DOCSLIB.ORG

EXECUTIVE INFORMATIONAL OVERVIEW Development, Clinical Practice, and Venture Development

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
EXECUTIVE INFORMATIONAL OVERVIEW Development, Clinical Practice, and Venture Development TopoTarget A/S Symbion Science Park 3 Fruebjergvej DK-2100 Copenhagen, Denmark Phone: +45 39 17 83 90 www.TopoTarget.com Unique Oncological Biopharmaceutical Opportunity Snapshot January 26, 2005 TopoTarget A/S is a privately held biopharmaceutical company focused on developing novel pharmaceuticals for cancer† and cancer-related indications, as well as on the identification of new indications for existing compounds. The Company’s first internally developed product, Topotect, is in Phase III as an antidote for extravasation, a severe form of tissue damage resulting from an incorrect administration of cytotoxic anthracyclines or chemotherapy drugs. Pending approval, the Company could launch Topotect in winter 2005/2006. This product, based on the concept of deoxyribonucleic acid (DNA) damage control, would provide TopoTarget access to profitable, lower-risk markets. TopoTarget is also developing Topotect for the treatment of brain metastases, a life-threatening condition that affects approximately 60% of primary small cell lung cancer (SCLC) patients. Topotect recently entered Phase I/II clinical trials for this indication. Additionally, TopoTarget is heavily involved in the management of chromatins, the proteins responsible for the formation of DNA-containing chromosomes. The Company’s expertise in this area has led to the development of PXD101, a Phase I anti-cancer histone deacetylase (HDAC) inhibitor that interferes with cell cycle arrest and angiogenesis, and has demonstrated anti-tumor activity in vivo. TopoTarget expects to employ this drug to target a variety of cancer indications, including multiple myeloma, malignant lymphoma, and ovarian, colorectal, and prostate cancer. TopoTarget also has a library of diverse HDAC inhibitors that have demonstrated efficacy in a variety of cancer and non-cancer indications. Key Points TopoTarget has three products in clinical trials, as well as approximately a half-dozen preclinical stage compounds. The Company’s most advanced product, Topotect, was granted Orphan Drug designation as an antidote for anthracycline extravasation in Europe in 2001 and could receive approval within the next 12 months. Orphan Drug designation was also granted by the U.S. Food and Drug Administration (FDA) in 2004. Following approval, TopoTarget expects to sell the product in Europe and partner it outside of Europe with a large pharmaceutical company. In May 2004, the National Cancer Institute (NCI) and TopoTarget signed a letter of intent to enter into a Cooperative Research and Development Agreement (CRADA) to conduct the preclinical and clinical development of PXD101, TopoTarget’s proprietary HDAC inhibitor. The agreement involves the determination of the most appropriate anti-cancer agents for use in combination with PXD101. Also, the NCI and TopoTarget are collaborating on the identification of anti-cancer drug candidates from TopoTarget’s library of HDAC inhibitors. In June 2004, TopoTarget and U.S.-based CuraGen Corporation (CRGN-NASDAQ) announced a license, collaboration, and commercialization agreement on a small molecule inhibitor program targeting HDAC in oncology. TopoTarget was founded by clinical oncologists who have an understanding of the realities of clinical practice. This enables the Company to choose intelligently between an array of possibilities and targets. Additionally, the Company has proven in-house clinical trial capabilities. TopoTarget’s leadership team is experienced in medical products, biopharmaceuticals, and pharmaceuticals, and has a track record of success over many decades in research, drug EXECUTIVE INFORMATIONAL OVERVIEW development, clinical practice, and venture development. The Company has achieved all of its key business and scientific milestones since its last funding round in June 2002. Over the next 24 months, TopoTarget could achieve more than a half-dozen separate potential revenue-generating milestones. †BOLD WORDS ARE REFERENCED IN GLOSSARY ON PAGES 45-48. Table of Contents Snapshot ................................................................................................................................................1 Key Points .....................................................................................................................................................1 Executive Overview.......................................................................................................................................3 Growth Strategy.............................................................................................................................................7 Intellectual Property.......................................................................................................................................9 Management and Board of Directors ..........................................................................................................12 Core Story ...................................................................................................................................................15 Cancer ....................................................................................................................................................15 The Cancer Cell Cycle ......................................................................................................................15 Advanced Stage Development...............................................................................................................20 