DOCSLIB.ORG

PIXUVRI, INN-Pixantrone

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
PIXUVRI, INN-Pixantrone 28 March 2019 EMA/250839/2019 Committee for Medicinal Products for Human Use (CHMP) Assessment report Pixuvri International non-proprietary name: pixantrone Procedure No. EMEA/H/C/002055/R/0046 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2019. Reproduction is authorised provided the source is acknowledged. Status of this report and steps taken for the assessment Current Description Planned Actual Date Need for step¹ date discussion² Start of procedure: 03 Dec 2018 03 Dec 2018 CHMP and PRAC Rapporteurs Joint Assessment 03 Jan 2019 07 Jan 2019 Report CHMP and PRAC members comments 07 Jan 2019 11 Jan 2019 Updated CHMP and PRAC Rapporteurs Joint 10 Jan 2019 17 Jan 2019 Assessment Report PRAC endorsed relevant sections of the 17 Jan 2019 17 Jan 2019 assessment report³ Request for supplementary information 31 Jan 2019 MAH responses to (RfSI) received on 05 Mar 2019 06 Mar 2019 CHMP and PRAC Rapporteurs' joint assessment 13 Mar 2019 15 Mar 2019 report PRAC endorsed relevant sections of the 14 Mar 2019 15 Mar 2019 assessment report CHMP and PRAC members comments 18 Mar 2019 21 Mar 2019 Updated CHMP and PRAC Rapporteurs joint 21 Mar 2019 22 Mar 2019 assessment report Opinion 28 Mar 2019 5 Apr 2019 ¹ Tick the box corresponding to the applicable step – do not delete any of the steps. If not applicable, add n/a instead of the date. ² Criteria for PRAC plenary discussion: interim results/outcome of the SOB that is a non-interventional PASS study challenging the benefit/risk balance of the product; new imposed non-interventional PASS resulting from the annual renewal (annex II condition); divergent positions between the Committees (CHMP and PRAC Rapp and CHMP and PRAC members) on specific aspects with significant impact on the B/R and any other situation at the discretion of the PRAC rapporteur. Criteria for CHMP plenary discussion: interim results/outcome of the SOB challenging the benefit/risk balance of the product; fulfilment of all SOBs; new imposed PASS/PAES resulting from the annual renewal (annex II condition); divergent positions between the Committees (CHMP and PRAC Rapp and CHMP and PRAC members) on specific aspects with significant impact on the B/R and any other situation at the discretion of the CHMP rapporteur. ³ Sections related to data on non-interventional PASS imposed as an SOB, Risk Management Plan (safety concerns, Pharmacovigilance plans, Risk minimisation Measures), sections on issues originating from parallel/recent PSUR or signal assessment, additional monitoring, pharmacovigilance inspections and Assessment report EMA/250839/2019 Page 2/107 preliminary conclusions on the benefit/risk balance. Declarations The assessor confirms that proprietary information on, or reference to, third parties or products are not included in this assessment, unless there are previous contracts and/or agreements with the third parties. (Non-Clinical/Clinical/Pharmacovigilance) The assessor confirms that reference to ongoing assessments or development plans for other products is not included in this assessment report. …………………………… Assessment report EMA/250839/2019 Page 3/107 Table of contents 1. Background information on the annual renewal ...................................... 5 2. Overall conclusions and benefit-risk balance .......................................... 5 2.1. Specific Obligations (SOBs) ................................................................................... 5 2.2. Benefit-risk Balance ............................................................................................. 5 3. Recommendations ................................................................................. 14 4. EPAR changes ....................................................................................... 14 Annex: Rapporteurs’ assessment comments on the renewal .................... 16 5. Specific Obligations ............................................................................... 17 5.1. Specific Obligations adopted with the initial marketing authorisation......................... 17 5.2. Outstanding Specific Obligations – status report for period covered .......................... 