pfizer inc (PFE) Key Developments
Pfizer Inc. Announces Oral Tofacitinib Meets Primary Endpoints in Pivotal Phase 3 Psoriasis Trials
Mar 23 15
Pfizer Inc. announced the presentation of detailed pooled results from two pivotal Phase 3 studies from the Oral treatment P soriasis Trials (OPT) program at the 73rd American Academy of Dermatology (AAD) Annual Meeting. These results, evaluating the efficacy and safety of tofacitinib citrate for the treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, have been selected for oral presentation during the Pearls from the Posters New and Noteworthy Research Finds. Additionally, an integrated analysis of safety data from the OPT global clinical development program for tofacitinib was presented during the Late-Breaking Research in Dermatology Forums. The detailed, pooled analysis of 16 week data from the OPT Pivotal #1 and OPT Pivotal #2 studies showed that tofacitinib 10 mg and 5 mg tablets twice daily met the co-primary efficacy endpoints of superiority over placebo at 16 weeks in the proportion of patients achieving a Physicians Global Assessment (PGA) response of clear or almost clear, and the proportion of patients achieving at least a 75% reduction in Psoriasis Area and Severity Index (PASI75), two commonly used measures of efficacy in psoriasis. Both the tofacitinib 10 mg and 5 mg twice-daily doses showed statistically significant superiority over placebo for key secondary efficacy endpoints presented at AAD, including proportion of patients achieving ?90% reduction in PASI (PASI90) relative to baseline at Week 16% change from baseline in Body Surface Area (BSA) at Week 16, change from baseline in Dermatology Life Quality Index (DLQI) at Week 16, and percentage change from baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 in patients with nail psoriasis.
Pfizer Inc. Presents at 2015 Deutsche Bank Pharma OneonOne Day, Mar-26-2015
Mar 23 15
Pfizer Inc. Presents at 2015 Deutsche Bank Pharma OneonOne Day, Mar-26-2015 . Venue: JW Marriott Denver at Cherry Creek, 150 Clayton Lane, Denver, CO 80206, United States.
Pfizer & Eli Lilly to Resume Tanezumab Phase 3 Program
Mar 23 15
Pfizer Inc. (PFE) and Eli Lilly and Company (LLY) announced that they are preparing to resume the Phase 3 clinical program for tanezumab. As a result, Pfizer expects to receive a $200 million upfront payment from Lilly in accordance with the collaboration agreement. A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. U.S. FDA decided to lift the partial clinical hold after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February 2015.
Pfizer Inc. Reports Top-Line Results from Phase 4 Study Evaluating LYRICA Capsules CV as Treatment for Adolescents with Fibromyalgia
Mar 12 15
Pfizer Inc. announced top-line results of a double-blind Phase 4 study evaluating the safety and efficacy of Lyrica (pregabalin) Capsules CV in adolescents (ages 12-17 years) with fibromyalgia. The primary endpoint of the study was not achieved as there was not a statistically significant difference between pregabalin and placebo in mean pain score. The treatment difference was 0.66 points, which reflects an improvement of 1.60 points from baseline for pregabalin-treated patients and 0.94 points for placebo (p=0.121). This study was conducted to fulfill a post-marketing commitment required by the U.S. Food and Drug Administration when Lyrica was approved for the management of fibromyalgia. The safety and efficacy of pregabalin in pediatric patients have not been established. A total of 107 adolescent patients were enrolled in this Phase 4, 15-week double-blind, randomized, placebo-controlled study from multiple centers across the U.S., Europe and Asia. This study is the first large pharmacological treatment study to be completed in this study population. Study medication was administered twice daily. Dosing started at 75 mg/day and was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day, with the optimized dose maintained for the next 12 weeks. The safety profile observed in this study is consistent with the known profile for Lyrica in prior fibromyalgia studies in adults, with the exception of mild nausea, which occurred at a higher rate in pregabalin-treated patients. The most common adverse events in this study in pregabalin treated patients were dizziness, nausea, headache, increased weight and fatigue. Full results from the study are expected to be submitted for publication when analyses are complete.
Pfizer Inc. Presents at 12th Annual BIO Asia International Conference, Mar-25-2015 11:30 AM
Mar 12 15
Pfizer Inc. Presents at 12th Annual BIO Asia International Conference, Mar-25-2015 11:30 AM. Venue: Grand Hyatt Hotel, Tokyo, Japan.