Biotechnology I Medical devices I Pharmaceutical I Hospitals I r&d
Piramal Pharma expands API manufacturing facilities
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Sanofi invests $ 200m in new vaccine production facility in France
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Lupin acquires Symbiomix Therapeutics LLC
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Highmark Health, Allegheny Health Network to invest more than $1 billion to improve health care quality, access in western PA
FOREIGN DIRECT INVESTMENTS & M&A REVIEW - november 2017
Highmark Healthand Allegheny Health Network (AHN) announced plans to invest an additional $700 million in new facility construction and existing facility expansion and renovation over the next four to five years to further improve access to affordable, high-quality health care services in the western Pennsylvania region. Coupled with $315 million in capital investments announced earlier this year to support the network's cancer and Erie market strategies, the additional projects bring the organization's total commitment to more than $1 billion in new and improved care sites and capabilities. The investments are expected to ultimately create more than 800 new health care jobs in the region. As key components of its strategy, AHN will open a new, 160+ bed, full-service hospital in Pine Township adjacent to its Wexford Health + Wellness Pavilion, while also forming a joint venture with Emerus, the nation's leading developer and operator of neighborhood hospitals, to build multiple additional facilities across the region that will provide unique local access to emergency, primary, and specialty care. The network also plans to further expand and renovate facilities at a number of its existing hospitals, including Forbes, Jefferson, West Penn, and Allegheny General, and will continue to make substantial investments that advance the capabilities of its leading clinical programs in cardiovascular care, women's health, the neurosciences, and orthopedics, among others. "Today's announcement further underscores the magnitude of our commitment to the region and to developing a nationally leading, value-based health care system that is unsurpassed in the quality, accessibility, and affordability of the services it provides," said David Holmberg, Highmark Health President and CEO. "Through our partnership with Emerus and the other significant capital investments planned for AHN, we are building a uniquely patient-centric health care system and taking every step necessary to ensure the network's exceptional care is more readily available to patients and our members in settings close to where they live and work." Through 2016, Highmark Health invested more than $1.4 billion in AHN assets and operations to enhance its clinical capabilities and grow its capacity to provide leading-edge care in the market, bringing the cumulative investment to nearly $2.5 billion through 2022. In June 2017, the network announced plans to invest more than $200 million over the next two years to enhance access to oncology services, including a new academic cancer institute that will be built on the campus of AGH and multiple community-based cancer treatment centers. The organization also is in the midst of a $115 million multi-phased capital investment plan for Saint Vincent Hospital in Erie that includes construction of a new emergency department, a state-of-the-art operating room suite, and a new Women's and Infants Center, among other planned projects.
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Piramal Pharma Solutions (PPS), a leading Contract Development and Manufacturing Organisation (CDMO) and part of Piramal Enterprises Ltd. (PEL), announced investments of $55 million across its sites in North America & Asia, to expand its API manufacturing capabilities and capacities. A part of this investment will go into new state-of-the-art, multi-purpose plants, with over 270kL of total capacity, to support the current pipeline of approximately 80 late-stage programs that PPS is currently assisting its partners with at various global sites. PPS will also expand its potency footprint (new Occupational Exposure Limit: ≥10 ng/m3) at its plant in Riverview, Michigan, while augmenting early development capabilities out of Ennore, India through additions of GMP kilo labs and a pilot plant. To serve its European biotech customers better, PPS will add early development capabilities in both, drug substance and drug product, out of its Morpeth, UK facility. Support functions such as Analytical capabilities, R&D infrastructure, automation, and IT systems will also be expanded at all API sites through this investment. Piramal supports API development and manufacturing through an integrated model across its five sites in North America, Europe and Asia. API Development activities including route scouting and process development are conducted at facilities in Aurora (CA), Ennore (IN) and Riverview (USA). These facilities are forward integrated with commercial API manufacturing units at Aurora (CA), Ennore (IN), Digwal (IN), Morpeth (UK) and Riverview (USA).
