Pharma Perspectives: The Top 10 Stories of 2016

By Patricia Van Arnum - DCAT Editorial Director

December 5, 2016

As 2016 comes to a close, what have been the top stories of 2016 thus far? DCAT Value Chain Insights (VCI) examines the top 10 news stories from 2016, including the leading mergers and acquisitions, deal-making, and other key news developments.

So far in 2016, key highlights include Teva's pending $40.5 billion acquisition of Allergan's generics business and Shire's completed $32 billion acquisition of Baxalta to create a rare-disease-focused pharma company. DCAT Value Chain Insights looks at the key deals, drug approvals, partnering, and manufacturing activity thus far in 2016.

A top 10 countdown for 2016
1. The $40.5 billion acquisition of Allergan’s generic business by Teva Pharmaceutical Industries. Teva’s $40.5 billion acquisition of the generics business of Allergan is one of the largest deals thus far in 2016. The deal, a friendly acquisition approved by the boards of both companies and completed in August 2016, was announced in November 2015 and followed Teva’s decision to terminate an acquisition of Mylan in 2015. In acquiring Allergan Generics, Teva strengthens its already strong generics portfolio. At the time of the announced acquisition, Allergan's generics pipeline had approximately 230 abbreviated new drug applications pending at the US Food and Drug Administration (FDA), including approximately 70 first-to-file applications, as well as nearly 1,000 marketing authorization applications filed outside of the US, according to company information.

Table I: DCAT Value Chain Insights: Top Stories of 2016 (as of December 5, 2016).
Ranking News development
Number 1 The $40.5 billion acquisition of Allergan’s generic business by Teva Pharmaceutical Industries
Number 2 Shire’s $32 billion acquisition of Baxalta
Number 3 Sanofi and Boehringer Ingelheim’s multi-billion dollar business swap
Number 4 Pfizer and Allergan. The $160 billion mega merger that wasn’t
Number 5 Biologics manufacturing investment on the rise
Number 6 The new Bayer as a pure-play life-sciences player
Number 7 Resurgence of the US pharmaceutical market
Number 8 The merger of Dow Chemical and DuPont
Number 9 New molecular entities; approvals trending downward
Number 10 GlaxoSmithKline selects first woman as Big Pharma CEO

Compiled by DCAT Value Chain Insights editorial staff.

 

2. Shire’s $32 billion acquisition of Baxalta. In June 2016, Shire closed on its $32 billion acquisition of Baxalta, which created a specialty biopharmaceutical company with a focus in rare diseases. The combined portfolio of the two companies will have an expanded range of therapeutic areas with more than 60 programs in development, including more than 50 that will address rare diseases and newly approved Baxalta products. Shire anticipates more than 30 recent and planned product launches from the combined pipeline, contributing approximately $5 billion in annual revenues by 2020. Baxalta was spun off from Baxter as a stand-alone biopharmaceutical company in 2015.

3. Sanofi and Boehringer Ingelheim’s multi-billion dollar business swap. Sanofi and Boehringer Ingelheim signed contracts in June 2016 to secure the strategic transaction initiated in December 2015 that consists of an exchange of Sanofi’s animal-health business (Merial) and Boehringer Ingelheim’s consumer healthcare business. The closing of the transaction is expected by year-end 2016.

The strategic swap lays the foundation for both companies to reach size and scale in two activities, respectively consumer healthcare for Sanofi, and animal health for Boehringer Ingelheim. Upon successful completion, Boehringer Ingelheim’s consumer healthcare business, with an enterprise value of EUR 6.7 billion ($7.2 billion), would be transferred to Sanofi,and Sanofi’s Merial, with an enterprise value of EUR 11.4 billion ($12.3 billion), would be transferred to Boehringer Ingelheim. The transaction includes a cash payment to Sanofi of EUR 4.7 billion ($5.1billion) to reflect the difference in value of the two businesses. Combining Merial and Boehringer Ingelheim’s current animal-health portfolio would more than double Boehringer Ingelheim's animal-health business to approximately EUR 3.8 billion ($4.1 billion) based upon 2015 global sales. With this transaction, Sanofi would integrate Boehringer Ingelheim’s consumer healthcare business in all countries except China. Joint consumer healthcare sales (excluding Venezuela) would amount to approximately EUR 4.9 billion ($5.3 billion) based upon 2015 global sales. Sanofi would enhance its position in several of its strategic categories: pain care, allergy solutions, cough & cold care, feminine care, digestive health, and vitamins, minerals, and supplements.

4. Pfizer and Allergan. The mega merger that wasn’t. In April 2016, Pfizer and Allergan called off their proposed $160 billion merger citing the US Department of Treasury’s issuance of temporary and proposed regulations to further reduce the benefits of and limit the number of corporate inversions, a move that the companies said created an adverse tax law change.

