Celgene Fact Sheet

Total Page:16

File Type:pdf, Size:1020Kb

Celgene Fact Sheet Celgene Fact Sheet NEWS EVENTS MARCH 2008 PROFILE CELGENE ACQUIRES PHARMION Celgene Corporation, as a leader in global biotechnology, has built an integrated discovery, In March 2008, Celgene Corporation completed its acquisition of Pharmion Corporation. development and commercialization platform This combination of two outstanding organizations came about as the result of the hard for drug and cell-based therapies that enables the work and talent of each and every employee. Celgene plans to build on both organization’s company to continue to develop value within accomplishments to reach the goal of becoming a leading global biopharmaceutical company its therapeutic franchise areas of cancer and while improving the lives of patients with unmet medical needs. inflammatory diseases. This target-to-therapeutic platform integrates both small molecule and This acquisition brings together three disease-altering therapies in REVLIMID®, THALOMID® cell-based and spans the critical functions and VIDAZA® and provides opportunities to build a new kind of organization focused on required to generate a large and diverse pipeline critical areas of medicine, turning incurable cancers into chronic manageable diseases and of innovative next generation drugs and cell helping healthcare providers deliver positive outcomes for their patients. therapies that address the source of the disease and not just the symptoms. DRIVING GLOBAL EXPANSION FRONT PAGE – we need to add the Euro- BUILDING ON SUCCESS REVLIMID receives Orphan Drug Status in Japan for multiple indications pean Approval for REVLIMID under Driving WITH THE PHARMION February Global Expansion- ACQUISITION 2008 VIDAZA accepted for review by EMEA for high-risk MDS Date in box June 2007 REVLIMID granted full Advances Celgene’s goal to become the leader in blood cancers THALIDOMIDE PHARMION Receives Positive Opinion for Treatment marketing authorization by the European Commission for of First-line Multiple Myeloma from European Medicines Agency use in combination with dexamethasone as a treatment for Leverages Celgene’s clinical, regulatory patients with multiple myeloma who have received at least and commercial potential worldwide January REVLIMID receives marketing authorization approval from Australian one prior therapy Creates substantial opportunity to 2008 Therapeutic Good Administration for treatment of Multiple Myeloma maximize VIDAZA’s potential through REVLIMID receives marketing authorization approval from Canadian combination studies as a result of two BACK PAGE – Therapeutic Products Directorate for treatment of deletion 5q MDS great companies coming together 1. Under Brian Gill’s title take out the Accelerates long-term operational and word “Global” More than 113 abstracts presented at ASH 2007; 25 oral presentations financial opportunities December including updated clinical data for REVLIMID in newly diagnosed multiple 2. Under Investment Considerations Broadens portfolio of disease- 2007 myeloma, non-deletion 5q MDS, chronic lymphocyctic leukemia (CLL) and section – change $2.7 billion to $2.5 billion altering therapies non-hodgkin’s lymphoma (NHL) 3. Under second bullet under Invest- Complements and expands Celgene’s industry leading programs for safety, September ment Considerations needs to read like REVLIMID, in combination with dexamethasone, was compendia listed for access and patient support 2007 newly diagnosed multiple myeloma this: Lead clinical candidates REVLIMID and REVENUE, R&D, & EPS Pharmion released landmark survival data on VIDAZA from a Phase III VIDAZA offer near-term life transforming 1400 August controlled trial in higher risk MDS patients, VIDAZA showed a survival 1300 2007 potential to turn incurable cancers into benefit of 9.4 months compared to conventional care 1200 chronic diseases 1100 REVLIMID granted full marketing authorization by the European 1000 June Commission for use in combination with dexamethasone as a 2007 treatment for patients with multiple myeloma who have received at PIPELINE – 900 least one prior therapy 800 Total Revenue R&D Investment 700 EPS 600 500 400 ORAL ANTI-INFLAMMATORY FRANCHISE 300 $Millions On May 22, Celgene announced plans to advance the