Group Project Strategic Analysis for Sanofi-Aventis Group TABLE OF CONTENTS ABSTRACT INTRODUCTION 1 EXTERNAL ANALYSIS 1.1 General Environmental Factors 1.1.1 Demographic 1.1.2 Economic 1.1.3 Political/Legal 1.1.4 Social Cultural 1.1.5 Technological 1.1.6 Global 1.2 Industry analysis 1.2.1 Industry description 1.2.2 Market size and growth rate 1.2.3 Significant rends in structure and scope of firms 1.2.4 Critical success factors required in the industry 1.2.5 Five forces analysis 2 INTERNAL ANALYSIS 2.1 Introduction 2.2 Key Resources and Capabilities 2.2.1 Drugs and Products on Market 2.2.2 Strengths in Research & Development 2.3 Threats from Generic Drugs and Strategies 2.4 Unique Opportunity – Expansion into Biopharmaceuticals 2.4.1 Drug Development Using Biotechnology 2.4.2 Current Biotech Drug Market 3 STRATEGY RECOMMENDATION AND IMPLEMENTATION 3.1 Sanofi-Aventis’s Alternative Strategies 3.2 Evaluation of the Resources and Capabilities of Biogen Idec 3.3 Projected Performance Following the Acquisition 2 3 3 3 3 3 4 4 5 6 6 6 7 7 7 8 8 8 8 8 9 10 11 11 11 12 12 13 14 REFERENCES 15 1 ABSTRACT The main objective of this paper is to strategically analyze the external factors and internal factors that affect the operation and success of Sanofi–Aventis and give brief recommendations. As one of the leading pharmaceutical companies in the world, Sanofi-Aventis is in a good position in terms of resources and capabilities that create competitive advantages for its growth. However, Sanofi-Aventis are also facing competitions from other big pharmaceutical companies, challenges from generic drugs, and difficulties from technology development. To ensure the healthy growth in the long run, it is necessary to maintain an innovative drug pipeline that can keep producing incremental revenue for Sanofi-Aventis. With the analysis of related external factors and internal resources and capabilities, we came up with a strategic recommendation for Sanofi-Aventis: to acquire an established pharmaceutical company Biogen Idec Inc. 2 INTRODUCTION Sanofi-Aventis, headquartered in Paris, France, is one of the leading pharmaceutical companies worldwide and number 1 in Europe. Sanofi-Aventis is engaged in the research, development, manufacture and marketing of pharmaceutical products and vaccines. The group operates in more than 100 countries across Europe, the Americas, Asia Pacific and Africa. It employs over 100,000 people across various locations. As the third largest pharmaceutical companies in the world, Sanofi-Aventis has solid resources and capabilities to support its healthy growth. Especially its world market presence in a few therapeutic areas with big potential growth, its strength in research and development, and its capacity for drug manufacturing and marketing, all place it in a good position for its healthy growth in the long run. However, Sanofi-Aventis are also facing competitions from other big pharmaceutical companies, challenges from generic drugs, and difficulties from technology development. For example, generic drugs are competing for the drugs representing 50% of its revenue. In addition, biological drug are getting more and more market share and some of them have better therapeutic mechanism than traditional small molecule medicine. Currently, there are about 270 biological medicines in clinical trials development, representing about 30% of all drugs in clinical development worldwide. With the analysis of related external factors and internal resources and capabilities, a strategic recommendation was given to support the continuing growth of Sanofi-Aventis. By implementing the acquisition strategy, Sanofi-Aventis can takeover an established pharmaceutical company such as Biogen Idec Inc. With the addition of Biogen Idec, Sanofi-Aventis can quickly get access the biologics that Biogen Idec has developed and speed up the entry to market and accelerate the research and development process toward larger proportion of biotechnology presence. 1. EXTERNAL ANALYSIS 1.1 GENERAL ENVIROMENTAL FACTORS 1.1.1 Demographic Influence As the global population continues to age, health spending increases. The number of people aging 65 and over has more than tripled since 1950’s. The 65 and above age demographic segment represent the prime growth opportunity group as they approach their peak years for consumption of medication and health care services. Globally the aging population is the key driver of booming healthcare business. Oncology demographic market segment is expected to touch $41 billion mark by 2008. More than 11million people are diagnosed with cancer every year worldwide. The group with its products such as Taxotere and Eloxatin has a significant presence in the oncology market, as there is strong demand for drugs. 