17 5.3. Other clinical studies of relevance ........................................................................ 91 5.4. Overall conclusion on Specific Obligations ............................................................. 96 6. Additional scientific data provided relevant for the assessment of the benefit/risk balance .................................................................................. 96 6.1. Quality .............................................................................................................. 96 6.2. Non-clinical ....................................................................................................... 96 6.3. Clinical pharmacology ......................................................................................... 96 6.4. Clinical efficacy .................................................................................................. 97 6.5. Clinical safety .................................................................................................... 97 6.6. Pharmacovigilance inspections ........................................................................... 101 6.7. Discussion ....................................................................................................... 101 7. Risk management plan ........................................................................ 101 7.1. Overall conclusion on the RMP ........................................................................... 107 8. Changes to the Product Information ................................................... 107 Assessment report EMA/250839/2019 Page 4/107 1. Background information on the annual renewal The European Commission issued on 10 May 2012, a conditional marketing authorisation (MA) for Pixuvri This implied that, pursuant to Article 14(7) of Regulation (EC) No 726/2004 and Article 5 of Commission Regulation (EC) No 507/2006, the marketing authorisation holder (MAH) has to complete ongoing studies, or to conduct new studies, as listed in Annex II.E of the MA, the so-called Specific Obligations (SOBs). These data form the basis of the renewal of the conditional MA. A conditional MA is valid for one year and may be renewed annually upon request by the MAH. Therefore, pursuant to Article 14 (7) of Regulation (EC) No 726/2004 and Article 6(2) of Commission Regulation (EC) No 507/2006, the MAH CTI Life Sciences Limited, submitted to the Agency on 30 November 2018 an application for renewal of the conditional MA for Pixuvri. The expiry date of the MA is 14 May 2019. The period covered by this annual renewal is 1 September 2017 to 31 August 2018. The application contained a justification in support of the possible granting of a marketing authorisation no longer subject to specific obligations. 2. Overall conclusions and benefit-risk balance 2.1. Specific Obligations (SOBs) Compliance of SOB data submitted During the period covered by this annual renewal data on the SOBs have been submitted that overall are compliant in terms of adherence to deadlines. Updated list of specific obligations (SOBs) None remaining. 2.2. Benefit-risk Balance During the period covered by this annual renewal, new data have been reported from the trial conducted as part of the SOBs. These data are considered comprehensive in the sense of the CMA regulation, as well as supportive of the positive benefit-risk of Pixuvri in the approved indication. Treatment of patients with relapsed DLBCL is challenging. If treatment with the currently most effective regimen in the first line (R-CHOP) fails to provide cure, the probability of achieving long-term disease suppression or cure with second or further lines of treatment is low. A potentially curative second line treatment is salvage chemotherapy followed by autologous stem cell transplantation (ASCT). However, significant associated toxicities preclude proceeding for a substantial fraction of patients, with comorbidities or advanced age, to this procedure. Recently, two CAR-T cell immunotherapies (Yescarta and Kymriah) were authorised in the EU for patients with relapsed or refractory DLBCL after two or more lines of systemic therapy which are intended for patients with sufficient disease control to await the manufacturing times and who are able to tolerate the conditioning regimen. The use of these products is associated with