Abbott
2009/9 Abbott to Acquire Solvay Pharmaceuticals Business
2010/5 Abbott Accelerates Emerging Markets Pharmaceutical Leadership With Zydus Cadila Collaboration
September 28, 2009 Solvay release Solvay presentation
2009/10/2 Abbott、Solvayの医薬品事業を買収
Abbott to Acquire Solvay Pharmaceuticals Business
・Diversifies
Abbott's pharmaceutical products, expanding international growth
platform
・Supports
long-term strategy to bolster presence in key global emerging
markets
・Adds
substantial R&D spending capacity to accelerate promising
pipeline programs
・Establishes
Abbott's presence in the growing global vaccines market
・Provides
accretion of approximately $0.10 to ongoing EPS in 2010,
accelerating to more than $0.20 by 2012, increasing thereafter
Abbott today announced a definitive agreement with the Solvay Group for Abbott to acquire Solvay's pharmaceuticals business for EUR 4.5 billion($6.6 billion) in cash, providing Abbott with a large and complementary portfolio of pharmaceutical products and a significant presence in key global emerging markets. The acquisition also includes full global rights to the fenofibrate 高脂血症治療薬;フィブラート系franchise. Currently Abbott has U.S. rights to fenofibrate and pays royalties to Solvay.
Belgium-based Solvay Pharmaceuticals will add more than $3 billion in annual sales, the majority outside the U.S. Solvay has significant presence and infrastructure in key high-growth emerging markets, including Eastern Europe and Asia. Emerging markets are growing faster and increasing in importance due to demographics, rising incomes and expanded treatment of chronic disease.
The acquisition will also add approximately $500 million to Abbott's annual pharmaceutical R&D investment, providing Abbott with the opportunity to further accelerate near and long-term pharmaceutical growth.
"The acquisition of Solvay Pharmaceuticals further diversifies our pharmaceutical portfolio, expands our presence in key high-growth emerging markets, enhances our investment in R&D and accelerates our long-term earnings-per-share growth outlook," said Miles D. White, chairman and chief executive officer, Abbott.
"In anticipation of future market needs, we are ensuring we have the technologies, products, infrastructure and reach to serve patients globally and continue to deliver sustainable industry-leading growth. This acquisition, as well as the others we've announced this year all contribute to achieving that long-term goal," said Mr. White.
"With this transaction Solvay Pharmaceuticals has found a new strong home, within a respected company with a solid and committed position in the industry," comments Christian Jourquin, chief executive officer, Solvay.
Solvay's pharmaceutical portfolio complements Abbott's presence and expertise in specialty markets such as cardiovascular disease, neuroscience and gastroenterology. Solvay has treatments for Parkinson's disease, Ménière's disease (abnormality of the inner ear), vertigo, and irritable bowel syndrome. Solvay also offers products to treat men's and women's hormonal health, and exocrine pancreatic insufficiency (inability to properly digest food), which is associated with several underlying conditions including cystic fibrosis and chronic pancreatitis.
The acquisition also includes Solvay's vaccines business, which will provide Abbott entry into the expanding global vaccines market. Solvay has a small molecular diagnostics unit that will become part of Abbott's diagnostics organization upon the transaction close.
"Abbott's international pharmaceutical business has grown significantly over the past several years, driven by specialty products in developed markets," said Olivier Bohuon, executive vice president, Pharmaceutical Products Group, Abbott. "In emerging markets where chronic disease is being treated more aggressively, the combined Abbott and Solvay portfolio of branded generics expands the global reach of these medicines. Solvay's business will also give us a platform to enter the attractive global vaccines market."
Financial Highlights
The transaction will be approximately $0.10 accretive to ongoing earnings per share in 2010, accelerating to more than $0.20 by 2012, increasing thereafter, all before one-time transaction-related items, which will be provided at a later date. These one-time transaction-related items are expected to occur between 2010 and 2012. The transaction also includes payments of up to EUR 300 million if certain sales milestones are met between 2011 and 2013.
Abbott plans to fund the transaction with cash currently on the balance sheet.
This transaction is subject to customary closing conditions and regulatory approvals and is expected to close in the first quarter of 2010. As a result, the deal will have no impact on 2009 ongoing earnings per share. The boards of directors of both companies have approved the proposed acquisition.
Barclays Capital served as an exclusive financial advisor to Abbott on this transaction.
About Solvay Pharmaceuticals
Solvay Pharmaceuticals is a research driven group of companies that constitutes the global pharmaceutical business of the Solvay Group. These companies seek to fulfill carefully selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology and men's and women's health. Its 2008 sales were EUR 2.7 billion, and it employs more than 9,000 people worldwide. For more information, visit www.solvaypharmaceuticals.com.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.