1.1.2 Economic Influence Through economic upturns, downturns and subsequent recovery, the pharmaceutical is one industry that continues to remain economically viable. The pharmaceutical industry in the year 3 2000 earned a 17 percent return on both revenues and assets, making it the top performing industry and the most profitable. According to the Pharmaceutical Research and Manufacturers of America, the drug industry trade group that represents the country’s leading research-based pharmaceutical and biotechnology companies, more than $30 billion was invested in the development and discovery of new drugs during the year 2001. Pharmaceutical company stocks have continued to show growth regardless of fluctuations in the nation’s economy. This record of steady growth may be attributed to several factors; one of which is the aging population of the baby-boomers requiring much heavier reliance on prescription medications for the treatment of chronic health conditions. 1.1.3 Political and Legal Influence Pharmaceutical products are subject to price controls or pressures and other restrictions in many markets across the world, including Japan, Germany, France and Italy. The rising cost of healthcare and related pharmaceutical product pricing has led to cost-containment pressures. Some governments intervene directly in setting prices. For instance, The German Federal Joint Committee recommended the German Ministry of Health to classify the group’s Acomplia among non-reimbursable drugs in January 2007, but France and Switzerland included Acomplia in the list of reimbursable drugs. In the US, third party payers such as state and federal government authorities, private health insurers, health maintenance organizations and managed care organizations increasingly challenge pharmaceutical product pricing. This trend towards managed healthcare in the US has led to various legislative proposals and enactments to reform healthcare and government insurance programs. In 1984, the Drug Price Competition and Patent Term Restoration Act created an abbreviated approval process for generic prescription drugs in the US. The sales of generic drugs in the US have increased dramatically since then. Today, nearly all top-selling drugs in the US have generic versions available soon after their patents expire, and generic manufacturers frequently take away more than half of a brand-name drug’s market. The US federal government enacted Medicare Prescription Drug Modernization Act of 2003 and Deficit Reduction Act of 2005, which significantly influence the manner in which pharmaceutical products are prescribed and purchased, resulting in lower prices and/or a reduction in demand. Under the Deficit Reduction Act, the US government intends to reduce its spending on Medicaid by nearly $5 billion and Medicare spending by over $6 billion over the next five years (by 2010). Furthermore, individual US states have passed legislation to control pharmaceutical product pricing. 1.1.4 Social Cultural Factors Social cultural segment has a major impact on the company. As a natural extension of its commitment to health care, sanofi-aventis has developed an active policy of social responsibility centered on the protection of its employees and it plays an active role throughout the world in 4 supporting or developing humanitarian initiatives. Sanofi-aventis operates in an increasingly complex environment. The Code of Ethics fully expresses the group's spirit and culture. This Code of Ethics together with the Group Value forms a core on which every employee worldwide will base his or her actions every day, referring to shared rules and principles. Sanofi-aventis is committed to protecting patients' health, answering public healthcare needs and acting responsibly in all aspects of its business. A major element of the group’s commitment is ensuring the quality of its products. In addition to exacting manufacturing standards, sanofiaventis also combats counterfeit imitation of its medicines. Counterfeit medicines have a direct impact on the health of patients and public healthcare. For this reason, this issue demands a forceful response. The Group's program confirms its commitment to the fight against malaria. Its involvement with this pathology goes back many years, mainly in Africa, where it is backed up by recognized scientific expertise and its relationships with the different players of the health sector. Sanofi-aventis aims to cut down animal experiments as much as possible. The protection and welfare of the animals for which the group is responsible is also an important matter. It maintains a global “Culture of Care” for all the animals and ensure highest standard of animal welfare. 1.1.5 Technology The importance of technology in the drug delivery sector is increasing as large pharmaceuticals companies adjust their business strategies to reflect the changing climate buffeting their industry. The need to feed direct-to-consumer marketing, difficulty in finding enough new drug candidates to fill pipelines that see less than one percent survive into late clinical trials, and pressure from manage care and health care economists to lower the cost of their products has created a focus on existing products and finding ways to maximize their business value. Often, drug delivery technology is seen as a way to effect near-term benefits. Embracing technology helps to focus efforts in the distribution process up to a level of accuracy that insures the "perfect order" is being achieved for clients time after time. Med Immune Inc. licensed Sanofi-Aventis for innovative drug manufacturing technology for creating viruses from segments of DNA, to be used in developing vaccines against seasonal and pandemic influenza. Using the same technology, Sanofi-Aventis developed a potential bird flu vaccine for humans, which a panel of U.S. experts recommended in February as an interim measure until better versions are developed. If approved, it would be the only U.S.