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Pharma major Lupin announced that its US subsidiary, Lupin, Inc., has acquired Symbiomix Therapeutics, LLC. Lupin had entered into an option to acquire the company earlier this year. Symbiomix is a privately held company focused on bringing innovative therapies to market for gynecologic infections that can have serious health consequences. The acquisition has been made for a cash consideration of USD 150 million including a USD 50 million upfront and other time-based payments. In addition, there are sales based contingent payments. The acquisition is funded from internal funds. The acquisition of Symbiomix and the Solosec™ franchise significantly expands Lupin’s branded women’s health specialty business, which is presently anchored by Methergine® (methylergonovine) tablets. On September 15, 2017, the US FDA approved Symbiomix’s lead product, Solosec™ (secnidazole) oral granules, for the treatment of bacterial vaginosis (BV) in adult women. Lupin expects Solosec™ to be commercially available by mid-2018. Solosec™ has been designated as a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) for the treatment of BV. QIDP designation is for medications intended to treat serious or life-threatening infections and makes Solosec™ eligible for at least 10 years of exclusivity in the United States. The FDA approval of Solosec™ was supported by a comprehensive set of studies, including two pivotal trials in BV and an open label safety study, which demonstrated efficacy for single-dose Solosec™ 2g. Solosec™ is the first and only single dose oral treatment approved for BV, the most prevalent gynecologic infection in the U.S., affecting 21 million women ages 14 to 49 annually. Compliance with the current leading therapy for BV has been shown to be only approximately 50%, and more than 50% of women treated for BV have a recurrence within 12 months. If left untreated or inadequately treated, BV can increase the risk of contracting sexually transmitted diseases and increase the risk of pre-term birth. US physicians prescribe more than 6 million prescriptions a year for bacterial vaginosis.
China Biologic Products Holdings, Inc., a leading fully integrated plasma-based biopharmaceutical company in China, announced that it has agreed to acquire 80% equity interest in Tianxinfu (Beijing) Medical Appliance Co., Ltd. ("TianXinFu") from PW Medtech Group Limited ("PWM"), a company listed on The Stock Exchange of Hong Kong Limited (Stock Code: 1358). TianXinFu, a medical device company primarily engaging in the manufacturing and sale of regenerative medical biomaterial products, is currently owned as to 80% by PWM and 20% by a third party. In exchange for its acquisition of 80% equity interest in TianXinFu from PWM, CBPO will issue 5,521,000 ordinary shares to PWM. Upon the closing of the proposed transaction, PWM is expected to hold approximately 16.66% of the outstanding share capital of CBPO taking into effect the new issuance. CBPO's board of directors has determined to exempt the proposed transaction from causing PWM to be deemed an "acquiring person" under CBPO's preferred shares rights agreement dated July 31, 2017. In addition, CBPO has decided to follow its home country practice and elected to be exempted from the shareholder approval requirement under the applicable rules of the NASDAQ Stock Market for the proposed transaction. Mr. David (Xiaoying) Gao, Chairman and Chief Executive Officer of China Biologic, commented, "We are excited to welcome TianXinFu to the China Biologic family. We believe that the synergies created by this transaction will further expand our top and bottom line financial performance. TianXinFu is the largest manufacturer of its core product, artificial dura mater, and together with other surgical consumable products it serves over 1,600 hospitals with a strong professional marketing and sales force in China. As well-established brands in our respective markets, we will be able to strengthen our core plasma therapeutics businesses by leveraging each other's existing market presence to cross-sell and offer bundle pricing opportunities; expand our customer bases by growing into each other's sales channels, hospitals, and departments. This acquisition will also enable us to unlock the market potential of our new or upcoming high margin coagulation factor products which have greater synergies with some of TianXinFu's main products. At the same time, our combined scale means reduced costs, optimized spending, broadened market exposure, and improved bargaining power with distributors, customers, and suppliers."
