated cell therapies, including SIG-002, for the treatment of Type 1 diabetes.
Lilly commenced a tender offer for Sigilon’s common stock for $14.92 per share plus one non-tradable contingent value right (CVR) worth up to $111.64 per share upon the achievement of certain specified milestones. 1,718,493 shares were obtained by Lilly, representing 76.61% of the issued and outstanding shares.
Source: Eli Lilly and Company
Gilead Takes Equity Stake and in Pact with Bio/Pharma Company Tentrarix
Gilead Sciences and Tentarix Biotherapeutics, a San Diego, California-based bio/pharmaceutical company, have entered three multi-year collaborations using Tentarix’s proprietary Tentacles platform to discover and develop conditional protein therapeutics for oncology and inflammatory diseases. Additionally, Gilead made an equity investment worth $66 million in Tentarix. In addition, Gilead has the option to acquire up to three select Tentarix subsidiaries containing the programs developed under the collaborations for $80 million per subsidiary.
Source: Gilead Sciences
UBS Asset Management, Reef Group Get OK To Create $1.1-Bn Life-Science Campus in UK
UBS Asset Management and Reef Group, a UK-based property investment group, have received planning approval to create a £900 million ($1.1 billion) life-science campus in Stevenage, Hertfordshire, UK. The companies acquired land from GSK for the development of the campus in July 2022. The new campus will be located alongside GSK’s existing Global R&D facility and Stevenage Bioscience Catalyst, a life-sciences hub, and incorporate the UK’s Cell and Gene Therapy Catapult, an independent innovation and technology organization for the advancement of cell and gene therapies.
The 15-building campus will be set around a central green with an interconnecting network of paths and open spaces. The buildings for the new campus will comprise a variety of different uses, including R&D labs and offices, GMP manufacturing facilities, flexible lab buildings, and training, innovation and collaboration spaces.
Construction is expected to start in late 2023 with completion for Phase One targeted for the fourth quarter of 2025.
Source: UBS Asset Management
Astellas To Open Life-Science Facility in Cambridge, Massachusetts
Astellas Pharma has announced plans to open a new life-sciences facility in Cambridge, Massachusetts.
Astellas expects to occupy two floors, or approximately 62,000 square feet, of the new facility in 2024. Astellas will house both laboratory and office areas. Over time, a few hundred Boston-based Astellas employees will operate out of the new building, representing functions including medical & development, business development and research.
AstraZeneca in 10-Year Renewables Energy Pact for Sweden-Based Ops
AstraZeneca and Statkraft, an Osio, Norway-based energy provider, have entered into an 10-agreement on wind power deliveries for AstraZeneca’s operations in Sweden.
Under the agreement, AstraZeneca will purchase 200 gigawatt-hours per year for 10 years, equivalent to two terawatt-hours. This corresponds to approximately 80% of the company’s total electricity needs at its research facility in Gothenburg and manufacturing facility in Södertälje.
Globally, AstraZeneca aims to halve its entire value chain footprint (Scope 3 emissions) by 2030, on the way to a 90% reduction by 2045 from a 2019 baseline.