Pfizer’s proposed $160 billion merger with the Dublin, Ireland-based Allergan, which the companies announced in November 2015, would have been the largest merger in the history of the pharmaceutical industry. Pfizer’s decision to pursue Allergan followed its interest in acquiring AstraZeneca in 2014, another mega merger for Pfizer that did not come to fruition. Pfizer announced in late May 2014 that it would not make a formal offer to acquire AstraZeneca following AstraZeneca’s decision to reject Pfizer’s non-binding $119-billion proposal. Pfizer’s interest in acquiring AstraZeneca was to build its pipeline and commercial portfolio, but it also had a financial component in establishing a new UK-incorporated holding company of the proposed combined company. The proposal for the deal brought to the fore the issue of corporate inversion, a practice by which a US-based multinational company restructures so that the US parent is replaced by a foreign corporation as a means to achieve a lower tax rate. A key issue going forward for Pfizer is what may be on its horizon in terms of deal-making: will the company pursue another large-scale acquisition or build its portfolio through smaller-scale deals? That question has been answered thus far in 2016 with Pfizer making several smaller-scale acquisitions. The most notable was the $14 billion acquisition of Medivation, a San Francisco-based biopharmaceutical company. Medivation’s portfolio includes Xtandi (enzalutamide), a prostate cancer drug that Medivation is parterned with Astellas and which generated global net sales of $2.2 billion in global net sales in the past four quarters as recorded by Astellas Pharma as of September 2016.

Pfizer also ended speculation in September 2016 that it separate the company into two independent companies, one focused on the company's innovator products and the second on the company's established products business. Pfizer had previously announced that it was considering separating the two businesses.

5. Biologics manufacturing investment on the rise. This year has seen several announced biologics manufacturing investments, a continuing trend. Shire announced earlier this year that it plans to expand its global biotechnology manufacturing capacity over the next four years by investing $400 million in Ireland. The company will create a biologics manufacturing campus, which it expects will lead to the creation of approximately 400 permanent jobs on a 120-acre site at Piercetown, County Meath. Construction of the new site will begin in mid-2016 with the site expected to be operational by mid-2019.

Earlier this year, Bristol-Myers Squibb completed a major expansion at its facility in Devens, Massachusetts. The $280- million project added two new buildings to the 89-acre Devens campus: a Biologics Development Building for designing processes for the early production of investigational medicines, and a Clinical Manufacturing Building where investigational medicines will be produced to support clinical trials. Both are new capabilities for Devens, a site that had previously focused solely on large-scale, bulk biologics manufacturing.

Bristol-Myers Squibb also plans to open a new EUR 900 million ($969 million) large-scale biologics manufacturing facility in Cruiserath, County Dublin, near Blanchardstown that will produce multiple therapies for the company’s growing immuno-oncology portfolio. The manufacturing facility is estimated to be operational in 2019. The new large-scale facility follows the company’s $750-million investment for a new biologics bulk manufacturing facility in Devens. 

Pfizer also reported in June that it will invest approximately $350 million in the development of a Global Biotechnology Center in the Hangzhou Economic Development Area in China. The facility will be Pfizer’s third biotechnology center globally and the first in Asia. It will ensure the local production of biosimilar medicines that will benefit patients both in China and globally, said Pfizer.

These investments are in addition to other recent large-scale investments. In December 2015, Boehringer Ingelheim announced an approximate EUR 500 million ($538 million) investment for a new large-scale biopharmaceutical production facility for active ingredients manufactured using cell cultures at its site in Vienna, Austria.

In 2014, AbbVie announced it will invest $320 million to establish operations in Singapore for small-molecule and biologics active drug substance manufacturing. The completed facility will provide manufacturing capacity for emerging compounds within AbbVie's oncology and immunology pipeline to serve markets globally. The investment will establish the first manufacturing presence in Asia by AbbVie. AbbVie anticipates the new facility will be fully operational by 2019; the small-molecule portion was completed earlier this year.

In November 2014, AstraZeneca announced plans to expand its biologics manufacturing center in Frederick, Maryland. The more than $200-million project will increase production capacity at the facility to support AstraZeneca’s pipeline and to meet future demand for its biologics portfolio, which currently represent nearly 50% of AstraZeneca’s overall pipeline, according to the company. AstraZeneca’s Frederick biologics manufacturing center is a FDA-licensed, large-scale cell-culture production facility with administrative, production, warehouse, laboratory and utility space. The expansion project is expected to be completed in mid-2017 and will add approximately 40,000 additional square feet of manufacturing, laboratory, and administrative space. AstraZeneca also acquired two Amgen facilities in Colorado to support build its bulk biologics manufacturing facility.