Chemotherapy...................................................................................................................................20 Extravasation................................................................................................................................21 Topotect for Extravasation ......................................................................................................26 Brain Metastases..........................................................................................................................30 Topotect for Brain Metastases ................................................................................................31 Histone Deacetylase (HDAC) Inhibitors for Multiple Indications ..................................................33 PXD101 ...................................................................................................................................34 Early Stage Development..................................................................................................................36 HDAC Inhibitor Library .................................................................................................................36 In-licensed .........................................................................................................................................37 Potential Milestones Within Next 12-24 Months..........................................................................................38 Historical Financial Results .........................................................................................................................39 Risks............................................................................................................................................................42 Recent Events .............................................................................................................................................44 Glossary of Lesser-Known Terms ...............................................................................................................45 Executive Informational Overview Page 2 Executive Overview TopoTarget A/S is a privately held biopharmaceutical company focused on developing novel compounds for cancer and cancer-related indications. The Company’s development efforts employ a broad understanding of the molecular mechanisms of cancer and the realities of clinical practice to develop new and potentially effective approaches to combat the various manifestations of the disease. Pipeline TopoTarget’s pipeline is based on two pillars: (1) early revenues from specialty products, and (2) value growth from more broad indication products. With regard to the first pillar, the Company could launch its first product, Topotect for extravasation, in winter 2005/2006. Topotect could provide the Company with a base for top-line growth and profitability by 2007. Additionally, TopoTarget is developing Topotect (currently in Phase I/II) for brain metastases and PXD101 (currently in Phase I) for multiple indications. The Company also possesses a range of preclinical compounds targeted at a variety of indications. Figure 1 provides a snapshot of the Company’s drug development pipeline, according to advanced stage and early stage development candidates. This is followed by an overview of its three leading and most advanced product candidates under development, as well as its earlier stage development candidates. Advanced Stage Development Figure 1 TopoTarget A/S DRUG DEVELOPMENT PIPELINE Product Indication Lead ID Lead OP Preclin Phase I Phase II Phase III Reg filing Sales Source: TopoTarget A/S. Executive Informational Overview Page 3 Topotect for extravasation. The Company’s first internally developed product, Topotect, is in Phase III as an antidote for extravasation, a severe form of tissue damage resulting from an adverse reaction to anthracyclines, a group of commonly used cytotoxic agents. Extravasation occurs when an anthracycline
Load more

Recommended publications
  • Company Coverage Report
    Company Coverage Report th Coverage initiated June 19 , 2009 Aurgalys is contracted by Onxeo to provide equity research Mickael Dubourd, Ph.D., SFAF Paris & Evry, France Onxeo E URONEXT : ONXEO [FR0010095596 – C OMPARTMENT C] August 1st, 2014 Share Price: €7.19 Onxeo, leader in orphan oncology (as of August 1st, 2014) Onxeo resulted from the merger of French BioAlliance Estimated price: Pharma and Danish Topotarget, both involved in orphan drug development for cancer. The combined entity will benefit €11.12 from experienced teams in this field and from a strong portfolio of products in late stage development. August 1st, High/Low since 01.01.14 11.74/4.30 2014, was Onxeo’s first day of trading on both Euronext Paris (€) and Nasdaq OMX Copenhagen. We are taking this opportunity to review Onxeo’s business strategy, drug Market Cap (€m) 226.4 pipeline and valuation. Three approved products, strong cash position, late stage Estimated Cash 27.0 development product portfolio Position (€m) Originating from BioAlliance's historical product portfolio, Sitavig and Estimated market cap. 350.1 Loramyc/Oravig have both been approved in the US and Europe. These two products will help generate short term revenues through licensing deals (€m) upfront and milestone payments as well as long term revenues with royalties nd Number of Shares (m) 31.5 on sales. Moreover, Beleodaq has just been approved in the US for 2 line Peripheral T-Cell Lymphoma (PTCL) and will be marketed by Spectrum Pharmaceutical. This is the first drug in the orphan oncology product portfolio to get US approval.
