2014年05月30日 人民網日本語版   

中米最大の製薬プロジェクトが浙江省で始動

海西輝瑞製薬有限公司(Hisun-Pfizer Pharmaceuticals)の生産基地が、29日に浙江省富陽市で正式に生産をスタートした。同公司は中国と米国の製薬分野における過去最大規模の協力プロジェクトの産物だ。新華社が伝えた。

同公司は投資額2億9500万ドル(約299億円)、登録資本金は2億5千万ドル(約253億円)。富陽市の生産基地には15億元(約244億円)が投入され、世界先端レベルの生産ラインが6本建設された。製品は抗ガン剤、抗生物質、心臓血管薬、糖尿病治療薬、ホルモン剤、向精神薬、免疫抑制剤など多岐にわたり、年間生産能力は2千万ボトル、15億錠に達する。

同公司は2012年の設立で、中国の製薬会社である浙江海正薬業株式有限公司(Zhejiang Hisun Pharmaceuticals)と、160年以上の歴史をもち、研究開発を土台とした、世界最大の製薬会社・米ファイザー社が合弁設立したもの。株式の51%を海正薬業が、49%をファイザーが保有し、中国大陸部企業が株式を保有する合弁有限会社だ。

 

2012/8/31  Pfizer と Mylan、日本での後発医薬品事業で長期戦略的業務提携

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June 02, 2011

Pfizer and Hisun Sign MOU to Increase Access to Quality and Low-Cost Medicines for Patients in China

Pfizer Inc. and Zhejiang Hisun Pharmaceuticals, a leading pharmaceutical company in China, today jointly announced the signing of a memorandum of understanding (MOU) on their intention to establish a joint venture. This potential partnership would aim to strengthen the ability of both companies to reach more patients with high-quality and low-cost medicines in the branded generics arena.
Under the MOU, the two companies will explore a potential business collaboration focused on manufacturing cooperation to deliver high-quality medicines, broader commercialization of medicines through a local and global sales and marketing infrastructure and research and development of off-patent medicines. Both parties could contribute select existing products and other relevant assets and capabilities to provide a solid platform for this potential joint venture.

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2012/2/17

Pfizer And Hisun Announce Progress On Potential Joint Venture To Increase Access To High Quality Branded Generic Medicines

Pfizer Inc.  and Zhejiang Hisun Pharmaceutical, a leading pharmaceutical company in China, today signed a framework agreement, advancing their previously announced memorandum of understanding (MOU) to establish a joint venture to develop, manufacture and commercialize off-patent pharmaceutical products in China and global markets. The framework agreement builds upon the MOU, and is an important milestone in the formation of a joint venture between the two companies. This potential partnership would aim to strengthen the ability of both companies to reach more patients with high-quality medicines in the branded generics arena.

According to the framework agreement, the potential joint venture will be named “Hisun Pfizer Pharmaceutical Co., Ltd.” Hisun will own 51% and Pfizer will own 49%, and the aggregate investment and registered capital will be USD 295 million and USD 250 million respectively. Both parties could contribute selected existing products, manufacturing sites, cash and other relevant assets after the joint venture is formed.

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2012年 9月 14日 
 

ファイザー・浙江海正薬業合弁、現地開発施設に229億円投資
 
 米製薬最大手ファイザーは、中国および海外市場向けに特許切れ医薬品の開発・製造・販売する目的で浙江海正薬業(ZHEJIANG HISUN PHARMACEUTICAL)と立ち上げた合弁会社が、合計2億9500万ドル(約229億円)の投資を行ったと明らかにした。

 2011年6月に設立された合弁会社、海正ファイザー薬業(Hisun-Pfizer Pharmaceuticals)の資本金は2億5000万ドル。出資比率は海正が51%、ファイザーが49%。

 ファイザーは声明で、ブランド後発薬を含む特許切れ医薬品は、世界の医薬品市場で急成長している分野の1つだと述べた。特に新興国市場では、コストとアクセスが特許切れ薬成長のけん引役となっている。また中国では国内製薬市場の70%をブランド後発薬が占めるとも指摘した。

 また合弁会社の登録施設および生産工場は浙江省阜陽に、管理センターと研究開発センターは上海と杭州にそれぞれ開設する計画だとも述べた。

 ファイザーの中国カントリーマネジャー、ウー・シャオビン氏は「合弁会社は、中国が続けている医療改革へのファイザーの信頼を示すもので、世界に通用する治療ソリューションを中国に広げるファイザーの努力にとって重要な節目となる」と述べた。

September 12, 2012

Pfizer And Hisun Announce Launch Of Hisun-Pfizer Pharmaceuticals Co., Ltd.

Joint Venture Between Multinational Pharmaceutical Company and Leading Chinese Pharmaceutical Company Aims to Provide High-Quality and Affordable Branded Generic Medicines for Patients in China and Global Markets

Pfizer Inc., the world’s largest research-based pharmaceutical company, and Zhejiang Hisun Pharmaceuticals, a leading Chinese pharmaceutical company, today announced the launch of Hisun-Pfizer Pharmaceuticals Co., Ltd., a joint venture formed between the two companies to develop, manufacture and commercialize off-patent pharmaceutical products in China and global markets. The creation of the joint venture marks an important milestone in strengthening the ability of both companies to reach more patients with high-quality and low-cost medicines in the branded generics arena.

Off-patent medicines, including branded generics, represent one of the fastest-growing segments in the global pharmaceutical market. This is especially true in emerging markets,
where cost and access are primary drivers of off-patent medicine growth. In China, branded generics account for 70% of the domestic pharmaceutical market.

Hisun-Pfizer will take advantage of Hisun’s strong product portfolio, broad market outreach and experience with the production and commercialization of branded generic medicines. The joint venture will also benefit from Pfizer’s world class research and development (R&D), manufacturing quality management, international market promotion and operational capabilities. It will focus on R&D and the production and commercialization of high-quality branded generic medicines, and the broader commercialization of existing medicines through a local and global sales and marketing infrastructure. It will be operated in accordance with international quality standards to advance both companies’ mission of bringing high-quality and affordable medicines to address the medical needs of patients in China and worldwide.

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, and is also one of the largest pharmaceutical joint venture projects in Zhejiang province.

Bai Hua, Chairman and President of Hisun, expressed that establishing this joint venture with a leading global pharmaceutical company is an important step towards achieving Hisun’s long-term vision of “becoming a widely respected international pharmaceutical company” by “persisting in pharmaceutical innovation for the benefit of human beings.” The partnership also paves the way for Hisun to transition from being an active pharmaceutical ingredients (API) manufacturer to an established branded generics company. “The joint venture will provide our patients with high-quality and low-cost branded generic medicines through our internationally compatible management systems and R&D and production technology. This will help us better contribute to the development of the Chinese pharmaceutical industry, advance the drug innovation and manufacturing capabilities of Zhejiang province and China, and lay a solid foundation for Chinese pharmaceutical companies to enter the international market,” he said.
“Providing high-quality, accessible and affordable health care to people over a vast area and from broad socioeconomic levels has become a primary objective of Chinese healthcare reforms, which is aligned with Pfizer’s mission to provide high-quality and affordable medicines to our patients,” said Xiaobing Wu, Country Manager of Pfizer China. “The joint venture demonstrates Pfizer’s commitment to China’s ongoing healthcare reforms and is an important milestone for Pfizer’s efforts to broaden the reach of its world-class healthcare solutions in China. We are glad to be partnering with Hisun in this venture to address the needs of our patients.”

