M923 (adalimumab biosimilar) / J&J - LARVOL DELTA

Momenta Pharma: Q1 FY 2016 Results (J&J) - Anticipated presentation of data from pharmacokinetics P1 study (NCT02675023) in healthy subjects at EULAR on June 10, 2016

Anticipated P1 data • Biosimilar

Momenta Pharma: J.P. Morgan Healthcare Conference (J&J) - “M923 Meets Primary Endpoint in Human Pharmacokinetic (PK) Study”; “324 healthy volunteers randomized 1:1:1 to receive single 40 mg injection M923, US HUMIRA^®, or EU HUMIRA, then followed for 71 days”; “PK bioequivalence demonstrated for all primary endpoints (C_max, AUC_0-inf and AUC_0-336) across each pairwise comparison (M923/US HUMIRA, M923/EU HUMIRA and EU HUMIRA/US HUMIRA): Geometric LS mean ratios all close to unity (100%), 90% CIs well within the confidence bounds of 80.00-125.00% (range 93-113%)”; “Incidence of AEs and ADAs for M923 was similar to reference products”

Clinical data • Biosimilar

M923: Launch in EU in 2020 (J&J) - Q3 2018 Results

Biosimilar launch

Momenta Pharmaceuticals announces global settlement with AbbVie to enable commercialization of M923, a proposed biosimilar to Humira (adalimumab) (J&J Press Release) - "Momenta...announced that it has executed agreements with AbbVie Inc., providing license rights for the global launch of M923, Momenta’s proposed biosimilar to HUMIRA. Under the terms of the agreements and subject to approval by health regulatory authorities, Momenta may launch M923 in the United States (US) on November 20, 2023 and in Europe upon approval by the European Medicines Agency. Momenta plans to submit a biologics license application for M923 to the US Food and Drug Administration in the fourth quarter of 2018 and a marketing authorization application in the European Union in the first half of 2019."

Biosimilar launch • BLA • European regulatory • Patent • Ankylosing Spondylitis • Crohn's disease • Idiopathic Arthritis • Immunology • Inflammation • Inflammatory Bowel Disease • Ocular Inflammation • Psoriasis • Rheumatoid Arthritis • Ulcerative Colitis • Uveitis

Momenta Pharmaceuticals announces positive top-line phase 3 results for M923, a proposed Humira (adalimumab) biosimilar (J&J Press Release) - P3, N=NA; NCT02581345; "Momenta Pharmaceuticals today announced that the confirmatory Phase 3 clinical study of M923...met its primary endpoint. The proportion of subjects in the study who achieved the primary endpoint, at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment, was equivalent between M923 and HUMIRA."

P3 data: top line • Biosimilar • Immunology • Psoriasis

M923: BLA filing in 2018 (J&J, 36th Annual J.P. Morgan Healthcare Conference)

BLA • Biosimilar

M923: BLA filing in 2018 (J&J, 36th Annual J.P. Morgan Healthcare Conference)

BLA • Biosimilar

Momenta Pharma: Q2 2015 Results (J&J) - Anticipated launch in 2018

Anticipated launch • Biosimilar

Usability of an AI for M923 in Subjects With Moderate to Severe RA (clinicaltrials.gov) - P3; N=51; Active, not recruiting; Sponsor: Baxalta US Inc.; Trial primary completion date: Dec 2016 ➔ Mar 2017

Trial primary completion date • Biosimilar • Immunology • Rheumatoid Arthritis

A single dose study comparing pharmacokinetics, safety, and immunogenicity of M923 (a proposed biosimilar to adalimumab), US-sourced adalimumab, and EU-sourced adalimumab in healthy subjects (EULAR 2016) - P1, N=324; EudraCT number: 2014-001043-20; "Bioequivalence was observed for all primary PK endpoints. Specifically, for the comparison of M923 with US-sourced adalimumab, the geometric LS mean ratios (90% CI) were Cmax = 102.58 (97.31-108.14); AUC0-inf = 104.20 (96.47-112.54); and AUC0-336 = 102.94 (97.88-108.27)."

P1 data • Ankylosing Spondylitis • Biosimilar • Inflammatory Bowel Disease • Psoriasis

Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis (clinicaltrials.gov) - P3; N=827; Completed; Sponsor: Momenta Pharmaceuticals, Inc.; Active, not recruiting ➔ Completed

Trial completion • Biosimilar • Psoriasis

A timeline of US biosimilar adalimumab launch dates (Center for Biosimilars) - AbbVie has struck agreements with multiple developers over biosimilar adalimumab, forestalling US market entry until 2023. Hulio - July 31; Hyrimoz - September 30; M923 - November 20."

Biosimilar launch • Ankylosing Spondylitis • Crohn's disease • Idiopathic Arthritis • Immunology • Inflammation • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Ulcerative Colitis

Momenta Pharmaceuticals reports second quarter 2013 financial results (Momenta Press Release) - "Momenta continues to advance toward achievement of defined milestones in 2014 for...M923 and M834 — two products targeting autoimmune and inflammatory indications...The milestones are achievement of technical development criteria and the first submission of an Investigational New Drug (IND) application in 2014 for its lead biosimilar M923..."

Anticipated IND • New molecule • Ankylosing Spondylitis • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

Pharmacokinetic equivalence, comparable safety, and immunogenicity of an adalimumab biosimilar product (M923) to Humira in healthy subjects. (PubMed, Pharmacol Res Perspect) - "The proportion of subjects with a confirmed antidrug antibody (ADA) response was similar across study arms. This study demonstrated bioequivalent PK among M923, US Humira, and EU Humira and demonstrated that the PK parameters were consistent with similar safety and tolerability profile and ADA response rates."

Clinical • Journal • PK/PD data • Biosimilar

Baxalta: Q4 & FY 2015 Results (Baxalta) - Anticipated dosing of last patient in pivotal P3 trial (NCT02581345) for chronic plaque-type psoriasis in 2016

Anticipated enrollment status • Biosimilar

Momenta Pharmaceuticals announces acceptance of a clinical trial application in Europe for M923, a biosimilar version of Humira(R) (GlobeNewswire) - “Momenta Pharmaceuticals… today announced the acceptance by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a Clinical Trial Application (CTA) to initiate a clinical trial for M923, a biosimilar version of Humira® (adalimumab), in its collaboration with Baxter International's biopharmaceutical business. Acceptance of the CTA triggers two milestones under the Baxter collaboration with an aggregate payment of $12 million. Momenta expects to receive the payment in December 2014.”

European regulatory • Ankylosing Spondylitis • Biosimilar • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

Momenta drops Humira biosimilar, pays GSK $43m in manufacturing hit (BioProcess International) - "Momenta says planned runs at manufacturing partner GSK could be reattributed to another product as it ends development of M923, a biosimilar candidate to Humira (adalimumab)....the firm has now made the decision to drop the adalimumab program M923."

Discontinuation