BOW100 (golimumab biosimilar) / Epirus - LARVOL DELTA

Results of Novel Clinical Study of Guselkumab and Golimumab Combination Therapy Show Adults with Moderately to Severely Active Ulcerative Colitis Maintained Higher Rates of Clinical, Histologic, and Endoscopic Remission at Week 38 (PRNewswire) - P2a | N=214 | VEGA (NCT03662542) | Sponsor: Janssen Research & Development, LLC | '"Exploring combinations of advanced therapies is an important step in continuing to innovate for the many patients living with ulcerative colitis,' said Bruce E. Sands, M.D., M.S...'These new data from the VEGA trial build upon and affirm our initial 12-week findings showing the potential clinical benefit of combining guselkumab and golimumab in treating adults with moderately to severely active ulcerative colitis.'"

Media quote

Guselkumab Plus Golimumab Shows Promise in Patients With Ulcerative Colitis (Gastroendonews) - '"This study is the first of its kind and opens you to the possibilities of the power of combining many different sorts of therapies to achieve better results,' said investigator Bruce Sands, MD, MS...'But I think we'll have to really study them carefully to understand which combinations will be safe and effective.'"

Media quote

Epirus Biopharmaceuticals reports third quarter 2015 financial results & provides business update (Epirus Press Release) - "EPIRUS Biopharmaceuticals...today reported financial results for the third quarter of 2015, and provided a business update...Completed regulatory submissions for marketing authorization of BOW015 (Infliximab) in multiple countries in Southeast Asia, including Malaysia, Thailand and Indonesia...global filing anticipated in 2017 for marketing approval in Europe, US and Canada."; Anticipated global filing for: BOW050 in 2018, BOW070 in 2019, BOW080 in 2020, BOW090 in 2021 and BOW100 in 2022.

Anticipated BLA • Anticipated Canadian regulatory • Anticipated EU regulatory • Non-US regulatory • Biosimilar

Epirus: Corporate Overview (Epirus Biopharmaceuticals) - Anticipated global filings for inflammatory diseases in 2022

Anticipated regulatory • Biosimilar