Uray Announces Vaccine Licensing and Supply Agreement with Bavarian Nordic

Bavarian Nordic to receive up to $225 million in upfront and milestone payments, plus double-digit commercialization royalties

Uray Pharma acquires commercialization rights for MVA-BN® RSV in Mainland China, Hong Kong, Macau, Taiwan, South Korea and Southeast Asia, and will bear all corresponding costs, including development and registration fees

Bavarian Nordic will be responsible for manufacturing and commercial supply of the vaccine once it is on the market

SHANGHAI, March 22, 2022 /PRNewswire/ -- Uriel Pharmaceuticals (the "Company") today announced that it has entered into an exclusive license and supply agreement with Bavarian Nordic, a Copenhagen-based integrated vaccine company, Focus on the development, production and commercialization of life-saving vaccines
.

The agreement includes the development and commercialization of MVA-BN® RSV in mainland China, Hong Kong, Macau, Taiwan and Korea and some Southeast Asian countries[1]

Under the terms of the agreement, Bavarian Nordic will receive an upfront payment of $12.
5 million and is eligible to receive up to $212.
5 million in future milestone payments, which will be triggered upon completion of certain clinical, regulatory and commercial milestones, in addition to There are progressive, double-digit commercialization commissions on future net sales
.

Urui Medicine will bear all costs and responsibilities for the clinical development, registration application and commercialization of the vaccine in the regions covered by the agreement
.

Subject to approval by the Chinese regulatory authorities (National Medical Products Administration, NMPA), the company will plan to conduct Phase 1 and Phase 3 trials in China to gain approval of the vaccine

The parties also entered into a supply agreement under which Bavarian Nordic will undertake future commercial production and supply of the vaccine
.

Mark G.
Lotter, CEO and Co-Founder of Uray, commented, "Uray is pleased to have reached an agreement with Bavarian Nordic for MVA-BN RSV, setting a new standard for RSV RSV prevention and aiding health conditions.
Suboptimal elderly patients, addressing their unmet medical needs
.

Given our continued investment in the respiratory field of Greater China and Asian markets, MVA-BN RSV is an ideal choice for the company's product portfolio

Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, said: "We are delighted to be working with Uray in our efforts to bring our late-stage RSV vaccine candidate to market
.

Combined with Uray's business performance in the region, our leadership in respiratory With the strength and focus on respiratory diseases, this collaboration provides a good opportunity for the MVA-BN RSV vaccine to be first-to-market to meet the unmet need for vaccine prevention in China's aging population and to prevent serious diseases caused by RSV infection

About Respiratory Syncytial Virus ( RSV)

About Respiratory Syncytial Virus ( RSV)

The RSV virus is a common virus that usually causes mild, cold-like symptoms but in severe cases can cause serious lung infections, including bronchitis and pneumonia, that can eventually lead to death
.

High-risk groups typically include infants and the elderly, as well as immunocompromised groups

A prospective study in the United States estimated that, in adults 65 years and older, the disease burden from infection and subsequent death from RSV was similar to that of non-pandemic influenza [2]
.

Therefore, preventing infection caused by RSV is one of the top priorities of governments and medical professionals worldwide

It is estimated that there are nearly 400 million people over the age of 60 for RSV vaccine in China, with an annual growth rate of 3%
.

About MVA-BN RSV

About MVA-BN RSV

Bavarian Nordic's vaccine candidate, MVA-BN RSV, is being developed to prevent respiratory syncytial virus (RSV) infection in the elderly
.

The vaccine uses five different RSV antigens to stimulate the body's broad immune response to RSV subtypes (A and B), mimicking the natural immune response observed after RSV infection
.
The vaccine candidate was developed based on Bavarian Nordic's proven MVA-BN platform technology, which has been used in a number of approved vaccines
.

In 2021, Bavarian Nordic disclosed results from a Phase 2 double-blind, placebo-controlled trial (n=61) recruiting healthy adult volunteers who were randomly assigned to receive a single regimen of MVA-BN RSV Vaccination or placebo
.
Volunteers received an intranasal challenge with RSV A strain 28 days after vaccination
.
The study achieved the primary endpoint by showing that the vaccinated subjects (30 people) had significantly less viral load compared to the placebo (31 people)
.
Clinical symptoms typically associated with RSV infection were significantly reduced in vaccinated subjects
.
In addition, the vaccine showed up to 79% vaccine efficacy in preventing symptomatic RSV infection [3]
.

Bavarian Nordic also previously reported very positive results from the MVA-BN RSV Phase 2 trial in 421 older adults, showing that the vaccine was well tolerated and induced broad and durable antibodies against RSV and T cellular responses, as well as mucosal immune responses that may be important for RSV prevention
.
The trial included revaccination of subjects one year later, after which the immune response was rapid and markedly increased, especially in subjects who were the weakest before the booster vaccine
.

MVA-BN RSV has been granted Breakthrough Therapy Designation by the U.
S.
Food and Drug Administration for the active use of vaccines for the prevention of lower respiratory tract disease caused by RSV in adults 60 years of age or older
.

About Uray Medicine

About Uray Medicine

Uray Pharma is a patient-centric, innovation-focused biopharmaceutical company with clinical and commercial-stage assets
.
Founded by Mark Lotter in 2014 with a mission to address critical unmet medical needs in Greater China and Asia Pacific, Yourui has built a late-stage clinical-stage innovative product portfolio while maintaining an independent and sustainable commercial operation
.
Urui's product portfolio is focused on specialty medicines and features a differentiated mix of commercialization-stage and innovative pipeline assets in respiratory, pain management, emergency care and iron deficiency anemia
.
Through partnering with the world's leading biopharmaceutical companies, Yourui has built a leading late-stage pipeline portfolio in respiratory and pain management, as well as a commercialized portfolio in critical care and iron deficiency anemia
.

About Bavarian Nordic

About Bavarian Nordic

Bavarian Nordic is an integrated vaccine company focused on the development, production and commercialization of life-saving vaccines
.
Bavarian Nordic is a global leader in smallpox vaccines and has been a long-term supplier of the US government's non-replicating smallpox vaccine, which is FDA-approved and also used to prevent monkeypox
.
The vaccine is approved for use as a smallpox vaccine in Europe and Canada
.
Bavarian Nordic's commercial product line also includes market-leading rabies and tick-borne encephalitis vaccines
.
Leveraging MVA-BN live virus vaccine platform technology, Bavarian Nordic has created a diverse portfolio of patented and collaborative product candidates designed to save and improve lives by unleashing the power of the immune system, including licensed to Janssen Pharmaceuticals, a Johnson & Johnson company Ebola vaccine
.
The company is also working to develop a next-generation COVID-19 vaccine
.
For more information, visit
.