Hisun and Pfizer first signed the Memorandum of Understanding to establish the joint venture during the Zhejiang Provincial Government Delegation’s visit to the U.S. in June 2011. In February 2012, during the visit of Mr. Xi Jinping, Vice President of China, to the U.S., the two companies signed the Framework Agreement at the Sino-US Economic & Trade Cooperation Forum held in Los Angeles. Mr. Xi and John Bryson, U.S. Secretary of Commerce, in addition to other senior officials from China and the U.S., attended the signing ceremony.


 February 5, 2015

Pfizer to Acquire Hospira

Transaction will significantly enhance Pfizer’s Global Established Pharmaceutical (GEP) Business
Transaction valued at $90 per Hospira share, for a total enterprise value of approximately $17 billion
Expected to be immediately accretive upon closing; $0.10-$0.12 accretion expected in first full year after close with additional accretion anticipated thereafter

Pfizer Inc. and Hospira, Inc. today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Hospira, the world’s leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, for $90 a share in cash for a total enterprise value of approximately $17 billion. The Boards of Directors of both companies have unanimously approved the merger, which is expected to be immediately accretive upon closing, accretive by $0.10 - $0.12 per share for the first full year following the close of the transaction with additional accretion anticipated thereafter.

"The proposed acquisition of Hospira demonstrates our commitment to prudently deploy capital to create shareholder value and deliver incremental revenue and EPS growth in the near-term," said Ian Read, Chairman and Chief Executive Officer, Pfizer. "In addition, Hospira’s business aligns well with our new commercial structure and is an excellent strategic fit for our Global Established Pharmaceutical business, which will benefit from a significantly enhanced product portfolio in growing markets. Coupled with Pfizer’s global reach, Hospira is expected to drive greater sustainability for our Global Established Pharmaceutical business over the long term."

This strategically complementary combination will add a growing revenue stream and a platform for growth for Pfizer’s GEP business. The expanded portfolio of sterile injectable pharmaceuticals, composed of Hospira’s broad generic sterile injectables product line, including acute care and oncology injectables, with a number of differentiated presentations, as well as its biosimilars portfolio, combined with GEP’s branded sterile injectables, including anti-infectives, anti-inflammatories and cytotoxics, will create a leading global sterile injectables business. The combination also reinforces GEP’s growth strategy to build a broad portfolio of biosimilars in Pfizer’s therapeutic areas of strength through the addition of Hospira’s portfolio that includes several marketed biosimilars. Pfizer will also use its existing commercial capabilities, global scale, scientific expertise and world class development capabilities to significantly expand the reach of Hospira’s products, which are currently distributed primarily in the United States, to Europe and key emerging markets, where GEP has a significant presence.

"The addition of Hospira has the potential to fundamentally improve the growth trajectory of the Global Established Pharmaceutical business, vault it into a leadership position in the large and growing off-patent sterile injectables marketplace by combining the specialized talent and capabilities of both companies, including enhanced manufacturing, and advance its goal to be among the world’s most preeminent biosimilars providers," said John Young, group president, Pfizer Global Established Pharmaceutical business. "We're excited to combine Hospira’s expertise and key talent with that of Pfizer to create a leading global business that will deliver an even broader portfolio of important and life-saving sterile injectable medicines to patients around the world."

"The Pfizer-Hospira combination is an excellent strategic fit, presenting a unique opportunity to leverage the complementary strengths of our robust portfolios and rich pipelines," said F. Michael Ball, Chief Executive Officer, Hospira. "I want to recognize and thank our 19,000 employees around the world for their tireless efforts to deliver more affordable healthcare solutions, increase patient access to high-quality care and drive sustained growth for our shareholders."

Both sterile injectables and biosimilars are large and growing categories. The global marketplace value for generic sterile injectables is estimated to be $70 billion in 2020. The global marketplace for biosimilars is estimated to be approximately $20 billion in 2020.

Pfizer expects to finance the transaction through a combination of existing cash and new debt, with approximately two-thirds of the value financed from cash and one-third from debt. In addition, Pfizer anticipates the transaction to deliver $800 million in annual cost savings by 2018.

The transaction is subject to customary closing conditions, including regulatory approvals in several jurisdictions and approval of Hospira's shareholders, and is expected to close in the second half of 2015.

Pfizer's financial advisors for the transaction were Guggenheim Securities, J.P. Morgan and Lazard, with Ropes & Gray LLP acting as its legal advisor and Clifford Chance LLP advising on international regulatory matters. Morgan Stanley served as Hospira’s financial advisor, while Skadden, Arps, Slate, Meagher & Flom LLP & Affiliates served as its legal advisor.
About Pfizer:

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.
About Hospira:

Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill. Learn more at www.Hospira.com

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ファイザーがバイオ後続品に注力、同業他社買収

米医薬品大手ファイザーは5日、同業のホスピーラを150億ドル相当で買収する方針を明らかにした。ジェネリック注射剤やバイオ後続品分野での事業拡大が狙いとみられる。

1株当たりの買収額は90ドルで、これはホスピーラ株の前日終値に39%上乗せした額となる。

ホスピーラはジェネリック注射剤を製造し、注射剤は医療施設で広範囲に利用されている。またバイオ後続品の販売や開発も手がける。バイオ後続品の開発費は先発品と比較して2割から3割安く、バイオ医薬品が特許切れを迎えるなか、各社ともバイオ後続品分野に積極的に取り組んでいる。

ホスピーラは、Johnson & Johnsonの関節リウマチ治療薬「レミケード」(一般名:インフリキシマブ)の類似薬について、FDAに承認を求めている。

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ホスピーラは特許が切れた価格の安い「ジェネリック医薬品」を手がけ、特に注射剤の分野に強く、ヨーロッパやオーストラリアを中心に売り上げを伸ばしています。ファイザーは今回の買収によって、市場が拡大しているジェネリック医薬品の分野を強化し、収益力を高めるねらいがあるとみられます。

ファイザーは去年、イギリスの大手製薬会社に対し、およそ12兆円に上る巨額の買収提案をしましたが、失敗に終わっていました。大手製薬会社は、主力の医薬品の特許が切れて軒並み売り上げが減少する傾向にあり、買収や合併によって売り上げを確保しようという動きが活発になっています。

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ホスピーラは、注射剤とインフュージョンテクノロジーの市場で世界をリードするヘルスケア企業です。 充実した製品ラインを有し、“アドバンスウェルネス (Advance Wellness™)”の見地から、高い付加価値を創造することで、医療費の軽減と、患者さんや医療従事者の皆さんの安全性の向上に貢献しています。

ホスピーラの高品質・低コストのジェネリック医薬品を提供することで、私たちは患者さんの医療費負担や世界の医療制度の財務体質の改善に取り組み、医療費全体の削減に貢献し続けます。

