CONTENTS

04 DCAT Thrives in the New Millennium

05 Photo Gallery

06 DCAT Highlights - Rebrands the organization - Launches DCAT Connect and Value Chain Insights - Changes governance structure after 53 years!

09 2000-2010 Mega-Mergers and a New Era of Regulatory Science - FDA approves first gene-targeted drug, the industry’s first “Magic Bullet” for cancer - FDA launches pharma GMPs for the 21st century - Sequencing of human genome is completed - Europe approves first follow-on biologic

13 2010-Present: Pharma Industry Crosses the Trillion Dollar Sales Mark - FDA approves 41 NMEs, a recent record - Pharma companies invest in biomanufacturing - EU approves first biosimilar mAbs - FDASIA enacted in the US

19 DCAT’s Past Presidents 2000-2015

20 DCAT’s Executive Director

ISSUE 09

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Building on the success of the first official DCAT Week in 1999, DCAT entered the new millennium focused on providing more objective educational programming and networking events to benefit its diverse membership. DCAT’s leadership also worked to revitalize the volunteer committees and task forces, and attract more international member companies while increasing DCAT’s international presence. DCAT’s success in the new millennium includes an increase in global membership and advancement in the organization’s use of technology. In recent years, DCAT created its own online member community – DCAT Connect – as well as Value Chain Insights (VCI) – a weekly e-newsletter providing essential information on pharmaceutical manufacturing, sourcing/procurement, and supply management. DCAT is committed to providing programs, events and services that help members expand their network of customers, suppliers and colleagues in the industry. Now, in 2015, DCAT is the premier business development association for the global pharmaceutical manufacturing industry, comprised of over 385 member companies.

DCAT Thrives in theNew Millennium

DCAT celebrating the 75th Anniversary of the DCAT Annual Dinner in 2001.

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Photo Gallery

DCAT Highlights

2003 DCAT Rebrands the Organization

DCAT changed its name to the Drug, Chemical & Associated Technologies Association in order to better reflect the innovation and expertise exhibited by its membership in the 21st century while maintaining the well-known DCAT acronym. Click here to read more.

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2001 Celebrates the 75th Anniversary of the DCAT Annual Dinner(Pictured Left)

Tradition and good humor surrounded the 75th DCAT Annual Dinner in 2001 with surprise guest Darrell Hammond of Saturday Night Live fame warming up the audience and an entertaining address by keynote speaker US Senator Bob Dole. Read a recap of the 75th Annual Dinner here.

2003 DCAT Headquarters Moves to Robbinsville, NJ

2006 First Member Luncheon at CPhI Tradeshow

In October 2006, DCAT held its first member event outside of the United States. The event was hosted by DCAT President-elect Joseph Colleluori and was a great success. Each year the luncheon serves as a welcomed respite from the busy show, and a great opportunity for members to network and meet the president-elect.

2007 DCAT Changes Executive Committee Makeup

DCAT’s Board of Directors voted to change the Executive Committee makeup from a regional US-based structure to an Industry Segment-based structure to better represent the membership and engage international members.

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2009 First FDA Speaker at DCAT Week

DCAT welcomed Dr. Janet Woodcock, Director of the FDA’s Center for Drug, Evaluation and Research, to speak at an education program and the DCAT Annual Dinner.

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2014 Changes in DCAT’s Governance Structure

At the board meeting in March 2014, DCAT’s Board of Directors voted to change the governance structure of the organization after 53 years. The Board is now comprised of 11 persons with an 18 member Advisory Council. >>

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2013 DCAT Launches DCAT Connect (Pictured Left)

Since its founding in 1890, DCAT has been dedicated to building a business development community for the pharmaceutical manufacturing industry. With the launch of DCAT Connect, a networking, discussion and information resource for individuals employed by member companies, DCAT takes that community online! To learn more about DCAT Connect, click here.

2013 DCAT Donates $30,000 to New STEM Teaching Fellowship

In April 2013, DCAT announced it would be supporting the launch of New Jersey’s Woodrow Wilson Teaching Fellowship, aimed at recruiting and training top science, technology, engineering and math (STEM) college graduates and professionals to work in high-need schools.

Thanks to a very generous $30,000 donation from DCAT member company, ChemWerth, DCAT is currently supporting DCAT Fellow, Brian Moshofksy.

Brian began his Masters program in the summer of 2014. He is currently in school and assistant teaching at Orange High School in Orange, NJ. To read more about the Fellowship, click here.

