ACINO SWITZERLAND Delivering Health – Ensuring Effective Relief Content CEO Letter 03 Acino at a glance 05 Our brand »Acino Switzerland« 06 Commercial Operations 08 Out-licensing 10 Contract Manufacturing 11 R&D and technologies 12 Our sites 14 Quality by tradition 17 Acino - Malaria Action 18 Discover the world of Acino – you will find our corporate film here: 2 Foreword »Delivering Health« is more than a vision, more than an ambition. In fact, for us it is the logical outcome of a corporate strategy focused on pharmaceutical innovation and quality. It also means doing the right things in the right way and realizing the full potential of our technological leadership and our people. Building on our core competencies in advanced drug delivery, we develop innovative pharmaceuticals in novel drug delivery formulations. Our development efforts have come to fruition: in Europe, Acino is the second largest manufacturer of transdermal therapeutic systems (TDS) and a top player for pellet technologies with an unparalleled range of solid dosage forms. We are proud to be recognized as a leader in turning drug delivery technologies into state-of-the-art medicines. Our aim is to create sustainable value for health care providers and pharmaceutical partner companies, for the ultimate benefit of patients around the world. We do this in compliance with highest Swiss quality standards, with much dedication and passion. In the recent past, we significantly expanded our foothold beyond Europe and successfully accessed up and coming markets in high growth regions. With a strategic focus on the Middle East, Africa, the CIS-region and Latin America, we truly go beyond borders, creating a new benchmark for quality pharmaceuticals to ensure effective relief. We invite you to step in and share our vision! Jostein Davidsen Chief Executive Officer 3 ACINO AT A GLANCE Who we are 4 ACINO AT A GLANCE Acino – Delivering Health Acino Pharma, a Swiss-based specialty pharmaceutical group, develops, manufactures and internationally markets well-proven and innovative pharmaceuticals in novel drug delivery forms, for many of which it holds its own patents. Acino focuses on advanced galenical forms that maximize the effectiveness of recognized active ingredients through targeted delivery and controlled release mechanisms. Under its brand »Acino Switzerland«, Acino provides Swiss-quality medicines to growth economies in the MENA-region, Sub-Sahara Africa, the CIS-region, Latin America and Asia, currently in more than 80 countries. With a strategic focus on high potential markets, Acino strives to extend its geographic footprint by organic growth or through acquisitions. As a partner of pharmaceutical companies worldwide, Acino offers in-house developed products for out-licensing and provides customized solutions from product development to contract manufacturing. Customers benefit from advanced technological solutions, highest product quality and a full spectrum of services – all under one roof. The Group operates three sites in Switzerland and one in Germany. Its production processes are certified according to national and international standards, including Swissmedic, EU, GMP, US FDA, and GCC regulations, as well as WHO and ISO norms. Acino Pharma: Delivering Health We are globally successful and a benchmark in terms of quality and innovative conception of Acino views its success as a commitment, obligation and reward alike. It is an inspiration to continuously provide excellent products and services based on a strong commitment to innovation and quality. pharmaceuticals – and we are proud of our commitment to enhance quality of life. 5 OUR BRAND »ACINO SWITZERLAND« We deliver what our brand promises With outstanding medicinal products we support physicians, pharmacists and other health care professionals in using the safest and most effective remedies which also contribute to an enhanced quality of life of their patients. Our pharmaceuticals are available around the globe under the »Acino Switzerland« brand and, in certain countries, under the trademark of our partners. 6 OUR BRAND »ACINO SWITZERLAND« The five elements of our brand promise High performance: Enabling health care professionals to do best in their job. Well-proven active agents: Working with what is known to work best. Enhancing quality of life: Providing patients with the highest level of relief. Swiss quality standard: Providing Swiss quality medication – worldwide. Advanced drug delivery technology: Ensuring maximum effectiveness and convenience. 