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Solvay opts for strategic
refocus of activities
Decision to
sell Pharmaceuticals Sector to Abbott
Solvay today announces that its Board of Directors has decided to
refocus the activities of the Solvay Group in order to accelerate
the implementation of its sustainable and profitable growth
strategy and to sell its entire pharmaceutical business to Abbott
for a total Entreprise Value of about EUR 5.2 billion. This
includes a purchase price of EUR 4.5
billion in cash
and additional
potential payments of up to EUR 300 million if certain milestones are met
between 2011 and 2013. It also includes the assumption of certain
liabilities,
which Solvay today values at approximately EUR 400 million. This
decision is the outcome of the thorough and in-depth analysis and
evaluation of the different strategic options for the
Pharmaceuticals Sector.
In addition the
transaction provides for the transfer of all employees of the
pharmaceutical business with their current employment conditions;
it also includes customary provisions limiting future exposure of
Solvay to its former pharmaceutical activities. This transaction
is expected to be closed in the first quarter of 2010, pending
the approval by the relevant competition authorities. Solvay will
communicate the impact of the transaction on its results when
finalized.
After closing of
the transaction, Solvay will reinvest the
proceeds in organic and sizeable external growth, focused on long term value
creation. This will be done by investing in high value-added
activities and strategic projects in chemicals and plastics, by continuing the geographical
expansion into regions with growth potential and by continuing
the development of activities and new products with low energy
footprint and which significantly reduce the cyclicality in
Solvay’s portfolio of activities. Studies about such
reinvestments are ongoing.
“The Board has
chosen to give all activities of the Group, Pharmaceuticals and
non-Pharmaceuticals, the best possibilities for their future
development, and this in the interest of all stakeholders
involved”, says Alois Michielsen, Chairman
of Solvay’s Board of Directors. “We are building a new refocused
Group with the financial means to further accelerate sustainable
growth on today’s strong foundations. Our
philosophy is unaltered: realizing sustained growth with leading
positions and stick to a conservative financial structure. The
proceeds from the divestment will be reinvested in external and
organic growth with a sharp focus on long term value creation”, adds Christian Jourquin, Chief
Executive Officer of Solvay.
“The acquisition
by Abbott is an acknowledgment of the performance of the
Pharmaceuticals Sector and the strengths and competences of its
employees. The Sector will further reinforce Abbott as a leading
company in its industry”, comments Werner Cautreels, Group
General Manager of the Pharmaceuticals Sector.
Citigroup, Morgan
Stanley and Rothschild served as financial advisors to Solvay on
this transaction.
Given this
announcement, the Solvay Investor Day which was scheduled for
29th September 2009 is cancelled.
Solvay 事業内訳
2008年実績(百万ユーロ)
Sales | REBIT* | 同左2007 | |
Pharmaceuticals | 2,699 | 509 | 457 |
Chemicals | 3,096 | 238 | 345 |
Plastics | 3,695 | 264 | 441 |
Corporate | -46 | ||
Total | 9,490 | 965 |
*Recurrent Earnings (経常損益)Before Interest and Tax
Pharmaceuticals
Solvay Pharmaceuticals operates in two key therapeutic fields, in which it undertakes a full range of Research and Development activities:
These are supplemented by two niche areas in which Solvay is well-established, with extensive know-how:
And by two other commercially important fields where existing products receive management and R&D support:
Sales Breakdown 2008: EUR 2 699 million
- Cardiometabolics 心臓血管分野 812
With the acquisition of Fournier Pharma (in 2005), Solvay Pharmaceuticals has now become the global leader in fenofibrate高脂血症治療薬;フィブラート系, a successful cardiometabolic product for treating raised blood lipids.
Fournier Pharma is an international privately owned research-based pharmaceutical company headquartered in France, with operations in 30 countries.
-
Neuroscience 神経科学 411
anti-depressant
fluvoxamine、Parkinsons’s disease medication, DUODOPA
-
Flu vaccines137
- Pancreatic enzymes膵酵素 217
- Gastroenterology消化器病 243
- Female and male hormone treatments 648
- Others 231
By geographic area
- Europe 46 %
-The Americas 42 %(Nafta 40%、Mercosur2%)
-Asia-Pacific 8 %
-Rest of the world 4 %
Abbott to Become No. 1 Pharmaceutical Company in India with Acquisition of Piramal's Healthcare Solutions Business
Strategic action will
propel Abbott to No. 1 position with annual sales growth
approaching 20 percentin India, expected to exceed $2.5 billion
in sales by 2020
Piramal's comprehensive portfolio of market-leading branded
generics spans multiple therapeutic areas; combined sales force
to become industry's largest in India
India, one of world's fastest-growing markets, generating nearly
$8 billion in pharma sales this year; expected to more than
double by 2015
Abbott announced a definitive agreement with Piramal Healthcare
Limited to acquire full ownership of Piramal's Healthcare
Solutions business (Domestic Formulations), a leader in the
Indian branded generics market, for an up-front payment of $2.12
billion, plus $400 million annually for the next four years,
giving Abbott the No. 1 position in the Indian pharmaceutical
market. This further accelerates Abbott's emerging markets growth
following the recent acquisition of Solvay
Pharmaceuticals
and announcements last week of Abbott's collaboration with Zydus
Cadila as well as the creation of a new stand-alone Established
Products Division to focus on expanding the global markets for
its leading branded generics portfolio.
