A Balanced Trade Context for HIV Patent Pool
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Fully Human Domain Antibody Therapeutics: the Best of Both Worlds
Drug Discovery Fully Human Domain Antibody Therapeutics: The Best of Both Worlds By combining the therapeutic benefits of small molecule drugs with those of fully human antibodies, Domain Antibodies are expected to have strong therapeutic and commercial potential. By Robert Connelly at Domantis Robert Connelly is Chief Executive Officer of Domantis. He has over 22 years’ commercial experience of the life science sector, including that gained in the fields of diagnostics, drug discovery technologies and antibody therapeutics. Prior to joining Domantis, he was CEO of Veritas Pharmaceuticals (Los Angeles, USA), an in vivo imaging start-up company. He spent over five years with IGEN International, latterly as Senior Vice President and General Manager, Life Sciences, where he took part in the company’s IPO and financing rounds, raising $130 million. The first 11 years of his career were spent at Abbott Laboratories in sales, marketing and management positions. Domain Antibodies (dAbs) are the smallest functional variable regions of either the heavy (VH) or light (VL) binding units of antibodies. At Domantis, we are chains of human antibodies. Domantis scientists applying our proprietary know-how in dAbs to deliver have used the variable domains sequences of human human therapies that address large, unmet medical antibodies to create a series of large and highly needs in areas such as inflammation, cancer and functional libraries of fully human dAbs, with each autoimmune diseases. Three and a half years after library comprising at least 1010 different dAbs. The opening our laboratories, we have a dozen proprietary dAbs selected from these libraries are both specific therapeutic programmes underway, and an additional for their biological target and are well folded and eight therapeutic programmes with partners. -
Power List 2018
APRIL 2018 # 40 Editorial Upfront In My View Sitting Down With Stop and look at how far Preparing for the EU’s new What can algae teach us Sophie Kornowski-Bonnet, the industry has come data protection regulation about medicine design? Roche Partnering 09 10 – 11 20 – 21 50 – 51 100 Power List 2018 www.themedicinemaker.com Continuous Growth Fibra-Cel® disks—3-D growth matrix for perfusion and continuous processes Suspend your disbelief: > Less susceptible to shear forces, The three-dimensional Fibra-Cel matrix clogging, and fouling entraps anchorage dependent and > Ideal for secreted product and vaccine suspension cells—for optimized growth production conditions and increased yields. > Suitable for GMP production > For use in autoclavable, sterilize-in- place or BioBLU® Single-Use Vessels www.eppendorf.com/Fibra-Cel Fibra-Cel® is a registered trademark owned by Imerys Minerals California, Inc., USA and licensed to Eppendorf, Inc., USA. Eppendorf®, the Eppendorf Brand Design and BioBLU® are registered trademarks of Eppendorf AG, Germany. All rights reserved, including graphics and images. Copyright © 2018 by Eppendorf AG. tmm_epp_ad_210x266_2018_04.indd 1 28.03.18 13:34 Online this Month The Power List The 2018 Power List, starting on page 24 of this issue, features 100 of the most inspirational professionals involved in A Scientist Walks into a Bar... format to the public”. Generally, drug development. The list was compiled it involves scientists speaking on a based on reader nominations and And gives a presentation as part variety of topics, from medicine, to feedback from a judging panel – but any of Pint of Science, a global science neuroscience, to robotics and more, in list will always be subjective. -
List of Section 13F Securities
List of Section 13F Securities 1st Quarter FY 2004 Copyright (c) 2004 American Bankers Association. CUSIP Numbers and descriptions are used with permission by Standard & Poors CUSIP Service Bureau, a division of The McGraw-Hill Companies, Inc. All rights reserved. No redistribution without permission from Standard & Poors CUSIP Service Bureau. Standard & Poors CUSIP Service Bureau does not guarantee the accuracy or completeness of the CUSIP Numbers and standard descriptions included herein and neither the American Bankers Association nor Standard & Poor's CUSIP Service Bureau shall be responsible for any errors, omissions or damages arising out of the use of such information. U.S. Securities and Exchange Commission OFFICIAL LIST OF SECTION 13(f) SECURITIES USER INFORMATION SHEET General This list of “Section 13(f) securities” as defined by Rule 13f-1(c) [17 CFR 240.13f-1(c)] is made available to the public pursuant to Section13 (f) (3) of the Securities Exchange Act of 1934 [15 USC 78m(f) (3)]. It is made available for use in the preparation of reports filed with the Securities and Exhange Commission pursuant to Rule 13f-1 [17 CFR 240.13f-1] under Section 13(f) of the Securities Exchange Act of 1934. An updated list is published on a quarterly basis. This list is current as of March 15, 2004, and may be relied on by institutional investment managers filing Form 13F reports for the calendar quarter ending March 31, 2004. Institutional investment managers should report holdings--number of shares and fair market value--as of the last day of the calendar quarter as required by Section 13(f)(1) and Rule 13f-1 thereunder. -