7 COMMERCIAL OPERATIONS Taking «Acino Switzerland» global Commercial Operations business Market entry preparations ongoing 8 COMMERCIAL OPERATIONS Our medicines are available under our own brand »Acino Switzerland« to physicians, pharmacists – and ultimately patients – around the globe. Committed to highest Swiss quality standards, our effective and safe medications support healthcare professionals in their mission to treat patients in the best possible way. Our portfolio comprises innovative pharmaceuticals in the therapeutic areas of pain & rheumatology, gastroenterology, infectiology, cardiovascular, urology, oncology, neurology (CNS), as well as in the field of malaria. Our skill base and core technologies offer numerous possibilities to develop innovative products with proven active ingredients according to market requirements. And yet, all our medications have something in common: they are effective therapies in novel delivery forms which provide patients with the greatest possible enhancement of their quality of life and convenience of use. Today, we are active in over 80 countries. But here it doesn’t stop. We are gradually expanding our geographic presence by entering strategic focus markets which provide significant growth opportunities for high quality pharmaceuticals of European origin. Welcome to Acino Switzerland – Ensuring Effective Relief. 9 OUT-LICENSING Acino – Your partner for peak performance, everywhere Innovation in drug delivery is our core competence. Convinced that the API (active pharmaceutical ingredient) is only half the medicine, we deploy our expertise to develop and manufacture exceptional drugs with well-proven active ingredients in complex drug delivery systems. Out-licensing products – our innovation becomes our partners’ competitiveness Tailored to specific customer needs, researchers at Acino identify differentiating features and address them during development to create more value-added products which support patient convenience and compliance. The results are compelling: high-quality medicinal products with established active ingredients in advanced drug delivery systems for out-licensing to pharmaceutical business partners around the globe. We succeed when our progress keeps you moving forward. Acino places emphasis on the development of medicinal products with a complex patent situation and higher development risks but less competition by other licensors. Such products include controlled release formulations, transdermal patches and long acting biodegradable implants. Our innovation enhances our partners’ competitiveness Out licensing 10 CONTRACT MANUFACTURING Acino possesses a strong know-how in difficult-to-make formulations applying the highest quality standards. Its manufacturing sites are fully fitted with state- and top-of-the-art tools and equipment. Processes and capacities are optimized and allow for flexibility in time-to-volume while assuring a high service level. Contract manufacturing and more, from a single source Pharmaceutical companies value Acino as a prime contract manufacturer of superior quality products. Acino covers the entire spectrum of services for business customers, from the strategic sourcing of active ingredients to the manufacture and packaging, in a highly competent and reliable fashion. As a partner of pharmaceutical companies worldwide, Acino provides customized one-stop solutions from product development to contract manufacturing, packaging and logistics. Our customers see us as a reliable full service partner for intelligent problem solving. We make things truly simple for our customers. 11 R&D AND TECHNOLOGIES Turning drug delivery expertise into innovative medicines Oral modified release From the traditional approach to modern interpretation – from immediate to controlled release: Acino offers an unparalleled range of solid dosage forms and is a top player when it comes to pellet technologies. Pellet-based modified release forms offer a high degree of flexibility in the design and development of different oral dosage forms. The benefit for physicians and patients is evident: therapy can be tailored to ensure effective relief and ease-of-use. Oral fast disintegrating Quick dissolution of the medicine – as with fast dissolving tablets and pellets (in stick packs) – leads to a rapid onset of action. Additionally, direct buccal drug absorption into the blood stream may result in an improved absorption of the drug into the body. Faster relief and easier drug intake, especially for the elderly and patients with difficulties swallowing, are clear advantages of rapidly disintegration formulations. 12 R&D AND TECHNOLOGIES On the skin Transdermal systems are drug-loaded adhesive patches. Placed on the skin, the patch delivers a defined dose of medication through the skin over one to several days. Tailored drug release profiles (rate and duration of action) can be designed through variation of the patch technology, materials (films, polymers), components (adhesive, adjuvant) and size. Patients live with the certainty of knowing that they are continuously receiving their medication, the right dose at the right time. Under the skin Biodegradable drug implants release the active ingredient at a defined and sustained rate into the body. Long dosing intervals and continuous and steady drug release over a prolonged time period (several weeks or months) make this drug delivery form unique. After application under the skin (subcutaneous) by physicians, patients are continuously medicated as prescribed and with the assurance of high treatment compliance. 