また、治療における技術統合を進めるために機器の顧客と協力することで、患者さんや医療従事者の安全、臨床転帰、コスト管理、そして医療従事者の効率と効果のさらなる改善に向けて、顧客の最適なパートナーとなるよう努めています。

さらにOne2One™ビジネスでは、先発医薬品を扱う製薬・バイオテクノロジー企業に対し、注射剤の製剤開発、充填、製造最終工程の受託製造サービスで世界をリードしています。

ホスピーラには、顧客と患者の皆さんの生活に良い影響を与え、そして私たちに関係する皆さんに価値を提供することによって、日々「新たな未来へ挑戦“Make a Difference”」できる機会があります。

会社名の由来:

「ホスピーラ」という会社名は、ホスピタル(病院)、スピリット(精神)、インスパイア(意欲)、そしてラテン語で希望を意味するスペロ(spero)に由来し、未来を私たちの意思で切り拓いていきたいという想いが込められています。

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WSJ

Pfizer to Buy Hospira for $16 Billion

Deal Will Expand Drug Maker’s Sales of Injectable Drugs, Biosimilars

Pfizer Inc. said Thursday it would buy smaller rival Hospira Inc. in a $16 billion deal that would transform the New York pharmaceutical company into a leading player in the emerging market for lower-priced knockoffs of costly biotech drugs.

Biotech drugs, made from living cells, are more complicated to make—and to copy—than traditional pills and therefore have proved highly resistant to low-cost competition, even after patents ran out. But after years of turning to these costly drugs to boost sales, big drug companies like Pfizer are now borrowing from the playbooks of generic makers and developing copycat versions of each other’s biotech drugs.

The lure is a global market that could soar to $20 billion in sales in five years, up from just a few billion dollars today, as health plans and governments seek to rein in spiraling health-care costs. These biotech-drug knockoffs, called biosimilars, can cost 20% to 30% less than the higher-price originals.

The Hospira deal underscores that the time has finally come for biosimilars, which have already gone on sale in some countries and could come to the U.S. as early as this year. Hospira is selling the drugs in Europe and Australia, and has asked health regulators for permission to sell two in the U.S. Acquiring Hospira would turn Pfizer, which has been trying to build up its biosimilars business, into a top player along with Novartis AG .

“The puzzle pieces come together in a very nice way,” Pfizer Chief Executive Ian Read said in an interview.

Pfizer is also interested in plugging Hospira’s portfolio of generic intravenous drugs and drug-infusion pumps, sold mostly in the U.S., into its world-wide commercial infrastructure, according to Pfizer executive John Young, who will run the combined businesses.

Hospira has had manufacturing issues in recent years, but Mr. Young said that due diligence left Pfizer feeling “comfortable that the issues have been or are being properly addressed.”

Under the terms of the deal, Hospira shareholders will receive $90 a share in cash, a 39% premium to Wednesday’s close. Pfizer said it expects the deal to close during the second half of this year and immediately add to earnings. Pfizer said it also expects to realize $800 million in cost savings within three years.

Pfizer stock rose 2.9% to $32.99 in 4 p.m. trading, while Hospira shares jumped 35% to $87.64.

Pfizer had been looking to do deals after being rebuffed last year in its $120 billion bid to buy AstraZeneca PLC and later, in its talks with Irish drug maker Actavis PLC.

And Pfizer executives indicated the Hospira acquisition wouldn’t stop Pfizer from doing more deals, even larger ones.

“We have lots of remaining capacity” to do more transactions, Pfizer Chief Financial Officer Frank D’Amelio said.

Pfizer was once the world’s leading pharmaceutical company by revenue, selling blockbuster pills like the cholesterol fighter Lipitor at premium prices. But Lipitor and other such drugs have lost U.S. patent protection in recent years, allowing low-price generic versions to go on sale and quickly dominate.

Just this year, Pfizer expects to lose $3.5 billion in sales due to generic competition.

To adjust, Pfizer and its rivals have been revamping their portfolios to sell a greater number of biotech drugs, which have traditionally been more insulated from low-cost competition.

For many years there weren’t any clear legal and regulatory paths for rival companies to sell knockoffs of biotech drugs, sometimes called biologics, without doing prohibitively costly testing akin to developing a new drug altogether.

In 2009, Pfizer paid $68 billion for Wyeth to acquire its biotech-drugs portfolio.

But that dynamic has started to shift. Biosimilar drugs are on sale in several countries overseas today, and they are coming soon to the U.S., causing a scramble among drug companies that had been counting on biotech drugs. In the U.S., the Affordable Care Act created a simplified pathway for companies to make their own versions of biotech drugs and prove to health regulators that their biosimilar medicines would work as well as the original drugs.

Last month, a panel of experts recommended the U.S. Food and Drug Administration green-light what would be the first therapy approved under the new pathway. The drug, developed by Novartis, would be a biosimilar version of Amgen Inc. ’s Neupogen treatment for chemotherapy patients, which generated $1.2 billion in world-wide sales last year. Analysts say the biosimilar Neupogen could be approved this year.

Biotech drugs with more than $100 billion in sales are expected to lose patent protection in the next five or 10 years, according to Pfizer. Industry officials expect there will be strong demand for lower-price versions of the drugs amid global pressures over drug costs.

In Norway, one biosimilar version of rheumatoid-arthritis treatment Remicade costs 72% less than the brand, according to Sanford C. Bernstein & Co.

With health-care systems looking to control costs, “we are a very hard proposition to stop,” Hospira Chief Executive Michael Ball said in an interview last month. “In the U.S., payers are coming to us to talk about biosimilars.”

Pfizer has been trying to build its own business in biosimilars, developing knockoffs of top-selling biotech drugs like AbbVie Inc. ’s Humira rheumatoid-arthritis therapy and Roche Holding AG ’s Avastin cancer therapy.

Yet Hospira, of Lake Forest, Ill., and Switzerland’s Novartis have led the way in biosimilars. Hospira has been selling biosimilars for seven years, and has three biosimilars on sale in Europe currently, Mr. Ball said. He said Hospira has asked the FDA to approve biosimilars of Remicade and anemia treatment Epogen.

Johnson & Johnson , which sells Remicade in the U.S. and certain other markets, reported the drug generated $6.9 billion in sales for the company last year. Epogen, from Amgen Inc., had $2 billion in world-wide sales last year.

Hospira, which is scheduled to report its 2014 results next week, had $4.4 billion in revenue last year, according to Pfizer. Meanwhile, Pfizer last month reported a 4% decline in 2014 revenue to $49.6 billion and a 58% drop in net income to $9.14 billion.