2014 DCAT Introduces Value Chain Insights

DCAT launches Value Chain Insights (VCI), a weekly e-newsletter providing essential information on pharmaceutical manufacturing, sourcing/procurement, and supply management. Produced by DCAT’s Editorial Director, Patricia Van Arnum, the publication features news and analysis of pharmaceutical and biopharmaceutical companies, contract manufacturers, and suppliers, as well as best practices, executive insights, market trends and regulatory developments. To learn more about VCI, click here.

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• 2014 DCAT Headquarters Moves! (Pictured Right)

As the organization continues to grow, the DCAT staff is growing, too! In August 2014, DCAT moved its headquarters to One Union Street in Robbinsville, NJ, to accommodate future growth.

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• 2015 DCAT Celebrates the 125th Anniversary! (Pictured Left)

In honor of this significant milestone, DCAT leaders and staff have planned many events to celebrate the 125th anniversary during DCAT Week ‘15 (March 16-19th in New York City). At the DCAT Member Company Networking Reception on Tuesday March 17th, there will be a time capsule ceremony and a Member Company Photo Parade. The DCAT Business Builder Session on Wednesday the 18th is a special anniversary program developed exclusively for DCAT members on strategies and tools for getting deals done and moving projects forward. And the 89th DCAT Annual Dinner will be especially festive this year with birthday cake and the premiere of the DCAT Anniversary Video – A Walk Through Our History.

2000 - 2010

INDUSTRY TIMELINEA year of mega-mergers. Pfizer and Warner-Lambert merge in a $90-billion deal to form the new Pfizer. The acquisition provides Pfizer with the anti-cholesterol drug Lipitor (atorvastatin), which would become Pfizer’s and the industry’s top-selling drug. The acquisition was built on a co-marketing agreement formed by the companies in 1996 for Lipitor. The drug was discovered by Parke-Davis Research, which Warner Lambert had earlier acquired; the drug was approved by the US Food and Drug Administration in 1996 and introduced in 1997.

Also, in 2000, Pharmacia & Upjohn completes its acquisition of Monsanto, which includes the pharmaceutical business, G.D. Searle, and the company is renamed Pharmacia. Following the merger, Pharmacia continues Searle’s agreement with Pfizer to promote Celebrex (celecoxib), a new drug to treat arthritis, which had been co-developed by Pfizer and Searle. Three years later in 2003, Pfizer and Pharmacia would merge following the 2002 spin-off of Pharmacia’s agricultural business, Monsanto.

The planned merger of Glaxo Wellcome and SmithKline Beecham, an approximate >>

2000

Following the wave of merger and acquisition (M&A) activity in the 1990s, which saw the emergence of new business combinations and names in the pharmaceutical marketplace (AstraZeneca, Aventis, Novartis, and Pharmacia & Upjohn), the pharmaceutical industry undergoes further change at an even larger scale with several mega-mergers in the 2000s.

The decade of the 2000s begins with the two largest: Pfizer’s acquisition of Warner-Lambert and the merger of GlaxoWellcome and SmithKline Beecham. It would be followed with other important deals (Pfizer’s acquisition of Pharmacia, the merger of Aventis and Sanofi-Synthélabo, Bayer’s acquisition of Schering AG, AstraZeneca’s acquisition of MedImmune, and Merck KGaA’s acquisition of Serono) and concludes with three more mega-mergers at the end of the decade: Pfizer’s acquisition of Wyeth; Roche’s acquisition of full ownership of Genentech; and Merck & Co.’s acquisition of Schering-Plough.

Also, a new era of regulatory science is entered into with the US Food and Drug Administration’s initiative, Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, in an effort to enhance and update the regulation of pharmaceutical manufacturing processes by merging science-based risk management with an integrated quality systems approach.

Mega-Mergers and a New Era of Regulatory Science

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Bristol-Myers Squibb acquires DuPont Pharmaceuticals Company, adding Sustiva (efavirenz), an antiviral drug, and Coumadin (warfarin sodium), an anticoagulant, to its portfolio.

Following a series of divestments and an increased focus on pharmaceuticals, American Home Products changes its name to Wyeth, taking the name from its pharmaceutical business, Wyeth-Ayerst.

