USA – Pfizer Inc has announced that it would acquire privately held ReViral Ltd for up to US$525 million in cash and milestone payments in order to gain access to experimental drugs against respiratory syncytial virus (RSV).
After acquiring Arena Pharmaceuticals for US$6.7 billion in December, this is the drugmaker’s second acquisition in less than six months to expand its drug portfolio.
The acquisition could signal a return to M&A for biopharma companies, particularly in an environment where companies appear to face difficulties going public.
RSV, a common respiratory virus that causes cold-like symptoms, is a leading cause of pneumonia in infants and the elderly.
ReViral, based in London, has four RSV therapies in development, with the lead product candidate, sisunatovir, and another treatment currently in mid-stage trials.
In a phase 2 RSV human challenge study in healthy adults, sisunatovir significantly reduced viral load, and it is currently in phase 2 clinical development in infants.
The sisunatovir development program is expected to continue in both adult and pediatric populations. A second program aims to inhibit RSV replication by targeting the viral N protein.
The program’s lead candidate is currently in phase 1 clinical development. The US Food and Drug Administration has granted sisunatovir Fast Track designation.
ReViral announced the completion of Part A of the phase 2 REVIRAL1 study of sisunatovir for the treatment of RSV infections in hospitalized infants in June 2021.
“Currently, treatment options for RSV are extremely limited and focus primarily on supportive care,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Bacterial Vaccines and Hospital, at Pfizer.
Pfizer estimates that ReViral’s RSV programs could generate an additional US$1.5 billion or more if they are successful enough to reach the market.
The pharma giant ended last year with US$81.3 billion, nearly doubling (up 95 percent) from the previous year, thanks to the US$36.781 billion generated by its COVID-19 vaccine, COMIRNATY, co-developed with BioNTech.
“We’re continuing to grow our pipeline—through our own research-and-development efforts, such as our investigational RSV vaccine programs, as well as strategic investments in companies like ReViral—with a focus on end-to-end capabilities to help protect patients from severe illness, hospitalization, and death,” stated Pfizer Chairman and CEO Albert Bourla.
Pfizer’s own RSV vaccine candidate is currently in late-stage testing.
The pharma giant is working on its own late-stage RSV vaccine candidate, PF-06928316 or RSVpreF, which targets prefusion F, a form of the viral fusion protein (F) used by RSV to attack human cells.
Pfizer launched the ongoing Phase III RENOIR trial (NCT05035212) in September to assess the efficacy, immunogenicity, and safety of a single dose of RSVpreF in adults aged 60 and up.
The FDA granted PF-06928316 Breakthrough Therapy Designation last month for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older.
In March, the FDA granted RSVpreF a separate Breakthrough Therapy Designation for the prevention of RSV-associated lower respiratory tract disease in infants from birth to six months of age through active immunization of pregnant women.
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