life-threatening and in some cases even fatal toxicities, excluding the patient population for whom ASCT is not an option. Assessment report EMA/250839/2019 Page 5/107 Pixuvri was approved in 2012 as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive Non-Hodgkin B-cell Lymphomas (NHL) with palliative intent approach as a third or fourth line treatment. With the results from study PIX306 the benefit of pixantrone in patients who had received prior treatment with rituximab would be corroborated and the requirement to convert a conditional MA into a full MA (that is, without specific obligations) fulfilled. The MAH has now provided results from study
Load more

Recommended publications
  • Monotherapy with Pixantrone in Histologically Confirmed Relapsed Or
    research paper Monotherapy with pixantrone in histologically confirmed relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: post-hoc analyses from a phase III trial Ruth Pettengell,1 Catherine Sebban,2 This post hoc analysis of a phase 3 trial explored the effect of pixantrone in Pier Luigi Zinzani,3 Hans Gunter patients (50 pixantrone, 47 comparator) with relapsed or refractory aggres- 4 5 Derigs, Sergey Kravchenko, Jack W. sive B-cell non-Hodgkin lymphoma (NHL) confirmed by centralized histo- 6 7 Singer, Panteli Theocharous, Lixia logical review. Patients received 28-d cycles of 85 mg/m2 pixantrone 7 8 Wang, Mariya Pavlyuk, Kahina M. dimaleate (equivalent to 50 mg/m2 in the approved formulation) on days Makhloufi8 and Bertrand Coiffier9,10 1, 8 and 15, or comparator. The population was subdivided according to 1St George’s University of London, London, UK, 2 previous rituximab use and whether they received the study treatment as Leon Berard Cancer Centre, Lyon, France, – 3Institute of Haematology “Le A Seragnoli”, 3rd or 4th line. Median number of cycles was 4 (range, 2 6) with pix- – University of Bologna, Bologna, Italy, 4St€adt Kli- antrone and 3 (2 6) with comparator. In 3rd or 4th line, pixantrone was Á Á nikum, Frankfurt-Hoeschest, Klinik fur€ Innere associated with higher complete response (CR) (23 1% vs. 5 1% compara- Medizin III, Frankfurt am Main, Germany, tor, P = 0Á047) and overall response rate (ORR, 43Á6% vs. 12Á8%, 5Chemotherapy and Intensive Treatment of Hae- P = 0Á005). In 3rd or 4th line with previous rituximab (20 pixantrone, 18 matology Diseases, Haematology Scientific Centre comparator), pixantrone produced better ORR (45Á0% vs.
    [Show full text]
  • Distinct Cargos of Small Extracellular Vesicles Derived from Hypoxic Cells and Their Effect on Cancer Cells
    International Journal of Molecular Sciences Review Distinct Cargos of Small Extracellular Vesicles Derived from Hypoxic Cells and Their Effect on Cancer Cells Geoffroy Walbrecq, Christiane Margue, Iris Behrmann and Stephanie Kreis * Department of Life Sciences and Medicine (DLSM), University of Luxembourg, 6, avenue du Swing, L-4367 Belvaux, Luxembourg; Geoff[email protected] (G.W.); [email protected] (C.M.); [email protected] (I.B.) * Correspondence: [email protected] Received: 17 June 2020; Accepted: 17 July 2020; Published: 17 July 2020 Abstract: Hypoxia is a common hallmark of solid tumors and is associated with aggressiveness, metastasis and poor outcome. Cancer cells under hypoxia undergo changes in metabolism and there is an intense crosstalk between cancer cells and cells from the tumor microenvironment. This crosstalk is facilitated by small extracellular vesicles (sEVs; diameter between 30 and 200 nm), including exosomes and microvesicles, which carry a cargo of proteins, mRNA, ncRNA and other biological molecules. Hypoxia is known to increase secretion of sEVs and has an impact on the composition of the cargo. This sEV-mediated crosstalk ultimately leads to various biological effects in the proximal tumor microenvironment but also at distant, future metastatic sites. In this review, we discuss the changes induced by hypoxia on sEV secretion and their cargo as well as their effects on the behavior and metabolism of cancer cells, the tumor microenvironment and metastatic events. Keywords: exosomes; extracellular vesicles; cancer; hypoxia; TME; immunity; biomarker 1. Introduction Extracellular vesicles are defined as particles, which are delimited by a lipid bilayer and which cannot replicate [1].
