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Mckesson Proceeds with the Celesio Acquisition the US FDA Issues

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Mckesson Proceeds with the Celesio Acquisition the US FDA Issues Vol. 21, No. 23 International Federation of Pharmaceutical Wholesalers December 4, 2014 McKesson Proceeds with the Celesio Acquisition (Sources: McKesson and Drug Store News) McKesson announced that the Stuttgart Higher Regional Court and profi t and loss transfer agreement, a newly formed Global approved the registration of the domination and profi t and loss Procurement team will lead the combined McKesson and Celesio transfer agreement between Celesio and McKesson Deutschland strategy with its manufacturing partners across the globe. GmbH & Co. KGaA (formerly known as Dragonfl y GmbH & Co. “Today marks an important achievement in the history of our KGaA), a wholly owned subsidiary of McKesson. Th e registration respective organizations. Upon registration, we will begin working of the domination profi t and loss transfer agreement marks a key together to provide the most advanced delivery of healthcare milestone in the acquisition of Celesio, fi rst announced on Oct. 24, products and services to customers and partners around the world. 2013, allowing McKesson and Celesio to operate as an integrated Our customers will benefi t from increased supply chain effi ciency, company. enhanced global sourcing, and a broad array of innovative product, “Today’s announcement is an important milestone and clears technology and business solutions,” said Paul Julian. “We remain the path for our companies to operate in an integrated way, creating committed to supporting Celesio and its business leaders as they a global leader in pharmaceutical purchasing and distribution," implement their strategy for growth and we are delighted to said John Hammergren, McKesson chairman and CEO. "With achieve this important milestone which allows our organizations the registration of the domination and profi t and loss transfer to more closely align in the areas where we can deliver further agreement, we will bring together the strengths and expertise value for our customers and manufacturing partners.” of our collective organizations to address the opportunities and Th e combined group is expected to have annual revenues needs facing our customers and business partners around the in excess of US$170 billion, approximately 85,000 employees world,” he said. “As the needs of the healthcare industry continue worldwide and operations in more than 20 countries. McKesson to evolve, broader global reach, channel infl uence, and greater and Celesio serve approximately 120,000 pharmacy and hospital purchasing scale are increasingly important. With complementary locations on a daily basis in the United States, Canada, Europe geographic footprints, shared values, and industry expertise across and Brazil, including more than 12,000 pharmacies that are either multiple markets, we will now serve our customers as one of the owned or are part of a strategic banner or franchise network of largest pharmaceutical wholesalers and providers of logistics and community pharmacies. healthcare services in the world." By the fourth year following the registration of the domination Th e operations of Celesio will be part of McKesson’s Distribution profi t and loss transfer agreement, McKesson expects to realize Solutions segment, led by Paul C. Julian, EVP and group president, annual synergies between US$275 million and US$325 million. McKesson Corporation – who is also a Director and past Chairman McKesson currently owns approximately 76% of the outstanding of IFPW. Th e operations of Celesio will continue to be led by its shares of Celesio and will continue to consolidate the fi nancial management board with Marc Owen as its chairman, overseen by results of Celesio. the Celesio Supervisory Board. Upon registration of the domination Th e US FDA Issues Draft Guidance on Product Tracing (Source: Drug Store News) Th e US Food and Drug Administration recently issued draft pharmaceutical wholesalers in the United States, stated: "While guidance on key product tracing provisions of the Drug Supply we are still in the process of evaluating this guidance, and will Chain Security Act, which is expected to be implemented by the provide a more comprehensive response to the FDA during the industry on Jan. 1, 2015. 