BioVersys and Shionogi Enter Into Global Research Collaboration For Broad-Spectrum Non-Tuberculous Mycobacteria (NTM) Clinical Candidate
Ad hoc announcement pursuant to Art. 53 LR
BASEL, Switzerland, July 02, 2025 (GLOBE NEWSWIRE) --
- The Global Research Collaboration is a research and exclusive license option agreement with Shionogi to jointly develop novel ansamycin leads from BioVersys’ BV500 program into clinical candidates
- Shionogi gets access to BioVersys’ proprietary ansamycin platform and the BV500 program
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BioVersys eligible to receive upfront and near-term research payments of CHF 5.0 million and, upon exercise of the license option, regulatory and sales milestones of up to CHF 479 million as well as royalties on future sales
BioVersys AG (SIX: BIOV), 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 today a research and exclusive license option agreement with the Japanese pharmaceutical company, Shionogi & Co., Ltd., to jointly develop novel ansamycin leads from BioVersys’ BV500 program into clinical candidates.
Under the terms of the agreement, BioVersys will receive an upfront payment and near-term research payments totaling 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 program 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 program.”
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 program 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 program 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 program has also received funding support and access to key expertise from the CF AMR Syndicate and the EU IHI funded RespiriNTM programme. Where applicable, these partnerships will continue during the ongoing research and development of BV500.
About non-tuberculous mycobacteria
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).1 NTM-PD affects approximately 250,000 people per year, predominantly in North America and Asia.3 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 infections2 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.3 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.4
About Shionogi
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.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders, cardiovascular diseases and gastroenterology. Shionogi’s research and development currently target two therapeutic areas: infectious diseases, and pain/CNS disorders. For more information, please visit https://www.shionogi.com/global/en/.
About BioVersys
BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3 ready), and tuberculosis (alpibectir, Phase 2a, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland.
BioVersys contact
Hernan Levett, CFO, Tel. +41 61 633 22 50; Mail: Hernan.levett@bioversys.com
For Media: media@bioversys.com
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Disclaimer
This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
1 Hamed KA & G. Tillotson “A narrative review of nontuberculous mycobacterial pulmonary disease: microbiology, epidemiology, diagnosis, and management challenges” Ex. Rev. Resp. Med. (2023), 17 (11), 973 - 988 https://doi.org/10.1080/17476348.2023.2283135
2 Daley CL et al. “Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline” Eur. Resp. J. (2020), 56, 2000535; https://doi.org/10.1183/13993003.00535-2020; Griffith DE et al. “An Official ATS/IDSA Statement: Diagnosis, Treatment, and Prevention of Nontuberculous Mycobacterial Diseases” Am. J. Respir. Crit. Care Med. (2007), 175, 367–416; https://doi.org/10.1164/rccm.200604-571ST
3 Jhun BW et al. “Prognostic factors associated with long-term mortality in 1445 patients with nontuberculous mycobacterial pulmonary disease: a 15-year follow-up study” Eur. Resp. J. (2020), 55, 1900798; https://doi.org/10.1183/13993003.00798-2019
4 Degiacomi G. et al. “Mycobacterium abscessus, an Emerging and Worrisome Pathogen among Cystic Fibrosis Patients” Int. J. Mol. Sci. (2019), 20, 5868; doi: 10.3390/ijms20235868
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