2018/12/19 

英GSK・米ファイザー、大衆薬を統合 売上世界一に
 

製薬世界大手の英GlaxoSmithKline(GSK)と米Pfizerは19日、一般用医薬品(大衆薬)事業を統合すると発表した。合弁会社を設立し、GSKが68%、Pfizerファイザーが32%出資する。GSKは統合完了から3年以内に新会社の株式を英国で上場させ、医療用医薬品・ワクチン大衆薬の2社体制を築く方針だ。

新会社の売上高は98億ポンド(約1兆4000億円)と、米ジョンソン・エンド・ジョンソン(J&J)を上回り世界最大の大衆薬メーカーになる。社名は「GSKコンシューマー・ヘルスケア」とし、2019年後半に統合を終える見通しだ。

GSKの大衆薬事業は歯磨きの「センソダイン」(日本名シュミテクト)や抗炎症剤「ボルタレン」などが主力製品で、17年12月期の部門売上高は71億ポンド(約1兆円)だった。ファイザーの大衆薬は痛み止め「アドビル」や、ビタミン剤「セントラム」などを手掛けている。17年12月期の部門売上高は34億ドル(約3800億円)だった。

GSKの狙いは医療用医薬品やワクチンの開発力強化にある。大衆薬はファイザーとの統合で収益力を引き上げる一方、将来的には切り離し、その売却収入を研究開発(R&D)拡充などに注ぎ込む構想だ。12月上旬には米がん治療薬ベンチャーのテサロを総額51億ドルで買収すると発表し、新薬開発に注力する戦略を鮮明にした。

エマ・ウォルムズリー最高経営責任者(CEO)は同日のアナリスト向け説明会で「英国を基盤とする新たな2つのグローバル企業を築く道筋を示すものだ」と強調した。大衆薬事業は統合完了から3年以内に切り離し、英国を拠点とする2社体制に移行させる。

GSKは4〜6月期に欧州製薬大手ノバルティス(スイス)から130億ドルで大衆薬の合弁事業を引き取り、完全子会社にした。ファイザーとの統合で規模をさらに引き上げて収益力を高める。22年までに年間5億ポンド規模のコストを削減できると見込んでいる。

一方、ファイザーは売上高全体の1割未満にとどまる消費者向け事業の売却を模索してきた。17年10月に切り離す方針を表明し、これまでに米日用品大手プロクター・アンド・ギャンブル(P&G)などが買い手に取り沙汰されていた。GSKも名乗りを上げたが、いったん撤退していた。合弁という新たな形で大型再編が実現する。

処方箋がいらない大衆薬は広告費などの費用がかさみ、利益を上げにくい。抗体医薬など医療用医薬品の研究開発の難易度が高まっており費用もかかる。世界の医薬品業界では創薬に注力するため大衆薬事業を切り離し、経営をスリム化する動きが相次いでいる。18年に入りP&Gはドイツ製薬大手メルクの大衆薬事業買収を決めた。

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Pfizerは2012年から、特許で保護された製品を扱うPfizer Innovative Health と、低成長のジェネリック製品を扱うPfizer Essential Health を分割して別々の企業として上場する案を検討してきた。

しかし、2016年9月、同社は会社分割を見送ると発表した。

2016/10/4  Pfizer、会社分割を見送り 

 

2018/12/19 GSK

GlaxoSmithKline plc and Pfizer Inc to form new world-leading Consumer Healthcare Joint Venture

Transaction provides a unique opportunity to accelerate GSK’s strategy and create substantial value for shareholders

Lays foundation for separation of GSK to create two new UK-based global companies focused on Pharmaceuticals/Vaccines and Consumer Healthcare

GlaxoSmithKline plc has reached agreement with Pfizer Inc to combine their consumer health businesses into a new world-leading Joint Venture, with combined sales of approximately £9.8 billion ($12.7 billion)[1].
GSK will have a majority controlling equity interest of 68% and Pfizer will have an equity interest of 32% in the Joint Venture.

The proposed all-equity transaction represents a compelling opportunity to build on the recent buyout of Novartis’ stake in GSK Consumer Healthcare, to create a new world-leading consumer healthcare business and to deliver further significant shareholder value. The proposed transaction also supports GSK’s key priority of strengthening its pharmaceuticals business over the next few years by increasing cashflows and providing an effective pathway through the separation of GSK Consumer Healthcare to build further support for investment in its R&D pipeline.

Novartisは2014年4月22日、大規模な事業再編を発表した。

GlaxoSmithKline (GSK) から抗がん剤製品群を買収するとともに、大衆薬事業はGSKの事業と統合し、GSK主体のJVとする
更にインフルエンザ以外のワクチン事業をGSKに売却する。
これとは別にインフルエンザワクチンの売却を進めており、動物薬事業はEli Lillyに売却する。
(インフルエンザワクチン事業は2014年10月、オーストラリアのワクチン大手CSLに275百万ドルで売却すると発表した。)

2014/4/25 Novartis、GSKとの取引等で事業再編

Novartisは2018年3月末に上記のGSKとの大衆薬事業JVの持分をGSKに130億ドルで譲渡することで合意した。

 

New Consumer Healthcare Joint Venture

The new Joint Venture will be well-positioned to deliver stronger sales, cash flow and earnings growth driven by category leading Power Brands, science-based innovation and substantial cost synergies. The combination will bring together two highly complementary portfolios of trusted consumer health brands, including GSK’s Sensodyne, Voltaren and Panadol and Pfizer’s Advil, Centrum and Caltrate. The Joint Venture will be a category leader in Pain Relief, Respiratory, Vitamin and Mineral Supplements, Digestive Health, Skin Health and Therapeutic Oral Health. The Joint Venture will be the global leader in OTC products with a market share of 7.3% ahead of its nearest competitor at 4.1% and have number 1 or 2 market share positions in all key geographies, including the US and China.

The proposed transaction is expected to realise substantial cost synergies, with the Joint Venture expected to generate total annual cost savings of £0.5 billion by 2022 for expected total cash costs of £0.9 billion and non-cash charges of £0.3 billion. Planned divestments targeting around £1 billion of net proceeds are expected to cover the cash costs of the integration. Up to 25% of the cost savings are intended to be reinvested in the business to support innovation and other growth opportunities. Overall the Joint Venture will target an Adjusted operating margin percentage in the ‘mid-to-high 20’s’ by 2022.

GSK expects the proposed transaction to be accretive to Total earnings in the second full year following closing, reflecting the impact and timing for the costs of integration; and to be accretive to Adjusted earnings and free cashflow in the first full year after closing

Future separation

The proposed transaction is transformational to the scale of GSK’s Consumer Healthcare business. Within 3 years of the closing of the transaction, GSK intends to separate the Joint Venture via a demerger of its equity interest and a listing of GSK Consumer Healthcare on the UK equity market. Over this period, GSK will substantially complete the integration and expects to make continued progress in strengthening its Pharmaceuticals business and R&D pipeline.

The intended separation of the Group will allow the two resulting companies to be established with appropriate capital structures for their future investment needs and capital allocation priorities. The new consumer healthcare company with its more durable cash flows will be able to support higher leverage levels than the GSK Group today, creating the opportunity on separation to reduce the leverage in the new Pharmaceuticals/Vaccines company.

Dividend expectations

GSK remains committed to its current dividend policy and confirms it continues to expect to pay 80 pence per share in dividends for 2018. Recognising the significance of this proposed transaction and the importance of dividends to shareholders, the company is today confirming that it expects to pay dividends of 80 pence per share for 2019.

Going forward, the proposed transaction enhances prospects for the Consumer Healthcare business and supports the development of GSK’s Pharmaceuticals business. With expected improvements in both businesses, GSK expects to be well positioned to deliver returns to shareholders alongside continued investment in its strategic priorities.

