BULLETIN MNS October 2009 PHARMACEUTICAL STARTING MATERIALS MARKET NEWS SERVICE (MNS) BI -MONTHLY EDITION Market News Service Pharmaceutical Starting Materials/Essential Drugs October 2009, Issue 5 The Market News Service (MNS) is made available free of charge to all Trade Support Institutions and enterprises in Sub-Saharan African countries under a joint programme of the International Trade Centre and CBI, the Dutch Centre for the Promotion of Imports from Developing Countries (www.cbi.nl). Should you be interested in becoming an information provider and contributing to MNS' efforts to improve market transparency and facilitate trade, please contact us at [email protected]. This issue continues the series, started at the beginning of the year, focusing on the leading markets in various world regions. This issue covers the trends and recent developments in eastern European pharmaceutical markets. To subscribe to the report or to access MNS reports directly online, please contact [email protected] or visit our website at: http://www.intracen.org/mns. Copyright © MNS/ITC 2007. All rights reserved 1 Market News Service Pharmaceutical Starting Materials Introduction WHAT IS THE MNS FOR PHARMACEUTICAL STARTING MATERIALS/ESSENTIAL DRUGS? In 1986, the World Health Assembly laid before the Organization the responsibility to provide price information on pharmaceutical starting materials. WHA 39.27 endorsed WHO‟s revised drug strategy, which states “... strengthen market intelligence; support drug procurement by developing countries...” The responsibility was reaffirmed at the 49th WHA in 1996. Resolution WHA 49.14 requests the Director General, under paragraph 2(6) “to strengthen market intelligence, review in collaboration with interested parties‟ information on prices and sources of information on prices of essential drugs and starting material of good quality, which meet requirements of internationally recognized pharmacopoeias or equivalent regulatory standards, and provide this information to member states”. MNS FOR PHARMACEUTICAL STARTING MATERIALS IS AIMED AT YOU: - If you need to purchase pharmaceutical active ingredients to produce essential drugs at reasonable cost. - If you wish to stay informed about worldwide prices; - If you need a guide to compare market prices and for your negotiations; - If you seek market information, industry and regulatory news with respect to APIs, generic drugs; - If you wish to remain informed about overall pharmaceutical industry developments relevant to developing countries. ASSURING QUALITY In this publication, quality is expressed in terms of pharmacopoeial standards, when 1 available . When the pharmacopoeial standard is indicated as quality standard, the latest edition of the pharmacopoeia would apply. In accordance with the principles of good manufacturing practices (GMP), it is the dosage form manufacturer who must assume responsibility for the quality of the final pharmaceutical products. The acceptability of each starting material has to be established by developmental (pre-formulation, development of pharmaceutics) studies and confirmed through validation programmes for manufacturing processes. The Information Providers screened by MNS, are those that exhibit their dedication to quality assurance by maintaining up to date ISO 9000 certification, conform to WHO GMP requirements and fulfil minimum batch certification and labelling requirements. MNS collects data from Information Providers on the following: (a) Batch certificate that meets the following minimum requirements including: Name and batch number of the Pharmaceutical Starting Material Name and address of the manufacturer Manufacture and expiry date/retest date Type of container Net weight of the content per container and the number of the containers Date of latest analysis Quality specifications (b) Minimum labeling requirements for Pharmaceutical Starting Materials including: Name of Pharmaceutical Starting Materials Batch number Name and address of manufacturer Specification of active materials Expiry or retest date Storage indication Name of supplier if applicable 1 The list of covered products includes additives and fillers for which no pharmacopoeial standards are available. 2 Market News Service Pharmaceutical Starting Materials The MNS does not guarantee the quality of the substances listed in this report. Licensing authorities in the respective countries of manufacture are expected to be responsible for the review and approval of the detailed composition and formulation when authorizing a pharmaceutical product to be marketed, including the specifications of its ingredients, as submitted by the manufacturer of the dosage form and oversee compliance with GMP requirements as recommended by WHO. 3 Market News Service Pharmaceutical Starting Materials INDEX INTRODUCTION ................................................................................................................... 2 INDUSTRY TRENDS ............................................................................................................ 5 REGIONAL FOCUS .............................................................................................................. 6 North America .................................................................................................................... 6 SELECTED INDUSTRY NEWS ............................................................................................. 9 REGULATORY UPDATES ................................................................................................. 13 PRICE INFORMATION ....................................................................................................... 16 CALENDAR OF EVENTS ................................................................................................... 48 APPENDICES ..................................................................................................................... 50 4 Market News Service Pharmaceutical Starting Materials Industry Trends At the end of the third quarter of 2009, the being adopted is to intensify the marketing outlook on future growth for brand drugs of drugs which have gone off-patent while has improved compared to what was expanding into only selected segments of originally anticipated but will remain low, the generic industry.2 according to analyses by pharmaceutical consulting firm, IMS Health. Global Major pharmaceutical companies are also pharmaceutical sales for 2009 were set to venturing into the vaccine business, a field grow by 2.5-3.5% in April. Revised figures which is becoming increasingly attractive place growth rates at 5.5-6.5%.1 Based on in light of recent high demand for drug sales information in 220 countries, vaccines. US-based Abbott Laboratories this trend is attributed to healthy growth in concluded a USD 6.6 billion deal with generic drug sales, supported by an Belgian biotechnology company, Solvay, upcoming patent expiry, dry drug pipelines to acquire vaccines. Johnson & Johnson is and a tough global economic climate. also set to acquire an 18% stake in Dutch biotechnology firm in order to maximise its vaccine technology. Merck has also Expansion of pharmaceutical companies entered into partnership with Australia- into emerging markets, a move already based CSL for gain marketing rights for its evident at the beginning of the year is flu vaccine. confirming itself as pharmaceutical companies, generic and brand alike Favourable developments are boosting the establish themselves in these markets. recent growth and developments The countries concerned, referred to as observed. Vaccines against papilloma EM-7 or “pharmerging” markets, include virus and pneumococcal disease are being China, India, Russia, Brazil, South Korea, marketed for higher values than was Mexico and Turkey. The strategy adopted previously the case: around USD 100 by brand pharmaceutical companies is to rather than a few dollars. The sector is link up with generic manufacturers who also benefiting from increased investment are already quite established in these thus increasing access to the latest markets. technologies. In fact, emerging technologies promise to make Earlier in May, Pfizer concluded a deal biopharmaceutical development quicker with Aurobindo aimed at seven emerging and more efficient. While the potential for markets; a month later, GSK entered into expansion is there, several possible partnership with India‟s Dr. Reddy‟s challenges remain. Namely, the Laboratories. Companies are also building development of such biotechnology up local presence through the construction products is a long and costly process. of low-cost manufacturing sites and R&D Also, because vaccines are manufactured linkages with local companies and and not reusable, an overproduction of academic institutions. A common strategy vaccines can often symbolize wastage. 5 Market News Service Pharmaceutical Starting Materials Regional Focus North America United States of America General Market Trends The US pharmaceutical market is the importing FDA-approved drugs of foreign largest in the world, ahead of the other origin, a measure which would save an major markets: western European estimated USD 50 billion. Another factor countries and Japan. In September 2009, which will also slow growth in drug sales is the US pharmaceutical market was valued the economic slowdown which has at USD 229.7 billion, whereas the top 5 resulted in higher unemployment, stripping European markets valued at USD 105.5 many of their employer-provided