Global Briefs: Roche, J&J, Pfizer, Sandoz & More

A roundup of news from BioNTech, Pfizer, Sandoz, Roche, J&J, and bluebird bio.

BioNTech Reports 2021 Revenues of $20 Bn
BioNTech, a Mainz, Germany-based biopharmaceutical company partnered with Pfizer for the companies’ COVID-19 vaccine, reported 2021 revenues of EUR 18.98 billion ($20.71 billion) and a net profit of EUR 10.3 billion ($11.2 billion) compared to 2020 revenues of EUR 482 million ($525 million) and a net profit of $15.2 million ($16.9 million)

The company plans to authorize a share repurchase program of up to $1.5 billion over the next two years (as reported on April 6, 2022) and will propose a special cash dividend of EUR 2.00 ($2.18) per share, pending approval.

For its full-year 2022 guidance, the company expects to have revenues of EUR 13 billion to EUR 17 billion ($14 billion to $18 billion).

Source: BioNTech

Pfizer To Acquire ReViral Therapies for $525 M
Pfizer has agreed to acquire ReViral, a Stevenage, UK-based clinical-stage bio/pharmaceutical company of antiviral therapeutics, with an initial focus on treating respiratory syncytial virus (RSV), for $525 million.

ReViral has a portfolio of therapeutic candidates, including sisunatovir, an orally administered inhibitor designed to block fusion of the RSV virus to the host cell, currently in Phase II clinical development in infants. The development program for sisunatovir is expected to continue in both adult and pediatric populations. A second program is focused on the inhibition of RSV replication targeting the viral N protein. The lead candidate in this program is currently in Phase I clinical development.

Under the agreement, Pfizer will acquire ReViral for a total consideration of up to $525 million, including upfront and development milestones. If successful, Pfizer says it believes annual revenue for these programs has the potential to reach or exceed $1.5 billion. The proposed transaction is subject to customary closing conditions, including receipt of regulatory approvals.

Source: Pfizer and ReViral

Sandoz Extends Antimicrobial Resistance Drug Pact
Sandoz, the generics and biosimilars business of Novartis, has announced the extension and expansion of its strategic collaboration with Ares Genetics, a Vienna, Austria-based company developing DNA-based infectious disease services for drug-response prediction to improve the way antimicrobial resistant (AMR) infections are diagnosed, and prevented, or treated.

The extension, until January 31, 2025, of the existing master services agreement with Ares reflects both companies’ recognition of the importance of surveillance data to inform better prescribing and use of antibiotics, a central component of the global AMR response strategy.

During the initial stage of the collaboration, Ares developed a digital anti-infectives platform, combining microbiology laboratory practices with bioinformatics and artificial intelligence (AI) methods to support the identification of effective antimicrobial compounds or compound combinations to address critical pathogens, which Sandoz can, in turn, use to drive product and commercial decisions.

In the upcoming next phase, both collaboration parties say they intend to focus further genomic surveillance for resistant pathogens, using Ares’ sequencing and bioinformatics technologies.

Source: Novartis

Roche, J&J Provide Ukraine Donation Updates
Roche and Johnson & Johnson (J&J) are donating additional medicines and diagnostics (Roche) and funds, hygiene kits, health packets and medical supplies (J&J) to Ukraine.

For Roche, beyond an already communicated donation of 150,000 packs of an antibiotic medicine, the new donation includes another 4,600 packs of specialized medicines for the treatment of influenza, rheumatoid arthritis, spinal muscular atrophy and various cancers. Roche is also donating reagents and consumables for automatic testing of up to 120,000 blood donations and 31,000 units for diabetes management.

J&J is providing product donations, including hygiene kits, health packets and medical supplies. Additionally, the company is donating $10 million to support the work of the International Rescue Committee, the International Federation of Red Cross, and Red Crescent, an international humanitarian movement, to provide humanitarian support for refugees in the border countries.

Source: Roche and Johnson & Johnson

bluebird bio Initiates Restructuring Plan
bluebird bio, a Cambridge, Massachusetts-based clinical-stage gene-therapy company, is initiating a restructuring plan intended to deliver up to $160 million in cost savings over the next two years (as reported on April 5, 2022).

The company says it intends to sharpen its focus on near-term catalysts, including anticipated US Food and Drug Administration (FDA) approvals in 2022 for its gene therapies for treating beta-thalassemia, a blood disorder that reduces the production of hemoglobin, and cerebral adrenoleukodystrophy, a rare metabolic disorder, and the potential submission of a biologics license application in the first quarter of 2023 for lovotibeglogene autotemcel, a gene therapy for sickle-cell disease.

The initiative is expected to reduce the company’s cash burn in 2022 to less than $340 million, with a 35% to 40% reduction in operating costs anticipated by year-end 2022, which is expected to be reflected in bluebird’s operating budget for 2023. As part of the changes, bluebird plans to reduce its workforce by approximately 30%. The restructuring is expected to extend the company’s cash runway into the first half of 2023.

Source: bluebird bio