-approved vaccine for the H5N1 and this would give the group a competitive advantage over its competitors. Pharmaceuticals Information Systems and all the other Customer Service Teams, work closely together with Sanofi-Aventis to add value by continually improving technology in daily operations. Customer Services technology is dedicated to utilizing Electronic Data Interchange (EDI) to transmit business information electronically. Benefits of EDI include: improved data accuracy, 5 faster cycle times, more responsive customer service, and reduced administrative costs. The company has a return of goods program that manages all complexities of return process, which is a dedication to customer satisfaction. This ensures simplified returns, quick compensations and provides reconciliation information. 1.1.6 Global Factor The company derives its revenue from a diverse geographic market. Europe contributes 43.1% of revenues in 2006, while US and other countries recorded 35.1% and 21.8% respectively. In the past quarter of a century, the pharmaceutical industry has undergone huge steps towards globalization. Pharmaceutical globalization has resulted in the creation of at least a couple of companies that have achieved nearly ten percent market shares, Sanofi-Aventis being one of them with over fifty percent. Globalization of the pharmaceutical industry actually is a fairly recent trend considering the overall existence of the industry. Globalization has occurred primarily through the merger of different pharmaceutical companies. These mergers have resulted in huge companies with operations spanning the entire globe. One benefit to pharmaceutical globalization is found in the area of research and development. Globalization has increased the revenue stream of pharmaceutical companies, and this expands their ability to undertake significant research and development programs. Analysts argue that without globalization and the significant revenue and profit streams enjoyed currently by pharmaceutical companies could not undertake research and development on the various drugs they are working on at this time. For example, research on drugs to control or even rid the world of AIDS and HIV could not be undertaken. Another benefit of globalization has been to make certain drugs available to poor nations. The pharmaceutical industry contends that globalization has brought drugs that never would have reached these poorer countries. 1.2 INDUSTRY ANALYSIS 1.2.1 Industry Description Sanofi-Aventis belong to the industry of life sciences tools & services that is comprised of companies enabling the drug discovery, development and production continuum by providing analytical tools, Instruments, consumables & supplies, clinical trial services and contract research Services. It includes firms primarily servicing the pharmaceutical and biotechnology industries. The pharmaceuticals segment dominates the industry group, generating 77.9% of the global value. Sanofi-aventis is one of the world’s largest pharmaceutical companies ranking number one in Europe. In the U.S., which is the fastest growing market region for the company, sanofi-aventis currently ranks among the top five pharmaceutical companies. Backed by a world-class R&D 6 organization, Sanofi-Aventis is developing leading positions in seven major therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines. 1.2.2 Market Size and Growth Rate The global pharmaceuticals, biotechnology & life sciences industry group grew by 8.9% in 2006 to reach a value of $738.1 billion. In 2011, the global pharmaceuticals, biotechnology & life sciences industry group is forecast to have a value of $1,079.7 billion, an increase of 46.3% since 2006. The pharmaceuticals segment dominates the industry group, generating 77.9% of the global value. The US accounts for 49.3% of the global industry group's value and the leading company in the industry group is Pfizer, which generates 7.5% of the global value. Sanofi-Aventis generates 4.5% ranking number three after Pfizer and GlaxoSmithKline. 1.2.3 Significant Trends in Structure and Scope of Firms Rising research and development (R&D) expenditures by pharmaceutical companies are, in part, a consequence of changing industry structure, particularly the rise of the biotechnology sector. The creation of a market for biomedical science and increased vertical competition within the industry are likely to spur innovation and raise productivity, but they also could induce socially wasteful spending and weaken academic science. With innovation increasingly dependent on financially vulnerable firms and complex contractual arrangements, R&D investment might be becoming more sensitive to price controls or other cost containment measures. Some of the factors driving higher R&D spending are in productivity perspective. Much of the increase is a response to the vastly expanded research opportunities created by advances in basic science. The number of drug targets has risen from 500 to more than 5,000 in recent years, and expansion of research activity to investigate them is a natural and desirable consequence. 