Roivant plans to initiate Phase 2 clinical trial in 2019
Agreement includes option to in-license additional anti-Gr(+) programs
Roivant Sciences and iNtRON Biotechnology today announced that they have entered into a global licensing agreement for SAL200, a novel investigational biologic for the treatment of infectious diseases caused by antibiotic-resistant staphylococci. This licensing deal is worth a total of US$667.5M inclusive of milestone payments, with royalties on net sales in the low double digits.
Under the terms of the agreement, iNtRON Bio will receive an upfront payment upon execution of the agreement and subsequent milestone payments for development, regulatory, and sales-driven events. This agreement also provides Roivant with the option to license iNtRON Bio’s non-clinical stage, anti-Gram-positive endolysin programs—including anti-VRE and anti-TB biologics—for an additional consideration of up to US$45M each. Roivant also has the first right of offer for iNtRON Bio’s anti-Gram-negative platform.
Roivant has created a dedicated subsidiary to pursue the global development and commercialization of endolysin products from iNtRON Bio. Roivant plans to initiate a Phase 2 trial for SAL200 in 2019.
“This partnership with iNtRON represents our commitment at Roivant Pharma to deliver transformational therapeutics,” said Mayukh Sukhatme, M.D., President of Roivant Pharma. “The development of novel anti-infective therapies is one of the greatest needs of our time and we hope to maximize the impact of SAL200 on public health through innovative approaches to both development and commercialization.”
“This partnership between iNtRON Bio and Roivant combines our industry-leading endolysin platform with their track record of operational excellence,” said Kyung Won Yoon, CEO of iNtRON Bio. “Together we hope to ensure that physicians have better options in their armamentarium in preparation for the ‘post-antibiotic era’ on the horizon.”
iNtRON Bio is a biotechnology company in Korea focused on the development of bacteriophage/endolysin-based novel anti-bacterials for the treatment of serious and life-threatening infections caused by multidrug-resistant bacteria. For more information, please visit www.intron.co.kr.
Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. We do this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit www.roivant.com.
SAL200, which contains bacteriophage-derived endolysin as its active pharmaceutical ingredient, may represent a potential breakthrough in addressing the problem of antibiotic-resistant bacterial infections due to its novel mode of action. In past pre-clinical studies, SAL200 showed bactericidal activity against the following pathogens: methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-intermediate Staphylococcus aureus (VISA), vancomycin-resistant Staphylococcus aureus (VRSA), linezolid-resistant Staphylococcus aureus (LRSA), linezolid-resistant MRSA (LR-MRSA), multi-resistant MRSA (mrMRSA), and coagulase-negative Staphylococcus (CoNS). The initial targeted indication of SAL200 is blood stream infections (BSI; bacteremia) caused by Staphylococcus aureus.
S. aureus bloodstream infection is a serious and life-threatening infection that is associated with a high mortality rate and places substantial cost and resource burdens on healthcare systems. According to data from the CDC, S. aureus bloodstream infections occurring in both hospital and community settings cause an estimated 119,000 hospitalizations and 30,000 deaths each year in the U.S. alone.