"This strategic action will advance Abbott into the leading
market position in India, one of the world's most attractive and
rapidly growing markets," said Miles D. White, chairman and
chief executive officer, Abbott. "Our strong position in
branded generics and growing presence in emerging markets is part
of our ongoing diversified pharmaceutical strategy, complementing
our market-leading proprietary pharmaceutical offerings and
pipeline in developed markets."
"Emerging markets represent one of the greatest
opportunities in health care ? not only in pharmaceuticals ? but
across all of our business segments. Today, emerging markets
represent more than 20 percent of Abbott's total business,"
said Mr. White.
"With this deal, the combined Healthcare Solutions and
Abbott businesses will become the clear market leader in India,
with a market share of approximately 7 percent," said Ajay
Piramal, chairman, Piramal Group. "This was our collective
vision and I am glad that those who are part of Piramal's
Healthcare Solutions business will realize this dream."
The Indian Pharmaceutical Market
India is one of the world's fastest-growing pharmaceutical
markets, due in large part to branded generics. The market will
generate nearly $8 billion in pharmaceutical annual sales this
year, a number that is expected to more than double by 2015.
Abbott estimates the growth of its Indian pharmaceutical business
with Piramal to approach 20 percent annually, with expected sales
of more than $2.5 billion by 2020.
Branded generics have significant brand equity in many
international markets, providing durable, sustainable franchises
for future growth. Piramal markets the products in its Healthcare
Solutions business in India only and does not market traditional
generic products. Today, branded generics account for 25 percent
of the global pharmaceutical market, have the majority of market
share in the largest emerging markets, and are expected to
outpace growth of patented and generic products.
The Mumbai-based Piramal Healthcare Solutions business has a
comprehensive portfolio of branded generics with annual sales
expected to exceed $500 million next year in India, and
market-leading brands in multiple therapeutic areas, including
antibiotics, respiratory, cardiovascular, pain and neuroscience.
This business grew 23 percent in 2010 (fiscal year ended March
31,2010), faster than the market in India. Piramal has a strong
commercial presence, including the largest sales force in India
with a unique model that includes dedicated sales personnel in
rural areas inhabited by 70 percent of the population. The
combined Abbott and Piramal sales forces will be the industry's
largest in India.
Piramal's Healthcare Solutions business will become part of
Abbott's newly created, stand-alone Established Products
Division. Piramal's Healthcare Solutions business employs more
than 5,000 people in India. Abbott, which is celebrating its
100th year in India, has more than 2,500 employees across all of
its businesses there.
Abbott's Established Products Strategy
Throughout the past decade, Abbott has built a leading portfolio
of branded generics, through its own products as well as those
acquired with the 2001 acquisition of Knoll's pharmaceutical
business. In 2007, the company established a separate business
unit within its international pharmaceutical division dedicated
to established products.
Additionally, a new geographic region focused on Russia, India
and China was created, which resulted in the doubling of Abbott's
growth rate in those countries.
Most recently, the company acquired Solvay Pharmaceuticals,
obtaining a diverse branded generics portfolio and providing
significant critical mass in key emerging markets.
As a result of these combined actions, Abbott is now among the
leading multinational health care companies in numerous emerging
markets. Approximately 20 percent of Abbott's pharmaceutical
sales today are in emerging markets.
"We have assembled a market-leading branded generics
portfolio tailored to the unique needs of emerging markets,
strongly positioning Abbott to meet the current and future
geographic and market dynamics in pharmaceuticals," said
Olivier Bohuon, executive vice president, global pharmaceuticals,
Abbott. "Piramal has built a reputation for high-quality,
well-known and trusted pharmaceutical brands. We look forward to
welcoming the accomplished staff of Piramal's Healthcare
Solutions business to Abbott."
Pharmaceutical sales in emerging markets are expected to grow at
three times the rate of developed markets and account for 70
percent of pharmaceutical growth over the next several years.
This explosive growth is occurring as demographics, rising
incomes, modernization of health systems and an increase in the
treatment of chronic disease create greater demand for medicines.
Financial Highlights
Under terms of the agreement, Abbott will purchase the assets of
Piramal's Healthcare Solutions business for a $2.12
billionup-front payment with payments of $400 million annually
for the next four years, beginning in 2011. The transaction will
not impact Abbott's ongoing earnings per share guidance in 2010.
Abbott plans to fund the transaction with cash on the balance
sheet.
