DEC. 17, 2015　New York Times　

AstraZeneca to Acquire Majority Stake in Acerta Pharma

The British drug maker AstraZeneca said on Thursday that it had agreed to acquire a majority stake in Acerta Pharma, a privately held cancer-drug developer with operations in the Netherlands and in California, for $4 billion.

The deal gives AstraZeneca the option to buy the remainder of the company for $3 billion more and would further bolster its line of cancer treatments.

Transactions in the health care sector have helped make 2015 a record year for global mergers and acquisitions.

Drug makers have used mergers and strategic investments to acquire promising treatments in late-stage development, hoping to claim the next blockbuster.

“The investment is consistent with our focus on long-term growth and reflects the role targeted business development plays in our business model,” Pascal Soriot, the AstraZeneca chief executive, said in a news release about the Acerta Pharma deal.

“We are boosting a key area in our comprehensive oncology portfolio with a late-stage, potential best-in-class medicine that could transform treatment for patients across a range of blood cancers,” he added.

Under the terms of the deal, AstraZeneca would acquire a 55 percent stake in Acerta for an initial payment of $2.5 billion. It would then pay $1.5 billion when acalabrutinib, Acerta’s treatment for blood cancer, receives regulatory approval in the United States or by the end of 2018.

It would then have the option to buy the remainder of the company after the approval of the drug in Europe and the United States, and other milestones.

AstraZeneca said that an extensive development program for acalabrutinib was underway and that it may be able to take the first steps toward regulatory approval of treating patients with certain types of blood cancer in the second half of 2016.

The top yearly sales of the drug could exceed $5 billion globally, AstraZeneca said.

The deal came after AstraZeneca announced on Monday that the companies were exploring “potential strategic options.”

AstraZeneca has said it would target similar small or midsize deals as it looks to bolster its drug pipeline after it fought off a $119 billion takeover bid by Pfizer last year, which would have created the world’s largest pharmaceutical company.

2014/5/12   Pfizer が AstraZenecaに買収提案

In November, AstraZeneca agreed to acquire ZS Pharma, a California-based biopharmaceutical company, for $2.7 billion in cash.

This week, AstraZeneca also announced that it would acquire the core respiratory business of Takeda Pharmaceutical Company of Japan for $575 million.

2015/12/17 日経

アストラゼネカ、中国でバイオ医薬強化 開発受託大手と提携

　アストラゼネカは薬明康徳のバイオ医薬品の生産拠点に総額１億ドルを投じる計画。子会社の米MedImmune, Inc.と薬明康徳の合弁会社が開発中の製剤の開発のスピードも上げ、炎症や免疫治療での用途を見込む。

　一方、中国での従来型の低分子医薬品の研究設備にも５千万ドルを充てる。競合が激しい同分野で研究開発力を高める狙いだ。

WuXi AppTec社 (NYSE: WX）は２０００年１２月に設立され、中国及びアメリカを拠点とする医薬品・生物医薬品・医療機器業務を取り扱う世界有数の受託会社です。技術革新主導型、顧客志向の会社として、弊社は創薬研究及び開発プロセスにおける広範で統合型のサービスを提供しています。コストパフォーマンスの良い効率的な各種業務受託解決法により、世界各地のお客様の研究開発時間短縮、医薬品・医療機器研究開発費低減の一助となるように弊社サービスは設計されています。

Sept. 10, 2012
MedImmune and WuXi AppTec Announce Joint Venture to Develop Novel Biologic for Chinese Market

MedImmune, the global biologics arm of AstraZeneca, and WuXi AppTec, a leading research and development outsourcing company, today announced that they have formed a joint venture to develop and commercialize MEDI5117(自己免疫疾患と炎症性疾患に用いる新規の生物製剤), a novel biologic for autoimmune and inflammatory diseases, in China.
MedImmune will provide technical and development expertise, while WuXi AppTec will provide local regulatory, manufacturing, pre-clinical and clinical trial support. When undertaking clinical trial development in China, the government requires local manufacture of medicines that have not been approved in other markets.
　

