Under the terms of the agreement, Roche is granted a worldwide exclusive license to develop and commercialize the compound. In a novel collaboration model, Roche and Proximagen will conduct additional phase II studies to further define the therapeutic potential of the VAP-1 inhibitor. Based on these data Roche will assume responsibility for late stage development and worldwide commercialization. Proximagen will receive an upfront payment, along with downstream development, regulatory and sales milestones. In addition, Proximagen will also receive tiered royalties on net sales of a potential future product containing the molecule.
"This agreement is a novel partnering model where regulatory responsibility and trial sponsorship will only transition upon the success of additional clinical studies," said Sophie Kornowski-Bonnet, PhD, Head of Roche Partnering. "A dedicated and very experienced team located at the Roche Innovation Center New York, will drive the development most efficiently from our side."
"This agreement will allow our companies to fully explore the significant and far-reaching potential of this novel VAP-1 inhibitor. Roche's deep expertise in drug development and proven success in commercialization will allow us to fully explore the unique attributes of this important molecule and the therapeutic benefits it may provide in the future," said William Pullman, MB, BS, BMedSc, PhD, FRACP, Chief Scientific Officer and Biotech Research Institute Division President, Upsher-Smith. "We are pleased to work with Roche on this compound as we share their commitment to patients."
The transaction is subject to the expiration or early termination of the applicable U.S. Hart-Scott-Rodino waiting period.
Since 2012, Proximagen has been a wholly-owned subsidiary of Upsher-Smith. With an integrated drug discover facility based in Cambridge, UK, Proximagen acts as Upsher-Smith's research and early development institute. Proximagen and its predecessor companies have a long heritage in discovery and development of novel small molecules, in particular in the areas of CNS, pain and inflammation.
Upsher-Smith Laboratories, Inc., founded in 1919, is a growing, fully integrated pharmaceutical company dedicated to its mission of delivering high-value, high-quality therapies and solutions which measurably improve individuals' lives. As a family-owned pharmaceutical company, we are able to adapt and thrive in a dynamic healthcare environment. Our world is constantly evolving, and we are continually adapting to the ever-changing needs of patients, physicians, pharmacists, and healthcare organizations. Where there is a need, we will work to deliver solutions that simplify access to treatment, deliver better health outcomes, and enhance life. Upsher-Smith has a particular focus on developing therapies for people living with central nervous system (CNS) conditions, such as seizure disorders.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.