Princeton-based international specialty pharma company partners with Baylor College of Medicine
PRINCETON, New Jersey and WASHINGTON, Oct. 20, 2015 /PRNewswire — Brighton Biotech, Inc. (BBI) and the National School of Tropical Medicine at Baylor College of Medicine today announced that BBI has acquired the exclusive global license for clinical development and commercialization of vaccines against the deadly infectious diseases Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). The vaccines are under development by the Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development – Product Development Partnership (Sabin PDP) together with a consortium of academic partners.
Princeton-based BBI, an international specialty pharmaceutical company, also will participate in Baylor’s pre-clinical research and product development program in advancing novel approaches to vaccines with demonstrated efficacy and without immune-enhancement against MERS and SARS.
“We are excited to join Baylor and Sabin PDP to develop and commercialize their novel approach, which has demonstrated efficacy in early pre-clinical studies in preventing SARS,” said Brighton Biotech Chief Operating Officer, Dr. Jurij Petrin.
“We cannot wait until global disasters happen to address these deadly diseases. MERS, for example, has a particularly high mortality rate of 40 to 50 percent,” added BBI Chief Medical Officer, Dr. Richard Sebastian Wanless. “We will move quickly and efficiently through the clinical and regulatory process so these vaccines are available as soon as possible.”
“We are delighted that BBI will join our group of consortium partners to accelerate the development of these important vaccines. Applying our PDP model we are poised to move these products quickly into first-in-human studies,” says Dr. Maria Elena Bottazzi, deputy director of Sabin PDP and associate dean of the National School of Tropical Medicine at Baylor.
“Each time an infectious disease outbreak occurs, the world scrambles to prevent needless suffering and death. Our goal is to get vaccines through the pipeline before the next emergency, rather than in the middle of one,” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor, president of Sabin, director of the Sabin PDP and director of Sabin Vaccine Institute Texas Children’s Hospital Center for Vaccine Development. “We are very pleased to partner with BBI to take these very promising vaccines through development in ways that aren’t cost prohibitive,” Hotez said.
BBI takes a lean, entrepreneurial approach to drug development and commercialization, with a core pharmaceutical team whose expertise is bringing products to markets, including emerging markets. They work through long-standing relationships with clinical research organizations and the support of outsourced services to minimize embedded costs while bringing drugs to market around the world.
“We have big pharma capabilities without a big pharma infrastructure,” said Petrin, a physician with 20 years of experience in the pharmaceutical and biotechnology industry in the areas of drug development and medical and regulatory affairs. Rather than a brick and mortar company, BBI works with an internal clinical research organization and a network of 25 smaller CROs around the world to acquire and develop pharmaceutical and biotechnological products intended for the treatment and/or prevention of serious unmet medical needs.
“It is critically important for us to address the threat of these infectious diseases so they cannot spread out of control and cause a catastrophic epidemic,” said Hotez.
The Baylor and BBI joint efforts are developing prototype subunit vaccines comprised of the SARS and MERS CoV spike proteins, which are the minimal receptor-binding domains, required for binding to the functional viral receptors in humans, Petrin said. He noted that the latest studies in mice with an optimized vaccine/adjuvant formulation have shown 100 percent efficacy with no detectable lung immunopathology, unlike prior attempts at vaccines with toxicity exceeding the risk of the disease itself.
About Brighton Biotech, Inc.
BBI is a privately held company founded in 2010. It is closely affiliated with Pharmaceutical Regulatory Services, Inc. and PRS Clinical, Inc., two privately owned consulting firms that provide BBI cost- and time-effective usage of best development practices employed at large pharmaceutical companies without the costly overhead. The company’s focus is to develop its products as quickly and as efficiently as possible, saving time and resources. Its founders and management team represent a unique combination of knowledge and R&D experience in both academia and industry. They are highly experienced in drug and vaccine development, regulatory affairs and clinical research. Learn more at www.brightonbiotech.com.
About Baylor College of Medicine
Baylor College of Medicine (www.bcm.edu) in Houston is recognized as a premier academic health sciences center and is known for excellence in education, research and patient care. It is ranked 21st among medical schools for research and 12th for primary care by U.S. News & World Report. Baylor is listed 19th among all U.S. medical schools for National Institutes of Health funding and number one in Texas. Located in the Texas Medical Center, Baylor has affiliations with seven teaching hospitals and jointly owns and operates Baylor St. Luke’s Medical Center, a part of CHI St. Luke’s Health. Currently, Baylor trains more than 3,000 medical, graduate, nurse anesthesia, physician assistant and orthotics students, as well as residents and post-doctoral fellows. Follow Baylor College of Medicine on Facebook (http://www.facebook.com/BaylorCollegeOfMedicine) and Twitter (http://twitter.com/BCMHouston).
About The Sabin Vaccine Institute and the Sabin Vaccine Institute Product Development Partnership
The Sabin Vaccine Institute (Sabin) is a nonprofit, 501(c)(3) organization dedicated to reducing needless human suffering from vaccine-preventable and neglected tropical diseases (NTDs) worldwide. Sabin develops new vaccines, advocates for increased use of existing vaccines and promotes expanded access to affordable medical treatments in collaboration with governments, academic institutions, scientists, medical professionals and nonprofit organizations. For more information, please visit www.sabin.org.
Sabin’s research and development of new vaccines is conducted through the Sabin Vaccine Institute Product Development Partnership (Sabin PDP), based at the Sabin Vaccine Institute and Texas Children’s Hospital Center for Vaccine Development in partnership with Baylor College of Medicine. The Sabin PDP works with leading private, academic and public institutions around the world to develop and test safe, effective and low-cost vaccines that benefit the world’s poorest communities. A complete overview of ongoing projects and partners is available at http://www.sabin.org/programs/vaccine-development.