1.2.4 Critical Success Factors Required in the Industry Technology is one of the most important factors that will influence, which pharmaceutical companies prevail in the information age. Effective, efficient and timely implementation of tools that speed information delivery is a primary driver of competitive advantage. However, difficulty often arises in determining how to adopt tools and integrate them into the business. Interruptions to the business and failures in software acquisition are frequently costly, in terms of money, resources, and lost opportunities necessitating an innovation-based approach. A study of strategic alliances between biotechnology and medical technology companies and pharmaceutical companies released by PricewaterhouseCoopers LLP revealed that partnership is a critical success factor, which earns an annual growth rate of 25 percent. The total value of new alliances valued in excess of $20 million in these industries is over $3.5 billion per annum. 7 1.2.5 Five Forces Analysis There are a huge number of generic drugs coming up driven by the high demand for the original supply. Generic manufacturers curtail the group's revenue growth and this is a major threat as far as eroding market share is concerned. It gives the buyers a high bargaining power for the drugs. Government action of controlling prices and licencing generic manufactures weaken the competitive position of the group as new entrants find it easy to acquire part of industry’s market share. Competitive rivalry is high because entry is likely and there are many other phamacytical firms in the industry; there is the threat of substitute products that buyers in the market attempt to control. The group has control of the suppliers. By subscribing to the United Nations Global Compact, Sanofi-Aventis pledged to support and apply its fundamental principles to human rights, working conditions, and the enviroment and fight agaist corruption. Sanofi-Aventis wishes to partner with all its suppliers to share the values of the company. The respect of this code determines the continuing commercial relationship between the suppliers and Sanofi-Aventis. The supplier makes sure that all the substances presenting an environmental risk are identified, labeled and stored in order to prevent any risk of pollution in the event of accidental emission or discharge. All these ensure the quality of supplies is up to standard. 2. INTERNAL ANALYSIS 2.1 INTRODUCTION Sanofi-Aventis registered global sales of €28 billion in the fiscal year of 2006[1]. The main revenue generation power comes from its strong portfolio and its established expertise in therapeutic areas which show strong growth and address major public health needs. Those areas include Thrombosis, Cardiovascular and Metabolic diseases, Central Nervous System disorders, Oncology, Internal Medicine and Vaccines. The general strategy of Sanofi-Aventis is to be dedicated to the discovery, development and manufacture of innovative and effective medicines and vaccines and making these available to the physicians and their patients. 2.2 KEY RESOURCES AND CAPABILITIES 2.2.1 Products on Market Sanofi-Aventis has two main business segments that contribute to its revenue generation. One is vaccines and the other is pharmaceutical. In 2006, the revenue coming from vaccines business was €2.5 billion, and the revenue from pharmaceutical business was €25.8 billion. The vaccines division of Sanofi-Aventis Group, Sanofi Pasteur, provided more than a billion doses of vaccine in 2006, making it possible to immunize more than 500 million people worldwide. The Company's heritage, to create vaccines that protect life, dates back more than a 8 century. It offers the broadest range of vaccines protecting against 20 infectious diseases. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than $1.3 million in research and development. Currently, Sanofi Pasteur produces approximately 40% of the influenza vaccine distributed in the United States. The company is expanding its influenza vaccine production facility in the United States, which is expected to come on-line by the end of 2008 or in early 2009, and could provide more than double US production capacity. In the pharmaceutical segment, Sanofi-Aventis has been put efforts to develop a strong product portfolio covering major therapeutic areas that address public health challenges. As one of the leading pharmaceutical companies worldwide, Sanofi-Aventis realized that it cannot base its success on a single drug. Its portfolio includes a broad range of highly innovative compounds that represent genuine therapeutic advances as well as mature and generic products. It