In a pair of very different developments, but both centered around the issue of infectious disease, Swedish Orphan Biovitrum AB (Sobi) has entered into agreements to acquire the perpetual rights to Synagis (palivizumab) in the United States from AstraZeneca and to participate in 50 percent of the future earnings of the candidate drug MEDI8897 in the United States, while Tulane University announced that the U.S. National Institutes of Health (NIH) had awarded its school of medicine a contract for up to $8.5 million over five years to develop a more effective and longer-lasting vaccine against pertussis, more commonly known as whooping cough.
Starting with Sobi and AstraZeneca, the deal calls for total upfront consideration of $1 billion in cash and $500 million equivalent in newly issued Sobi shares.
Synagis is a medicine for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) infection in high-risk infants—it is the only approved preventative medicine for the condition. Synagis is an attractive product for Sobi due to its orphan patient population and immunology profile. MEDI8897 is a follow-on candidate to Synagis, a monoclonal antibody (mAb) being investigated for the prevention of LRTI caused by RSV in a larger patient population.
“I am excited about adding Synagis to our portfolio as it remains the only product preventing RSV infection in this vulnerable patient group with a great medical need. The addition of Synagis will become an important strategic catalyst for Sobi’s future development and will form a powerful platform for growth in rare diseases,” said Sobi President and CEO Guido Oelkers. “We see the acquisition as a stepping stone to drive sustainable growth in the U.S. and make Sobi more attractive for partnering. It also increases the overall specialty care franchise and diversifies our portfolio in immunology. The expected earnings of this acquisition will increase the financial flexibility to support further growth initiatives.”
“Sobi’s focus on Synagis will enable infants in the U.S. to continue benefiting from this important treatment. Meanwhile, the successful development and commercialization of MEDI8897 remains important for AstraZeneca,” added AstraZeneca’s CEO, Pascal Soriot.
Synagis is an RSV F protein inhibitor monoclonal antibody (mAb) that acts as a prophylaxis against serious RSV disease. AstraZeneca has a partnership agreement with AbbVie Inc. for the rights to Synagis outside the United States, which will not be impacted by the proposed transaction.
MEDI8897 is a single-dose, extended half-life anti-RSV F mAb being developed for the prevention of LRTI caused by RSV in all infants entering their first RSV season and children with chronic lung disease or congenital heart disease entering their first and second RSV season. MEDI8897 is being developed for the passive immunization of a broad infant population and has been engineered to have a long half-life so that only one dose will be needed for the entire RSV season. The current development plan includes initiation of a Phase 3 study in healthy full-term and late pre-term infants. MEDI8897 has received Fast Track Designation from the U.S. Food and Drug Administration in March 2015.
Moving on to Tulane and the NIH—and away from a virus to a bacterium—microbiologist Dr. Lisa Morici and immunologist Dr. James McLachlan at the university will lead the project to use outer membrane vesicles (OMVs), which are nanoparticles shed by bacteria as they grow, to stimulate a more potent immune response than current vaccines against pertussis.
The researchers will add OMVs to DTaP, an existing vaccine against three deadly diseases caused by bacteria—diphtheria, tetanus and pertussis—and they will evaluate the OMV-based vaccine’s safety and effectiveness in animal models to pave the way for potential clinical studies.
Worldwide, there are an estimated 24.1 million cases of pertussis and about 160,700 deaths per year, according to the U.S. Centers for Disease Control. Despite widespread vaccination, pertussis cases have spiked in the United States in the last decade and a half with almost 18,000 reported in 2016. Part of the increase is blamed on limitations of the current vaccine, which doesn’t provide lasting immunity and may not prevent person-to-person transmission. Children must get a series of doses before age 1 and need another at the end of adolescence. Continued compliance is also an issue as adults need a booster shot to retain immunity.
Tulane researchers believe their vaccine formulation can address many of those drawbacks by providing longer-lasting immunity in fewer doses.
OMVs are an emerging technology as a new class of adjuvants or immune system triggers in next-generation vaccines. Our bodies recognize OMVs secreted by live bacteria during natural infection. When used in vaccines, they can fool the body into mounting a similar immune response.
“If you get infected with a pathogenic organism—a virus or bacteria—it generally engages almost every aspect of the immune system, but most vaccines typically engage only one or two aspects,” said McLachlan, an associate professor of microbiology and immunology. “We thought that if a real infection can engage all the arms of the immune system, then maybe a facsimile of a bacteria could as well.”
Preliminary studies have shown that OMVs can do so, and Morici has used the technology to develop successful vaccines against other diseases such as melioidosis, which is caused by Burkholderia pseudomallei.
“We have worked with outer membrane vesicles for years. They are an extremely potent adjuvant,” said Morici, an associate professor of microbiology and immunology. “An OMV presents to the immune system similar to an intact bacterium—but it’s non-infectious and non-replicating, so it’s much safer.”