Biotechnology continues to advance in the pharmaceutical industry. Biogen opens one of the largest biologic manufacturing facilities in the world, a 90,000-liter large-scale manufacturing plant in Research Triangle Park, North Carolina. The biotechnology company, Amgen, completes its acquisition of Immunex for approximately $16 billion, making it (at the time) one of the largest acquisitions among biotechnology companies. With it, Amgen acquires the arthritis drug Enbrel (etanercept), a fusion protein produced by recombinant DNA (which is co-marketed by Wyeth). The US Food and Drug Administration approves Abbott Laboratories’ Humira (adalimumab), a fully human monoclonal antibody. It will become one of the industry’s top-selling drugs.

The US Food and Drug Administration approves Gleevec (imatinib), a gene-targeted drug for patients with chronic myeloid leukemia. Gleevec is the first gene-targeted drug to receive FDA approval. It is featured on the cover of TIME magazine as a “magic bullet” by ushering in a new approach to cancer treatment.

The Generic Pharmaceutical Association (GPhA) is founded in 2000 following the merger of three industry trade associations: the Generic Pharmaceutical Industry Association, the National Association of Pharmaceutical Manufacturers, and the National Pharmaceutical Alliance.

Soon after entering its fifth decade since its founding in 1972, Mylan posts revenue of $1 billion. Two years later in 2004, Mylan was added to the S&P 500 and ships 11 billion doses of pharmaceuticals.

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The biotechnology company, Genzyme, eclipses the $1 billion mark in sales and grows its employee base to more than 5,200 worldwide. By the end of the decade, the company will reach nearly $4 billion in revenues with more than 12,000 employees worldwide.

The US Food and Drug Administration launches Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach, in an effort to enhance and update the regulation of manufacturing processes and end-product quality of animal and human drugs and biological medicines by merging science-based risk management with an integrated quality systems approach.

2002

2000 (cont.)

2001

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$76-billion deal, is announced in January 2000 and completed in December 2000, forming GlaxoSmithKline.

Novo Nordisk is split into three separate companies operating under the umbrella of the Novo Group: Novo Nordisk A/S, Novozymes A/S, and Novo A/S.

Omnitrope (somatropin [rDNA origin]) receives European Commission approval as the first product approved under the European Union’s new regulatory pathway for follow-on biologics. Sandoz received approval. >>

Several key drug approvals are made in 2004. Genentech’s Avastin (bevacizumab) is approved by the US Food and Drug Administration. A recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF), it is the first in an innovative class of drugs used to treat metastatic colorectal cancer that works by preventing the formation of new blood vessels, a process called angiogenesis. OSI Pharmaceuticals’/Genentech’s Tarceva (erlotinib hydrochloride) is approved by the FDA. It is an oral drug that works by inhibiting the activity of a specific enzyme (tyrosine kinase), part of the human epidermal growth factor receptor (EGFR), a signaling pathway which plays a key role in the formation and growth of numerous cancers. Also in 2004, the FDA approves Gilead Sciences’ Truvada, a one-tablet, once-a-day fixed-dose co-formulation of two antiviral drugs, tenofovir disoproxil fumarate and emtricitabine as an HIV combination therapy.

Hospira is launched as a separate company following a spin off by Abbott Laboratories of its hospital products business. And in 2004, several Novartis generic-drug businesses are unified under Sandoz, and the unit is named a division of the Novartis Group, joining Pharmaceuticals and Consumer Health.

Teva Pharmaceutical Industries begins a series of key acquisitions beginning with Sicor in 2004, followed by IVAX in 2006, and Barr Pharmaceuticals in 2008.

Pharmaceutical companies increase investment in China. Among two noteworthy moves, in 2004, Roche establishes a research and development center in Shanghai. Two years later in 2006, Novartis announces the creation of a strategic biomedical research and development center in Shanghai.

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2006

On April 14, 2003, the US National Human Genome Research Institute, the US Department of Energy, and their partners in the International Human Genome Sequencing Consortium announced the successful completion of the Human Genome Project, laying the foundation for genomic-based research, and with it, a new paradigm for pharmaceutical research and development. With this understanding, it is hoped that genome-based research will enable medical science to develop highly effective diagnostic tools, better understand the health needs of people based on their individual genetic makeups, and design new and highly effective treatments for disease.

In a decade of mergers and business combinations, in 2003, Pfizer acquires Pharmacia, and the biotechnology companies, Biogen and IDEC Pharmaceuticals, merge to form Biogen Idec. In 2003, Bayer Healthcare AG is established as an independent legal entity as part of the reorganization of the chemical giant Bayer, and in 2005, Bayer completes its acquisition of Roche’s over-the-counter drug business, making Bayer one of the largest suppliers of nonprescription medicines. Also in 2004, Aventis (which had been formed in 1999 from the merger of the life sciences operations of Hoechst and Rhône-Poulenc) merges with Sanofi-Synthélabo to form Sanofi-Aventis.