    [Show full text]
  • RSAP1359 Proof 41..55
    MEDICINES AUTHORITY REGULATOR AND INDUSTRY PERCEPTIONS OF BIOSIMILAR INTERCHANGEABILITY Druedahl, Louise C.; De Bruin, Marie L.; Hoogland, Hans; Minssen, Timo; van de Weert, Marco; Sporrong, Sofia Kalvemark; Almarsdottir, Anna Birna DOI: 10.1016/j.sapharm.2019.09.006 Publication date: 2019 Document version Publisher's PDF, also known as Version of record Document license: CC BY Citation for published version (APA): Druedahl, L. C., De Bruin, M. L., Hoogland, H., Minssen, T., van de Weert, M., Sporrong, S. K., & Almarsdottir, A. B. (2019). MEDICINES AUTHORITY REGULATOR AND INDUSTRY PERCEPTIONS OF BIOSIMILAR INTERCHANGEABILITY. E45-E46. https://doi.org/10.1016/j.sapharm.2019.09.006 Download date: 28. sep.. 2021 Research in Social and Administrative Pharmacy 15 (2019) e41ee55 Contents lists available at ScienceDirect Research in Social and Administrative Pharmacy journal homepage: www.rsap.org 9th Nordic Social Pharmacy Conference 2019. Conference abstracts ATTITUDES TOWARDS DEPRESCRIBING IN OLDER ADULTS WITH Pottegård a,c. a Hospital Pharmacy Funen, Odense University Hospital, LIMITED LIFE EXPECTANCY: TWO SYSTEMATIC REVIEWS Odense, Denmark; b OPEN, Odense Patient data Explorative Network, Odense, Denmark; c Clinical Pharmacology and Pharmacy, Department of Alaa Burghle a,b, Carina Lundby a,b, Jesper Ryg c,d, Jens Søndergaard e, Anton Public Health, University of Southern Denmark, Odense, Denmark; Pottegård a,b, Trine Graabæk a,b, Dorthe Nielsen f,g,h. a Hospital Pharmacy d Research and Development, Danish College of Pharmacy Practice, Hillerød, Funen, Odense University Hospital, Odense C, Denmark; b Clinical Denmark; e Social and Clinical Pharmacy, School of Pharmacy, Copenhagen Pharmacology and Pharmacy, Department of Public Health, University of University, Copenhagen, Denmark Southern Denmark, Odense C, Denmark; c Department of Geriatric E-mail address: [email protected] (A.
    [Show full text]
  • National Cancer Institute Cancer National
    DIVISION OF CANCER TREATMENT AND DIAGNOSIS National Cancer Institute Cancer National PROGRAM ACCOMPLISHMENTS 2006 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health TABLE OF CONTENTS Foreword . iii Division of Cancer Treatment and Diagnosis Overview . .1 Major Ongoing Initiatives and Accomplishments . .7 Biometric Research Branch Overview . 11 Partnerships and Collaborations . 12 Scientific Advances . 17 Other Biostatistical Research . 24 Tools, Products, and Resources . 27 Cancer Diagnosis Program Overview . 29 Major Ongoing Initiatives . 30 Current Funding Opportunities . 34 Partnerships and Collaborations . 36 Scientific Advances . 39 Tools, Products, and Resources . 41 Cancer Imaging Program Overview . 45 Major Ongoing Initiatives . 47 Current Funding Opportunities . 54 Partnerships and Collaborations . 57 Scientific Advances . 61 Tools, Products, and Resources . 63 Cancer Therapy Evaluation Program Overview . 65 Major Ongoing Initiatives . 67 Significant Ongoing Clinical Trials . 71 Current Funding Opportunities . 73 Partnerships and Collaborations . 75 Scientific Advances . 79 Tools, Products, and Resources . 92 TABLE OF CONTENTS ■ i Developmental Therapeutics Program Overview . 95 New Initiatives . 97 Major Ongoing Initiatives . .100 Current Funding Opportunities . .104 Tools, Products, and Resources . .105 History-Marking Event . .114 Scientific Advances . .115 Radiation Research Program Overview . .119 Partnerships and Collaborations . .121 Scientific Advances . .127 Tools, Products, and Resources . .129
    [Show full text]
  • Belinostat Phase II Trial Initiated in Platinum-Resistant Ovarian Cancer by the Gynecologic Oncology Group (GOG) Supported by the National Cancer Institute (US)