China Biologic to acquire TianXinFu from PWM
Stryker to acquire VEXIM
Stryker Corporation, announced that it has acquired control of VEXIM, a French medical device company listed on the Euronext Growth stock exchange in France. VEXIM, headquartered in Balma, France, specializes in the development and sale of vertebral compression fracture (VCF) solutions. The company’s flagship product is the SpineJack® system, a mechanical expandable VCF implant for fracture reduction and stabilization. The VEXIM portfolio is highly complementary to the Interventional Spine (IVS) business of Stryker’s Instruments division whose key products include an extensive and innovative portfolio for vertebral augmentation, vertebroplasty and radiofrequency ablation procedures, along with a diagnostic tool and decompression treatment advances for contained disc herniations. VEXIM had sales of €18.5M in 2016 which was 33% growth over 2015 revenue. VEXIM has a direct sales force in Europe with sales in France, Germany, Spain, and Italy and an international distribution network in selected countries in Eastern Europe, Middle East, Latin America and Asia. The SpineJack product will be sold in the US upon receiving 510(k) clearance. VEXIM anticipates filing for clearance in 2018. Stryker indirectly acquired securities held by certain VEXIM shareholders (Truffle Capital, Bpifrance Participations and Kreaxi) and managers (Vincent Gardès and José Da Gloria) of VEXIM representing in the aggregate 50.7 % of the share capital and 50.3 % of the voting rights of the company, and 37.1 % of the outstanding BSAAR warrants. Stryker paid EUR 20.00 per share and EUR 3.91 per BSAAR warrant. This price represents an aggregated equity value of VEXIM on a fully diluted basis of approximately EUR 183 million, which corresponds to an enterprise value of approximately EUR 162 million. In accordance with French tender offer laws and regulations, Stryker will file a simplified cash public offer to purchase all remaining VEXIM shares and BSAAR warrants (the “Offer”). The Offer will be filed on October 25, 2017 with the French stock market authority (the "AMF"), at the same prices per share and per BSAAR warrant as the prices paid for the controlling blocks, and will be subject to the AMF’s clearance. If Stryker owns at least 95% of the share capital, voting rights and fully-diluted shares of VEXIM at the closing of the Offer, it intends to squeeze out the remaining non-tendered shares and BSAAR warrants to own 100% of VEXIM and delist the company.
Bracket acquires mProve Health Inc.
Bracket,a leading clinical trial technology and specialty services provider, announced the strategic acquisition of mProve Health Inc. (mProve), a leading provider of mobile technologies for life science companies. The acquisition centers on both companies' support of tech-enabled clinical trials that improve patient engagement through the use of "Bring Your Own Device" mobile tools in clinical trials. Early-to-market with Electronic Clinical Outcomes Assessments (eCOA) and the first Randomization and Trial Supply Management (RTSM) mobile application, Bracket is at the forefront of digitization in clinical trials. Bracket helps biopharmaceutical sponsors and CROs increase the power of their data and identified a need to bring greater accuracy through technology. Included in mProve's suite of regulatory compliant mHealth solutions is mPulse, an Electronic Patient-Reported Outcomes (ePRO) platform for enabling data collection via standalone native mobile apps or SMS text. Other apps will enable communication with doctors and provide reminders and education. In a recent report by KNect365, 94% of clinical trials professionals surveyed are looking to increase the utilization of mHealth, surpassing big data (86%) and cloud technology for EMRs (84%). These findings, among others, indicate mHealth technology as one of the most powerful opportunities in clinical trials. While mainstream eCOA providers are challenged to retrofit their systems to support emerging mHealth technologies and the BYOD movement, Bracket is now positioned for success with native mHealth capability. "This acquisition is an opportunity to bring the shared visions of mProve and Bracket into focus," said Jeff Lee, CEO of mProve. "Both organizations center on improving patient engagement and driving adoption of the mHealth to do so. Together, we are well situated for a future of tech-enabled clinical trials."
The European Investment Bank has agreed to provide EUR 100 million to finance construction of the new Amphia Hospital in Breda. Amphia is one of the most advanced clinical hospitals in the Netherlands and the new hospital will strengthen healthcare for the North Brabant province. This is the first Dutch hospital to be financed by the EIB under the Investment Plan for Europe. During the formal ceremony in Breda finance agreements were also signed with BNG, Rabobank and ING. Construction of the new Amphia Hospital is one of the most significant capital investments in the country. The EIB is providing a low-interest rate and 27 year long-term loan. The new support for Amphia and backing for investment in the new hospital follows detailed due diligence and examination of technical and financial proposals. "Long-term investment is vital for modern health care in the Netherlands, which will have to care for an aging population using the latest technology. The EIB is pleased that to finance the new Amphia hospital, together with three leading Dutch banks. The loan signed today follows EIB support for hospital investment in Amsterdam, Maastricht, Tilburg, Rotterdam and Deventer in recent years," said Pim van Ballekom, Vice President of the European Investment Bank.