    [Show full text]
  • CTI Corporate Presentation
    20062006 InvestInvest NorthwestNorthwest conferenceconference JamesJames A.A. Bianco,Bianco, M.D.M.D. PresidentPresident andand CEOCEO C E L L T H E R A P E U T I C S, I N C. (N A S D A Q : C T I C) ForwardForward LookingLooking StatementStatement This presentation contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The forward-looking statements contained in this presentation include statements about future financial and operating results, and risks and uncertainties that could affect CTI’s product and products under development. These statements are not guarantees of future performance, involve certain risks, uncertainties and assumptions that are difficult to predict, and are based upon assumptions as to future events that may not prove accurate. Therefore, actual outcomes and results may differ materially from what is expressed herein. In any forward-looking statement in which CTI expresses an expectation or belief as to future results, such expectation or belief is expressed in good faith and believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will result or be achieved or accomplished. The following factors, among others, could cause actual results
    [Show full text]
  • CLINICAL CANCER LETTER Cancer Research News for Clinicians
    Vol. 27 No. 1 THE January 2004 CLINICAL CANCER LETTER Cancer research news for clinicians © Copyright 2004 American Society of Hematology: The Cancer Letter Inc. New Treatment Approaches For A Variety All rights reserved. Of Leukemias Described At ASH Meeting By Lawrence M. Prescott SAN DIEGO—A number of new treatment approaches appear to ASH Annual Meeting: be of real value in patients with a variety of leukemias including acute Trisenox In Children promyelocytic leukemia, chronic lymphocytic leukemia, acute myeloid With APML leukemia, and chronic myeloid leukemia, according to investigators . Page 2 presenting their findings at the 45th annual meeting of the American Society of Hematology last month. (Continued to page 2) Campath In CLL . Page 2 ASH Highlights: Improved Treatments For NHL, Genasense In AML Poor Prognostic Factors For B-Cell In Children . Page 3 By Lawrence M. Prescott SAN DIEGO—New therapeutic modalities for the treatment of Gleevec For CML adults with relapsed and aggressive non-Hodgkin’s lymphoma, as well as . Page 4 the identification of poor prognostic factors in children with advanced B- cell NHL and ways to combat this problem are proving to be of particular Zevalin In Mantle Cell benefit in developing effective therapeutic modalities for patients with . Page 4 forms of difficult-to-treat NHL, said investigators at the 45th annual meeting of the American Society of Hematology. Rituxan In NHL . Page 6 Pixantrone in Relapsed Aggressive NHL A variant of the CHOP (cyclophosphamide, vincristine, prednisone, Sphingosomal Vincristine and doxorubicin) regimen, which substitutes the new anthracycline-derived drug pixantrone for doxorubicin in elderly patients with aggressive NHL Tested in Relapsed NHL who had failed prior doxorubicin-containing CHOP, proved to be a feasible .
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2009/0226431 A1 Habib (43) Pub
    US 20090226431A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0226431 A1 Habib (43) Pub. Date: Sep. 10, 2009 (54) TREATMENT OF CANCER AND OTHER Publication Classification DISEASES (51) Int. Cl. A 6LX 3/575 (2006.01) (76)76) InventorInventor: Nabilabil Habib,Habib. Beirut (LB(LB) C07J 9/00 (2006.01) Correspondence Address: A 6LX 39/395 (2006.01) 101 FEDERAL STREET A6IP 29/00 (2006.01) A6IP35/00 (2006.01) (21) Appl. No.: 12/085,892 A6IP37/00 (2006.01) 1-1. (52) U.S. Cl. ...................... 424/133.1:552/551; 514/182: (22) PCT Filed: Nov.30, 2006 514/171 (86). PCT No.: PCT/US2O06/045665 (57) ABSTRACT .."St. Mar. 6, 2009 The present invention relates to a novel compound (e.g., 24-ethyl-cholestane-3B.5C,6C.-triol), its production, its use, and to methods of treating neoplasms and other tumors as Related U.S. Application Data well as other diseases including hypercholesterolemia, (60) Provisional application No. 60/741,725, filed on Dec. autoimmune diseases, viral diseases (e.g., hepatitis B, hepa 2, 2005. titis C, or HIV), and diabetes. F2: . - 2 . : F2z "..., . Cz: ".. .. 2. , tie - . 2 2. , "Sphagoshgelin , , re Cls Phosphatidiglethanolamine * - 2 .- . t - r y ... CBs .. A . - . Patent Application Publication Sep. 10, 2009 Sheet 1 of 16 US 2009/0226431 A1 E. e'' . Phosphatidylcholine. " . Ez'.. C.2 . Phosphatidylserias. * . - A. z' C. w E. a...2 .". is 2 - - " - B 2. Sphingoshgelin . Cls Phosphatidglethanglamine Figure 1 Patent Application Publication Sep. 10, 2009 Sheet 2 of 16 US 2009/0226431 A1 Chile Phosphater Glycerol Phosphatidylcholine E.