2003

2003-2004

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The US Food and Drug Administration approves Merck & Co.’s recombinant vaccine, Gardasil, the first vaccine developed against human papillomavirus (HPV) cancers and the first preventative cancer vaccine for cervical cancer, representing a major scientific achievement. Recombinant vaccines are made by genetic engineering, the process and method of manipulating the genetic material of an organism. In this case, the genes that code for a specific protein from each of the four virus types of HPV are expressed in yeast to create large quantities of the protein. The protein that is produced is purified and then used to make the vaccine. Because the vaccine only contains a protein, and not the entire virus, the vaccine cannot cause the HPV infection. It is the body’s immune response to the recombinant protein(s) that then protects against infection by the naturally occurring virus.

2006

Novartis announces a $1-billion investment over five years to build a pharmaceutical research institute in China.

The decade of the 2000s ends with three mega-deals. Pfizer acquires Wyeth for $68 billion. Merck & Co. and Schering-Plough merge in a $41 billion deal. Roche acquires the remaining part of Genentech that it did not already own to gain full ownership of Genentech for nearly $47 billion.

2009

2009

AstraZeneca acquires MedImmune, a Gaithersburg, Maryland-based biopharmaceutical company, for approximately $15 billion. Schering-Plough acquires Organon BioSciences, the former pharmaceutical business of the Dutch chemical company, Akzo Nobel. Merck KGaA acquires Serono, a biopharmaceutical company.

Bayer announces a public takeover offer for Schering AG, (Berlin, Germany) and Schering AG is renamed Bayer Schering Pharma AG. Bayer Schering Pharma AG, headquartered in Berlin, now operates together with Bayer’s existing pharmaceuticals business as a division of the Bayer HealthCare subgroup. At the turn of the year 2008/2009, the pharmaceuticals businesses of Bayer and Bayer Schering Pharma in Germany are combined into a single legal entity.

Johnson & Johnson acquires Pfizer Consumer Healthcare for $16.6 billion.

The US Food and Drug Administration approves the first vaccine for humans against the H5N1 influenza virus, commonly known as avian or bird flu.

Novartis becomes the first company to produce influenza A (H1N1) vaccine with cell-culture technology, an advancement over traditional egg-based production processes. Novartis opens a large-scale manufacturing plant for influenza cell-culture and vaccines in Holly Springs, North Carolina.

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2010 - Present

INDUSTRY TIMELINE

Reflecting increasing product development in biologics, Sanofi-Aventis details a plan to evolve select chemical production facilities in France to biomanufacturing and vaccine production, representing an investment of EUR 700 million ($797 million). The company also simplifies its name from Sanofi-Aventis to Sanofi.

Novartis proposes to complete a majority stake in the eye-care company, Alcon, followed by a share direct merger of Alcon into Novartis. In 2011, the Alcon merger is completed and Alcon becomes the Eye Care Division of Novartis.

Also in 2010, Abbott completes its acquisition of Belgium-based Solvay Pharmaceuticals and of Piramal’s Healthcare Solutions business, which expands its presence in branded generics as well as emerging markets.

In one of several investments by the large pharmaceutical companies in China in the 2010s, Novo Nordisk announces it plans to double the number of employees at its R&D center in China from 100 to 200 employees by 2015. The company had established its R&D center in China in 1997. In 2012, the company announced an additional investment of $100 million to expand its R&D facility in Beijing. >>

In the United States, the Patient Protection and Affordable Care Act is signed into law, which includes authorization to establish an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to or “interchangeable” with an FDA-approved biological product. The US Food and Drug Administration forms a working group to plan the agency’s approach to implementing the statute for establishing a regulatory pathway for biosimilars in the US.

2010

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2010

Now in 2015, the pharmaceutical industry can look back at the first years of the decade of the 2010s with a major milestone: in 2014, total global spending on medicines surpassed one trillion dollars for the first time in history. Other important achievements were made. In 2014, the US Food and Drug Administration’s Center for Drug Evaluation and Research approved 41 new molecular entities (NMEs), surpassing a recent high of 39 NME approvals in 2012 and exceeding the industry’s annual average of 25 NMEs approved from 2005 through 2013. Also, several companies announce major investments in biomanufacturing as well as in emerging markets, including China.

