Global Briefs: Novartis, Gilead, J&J, GSK & More

A roundup of news from Novartis, Gilead Sciences, MiroBio, bluebird bio, Johnson & Johnson, GlaxoSmithKline, Takeda, Pfizer, and CytoReason. Highlights below.

* Novartis To Petition US Supreme Court To Hear Patent Case for MS Drug
* Gilead Acquires MiroBio for $405 M
* FDA OKs Bluebird Bio’s Gene Therapy; Sets Price at $3.0 M
* J&J Opens New R&D Site in San Francisco
* GSK Launches Sustainability Procurement Program for its Suppliers
* Takeda in 12-Year Sustainable Energy Pact
* Pfizer, CytoReason Extend $110-M Deal for AI Drug Development

Novartis To Petition US Supreme Court To Hear Patent Case for MS Drug
A federal appeals court has denied Novartis’ petition to rehear a negative decision regarding the validity of the company’s patent covering a 0.5-mg-dosing regimen for Gilenya, Novartis’ oral drug for multiple sclerosis. Novartis says it plans to file a petition seeking further review of the federal appeals court’s decision with the US Supreme Court.

In August 2020, a federal district court (the US District Court for the District of Delaware) issued a favorable decision and a permanent injunction was granted against HEC Pharma, a Guangdong, China-based bio/pharmaceutical company, until the expiration of the US patent in question (US Patent No. 9,187,405) until December 2027 (including pediatric exclusivity). HEC Pharma was the only remaining abbreviated new drug application filer challenging this patent.

In January 2022, a three-judge panel of the US Court of Appeals for the Federal Circuit (CAFC) issued a decision upholding the validity of the dosing regimen patent. HEC subsequently filed a petition for rehearing with the CAFC and, in June 2022, a modified panel from the CAFC issued a reversal of its previous decision and found the patent invalid.

Source: Novartis

Gilead Acquires MiroBio for $405 M
Gilead Sciences has completed its acquisition of MiroBio, an Oxford, UK-based bio/pharmaceutical company, for approximately $405 million.

MiroBio is focused on developing therapeutics that restore immune balance with agonists targeting immune inhibitory receptors. The company has a proprietary drug-discovery platform, I-ReSToRE, to assess these receptors’ roles in immunity and their potential as therapeutic targets for immune-mediated disease. The acquisition will provide Gilead with MiroBio’s proprietary discovery platform and portfolio of immune inhibitory receptor agonists.

MiroBio’s lead investigational antibody, MB272, is in Phase I development and targets T, B, and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.

Source: Gilead Sciences

FDA OKs Bluebird Bio’s Gene Therapy; Sets Price at $3.0 M
The US Food and Drug Administration (FDA) has granted accelerated approval of bluebird bio’s Skysona (elivaldogene autotemcel), a gene therapy, for slowing the progression of cerebral adrenoleukodystrophy (CALD), a rare neurologic dysfunction, in boys 4-17 years of age. The company has set the wholesale acquisition cost of the therapy in the US at $3.0 million.

CALD is a rare neurodegenerative disease that primarily affects young boys and causes irreversible neurologic decline, including disabilities such as loss of communication, cortical blindness, requirement for tube feeding, total incontinence, wheelchair dependence, or complete loss of voluntary movement.

The company anticipates that commercial product will be available by the end of 2022 through a limited number of qualified treatment centers in the US, including Boston Children’s Hospital and Children’s Hospital of Philadelphia.

Source: bluebird bio

J&J Opens New R&D Site in San Francisco
Johnson & Johnson has opened its a 200,000-R&D facility in its San Francisco Bay Campus in San California. The facility co-locates teams and capabilities from Janssen R&D, Johnson & Johnson Innovation, and Johnson & Johnson Technology and will house up to 400 employees, more than doubling the R&D presence of J&J in the Bay Area.

The R&D focus at the new site spans Janssen’s therapeutic areas and functions, including emerging science and technologies for gene and RNA therapies, treatments and approaches for retinal and infectious diseases, and advanced data science, including artificial intelligence and machine learning.

Source: Johnson & Johnson

GSK Launches Sustainability Procurement Program for Suppliers
GlaxoSmithKline (GSK) has launched a sustainable procurement program for suppliers to support the company’s goals of having a net zero impact on climate and a net positive impact on nature. The program will require and support suppliers to take action on carbon, power, heat, transport, water, waste, and sustainable, deforestation-free sourcing of materials.

For GSK, 40% of the company’s carbon footprint sits within its supply chain, and suppliers account for a substantial part of the company’s impact on water, waste and biodiversity globally.

Specific areas of action will include: (1) disclosing emissions; (2) setting carbon reduction targets and delivery plans aligned to the 1.5°C Science Based Targets initiative; (3) switching to renewable power and heat; (4) achieving water neutrality in water-stressed areas; (4) achieving 10% waste reduction; (5) aligning to GSK’s responsible sourcing minimum standards; and (6) for transport suppliers, providing green transport solutions.

As part of this new program, GSK says it will support its suppliers with education and the adoption of new environmental sustainability measures. Next month (October 2022), GSK will bring together over 160 suppliers to discuss how to work together toward these shared goals and to understand the support that these suppliers will need to do so.

Source: GlaxoSmithKline

Takeda in 12-Year Sustainable Energy Pact
Takeda and Enel North America, a green-energy company, have signed a 12-year virtual power purchase agreement (VPPA) for the electricity delivered to the power grid from a 79 megawatt portion of Enel’s Seven Cowboy wind project in the state of Oklahoma in the US.

The deal is part of Takeda’s goals of reducing 40%  of Scopes 1 and 2 greenhouse gas (GHG) emissions by 2025 and achieving net-zero GHG emissions for Scopes 1 and 2 before 2035. Scope 1 emissions are direct GHG emissions that occur from sources that are controlled or owned by an organization (e.g., emissions associated with fuel combustion in boilers, furnaces, vehicles). Scope 2 emissions are indirect GHG emissions associated with the purchase of electricity, steam, heat, or cooling.

Through the agreement, Takeda will purchase approximately 350,000 megawatt hours of electricity from Enel annually, equivalent to the electricity needed to power around 30,000 US homes each year. The project is expected to begin operations by 2023.

The agreement accounts for more than 100,000 tons of the company’s current total greenhouse gas emissions or approximately 20% of current enterprise Scope 1 and 2 emissions. The renewable energy certificates provided under the agreement will cover the electricity usage for Takeda’s US facilities including ist BioLife Plasma Services centers in the US, global manufacturing and supply, research and development and other office locations with the ability to accommodate expansions.

Source: Takeda

Pfizer, CytoReason Extend $110-M Deal for AI Drug Development
Pfizer and CytoReason have extended their partnership to use CytoReason’s artificial intelligence (AI) technology for Pfizer’s drug-development programs in a deal worth up to $110 million ($20 million equity stake and $90 million in potential additions).

Since launching a collaboration in 2019, Pfizer has used CytoReason’s biological models in its research to enhance the understanding of the immune systemas it develops idrugs for immune-mediated and immuno-oncology diseases. CytoReason’s platform has provided Pfizer with multiple insights in research and development programs across over 20 diseases.

Under the agreement, Pfizer will make a $20-million equity investment, have options to license CytoReason’s platform and disease models, and fund supplementary project support, in a deal potentially worth up to $110 million over the next five years (as reported on September 20, 2022).

Source: Pfizer