BioVersys AG, a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multidrug-resistant (MDR) bacteria, announced a research and exclusive license option agreement with the Japanese pharmaceutical company, Shionogi & Co., Ltd., to jointly develop novel ansamycin leads from BioVersys’ BV500 programme into clinical candidates.
• Under the terms of the agreement, BioVersys will receive an upfront payment and near-term research payments totalling CHF 5.0 million.
• Once clinical candidates have been selected, Shionogi may exercise a license option for which BioVersys would be eligible to receive up to CHF 479 million in regulatory and sales milestones, as well as tiered royalties on global sales.
• The BV500 NTM programme is derived from the company’s proprietary Ansamycin Chemistry platform.
• BioVersys’ research teams in Lille (France) and Basel (Switzerland) have identified and developed several advanced, highly potent and orally bioavailable lead candidates, with broad-spectrum in vitro and in vivo anti-NTM activity, which are devoid of cross-resistance with other therapeutic classes.
Dr Marc Gitzinger, CEO & co-founder: “We are excited to work with our colleagues at Shionogi to advance the development of our NTM asset expeditiously towards patients in need. This collaboration reduces research and development risk for BioVersys while preserving financial discipline. It also expands the reach of our pipeline and ensures the expedited development of our drug candidates. Shionogi is an ideal partner for this programme, given its expertise and commitment in infectious diseases and the company’s global reach. Partnerships like this one strongly benefit patients and other stakeholders. Beyond the BV500 program, BioVersys remains on track to initiate the phase 3 trial for our most advanced asset BV100 later this year and we look forward to updating our stakeholders on the progress.”
John Keller, Ph.D. director of the board, senior vice president, R&D Supervisory Unit at Shionogi & Co., Ltd.: “We are pleased to announce this partnership with BioVersys. This collaboration reflects our commitment to advancing innovative treatments for infectious diseases with significant unmet medical needs, and Shionogi will be bringing our scientific knowledge and operational capabilities fully to bear to maximize the potential of BioVersys’ BV500 programme.”
Dr. Nawaz Khan, head of research at BioVersys: “BV500 has the potential to become a best in class therapeutic for NTM infections. We are proud that the programme attracted such a strong partner. This is a validation of our work and will accelerate the development of the project. We look forward to the partnership with our colleagues at Shionogi and to the opportunity to leverage a broad range of complementary expertise.”
The joint research teams aim to deliver clinical candidates and back-up molecules during the research collaboration period. Shionogi will have the exclusive option to license a selected number of molecules for further clinical development and global commercialization.
• The BV500 programme arose from a successful collaboration within the SmartLab public private partnership with the University of Lille (France) as an incubator for early-stage idea generation, underlining that efficient research in the field of antibiotics works best in collaboration.
• The BV500 programme has also received funding support and access to key expertise from the CF AMR Syndicate and the EU IHI funded RespiriN programme.
• Where applicable, these partnerships will continue during the ongoing research and development of BV500.
• Non-tuberculous Mycobacteria (NTM) are ubiquitous environmental bacteria whose common clinical manifestation is pulmonary (lung) disease (NTM-PD or NTM-LD) caused most frequently by Mycobacterium avium complex (MAC) and Mycobacterium abscessus subspecies (MAB).
• NTM-PD affects approximately 250,000 people per year, predominantly in North America and Asia. Treatment of NTM infections is challenging due to variable intrinsic bacterial susceptibility, acquired resistance to commonly used antimicrobial agents, length of therapy (at least 12 months) and adverse effects associated with current treatment options.
• Macrolide-based, triple drug regimens, plus aminoglycosides for chronic/relapsing infections are considered only moderately effective for treating MAC, whereas no therapy of predictable efficacy exists for the treatment of MAB, a pathogen associated with up to 50% mortality.
• People with preexisting conditions, including cystic fibrosis (CF), other lung diseases and immune-compromised patients are more easily colonised.
• The incidence of NTM infections among people living with CF has increased from 3.3% to 22.6%, with MAB becoming a more prominent pathogen.
Shionogi & Co., Ltd. is a 147-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.