This transaction is subject to shareholder approval of Piramal
Healthcare Limited and other customary closing conditions, and is
expected to close in the second half of 2010. This transaction is
being conducted by a wholly-owned subsidiary of Abbott, resulting
in full ownership of the assets of Piramal's Healthcare Solutions
business (Domestic Formulations).
Abbott Conference Call
Abbott will conduct a special conference call today at 7:30 a.m.
Central time (8:30 a.m. Eastern time) to provide an overview of
the transaction. The live Web cast will be accessible through
Abbott's Investor Relations Web site at www.abbottinvestor.com.
For more information on today's announcement, please go to
Abbott's press kit at /PHSMediaKit.
About the Piramal Group
The Piramal Group, led by Ajay G. Piramal is one of India's
foremost business conglomerates. Driven by the core values of
Knowledge Action Care, the Piramal Group has interests in a
myriad of industries that encompass healthcare, drug discovery
& research, diagnostics, glass, real estate and financial
services. The Piramal Group steadfastly pursues inclusive growth
while adhering to ethical and value driven practices. The Group's
turnover exceeded US $1 billion in FY2010.
About Abbott
Abbott (NYSE: ABT) is a global, broad-based health care company
devoted to the discovery, development, manufacture and marketing
of pharmaceuticals and medical products, including nutritionals,
devices and diagnostics. The company employs approximately 83,000
people and markets its products in more than 130 countries.
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Abbott Accelerates
Emerging Markets Pharmaceutical Leadership With Zydus Cadila
Collaboration; Separately Creates Stand-Alone Established
Products Division
Abbott licenses 24
Zydus pharmaceutical products for 15 high-growth emerging
markets; holds option for more than 40 additional products
Abbott also
announces the creation of new stand-alone Established Products
Division with $5 billion in current pharmaceutical sales;
business focused on fast-growing emerging markets
Emerging markets
expected to grow at three times the rate of developed markets,
accounting for 70 percent of global pharma industry growth in
next several years
Further
strengthening its global competitive position, Abbott today
announced a licensing and supply agreement
with Zydus Cadila of India for a portfolio of pharmaceutical
products that Abbott will commercialize in 15 emerging markets,
enabling the company to further accelerate its emerging markets
growth.
Abbott also
announced the formal creation of a stand-alone Established
Products Division (EPD) concentrated on expanding the
market for Abbott's established pharmaceutical portfolio outside
of the U.S., particularly focused in emerging markets. EPD will
be led by Michael J. Warmuth, an Abbott leader with significant
experience in Abbott's pharmaceutical business, who most recently
led Abbott's Diagnostics Division.
"Our new
Established Products Division, with $5 billion in sales, will
focus on expanding our presence and product offerings in the
world's fastest-growing emerging markets," said Olivier
Bohuon, executive vice president, Pharmaceutical Products Group,
Abbott. EPD is part of the Pharmaceutical Products Group
reporting to Bohuon.
Abbott's growing
portfolio of established products consists of branded generics -
products that have significant brand equity in many international
markets - providing durable, sustainable franchises for future
growth. This complements Abbott's successful proprietary products
business and proprietary pharmaceutical pipeline.
The Zydus Cadila
Collaboration
Under the Zydus
agreement, Abbott will gain rights to at least 24 Zydus products
in 15 key emerging markets where Abbott has a strong and growing
presence. The agreement also includes an option for the addition
of more than 40 Zydus products to the collaboration.
"The Zydus
agreement complements our established products strategy,
augmenting this business with a broad portfolio of branded
generics," said Bohuon.
The collaboration
includes medicines for pain, cancer and cardiovascular,
neurological and respiratory diseases. The partnership will
leverage Abbott's powerful emerging markets infrastructure to
commercialize the Zydus products, with product launches beginning
in early 2012.
"We have
always believed in working with partners for win-win alliances
that look at new opportunities for growth and expansion,"
said Chairman and Managing Director Zydus Cadila, Pankaj R.
Patel. "In this alliance we see tremendous opportunity to
participate in multiple ways in a market that is growing and
expanding rapidly. Building on our mutual strengths we are
creating a considerable competitive advantage for value creation
for both partners over the long term."
The financial terms
of the agreement were not disclosed.
Abbott's
Established Products Strategy
Abbott's new
Established Products Division will market Abbott's established
products portfolio outside of the U.S., with a focus on
accelerating growth in emerging markets.
Throughout the past
decade, Abbott has built a leading portfolio of branded generics,
through its own products as well as those acquired with the 2001
acquisition of Knoll's pharmaceutical business. In 2007, the
company established a separate business unit within its
international pharmaceutical division dedicated to established
products.
Additionally, a new
geographic region focused on Russia, India and China was created
which resulted in the doubling of Abbott's growth rate in those
countries.