EIB confirms US$ 117 million support for new Amphia hospital in Breda under Juncker Plan
Sanofi invests US$ 200m in new vaccine production facility in France
Sanofiis investing €170 million to expand a vaccine manufacturing site in Val de Reuil, France. The expansion further strengthens Sanofi’s position as one of the world’s leading seasonal flu vaccine providers. The new facility will allow Sanofi Pasteur, the Vaccines global business unit of Sanofi, to expand supply of VaxigripTetra® to up to 70 countries in six continents. The new quadrivalent influenza vaccine contains two A strains and two B strains of influenza virus, as per World Health Organization recommendation. “This project brings together the expertise of our people with our leading industrial know-how and illustrates our commitment to manufacturing excellence solutions,” said Philippe Luscan, Executive Vice President, Global Industrial Affairs, Sanofi. “Our investment underlines Sanofi’s intent to strengthen our industrial capacities in France as a major centre of influenza vaccines production for worldwide markets.”
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AMNEAL & IMPAX TO COMBINE
Amneal Pharmaceuticals LLC, and Impax Laboratories, Inc., announced that they have entered into a definitive business combination in an all-stock transaction. As a result of the transaction, Amneal Holdings members will own approximately 75% and Impax shareholders will own approximately 25% of the new company's pro forma shares on an as converted basis. The combined company, to be named Amneal Pharmaceuticals, Inc., will have a robust generics business that will rank as the 5th largest in the United States by gross revenue and a growing, high-margin specialty franchise. The combined company is expected to have 2018 pro forma adjusted EBITDA of approximately $700 million to $750 million, which includes expected significant cost savings within the first full year of close. In addition to its broad existing commercial product portfolio, the combined organization will have a diverse and differentiated pipeline with more than 300 products either filed with the FDA or in active stages of development, a foundation for international expansion with select commercial presence in the United Kingdom and Germany, and cost-efficient global manufacturing and development capabilities in all dosage forms. The transaction is expected to enhance the combined organization's competitive position and allow for continued success in an evolving generics market. "In the 15 years since our family founded Amneal, we have established the company as a leader in the U.S. generic pharmaceuticals industry, and today marks an important milestone in these efforts," said Chirag Patel, Co-Chief Executive Officer and Co-Chairman of Amneal. "This transaction combines the complementary strengths of both Amneal and Impax to create an even stronger company with the diversification, capabilities and resources to deliver enhanced value for patients, new opportunities for our collective employees and increased growth and value creation for shareholders." "We are excited to join with Impax to create one of the most dynamic companies in the pharmaceutical industry," said Chintu Patel, Co-Chief Executive Officer and Co-Chairman of Amneal. "This combination will help us achieve our long-term goals of providing greater access to safe and affordable medicine for people around the world, while also positioning us for continued success."
Sweden running away as Europe’s healthiest nation
Tata Consultancy Services, a leading global IT services, consulting and business solutions organization, annouced new research findings highlighting Sweden’s passion for a healthy lifestyle. It had conducted a study of over 1000 runners in the country to gauge their attitudes and preferences towards running. Sweden is currently ranked by the European Commission as the top country for health and sports activity levels, with 70% of Swedes saying they excercise or play sports once a week, making it the most active nation in the continent. In addition, the new study from TCS shows that one in three swedes have taken up running regularly as a form of exercise. Notably, three quarters (77%) of those Swedes who are runners prefer to go outdoors in nature for their excercise, rather than going to a gym or running in the city. The study also highlights that while 82% of Swedish runners prefer to run alone, nearly half (49%) said that setting goals along with other people, by leveraging technology and wearables, helped their own motivation. These findings come as the world’s largest cross-country race – TCS Lidingöloppet – is set to take place on September 22nd-24th, 2017 in Sweden, where over 15,000 people are expected to turn out from around the world to take part. The event is growing in international stature and also in terms of corporate engagement. In 2016, as part of its initiative to enhance wellness and health in the communities it operates in, TCS had signed on as title sponsor to the TCS Lidingöloppet run. It is also fielding a team of 650 runners at the event this year, comprising its employees and clients, who are executives at some of Sweden’s leading companies. Avinash Limaye, Country Manager, TCS Sweden, commented, “The new research highlights the passion that people in Sweden have for running and maintaining an active lifestyle. With Sweden being the most active nation in Europe, our second year of sponsorship for TCS Lidingöloppet race is a great opportunity to inspire thousands of people towards boosting health and wellbeing – fronts that both Sweden and TCS have taken a leadership position on.” According the European Commission’s Digital Innovation scoreboard, Sweden is also a leader in technology and innovation having ranked second in the overall league table. Building on this appetite for tech and innovation across Sweden, TCS has also launched a new mobile app to allow runners and spectators to track each person’s progress and engage in the race event through their mobile devices.