Emma Walmsley, Chief Executive Officer, GSK, said:

“Eighteen months ago, I set out clear priorities and a capital allocation framework for GSK to improve our long-term competitive performance and to strengthen our ability to bring new breakthrough medicines and better healthcare products to people around the world. We have improved our operating performance and have set out a new approach to R&D. We have also started to reshape the Group’s portfolio through prioritisation of R&D programmes, acquisitions such as that proposed with the oncology biopharmaceutical company, TESARO, the minority buy-out of the consumer healthcare business and a series of non-core product divestments.

“The transaction we have announced today is a unique opportunity to accelerate this work. Through the combination of GSK and Pfizer’s consumer healthcare businesses we will create substantial further value for shareholders. At the same time, incremental cashflows and visibility of the intended separation will help support GSK’s future capital planning and further investment in our pharmaceuticals pipeline.

“With our future intention to separate, the transaction also presents a clear pathway forward for GSK to create a new global Pharmaceuticals/Vaccines company, with an R&D approach focused on science related to the immune system, use of genetics and advanced technologies, and a new world-leading Consumer Healthcare company.

“Ultimately, our goal is to create two exceptional, UK-based global companies, with appropriate capital structures, that are each well positioned to deliver improving returns to shareholders and significant benefits to patients and consumers.”

Approvals and closing

The proposed transaction is subject to approval by GSK shareholders and conditional upon the receipt of certain anti-trust authority approvals. Subject to these approvals, the transaction is expected to close in the second half of 2019. The Board intends to recommend that shareholders vote in favour of the proposed transaction.

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2018/12/19 Pfizer

Pfizer and GlaxoSmithKline Announce Joint Venture to Create a Premier Global Consumer Healthcare Company

Establishes a new focused global consumer healthcare business with the independence and sustainability to deliver significant value Equity split of 32% Pfizer and 68% GlaxoSmithKline

Pfizer Inc. and GlaxoSmithKline plc today announced they have entered into an agreement to create a premier global consumer healthcare company with robust iconic brands. The Boards of Directors of both companies have unanimously approved the transaction under which Pfizer will contribute its consumer healthcare business to GlaxoSmithKline’s existing consumer healthcare business. The 2017 global sales for the combined business were approximately $12.7 billion.

“We are pleased to announce this new joint venture for Pfizer Consumer Healthcare, delivering on our commitment to complete the strategic review for this business in 2018,” stated Ian Read, Chairman and current Chief Executive Officer, Pfizer. “Pfizer and GSK have an excellent track record of creating successful collaborations, and we look forward to working together again to unlock the potential of our combined consumer healthcare businesses.”

Under the terms of the transaction, Pfizer will receive a 32% equity stake in the joint venture, entitling Pfizer to its pro rata share of the joint venture’s earnings and dividends, which will be paid on a quarterly basis. Pfizer will have the right to appoint three out of the nine members of the joint venture’s board. The transaction is expected to deliver $650 million in peak cost synergies and to be slightly accretive for Pfizer in each of the first three years after the close of the transaction, which is anticipated during the second half of 2019, subject to receipt of GSK shareholder approval and regulatory approvals, and satisfaction of other customary closing conditions.

As Pfizer will own less than 50% of the joint venture, Pfizer anticipates deconsolidating Pfizer Consumer Healthcare from its financial statements following the closing of the transaction. In the near- to medium-term, this deconsolidation is not expected to have a material impact on Pfizer’s top-line growth. In addition, given the Consumer Healthcare business records lower margins than Pfizer’s other businesses, the deconsolidation is expected to have a slight positive impact on Pfizer’s operating margins over the next several years.

Following the integration of the combined business, GSK intends to separate the joint venture as an independent company via a demerger of its equity interest to its shareholders and a listing of the Consumer Healthcare business on the UK equity market. GSK will have the sole right to decide whether and when to initiate a separation and listing for a period of five years from closing of the proposed transaction. GSK may also sell all or part of its stake in the joint venture in a contemporaneous IPO.

Should a separation and listing occur during the first five years after closing, Pfizer has the option to participate through the distribution of its equity interest in the joint venture to its shareholders or the sale of its equity interest in a contemporaneous IPO. After the fifth anniversary of the closing of the proposed transaction, both GSK and Pfizer will have the right to decide whether and when to initiate a separation and public listing of the joint venture.

“The combination of these leading businesses with distinct regional and category strengths will be more sustainable and broader in scope than either company individually,” said Albert Bourla, Chief Operating Officer and incoming Chief Executive Officer, Pfizer. “We believe that this joint venture is a great opportunity to ensure the future success of Pfizer Consumer Healthcare while unlocking meaningful after-tax value for Pfizer shareholders.”

The joint venture will be a category leader in pain relief, respiratory, vitamin and mineral supplements, digestive health, skin health and therapeutic oral health and will be the largest global consumer healthcare business. In addition, the joint venture is expected to be the first or second largest consumer healthcare player in key geographies, including the United States, Europe, China, India and Australasia. The joint venture will operate globally under the GSK Consumer Healthcare name.

“The transaction is a testament to the success of our Consumer Healthcare business, including its excellent reputation, talented colleagues, high-quality products and market reach,” said Chris Slager, President, Pfizer Consumer Healthcare. “The dedication and hard work of the Pfizer Consumer Healthcare team is impressive and inspiring. I am proud of our colleagues around the world who are passionate about the success of this business and the important role it plays in empowering consumers to take health and wellness into their own hands.”

Emma Walmsley, GSK CEO, will be Chair of the new joint venture. Brian McNamara, currently CEO GSK Consumer Healthcare, will be CEO of the new joint venture and Tobias Hestler, currently CFO GSK Consumer Healthcare, will be CFO.

Until separation, the joint venture will be consolidated in GSK’s financial statements.

For the year ended December 31, 2017, the Pfizer Consumer Healthcare business recorded revenues of approximately $3.5 billion and the GSK Consumer Healthcare business recorded revenues of approximately $9.2 billion.

GSK has agreed to pay a break fee of $900 million if (i) the GSK Board of Directors changes, withdraws or qualifies its recommendation of the transaction to its shareholders for approval; (ii) GSK’s shareholders vote on the proposed transaction and do not approve it; or (iii) GSK’s shareholders do not approve the proposed transaction by September 30, 2019 (subject to extension in certain circumstances).

Centerview Partners LLC, Guggenheim Securities, LLC and Morgan Stanley & Co. LLC served as Pfizer’s financial advisors, Wachtell, Lipton, Rosen & Katz, and Clifford Chance LLP served as its legal advisors, and Skadden, Arps, Slate, Meagher & Flom LLP served as its tax advisor.


