英AstraZeneca
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。
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.
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
英製薬大手アストラゼネカは中国の医薬品開発受託大手、藥明康德新藥開發(WuXi AppTec) と提携し、中国でのバイオ医薬品事業を強化すると発表した。両社で中国向け製剤を共同開発し、薬明康徳の生産拠点を買収する権利も取得する。中国は米国に次ぐ世界第２位の医薬品市場に成長しており、アストラゼネカは総額150億ドル（約１兆8400億円）以上を投じ収益拡大に動く。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.
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 TudorzaTM PressairTM (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.
CinCorが高血圧や慢性腎臓病などの治療薬として開発中の「baxdrostat」と、アストラゼネカの糖尿病治療薬「フォシーガ」を組み合わせる狙いだ。フォシーガは心不全や腎臓病の患者にも効果があることが示され、売り上げが急増した。
AstraZeneca has entered into a definitive agreement to acquire CinCor Pharma, Inc. (CinCor), a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension 高血圧 as well as chronic kidney disease.
The acquisition will bolster AstraZeneca’s cardiorenal pipeline by adding CinCor’s candidate drug, baxdrostat (CIN-107), an aldosterone synthase inhibitor アルドステロン合成酵素阻害剤 (ASI) for blood pressure lowering in treatment-resistant hypertension.
Baxdrostat represents a potentially leading next-generation ASI as it is highly selective for aldosterone synthase and spares the cortisol pathway in humans1. The opportunity also brings the potential for combination with Farxiga and complements AstraZeneca’s strategy to provide added benefit across cardiorenal diseases, where there is a high unmet medical need.
Mene Pangalos, Executive Vice President BioPharmaceuticals R&D, AstraZeneca, said: “Acquiring CinCor supports our commitment to cardiorenal disease and further strengthens our pipeline with baxdrostat. Excess levels of aldosterone are associated with hypertension and several cardiorenal diseases, including chronic kidney disease and coronary artery disease and being able to effectively reduce this would offer a much-needed treatment option for these patients.”
Marc de Garidel, CEO CinCor, said: “We are excited about the proposed acquisition of CinCor Pharma by AstraZeneca as we believe it offers the prospect of accelerating the development timeline and expanding the breadth of benefits patients with cardiorenal diseases might obtain from baxdrostat, if approved. CinCor is committed to ensuring a smooth transition of the development responsibilities to AstraZeneca once the acquisition is consummated. Thank you to all who have played, and will continue to play, essential roles in developing and evaluating baxdrostat as a potential novel treatment for cardiorenal diseases.”
Financial considerations
Under the terms of the agreement, AstraZeneca will initiate a tender
offer to acquire all of CinCor’s outstanding
shares for a price of $26 per share in cash at closing, plus
a non-tradable contingent value right of $10 per
share in cash payable upon a specified regulatory submission of a
baxdrostat product. The upfront cash portion of the consideration
represents a transaction value of approximately
$1.3bn and a 121% premium over CinCor’s closing market price on
06 January 2023. Combined, the upfront and maximum potential contingent
value payments represent, if achieved, a transaction value of
approximately $1.8bn and a 206% premium
over CinCor’s closing market price on 6 January 2023. As part of the
transaction, AstraZeneca will acquire the cash and marketable securities
on CinCor’s balance sheet, which totalled approximately $522m as of 30
September 2022.
Notes
Baxdrostat (CIN-107)
Baxdrostat is a highly selective, oral small molecule inhibitor of
aldosterone synthase, the enzyme responsible for the synthesis of
aldosterone in the adrenal gland, in development for patient populations
with significant unmet medical needs, including treatment-resistant
hypertension, primary aldosteronism and chronic kidney disease.
Baxdrostat selectively targets aldosterone synthase, which is encoded by
the CYP11B2 gene while having a much lower affinity for the blocking
activity of 11ß-hydroxylase, the enzyme responsible for cortisol
synthesis, which is encoded by the CYP11B1 gene. In clinical trials,
baxdrostat was observed to significantly lower aldosterone levels
without affecting cortisol levels, across a wide range of doses1.
In patients with treatment-resistant hypertension, a key focus area, baxdrostat met the primary endpoint in the BrigHTN Phase II trial showing a statistically significant reduction in systolic blood pressure (SBP) after a 12-week treatment period1,2. Baxdrostat did not meet the primary endpoint of showing a statistically significant reduction in SBP at eight weeks in the HALO Phase II trial in patients with uncontrolled hypertension3,4. Baxdrostat was well tolerated in both trials. Two additional Phase II trials are ongoing in hypertensive patients with primary aldosteronism (Spark-PA)5 and in chronic kidney disease (CKD)6. A Phase III trial of baxdrostat is planned to start in treatment-resistant hypertension during the first half of 2023.
CinCor holds the exclusive, worldwide licence to baxdrostat, which will remain in place following the transaction.