    To NASDAQ OMX Copenhagen A/S TopoTarget A/S Announcement No. 01-10 / Copenhagen, January 6 2010 Symbion Fruebjergvej 3 DK 2100 Copenhagen Denmark Tel: +45 39 17 83 92 Fax: +45 39 17 94 92 CVR-nr: 25695771 www.topotarget.com Belinostat phase II trial initiated in platinum-resistant ovarian cancer by the Gynecologic Oncology Group (GOG) supported by the National Cancer Institute (US) Copenhagen, Denmark – January 6, 2010 – TopoTarget A/S (OMX: TOPO) announced today that GOG (The Gynecologic Oncology Group, US) has initiated a phase II trial evaluating efficacy and safety of belinostat and carboplatin in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube or peritoneal cancer. GOG receives support for this trial from the National Cancer Institute (NCI) of the National Institutes of Health (NIH). “Positive efficacy and safety data with belinostat and carboplatin and paclitaxel (BelCaP) in patients with platinum resistant ovarian cancer have previously been announced by TopoTarget. We are very pleased that GOG now initiates this phase II study with belinostat and carboplatin (BelCar) in this difficult to treat patient population. Platin-resistance is a huge unsolved clinical problem in relapsing ovarian cancer and hopefully GOG will be able to show that BelCar, without additional paclitaxel is active in the platinum resistant setting.” said MD., Professor Peter Buhl Jensen, CEO of TopoTarget “ if GOG is able to repeat our initial positive results in platinum resistant patients we hope to advance into pivotal trials.” The study A Phase II evaluation of belinostat and carboplatin in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.
    [Show full text]
  • Clinical Study Report Belinostat Study Report No: PXD101-CLN-8/PXD101-040-EU
    Topotarget A/S - Spectrum Pharmaceuticals, Inc. Module 5 Clinical Study Report Belinostat Study Report No: PXD101-CLN-8/PXD101-040-EU 2 SYNOPSIS NAME OF COMPANY: Individual Study Table (FOR NATIONAL AUTHORITY Topotarget A/S, CuraGen, and Spectrum Referring to Part of the USE ONLY) Pharmaceuticals, Inc. Dossier: NAME OF FINISHED PRODUCT: Belinostat Injection 50 mg/mL Volume: NAME OF ACTIVE INGREDIENT: Belinostat (PXD101) Page: TITLE OF STUDY: A Phase 1/2 Safety, Pharmacodynamic, and Pharmacokinetic Study of Intravenously Administered PXD101 Plus Carboplatin or Paclitaxel or Both in Patients with Advanced Solid Tumors INVESTIGATORS: Coordinating Investigator (Site 001): Dr. Ulrik Lassen, Department of Oncology, The Finsen Center, Copenhagen University Hospital, Copenhagen, DK. Principal Investigators: Site 002: Dr, Johann de Bono. Site 003: Dr. Robert John Jones. Site 004: Dr. Lisa Sengeløv. Site 101: Dr. Richard Penson. Site 102: Dr Don Dizon. Site 105: Dr. James Hoffman. Site 106: Dr. John Micha. Site 108: Dr. Neil Finkler. Site 109 Dr. Patricia Braly. Site 111: Dr. Paul Celano. STUDY CENTERS: Part A: The Phase 1 part (advanced tumor) was conducted at: • Site 001: The Finsen Center, Copenhagen University Hospital, DK • Site 002: The Royal Marsden NHS Trust, Cancer Research, UK • Site 101: Massachusetts General Hospital Cancer center, Boston, US Part B: The Phase 2 part, MTD expansion phase (ovarian cancer) was conducted at: • Site 001: The Finsen Center, Copenhagen University Hospital, DK • Site 002: The Royal Marsden NHS Trust, Cancer
    [Show full text]
  • Pricing of Cancer Medicines and Its Impacts
    ACCESS TO MEDICINES, VACCINES AND PHARMACEUTICALS TECHNICAL REPORT Pricing of cancer medicines and its impacts A comprehensive technical report for the World Health Assembly Resolution 70.12 Operative paragraph 2.9 on pricing approaches and their impacts on availability and affordability of medicines for the prevention and treatment of cancer TECHNICAL REPORT Pricing of cancer medicines and its impacts Pricing of cancer medicines and its impacts ISBN 978-92-4-151511-5 © World Health Organization 2018 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization.