development of leading oral 200 anti-inflammatory candidates across a broad range of inflammatory diseases. CC-10004 $1.00 100 (apremilast), an oral TNF antagonist and anti-inflammatory agent has demonstrated significant 0 0 EPS -0.12 -0.02 -0.08 0.08 0.15 0.18 0.53 1.06 activity and an excellent side effect profile in a placebo controlled proof-of-mechanism trial in -$1.00 -100 psoriasis. Based on these results, Celgene is accelerating clinical and regulatory strategies for ’00 ’01 ’02 ’03 ’04 ’05 ’06 ’07 CC-10004 in psoriasis, psoriatic arthritis, rheumatoid arthritis and other inflammatory diseases. CELGENE CORPORATION 86 Morris Avenue • Summit, NJ 07901 • P: 908-673-9000 • F: 908-673-9001 • www.celgene.com PRODUCT PIPELINE Regulatory Filing IMiDs® Compounds: Pre-clinical Phase I Phase II Phase III and Approval / INVESTOR CONTACT *FDA Registered REVLIMID®: Multiple Myeloma (US) . INFORMATION REVLIMID: MDS deletion 5Q (US) . Brian Gill REVLIMID: Multiple Myeloma (EMEA). Vice President REVLIMID: MDS deletion 5Q (EMEA). Corporate Communications REVLIMID: Multiple Myeloma (SWISS) . Email: [email protected] REVLIMID: MDS deletion 5Q (SWISS) . Mary Ann Ondish REVLIMID: MDS . Assoc. Director REVLIMID: CLL. Investor Relations REVLIMID: NHL . Email: [email protected] REVLIMID: Solid Tumors . CELGENE EXECUTIVE pomalidomide (CC-4047): Myelofibrosis. OFFICERS pomalidomide (CC-4047): Multiple Myeloma . Sol J. Barer, Ph.D. pomalidomide (CC-4047): Solid Tumors . Chief Executive Officer pomalidomide (CC-4047): Sickle Cell Anemia CC-11006: MDS . Robert J. Hugin President and COO CC-10015: Rheumatology. CC-16057: Oncology/Inflammation . David W. Gryska, Senior Vice President and CFO THALOMID®: Multiple Myeloma (US) . ANALYST COVERAGE ENL. Alliance Bernstein Banc of America Thalidomide Pharmion 50 MG: Bear Stearns BMO Capital Markets Multiple Myeloma (EMEA). Citigroup Smith Barney Other Cancer. Cowen Credit Suisse Securities VIDAZA® (azacitidine): Friedman, Billings, Ramsey MDS (US) . Goldman Sachs Jeffries MDS (EMEA) . JMP Securities AML . JP Morgan Chase Lazard Capital Markets Solid Tumors . Leerink Swan MDS/AML (Oral azacitidine) . Lehman Brothers ® Merrill Lynch ALKERAN : Morgan Stanley Multiple Myeloma\Ovarian Cancer Robert W. Baird Rodman & Renshaw Ritalin®/FOCALIN™: Thomas Weisel Partners FOCALIN: ADHD . UBS Wachovia Ritalin LA®: ADHD . William Blair & Co FOCALIN XR™: ADHD . INVESTMENT Anti-Inflammatory: CONSIDERATIONS apremilast (CC-10004): Psoriasis . apremilast (CC-10004): Psoriatic Arthritis . Profitable and accelerating revenue apremilast (CC-10004): Behcet’s Syndrome . growth supporting development of CC-11050: Inflammatory . multiple clinical compounds across several high potential programs Kinase Inhibitors: JNK 930: Fibrotic Diseases . Lead clinical candidates REVLIMID and VIDAZA offer near-term life Ligase Inhibitors: transforming potential to turn incurable Ubiquitin Ligase: Cancer . cancers into chronic diseases Stem Cells and Tissue Products: Cutting edge research in cellular Lifebank USA: Private Stem Cell Banking . signaling technology delivering next HPP: Transplants . generation therapies with potential to PDA-001: Autoimmune/Cancer. change standard of care BIOVANCE and Acelagraft™ . Strong, evolving intellectual property MGCD0103: estate supporting a broad, deep, Solid Tumors (w/ gemcitabine) . proprietary pipeline addressing large, Hematologic Malignancies. international commercial opportunities w/ Vidaza in MDS/AML . Financial strength with over $2.5 w/ Vidaza in lymphoma . billion in cash and marketable AMRUBICIN®: securities positioned to support SCLC. long-term growth strategy w/ Cisplatin for SCLC . Effective senior management team Breast Cancer. experienced in successful execution of ACTIVIN INHIBITOR corporate strategies ACE-011 Cancer-related bone loss . The products represented as in development and found in the product pipeline are intended for investors and members of the media to provide general information on Celgene. This information is not represented to be a complete description and is subject to change without notice. Celgene Corporation may from time to time update this information but does not warrant that will take place at any particular time nor assume any obligation to update this information..