Pharma Industry Crosses the Trillion Dollar Sales Mark

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In another investment in China, Merck & Co. establishes its Asia R&D headquarters in Beijing and commits to invest more than $1.5 billion in R&D in China over the next five years.

Zhejiang Hisun Pharmaceuticals and Pfizer launch Hisun-Pfizer Pharmaceuticals Co. Ltd., a joint venture between the two companies to develop, manufacture, and commercialize off-patent pharmaceutical products in China and global markets. It is one of the first joint ventures between a multinational pharmaceutical company and a local leading pharmaceutical company in branded generic medicines in China.

GlaxoSmithKline completes its $3.6 billion acquisition of the biotechnology company, Human Genome Sciences.

The generic-drug company, Watson Pharmaceuticals, completes its acquisition of Actavis, and in January 2013, changes its name to Actavis.

Abbott announces plans to separate into two publicly traded companies, one focused in diversified medical products and the other in research-based pharmaceuticals.

To address the problem of counterfeit medicines, in July 2011, the European Union adopted a new directive, the EU Falsified Medicines Directive, to prevent falsified medicines entering the legal supply chain. The directive provides for harmonized safety and strengthened control measures across Europe by applying new measures in four main areas: safety features of medicines (including bar coding); supply chain and good distribution practices; active ingredients and excipients; and Internet sales. The Directive came into force on July 2011 with EU member states required to apply its measures beginning in 2013.

The US Food and Drug Administration approves the commercial manufacture of Bristol-Myers Squibb’s biologic, Orencia (abatacept), at the company’s new bulk biologics manufacturing facility in Devens, Massachusetts. Construction of the new facility was completed in 2009 and validation started in 2010. The new facility, which had an initial investment of $750 million, represents the single largest capital investment by the company in its history.

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2011

Sanofi completes its acquisition of the biotechnology company, Genzyme, for $20.1 billion.

Also in 2014, Johnson & Johnson completes its acquisition of Crucell, a developer and manufacturer of antibodies and vaccines. Crucell’s key biomanufacturing technology, PER.C6, is a biomanufacturing platform based on a human cell line.

Teva Pharmaceutial Industries completes its acquisition of Cephalon to build its branded and specialty pharmaceutical portfolio. The move follows Teva’s 2010 acquisition of the German generics company, Ratiopharm.

2011

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Roche receives FDA approval for Gazyva (obinutuzumab) for treating chronic lymphocytic leukemia, making it the first drug with FDA Breakthrough Therapy Designation approved by the FDA. FDA Breakthrough Therapy Designation, authorized by the Food and Drug Safety and Innovation Act of 2012, is intended to expedite the development and review of drugs for serious or life-threatening conditions. In 2013 the FDA approved two additional new molecular entities with Breakthrough Therapy Designation: Pharmacyclics’/Janssen’s Imbruvica (ibrutinib) for treating mantle cell lymphoma (it would later also be approved for treating chronic lymphocytic leukemia) and Gilead Sciences’ Sovaldi (sofosbuvir) for treating hepatitis C virus infection. Sovaldi, approved in the US in December 2013 and in the European Union in January 2014, would become one of the industry’s top-selling drugs with 2014 global sales of $10.28 billion. >>

Roche announces an investment of CHF 800 million ($851 million) in biologics manufacturing over the next five years in sites in Germany (Penzberg), Basel (Switzerland), and California (Vacaville and Oceanside).

Also in 2013, Amgen announces an investment for a new biomanufacturing plant in Singapore for monoclonal antibodies. It also completes the acquisition of Onyx Pharmaceutical for $10.4 billion.

Merck & Co. opens a new $120-million packaging facility in Hangzhou, China, for tablets and sterile products. It is the latest investment in China by Merck, which in 2011, established its Asia R&D headquarters in Beijing.

Also in 2013, Boehringer Ingelheim inaugurated the expansion of its manufacturing plant (packaging) and the building of its chemicals R&D laboratory, Center of Competence, in the Zhangjiang High-Tech Park in Shanghai, China. The expansion, with a total investment of approximately EUR 70 million ($79.6 million), will make the Zhangjiang plant one of Boehringer Ingelheim’s most important sites in the Asia Pacific region.

