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On December 19, Pfizer and LianBio announced that Pfizer will exercise its option to acquire the development and commercialization rights of respiratory syncytial virus (RSV) therapeutic candidate, sisunatovir, in Chinese mainland, Hong Kong, Macau and Singapore under a strategic cooperation agreement between the two companies aimed at bringing more innovative drugs to Greater China
.
Sisunatovir is an investigational drug
for the treatment of respiratory syncytial virus (RSV) infection in children and adults.
The FDA has granted sisunatovir Express Track status
.
Sisunatovir is currently being evaluated as a potential therapy for the treatment of children and adults infected with RSV
.
According to the market view, Pfizer and LianBio have further strengthened their cooperation this time, focusing on the major gaps in the treatment of patients who are vulnerable to serious complications of RSV; Since Pfizer's RSV vaccine has been successfully tested in phase III and is expected to be approved by the US FDA in the first half of 2023, this cooperation means that Pfizer's layout in the RSV field from prevention to treatment drugs has been extended and will be expanded to the Chinese market
.
01
155 million targeting the RSV treatment gap
Under the terms of Pfizer's acquisition of the development and commercialization rights to Sisunatovir, LianBio will receive a total of $20 million in restricted cash paid by Pfizer to it in 2020 pursuant to the strategic partnership agreement between the parties
。 In addition, LianBio is eligible for potential development and commercial milestone payments of up to $135 million, as well as tiered sales share of a low-single-digit percentage of net sales
of the drug in licensed territories.
Pfizer will be responsible for all development and commercialization activities of Sisunatovir in the Licensed Territories and bear all associated costs; At the same time, LianBio's obligation to pay sales share and milestone payments in respect of sisunatovir will also be waived
.
As an oral fusion inhibitor, sisunatovir is designed to block RSV replication
by inhibiting the fusion of the virus mediated by the F protein with host cells.
According to the results of the Phase 2 RSV Human Challenge Trial in a healthy adult volunteer population, sisunatovir significantly reduces viral load
.
A global Phase 2 clinical study of sisunatovir in pediatric patients is also underway and will be initiated
based on feedback from regulatory agencies.
It is worth mentioning that sisunatovir was originally a product
of ReViral.
In June 2022, Pfizer completed the acquisition of ReViral and the Company's portfolio of RSV therapeutic candidates, but this acquisition excludes the development and commercialization rights of sisunatovir in the Chinese mainland, Hong Kong, Macau and Singapore regions, which was previously granted
by ReViral in March 2021 for $119 million ($14 million down payment + up to $105 million milestone payment).
LianBio was founded in 2019 and incubated by Perceptive Advisors
, an established investment institution.
Less than nine months after its establishment, LianBio has reached 8 partnerships
.
Throughout its pipeline progress, a number of products including mavacamten, TP-03, NBTXR3, infigratinib, LYR-210, etc.
have advanced to clinical phase III and have been clinically validated
.
In the past three years, LianBio has established an R&D pipeline covering five fields of cardiovascular and kidney, oncology, ophthalmology, inflammation and respiration through the license-in model, and listed on NASDAQ shortly after its establishment, and completed a strategic financing
of 310 million US dollars.
In fact, as early as 2020, LianBio and Pfizer entered into a collaboration agreement to develop and commercialize transformative products in Greater China by combining their capabilities in clinical development, registration and commercialization
.
Under the agreement, Pfizer will contribute up to $70 million to license the introduction, development and commercialization
of LianBio's drugs.
LianBio may, in its sole discretion, provide Pfizer with product candidates, and Pfizer may elect to obtain priority bargaining rights for commercial rights to the cooperative drug
.
Sisunatovir's clinical development program is the first development project
launched under the framework of the strategic partnership between Pfizer and LianBio.
02
Pfizer fully deploys RSV
Respiratory syncytial virus (RSV) is an important pathogen that causes lower respiratory tract infections in infants, the elderly, and immunocompromised patients, and is the main cause of bronchitis and pneumonia, with symptoms similar to colds
.
Although infection with the RSV virus presents with regular cold symptoms such as headaches and inflammation in normal adults, the threat of RSV can be fatal to vulnerable groups such as infants or the elderly
.
According to WHO statistics, 65 million children are diagnosed with RSV infection every year in the world, of which 3.
5 million children are hospitalized due to RSV infection every year, the infection rate of children under 2 years of age is as high as 90%, and 160,000 children die
from RSV infection every year.
In addition, an estimated 5.
5% of adults aged 65 years or older worldwide are also infected with RSV
each year.
Unfortunately, until now, there has not been a vaccine to prevent RSV
.
Based on the scarcity and huge market potential of RSV vaccines, international giants have laid out, and in recent years have increased research and development efforts and accelerated clinical trial processes, Pfizer, GlaxoSmithKline, Johnson & Johnson, Sanofi Vaccines, Moderna and other companies have accelerated product research and development
.
In March, Pfizer announced that the U.
S.
FDA had granted RSV vaccine breakthrough therapy designation (BTD): active immunization
for the prevention of lower respiratory tract infection (LRTI) caused by RSV.
In November, Pfizer announced positive top-line data from the Phase III clinical trial (NCT04424316) MATISE (Safety and Efficacy Study of Maternal Immunisation) showing that maternal vaccines against respiratory syncytial virus (RSV) reduced the incidence of severe neonatal disease by 81.
8%, meeting the study target
.
Pfizer said it plans to submit data
on the vaccine to the FDA by the end of the year.
In order to further consolidate the competitive advantage in the RSV field, on April 7 this year, Pfizer announced that it reached a definitive agreement with ReViral to acquire the latter for $525 million; with the completion of Pfizer's acquisition of ReViral and the company's RSV treatment candidate portfolio in June, the "closed loop" of RSV from prevention to treatment is also an important link
.