CryoLife, Inc., a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced that it has entered into a definitive agreement to acquire JOTEC AG (“JOTEC”). JOTEC is a German-based, privately-held developer of technologically differentiated endovascular stent grafts, and cardiac and vascular surgical grafts, focused on aortic repair. The combination of CryoLife and JOTEC will create a Company with a broad and highly competitive product portfolio focused on aortic surgery, and will position CryoLife to compete strongly in the important and growing endovascular surgical markets. Pat Mackin, Chairman, President, and Chief Executive Officer of CryoLife, said, “We believe this acquisition will enable CryoLife to deliver sustained, high single-digit revenue growth, while also diversifying our revenues into a significantly larger addressable market. JOTEC has a technologically differentiated product portfolio addressing the $2 billion global market for stent grafts used in endovascular and open repair of aortic diseases. Their advanced product portfolio has allowed them to achieve a 17 percent revenue CAGR over the past five years, significantly outpacing the growth in the overall European market. We expect the acquired portfolio to continue to post double-digit growth outside of the United States for at least the next five years. In addition, the acquisition will leverage our global infrastructure and accelerate our ability to go direct in Europe, and will foster considerable cross-selling opportunities between the CryoLife and JOTEC product portfolios. The transaction will also drive gross margin expansion and accelerate our trajectory towards 20 percent or higher operating margins. We believe this will position CryoLife to deliver growth in non-GAAP EPS at a CAGR of at least 20 percent over the next five years.” Thomas Bogenschütz, Chief Executive Officer of JOTEC, commented, “CryoLife is ideally positioned to accelerate adoption of our products through its highly complementary and global cardiac and vascular surgery business. We are looking forward to working with CryoLife’s team to drive growth of our existing business, expand into new geographies, and accelerate our R&D initiatives in key markets such as the U.S.”
CryoLife to acquire JOTEC
A KPMG survey of more than 1,000 consumers reveals a shift in people turning to technology for instant advice on health and wellness, instead of seeking professional help in person. Millennials in particular are looking for convenience. KPMG surveyed more than 1,000 UK consumers on their health and wellness Majority use the internet to self-diagnose before seeking professional help Almost half of under-35s are willing to pay privately for access to improved health and wellness services Pharmacies are seriously underutilised, revealing clear opportunities to improve services. A KPMG survey of more than 1,000 consumers reveals a shift in people turning to technology for instant advice on health* and wellness**, instead of seeking professional help in person. Millennials in particular are looking for convenience. Dr Internet Almost two-thirds (62 per cent) of respondents said they attempt to self-diagnose when they have a health issue – looking for immediate and convenient advice from the internet. Strikingly, only 15% said they seek advice from a pharmacist. Pay for better services Health Fifty per cent of all respondents rated our country’s healthcare system as ‘poor’ or ‘very poor’. Under-35s in particular revealed that they are looking for convenience and are willing to pay for access to improved services over and above what is provided for free by the NHS. Almost half (42%) of those millennials surveyed revealed they would delve into their pockets to get a better health service, compared to only 32 per cent overall saying they would cough up. Wellness More than 40 per cent agreed they would be willing to pay for improvements in services delivered outside of GP practices or hospitals – such as nutrition advice and support for smoking cessation. While more than 60 percent in the under-35 group said that they would be prepared to fork out.