2013

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2013

In the United States, the Food and Drug Administration Safety and Innovation Act (FDASIA) is signed into law and includes the Generic Drug User Fee Amendments of 2012 (GDUFA), which allow the FDA to collect user fees from industry to fund reviews of generic drugs based on a similar model as the Prescription Drug User Fee Act (PDUFA), which is used to collect user fees to fund reviews of innovator drugs. FDASIA also includes measures to promote innovation by authorizing the FDA to designate a drug as a Breakthrough Therapy, which is intended to expedite the development and review of drugs for serious or life-threatening conditions. FDASIA also has measures to increase stakeholder involvement in FDA processes and enhance the safety of the drug supply chain.

AbbVie launches as an independent company following the separation of the former Abbott into two separate companies: AbbVie, focused on research-based pharmaceuticals, and Abbott, focused on diagnostics, medical devices, nutritionals, and branded generic pharmaceuticals.

2012

2013

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Roche gains FDA approval for Kadcyla (ado-trastuzumab emtansine), an antibody drug conjugate (ADC), for treating HER2-positive metastatic breast cancer. It is only the third ADC approved by the FDA, which had approved Adcetris (brentuximab vedotin) in 2011 for treating Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma, marketed by Seattle Genetics and Takeda, and Pfizer’s Mylotarg (gemtuzumab ozogamicin) in 2001 for treating acute myeloid leukemia, which was subsequently withdrawn in 2010. ADCs represent a specialized class of drugs that link a small-molecule, often a cytotoxic small molecule, to a monoclonal antibody.

2013

The global pharmaceutical market passes the trillion dollar market for the first time in its history as total global spending on medicines reaches $1 trillion.

The first biosimilars of a monoclonal antibody are approved in the European Union; two biosimilars of the reference product, infliximab, an anti-inflammatory medicine, are approved.

In the United States, the Drug Quality and Security Act (DQSA) is signed into law. Title II of DQSA, known as the Drug Supply Chain Security Act (DSCSA), outlines critical steps to build an electronic, interoperable system to identify and trace prescription drugs as they are distributed in the United States. DSCSA has staged implementation over a 10-year period, and in February 2014, the FDA issues its implementation plan for the new law.

The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) approves 41 new molecular entities (NMEs), surpassing the industry’s recent high of 39 NME approvals in 2012, exceeding 2013’s total of 27 NME approvals, and eclipsing the average annual number of NMEs approved during the past decade. From 2005 through 2013, FDA’s CDER approved an average of 25 NMEs per year. Reflecting the more specialized nature of drug development, however, 41% (17 of the 41 drugs) of the 2014 NME approvals were orphan drugs to treat rare diseases.

Actavis makes two major acquisitions. It completes its $28 billion acquisition of Forest Laboratories in July 2014, and in November 2014, announces it will acquire the specialty pharmaceutical company, Allergan, for $66 billion in a deal that is expected to close in the second quarter of 2015. The proposed combination of Allergan and Actavis will create one of the top 10 global pharmaceutical companies by sales revenue, with combined annual pro forma revenues of more than $23 billion anticipated in 2015. The acquisitions followed Actavis’ 2013 acquisition of Warner Chilcott. In February 2015, Actavis announced it was changing its corporate name to Allergan, pending shareholder approval and closing of the Allergan deal. The Actavis name will continue to be used for select products and geographies.

Also in 2014, Novartis and GlaxoSmithKline (GSK) announce a major three-part transaction under which Novartis and GSK agreed to combine their consumer healthcare businesses into a joint venture. GSK will divest its oncology products to Novartis, and GSK will acquire Novartis’ vaccine business (excluding flu) in a transaction that is expected to close in the first half of 2015. In a separate transaction, Novartis agrees to divest its animal health business to Eli Lilly and Company, a deal that closes in January 2015.

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Baxter International Inc. announces plans to create two separate, independent global healthcare companies: one focused on developing and marketing biopharmaceuticals and the other on medical products. It later announces that Baxalta Incorporated will be the name of the new, publicly traded biopharmaceutical company that is expected to launch in mid-2015.

2014

Several pharmaceutical companies announce biomanufacturing investments. Bristol-Myers Squibb announces plans to construct a new large-scale biologics manufacturing facility in Cruiserath County, Dublin, Ireland. The investment, scheduled to be finalized in the second half of 2015, is expected to be comparable to the $900 million investment by the company to construct and operationalize the company’s biologics facility in Devens, Massachusetts, which at the time of its completion in 2009, was the company’s single largest capital investment in its history. The completion of the new Irish facility, including commissioning and validation, is anticipated to take approximately four years and is estimated to become operational in 2019.