Antiretroviral Price Reductions
UNTANGLING THE WEB OF ANTIRETROVIRAL PRICE REDUCTIONS 18th Edition – July 2016 www.msfaccess.org PREFACE In this report, we provide an update on the key facets of HIV treatment access. It includes the latest HIV treatment guidelines from World Health Organization (WHO), an overview on pricing for first-line, second-line and salvage regimens, and a summary of the opportunities for – and threats to – expanding access to affordable antiretroviral therapy (ART). There is a table with information on ARVs, including quality assurance, manufacturers and pricing on pages 55 to 57. THE MSF ACCESS CAMPAIGN In 1999, on the heels of Médecins Sans Frontières (MSF) being awarded the Nobel Peace Prize – and largely in response to the inequalities surrounding access to HIV/AIDS treatment between rich and poor countries – MSF launched the Campaign for Access to Essential Medicines. Its sole purpose has been to push for access to, and the development of, life-saving and life-prolonging medicines, diagnostics and vaccines for patients in MSF programmes and beyond. www.msfaccess.org MSF AND HIV Médecins Sans Frontières (MSF) began providing antiretroviral therapy to a small number of people living with HIV/AIDS in 2000 in projects in Thailand, South Africa and Cameroon. At the time, treatment for one person for one year cost more than US$10,000. With increased availability of low-cost, quality antiretroviral drugs (ARVs), MSF provides antiretroviral treatment to 240,100 people in 18 countries, implements treatment strategies to reach more people earlier in their disease progression, and places people living with HIV at the centre of their care. -
The Path Less Costly
COMMENtaRY CASE STUDY The path less costly Brady Huggett When faced with a competitive threat, two companies took diametrically opposite approaches. Both were ultimately successful, but Genzyme’s decision proved to be the cleaner and cheaper option. s the world’s leader in developing enzyme-replacement drugs, and Novartis of Basel. Houston-based Tanox was founded in 1986 to AGenzyme has always understood the importance of first to market. In focus on anti-IgE antibodies and by 1989 was looking for a clinical 1991, the company obtained approval for Ceredase (alglucerase injection), development partner; it sent samples of its candidate to both Genentech an enzyme replacement therapy for lysosomal storage disease (LSD) type and Ciba Geigy (the company that would later become Novartis). 1 Gaucher. Three years later, its second-generation product, Cerezyme Genentech passed. Ciba Geigy, however, began working with Tanox (imiglucerase for injection), was also cleared for commercialization. The on anti-IgE antibodies for allergic diseases. lack of treatments for lysosomal storage diseases and effective patient out- Yet Genentech clearly had interest in the area, because it began its own reach and marketing meant that Genzyme could command soaring prices anti-IgE program a few years later—a move that prompted a misappro- for its orphan treatments. In 2000, the two drugs alone provided 66% of priation suit from Tanox. The companies fought in court for three years Genzyme’s entire product revenue. before Genentech, Tanox and Novartis reached a settlement and entered At this time, Novazyme Pharmaceuticals was a young company devel- a cross-licensing agreement for anti-IgE antibodies. -
Licensing Terms and Effectiveness of the Medicines Patent Pool
Oldenburger Studien zur Europäisierung und zur transnationalen Regulierung (ISSN: 1866‐8798) Ausgewählte Abschlussarbeiten ST 2013/05 Licensing Terms and Effectiveness of the Medicines Patent Pool Mareike Sophie Müller Jean Monnet Centre for Europeanisation and Transnational Regulations Oldenburg Fakultät I • Carl-von-Ossietzky-Universität Oldenburg • 26111 Oldenburg Abrufbar im Internet unter: http://www.uni-oldenburg.de/cetro/31251.html Content List of abbreviations IV 1. Introduction 1 2. Intellectual property in the field of pharmaceuticals 5 3. Patent pools and their development of application 8 4. The Medicines Patent Pool 4.1 Patent pools in the field of medicines: The foundation of the Medicines Patent Pool 10 4.2 Motives to establish the Medicines Patent Pool 12 4.3 The MPP’s entities and its operating mechanism 14 5. Licenses granted to the MPP and their licensing terms 5.1 Licenses in the pool 16 5.2 Field of use 23 5.3 Geographic coverage 24 5.4 Termination provisions of the license agreements 33 6. Sublicenses granted by the MPP and their licensing terms 6.1 Sublicensees of the patents licensed to the pool 35 6.2 Sourcing of active pharmaceutical ingredients 44 6.3 Royalties 46 6.4 Ability of sublicensees to supply to countries outside the licensed territory 49 6.5 Grant back provisions 52 6.6 Ability to challenge the licensed patents 55 6.7 Termination of the sublicense agreements 57 7. Effectiveness of the License Agreements 7.1 The MPP-NIH License 60 7.2 The MPP-Gilead License and associated sublicenses 61 7.3 The MPP-ViiV Healthcare License and associated sublicenses 63 7.4 The MPP-Roche License 64 8. -