Recommended publications
  • Abstracts from the 5Th World Psoriasis & Psoriatic Arthritis Conference 2018
    ISSN 0001-5555 ActaDV Volume 98 2018 Supplement No. 219 ADVANCES IN DERMATOLOGY AND VENEREOLOGY A Non-profit International Journal for Interdisciplinary Skin Research, Clinical and Experimental Dermatology and Sexually Transmitted Diseases Abstracts from the 5th World Psoriasis & Psoriatic Arthritis Conference 2018 Official Journal of June 27–30, 2018 - European Society for Dermatology and Psychiatry Affiliated with Stockholm, Sweden - The International Forum for the Study of Itch Immediate Open Access Acta Dermato-Venereologica www.medicaljournals.se/adv DV cta A enereologica V ermato- D cta A DV cta A dvances in dermatology and venereology A Abstracts from the 5th World Psoriasis & Psoriatic Arthritis Conference 2018 www.medicaljournals.se/acta doi: 10.2340/00015555-2978 Journal Compilation © 2018 Acta Dermato-Venereologica. Acta Derm Venereol 2018; Suppl 219 2 5th World Psoriasis & Psoriatic Arthritis Conference 2018 Ref.no Title Biomarkers and Imaging 001 A metagenomics study of the elbow of psoriasis subjects and their healthy relatives Clinical phenotypes 002 Nail disorders in patients with Psoriasis vulgaris 003 Psoriasis hidden in Gottron’s papules Comorbidities 004 Characteristics of psoriasis in obese patients versus non-obese patients; a multicenter study 005 Psoriasis and comorbidity 006 Risk of periodontal disease in patients with chronic plaque psoriasis 007 Splenomegaly and Psoriasis - A case report 008 Psoriasis as predictor for cardiovascular and metabolic comorbidity in middle-aged women 009 A Case of Concurrent Psoriasis and Vitiligo 010 Successful long-term double disease control by adalimumab in a patient with psoriasis vulgaris and hidradenitis suppurativa 011 Clinical and epidemiological caracterization of psoriasis and psoriatic arthritis on a multidisciplinary assesment model.
    [Show full text]
  • Us 8530498 B1 3
    USOO853 0498B1 (12) UnitedO States Patent (10) Patent No.: US 8,530,498 B1 Zeldis (45) Date of Patent: *Sep. 10, 2013 (54) METHODS FORTREATING MULTIPLE 5,639,476 A 6/1997 OShlack et al. MYELOMAWITH 5,674,533 A 10, 1997 Santus et al. 3-(4-AMINO-1-OXO-1,3-DIHYDROISOINDOL- 395 A 22 N. 2-YL)PIPERIDINE-2,6-DIONE 5,731,325 A 3/1998 Andrulis, Jr. et al. 5,733,566 A 3, 1998 Lewis (71) Applicant: Celgene Corporation, Summit, NJ (US) 5,798.368 A 8, 1998 Muller et al. 5,874.448 A 2f1999 Muller et al. (72) Inventor: Jerome B. Zeldis, Princeton, NJ (US) 5,877,200 A 3, 1999 Muller 5,929,117 A 7/1999 Muller et al. 5,955,476 A 9, 1999 Muller et al. (73) Assignee: Celgene Corporation, Summit, NJ (US) 6,020,358 A 2/2000 Muller et al. - 6,071,948 A 6/2000 D'Amato (*) Notice: Subject to any disclaimer, the term of this 6,114,355 A 9, 2000 D'Amato patent is extended or adjusted under 35 SS f 1939. All et al. U.S.C. 154(b) by 0 days. 6,235,756 B1 5/2001 D'Amatoreen et al. This patent is Subject to a terminal dis- 6,281.230 B1 8/2001 Muller et al. claimer 6,316,471 B1 1 1/2001 Muller et al. 6,326,388 B1 12/2001 Man et al. 6,335,349 B1 1/2002 Muller et al. (21) Appl. No.: 13/858,708 6,380.239 B1 4/2002 Muller et al.