Most recently, the
company acquired Solvay Pharmaceuticals, obtaining a diverse
branded generics portfolio and providing significant critical
mass in key emerging markets.
As a result of
these combined actions, Abbott is now among the leading
multi-national health care companies in numerous emerging
markets. Approximately 20 percent of Abbott's pharmaceutical
sales today are in emerging markets.
Emerging Markets
Opportunity
Pharmaceutical
sales in emerging markets are expected to grow at three times the
rate of developed markets and account for 70 percent of the
industry's growth over the next several years. Branded generics
represent the most significant growth opportunity in emerging
markets. Today, branded generics account for 25 percent of the
global pharmaceutical market, have the majority of market share
in the largest emerging markets, and are expected to outpace
growth of patented and generic products.
About Zydus Cadila
Zydus Cadila is an
innovative global pharmaceutical company that discovers,
develops,manufactures and markets a broad range of healthcare
therapies. With an aim to be a research-based pharmaceutical
company by 2020, Zydus Cadila invests nearly 8 percent of its
turnover on research annually. The group employs over 11,000
people worldwide and is dedicated to improving people's lives.
Additional
information about Zydus is available at
http://www.zyduscadila.com.
About Abbott
Abbott (NYSE: ABT)
is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of
pharmaceuticals and medical products, including nutritionals,
devices and diagnostics. The company employs approximately 83,000
people and markets its products in more than 130 countries.
米 MylanがAbbottの一部事業を買収、税負担も軽減
米ジェネリック(後発)医薬品メーカーのマイランは、米医薬品大手、アボット・ラボラトリーズが保有する米国外の先進国市場における特殊・ブランデッド(承継)ジェネリック事業について、約53億ドル相当の株式で買収すると発表した。(ジェネリックメーカーが、
長期収載品を新薬メーカーから、 ブランドをそのまま引き継いで生産・販売する医薬品)
発表を受け、マイランの株価は14日終値が2.1%上昇。アボット株は1.3%高となった。
合意によると、アボットはオランダで設立される新会社に欧州や日本、カナダ、オーストラリア、ニュージーランドにある資産を移し、マイランが新会社の部門と統合する。マイランは、法人を軽課税国に置いて税負担を軽くすることも可能になるという。
マイランは買収により、消化薬のクレオンや鎮痛薬のブルフェン、インフルエンザワクチンなど、年間売上高で約20億ドル相当の事業を獲得することになる。
アボットは新会社の株式1億500万株を受け取るが、これを比較的早期に売却してさらなる医療機器事業買収や自社株買いなどの資金に充当していく方針。力強い成長が見込める新興国市場では引き続き、自社でブランデッドジェネリック事業を展開していくとしている。
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July 14, 2014
Abbott
Abbott to Sell its Developed Markets Branded Generics Pharmaceuticals
Business to Mylan
Abbott will retain its branded generics pharmaceuticals business in emerging
markets
Transaction expected to positively
impact Abbott's sales and ongoing earnings-per-share growth rates
"This transaction provides Abbott with additional strategic flexibility as we continue to actively manage and shape our portfolio, reflecting our commitment to long-term, durable growth," said Miles D. White, chairman and chief executive officer, Abbott. "Our branded generics pharmaceuticals business will focus on emerging markets, where demographic changes and increasing access to healthcare are expected to drive sustainable growth."
Abbott's
Branded Generics Pharmaceuticals Business
Following the closing of the transaction, Abbott's
branded generics pharmaceuticals business will focus in emerging geographies
where demographics and growing healthcare systems are combining to create an
increased rate of patient access to healthcare and where the majority of
healthcare products are paid for by the consumer. The branded generics
business that will remain with Abbott
generated 2013 sales of $2.9 billion and is
expected to have a sales growth rate in the upper-single to double digits.
Transaction Details and Financial Terms
Under the terms of the agreement, Abbott
will sell its developed markets branded generics pharmaceuticals business to
Mylan for 105 million shares or approximately 21 percent, on a fully diluted
basis, of a newly formed entity that will combine Mylan's existing business
and Abbott's developed markets
pharmaceuticals business, and will be a publicly traded company.
The business to be sold operates in Europe, Japan, Canada, Australia and New Zealand and includes approximately 3,800 employees. It includes a broad portfolio of medicines, as well as manufacturing facilities in France and Japan. Abbott will retain its product portfolio and manufacturing facilities in other geographies as well as its manufacturing facilities in the Netherlands, Germany and Canada.
Following the transaction, which is expected to close in the first quarter of 2015, Abbott expects that its sales growth rate will be 100 basis points higher, and the growth rate of its ongoing net income will be in excess of 200 basis points higher. The ongoing net income associated with Abbott's developed markets pharmaceuticals business is expected to be approximately $0.22 per share in 2015. Accordingly, Abbott's ongoing earnings per share from continuing operations is expected to be lower following the close of this transaction by this amount.