 


June 17, 2019 

Pfizer to Acquire Array BioPharma

—Proposed acquisition strengthens Pfizer’s innovative biopharmaceutical business and is expected to accelerate its growth trajectory particularly in the long term —Opportunity to strengthen category leadership in Oncology with the addition of a breakthrough combination of BRAF/MEK inhibitors under investigation for a potential first-in-class therapy for patients with BRAF-mutant metastatic colorectal cancer —Expands Pfizer’s pipeline with multiple high-potential targeted investigational cancer therapies and adds a large portfolio of royalty-generating out-licensed medicines —Plans to maintain highly productive research unit in Boulder to complement Pfizer’s research hubs —Transaction valued at $48 per Array share in cash, for a total enterprise value of approximately $11.4 billion

Array BioPharma Inc.は、コロラド州ボルダーに本社を置き、癌治療に用いられる低分子薬を中心に新薬の発見、開発、商品化を事業とする企業です。

同社は1998年に設立され、癌の治療薬や多発性骨髄腫の治療薬、拡張型心筋症のための薬、C型肝炎のための薬品、胃がん・乳がんの治療薬などを製品候補として、Biogen Idec MA Inc.など複数の企業との共同契約のもとで開発を進めています。

Array BioPharma Inc.2018627、米国食品医薬品局(FDA)がFDAの承認した検査法により検出されたBRAFV600EしくはBRAFV600K遺伝子変異陽性の切除不能または転移性の悪性黒色腫患者の治療薬として、BRAFTOVIカプセルとMEKTOVI® 錠の併用療法を承認したことを発表した。

20175月に小野薬品工業はArray社と、BRAF阻害剤のエンコラフェニブおよびMEK阻害剤のビニメチニブに関するライセンス契約を締結し、小野薬品が日本および韓国で両剤を開発 および 商業化する権利をArray社から取得しました。

ファイザーの発表資料によると、同社はアレイが他社にライセンスを供与した治療薬について、使用に伴うロイヤルティーを受け取る。さらにアレイが開発している複数の治療薬に加え、将来的には大腸がんなど他のがん治療でビラフトビとメクトビが使用された場合の売り上げもファイザーが受け取ることになる。



Pfizer Inc. and Array BioPharma Inc. today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Array, a commercial stage biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need. Pfizer has agreed to acquire Array for $48 per share in cash, for a total enterprise value of approximately $11.4 billion. The Boards of Directors of both companies have approved the merger.

Array’s portfolio includes the approved combined use of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for the treatment of BRAFV600E or BRAFV600K mutant unresectable or metastatic melanoma. The combination therapy has significant potential for long-term growth via expansion into additional areas of unmet need and is currently being investigated in over 30 clinical trials across several solid tumor indications, including the Phase 3 BEACON trial in BRAF-mutant metastatic colorectal cancer (mCRC).

In the U.S., colorectal cancer 大腸癌 is the third most common type of cancer in men and women. An estimated 140,250 patients were diagnosed with cancer of the colon or rectum in 2018, and approximately 50,000 are estimated to die of their disease each year.1BRAF mutations are estimated to occur in up to 15% of colorectal cancer cases and represent a poor prognosis for these patients.

“Today’s announcement reinforces our commitment to deploy our capital to bring breakthroughs that change patients’ lives while creating shareholder value,” said Albert Bourla, chief executive officer of Pfizer. “The proposed acquisition of Array strengthens our innovative biopharmaceutical business, is expected to enhance its long-term growth trajectory, and sets the stage to create a potentially industry-leading franchise for colorectal cancer alongside Pfizer’s existing expertise in breast and prostate cancers.”

In addition to the combination therapy for BRAF-mutant metastatic melanoma, Array brings a broad pipeline of targeted cancer medicines in development, as well as a portfolio of out-licensed potentially best-in-class and/or first-in-class medicines, which are expected to generate significant royalties over time.

“We are incredibly proud that Pfizer has recognized the value Array has brought to patients and our remarkable legacy discovering and advancing molecules with great potential to impact and extend the lives of patients in critical need,” said Ron Squarer, Array chief executive officer. “Pfizer shares our commitment to patients and a passion for advancing science to develop even more options for individuals with unmet needs. We’re excited our team will have access to world-class resources and a broader research platform to continue this critical work.”

In May 2019, Array announced results from the interim analysis of the Phase 3 BEACON mCRC trial: The second-or-third-line treatment with the BRAFTOVI triplet combination (BRAFTOVI + MEKTOVI + cetuximab) showed statistically significant improvement in overall response rate and overall survival compared to the control group, reducing the risk of death by 48%. The triplet combination could be the first chemotherapy-free, targeted regimen for patients with BRAF-mutant mCRC. Array intends to submit these data for regulatory review in the United States in the second half of 2019.

“We are very excited by Array’s impressive track record of successfully discovering and developing innovative small-molecules and targeted cancer therapies,” said Mikael Dolsten, Pfizer chief scientific officer and president, Worldwide Research, Development and Medical. “With Array’s exceptional scientific talent and innovative pipeline, combined with Pfizer’s leading research and development capabilities, we reinforce our commitment to advancing the most promising science, regardless of whether it is found inside or outside of our labs.”

Upon the close of the transaction, Array’s employees will join Pfizer and continue to be located in Cambridge, Massachusetts and Morrisville, North Carolina, as well as Boulder, Colorado, which becomes part of Pfizer’s Oncology Research & Development network in addition to La Jolla, California and Pearl River, New York.

Pfizer expects to finance the majority of the transaction with debt and the balance with existing cash. The transaction is expected to be dilutive to Pfizer’s Adjusted Diluted EPS by $0.04 -$0.05 in 2019, $0.04 -$0.05 in 2020, neutral in 2021, and accretive beginning in 2022, with additional accretion and growth anticipated thereafter. Pfizer will provide any appropriate updates to its current 2019 guidance in conjunction with its third quarter 2019 earnings release.

Under the terms of the merger agreement, a subsidiary of Pfizer will commence a cash tender offer to purchase all outstanding shares of Array common stock for $48 per share in cash for a total enterprise value of approximately $11.4 billion. The closing of the tender offer is subject to customary closing conditions, including regulatory approvals and the tender of a majority of the outstanding shares of Array common stock (on a fully-diluted basis). The merger agreement contemplates that Pfizer will acquire any shares of Array that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pfizer expects to complete the acquisition in the second half of 2019.

Pfizer’s financial advisors for the transaction were Guggenheim Securities, LLC, and Morgan Stanley & Co. LLC, with Wachtell, Lipton, Rosen & Katz acting as its legal advisor. Centerview Partners served as Array’s exclusive financial advisor, while Skadden, Arps, Slate, Meagher & Flom LLP served as its legal advisor.

 


November 20, 2020

Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the U.S. FDA for COVID-19 Vaccine

Pfizer Inc. and BioNTech SE announced they will submit a request today to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.

The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis was based on 170 confirmed cases of COVID-19. This submission also is supported by solicited safety data from a randomized subset of approximately 8,000 participants ≥18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. The submission also includes solicited safety data on approximately 100 children 12-15 years of age. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. To date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine.

“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”

“Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”

The companieshave already initiated rolling submissions with several regulatory agencies around the world, including the EMA and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and intend to submit applications to other regulatory agencies worldwide in the coming days. In some cases, governments may have regulatory pathways similar to an EUA. The companies will be ready to distribute the vaccine candidate within hours after authorization.

Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in the clinical trial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic.

The BNT162b2 vaccine candidate is not currently approved for distribution anywhere in the world. Both collaborators are committed to developing this novel vaccine with preclinical and clinical data at the forefront of all their decision making.