Novartis is proceeding with a major biomanufacturing investment. In 2012, the company announced the planned construction of a new biotechnology production site in Singapore with a planned investment of more than $700 million. The new facility will focus on drug substance manufacturing based on cell culture technology. Ground was broken in February 2013, and construction was completed in the third quarter of 2015 for Phase One of the project. The company expects Phase One of this project to be operational in 2017 and Phase Two in 2019. It will be co-located with the company’s pharmaceutical production site based in Tuas, Singapore. In the future, Singapore is expected to be a technological competence center for both biotechnology and pharmaceutical manufacturing at Novartis.

6. The new Bayer as a pure-play life-sciences player. Having successfully floated its material sciences business, Covestro, Bayer is now positioned as a pure-play life sciences company with projected 2016 sales in its life-sciences business of approximately EUR 35 billion ($38 billion). Bayer's focus on life sciences is being led by Werner Baumann, who became chairman of the board of management of Bayer AG on May 1, 2016, succeeding Marijn Dekkers. Bayer took on a new corporate structure in January 2016 with three divisions: pharmaceuticals, consumer health, and crop science, and a separate business unit, animal health. Bayer's former MaterialScience subgroup, renamed Covestro, became legally and economically independent on September 1, 2015, and Covestro AG was floated on the stock market in October 2015. Bayer currently still owns around 69% of Covestro. Bayer’s first large-scale move in life sciences in 2016 was in its crop science business with a $66 billion pending acquisition of the agricultural and seed company, Monsanto, which is expected to close at the end of 2017.

7. Resurgence of the US pharmaceutical market. Total spending on medicines in the US reached $310 billion in 2015 on an estimated net price basis, up 8.5% from the previous year, according to the IMS Institute for Healthcare Informatics. Specialty drug spending reached $121 billion on a net price basis, up more than 15% from 2014. Spending on specialty medicines in the US has nearly doubled in the past five years, contributing more than two-thirds of overall medicine spending growth between 2010 and 2015. Increased specialty spending was driven primarily by treatments for hepatitis, autoimmune diseases and oncology, which accounted for $19.3 billion in incremental spending. Overall, 2015 saw a 21.5% spending increase for specialty medicines to $150.8 billion on an invoice price basis.

8. The merger of Dow Chemical and DuPont. Expected to close later in 2016 is the $60 billion mega merger, first announced in 2015, of Dow Chemical and DuPont in an all-stock merger of equals that would produce a company with a market capitalization of approximately $130 billion. The combined company will be named DowDuPont. A combined Dow Chemical and DuPont would generate pro forma sales of approximately $83 billion, placing it as the number one chemical company in the world ahead of the current number one global chemical company, BASF.

The plan, however, is to break the company into three separate standalone companies, one specializing in agricultural chemicals, a second in plastics and other materials, and a third in specialty products, which would include electronics, nutrition, and health. The merger transaction is expected to close in the second half of 2016, subject to customary closing conditions, including regulatory approvals, and approval by both Dow and DuPont shareholders. The subsequent separation of DowDuPont, which the companies intend to pursue, would be expected to occur 18-24 months following the closing of the merger. The transaction is expected to deliver approximately $3 billion in cost synergies, with 100% of the run-rate cost synergies achieved within the first 24 months following the closing of the transaction. Additional upside of approximately $1 billion is expected from growth synergies.

9. New molecular entities; approvals trending downward. Through November 30, 2016, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) had approved 19 new molecular entities (NMEs). In 2015, FDA’s CDER approved 45 NMEs, a recent high, surpassing 2014’s level of 41 NME approvals and 2012’s 39 NME approvals. Thus far in 2016, this year has been a slow year for NME approvals although the end of the year typically sees a wave of activity but certain cautionary notes are emerging in 2016. 

Although the jury is still out, it seems unlikely that 2016 will meet the same approval levels for NMEs recently that had recently reversed a slow approval path for NMEs. From 2004 to 2012, CDER averaged 26 NME approvals per year, which was bolstered by approval levels in 2012 and 2013. The period of 2005 to 2010 was a slower period for NME approvals. In 2005, 20 NMEs were approved, 22 in 2006, 18 in 2007, 24 in 2008, and 26 in 2009.

10. First woman to lead Big Pharma company. In September 2016, GlaxoSmithKline (GSK) appointed Emma Walmsley to the position of chief executive officer (CEO) designate, effective on March 31, 2017 when the current GSK CEO, Andrew Witty, retires. Ms. Walmsley is currently the CEO of GSK’s consumer healthcare division. She will join the GSK board of directors from January 1, 2017. Ms. Walmsley is currently president of GSK consumer healthcare and has been a member of GSK’s corporate executive team since 2011. She joined GSK in 2010 from L’Oreal where, over the course of her 17-year career, she held a variety of marketing and general management roles in the UK, Europe, and US. From 2007, she was based in Shanghai as general manager, consumer products for L’Oreal China.