Abbott does not expect to be a long-term shareholder in Mylan and plans ultimately to redeploy the net proceeds from this transaction to opportunities that would be accretive to earnings over time.
In May, Abbott announced the acquisition of the Latin American pharmaceutical company CFR Pharmaceuticals, which is expected to be approximately $0.07 accretive to Abbott's ongoing earnings per share in 2015.
Abbott expects to report its developed markets branded generics pharmaceuticals business as Discontinued Operations beginning in the third quarter 2014.
Morgan Stanley advised Abbott on the transaction.
------------
Jul 14, 2014 Mylan
Mylan To Acquire Abbott's Non-U.S.
Developed Markets Specialty And Branded Generics Business In An All-Stock
Transaction
Mylan Inc. today announced that it has entered into a definitive agreement
with Abbott whereby Mylan will acquire Abbott's non-U.S.
developed markets specialty and branded generics business in an
all-stock transaction. Upon closing, Abbott will receive 105 million shares
of the combined company worth approximately $5.3 billion based on Mylan's
closing price of $50.20 on Friday, July 11, 2014, representing an
approximately 21% ownership stake. The transaction will instantly further
diversify Mylan's business and strengthen its commercial platform outside
the U.S., building new opportunities for growth and additional sales
channels in the acquired markets. It also is expected to provide Mylan with
significant additional financial firepower to pursue future opportunities,
an additional $600 million of annual post-close EBITDA, an optimized global
tax structure and enhanced balance sheet capacity.
The Assets, which are being acquired on a debt-free
basis, include an attractive portfolio of more than 100 specialty and
branded generic pharmaceutical products in five major therapeutic areas
(cardio/metabolic, gastrointestinal, anti-infective/respiratory, CNS/pain
and women's and men's health) and include several patent protected, novel
and/or hard-to-manufacture products with continued growth potential. With a
strong presence in Europe, Japan, Canada, Australia and New Zealand, the
Assets are expected to provide approximately $1.9 billion in annual
additional revenues at deal close. The business includes an active sales
organization of approximately 2,000 representatives in more than 40 non-U.S.
markets, as well as two high-quality manufacturing facilities.
Following the transaction, Mylan expects to have approximately $10 billion
in pro forma 2014 sales, adjusted EBITDA of approximately $3 billion at
transaction close, an attractive and diverse portfolio of more than 1,400
specialty and generic products, an enhanced global commercial
infrastructure, and an expanded high-quality manufacturing platform.
Mylan Executive Chairman Robert J. Coury commented, "We have been actively
looking at a wide range of opportunities, and the acquisition of this
business is absolutely the right next strategic transaction for Mylan as it
builds on our strong momentum, expands and further diversifies our business
in our largest markets outside of the U.S., and clearly positions Mylan for
the next phase of growth through enhanced financial flexibility and a more
competitive global tax structure. In addition to maximizing our growth
drivers, the transaction is expected to be immediately and significantly
accretive, and to create significant additional cash financial flexibility
at close, which we fully intend to put to use to fund future opportunities
in this continually consolidating sector. The numerous strategic and
financial benefits of this transaction will allow Mylan to potentially
accelerate achievement of our long-term financial targets to the benefit of
our shareholders."
Mylan CEO Heather Bresch said, "We targeted this differentiated business
with a complementary portfolio of attractive specialty and branded generic
products, many of which have strong continued growth potential. The Assets
also have an impressive commercial infrastructure and capabilities, which
provide us with reach in the physician and patient channels in the acquired
markets, complementing our reach in pharmacies. This enhanced commercial
platform will help us drive the continued expansion of EpiPen® Auto-Injector
globally and enable us to more effectively launch important growth drivers,
such as respiratory and biologics. We believe Mylan is uniquely positioned
to realize improved financial performance and profitability from these
assets by leveraging our integrated, efficient operating platform, more
effectively distributing the portfolio across channels, and maintaining a
greater strategic focus on key products. We have experience successfully
integrating large, complex transactions such as this one, and we are
confident in our ability to deliver the value inherent from this
combination."
Bresch continued, "In addition to creating value for our shareholders, this
transaction delivers on our mission of providing the world's 7 billion
people access to high-quality medicine. The Abbott team associated with this
business shares Mylan's uncompromising commitment to quality, our
high-performance culture and our passion for making a difference. We look
forward to welcoming them and their strong sales organization to Mylan and
benefiting from their capabilities."
"Mylan is the right organization for our developed markets branded generics
business," said Miles D. White, Chairman and Chief Executive Officer of
Abbott. "Mylan has the scale and breadth across critical distribution
channels and a complementary portfolio that will quickly position this
business for success. Mylan also shares our commitment to patients and
product quality."
