March 3, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Paris-based Sanofi Pasteur announced that it had inked a development agreement with MedImmune , the research-and-development art of AstraZeneca .
The two companies will work to develop and commercialize a monoclonal antibody, MEDI8897, to prevent Respiratory Syncytial Virus (RSV) associated illness in newborns and infants. MEDI8897 is a monoclonal antibody (mAb) that neutralizes RSV by binding the RSV fusion (F) protein expressed on virions and infected cells. The compound is being evaluated in a Phase IIb trial in preterm infants and plans are currently being made for a Phase III trial in healthy full-term infants. The U.S. Food and Drug Administration (FDA) gave MEDI8897 fast-track designation in 2015.
RSV is a respiratory virus that causes lung infections. In healthy adults, it appears as a mild, cold-like illness and people generally recover in one or two weeks. However, in infants and older adults, it can be a serious illness. RSV, according to the U.S. Centers for Disease Control and Prevention (CDC), is the most common cause of bronchiolitis and pneumonia in children younger than one year of age in the U.S.
The deal could hit $649 million. Under the agreement, Sanofi will pay AstraZeneca about $127 million up front, with another $523 million in various milestone payments. The two companies will share costs and profits equally. MedImmune will lead development activities up to first approval. Sanofi will direct commercialization. AstraZeneca will handle manufacturing.
“RSV is considered to be the most important missing indication in the vaccination schedule of newborns,” said David Loew, executive vice president of Sanofi and head of Sanofi Pasteur, in a statement. “As a global leader in the pediatric vaccine industry, this deal with MedImmune therefore makes perfect sense for Sanofi Pasteur. RSV causes major, seasonal worldwide outbreaks and the severity is predominant among young infants. We look forward to working with MedImmune to offer a solution to this common lower-respiratory disease when infants are most vulnerable.”
Arsalan Arif, writing for Endpoints News, writes, “AstraZeneca has been doing deals for a number of assets it no longer wants to control. And Sanofi has been on the hunt to reform its internal pipeline of projects. Sanofi, though, has been frustrated by an inability to close a major acquisition, with Pfizer outgunning its negotiators on Medivation and J&J taking charge of Actelion.”
Sanofi had a collaboration deal with Regeneron on REGN2222 for RSV, but Sanofi stepped away from that program. REGN2222 is now in Phase III trials.
On March 1, 2017, MedImmune signed a three-year research deal with Ann Arbor, Mich.-based Michigan Medicine to find and development therapies for the prevention and treatment of diabetes, obesity and other metabolic disorders.
“Creating new avenues for the exchange of innovative ideas and groundbreaking research among scientists from industry and academia is a critical part of drug discovery and development, and our partnership with Michigan Medicine is positioned to be living proof of that,” said Cristina Rondinone, head of Cardiovascular and Metabolic Diseases Innovative Medicines at MedImmune, in a statement. “As the number of patients suffering from obesity continues to expand at an alarming rate, the need to identify new therapies is more important than ever. In working collaboratively with Michigan Medicine’s world-renowned metabolic scientists, we are creating an excellent team of researchers with potentially transformative implications for patients.”
