TNF-α kinoid / Neovacs, Debiopharm - LARVOL DELTA

2013 half-year financial results (Neovacs Press Release) - "The Company completed the protocol for the phase IIb study of its anti-TNF therapeutic vaccine (TNF-Kinoid) in RA....Consistent with its clinical development plan, the Company expects the study to begin in the second half of 2013 with the inclusion of the first patients."

Anticipated new P2b trial • Rheumatoid Arthritis

Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2; N=140; Active, not recruiting; Sponsor: Neovacs; Recruiting -> Active, not recruiting

Enrollment closed • Biosimilar • Immunology • Pain • Rheumatoid Arthritis

Active therapeutic immunization with TNF-Kinoid in rheumatoid arthritis patients with secondary resistance to TNF-α antagonists is safe and immunogenic (EULAR 2012) - P=NA, N=40; No related serious adverse event has been reported; Few minor transient local & systemic reactions have been recorded following immunization; Among the 21 patients who developed anti-TNF Abs, 48% present a moderate to good response according to EULAR score as opposed to only 31% of the 16 patients without Abs

Clinical data • Rheumatoid Arthritis

Neovacs announces top line phase IIb clinical trial results of TNF-Kinoid in RA and update on clinical programs (Neovacs Press Release) - P2b, N=140; "NEOVACS...announced top line data on the Phase IIb clinical trial of TNF-Kinoid in Rheumatoid Arthritis (RA)....This trial confirmed the immunogenicity and good tolerance of TNF-Kinoid with no safety issues, but did not meet its primary efficacy endpoint."; Anticipated new P2b trial in US in early 2016; Anticipated new P2b trial in Europe, Latin America and Asia in 2015.

Anticipated new P2b trial • P2b data • Rheumatoid Arthritis

Clinical Efficacy of TNF-Kinoid in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P2; N=143; Completed; Sponsor: Neovacs; Active, not recruiting -> Completed

Trial completion • Biosimilar • Immunology • Inflammation • Rheumatoid Arthritis

Financial results for the first half of 2011 (Neovacs) - Neovacs announced its financial results & key developments for the first half of 2011; Anticipated interim P2 data (TNF-K-003 study) of first two dose groups (90 and 180 mcg) in Oct '11; Anticipated full results of the P2 study in Dec '11

Anticipated P2 data • Rheumatoid Arthritis