DISRUPTIVE INNOVATIONS AND GLOBAL NETWORKS: THE CASE OF GENOMICS AND PHARMACEUTICAL INDUSTRY APRIL 2014

Transcription

1 DISRUPTIVE INNOVATIONS AND GLOBAL NETWORKS: THE CASE OF GENOMICS AND PHARMACEUTICAL INDUSTRY MARÍA A. POZAS CENTER FOR SOCIOLOGICAL STUDIES EL COLEGIO DE MEXICO APRIL 2014

2 The sequencing of the entire human genome - mapping and location of all human genes - achieved in 2001 is considered a radical innovation with potential to change in the coming years the paradigm of medicine and health systems worldwide. We hypothesize that genomics, as a disruptive innovation, tends to produce global reorganization of several industries. Its global production networks become the fastest channel for genomics diffusion and dissemination. To illustrate this hypothesis, the case of global pharmaceutical industry is analyzed as well as the form in which the new paradigm for drugs production modifies the domestic pharmaceutical industry in Mexico

3 DRUGS PRODUCTION CHANGING PARADIGM

4 MOLECULAR PATHWAY NEW METHOD OF DRUGS DISCOVERY

5 PATENT EXPIRATION DATES OF MAJOR PRODUCTS FOR R&D-BASED PHARMACEUTICAL TRANSNATIONAL CORPORATIONS Patent owner Drug name Indicated use Patent expiry Abbott Kaletra HIV/AIDS 2016 Norvir HIV/AIDS 2014 Astellas Prograf Transplant rejection 2008 Protopic Dermatitis 2014 VEScare Overactive bladder 2015 Astra Zeneca Crestor Cholesterol 2016 Seroquel Schizophrenia 2012 Boehringer Ingelheim Flomax Prostatic hypertrophy 2009 Bristol-Myers Squibb Efavirenz HIV/AIDS 2012 Daiichi Sankyo Cravit Infectious disease 2010 Mevalotin Cholesterol 2006 Olmetec High blood pressure 2016 Eisai Aricept Alzheimer s 2010 AcipHex Gastroesophageal reflux 2013 Eli Lilly Zyprexa Schizophrenia 2011 Glaxo Smith Kline Epivir HIV/AIDS 2014 Relenza Influenza 2014 Seretide/Advair Asthma 2010 Hycamtin Cancer 2010 Johnson & Johnson Cozaar High blood pressure 2010 Merck Diovan High blood pressure 2010 Singulair Asthma 2012 Novartis Zometa Cancer 2013 Pfizer Lipitor Cholesterol 2011 Viagra Erectile dysfunction 2012 Xalatan Glaucoma 2011 Sanofi-Aventis/Bristol-Myers Squibb Plavix Anticoagulant/heart disease 2012 Sanofi-Aventis Taxotere Breast cancer 2013 Takeda Actos Diabetes 2011 Blopress High blood pressure 2012 Leuprorelin Prostate cancer 2014 Prevacid Ulcer 2009 Source: United Nations Conference on Trade and Development (UNCTAD), Investment in Pharmaceutical Production in the Least Developed Countries (UNCTAD/DIAE/PCB/2011/5), Geneva, United Nations, [1] Note: Trademark registrations compiled by UNCTAD from United States Patent and Trademark Office, Trademark Electronic Search System; patent expiry dates compiled by UNCTAD from various sources, including investors reports and Internet searches (2011).

6 NEW GLOBAL STRATEGY MERGERS BETWEEN LARGE PHARMACEUTICAL COMPANIES TO BALANCE LOSSES DIVERSIFING THERAPEUTIC CATEGORIES AND EXPANDING THE MARKET MERGERS OR ACQUISITIONS OF GENERIC PHARMA COMPANIES IN EMERGING COUNTIRES TO KEEP MARKET SHARE IN EXPIRED PATENT DRUGS NEW RESEARCH MODELS IN ORDER TO ADAPT DRUGS TO SPECIFIC NEEDS IN DEVELOPING COUNTRIES SALE AS COMBOS, COMBINATIONS OF DRUGS ALREADY IN THE IN ORDER TO KEEP THE RATE OF NEW PRODUCTS