    [Show full text]
  • Cereblon and Its Downstream Substrates As Molecular Targets of Immunomodulatory Drugs
    Int J Hematol (2016) 104:293–299 DOI 10.1007/s12185-016-2073-4 PROGRESS IN HEMATOLOGY Mechanisms of action of novel drugs in multiple myeloma and those responsible for the acquired resistance Cereblon and its downstream substrates as molecular targets of immunomodulatory drugs Takumi Ito1,2 · Hiroshi Handa1 Received: 15 June 2016 / Revised: 19 July 2016 / Accepted: 19 July 2016 / Published online: 26 July 2016 © The Japanese Society of Hematology 2016 Abstract Thalidomide was first developed as a sedative History of immunomodulatory drugs (IMiDs) around 60 years ago, but exhibited teratogenicity, leading to serious defects such as limb deformities. Nevertheless, Immunomodulatory drugs (IMiDs) are a new class of anti- thalidomide is now recognized as a therapeutic drug for the cancer drugs for which the parent molecule is thalidomide. treatment of Hansen’s disease and myeloma. Immunomod- Thalidomide (Fig. 1) was developed as a sedative in 1950s ulatory drugs (IMiDs), a new class of anti-cancer drug by the German pharmaceutical company Grunenthal. derived from thalidomide, have also been developed and Experiments using rodents initially suggested it to be safe exert potent anti-cancer effects. Although the molecular for use in humans, and the drug was sold over 40 countries, mechanism of thalidomide and IMiDs remained unclear for including Japan. However, as is widely known, thalidomide a long time, cereblon, a substrate receptor of the CRL4 E3 was found to have serious teratogenic effects. Use during ubiquitin ligase was identified as a primary direct target by pregnancy is associated with developmental defects of the a new affinity technique. A growing body of evidence sug- limbs and ears.
    [Show full text]
  • Characterization of Ocular Adverse Events in Patients Receiving
    Characterization of Ocular Adverse Events in Patients Receiving Belantamab Mafadotin for ≥12 Months: Post-Hoc Analysis of DREAMM-2 Study in Relapsed/Refractory Multiple Myeloma S. LONIAL1; A.K. NOOKA1; P. THULASI2; A.Z. BADROS3; B.H. JENG3; N.S. CALLANDER4; D. SBOROV5; B.E. ZAUGG6; R. POPAT7; S. DEGLI ESPOSTI8; J. BARON9; A. DOHERTY9; E. LEWIS10; J. OPALINSKA9; P. PAKA9; T. PIONTEK9; I. GUPTA9; A.V. FAROOQ11; A. JAKUBOWIAK11 | 1Emory University, Winship Cancer Institute, Atlanta, GA, USA; 2Emory Eye Center, Emory University, Atlanta, GA, USA; 3University of Maryland School of Medicine, Baltimore, MD, USA; 4University of Wisconsin, Carbone Cancer Center, Madison, WI, USA; 5Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA; 6Moran Eye Center, University of Utah, Salt Lake City, UT, USA; 7University College London Hospitals, NHS Foundation Trust, London, UK; 8NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK; 9GlaxoSmithKline, Collegeville, PA, USA; 10GlaxoSmithKline, Research Triangle Park, NC, USA; 11University of Chicago Medical Center, Chicago, IL, USA Dose delays and reductions related to ocular adverse events INTRODUCTION RESULTS All 14 patients required ≥2 dose delays, with dose reduction (to 1.92 mg/kg) in CONCLUSIONS Belantamab mafodotin (belamaf; GSK2857916) is a first-in-class, monomethyl auristatin F (MMAF)-containing 12 patients (86%). Demographics, efficacy, and overall safety information for patients treated with belamaf In this subset of 14 patients from the DREAMM-2 study, the median duration of response was antibody–drug conjugate (ADC) that binds to B-cell maturation antigen (BCMA) and eliminates multiple myeloma cells by for ≥12 months ● Patients experienced a mean of 3.6 dose delays over the ≥12 months of treatment a multimodal mechanism of action.1 (median: 3.5, range: 2–6).