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2007年 04月 23日

英AstraZeneca、米MedImmune, Inc.を150億ドルで買収へ

英医薬品大手AstraZenecaは2007年4月23日、米バイオテクノロジー会社MedImmune, Inc.を150億ドル以上で買収することで合意したと発表した。英ゼネカ・グループとスウェーデンのアストラ社が１９９９年に合併してアストラゼネカが誕生して以来、最大の企業買収となる。

2015年 12月 16日　

武田薬品、英アストラゼネカに呼吸器系疾患事業を売却

英製薬大手アストラゼネカは、武田薬品の呼吸器系疾患領域事業を買収することで合意した。買収額は5億7500万ドル。

アストラゼネカは慢性閉塞性肺疾患（COPD）の治療薬ダクサス（一般名：roflumilast）、呼吸器疾患治療剤 アルベスコおよびアレルギー用点鼻薬オムナリス（一般名：ciclesonide）を含む呼吸器系疾患領域事業を取得する。

ダクサスは武田が買収したナイコメッドの画期的新薬

武田薬品の発表によると、各国・地域で販売されている同領域の製品や複数の前臨床段階にある化合物も移管される。移管の完了にあたり、一定数の従業員がアストラゼネカに移籍する。

武田は2014年に、消化器系疾患領域、オンコロジー、中枢神経系疾患領域、代謝性・循環器系疾患領域を4つの重点疾患領域と定めている。

アストラゼネカは米国でroflumilastを「Daliresp」の商品名で販売している（2015/2にActavis から取得）。

February 5  2015

Agreement strengthens AstraZeneca’s aclidinium respiratory franchise and adds immediate revenues with long-term growth potential

AstraZeneca and Actavis Plc today announced that they have entered into a definitive agreement under which AstraZeneca will acquire the rights to Actavis’ branded respiratory business in the US and Canada for an initial consideration of $600 million on completion and low single-digit royalties above a certain revenue threshold.

Upon completion of the transaction, AstraZeneca will own the development and commercial rights in the US and Canada to Tudorza^TM Pressair^TM (aclidinium bromide inhalation powder), a twice-daily long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD), and Daliresp® (roflumilast), the only once-daily oral PDE4 inhibitor currently on the market for COPD. AstraZeneca will also own development rights in the US and Canada for LAS40464, the combination of a fixed dose of aclidinium with formoterol long acting beta agonist (LAMA/LABA) in a dry powder inhaler, which is approved in the EU under the brand name Duaklir® Genuair®.

12 December 2020　

AstraZeneca to acquire Alexion, accelerating the Company's strategic and financial development

AstraZeneca and Alexion Pharmaceuticals, Inc. (Alexion) have entered into a definitive agreement for AstraZeneca to acquire Alexion.

Alexionは1992年に設立され、現在、世界約50カ国において生命を脅かす重篤な希少疾患を抱える患者のために日々尽力しています。

Alexionは補体阻害の分野でのグローバルリーダーです。生命を脅かす重篤な超希少疾患である発作性夜間ヘモグロビン尿症（PNH）と非典型溶血性尿毒症症候群（aHUS）に対する世界最初で唯一の承認薬として終末補体阻害剤ソリリス^®（一般名：エクリズマブ）を開発し、販売しています。現在、ソリリスはPNH治療の適応で約50カ国、aHUS治療の適応では約40カ国で承認されています。

補体（Complement）とは、生体が病原体を排除する際に抗体および貪食細胞を補助するという意味で命名された免疫システム (補体系) を構成するタンパク質

また、代謝性フランチャイズとして、生命を脅かす超希少疾患である低ホスファターゼ症（HPP）の患者に対する非常に革新的な酵素補充療法、ストレンジック^®（一般名：アスホターゼ　アルファ）を販売しています。ストレンジックは日本、米国、欧州およびカナダで承認を取得しています。

Alexion shareholders will receive $60 in cash and 2.1243 AstraZeneca American Depositary Shares (ADSs) (each ADS representing one-half of one (1/2) ordinary share of AstraZeneca, as evidenced by American Depositary Receipts (ADRs)) for each Alexion share. Based on AstraZeneca's reference average ADR price of $54.14, this implies total consideration to Alexion shareholders of $39bn or $175 per share.

The boards of directors of both companies have unanimously approved the acquisition. Subject to receipt of regulatory clearances and approval by shareholders of both companies, the acquisition is expected to close in Q3 2021, and upon completion, Alexion shareholders will own c.15% of the combined company.

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases. This acquisition allows us to enhance our presence in immunology. We look forward to welcoming our new colleagues at Alexion so that we can together build on our combined expertise in immunology and precision medicines to drive innovation that delivers life-changing medicines for more patients."

Ludwig Hantson, Ph.D., Chief Executive Officer, Alexion, said: “For nearly 30 years Alexion has worked to develop and deliver transformative medicines to patients around the world with rare and devastating diseases. I am incredibly proud of what our organisation has accomplished and am grateful to our employees for their contributions. This transaction marks the start of an exciting new chapter for Alexion. We bring to AstraZeneca a strong portfolio, innovative rare disease pipeline, a talented global workforce and strong manufacturing capabilities in biologics. We remain committed to continuing to serve the patients who rely on our medicines and firmly believe the combined organisation will be well positioned to accelerate innovation and deliver enhanced value for our shareholders, patients and the rare disease communities.”