Genentech 2002 Annual Report the Acceleration of Scientific Knowledge Over Time Has Been Profound— and It Is Ceaseless
What we don’t yet know could change everything. Genentech 2002 Annual Report The acceleration of scientific knowledge over time has been profound— and it is ceaseless. Today, the span of time between great discoveries in medicine gets smaller and smaller due in part to the relatively new field of biotechnology. And the number of breakthroughs and new approaches to disease continues to grow. At Genentech, we believe we have only just begun to scratch the surface of biotechnology’s potential. Without a doubt, future discoveries will dramatically change our understanding of serious illnesses and potential treatments. Even more importantly, science is likely to create dramatic change at a more personal level— increasing the length and quality of life for our loved ones and ourselves. What if one day everyone could survive cancer? Cancer is the second leading cause of death in the United States behind heart disease, with over 1.2 million new cases diagnosed per year. Some predict it will become number one in the next 10 years. Curing cancer is our ultimate goal, but if we are able to keep cancer in check, extend patients’ lives and improve their quality of life, that will be a major victory over the disease. Genentech developed the first two therapeutic antibodies for cancer in the United States, Rituxan® (Rituximab), which was co-developed with IDEC Pharmaceuticals, and Herceptin® (Trastuzumab) — both of which attack malignant cells without causing extensive damage to healthy tissues. Rituxan and Herceptin are different from chemotherapy in that, although they are serious medicines, they tend to have relatively few side effects and can sometimes be taken for prolonged periods to stave off the disease. -
Taking the Pulse of Biotech
A Conversation with Nancy Chang OnTheRecord Taking the Pulse of Biotech Biotechnology is risky business. For every start-up that succeeds, between 15 and 20 fail. for HIV, just to prepare the materials alone cost $50,000 per patient, not counting our Houston Branch board member Nancy Chang beat the odds with Tanox Inc., a 20-year-old costs or our time. biotech company that has agreed to be acquired by industry behemoth Genentech Inc. When Tanox first started, I put every- thing I had into the company. We didn’t pay ourselves salaries; the company’s first tele- Q: With such a high failure rate, are biotechs phone system was built on borrowed mon- at risk of extinction? ey. But we did what we had to do to make progress, to grow the company, and these A: Just the opposite. Pharmaceutical compa- were gutsy, risky moves. nies are realizing that it’s so expensive to discover new drugs that they’re relying more Q: How has globalization changed the and more on biotechs for the discovery, de- pharmaceutical industry? velopment and concept phases. Look at it as Big Pharma relying on the little guy. This A: Every biotech company that starts out to- way, they don’t have to pay for the failures. day is global by necessity. You have to learn Eventually, they partner with the smaller how to do business all over the world, to do biotechs that do pass muster. research and development work outside the U.S., to have partnerships with international Q: You came to the U.S. -
Antibodies to Watch in 2021 Hélène Kaplona and Janice M
MABS 2021, VOL. 13, NO. 1, e1860476 (34 pages) https://doi.org/10.1080/19420862.2020.1860476 PERSPECTIVE Antibodies to watch in 2021 Hélène Kaplona and Janice M. Reichert b aInstitut De Recherches Internationales Servier, Translational Medicine Department, Suresnes, France; bThe Antibody Society, Inc., Framingham, MA, USA ABSTRACT ARTICLE HISTORY In this 12th annual installment of the Antibodies to Watch article series, we discuss key events in antibody Received 1 December 2020 therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The Accepted 1 December 2020 coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the KEYWORDS healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two Antibody therapeutics; anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were cancer; COVID-19; Food and authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed Drug Administration; antibodies levilimab and itolizumab had been registered for emergency use as treatments for COVID-19 European Medicines Agency; in Russia and India, respectively. Despite the pandemic, 10 antibody therapeutics had been granted the immune-mediated disorders; first approval in the US or EU in 2020, as of November, and 2 more (tanezumab and margetuximab) may Sars-CoV-2 be granted approvals in December 2020.* In addition, prolgolimab and olokizumab had been granted first approvals in Russia and cetuximab saratolacan sodium was first approved in Japan. The number of approvals in 2021 may set a record, as marketing applications for 16 investigational antibody therapeutics are already undergoing regulatory review by either the FDA or the European Medicines Agency. -
Antiretroviral Treatment of Adult HIV Infection 2010 Recommendations of the International AIDS Society–USA Panel