    [Show full text]
  • Master Thesis
    Master Thesis University-Industry collaborations – What are potential conflicts and how to mitigate them? A study on the Danish pharmaceutical industry Master Thesis – Management of Innovation and Business Development (MIB) Supervisor: Christoph Grimpe Hand in: 02.05.2017 Overall number of pages: 114 No. of Characters: 249.408 Kristina Homann Fabian Steinhart Copenhagen Business School May 02nd 2017 Abstract: The purpose of this master thesis is to find answers for two underlying research questions, namely the conflicts companies experience when engaging in University-Industry collaborations, hereafter referred to as U-I collaborations, and the levers firms can pull to increase the attractiveness of U-I collaborations. To provide the theoretical basis for the answering of the research questions, the formation process, different types, motivations as well as outcomes for U-I collaborations from a firm’s perspective are considered. Following this, a selection of theoretical internal and external conflicts and corresponding levers is provided. Taking a more practical approach, the above mentioned theoretical basis is analyzed and discussed in the remaining part of this master thesis, using a deductive research approach. Based on a preparatory scoping interview process, three Danish pharmaceutical companies, namely Novo Nordisk, Lundbeck and LEO Pharma, have been selected for a semi-structured qualitative interview process. Thereby, the conflicts the companies are facing, namely the difficult interactions with the legal departments of the universities and the firm internal dissemination of the knowledge gathered during the U-I collaboration, are found as the main conflicts from the companies’ perspective resulting in a need to consider the implementation of counteracting levers.
    [Show full text]
  • 140703EN NDA Belinostat
    FDA approval of Beleodaq™ (belinostat) Accelerated Approval of Topotarget’s Beleodaq™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma Early Action follows Priority Review 5 weeks before PDUFA Date Trigger milestone payment of USD 25 million to Topotarget Beleodaq™ is expected to be available to patients in July 2014 and will be launched through Spectrum Pharmaceutical's existing oncology sales force The Orphan Oncology Innovator BioAlliance Pharma and Topotarget are merging to create Onxeo, following approval of both companies shareholders end of June 2014 Paris, July 3, 2014 – BioAlliance Pharma SA (Euronext Paris - BIO), an innovative Company specialized in the development of drugs in orphan oncology diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Topotarget Accelerated Approval of Beleodaq™ for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL). This follows a Priority Review of the Beleodaq™ New Drug Application (NDA) and was an Early Approval action prior to the August 9, 2014 PDUFA (Prescription Drug User Fee Act) date. Beleodaq™ was granted marketing authorization under the FDA’s accelerated approval program, which allows conditional approval of a medicine for a life-threatening disease based on early evidence suggesting clinical benefit. The approval is based on results from the BELIEF study, which enrolled 129 PTCL patients refractory to or who had failed at least one prior systemic therapy. A milestone cash payment of USD 25 million from Spectrum Pharmaceuticals is triggered by the NDA approval. A double-digit royalties as well as sales milestones of the aggregated net sales will be received by the company.