Manufacturing and Delivery Capabilities

While Pfizer and BioNTech await potential authorization or approval from regulatory agencies, the companies continue to work in collaboration with governments and Ministries of Health around the world that will distribute the vaccine, subject to authorization or approval, to help ensure it can reach those most in need as quickly as possible.

Pfizer is bringing its leading in-house manufacturing capabilities to this effort, with the ability and experience to quickly scale, manufacture and distribute large quantities of vaccine at high quality, leveraging multiple sites in the U.S. and Europe, and complementing the mRNA manufacturing expertise of BioNTech, gained over almost a decade. Pfizer and BioNTech’s combined manufacturing network has the potential to supply up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses by the end of 2021 (subject to clinical success, manufacturing capacity, and regulatory approval or authorization).

Pfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months. The company has developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) up to 15 days. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. Once thawed, the vaccine vial can be stored for up to 5 days at refrigerated (2 - 8oC) conditions.

From the start of the research program earlier this year, Pfizer and BioNTech have successfully supplied and distributed their investigational vaccine to more than 150 clinical trial sites across the U.S., as well as Europe, Latin America, and South Africa. Based on their collective experience, the companies believe in their capability to distribute the vaccine globally upon approval or authorization.

About the Study

The Phase 3 clinical trial of BNT162b2, which is based on BioNTech's proprietary mRNA technology, began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in the U.S., Germany, Turkey, South Africa, Brazil and Argentina. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed.


August 23, 2021

Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older

 Pfizer Inc.  and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. COMIRNATY is the first COVID-19 vaccine to be granted approval by the FDA.

The vaccine has been available in the U.S. under Emergency Use Authorization (EUA) since December 11, 2020 (as the Pfizer-BioNTech COVID-19 Vaccine). The EUA permitted essential rollout of vaccine doses across the U.S. to help provide protection during the COVID-19 public health emergency, based on initial data from the pivotal Phase 3 clinical trial.

For FDA approval, Pfizer and BioNTech submitted a comprehensive data package that included longer-term follow-up data from the Phase 3 trial, where the vaccine’s high efficacy and favorable safety profile were observed up to six months after the second dose. The BLA submission package also included the manufacturing and facilities data required for licensure. Pfizer and BioNTech completed submission of the BLA in May 2021, and the BLA was granted Priority Review in July 2021.

“Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. About 60 percent of eligible Americans are fully vaccinated, and infection, hospitalization and death rates continue to rise rapidly among unvaccinated populations across the country,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans now that we have FDA approval.”

“Today's full approval by the FDA underlines the vaccine's high efficacy and favorable safety profile,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Our companies have shipped more than one billion doses worldwide, and we will continue to work tirelessly to broaden the access to our vaccine and to be prepared for potential emerging escape variants.”

As announced on August 16, Pfizer and BioNTech plan to seek licensure of a third, or booster, dose of COMIRNATY in individuals 16 years of age and older via a supplemental BLA. The companies also intend to submit a supplemental BLA to support potential full FDA approval of COMIRNATY in individuals 12 through 15 years of age once the required data out to six months after the second vaccine dose are available. In the meantime, the vaccine remains available to 12- to 15-year-olds under the Emergency Use Authorization (EUA) granted by the FDA on May 10, 2021. For individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise, a third dose of the vaccine also remains available under EUA

following an amendment by the FDA on August 12.

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer), Canada and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Indication & Authorized Use

COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to:

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

EUA Statement

This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Important Safety Information

Individuals should not get the Pfizer-BioNTech COVID-19 Vaccine if they:

Individuals should tell the vaccination provider about all of their medical conditions, including if they:

The vaccine may not protect everyone.

Side effects reported with the vaccine include:

There is no information on the use of the vaccine with other vaccines.


August 23, 2021                                                   

Pfizer to Acquire Trillium Therapeutics Inc.

Proposed acquisition strengthens Pfizer’s category leadership in Oncology with addition of next-generation, investigational immuno-therapeutics for hematological malignancies

Expands innovative pipeline, potentially enhancing growth in 2026-2030 and beyond

Pfizer to host analyst and investor call at 10:00 a.m. ET today with Pfizer Oncology executives

Pfizer Inc.  and Trillium Therapeutics Inc.  today announced that the companies have entered into a definitive agreement under which Pfizer will acquire Trillium, a clinical stage immuno-oncology(癌免疫)company developing innovative therapies for the treatment of cancer. Under the terms of the agreement, Pfizer will acquire all outstanding shares of Trillium not already owned by Pfizer for an implied equity value of $2.26 billion, or $18.50 per share, in cash. This represents a 118% premium to the 60-day weighted average price for Trillium.                  *2020/9 25百万ドル投資

Trillium’s portfolio includes biologics that are designed to enhance the ability of patients’ innate immune system to detect and destroy cancer cells. Its two lead molecules, TTI-622 and TTI-621, block the signal-regulatory protein α (SIRPα)–CD47 axis, which is emerging as a key immune checkpoint in hematological malignancies. TTI-622 and TTI-621 are novel, potentially best-in-class SIRPα-Fc fusion proteins that are currently in Phase 1b/2 development across several indications, with a focus on hematological malignancies.

“Today’s announcement reinforces our commitment to pursue scientific breakthroughs with the addition of potentially best-in-class molecules to our innovative pipeline,” said Andy Schmeltz, Global President & General Manager, Pfizer Oncology. “The proposed acquisition of Trillium builds on our strong track record of leadership in Oncology, enhancing our hematology portfolio as we strive to improve outcomes for people living with blood cancers around the globe. Our deep experience in understanding the science of blood cancers, along with the diverse knowledge base we have developed across our growing hematology portfolio of eight approved and investigational therapies, provide us with a foundation to advance these important potential medicines to patients who need them.”

Hematological malignancies are cancers that affect the blood, bone marrow, and lymph nodes. This classification includes various types of leukemia, multiple myeloma, and lymphoma. More than 1 million people worldwide were diagnosed with a blood cancer in 2020, representing almost 6% of all cancer diagnoses globally. In 2020, more than 700,000 people worldwide died from a form of blood cancer.

“We’re delighted to announce Pfizer’s proposed acquisition of Trillium. Today’s announcement reflects Trillium’s potentially best in class SIRPα–CD47 status and contribution to immuno-oncology,” said Dr. Jan Skvarka, Chief Executive Officer of Trillium. “Trillium has the only known SIRPα–CD47 targeting molecules with clinically meaningful monotherapy responses as well as a strong basis for combination therapies, which is supported by preclinical evidence with a diverse set of therapeutic agents. With Pfizer’s global reach and deep capabilities, we believe our programs will advance more quickly to the patients we’ve always aspired to serve. We believe this is a good outcome for patients and our shareholders.”