AbbVie announces its first manufacturing facility in Asia with plans to invest $320 million to construct a bulk biologics manufacturing facility in Singapore, expected to be operational in 2019. The company will also acquire a small-molecule active pharmaceutical ingredient manufacturing plant in Singapore.

Also in 2014, AstraZeneca announces plans to expand its large-scale cell-culture manufacturing facility in Frederick, Maryland. The more than $200-million project will increase production capacity to support AstraZeneca’s maturing pipeline and to meet future demand for its biologics portfolio, which currently represent nearly 50% of AstraZeneca’s overall pipeline. The expansion project is expected to be completed in mid-2017.

In another investment among pharma companies in China, Merck KGaA´s biopharmaceuticals division breaks ground for a new EUR 80 million ($105 million) pharmaceutical manufacturing facility in Nantong, China. The new facility, which will be the company’s second-largest pharmaceutical manufacturing facility worldwide, will focus on the bulk production and packaging of products for the treatment of diabetes, cardiovascular diseases, and thyroid disorders.

Roche announces an investment of CHF 3 billion ($3.19 billion) for a new R&D center, office building, and infrastructure upgrades at its corporate headquarters site in Basel, Switzerland. >>

Also in 2014, Merck KGaA agrees to acquire Sigma-Aldrich for $17 billion, signaling the company’s strategic emphasis in life science products and services. The company is already positioned in that market through EMD Millipore. Closing is expected in mid-year 2015, subject to regulatory approvals and other customary closing conditions.

Also in 2014, Bayer completes its previously announced $14.2 billion acquisition of Merck Consumer Care from Merck & Co., positioning Bayer further in the over-the-counter (OTC) market. Also in 2014, Mylan agrees to acquire Abbott’s non-US developed markets specialty and branded generics business, which further diversifies Mylan’s business outside of the US and provides entry into the OTC market. The deal is expected to close in the first quarter of 2015.

2014

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2014 (cont.)

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In an important advancement in vaccine manufacturing, Novartis receives US Food and Drug Administration approval for production of a cell-culture influenza vaccine at its facility in Holly Springs, North Carolina, making it the first FDA-approved seasonal influenza vaccine not manufactured using chicken eggs, the traditional method for producing vaccines. The facility is the result of a joint partnership between Novartis and the US Department of Health and Human Services’ Biomedical Advance Research and Development Authority (BARDA).

2014

Pfizer agrees to acquire Hospira, a provider of injectable drugs and infusion technologies and biosimilars for approximately $17 billion in a deal expected to close in the second half of 2015.

US Food and Drug Administration Commissioner Margaret Hamburg announces she will be leaving her post, effective at the end of March 2015. She was appointed as FDA Commissioner in 2009. Dr. Stephen Ostroff, FDA’s Chief Scientist, will serve as Acting Commissioner until a successor is named.

2015

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DCAT’s Past Presidents2000 - 2015

2004-2005Patrick Vazquez, Alpharma HPI

2009-2010Joseph Principe, Piramal Healthcare

2012-2013Tyson Popp, West Pharmaceutical Services, Inc.

2003-2004H. Lee Armstrong, Interchem Corporation

2008-2009James K. Martin, Schering-Plough Corporation

2011-2012Joan Connolly, Connovan Consulting

2014-2015George Svokos, AMRI

2000-2001John M. Pashko,Merck & Co., Inc.

2005-2006Lynda M. Doyle, DSM Nutritional Products, Inc.

2001-2002George M. Simmons, First Chemical Corporation

2006-2007Joseph Colleluori, Lonza Inc.

2002-2003Joel W. Jones, The Dow Chemical Company

2007-2008Dix Weaver, Eli Lilly and Company

2010-2011Bob Kanuga, Merck & Co., Inc.

2013-2014Lyra Myers, Roche

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Please note each president is listed with their company at the time of their DCAT presidency and may not reflect their current company affiliation.

DCAT’s Executive Director

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Margaret Timony, Executive Director (1999-Present)Margaret Timony joined the DCAT organization in December 1998 as Deputy Executive Director and was named Executive Director in September 1999. Bringing nearly a decade of association management experience and a keen interest in technology to the association, Margaret helped lead DCAT into the 21st century and establish it as the premier business development association for the global pharmaceutical manufacturing industry.