    [Show full text]
  • Apremilast and Systemic Retinoid Combination Treatment for Moderate to Severe Palmoplantar Psoriasis
    CASE LETTER Apremilast and Systemic Retinoid Combination Treatment for Moderate to Severe Palmoplantar Psoriasis Tali Czarnowicki, MD, MSc; B. Peter Rosendorff, PhD; Mark G. Lebwohl, MD copy accumulating evidence suggests that it is accompanied PRACTICE POINTS by a multitude of systemic inflammatory comorbidities.5 • Palmoplantar psoriasis is challenging to treat and is This insight supports the concept of systemic treatment unresponsive to many modalities. for patients with moderate to severe psoriasis. As a • Combination, rotational, and sequential treatment chronic disease, psoriasis requires continuous therapy. approaches may minimize side effects and loss of The treatment approach should focus on achieving efficacy as well as enhance treatment responses. efficacynot and minimizing side effects. These goals can • Apremilast and acitretin combination therapy led to be achieved by combination, rotational, and sequential 90% skin improvement in a case of severe recalcitrant treatment approaches.6 Many therapeutic combinations palmoplantar psoriasis. have proven effective, using beneficially different mecha- nisms of action (MOAs) and toxicity profiles.7 We present a patient with moderate to severe recalcitrant palmo- Doplantar psoriasis who demonstrated improvement with To the Editor: combination therapy. Psoriasis is a chronic inflammatory papulosquamous skin A 50-year-old man presented with palmoplantar pso- disease affecting 2% to 3% of the population.1 Its patho- riasis of 7 years’ duration. His medical history included genesis is multifactorial, consisting of a disrupted skin mild hyperlipidemia treated with atorvastatin. Prior topi- barrier and dysregulated immune activation.2 cal treatments including calcipotriene, betamethasone A wide armamentarium of topical and systemic treat- dipropionate, and tacrolimus ointment did not result in ments targeting different aspects of the disease patho- improvement.
    [Show full text]
  • Nurse-Led Drug Monitoring Clinic Protocol for the Use of Systemic Therapies in Dermatology for Patients
    Group arrangements: Salford Royal NHS Foundation Trust (SRFT) Pennine Acute Hospitals NHS Trust (PAT) Nurse-led drug monitoring clinic protocol for the use of systemic therapies in dermatology for patients with inflammatory dermatoses Lead Author: Dawn Lavery Dermatology Advanced Nurse Practitioner Additional author(s) N/A Division/ Department:: Dermatology, Clinical Support and Tertiary Medicine Applies to: (Please delete) Salford Royal Care Organisation Approving Committee Dermatology clinical governance committee Salford Royal Date approved: 13 February 2019 Expiry date: February 2022 Contents Contents Section Page Document summary sheet 1 Overview 2 2 Scope & Associated Documents 2 3 Background 3 4 What is new in this version? 3 5 Policy 4 Drugs monitored by nurses 4 Acitretin 7 Alitretinoin Toctino 11 Apremilast 22 Azathioprine 26 Ciclosporin 29 Dapsone 34 Fumaric Acid Esters – Fumaderm and Skilarence 36 Hydroxycarbamide 39 Hydroxychloroquine 43 Methotrexate 50 Mycophenolate moefetil 57 Nurse-led drug monitoring clinic protocol for the use of systemic therapies in dermatology for patients with inflammatory dermatoses Reference Number GSCDerm01(13) Version 3 Issue Date: 11/06/2019 Page 1 of 77 It is your responsibility to check on the intranet that this printed copy is the latest version Standards 67 6 Roles and responsibilities 67 7 Monitoring document effectiveness 67 8 Abbreviations and definitions 68 9 References 68 10 Appendices N/A 11 Document Control Information 71 12 Equality Impact Assessment (EqIA) screening tool 73 Group arrangements: Salford Royal NHS Foundation Trust (SRFT) Pennine Acute Hospitals NHS Trust (PAT) 1. Overview (What is this policy about?) The dermatology directorate specialist nurses are responsible for ensuring prescribing and monitoring for patients under their care, is in accordance with this protocol.
