CELGENE

Celgene Announces Plans to Transfer Listing of Celgene’s Contingent Value Rights Following Closing of Acquisition by Bristol-Myers Squibb

Retrieved on: 
Wednesday, November 20, 2019

Celgene Corporation (NASDAQ: CELG) announced today that following the completion of Celgenes acquisition by Bristol-Myers Squibb Company (NYSE: BMY), Bristol-Myers Squibb and Celgene plan to transfer the listing of Celgenes contingent value rights (NASDAQ: CELGZ) (Celgene CVRs) that are related to Celgenes ABRAXANE product from the NASDAQ Global Market to the New York Stock Exchange (NYSE).

Key Points: 
  • Celgene Corporation (NASDAQ: CELG) announced today that following the completion of Celgenes acquisition by Bristol-Myers Squibb Company (NYSE: BMY), Bristol-Myers Squibb and Celgene plan to transfer the listing of Celgenes contingent value rights (NASDAQ: CELGZ) (Celgene CVRs) that are related to Celgenes ABRAXANE product from the NASDAQ Global Market to the New York Stock Exchange (NYSE).
  • As a result, Celgene notified the NASDAQ Global Market today of its intent to initiate the voluntary delisting of the Celgene CVRs.
  • Forward-looking statements can be identified by the words expects, anticipates, believes, intends, estimates, plans, will, outlook and similar expressions.
  • Forward-looking statements are based on managements current plans, estimates, assumptions and projections, and speak only as of the date they are made.

Celgene Receives CHMP Positive Opinion for REVLIMID® (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously Treated Follicular Lymphoma

Retrieved on: 
Friday, November 15, 2019

In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.

Key Points: 
  • In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.
  • REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.
  • To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.
  • 7 ClinicalTrials.gov Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) (AUGMENT).

Celgene to Present New and Updated Data on Key Hematology Pipeline Therapies at American Society of Hematology (ASH) 2019 Annual Meeting

Retrieved on: 
Wednesday, November 6, 2019

Information about the REVLIMID REMS program is available at www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.

Key Points: 
  • Information about the REVLIMID REMS program is available at www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.
  • Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study.
  • Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patients underlying risks.
  • Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant.

Celgene Corporation Names Second Round of Celgene Cancer Care Links™ Program Grant Recipients

Retrieved on: 
Friday, September 20, 2019

Celgene Cancer Care Links is a grant program to support health care capacity initiatives that enhance patient cancer care in resource-constrained countries.

Key Points: 
  • Celgene Cancer Care Links is a grant program to support health care capacity initiatives that enhance patient cancer care in resource-constrained countries.
  • Celgene Cancer Care Links is a demonstration of Celgene's commitment to improving the lives of patients worldwide.
  • The Celgene Cancer Care Links program is also featured in Access Accelerated, a group of over 20 biopharmaceutical companies developing innovative and sustainable solutions to improve access to non-communicable disease treatment and care in low and middle-income countries.
  • For more information on these programs, as well as Celgenes Corporate Responsibility and Global Health efforts, please visit the following links:

Celgene Announces Phase 3 QUAZAR® AML-001 Study of CC-486 as Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Met Primary and Key Secondary Endpoints

Retrieved on: 
Thursday, September 12, 2019

Celgene Corporation (NASDAQ: CELG) today announced top-line results from the international phase 3, randomized, double-blind, placebo-controlled study, QUAZAR AML-001.

Key Points: 
  • Celgene Corporation (NASDAQ: CELG) today announced top-line results from the international phase 3, randomized, double-blind, placebo-controlled study, QUAZAR AML-001.
  • The study demonstrated that maintenance treatment with CC-486 resulted in a highly statistically significant and clinically meaningful improvement in overall survival compared to placebo.
  • The key secondary endpoint of relapse-free survival (RFS) also showed a statistically significant improvement.
  • Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control.

Data from Ozanimod Clinical Development Program in Relapsing Forms of Multiple Sclerosis to Be Presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis

Retrieved on: 
Monday, September 9, 2019

Celgene is committed to furthering our understanding of multiple sclerosis (MS) and the full potential of ozanimod, said Terrie Curran, President, Global Inflammation and Immunology, Celgene.

Key Points: 
  • Celgene is committed to furthering our understanding of multiple sclerosis (MS) and the full potential of ozanimod, said Terrie Curran, President, Global Inflammation and Immunology, Celgene.
  • A New Drug Application for ozanimod for the treatment of adults with RMS is currently under review by the U.S. Food and Drug Administration (FDA).
  • Under the Prescription Drug User Fee Act, the FDA has set its action date as March 25, 2020.
  • Multiple sclerosis (MS) is a disease in which the immune system attacks the protective myelin sheath that covers the nerves.

U.S. FDA Approves INREBIC® (Fedratinib) as First New Treatment in Nearly a Decade for Patients With Myelofibrosis

Retrieved on: 
Friday, August 16, 2019

We are excited to provide INREBIC as a new treatment option that may be used in patients with myelofibrosis, including patients previously treated with ruxolitinib.

Key Points: 
  • We are excited to provide INREBIC as a new treatment option that may be used in patients with myelofibrosis, including patients previously treated with ruxolitinib.
  • Thiamine levels should be assessed in all patients prior to starting INREBIC, periodically during treatment, and as clinically indicated.1 Do not start INREBIC in patients with thiamine deficiency; replete thiamine prior to treatment initiation.
  • Dosage reductions due to an adverse reaction during the randomized treatment period occurred in 19% of patients who received INREBIC.
  • INREBIC is a much-welcomed new treatment for the myelofibrosis community, said Ann Brazeau, Chief Executive Officer and Founder, MPN Advocacy and Education International.

FDA Approves OTEZLA® (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease

Retrieved on: 
Friday, July 19, 2019

OTEZLA, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the first and only approved treatment option for oral ulcers associated with Behets Disease, a rare, chronic, multisystem inflammatory disease that is difficult to treat.

Key Points: 
  • OTEZLA, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the first and only approved treatment option for oral ulcers associated with Behets Disease, a rare, chronic, multisystem inflammatory disease that is difficult to treat.
  • Behets Disease is a chronic inflammatory disease in which patients present with symptoms such as oral ulcers that can have a significant impact on daily life, said Mirta Avila Santos, M.D., Executive Director, American Behets Disease Association.
  • Todays approval for OTEZLA marks an important milestone for people with Behets Disease who have been eagerly waiting for treatment options for their oral ulcers.
  • Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behets Disease.