REVIEW CLINICIAN’S CORNER Antiretroviral Treatment of Adult HIV Infection 2010 Recommendations of the International AIDS Society–USA Panel Melanie A. Thompson, MD Context Recent data regarding the consequences of untreated human immunodefi- Judith A. Aberg, MD ciency virus (HIV) infection and the expansion of treatment choices for antiretroviral- Pedro Cahn, MD naive and antiretroviral-experienced patients warrant an update of the International AIDS Society–USA guidelines for the use of antiretroviral therapy in adults with HIV infection. Julio S. G. Montaner, MD Objectives To provide updated recommendations for management of HIV- Giuliano Rizzardini, MD infected adults, using antiretroviral drugs and laboratory monitoring tools available in Amalio Telenti, MD, PhD the international, developed-world setting. This report provides guidelines for when to initiate antiretroviral therapy, selection of appropriate initial regimens, patient moni- Jose´ M. Gatell, MD, PhD toring, when to change therapy, and what regimens to use when changing. Huldrych F. Günthard, MD Data Sources and Study Selection A panel with expertise in HIV research and Scott M. Hammer, MD clinical care reviewed relevant data published or presented at selected scientific con- Martin S. Hirsch, MD ferences since the last panel report through April 2010. Data were identified through a PubMed search, review of scientific conference abstracts, and requests to antiret- Donna M. Jacobsen, BS roviral drug manufacturers for updated clinical trials and adverse event data. Peter Reiss, MD, PhD Data Extraction and Synthesis New evidence was reviewed by the panel. Rec- Douglas D. Richman, MD ommendations were drafted by section writing committees and reviewed and edited by the entire panel. -
DRUG INDUSTRY: Profits, Research and Development Spending
United States Government Accountability Office Report to Congressional Requesters November 2017 DRUG INDUSTRY Profits, Research and Development Spending, and Merger and Acquisition Deals GAO-18-40 November 2017 DRUG INDUSTRY Profits, Research and Development Spending, and Merger and Acquisition Deals Highlights of GAO-18-40, a report to congressional requesters Why GAO Did This Study What GAO Found Retail prescription drug expenditures GAO’s analysis of revenue, profit margin, and merger and acquisition deals were estimated to account for about 12 within the worldwide drug industry from 2006 through 2015 identified key trends: percent of total personal health care service spending in the United States • Estimated pharmaceutical and biotechnology sales revenue increased in 2015, up from about 7 percent from $534 billion to $775 billion in 2015 dollars. through the 1990s. Much of this growth • About 67 percent of all drug companies saw an increase in their annual was driven by use of expensive brand- name drugs, but price increases have average profit margins from 2006 to 2015. Among the largest 25 been reported for some generic drugs companies, annual average profit margin fluctuated between 15 and 20 as well. Prior GAO reports have percent. For comparison, the annual average profit margin across non- identified multiple reasons for drug drug companies among the largest 500 globally fluctuated between 4 price increases, including limited and 9 percent. competition. Experts have questioned • The number of reported mergers and acquisitions generally held steady whether consolidation among drug during this period, but the median disclosed deal value increased. companies could reduce competition and R&D investment in new drugs. -
Where Science Meets Life. Genentech 2006 Annual Report
Where science meets life. Genentech 2006 Annual Report Header Genentech’s novel medicines are where cutting-edge science meets everyday life, where scientists working hard in labs intersect with individuals working hard to enjoy their lives while confronting serious and life-threatening illnesses. Our scientists and patients inspire each other and the rest of us at Genentech as we strive to develop therapies that dramati- cally improve the treatment options for people with critical medical conditions. On Cover: Ellen Filvaroff, Senior Scientist; Alex Alvarado, Nutropin AQ® Patient and Recipient of Free Medicine From the Genentech® Access to Care Foundation Our Mission Genentech’s mission is to be the leading biotechnology company, using human genetic information to discover, develop, manufacture and commercialize biotherapeutics that address significant unmet medical needs. The company is committed to high standards of integrity in contributing to the best interests of patients, the medical profession, our employees and our communities, and to seeking significant returns to our stockholders based on the continual pursuit of scientific and operational excellence. Letter to Stockholders Arthur D. Levinson, Ph.D. Chairman and Chief Executive Officer “We see tremendous advances in understanding the biological basis of many debilitating diseases, and we believe these advances play to Genentech’s greatest strengths as we try to translate the biology into new therapies.” Letter to Stockholders Dear Stockholders, I am happy to report that 2006 was another remarkable market for Genentech, the Lucentis launch was our most year for Genentech, with important developments across successful to date. Lucentis had U.S. sales of $380 million all areas of the business.