BRISTOL MYERS SQUIBB

Bristol Myers Squibb Receives Positive CHMP Opinion for Zeposia (ozanimod) as a Treatment for Adult Patients with Moderately to Severely Active Ulcerative Colitis

Retrieved on: 
Friday, October 15, 2021

The CHMP adopted this positive opinion based on data from True North, a pivotal Phase 3 trial evaluating Zeposia as an induction and maintenance therapy versus placebo in adult patients with moderately to severely active UC.

Key Points: 
  • The CHMP adopted this positive opinion based on data from True North, a pivotal Phase 3 trial evaluating Zeposia as an induction and maintenance therapy versus placebo in adult patients with moderately to severely active UC.
  • The U.S. Food and Drug Administration approved Zeposia for the treatment of adults with moderately to severely active UC on May 27, 2021.
  • Bristol Myers Squibb thanks the patients and investigators involved in the True North clinical trial.
  • Bristol Myers Squibb is continuing to evaluate Zeposia in an open-label extension trial, which is ongoing and designed to assess the longer-term profile of Zeposia for the treatment of moderately to severely active ulcerative colitis.

Bristol Myers Squibb Announces Up to Five Years of Data from Long-Term DAYBREAK Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis

Retrieved on: 
Wednesday, October 13, 2021

Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared with 10-15% with progressive forms of the disease.

Key Points: 
  • Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared with 10-15% with progressive forms of the disease.
  • Bristol Myers Squibb is inspired by a single vision transforming patients lives through science.
  • Zeposia was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsing forms of multiple sclerosis in March 2020.
  • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis

Retrieved on: 
Thursday, October 7, 2021

Bristol Myers Squibb would like to thank the patients and investigators who were involved in the LATTICE-UC clinical trial.

Key Points: 
  • Bristol Myers Squibb would like to thank the patients and investigators who were involved in the LATTICE-UC clinical trial.
  • Bristol Myers Squibb continues to expect greater than $4 billion non-risk adjusted revenue target for deucravacitinib in 2029.
  • LATTICE-UC (IM011-024) is a Phase 2, randomized, placebo-controlled, multicenter study evaluating the safety and efficacy of deucravacitinib in participants with moderate to severe ulcerative colitis (UC).
  • IM011-127 is a Phase 2, randomized, placebo-controlled, multicenter study evaluating the safety, efficacy and biomarker response of deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

Bristol Myers Squibb Data at the EADV 30th Anniversary Congress Highlight the Growing Body of Evidence on Deucravacitinib and Scientific Advancements for Patients with Serious Dermatologic Diseases

Retrieved on: 
Thursday, September 30, 2021

Bristol Myers Squibb (NYSE: BMY) today announced that data from 19 company-sponsored scientific presentations are being shared at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress taking place September 29 October 2, 2021.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced that data from 19 company-sponsored scientific presentations are being shared at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress taking place September 29 October 2, 2021.
  • These data (Presentation #2857) are being presented today during the Late Breaking News Session from 3:45 4:45 p.m. CEST.
  • Bristol Myers Squibb-sponsored abstracts presented at EADVs 30th Anniversary Congress can be found below and accessed online here .
  • Visit this page on BMS.com for more information on Bristol Myers Squibbs scientific approach and resources on dermatologic immune-mediated diseases.

Eisai and Bristol Myers Squibb Enter Into Global Strategic Collaboration for Eisai’s MORAb-202 Antibody Drug Conjugate

Retrieved on: 
Thursday, June 17, 2021

Eisai Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC).

Key Points: 
  • Eisai Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the companies have entered into an exclusive global strategic collaboration agreement for the co-development and co-commercialization of MORAb-202, an antibody drug conjugate (ADC).
  • MORAb-202 is Eisais first ADC and combines Eisais in house developed anti-folate receptor alpha (FR) antibody, and Eisais anticancer agent eribulin, using an enzyme cleavable linker.
  • Bristol Myers Squibb will be solely responsible for developing and commercializing the drug in regions outside of the collaboration territories.
  • The parties will share profits, research and development and commercialization costs in the collaboration territories and Bristol Myers Squibb will pay Eisai a royalty on sales outside of the collaboration territories.

Bristol Myers Squibb Presents New Data at Digestive Disease Week® on Zeposia (ozanimod) Highlighting Clinical Benefits and Safety Profile in Patients with Ulcerative Colitis

Retrieved on: 
Sunday, May 23, 2021

Of these, 80% and 54.6% of patients who received Zeposia and placebo, respectively, completed the study.

Key Points: 
  • Of these, 80% and 54.6% of patients who received Zeposia and placebo, respectively, completed the study.
  • Patients discontinuing treatment due to TEAEs included 3 patients receiving Zeposia and 6 patients receiving placebo; disease relapse (13.5% Zeposia, 33.9% placebo) was the most common reason for discontinuation.
  • Ulcerative colitis has a major impact on patients' health-related quality of life, including physical functioning, social and emotional well-being and ability to work.
  • The European Medicines Agency validated Bristol Myers Squibb\xe2\x80\x99s Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active ulcerative colitis in December 2020.

Bristol Myers Squibb Presents Positive Data from Two Pivotal Phase 3 Psoriasis Studies Demonstrating Superiority of Deucravacitinib Compared to Placebo and Otezla® (apremilast)

Retrieved on: 
Friday, April 23, 2021

PASI 75 is defined as at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores.

Key Points: 
  • PASI 75 is defined as at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores.
  • In the same timeframe across both studies, EAIRs for AEs leading to discontinuation were 9.4 with placebo, 4.4 with deucravacitinib and 11.6 with Otezla.
  • Bristol Myers Squibb scientists designed deucravacitinib to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-12, IL-23 and Type 1 interferon (IFN), key cytokines involved in psoriasis pathogenesis.
  • In addition to POETYK PSO-1 and POETYK PSO-2, Bristol Myers Squibb is evaluating deucravacitinib in three other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462); POETYK PSO-4 (NCT03924427); POETYK PSO-LTE (NCT04036435).