    [Show full text]
  • Topotarget A/S Rodman & Renshaw Annual Global Investment Conference 2013 Safe Harbor Statement
    Topotarget A/S Rodman & Renshaw Annual Global Investment Conference 2013 Safe harbor statement This announcement may contain forward-looking statements, including statements about Topotarget A/S’ expectations to the progression of Topotarget A/S’ clinical pipeline and with respect to cash burn guidance. Such statements are subject to risks and uncertainties of which many are outside the control of Topotarget A/S, and which could cause actual results to differ materially from those described. Topotarget A/S disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by Danish law. 2 Topotarget at a glance A Scandinavian-based biopharmaceutical company dedicated to develop and market cancer therapies • Situated in Copenhagen, Denmark with ~14 employees and a lean cost structure • Focused on the development and commercialization of belinostat, a molecular targeted cancer therapy NASDAQ OMX Listing Copenhagen 22% Symbol TOPO Denmark Switzerland 45% Market UK capitalization EUR 48 million Sweden (as of Aug 28, 2013) 20% ROW No. of shares 143,317,114 8% 4% 3 Building a strong commercial profile for belinostat Large sales potential in solid First registration filing tumors (CRC, bladder, expected Q4 2013 ovarian, NSCLC) Partnership with Spectrum Outstanding safety profile. Pharmaceuticals, Inc. Belinostat tested in more Pursuing partnerships in EU than 1,100 patients and Asia-Pac Belinostat – a pan-HDACi - Orphan indications (PTCL,
    [Show full text]
  • A Preclinical Study on the Rescue of Normal Tissue by Nicotinic Acid in High-Dose Treatment with APO866, a Specific Nicotinamide Phosphoribosyltransferase Inhibitor
    Published OnlineFirst June 1, 2010; DOI: 10.1158/1535-7163.MCT-09-1130 Research Article Molecular Cancer Therapeutics A Preclinical Study on the Rescue of Normal Tissue by Nicotinic Acid in High-Dose Treatment with APO866, a Specific Nicotinamide Phosphoribosyltransferase Inhibitor Uffe Høgh Olesen1,2, Annemette V. Thougaard2, Peter Buhl Jensen2, and Maxwell Sehested1,2 Abstract Inhibitor of nicotinamide phosphoribosyltransferase APO866 is a promising cancer drug currently in phase II clinical trials in oncology. Here, we present a strategy for increasing the therapeutic potential of APO866 through the rescue of normal tissues by coadministration of nicotinic acid (Vitamin B3). We examined the toxicity profile of APO866 in B6D2F1 mice and the effect of oral administration of nicotinic acid on tissue toxicity. Nicotinic acid (50 mg/kg) protects mice from death and severe toxicity from an APO866 dose (60 mg/kg) four times the monotherapy maximum tolerated dose (15 mg/kg). In a panel of six cancer cell lines, we find that three (including ML-2 cells) are protected by nicotinic acid in vitro, whereas the cytotoxi- city of APO866 remains unaffected in the remaining three (including A2780 cells). A selective biomarker for the protection by nicotinic acid was subsequently identified by quantitative RT-PCR. The expression of nicotinic acid phosphoribosyltransferase is low in the cell lines not rescued from APO866 by nicotinic acid compared with protected cell lines. The findings in cell lines translated into xenograft models in which the combination of 50 mg/kg nicotinic acid and 50 mg/kg APO866 in mouse xenografts of A2780 cells increased life span by >3-fold compared with standard treatment of 15 mg/kg, and the effect of APO866 was clearly decreased when using the same treatment paradigm in ML-2 xenografts.