In clinical studies to-date, TTI-622 and TTI-621 have demonstrated activity as monotherapy in relapsed or refractory lymphoid malignancies, including Diffuse Large B-cell Lymphoma (DLBCL), Peripheral T-cell lymphoma (PTCL), Follicular Lymphoma (FL), and other lymphoid malignancies. As of July 26, 2021, Phase 1 data for TTI-622 in 30 response-evaluable patients have shown deep and durable responses in heavily pretreated patients, including two complete responses (CRs), one lasting over 114 weeks, with responses ongoing. TTI-622 and TTI-621 are currently the only known CD47-targeted molecules that have demonstrated meaningful single agent activity and CRs in multiple hematological malignancies. Thus far, adverse events (AEs) reported with TTI-622 and TTI-621 have been manageable. Related Grade 3 and 4 AEs with TTI-622 were rare and limited to transient cytopenias. In particular, the molecules demonstrate minimal red blood cell binding and few reported cases of anemia, an observed risk with other CD47-targeted approaches. Further data are expected to be shared at a forthcoming medical conference.

“We are encouraged by the early clinical data for TTI-622 and TTI-621 monotherapy for patients with heavily pretreated lymphoid malignancies and early encouraging activity for TTI-622 in patients with multiple myeloma. Just as PD-1 and PD-L1 blockers have proven to be effective immuno-therapeutics for many solid tumors, the SIRPα-CD47 interaction defines a second key immune checkpoint for which disrupting agents are expected to become another important backbone immunotherapy for multiple types of cancer, especially hematological cancers,” said Chris Boshoff, MD, PhD, Chief Development Officer, Oncology, Pfizer Global Product Development. “Utilizing Pfizer’s leading research and global development capabilities, we plan to accelerate the clinical development of SIRPα fusion proteins as a potential new scientific breakthrough and explore combinations within our own portfolio and with innovative next-generation medicines for hematological malignancies.”

In September 2020, as part of the Pfizer Breakthrough Growth Initiative (PBGI), Pfizer invested $25 million in Trillium and Jeff Settleman, Senior Vice President and Chief Scientific Officer of Pfizer’s Oncology Research & Development Group, was named to Trillium’s Scientific Advisory Board. Established in June 2020, PBGI’s goal is to provide funding for scientific research as well as access to Pfizer’s experts to ensure the continuity of clinical programs that could be of potential strategic interest for Pfizer. Pfizer has committed to providing up to $500 million in total funding to the PBGI.

Additional Transaction Details

The proposed acquisition of Trillium is to be completed by way of a statutory plan of arrangement under the Business Corporations Act (British Columbia) and subject to customary closing conditions, including approval of 66⅔% of the votes cast by Trillium shareholders, voting together as one class, at a special meeting of Trillium and approval of 66⅔% of the votes cast by Trillium shareholders and warrant holders, voting together as one class, at a special meeting of Trillium. Completion of the acquisition is also subject to court and regulatory approval, as well as certain other closing conditions customary for transactions of this nature.

Pfizer’s financial advisors for the transaction are BofA Securities, Inc., with Ropes & Gray LLP and Norton Rose Fulbright Canada LLP acting as its legal advisors. Centerview Partners LLC served as Trillium’s financial advisor, while Goodwin Procter LLP and Baker McKenzie LLP (Canada) served as its legal advisors.


Pfizer、バイオ医薬品Arena Pharmaceuticals買収 現金67億ドル

Pfizerは12月13日、米バイオ医薬品
Arena Pharmaceuticals
を現金67億ドルで買収すると発表した。

買収提示額は1株当たり100ドル。Arena 株式は寄り前の取引で92%上昇の95.90ドルとなった。

Pfizer幹部は「Arena買収案は当社の炎症・免疫分野における能力と専門性を補完する」とした。買収は2022年上半期に完了する予定。

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December 13, 2021

Pfizer to Acquire Arena Pharmaceuticals

Proposed acquisition offerspotentially new, differentiated best-in-class approach to address unmet need for a broader number of patients with immuno-inflammatory diseases

Expands innovative pipeline potentially enhancing growth through 2025 and beyond

Transaction valued at $100 per Arena share in cash, for a total equity value of approximately $6.7 billion

Pfizer to host analyst and investor call at 10am EST today with Pfizer I&I executives

Pfizer today announced that the companies have entered into a definitive agreement under which Pfizer will acquire Arena, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Under the terms of the agreement, Pfizer will acquire all the outstanding shares of Arena for $100 per share in an all-cash transaction for a total equity value of approximately $6.7 billion. The boards of directors of both companies have unanimously approved the transaction.

Arena’s portfolio includes diverse and promising development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology, including etrasimod, an oral, selective sphingosine 1-phosphate (S1P) receptor modulator currently in development for a range of immuno-inflammatory diseases including gastrointestinal and dermatological diseases.

“The proposed acquisition of Arena complements our capabilities and expertise in Inflammation and Immunology, a Pfizer innovation engine developing potential therapies for patients with debilitating immuno-inflammatory diseases with a need for more effective treatment options,” said Mike Gladstone, Global President & General Manager, Pfizer Inflammation and Immunology. “Utilizing Pfizer’s leading research and global development capabilities, we plan to accelerate the clinical development of etrasimod for patients with immuno-inflammatory diseases.”

Arena has built a robust development program for etrasimod, including two Phase 3 studies in ulcerative colitis (UC), a Phase 2/3 program in Crohn’s Disease, a planned Phase 3 program in atopic dermatitis, and ongoing Phase 2 studies in eosinophilic esophagitis and alopecia areata.

In UC, the randomized, placebo-controlled, dose-ranging, Phase 2 study (OASIS) evaluated the efficacy and safety of etrasimod in moderate to severe UC patients over 12 weeks versus placebo. In the study, most patients who achieved clinical response, clinical remission, or endoscopic improvement at week 12 experienced sustained or improved effects up to week 46 with etrasimod 2 mg in the open-label extension. Etrasimod also demonstrated a favorable benefit/risk profile, consistent with safety findings reported in the double-blind portion of OASIS. The findings are encouraging as there remains significant unmet need for safe and effective oral therapies in UC for patients with inadequate response, loss of response, or intolerance to conventional or advanced therapies. The OASIS trial supported the advancement of the ELEVATE UC 52 and UC 12 trials, which are currently fully enrolled, and for which data are expected in 2022.

In addition, Arena’s pipeline includes two development-stage cardiovascular assets, temanogrel and APD418. Temanogrel is currently in Phase 2 for the treatment of microvascular obstruction and Raynaud's phenomenon secondary to systemic sclerosis. APD418 is currently in Phase 2 for acute heart failure.

“We’re delighted to announce Pfizer’s proposed acquisition of Arena, recognizing Arena’s potentially best in class S1P molecule and our contribution to addressing unmet needs in immune-mediated inflammatory diseases,” said Amit D. Munshi, President and Chief Executive Officer of Arena. “Pfizer’s capabilities will accelerate our mission to deliver our important medicines to patients. We believe this transaction represents the best next step for both patients and shareholders.”

Pfizer expects to finance the transaction with existing cash on hand.

Under the terms of the merger agreement, Pfizer will acquire all of the outstanding shares of Arena common stock for $100 per share in cash. The proposed transaction is subject to customary closing conditions, including receipt of regulatory approvals and approval by Arena’s stockholders.

Pfizer’s financial advisors for the transaction are BofA Securities and Centerview Partners LLC, with Ropes & Gray and Arnold & Porter Kaye Scholer LLP acting as its legal advisors. Guggenheim Securities, LLC and Evercore Group LLC served as Arena’s financial advisors, while Cooley LLP served as its legal advisor.