is particularly strong in both oncology and disorders of the central nervous system. Sanofi-Aventis has 15 top drugs on market with double digit growth excluding the impact from generic drugs. Some of them are so-called blockbuster drugs with annual sales over a billion US dollars. Their trade names are: Lovenox®, Plavix®, Lantus®, Taxotere®, Eloxatin®, Stilnox®/Ambien®/Ambien CRTM, Copaxone®, Aprovel®, Allegra®, Tritace®, Amaryl®, Xatral®, Actonel®, Depakine®, and Nasacort®. Among them, Lovenox is the best selling medicine of Sanofi-Aventis. Its 2006 sales reached €2.435 billion [1]. Lovenox, first launched in 1987, is the world's leading low-molecular-weight heparin for any anticoagulant of its kind. On all the major markets, Lovenox is the leader including the United States, Germany, France, Italy, Spain and the United Kingdom. This drug has been used to treat more than 118 million patients in 96 countries. For nine months in 2007, its sales has been more than €1.9 billion, and had a double digit growth of 12.1% [3]. Plavix, the 2nd best-selling drug of the company, known as an anti-platelet agent, is a blood-thinning treatment to prevent heart attacks. It is usually used in the treatment of coronary artery disease and peripheral vascular disease. It was launched in US in 1998, and currently marketed in over 80 countries, including the United States, through an alliance with Bristol-Myers Squibb. Despite the threats from generic drugs, the sales of Plavix have been back on track. Its 2006 sales were €2.229 billion [1], and have increased by 12.9% for the third quarter of 2007 [3]. Lantus, another product, is a long acting insulin for the treatment of adults with type 2 diabetes and of adults and children over the age of 6 with type 1 diabetes. It was first launched in Germany in 2000, then in the U. S. in 2001, in the U.K. in 2002, and in France in 2003. It is now marketed in more than 70 countries. Since December 2003, Lantus has been the world’s most frequently prescribed insulin. In 2006, its sales revenue was €1.666 billion [1] . Ambien CR™, used to improve sleep continuity without increasing residual effects upon wakening, was launched in the United States in September 2005 when Ambien lost patent protection. In Japan, it is sold under the brand name Myslee, and in other markets about 100 countries, the trade name is Stilnox [1]. 2.2.2 Strengths in Research & Development Sanofi-Aventis has about 17,600 research staff working on all research and development processes over 25 research and development centers on three continents [2]. The investment devoted to R&D has been reached 15.6% of sales. From the above facts, Sanofi-Aventis has 9 clearly focused its business activities on the long-term perspective, and has been established one of the most fertile and innovative portfolios in the pharmaceutical industry. Compared to other industry areas, the whole pharmaceutical industry has a much bigger proportion investment in research and development process. In 2006, the R&D expenses of Sanofi-Aventis Group reached €4.4 billion, indicating an increase of 9.5% compared that of 2005. Significant growth demonstrates its efforts and achievement in its seven areas of expertise. New programs were initiated in 2006, particularly involving prevention of diabetes and cardiovascular disease, sleep disorders, depression and anxiety, and oncology. At Sanofi-Aventis, a rich, innovative and balanced R&D portfolio has been developed. Until September 17, 2007, it has 123 products under development. Among them, 60 products in phases IIa, IIb and III, and 63 products in preclinical and phase I. On the other hand, innovation in health is not just limited to the discovery of new medicines or vaccines. Developing a new formulation of an existing drug is another channel to provide patients with an improved quality of life. Some new formulations facilitate easier and less frequent administration, or reduced side effects. To ensure patients receive the most effective treatment, in the shortest possible time, several research strategies are pursued in parallel for each of the therapeutic areas. These can include: new therapeutic indications, new formulations, molecular, physiopathological and exploratory approaches, biotechnology, genomics and proteomics. 2.3 Threats from Generic Drugs and Corresponding Strategies In pharmaceutical industry, brand-name drug companies are always threatened by generic medicines. A generic version of the brand-name drug only needs the proven bioequivalence to get marketing approval from US FDA. The generic companies incur fewer costs in creating the generic drug, and are therefore able to maintain profitability while offering the drug at a much lower price. Once hitting the market, a generic drug generally takes the market share rapidly due to its low cost and incentive from the insurance companies. In addition, the costs of these generic drugs are so low that many developing countries can easily afford. For example The Thailand is going to import millions of generic version pills of Plavix with just 3 US cents per pill from India. To extend the period of