Prescription for change: consumers demanding greater choice and convenience from health services
Smartphones an effective way to curb costs in the Swiss healthcare industry
Data from the Federal Statistical Office (FSO) shows that healthcare costs in Switzerland have doubled since 1995: In 2014, direct healthcare costs totaled CHF 74.6 billion (CHF 759 per resident per month) – equal to 11.6% of Switzerland’s gross domestic product. Almost 80% of these costs are incurred by 2.2 million chronically ill patients. “Direct costs” here mean expenses incurred as a direct result of treatment, such as physicians’ fees or surgery costs. With the onward march of digitalization, the number of smartphone users in Switzerland is increasing by around 10 percentage points each year. KPMG Switzerland’s Sector Head Healthcare Michael Herzog argues that, «With one eye on the associated technological opportunities, if smartphones were to be linked up to electronic patient records in the future, this would present an effective starting point for cost savings.» In this context, KPMG Switzerland has calculated what impact digitalization could have on honing and streamlining medical treatment and, in particular, on stabilizing costs in the healthcare industry. Electronic patient records and smartphones could increase efficiency The Federal Act on the Electronic Patient Record (EPRA) was approved by Parliament in June 2015 and came into force in April 2017. As a framework act, it sets out the conditions for the centralized electronic processing of sensitive patient information. In the future, it will allow healthcare specialists to access existing data on their patients’ treatment that has already been collected and recorded by third parties at an earlier stage.
Boston Scientific Corporation announced a definitive agreement to acquire Apama Medical Inc., a privately-held company that is developing the Apama Radiofrequency (RF) Balloon Catheter System for the treatment of atrial fibrillation (AF). The transaction consists of $175 million in cash up-front and a maximum of $125 million in contingent payments over the period of 2018-2020 based on achievements of clinical and regulatory milestones. AF, a common heart rhythm disorder estimated to affect more than 33 million people worldwide,1 is commonly treated with anti-arrhythmic drugs as well as cardiac ablation – the process of delivering energy to the areas of the heart muscle causing an abnormal rhythm. The standard of care in AF ablations is pulmonary vein isolation (PVI) – the application of energy to create lines of scar tissue around the pulmonary veins in the left atrium to block unwanted electrical signals that trigger AF. PVI is currently performed using two different technologies: point-by-point RF-based ablation and single-shot balloon-based ablation. The Apama RF balloon – a single-shot, multi-electrode technology – is designed to combine the primary benefits of both RF point-by-point and balloon-based ablation approaches, notably the ability to deliver differentiated levels of energy and shortened procedure times. The technology incorporates built-in digital cameras with LED lights and sensing electrodes on the balloon which allow for real-time visualization and assessment of catheter electrode contact. This is intended to provide physicians with higher confidence of effective energy delivery and the ability to customize the amount of energy delivered around the circumference of the balloon, while further reducing procedure times when compared to existing balloon technologies.
Boston Scientific Announces Agreement to Acquire Apama Medical
Merck Invests $41 Million in its Italian Biotech Manufacturing Site of Bari
Merck will invest € 35 million in its production site Bari in a new production line for the aseptic filling of biotechnologically produced medicines in the isolator. This was announced by the leading science and technology company on the occasion of the 25th anniversary of the Italian site. The scientific and technological leadership of the plant in the southern Italian region of Apulia was honored at the event. "This investment demonstrates the importance of the Modugno-Bari production location for our growing healthcare business," said Stefan Oschmann , CEO and CEO of Merck . "This is how we can help ensure the supply of medicines that improve the quality of life of people around the world." The new production line is to be fully operational in 2022. It will be equipped with an isolator of the latest technology and a high level of automation. Insulator technology is considered as the best practice in aseptic filling and as a prerequisite for the safety of injection preparations. On the new production line, biotech drugs are to be filled for the multiple sclerosis, fertility and endocrinology therapeutic areas - with a capacity of 14 million units per year. Already in 2014, Merck invested € 50 million in Bari in a fully automatic production line in the isolator and an automated warehouse. The company employs 225 people at its location in 1992 . Bari is specialized in filling and finishing for biotech drugs for multiple sclerosis, fertility and endocrinology, which are supplied in more than 150 countries. Merck also produces some products under development at its site.
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