tepilamide fumarate (PPC-06) / Azurity Pharma, Dr. Reddy’s - LARVOL DELTA

Tepilamide Fumarate (PPC-06) Extended Release Tablets in Patients with Moderate-to-Severe Plaque Psoriasis: Safety and Efficacy Results from the Randomized, Double-blind, Placebo-controlled AFFIRM Study. (PubMed, J Clin Aesthet Dermatol) - "High placebo response somewhat limits the utility of these findings. Patients with moderate-to-severe plaque psoriasis treated with oral tepilamide fumarate demonstrated positive response."

Clinical • Journal • Dermatology • Gastrointestinal Disorder • Immune Modulation • Immunology • Infectious Disease • Inflammation • Psoriasis

A number of actionable events for XenoPort, with capital to back them up (Propthink) - Anticipated peak sales of approximately $100M by 2020 for arbaclofen placarbil; Anticipated FDA approval decision for Biogen Idec’s BG-12 March 28.

Anticipated FDA event • Anticipated sales • Multiple Sclerosis

Wedbush PacGrow LifeSciences Management Access Conference (Xenoport) - Anticipated results from P1 trial for healthy volunteers in Q4 2012

Anticipated P1 data • Multiple Sclerosis • Psoriasis

XenoPort reports first quarter financial results (Businesswire) - Anticipated preclinical and P1 data for XP23829 by Q2/Q3 2013; Anticipated new P2/3 trial by Q4 2013; Anticipated P3 data of arbaclofen placarbil (AP) in MS in Q2 2013; Anticipated NDA submission for AP in Q4 2013.

Anticipated NDA • Anticipated new P2/3 trial • Anticipated P1 data • Anticipated P3 data • Anticipated preclinical • Multiple Sclerosis

XenoPort reports fourth quarter and year-end 2013 financial results (Xenoport Press Release) - Anticipated IND of XP23829 for psoriasis; Anticipated P2  trial of XP23829 for psoriasis by mid-2014. "We [XenoPort] hope to establish optimal dosing of XP23829 in our planned Phase 2 psoriasis study and use this information for dose selection for potential Phase 3 trials in psoriasis and/or relapsing forms of MS."

Anticipated IND • Anticipated new P2 trial • Anticipated new P3 trial • Anticipated phase shift • Multiple Sclerosis • Psoriasis

Xenoport: one door closed, two more opened (SeekingAlpha) - "Currently, Xenoport is wrapping up two clinical studies....The two studies should build enough confidence within the FDA to allow Xenoport to continue with Phase 2, and 3 trials."

Pipeline update • Multiple Sclerosis

A comparison of XP23829 with DMF, the active ingredient of BG-12 (CMSC - ACTRIMS 2012) - Mice treated with DMF at 15 and 90 mg/kg-eq of MMF showed a 29% and 32% reduction in last day disease score (LDDS) compared to vehicle-treated animals; Animals treated with XP23829 at 11 and 90mg/ kg-eq MMF had reductions in LDDS of 57% and 69%, respectively

Preclinical-animal • Multiple Sclerosis

XenoPort awarded U.S. patent directed to composition and formulations of XP23829, a novel fumarate analog for the potential treatment of relapsing-remitting multiple sclerosis and psoriasis (Xenoport) - XenoPort announced that it was awarded U.S. Patent 8,148,414 for prodrugs of methyl hydrogen fumarate, pharmaceutical compositions thereof, and methods of use; The term of the patent extends until 2029, subject to potential Hatch-Waxman patent term extensions; XenoPort intends to file an IND for XP23829 for the treatment of RRMS with FDA in the Q2 '12 & expects to initiate human clinical trials later this year

Anticipated IND filing • Anticipated P1 initiation • Patent update • Multiple Sclerosis

XenoPort reports fourth quarter and year-end 2012 financial results (Xenoport) - "We are equally excited about our progress on XP23829. Our first clinical trial provided the type of positive results we expected, and we are looking forward to receiving the results of two additional Phase 1 trials and of 13-week toxicology studies by mid-year. With these data in hand, we hope to speak to regulatory authorities about potential development paths in several indications, including...psoriasis. We are looking forward to reporting our progress later in 2013."

Anticipated P1 data • Anticipated pipeline update • Anticipated regulatory • Psoriasis

XenoPort reports fourth quarter and year-end 2012 financial results (Businesswire) - "we are awaiting our Phase 3 AP clinical trial results in the second quarter...Assuming positive results, we would target the submission of a New Drug Application (NDA) in the United States for AP for the treatment of spasticity for patients with MS or spinal cord injury by the end of this year...about...XP23829...looking forward to receiving the results of two additional Phase 1 trials and of 13-week toxicology studies by mid-year. With these data in hand, we hope to speak to regulatory authorities about potential development paths in several indications, including...(RRMS)...”

Anticipated NDA • Anticipated P1 data • Anticipated P3 data • Multiple Sclerosis

XenoPort to release fourth quarter and year-end financial results on February 25, 2016 (Xenoport Press Release) - "XenoPort...announced today that it will release its fourth quarter and year-end financial results on February 25, 2016 at approximately 4:30 p.m. Eastern Time. The company will host a conference call at 5:00 p.m. Eastern Time that same day to provide a summary of its financial results and general business updates."

Commercial • Multiple Sclerosis