market exclusivity on their brand name drugs, and prevent generic competition, most pharmaceutical companies usually involve aggressive litigation to preserve or extend patent protection. Different from patent protection in other industries, patents issued on novel medicine compounds start quite early in the drug development process, at which time the 'clock' to patent expiration begins ticking. Drug companies may seek new patents on the production of specific forms of these compounds in the later period. For example, developing new formulation technology on the same effective compound, adding different inactive components in a drug salt, or making a specific hydrate form of the drug salt are all alternative strategies to 'reset the clock' on patent expiration. For Sanofi-Aventis, the US patent on Lovenox had been due to expire in 2012, and the patent on Plavix expires in 2011. The future sales of these blockbuster drugs are threatened by increasing patent challenges from generic manufacturers that are keen to get some of their market shares. For example, Sanofi-Aventis and Bristol-Myers Squibb may face lawsuit to protect the patent of 10 Plavix [5] [6]. Regarding to the patent of Lovenox, Sanofi-Aventis has lost its patent infringement suit against Amphastar Pharmaceuticals and Teva Pharmaceutical Industries in February 2007. Amphastar and Teva are seeking FDA permission to sell a copycat version of Lovenox. Another company, Momenta Pharmaceuticals is also developing a version of Lovenox under an agreement with Novartis's Sandoz unit. Sanofi-Aventis said it is currently evaluating its options for further legal recourse and will continue to vigorously defend its intellectual property rights. Actually, Sanofi-Aventis is facing looming generic competition for drugs representing 50% of its revenues. Therefore, it is time for Sanofi-Aventis to take some actions to refresh its current drug portfolio to find new growth drivers. In addition to the above litigation approach that can protect the “market exclusivity” rights of their self-developed drugs, big drug companies can also diversify their product portfolio to diminish the impact of generic drugs. Expanding into biopharmaceuticals is one of the choices. 2.4 Unique Opportunity – Expansion into Biopharmaceuticals 2.4.1 Drug Development Using Biotechnology New medical therapies are often brought in by biotechnology with landmark breakthroughs. Moreover, modern biotechnology can be used to manufacture existing drugs more easily and cheaply. For example, Insulin, which is widely used for the treatment of diabetes, was previously extracted from the pancreas of bovines and pigs. That was a very expensive process and also associated with undesirable allergic responses. By applying genetically engineered bacterium, the production of vast quantities of human insulin was realized at low cost. Traditional pharmaceutical companies develop drugs with relatively simple molecules through trial and error method to treat the symptoms of a disease or illness, while biological medicines are larger biological molecules known as proteins. These biological medicines include range from relatively simple proteins such as insulin, for treating diabetes, to complex monoclonal antibodies such as Herceptin, used to treat a specific type of breast cancer. Those big molecules directly target the underlying mechanisms and pathways of a malady. They have the advantages that are not accessible with traditional medicines. On the other hand, the manufacturing processes of traditional medicine and bio-medicine are different. For example, small molecules are manufactured by chemistry, while large molecules are created by living cells such as bacteria cells, yeast cells, and animal cells. 2.4.2 Current Biological Medicines Market At this stage, biopharmaceutical companies make up about 10% of all drugs on the market. In 2005, the total revenue generated by around 300 biopharmaceuticals across the globe, has reached to $85 billion. Until now, about 800 million people have been treated by biological medicines. In addition, there are about 270 biological medicines in clinical trials worldwide, representing about 30% of all drugs in clinical development. In the future, biological medicines will become increasingly important for health and economic success. Currently, several of the world's top drug makers, such as Pfizer Inc, Sanofi-Aventis SA and Johnson & Johnson, are keen to expand in the hot area of biotech medicine. In early 2005, Pfizer, 11 for example, agreed to acquire Angiosyn, Inc., which had developed a promising drug to avoid blindness. The $527 million deal was an example that large drug makers have strong interest in acquiring biotech companies. In November 2007, Sanofi-Aventis just announced it will raise its stake in biotech drug producer Regeneron to 19% from 4%. This is an indication that SanofiAventis is raising its stake in biotech drug. 3. STRATEGIC RECOMMENDATIONS FOR SANOFI-AVENTIS 3.1 Sanofi-Aventis’s Alternative Strategies Currently, Sanofi-Aventis has a proportion of biotech-derived drugs about 10 percent. To increase the portion of