    [Show full text]
  • Taking Profit out of Esas, Insurer Sending Controversial Drugs
    Vol. 36 No. 13 April 9, 2010 © Copyright 2010 The Cancer Letter Inc. All rights reserved. Price $375 Per Year. To subscribe, call 800-513-7042 or visit www.cancerletter.com. PO Box 9905 Washington DC 20016 Telephone 202-362-1809 Taking Profit Out Of ESAs, Insurer Sending Controversial Drugs Directly To Patients By Paul Goldberg Oncologists treating cancer patients insured through the Blue Cross Blue Shield Association of Massachusetts will no longer be able to bill for ESAs: erythropiesis-stimulating agents. Doctors, Hospitals These controversial drugs will instead be shipped by specialty Protest “Brown Bagging” pharmacies directly to patients who would either inject themselves or use the By Massachusetts Blues services of a home care nurse or a nurse at the oncologist’s office. Page 2 This practice of shipping drugs directly to patients as part of a pharmacy benefit is called “brown bagging.” The Massachusetts Blues are apparently the first insurer to take this step toward making administration of ESAs less FDA News: lucrative to physicians, and industry sources said that other insurers would Agency Requires (Continued to page 2) Companion Diagnostic For Drugs Claiming FDA News: Benefit In Subsets . Page 4 ODAC Votes Against Cell Therapeutics Agent; Requires ChemGenex To Develop Diagnostic NCI News: The FDA Oncologic Drugs Advisory Committee March 22 voted against Report Urges Changes approval of the Cell Therapeutics agent Pixuvri (pixantrone dimaleate) for To Cut Activation Times relapsed or refractory aggressive non-Hodgkin’s lymphoma. For Phase III Trials In a 9-0 vote, the committee said the single clinical trial of pixantrone was inadequate to support approval.
    [Show full text]
  • Chemotherapy Regimens for Lymphoma
    Helpline freephone 0808 808 5555 [email protected] www.lymphoma-action.org.uk Chemotherapy regimens for lymphoma Chemotherapy drugs for lymphoma are usually given as a ‘regimen’, a treatment plan that includes more than one type of drug. We have separate information about how chemotherapy works, the ways it’s given and its possible side effects. On this page What is a chemotherapy regimen? Why is chemotherapy given as a regimen? Common chemotherapy regimens for lymphoma Frequently asked questions What is a chemotherapy regimen? A chemotherapy regimen is a treatment plan that usually involves more than one drug. The regimen sets out: • the name of the drugs • the dose of each drug • how often you take the drugs • how the drugs are given • how long you take each drug for. Most regimens are given as a block of chemotherapy followed by a rest period to allow your body to recover. This is known as a ‘cycle’. Cycles often last between 2 and 4 weeks. A whole course of treatment can vary from several weeks to a number of months. Why is chemotherapy given as a regimen? Some chemotherapy drugs are given on their own. Examples include pixantrone and bendamustine. Often, however, a combination of chemotherapy drugs are given to treat lymphoma. Each drug works in a slightly different way to kill the lymphoma cells. For some types of lymphoma, this might mean that the drugs are able to kill more of the lymphoma than if you have them alone. You might be interested in our animation video that explains how chemotherapy works.