    [Show full text]
  • Overcoming the Immunosuppressive Tumor Microenvironment in Multiple Myeloma
    cancers Review Overcoming the Immunosuppressive Tumor Microenvironment in Multiple Myeloma Fatih M. Uckun 1,2,3 1 Norris Comprehensive Cancer Center and Childrens Center for Cancer and Blood Diseases, University of Southern California Keck School of Medicine (USC KSOM), Los Angeles, CA 90027, USA; [email protected] 2 Department of Developmental Therapeutics, Immunology, and Integrative Medicine, Drug Discovery Institute, Ares Pharmaceuticals, St. Paul, MN 55110, USA 3 Reven Pharmaceuticals, Translational Oncology Program, Golden, CO 80401, USA Simple Summary: This article provides a comprehensive review of new and emerging treatment strategies against multiple myeloma that employ precision medicines and/or drugs capable of improving the ability of the immune system to prevent or slow down the progression of multiple myeloma. These rationally designed new treatment methods have the potential to change the therapeutic landscape in multiple myeloma and improve the long-term survival outcome. Abstract: SeverFigurel cellular elements of the bone marrow (BM) microenvironment in multiple myeloma (MM) patients contribute to the immune evasion, proliferation, and drug resistance of MM cells, including myeloid-derived suppressor cells (MDSCs), tumor-associated M2-like, “alter- natively activated” macrophages, CD38+ regulatory B-cells (Bregs), and regulatory T-cells (Tregs). These immunosuppressive elements in bidirectional and multi-directional crosstalk with each other inhibit both memory and cytotoxic effector T-cell populations as well as natural killer (NK) cells. Immunomodulatory imide drugs (IMiDs), protease inhibitors (PI), monoclonal antibodies (MoAb), Citation: Uckun, F.M. Overcoming the Immunosuppressive Tumor adoptive T-cell/NK cell therapy, and inhibitors of anti-apoptotic signaling pathways have emerged as Microenvironment in Multiple promising therapeutic platforms that can be employed in various combinations as part of a rationally Myeloma.
    [Show full text]
  • COMPARISON of the WHO ATC CLASSIFICATION & Ephmra/Intellus Worldwide ANATOMICAL CLASSIFICATION
    COMPARISON OF THE WHO ATC CLASSIFICATION & EphMRA/Intellus Worldwide ANATOMICAL CLASSIFICATION: VERSION June 2019 2 Comparison of the WHO ATC Classification and EphMRA / Intellus Worldwide Anatomical Classification The following booklet is designed to improve the understanding of the two classification systems. The development of the two systems had previously taken place separately. EphMRA and WHO are now working together to ensure that there is a convergence of the 2 systems rather than a divergence. In order to better understand the two classification systems, we should pay attention to the way in which substances/products are classified. WHO mainly classifies substances according to the therapeutic or pharmaceutical aspects and in one class only (particular formulations or strengths can be given separate codes, e.g. clonidine in C02A as antihypertensive agent, N02C as anti-migraine product and S01E as ophthalmic product). EphMRA classifies products, mainly according to their indications and use. Therefore, it is possible to find the same compound in several classes, depending on the product, e.g., NAPROXEN tablets can be classified in M1A (antirheumatic), N2B (analgesic) and G2C if indicated for gynaecological conditions only. The purposes of classification are also different: The main purpose of the WHO classification is for international drug utilisation research and for adverse drug reaction monitoring. This classification is recommended by the WHO for use in international drug utilisation research. The EphMRA/Intellus Worldwide classification has a primary objective to satisfy the marketing needs of the pharmaceutical companies. Therefore, a direct comparison is sometimes difficult due to the different nature and purpose of the two systems.