biotechnology presence, big pharmaceutical companies like SanofiAventis have two options. One strategy is to build internal capabilities and capacity for protein manufacturing in quality and scale from time to time, which will involve strengthening internal biotechnology R&D position, establishing biologics manufacturing capacity and building largescale manufacturing plant. However, the process to develop new medicines requires a significant amount of time and financial investment because all new therapies must undergo a stringent process of preclinical and clinical evaluation to ensure that new products are safe and effective. This is a special feature for new product development in pharmaceutical industry. Generally, the number of potential compounds that move from discovery to approval and marketing are reduced in each stage of development. Assume that we have 5,000 compounds that enter preclinical testing, only five of them will be able to continue on to clinical trials in humans, and only one of them will be approved for marketing in the United States. It is a long and uncertain journey taking an untested chemical and turning it into an approved medicine. On average it takes 12 to 15 years and between $800 million and $1.7 billion to bring a medicine to market. Therefore, it is not an easy path to build the internal capacity. To establish a partnership with a biotech company is also another option. In November 2007, Sanofi-Aventis just announced it will raise its stake in biotech drug producer Regeneron from 4% to 19% spending some $400 million. However, Regeneron does not have any product on the market until now. Sanofi-Aventis is planned to discover, develop, and commercialize fullyhuman therapeutic antibodies utilizing Regeneron's novel technologies, which improves the ability to develop new product candidates as well as identify specific genes of therapeutic interest. Still, the process of new drug development will go through the long journey from discovery, clinical trials, and finally to marketing. Another strategy is to acquire established biotech companies with a few drugs on market. This is a more practical strategy because the acquiring company can enter markets quickly, and overcome the high costs of developing products internally through gaining access to the established portfolio of new drug products and drug candidates. Another reason that Sanofi-Aventis could choose acquisition strategy is due to its experience and expertise for dealing with acquisition and merger while creating values by integrating two firms’ operations. In 2004 [4], a $67 billion merger between Sanofi Synthelabo and Aventis created the 12 current Sanofi-Aventis, the third largest drug manufacturer in the world. Following the merger agreement, a rapid and smooth integration process was taken making up a new operational community of 100,000 employees located in 80 countries from September to December 2004. 3.2 Evaluation of the Resources and Capabilities of Biogen Idec One of the appropriate takeover targets for Sanofi-Aventis is Biogen Idec Inc. It is involved in the development, manufacturing and commercialization of therapies using biotechnology. It has 3,700 employees worldwide and it has direct commercial presence in 25 key markets and network of distribution partners in more than 70 markets. Over years, Biogen Idec has made significant investments to advance their product pipeline, and has established momentum to expand within and beyond their core therapeutic areas of neurology, oncology and immunology. Currently the Company has five products on market. They are Avonex, Rituxan, Tysabri, Zevalin, and Fumaderm respectively. In 2006, its revenue grew to more than $2.68 billion [7], which represented an increase of approximately 11% over that of 2005. Revenues for Avonex, the number one prescribed therapy for MS, accounted for $1.71 billion. Rituxan, the 2nd best seller of Biogen Idec, had sales of $811 million in 2006, which grew by 14% compare to 2005. Biogen Idec markets Rituxan in the United States in collaboration with Genentech, Inc. Avonex and Rituxan generated very strong financial results and maintained their rankings among the top 10 biotechnology products sold worldwide. Biogen Idec recognized $36 million revenue related to Tysabri, by collaborating with Elan Corporation. In 2006, Biogen Idec generated operating cash flow of more than $841 million and had $2.3 billion in cash and marketable securities at the end of 2006. Another attraction of Biogen Idec is its more than 20 drug candidates in the pipeline of different stages of clinical trials. Those can help the acquiring firm quickly get a closer market entry for those promising drugs covering neurology, oncology and immunology. Strong position in research and development is another key value of Biogen Idec. Biogen Idec has been aggressively invested in research and development. In 2006, its budget for R&D exceeded $750 million and had 750 employees in R&D [7]. Additionally, Biogen Idec puts discovery and development efforts for updating its existing products. For example, by extending their use to other diseases, it