    [Show full text]
  • Management of Multiply Relapsed Aggressive Non-Hodgkin Lymphoma
    MANAGEMENT OF MULTIPLY RELAPSED AGGRESSIVE NON-HODGKIN LYMPHOMA: NEW PERSPECTIVES This symposium took place on 13th June 2017, as a part of the 14th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland Chairpersons Eric Van Den Neste,1 Ruth Pettengell2 Speakers Pier Luigi Zinzani,3 Eric van Den Neste,1 Ruth Pettengell,2 Amjad Hayat,4 Kai Hübel5 1. Department of Haematology, Cliniques Universitaires, Saint-Luc, Brussels, Belgium 2. St George’s, University of London, London, UK 3. Institute of Hematology “Lorenzo e Ariosto Seràgnoli” University of Bologna, Bologna, Italy 4. University College Hospital, Galway, Ireland 5. Department of Haematology/Oncology, University of Cologne, Cologne, Germany Disclosure: All speakers have received research grants and/or honoraria from CTI and/or Servier. Acknowledgements: Writing assistance was provided by Karen Yee, ApotheCom, London, UK. Support: The symposium and publication of this article was funded by Servier. The views and opinions expressed are those of the authors and not necessarily Servier. Citation: EMJ. 2017;2[3]:22-30. MEETING SUMMARY Patients with refractory/relapsed (R/R) non-Hodgkin lymphoma (NHL) make up a very heterogeneous population with a poor life expectancy. The objective of this symposium was to provide an overview of the current treatment landscape for aggressive NHL, as well as the future research on new treatments. Transplant-eligible patients receive salvage chemotherapy, followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT). Patients who fail transplant or are transplant-ineligible generally receive palliative treatment or enter clinical trials; there is no standard of care and thus there is a high unmet clinical need.
    [Show full text]
  • Treatment Options of Mature, Nodal T-Cell Lymphomas
    Open Access Austin Journal of Cancer and Clinical Research Special Article - T-Cell Lymphoma Treatment Options of Mature, Nodal T-Cell Lymphomas Illés Á and Miltényi Z* Department of Hematology, Faculty of Medicine, Abstract University of Debrecen, Hungary T-cell lymphomas represent only 10-15% of non-Hodgkin lymphomas. T *Corresponding author: Zsófia Miltényi, Department cell lymphomas are more agressive, heterogenous diseases and have worse of Hematology, Faculty of Medicine, University of prognosis than B cell lymphomas. A number of new drugs are tested and Debrecen, Nagyerdei krt. 98 4032 Debrecen, Hungary approved in the therapy of peripherial T cell lymphomas, which hopefully will increase survival. CHOP and CHOP-like protocol are recommended for the Received: July 06, 2016; Accepted: August 02, 2016; first-line treatment, but it is efficacy alone only in ALK+ anaplastic large cell Published: August 04, 2016 lymphoma. Guidelines recommend front-line autologous hematopoetic stem cell transplantation in the other most frequent subtypes. A number of new drugs are tested and approved in the therapy of peripherial T cell lymphomas, eg. romidepsin, pralatrexate, belinostat, brentuximab vedotin etc., which hopefully will increase survival. Keywords: T cell lymphoma; Treatment; New drugs Abbrevations PTCL-NOS and AITL was 70%, 49%, 32% and 32% and the 5-year failure-free survival (FFS) was 60%, 36%, 20% and 18% [3]. The AE: Adverse Event; AHSCT: Autologous Hemopoetic Stem Cell frontline treatment in the most frequent PTCL types is combination
    [Show full text]
  • Lists of Medicinal Products for Rare Diseases in Europe*
    March 2021 Lists of medicinal products for rare diseases in Europe* the www.orpha.net www.orphadata.org General Table of contents PART 1: List of orphan medicinal products in Europe with European orphan designation and European marketing authorization 3 Table of contents 3 Methodology 3 Classification by tradename 5 Annex 1: Orphan medicinal products withdrawn from the European Community Register of orphan medicinal products 22 Annex 2: Orphan medicinal products withdrawn from use in the European Union 31 Classification by date of MA in descending order 33 Classification by ATC category 34 Classification by MA holder 35 PART 2 : 37 List of medicinal products intended for rare diseases in Europe with European marketing authorization without an orphan designation in Europe 37 Table of contents 37 Methodology 37 Classification by tradename 38 Classification by date of MA in descending order 104 Classification by ATC category 106 Classification by MA holder 108 For any questions or comments, please contact us: [email protected] Orphanet Report Series - Lists of medicinal products for rare diseases in Europe. March 2021 http://www.orpha.net/orphacom/cahiers/docs/GB/list_of_orphan_drugs_in_europe.pdf 2 PART 1: List of orphan medicinal products in Europe with European orphan designation and European marketing authorization* Table of contents List of orphan medicinal products in Europe with European orphan designation and European marketing authorisation* 3 Methodology 3 Classification by tradename 5 Annex 1: Orphan medicinal products removed or withdrawn from the European Community Register of orphan medicinal products 22 Annex 2: Orphan medicinal products withdrawn from use in the European Union 31 Classification by date of MA in descending order 33 Classification by ATC category 34 Classification by MA holder 35 Methodology This part of the document provides the list of all orphan with the list of medicinal products that have been granted a medicinal products that have received a European Marketing marketing authorization (http://ec.europa.