    [Show full text]
  • Biopartnering Executive Summary
    BIOWORLD® BIOPARTNERING REPORT 2009: STRATEGIES AND PARADIGMS OF THE DEAL EXECUTIVE SUMMARY By Michael Harris, BioWorld Executive Editor and Amanda Lyle, BioWorld Managing Editor LIST OF CONTENTS Introduction and Analysis Trends Depressing First Half of 2008 in Worldwide Public Markets Drug/Device Combos Could Salvage Dropped Compounds A Match Made in Heaven; R&D Productivity Via Partnering Drug and Medical Device Deals: A Different Type of Partnership As Big Pharma Model Falters, Biotech Rides to the Rescue Deals to M&As: The Culture of False-Flagging, Shape-Shifting Notable Deals Autoimmune and Inflammation Deals Immunomedics Inks Potential $620M Deal with Nycomed ARYx Seeking New Partner for GI Program after P&G Bails Out UCB Licenses Keppra, Cimzia Rights in Japan Alizyme, Norgine Team Up in $67M Marketing Deal Bionomics Signs Merck Serono in MS, Autoimmune Partnership TransPharma Gets $35M in Osteo Deal with Lilly QLT Sells Acne Gel Product Aczone for $150M to Allergan Start-up TFT Adds NF-Kappa B Decoy Program from Anesiva Early Stage Antibody Nets EUSA $44M from GSK Scil, Pfizer Enter $250M Deal for Preclinical Osteo Drug Catalyst Partners with Centocor for Engineered Protease Drugs Galapagos Inks $395M Deal with Lilly for Osteo Drugs Alba Inks Ex-U.S./Japan Deal with Shire for Celiac Drug Excaliard Snags $15.5M and Isis Fibrosis Drugs Galapagos and Janssen in RA Partnership Axcan, Cellerix Deal for Adult Stem Cell Therapy Radius Grants Novartis Option to BA058 in Potential $500M Deal Microbia, Forest Collaborate: Up to $330M for
    [Show full text]
  • Phase I Pharmacokinetic Study of Belinostat for Solid Tumors and Lymphomas in Patients with Varying Degrees of Hepatic Dysfunction
    CTEP #8846 Clinical Center #11-C-0060 Phase I Pharmacokinetic Study of Belinostat for Solid Tumors and Lymphomas in Patients with Varying Degrees of Hepatic Dysfunction Abbreviated Title: PhI Belinostat ODWG Coordinating Center: Developmental Therapeutics Clinic (DTC) National Cancer Institute 10 Center Drive, 12N226 Bethesda, MD 20892 Principal Investigator: Naoko Takebe, MD, PhDA-E, DTC Bldg 31 Room 3A44 Bethesda, MD 20892 Phone: (240) 781-3398; Fax: (240) 541-4515 [email protected] NIH Co-Investigators: James H. Doroshow, MDA-E, DCTD Alice P. Chen, MDA-E, DCTD Howard Streicher, MDA-E, CTEP/DCTD Geraldine O’Sullivan Coyne, MDA-E, DCTD Non-NCI Co-investigators Lamin Juwara, CRNPA,B,E, Leidos Biomed/FNLCR Participating Centers: NCI Organ Dysfunction Working Group (ODWG): Albert Einstein College of Medicine University of California Davis Cancer Center Emory University University of Southern California/Norris Karmanos Cancer Institute Comprehensive Cancer Center City of Hope Comprehensive Cancer Center Referral Contact: Nancy Moore, RNA,B,E Bldg 10/RM 8D53 National Cancer Institute Phone: (240) 760-6045; Fax: (301) 451-5625 [email protected] Roles: Aobtains information by intervening or interacting with living individuals for research purposes; Bobtains identifiable private information about living individuals; Cobtains the voluntary informed consent of individuals to be subjects; Dmakes decisions about subject eligibility; Estudies, interprets, or analyzes identifiable private information or data/specimens for research purposes 1 CTEP #8846 Clinical Center #11-C-0060 CoH Pharmacy Contact: Timothy Synold, Pharm D FWA#: 00000692 (626) 256-4673 x 62110 Fax: (626) 471-9376 PI: Vincent Chung, MD, FACP [email protected] (626) 471-9200 Fax: (626) 301-8233 Cecilia Lau, Clinical Pharmacist [email protected] (626) 256-4673 x 64165 Fax: (626) 301-5237 PI: Edward Newman, Ph.D.
    [Show full text]