Revio Therapeutics ("Revio") and Welding Group ("Welding") today announced the signing of a co-development and licensing agreement for Revio's proprietary specialty oncology product. The 505(b)(2) product, designed based on an innovative dosage form with significant patient compliance and ease-of-use advantages, will be developed by Revio and commercialized by Welding through the partnership across the United States, Europe, and select global markets.
A New Standard in Patient-Centric Oncology Care
This collaboration combines Revio's innovative 505(b)(2) drug development expertise with Welding's commercial market access capabilities as well as therapeutic area expertise, positioning both organizations to address critical unmet needs in oncology patient care. Consistent with Revio’s business model of de-risking early, the program achieved a key milestone with the completion of a pre-IND meeting in which the U.S. FDA green-lit the proposed development strategy and study designs.
Kiran Kumar, Co-Founder & CSO, Revio Therapeutics
"This partnership with Welding represents a pivotal milestone for Revio Therapeutics. Featuring an unique dosage form in cancer therapeutics, our 505(b)(2) product was purpose-built to improve the daily lives of oncology patients through enhanced safety, compliance and simplified administration. The program is also a testament to Revio’s proprietary AI tool – RethinkTx which was instrumental in product ideation, development planning and regulatory validation. Welding's proven capabilities along with its alliance with ONconcept ® consortium makes them the ideal partner to bring this innovation to patients worldwide."
Lars Hallmayer, Managing Director, Welding Group
"We are pleased to partner with Revio on this innovative oncology asset. Its distinctive patient-focused design strongly aligns with our commitment to advancing impactful therapies. Together, we aim to expedite access for patients with the greatest need."
Target Markets:
United States, Europe, and additional global markets
About the 505(b)(2) Regulatory Pathway
The 505(b)(2) pathway enables the development of improved formulations or delivery mechanisms by leveraging existing safety and efficacy data, allowing for a potentially faster and more efficient route to market while delivering meaningful innovation for patients.
About Revio Therapeutics
At Revio we create opportunities to leverage novel biology to explore new indications, innovate dosage forms, and delivery systems creating better value for all stakeholders. We believe proven medicines hold untapped potential to address unmet needs, offering faster solutions for rare and specialty indications. We are reimagining this under-explored space through de-risked development programs designed to deliver better outcomes for patients, healthcare providers, partners, and investors alike.
Website: www.reviotx.com
About Welding
WELDING Group, headquartered in Hamburg, is a family-owned company with over 70 years of international experience. The company specializes in the procurement and distribution of pharmaceutical active ingredients, food additives, and feed additives, as well as the development, approval, licensing, and delivery of generic pharmaceuticals. In this regard, WELDING also offers a comprehensive range of services in the field of quality assurance and regulatory affairs. . Our success is built on experts with a proven track record in identifying and realizing product opportunities, enabling us to create substantial synergies between our global partners in Asia, Europe and the US.
Website: www.welding.eu/en
Media Contacts
For Revio Therapeutics:
Kiran Kumar
Co-founder & Chief Strategy Officer
kiran@reviotx.com
Tel: + 1 (732) 666 7259
For Welding Group:
Lars Hallmayer
Managing Director
lars.hallmayer@welding.eu
Tel: +49(40)35908173
A New Standard in Patient-Centric Oncology Care
This collaboration combines Revio's innovative 505(b)(2) drug development expertise with Welding's commercial market access capabilities as well as therapeutic area expertise, positioning both organizations to address critical unmet needs in oncology patient care. Consistent with Revio’s business model of de-risking early, the program achieved a key milestone with the completion of a pre-IND meeting in which the U.S. FDA green-lit the proposed development strategy and study designs.
Kiran Kumar, Co-Founder & CSO, Revio Therapeutics
"This partnership with Welding represents a pivotal milestone for Revio Therapeutics. Featuring an unique dosage form in cancer therapeutics, our 505(b)(2) product was purpose-built to improve the daily lives of oncology patients through enhanced safety, compliance and simplified administration. The program is also a testament to Revio’s proprietary AI tool – RethinkTx which was instrumental in product ideation, development planning and regulatory validation. Welding's proven capabilities along with its alliance with ONconcept ® consortium makes them the ideal partner to bring this innovation to patients worldwide."
Lars Hallmayer, Managing Director, Welding Group
"We are pleased to partner with Revio on this innovative oncology asset. Its distinctive patient-focused design strongly aligns with our commitment to advancing impactful therapies. Together, we aim to expedite access for patients with the greatest need."
Target Markets:
United States, Europe, and additional global markets
About the 505(b)(2) Regulatory Pathway
The 505(b)(2) pathway enables the development of improved formulations or delivery mechanisms by leveraging existing safety and efficacy data, allowing for a potentially faster and more efficient route to market while delivering meaningful innovation for patients.
About Revio Therapeutics
At Revio we create opportunities to leverage novel biology to explore new indications, innovate dosage forms, and delivery systems creating better value for all stakeholders. We believe proven medicines hold untapped potential to address unmet needs, offering faster solutions for rare and specialty indications. We are reimagining this under-explored space through de-risked development programs designed to deliver better outcomes for patients, healthcare providers, partners, and investors alike.
Website: www.reviotx.com
About Welding
WELDING Group, headquartered in Hamburg, is a family-owned company with over 70 years of international experience. The company specializes in the procurement and distribution of pharmaceutical active ingredients, food additives, and feed additives, as well as the development, approval, licensing, and delivery of generic pharmaceuticals. In this regard, WELDING also offers a comprehensive range of services in the field of quality assurance and regulatory affairs. . Our success is built on experts with a proven track record in identifying and realizing product opportunities, enabling us to create substantial synergies between our global partners in Asia, Europe and the US.
Website: www.welding.eu/en
Media Contacts
For Revio Therapeutics:
Kiran Kumar
Co-founder & Chief Strategy Officer
kiran@reviotx.com
Tel: + 1 (732) 666 7259
For Welding Group:
Lars Hallmayer
Managing Director
lars.hallmayer@welding.eu
Tel: +49(40)35908173