13 OUR SITES Four sites, one goal – Delivering Health Aesch, Dornacherstrasse (Switzerland) Home to a sophisticated R&D unit focused on oral drug delivery forms and biodegradable implants as well as FDA-compliant state-ofthe-art manufacturing facilities specialized in complex pharmaceutical dosage forms with controlled release. The Aesch site is one of the top manufacturing sites for pellets. Liesberg (Switzerland) The manufacturing site at Liesberg in the Jura Mountains near Basle is a traditional production site specialized in a variety of solid oral dosage, primarily for larger volume business-to-business customers. Aesch, Pfeffingerring (Switzerland) The logistics site with primary and secondary packaging is located in close proximity to the main manufacturing facilities. On about 3 000 square meters the site features a fully automated high-bay warehouse with 8 000 pallet racks and manages the logistics of numerous customers. Miesbach (Germany) R&D and manufacturing facilities for transdermal patches and manufacturing of implants are located in Miesbach. As a specialty, the site is also licensed to handle controlled substances. In view of several product launches coming up in the near-term, capacities are constantly being expanded. In 2012, a new factory for transdermals was completed. 14 OUR SITES ACINO AESCH (CH) Headquarters, R&D, Manufacturing oral technologies ACINO Logistics (CH); Packaging & Warehousing ACINO LIESBERG (CH); Manufacturing Oral technologies ACINO MIESBACH (D) Manufacturing transdermal patches and implants 15 QUALITY BY TRADITION Quality by tradition 16 QUALITY BY TRADITION Acino – Swiss quality and product excellence for international markets Switzerland, the world’s most competitive economy*, is internationally renowned for innovation and technological leadership. Over the last two decades, the Basle region, cradle of the Swiss pharmaceutical and chemical industry and home to Acino, has developed into a globally leading life science cluster. Successful companies share some typical Swiss beliefs: differentiation through innovation and highest quality standards. We are proud to say, that Acino is one of them. The deeply rooted Swiss quality pledge is reflected in all of Acino’s activities: from the igniting idea to the final product, from technological development to state-of-the-art production, nothing is left to chance. Safeguarding a high level of product quality and regulatory compliance is a fundamental objective of Acino and its operations. In line with its strategic importance and priority, the Quality Assurance (QA) function focusing on design, implementation and maintenance of state of the art QA systems, is reporting directly to the CEO. In doing so, we take on the dedication of health care providers to treat their patients in the best possible way. When you choose Acino, you are choosing quality you can rely on. * The Global Competitiveness Report 2013-2014, World Economic Forum 17 ACINO – MALARIA ACTION Acino – Malaria Action Malaria affects the lives of millions across the world. The World Health Organization (WHO) estimates that each year, there are nearly 400 million cases of malaria and close to 1 million deaths. Most people who are affected by malaria live in countries where economic resources are scarce, and they often cannot afford treatment. With 2.4 billion people at risk for malaria, this serious health concern cannot be overlooked. Acino, a member of the Swiss Malaria Group, is providing effective antimalarial treatments, reaching out to local populations in endemic countries and supporting visiting travelers. Our initiative stands for our dedication to changing the malaria reality. Acino’s anti-malarials, effective medicines in novel formulations: Artequin (artesunate & mefloquine hydrochloride) as a tablet and a pediatric formulation (pellets in a stick pack) Mephaquin (mefloquine base) as a tablet Plasmotrim (artesunate) as a rectal capsule (Rectocaps™) Trademarks might be subject to local / regional adaption. Indication for use might differ according to local requirements / registration. MALARIA ACTION 18 Acino is proud to be the recipient of the Frost & Sullivan Award 2014 for Best Practices in Enabling Technology Leadership in the pharmaceutical drug delivery industry. Frost & Sullivan presents this award to the company that has achieved technology excellence and visionary innovation. Acino is being recognized for its innovative, cutting-edge technology portfolio, pioneering best practices and delivering excellence in the pharmaceutical drug delivery space. Drug delivery system diversity, excellent product and service value, exceptional customer experience and Acino’s contribution to better therapeutic efficacy and patient compliance were contributing factors taken into consideration. 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