Strategic Rationale
This transaction further diversifies Mylan's business outside of the U.S. by
adding a differentiated and attractive portfolio of durable specialty and
branded generic products and providing entry into the over-the-counter
market. Key products include Creon®, Influvac®, Brufen®, Amitiza® and
Androgel®, among others.
The addition of the Assets also enhances Mylan's geographic reach and
provides Mylan with enhanced scale and critical mass in Mylan's largest
markets outside of the U.S. The transaction is expected to approximately
double Mylan's revenues in Europe by strengthening its presence in Italy,
the United Kingdom, Germany, France, Spain and Portugal, among others. It
also is expected to more than double Mylan's revenues in Canada and Japan,
and build on Mylan's business in Australia and New Zealand. The transaction
also provides Mylan with a meaningful presence in the specialty and branded
generics market in Central and Eastern Europe.
The combination significantly expands Mylan's commercial platform and
capabilities. The business's strong salesforce in key developed markets
enhances Mylan's reach with physicians and patients and complements Mylan's
existing strength in pharmacies. This platform provides Mylan with the
enhanced infrastructure and expertise to more effectively execute on growth
drivers that require access to the physician channel, such as the global
expansion of EpiPen® Auto-Injector® and the launch of biologics and
respiratory products, including generic Seretide® and generic Advair®.
Mylan expects to maximize the business's strong portfolio and attractive
financial profile to drive enhanced financial performance from the business,
including stabilizing revenues and growing EBITDA and EBITDA margins.
Financial Highlights
The transaction is expected to be immediately and significantly accretive to
Mylan, with expected year one adjusted diluted EPS accretion of
approximately $0.25, increasing thereafter through 2018. The combination is
expected to deliver in excess of $200 million in pre-tax operational
efficiencies by the end of year three post-close.
Mylan's pro forma leverage at close is expected to be approximately 2.3x
debt-to-adjusted EBITDA, substantially below current levels, giving the
company ample financial flexibility to pursue future opportunities. Strong
cash flow generation will further enhance Mylan's balance sheet and
financial flexibility and create additional shareholder value. Finally, the
transaction is expected to lower Mylan's tax rate to approximately 20-21% in
the first full year, and to the high teens thereafter, enhancing the
company's competitiveness.
Mylan believes this transaction gives it the potential to accelerate its
previously stated financial targets for 2018, including at least $6.00 in
adjusted diluted EPS.ii
Transaction Structure
Abbott will carve out the Assets and transfer them to a new public company
("New Mylan") organized in the Netherlands. Immediately following the
transfer, Mylan will merge with a wholly owned subsidiary of New Mylan, and
New Mylan will become the parent company of Mylan. The new public company
will be called Mylan N.V. and will be led by
the current Mylan leadership team and headquartered in Pittsburgh.
Under the terms of the transaction agreement, Abbott will receive 105
million shares of New Mylan upon closing, resulting in Mylan shareholders
owning approximately 79% of New Mylan and Abbott indirectly owning
approximately 21% of New Mylan. Mylan shareholders will recognize gain for
U.S. federal income tax purposes on the exchange of Mylan common shares for
New Mylan ordinary shares.
Shares of New Mylan will continue to trade in the U.S. on the NASDAQ under
Mylan's existing ticker symbol MYL.
The transaction has been unanimously approved by Mylan's Board of Directors
and is expected to close in the first quarter of 2015, subject to certain
closing conditions, including regulatory clearances and approval by Mylan's
shareholders.
Centerview Partners served as financial advisor to Mylan, and Cravath,
Swaine & Moore LLP served as its legal advisor.