    [Show full text]
  • Australian Pi – Pomalyst (Pomalidomide) Capsules
    AUSTRALIAN PI – POMALYST (POMALIDOMIDE) CAPSULES Teratogenic effects: Pomalyst (pomalidomide) is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If pomalidomide is taken during pregnancy, it may cause birth defects or death to an unborn baby. Women should be advised to avoid pregnancy whilst taking Pomalyst (pomalidomide), during dose interruptions, and for 4 weeks after stopping the medicine. 1 NAME OF THE MEDICINE Australian Approved Name: pomalidomide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mg capsule contains 1 mg pomalidomide. Each 2 mg capsule contains 2 mg pomalidomide. Each 3 mg capsule contains 3 mg pomalidomide. Each 4 mg capsule contains 4 mg pomalidomide. For the full list of excipients, see Section 6.1. Description Pomalidomide is a yellow solid powder. It is practically insoluble in water over the pH range 1.2-6.8 and is slightly soluble (eg. acetone, methylene chloride) to practically insoluble (eg. heptanes, ethanol) in organic solvents. Pomalidomide has a chiral carbon atom and exists as a racemic mixture of the R(+) and S(-) enantiomers. 3 PHARMACEUTICAL FORM Pomalyst (pomalidomide) 1 mg capsules: dark blue/yellow size 4 gelatin capsules marked “POML” in white ink and “1 mg” in black ink. Each 1 mg capsule contains 1 mg of pomalidomide. Pomalyst (pomalidomide) 2 mg capsules: dark blue/orange size 2 gelatin capsules marked “POML 2 mg” in white ink. Each 2 mg capsule contains 2 mg of pomalidomide. Pomalyst (pomalidomide) 3 mg capsules: dark blue/green size 2 gelatin capsules marked “POML 3 mg” in white ink.
    [Show full text]
  • Pomalidomide the POMALYST® Program
    Pomalidomide The POMALYST® Program Overview Multiple myeloma is a type of cancer that begins in plasma cells in bone marrow. Plasma cells are white blood cells that make antibodies. The abnormal plasma cells build up in the bone marrow and sometimes in the solid part of the bone. Pomalidomide (brand name Pomalyst®) is approved to treat certain patients with multiple myeloma, but only under a restricted distribution program. Before you start taking this drug, you and your loved ones should read the important information in this brochure about the medication, side effects, and the rules you must follow if you choose pomalidomide, including the requirement to use birth control. Safety Pomalidomide is similar to the drug thalidomide and can cause the same life threatening birth defects. Both medications are approved by the Food and Drug Administration (FDA) to treat multiple myeloma within restricted distribution programs. For pomalidomide, the program is called Pomalyst REMS™ (Risk Evaluation and Mitigation Strategy). The program is in place to make sure that everyone is following the established safety guidelines. Only providers (doctors, nurse practitioners, etc.) and pharmacies certified by this program can write prescriptions for this medication or dispense it. To be considered for pomalidomide: • you must have already tried at least 2 other therapies, including lenalidomide and bortezomib • your disease must have progressed within 60 days of completing your last therapy • you must enroll in the Pomalyst REMS program and agree to comply with the program’s requirements (detailed in this brochure) Your healthcare provider will counsel you about the risks and benefits of this therapy.
    [Show full text]
  • Australian Public Assessment Report for Apremilast
    Australian Public Assessment Report for Apremilast Proprietary Product Name: Otezla Sponsor: Celgene Pty Ltd October 2015 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) · The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating medicines and medical devices. · The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website <https://www.tga.gov.au>. About AusPARs · An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. · AusPARs are prepared and published by the TGA. · An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations, and extensions of indications. · An AusPAR is a static document, in that it will provide information that relates to a submission at a particular point in time. · A new AusPAR will be developed to reflect changes to indications and/or major variations to a prescription medicine subject to evaluation by the TGA.
    [Show full text]
  • Prior Authorization Inflammatory Conditions – Otezla® (Apremilast Tablets)
    Cigna National Formulary Coverage Policy Prior Authorization Inflammatory Conditions – Otezla® (apremilast tablets) Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 42932 Conditions Not Covered....................................... 2 Background .......................................................... 3 References .......................................................... 4 Revision History ................................................... 4 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation.
    [Show full text]