Strategic rationale

Both companies share the same dedication to science and innovation to deliver life-changing medicines. The capabilities of both organisations will create a company with great strengths across a range of technology platforms, with the ability to bring innovative medicines to millions of people worldwide. The combined company will also have an enhanced global footprint and broad coverage across primary, speciality and highly specialised care.

Scientific leadership - accelerated presence in immunology

AstraZeneca has built a growing scientific presence in oncology, and in cardiovascular, renal and metabolism, and respiratory diseases, with a focus on organ protection. AstraZeneca has developed a broad range of technologies, initially focused on small molecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. More recently, AstraZeneca has increased its efforts in immunology research and the development of medicines for immune-mediated diseases.

Alexion has pioneered complement inhibition for a broad spectrum of immune-mediated rare diseases caused by uncontrolled activation of the complement system, a vital part of the immune system. Alexion's franchise includes Soliris (eculizumab), a first-in-class anti-complement component 5 (C5) monoclonal antibody. The medicine is approved in many countries for the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uremic syndrome, generalized myasthenia gravis and neuromyelitis optica spectrum disorder. More recently, Alexion launched Ultomiris (ravulizumab), a second-generation C5 monoclonal antibody with a more convenient dosing regimen.

Alexion's immunology expertise extends to other targets in the complement cascade beyond C5 as well as additional modalities, with its deep pipeline including Factor D small-molecule inhibitors of the alternative pathway of the complement system, an antibody blocking neonatal Fc receptor (FcRn)-mediated recycling, and a bi-specific mini-body targeting C5, among others. The FcRn extends the half-life and hence the availability of pathogenic immunoglobulin G (IgG) antibodies.

AstraZeneca, with Alexion's R&D team, will work to build on Alexion's pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond.

Alexion's leading expertise in complement biology will accelerate AstraZeneca's growing presence in immunology. The acquisition adds a new technology platform to AstraZeneca's science and innovation-driven strategy. The complement cascade is pivotal to the innate immune system. It plays a crucial role in many inflammatory and autoimmune diseases across multiple therapy areas, including haematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. In contrast, AstraZeneca's capabilities in genomics, precision medicine and oligonucleotides can be leveraged to develop medicines targeting less-frequent diseases. Combining AstraZeneca’s capabilities in precision medicine and Alexion’s expertise in rare-disease development and commercialisation will enable the new company to develop a portfolio of medicines addressing the large unmet needs of patients suffering from rare diseases.

The combined companies will bring together two rapidly converging, patient-centric models of care delivery with combined strengths in immunology, biologics, genomics and oligonucleotides to drive future medicine innovation. AstraZeneca intends to establish Boston, Massachusetts, US as its headquarters for rare diseases, capitalising on talent in the greater Boston area.

Industry-leading revenue growth; enhanced geographical presence and broad coverage across primary, specialised and highly specialised care

AstraZeneca's acquisition of Alexion, with its strong commercial portfolio and robust pipeline, will support its long-term ambition to develop novel medicines in areas of immunology with high unmet medical needs. Alexion achieved impressive revenue growth over the last few years, with revenues of $5.0bn in 2019 (21% year-on-year growth). Alexion has exhibited skilful commercial execution in building its 'blockbuster' C5 franchise. The success of the franchise is demonstrated by the effective transition of over 70% of PNH patients from Soliris to Ultomiris in less than two years of launch in its key markets, including the US, Japan and Germany, as well as the strong pipeline of additional indications for Ultomiris.

Rare diseases is a high-growth therapy area with rapid innovation and significant unmet medical need. Over 7,000 rare diseases are known today, and only c.5% have US Food and Drug Administration-approved treatments.1 The global rare disease market is forecasted to grow by a low double digit percentage in the future.2

AstraZeneca intends to build on its geographical footprint and extensive emerging markets presence to accelerate the worldwide expansion of Alexion's portfolio.

The two companies have been on converging paths, AstraZeneca expanding its presence from primary to speciality care, whereas Alexion has been progressing from ultra-orphan to orphan and speciality conditions.

The acquisition strengthens AstraZeneca's industry-leading growth, underpinned by its broad portfolio of medicines, which will enable the new company to bring innovative medicines to a broad range of healthcare practitioners in primary, speciality and highly specialised care.

The combined company is expected to deliver double-digit average annual revenue growth through 2025.