60-day comment period, it does appear to give the supply chain According to the guidance, trading partners can utilize current a degree of fl exibility in preparing for the January 1 deadline to paper-based or electronic-based methods for the interoperable have in place processes and protocols to capture transaction data exchange of data to provide product tracing information to from suppliers and have the capacity to pass that information subsequent purchasers. Such methods could include, but are not along to downstream customers." More recently HDMA expressed limited to, the use of: (1) Paper or electronic versions of invoices; concerns about the pharmaceutical supply chain’s ability to (2) Paper versions of packing slips; (3) Electronic Data Interchange comprehensively meet the implementation deadline of January standards, such as 856 Advance Ship Notice (ASN), which is 1 for key product tracing provisions of the Drug Supply Chain currently used to provide the receiving entity with advance data on Security Act (DSCSA), stating: "…. HDMA has been a long- shipments; and (4) EPCIS, or Electronic Product Code Information time champion of the DSCSA as it represents the best solution Services, which defi nes a data-sharing interface that enables for enhancing supply chain security, creating uniformity across supply chain partners to capture and communicate data about the the country and ensuring the safety of our nation’s drug supply. movement and status of objects in the supply chain. Th is is, however, a learning experience for all involved, and at this Th e Healthcare Distribution Management Association time, we expect continued development through at least the fi rst (HDMA), the national association representing the principal quarter of 2015, particularly as distributors expand their focus to also include on-boarding dispenser customers." Copyright © 2014 - International Federation of Pharmaceutical Wholesalers, Inc. All Rights Reserved. Number of Pages 2 FOCUS December 4, 2014 Page 2 Aft er over a year of test operations, Amgen has offi cially UPS Expands Its Temperature-Sensitive opened its research center in iHuman Institute, the life science Shipping research facility of ShanghaiTech University in Shanghai, China. (Source: Press Release) Th e center will have substantial autonomy and has two major roles, UPS announced the launch of UPS Temperature True Cryo, to focus on translational medicine research, specifi cally for unmet which broadens the scope of UPS temperature-sensitive shipping needs in China, and to engage in very basic discovery research off erings to include cryogenic solutions for UPS healthcare activities to serve Amgen's global drug discovery development. In customers. Th e service includes real-time tracking and intervention addition, the center will act as a bridge between top-level scientists services, which, when combined with UPS's proactive monitoring, in China and the US to share the most advanced technologies in risk mitigation solutions and global network of control towers, will the global bioscience industry. provide complete visibility for cryogenic shipments at every stage Cardinal Health's US physician offi ce sales team and of the supply chain journey. distribution business, with annual revenue of more than US$300 Th e expansion is the latest addition to the UPS Temperature million, will be transitioned into Henry Schein's Medical Group, True suite of solutions. Th e innovative solution uses Cryoport's which will service accounts at more than 25,000 physician offi ce cryogenic and related technologies, which allow UPS customers to locations. Th e fi rms jointly made the announcement, describing use liquid nitrogen stored in dry vapor form to keep products frozen the deal as a "long-term strategic agreement." Henry Schein has at -150 degrees C for 10 days while in transit or storage, providing committed to purchase Cardinal Health brand products and use a reliable, safe container for cryopreservation of products. It can the Dublin, Ohio-based company as a primary source for various also be paired with the industry risk management, intervention medical products. and insurance solution, UPS Proactive Response Secure, to provide Mediceo Corporation recently initiated full-scale operations coverage for time- and temperature-sensitive shipments. of its contract post-marketing surveillance (PMS) business and "Th ere is a growing spectrum of demand across hopes to reach contract PMS agreements with 3 companies (for 4 tissue engineering, regenerative medicine, gene therapy, products) including its current client before the end FY2014. Th e biopharmaceutical research and reproductive health, and we are company expects this business to generate revenue of ¥100 million excited to add UPS Temperature True Cryo to meet our clients' (US$834,000) per drug per year as the business develops. needs," said John Menna, UPS's vice president of global strategy for Ranbaxy Laboratories has launched Infi mab (BOW015), healthcare logistics. "Th e value and irreplaceable nature of products the fi rst Remicade (Infl iximab) biosimilar in India. Being requiring cryopreservation highlight the need for a combination of introduced in the Indian market through a licensing partnership cryogenic capability and fi nancial risk mitigation - Temperature with Epirus Biopharmaceuticals,
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