    [Show full text]
  • Cti Making Cancer More Treatable
    Filed by Cell Therapeutics, Inc. Pursuant to Rule 425 under the Securities Act of 1933 And deemed filed pursuant to Rule 14a-12 Of the Securities and Exchange Act of 1934 Subject Company: Cell Therapeutics, Inc. Commission File No: 001-12465 The following presentation is being used by Dr. James Bianco of Cell Therapeutics, Inc. (“CTI”) at presentations involving the proposed business combination between CTI and Novuspharma S.p.A. (“Novuspharma”). [GRAPHIC] cti Making cancer more treatable CELL THERAPEUTICS, INC. NASDAQ: CTIC Forward Looking Statement This presentation contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The forward-looking statements contained in this presentation include statements about future financial and operating results, the proposed CTI/Novuspharma merger, and risk and uncertainties that could affect CTI’s product and products under development. These statements are not guarantees of future performance, involve certain risks, uncertainties and assumptions that are difficult to predict, and are based upon assumptions as to future events that may not prove accurate. Therefore, actual outcomes and results may differ materially from what is expressed herein. For example, if either of the companies do not receive required stockholder approvals or fail to satisfy other conditions to closing, the transaction will not be consummated. In any forward-looking statement in which CTI expresses an expectation or belief as to future results, such expectation or belief is expressed in good faith and believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will result or be achieved or accomplished.
    [Show full text]
  • 2004 CTI Annual Report
    Together we are redefining the landscape of cancer therapies. cti annual report 2004 Cell Therapeutics, Inc. 501 Elliott Avenue West Seattle, Washington 98119 206.282.7100 www.cticseattle.com directors* senior management team* James A. Bianco, M.D. James A. Bianco, M.D. President, Chief Executive OKicer, and Director President, Chief Executive Ogcer, and Director Cell Therapeutics, Inc. Steve Aselage Max E. Link, Ph.D.(1, 2) Executive Vice President, Chairman of the Board of Directors Global Commercial Operations Former Chairman and CEO, Centerpulse, Ltd. Louis A. Bianco John M. Fluke Jr.(2, 3) Executive Vice President, Director Finance and Administration Chairman, Fluke Capital Management James Canfield, S.P.H.R.** Vartan Gregorian, Ph.D.(1) Executive Vice President, Director Chief Administrative Ogcer President, Carnegie Corporation Richard E. Leigh, Jr. Mary O. Mundinger, D.P.H.(1, 3) Executive Vice President, Director General Counsel and Corporate Secretary Dean of School of Nursing, Columbia University Jack W. Singer, M.D. Phillip M. Nudelman, Ph.D.(2, 3) Executive Vice President, Director Chief Medical Ogcer, and Director President and CEO, Hope Heart Institute Silvano Spinelli Erich Platzer, M.D. Executive Vice President, Director Development and Managing Director, Former Chairman of the Board of Directors Cell Therapeutics (Europe) S.r.l., and Director Novuspharma Except for the historical information contained herein, the matters Jack W. Singer, M.D. set forth in this Annual Report include information concerning Director our drug development pipeline, including anticipated regulatory timelines and the status of clinical trials, which are forward-looking Executive Vice President, Chief Medical Ogcer statements within the meaning of the “safe harbor” provisions of Cell Therapeutics, Inc.
    [Show full text]