Farxiga
Farxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2
inhibitor. Research has shown Farxiga’s efficacy in preventing
and delaying cardiorenal disease, while also protecting the organs –
important findings given the underlying links between the heart, kidneys
and pancreas7-9. Damage to one of these organs can
cause the other organs to fail, contributing to leading causes of death
worldwide, including T2D, HF and chronic kidney disease (CKD)10-13.
The cornerstone of this landmark investment is a new multi-billion dollar US manufacturing facility that will produce drug substances for the Company’s innovative weight management and metabolic portfolio, including oral GLP-1, baxdrostat, oral PCSK9 and combination small molecule products. The new state-of-the-art centre will produce small molecules, peptides and oligonucleotides. This multi-billion dollar capital investment is in addition to the $3.5 billion announced in November 2024.
1. Oral GLP-1（経口GLP-1受容体作動薬）
概要：GLP-1（グルカゴン様ペプチド-1）は、インスリン分泌を促進し、血糖を下げるホルモンです。これまでのGLP-1製剤（例：オゼンピック、トルゼパチドなど）は注射剤が中心でした。
経口GLP-1の目的：注射ではなく錠剤でGLP-1受容体作動薬を投与できるようにすること。患者の利便性が大きく向上します。
アストラゼネカの候補：正式なコード名・開発番号は非公開ですが、2023年後半から経口GLP-1の開発に注力していると発表。ノボノルディスクの「リベルサス（セマグルチド錠）」と競合する製剤です。
対象疾患：2型糖尿病、肥満症。
2. Baxdrostat（バクスドロスタット）
分類：選択的アルドステロン合成酵素阻害薬（CYP11B2阻害剤）
作用機序：アルドステロンの合成を選択的に抑えることで、血圧を下げます。
開発目的：
難治性高血圧（既存の治療薬で十分にコントロールできない高血圧）
原発性アルドステロン症
慢性腎疾患（CKD）への応用も期待されている
アストラゼネカの戦略：バクスドロスタットは2022年に買収したCinCor Pharmaから取得。現在は第3相試験段階。
3. Oral PCSK9（経口PCSK9阻害薬）
概要：PCSK9は、LDLコレステロール（悪玉コレステロール）を増加させるタンパク質。これを阻害することで、血中のLDL-Cを下げる作用があります。
従来製剤との違い：
既存のPCSK9阻害薬（例：レパサ（エボロクマブ）、プラルエント（アリロクマブ））は注射剤。
経口PCSK9阻害薬は錠剤での投与を目指すため、利便性が高い。
アストラゼネカの状況：
Ionis社との共同開発（RNAベースのアプローチ）も含まれている可能性あり。
薬剤候補名は非公開、あるいは開発初期段階で外部に明かされていない。
The drug substance facility, planned to be in the Commonwealth of Virginia, would be AstraZeneca’s largest single manufacturing investment in the world. The facility will leverage AI, automation, and data analytics to optimise production.
The $50 billion investment across our R&D and manufacturing footprint in the US over the next five years also includes:
Collectively, these investments will help deliver AstraZeneca’s ambition of reaching $80 billion in Total Revenue by 2030, of which we expect 50% would be generated in the US.
Howard Lutnick, US Secretary of Commerce, said: “For decades Americans have been reliant on foreign supply of key pharmaceutical products. President Trump and our nation’s new tariff policies are focused on ending this structural weakness. We are proud that AstraZeneca has made the decision to bring substantial pharmaceutical production to our shores. This historic investment is bringing tens of thousands of jobs to the US and will ensure medicine sold in our country is produced right here.”
Governor Glenn Youngkin, Commonwealth of Virginia, said: “I want to thank AstraZeneca for choosing Virginia as the cornerstone for this transformational investment in the United States. This project will set the standard for the latest technological advancements in pharmaceutical manufacturing, creating hundreds of highly skilled jobs and helping further strengthen the nation's domestic supply chain. Advanced manufacturing is at the heart of Virginia's dynamic economy, so I am thrilled that AstraZeneca, one of the world's leading pharmaceutical companies, plans to make their largest global manufacturing investment here in the Commonwealth.”
Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “Today’s announcement underpins our belief in America’s innovation in biopharmaceuticals and our commitment to the millions of patients who need our medicines in America and globally. It will also support our ambition to reach $80 billion in revenue by 2030. I look forward to partnering with Governor Youngkin and his team to work on our largest single manufacturing investment ever. It reflects the Commonwealth of Virginia’s desire to create highly skilled jobs in science and technology, and will strengthen the country’s domestic supply chain for medicines.”
Notes
AstraZeneca in the US
The US is AstraZeneca’s largest market and home to 19
R&D, manufacturing and commercial sites. We employ more
than 18,000 people and support 92,000 jobs overall
across the United States. In 2024 we contributed $5
billion directly to the economy and created
approximately $20 billion worth of overall value for the
American economy.
Today the US represents 42% of our Total Revenue with an ambition to reach 50% by 2030. This underscores the critical role the US plays in our ability to deliver on our ambition to launch 20 new medicines by the end of the decade.