- Novavax initially awarded approximately $2 million by PATH
- Potential for future PATH funding of 50% of external costs to develop maternal RSV vaccine available for low-resource countries
- Novavax retains global rights to commercialize RSV vaccine
ROCKVILLE, Md., July 18, 2012 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) announced a clinical development partnership with PATH to develop its RSV (respiratory syncytial virus) vaccine to protect infants through maternal immunization in low-resource countries. Novavax has been awarded approximately $2 million by PATH for initial funding under the partnership to partially support a Phase II dose-ranging clinical trial in women of childbearing age planned for the second half of this year. Following this initial study, PATH may elect to continue to partner with Novavax and provide support for the external clinical development costs through commercialization for this indication.
RSV is the most common cause of childhood respiratory infection globally, with a disease burden of 64 million cases and approximately 160,000 deaths annually. Severe RSV disease necessitates 3.4 million hospital admissions per year and disproportionately affects infants below 6 months of age. A severe episode of RSV bronchiolitis can lead to recurrent bouts of reactive airway disease/asthma for many years after the initial event. It is a highly contagious virus that occurs as a predictable epidemic from late fall through early spring in the U.S. and other northern hemisphere regions and can have more than two annual peaks in tropical climates. RSV disease burden in low-resource countries is significant, and available data indicate that the virus is responsible for a high proportion of childhood acute lower respiratory infection in these settings, particularly in the first few months of life. Currently, there is no approved RSV prophylactic vaccine available. Maternal immunization is a widely practiced strategy for protecting infants in a variety of diseases, such as neonatal tetanus. Maternal immunization leads to heightened antibodies in infants and thereby protects them against the targeted disease, and thus may be a viable strategy to protect young infants from RSV illness.
Under the collaboration, Novavax's Phase II clinical trial planned for later this year will be designed to evaluate the immune response to different doses of this vaccine candidate in women of childbearing age. PATH will fund on a non-dilutive basis approximately $2 million of Novavax's external clinical development costs for that trial. PATH and Novavax may then progress the clinical development of Novavax's recombinant RSV fusion (F) protein vaccine candidate with the goal of immunizing pregnant women, such that high levels of maternal RSV antibodies will be transmitted to their offspring through the placenta before birth, providing protection against infection in the early infancy period, when the disease burden is the highest. Thereafter, Novavax and PATH can elect to continue to collaborate on additional phases to develop the vaccine for maternal immunization in low-resource countries, with PATH potentially funding 50% of Novavax's external clinical development costs. Novavax will retain global rights to commercialize the product and has made a commitment to make the product affordable and available in low-resource countries.
"We are very proud to partner with PATH, an internationally recognized organization transforming global health through innovation, on our RSV vaccine candidate that has the potential to impact health conditions in the developing world. This partnership further validates the promise of our recombinant nanoparticle vaccines," said Stanley C. Erck, President and CEO of Novavax. "This partnership with PATH complements our corporate strategy to develop this RSV vaccine for multiple indications in affected patient populations, in all markets throughout the world with multiple partners. We estimate that the world-wide market for an RSV vaccine could exceed $5 billion."
"Based on Novavax's Phase I clinical trial results, we view this RSV vaccine as a promising candidate to address a very large unmet need in infant populations throughout the world, but particularly in low-resource countries," said Dr. Kathleen Neuzil, director of PATH's RSV vaccine project. "This collaboration with Novavax also fits well with our goal to collaborate with private and public-sector partners to advance the development of promising vaccines that can be affordable and accessible for people in low-resource countries."
About Novavax's RSV Program
Novavax's recombinant nanoparticle vaccine for the prevention of RSV is comprised of a highly purified RSV fusion (F) protein. In 2011, Novavax announced the results from a blinded, placebo-controlled, dose-escalating Phase I trial to assess the safety and tolerability of aluminum phosphate-adjuvanted and unadjuvanted formulations of our RSV vaccine candidate. The primary safety findings were local pain and tenderness at the site of injection, the majority of which were mild in nature with no dose-related increase observed. There were no observed vaccine-related serious adverse events or trends for related systemic side effects. A secondary objective of the study was to evaluate total and neutralizing anti-RSV antibody responses and assess the impact of the adjuvant. The study enrolled 150 healthy adults 18 to 49 years old who were allocated to six cohorts that included four dose levels of vaccine. The antibody response to the RSV F protein was significantly increased compared to placebo (p less than 0.001) in all groups and increased by 19-fold in the highest-dose group at day 60. A significant dose-response pattern was observed. High rates of seroconversion were seen at all doses including a rate of 100% at the highest-dose-adjuvant group.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website, www.novavax.com.
About PATH
PATH is an international nonprofit organization that transforms global health through innovation. PATH takes an entrepreneurial approach to developing and delivering high-impact, low-cost solutions, from lifesaving vaccines and devices to collaborative programs with communities. Through its work in more than 70 countries, PATH and its partners empower people to achieve their full potential. For more information, please visit www.path.org.
Forward Looking Statements
Statements herein relating to the future of Novavax and its financial position are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2011, and filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.