7 PHARMACEUTICAL M&A DEALS Date Company M&A target 1995 Glaxo B.Wellcome 1999 Astra Zeneca 2000 Pfizer Warner-Lambert 2004 Sanofi Aventis 2006 Bayer Schering-Plough 2006 Merck & Co. Serono 2007 Astra Zeneca MedImmune 2008 Novartis Alcon 2008 Teva (generics) Barr Pharma 2008 Roche Genetech 2009 Pfizer Whyeth 2009 Merck & Co. Schering-Plough 2009 Sanofi-Aventis Zentiva (generics) 2009 GlaxoSmithKline Stiefel Laboratories 2009 Sanofi-Aventis Merial (animal health) 2009 Abbott Laboratories/Solvy (pharmaceutical division) Solvy (pharmaceutical division) 2010 Merck-German Millipore 2010 Teva Ratiopharm 2010 Astellas Pharma OSI Pharmaceutical 2011 Sanofi Genzyme 2011 Bristol-Myers-Squibb Amira Pharma 2011 Johnson y Johnson Synthes 2012 Bristol-Myers-Squibb/Astra Zenca Amylin Pharma 2012 Glaxo Smith Kline Human Genome Sciences 2012 Bristol-Myers-Squibb Inhibitex 2012 Novartis Fouguera Pharma 2012 Astra Zeneca Ardea Biosciences 2013 Astra Zeneca Omthera Source: Compiled by the author from various sources, including companies websites and Internet searches (2012).

8 In 2003 less than 100 trials per year were performed (AMIIF 2009). In 2005 the figure had risen to 2,025 research, grouped into 425 protocols and 22 therapeutic areas (AMIIF 2009). Investing in this type of study grew at a rate close to 15% annually (AMIIF 2009) In these research projects were involved over two thousand researchers coming from research institutions in the whole country, 80% of which are public institutions (AMIIF 2009) In 2011 the marketing of the 186 companies in the sector established in the country, of which 47 are subsidiaries of large multinationals, increased by 6.4 percent compared to (CANIFARMA, 2012). On average industry sales grew 12% in the last five years ( ). (CANIFARMA, 2012). Finally, between 1993 and 2002 manufacturing of chemicals and pharmaceutical products in the country increased at a real rate of 4.85 % annually (Ministry of Health, 2005)

9 Diagram 1: Development process for new drugs and treatments I Activities performed in public research centers in Mexico

10 ABSORPTIVE CAPACITIES A country s absorptive capacity is measured by the existence of qualified human resources, scientific experience, accumulated technical abilities, infrastructure, and models of cooperation among universities, research centres and health institutions (hospitals and clinics). When combined with an efficient regulatory system, these capacities shape the structure of a host country s health sector.

11 CHART 4 SCIENTIFIC AND TECHNICAL SERVICES RENDERED BY FOUR MEXICAN PUBLIC RESEARCH CENTERS TO THE PHARMACEUTICAL AND FOOD INDUSTRIES, Public Sector Research Centers Foreign pharmaceutical and food companies Domestic pharmaceutical companies and health centers GREEN: Services BLUE: Services RED: Services

12 EXAMPLE OF SCIENTFIC KNOWLEDGE OUTSOURCED BY PROJECTS NAME Analysis of endometrial genetic expression Development of a new method to control cervical-uterine cancer Proteomic analysis and techniques of assisted reproduction Proteomic analysis of spermatozoon Development of a serological testing system for the early detection of human papillomavirus (HPV) antibodies Evaluation of automated polymerase chain reaction (PCR) tests for the detection of HPV Evaluation of penetration effectiveness of pesticides for vector control Clinical trial for diabetes mellitus control Home perimeter infection as a determinant of dengue transmission Clinical trial phase II to evaluate vaccine immunogenicity and security Evaluation of inhibitory activity of antiseptics and disinfectants in clinical bacterial insulation in hospitals Sensitivity to broad-spectrum antibiotics in clinic insulation of entire bacterium responsible for nosocomial infections; sensitivity to broad-spectrum in vitro antibiotics in clinic insulation; effect of supplementation with polyunsaturated fatty acids in neurologic development Identification of individuals with high probability of HCV infections Randomized clinical study of a complementary diet programme in adult Mexican women Food intake of urban Mexican population Evaluation of fatty acids intake by the Mexican population Evaluation of the impact of fortified milk on the nutritional condition of beneficiary children Viability of school programs in the National Strategy against obesity and excess weight Evaluation of the efficacy of incrementing milk in the in children with severe malnutrition; effects of vitamin D on the health of pre-school children Efficacy of consuming iron-enhanced beans for humans Intake of a diet high in vitamins and minerals in Mexican women