could add substantial value to the company. For biotechnology pharmaceutical industry, process sciences and manufacturing are key issues affecting the capabilities and capacity for biomanufacturing. Especially, up to 1,000-fold higher dosing than earlier first-generation biologics are required in today's protein-based drugs and monoclonal antibody therapeutics. Sales of such biomedicines are accelerating, and there are more drug candidates in late-stage development. Therefore, biomanufacturing capability and capacity has become a critical issue for all biomedicine companies. Over years, Biogen Idec has established three licensed and dedicated biological bulk-manufacturing facilities. One of the three facilities is its large-scale manufacturing plant in Research Triangle Park, NC, which is one of the world's largest cell culture facilities with 90,000 liters of bioreactor capacity. This facility’s exceptional design, innovative modular construction methods, and strong safety record, has won recognition from the whole industry. Two other licensed manufacturing facilities are operated in Research Triangle Park, NC and Cambridge, MA respectively. Currently, they have 13 another large-scale manufacturing plant under construction in Hillerød, Denmark. The capacity will be 90,000-liter and is scheduled to operate in 2009. Plus the capacity from this soon coming on-line facility, Biogen Idec will be powered with nearly 200,000 liters of capacity for biomanufacturing in 2009. 3.3 Projected Performance Following the Acquisition Based on Sanofi-Aventis’s total sales revenue in 2006 ($38.9 billion), 10% of it that accounted for biotech-derived drugs, is about $3.89 billion. As mentioned previously, Biogen Idec had revenue of $2.68 billion. If we use these figures of both Sanofi-Aventis and Biogen Idec to do the estimation, with the acquisition of Biogen Idec, the revenue from biotech drugs will increase to $6.57 billion, which will be 15.8% of the total revenue. By this ratio, Sanofi-Aventis is close to its aim to double or triple the proportion of its biotech drugs by 2012. Biogen Idec could strengthen the global biotech presence of Sanofi-Aventis. With the addition of Biogen Idec, Sanofi-Aventis can speed on the market access in biotech drugs. Usually, it takes a long period to market an approved drug and even difficult to produce a blockbuster drug. It not only involves the effectiveness and safety of the drug itself, but related to lots of other factors such as marketing and management, competition from same category products or even generic drugs. By implementing acquisition strategy, Sanofi-Aventis can quickly have the market share of Biogen Idec’s Avonex, the number one prescribed therapy for multiple sclerosis (MS). And with Tysabri re-launched in the US and launched in Europe in the third quarter of 2006, it showed a bright future for the Tysabri to become a new market driver. Especially when considering that there are more than 400,000 patients being treated today for MS, and many thousands who have abandoned treatment for various reasons, there is a big space for Tysabri to explore. Physicians and patients impressed by Tysabri’s convenient dosing regimen and efficacy are showing increasing interest to it. In addition, with the expertise of Biogen Idec in biotech R&D, Sanofi-Aventis could accelerate the development and marketing process in biological therapeutics. The 20 drug candidates that Biogen Idec is currently working on could position Sanofi-Aventis in the most front field of biologics. Moreover, Sanofi-Aventis could integrate the most innovative biotechnologies important for drug discovery and development. Following the acquisition, Sanofi-Aventis could restructure its internal biotech research programs located in Boston and Tucson, Arizona with the two research centers of excellence of Biogen Idec located in San Diego, CA and Cambridge, MA. In this way, operation cost may be mitigated and internal cooperation can be strengthened. The scale of biomanufacturing capacity will be significantly enlarged by considering Biogen Idec’s the nearly 200,000 liters of capacity for biomanufacturing in 2009. Through integrating the international distribution network of Biogen Idec that covers over 70 countries with its own channels, Sanofi-Aventis will solidify its power of drug marketing. 14 REFERENCES 1) 2) 3) 4) 5) Annual Report 2006 Sanofi-Aventis. www.sanofi-aventis.com Sustainable Development Report 2006 Sanofi-Aventis. www.sanofi-aventis.com Third Quarter 2007 Sales and Earnings. www.sanofi-aventis.com Sustainable Development Report 2004 Sanofi-Aventis. www.sanofi-aventis.com Preliminary Injunction against Apotex Upheld on Appeal - Press Release. http://www.earthtimes.org/articles/show/news_press_release,32577.shtml. Retrieved on November 30, 2007 6) U.S. Judge Upholds Bristol, Sanofi patent on Plavix — Press Release. http://www.reuters.com/article/businessNews/idUSN1931607820070619?pageNumber=1. Retrieved on November 30, 2007 7) Annual Report 2006 Biogen Idec. www.biogenidec.com 8) 8. Data monitor (Published March 2007) www.datamonitor.com/companies/company 15