マイラン社は、ジェネリック医薬品とスペシャリティー医薬品の世界有数の製薬企業として、140以上の国と地域で製品を提供しています。さらに、フランス、日本、イギリス、米国を含む世界のジェネリック医薬品市場の多くで、トップクラスの企業としての地位を確立しています。
当社の医薬品事業は、ジェネリック、API、スペシャリティーの3種類に分類されます。ジェネリック事業はさらに、北米地域、欧州・中東・アフリカ地域、アジア太平洋地域と地域別に分けられています。 マイラン社は、グローバルな企業体として事業展開する一方で、各国市場のニーズにきめ細やかに対応することができるため、この競争の激しいグローバルなジェネリック医薬品およびスペシャリティー医薬品業界での順調な成長が期待されています。
North America
数量ベースの売上高で世界上位にランクインするジェネリック医薬品企業であるマイラン社は、世界最大の米国市場における存在意義を引き続き高めていきます。
マイラン社が米国で強力な地位を築けた背景には、ジェネリック事業の成長にとって鍵となる、新製品発売に必要な当局の承認を安定的に獲得してきたことがあります。またマイラン社には、長期にわたり高い品質への評判を維持しつつ大量の製品を安定供給してきた実績があります。 米国市場は今後も成長を続けると予測されます。高齢化する人口、医療費削減への強い要望、ジェネリック医薬品への依存が高まる中で需要がますます高まるでしょう。Mylan North Americaは、米国における高品質で低コストのジェネリック医薬品への需要を今後も満たしていくため、十分な態勢を整えています。 マイラン社の北米事業には、ウェストバージニア州モーガンタウンを本拠とするMylan Pharmaceuticals、マイラン社のカナダ事業、Mylan Technologies、およびUDL Laboratoriesがあります。 EMEA
マイラン社は欧州、中東およびアフリカ(EMEA)全域において、製造、包装、配送、販売等を行っています。マイラン社のEMEA事業は、フランスで最大手であるほか、複数の国において上位ランクインをコンスタントに維持しています。
マイラン社のEMEA事業においては、オーストリア、ベルギー、チェコ、デンマーク、フィンランド、フランス、ドイツ、ハンガリー、イタリア、オランダ、ノルウェー、ポーランド、ポルトガル、スカンジナビア諸国、スロバキア、スロベニア、スペイン、スウェーデン、スイス、南アフリカ、英国においてマイラン社の名のもと事業展開しています。 それ以外にもマイラン社のEMEA事業は、Arcana Arzneimittel、Generics Pharma Hellas、Gerard Laboratories、Qualimed等の企業を傘下に持ちます。またDocpharmaを通じて、ベルギー、オランダ、ルクセンブルクでのジェネリック医薬品販売を行っています。 APAC
マイラン社のアジア太平洋(APAC)事業は、子会社のアルファファームを通じてオーストラリアでトップクラスの地位を獲得しているほか、世界第2位の医薬品市場である日本では子会社のマイラン製薬を通じ、またニュージーランドでは事業展開することで、各市場での大手企業としてのポジションを確立しています。
さらにマイランラボラトリーズリミテッド(旧マトリックスラボラトリーズリミテッド)が運営する好調なAPI事業も、マイラン社のアジア太平洋事業に含まれています。インドのハイデラバードを本拠とするマイランラボラトリーズリミテッドは、インドと中国にある9つの工場でAPIおよび中間体を製造しています。 Other Areas
米国のジェネリック医薬品業界における最大手として長い歴史を持つマイラン社は、グローバルな医薬品企業へと飛躍し、現在、世界有数のジェネリックおよびスペシャリティー医薬品企業となりました。マイラン社は世界各地の確立された市場においてランキング上位の地位も確保し、アフリカ、中国、インド、南米などの地域も含む140以上の国や地域で事業展開しています。
マイラン社はまた、フロリダ州タンパを本拠として特許技術の研究開発を行うSomerset Pharmaceuticals Inc.も所有しています。Somersetは、大うつ病性障害の治療に使われる経皮吸収パッチ、EMSAM®*を開発しました。この製品は現在、Mylan Technologiesが製造し、デイが米国における販売を行っています。
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2016/9/20 Johnson & Johnson、Abbott Medical Optics を買収
Abbottは事業の「選択と集中」を加速させ、循環器系の医療器具や診断分野に経営資源を集中させる。
Abbott to Acquire St. Jude Medical
COMBINATION WILL CREATE A PREMIER MEDICAL DEVICE LEADER AND STRENGTHEN ABBOTT'S LONG-TERM GROWTH POTENTIAL
- Acquisition will enhance Abbott's global scale and capabilities and will further diversify its portfolio of best-in-class products and revenue sources
- Combined portfolio will include top positions in high-growth markets and an industry-leading pipeline
- Transaction expected to be accretive to Abbott's adjusted earnings per share(1) in the first full year after closing and increasing thereafter
Abbott and St. Jude Medical, Inc. announced
today a definitive agreement for Abbott to acquire St. Jude Medical, creating a
premier medical device leader with top positions in high-growth cardiovascular
markets, including atrial fibrillation, structural heart and heart failure as
well as a leading position in the high-growth neuromodulation market. Under the
agreement, St. Jude Medical shareholders will receive $46.75 in cash and 0.8708
shares of Abbott common stock, representing total consideration of approximately
$85 per share. At an Abbott stock price of $43.93(2), this represents a
total transaction equity value of $25 billion. The combined company will
have an industry-leading pipeline expected to deliver a steady stream of new
medical device products across cardiovascular, diabetes, vision and
neuromodulation patient care.
St. Jude Medical's strong positions in heart failure devices, atrial
fibrillation and cardiac rhythm management complement Abbott's leading positions
in coronary intervention and transcatheter mitral repair. Together, the company
will compete in nearly every area of the cardiovascular market and hold the No.
1 or 2 positions across large and high-growth cardiovascular device markets.
This best-in-class combined portfolio will have the depth, breadth and
innovation to help patients restore their health, reduce costs for payors and
deliver greater value to customers.
"Bringing together these two great companies will create a premier medical
device business and immediately advance Abbott's strategic and competitive
position," said Miles D. White, chairman and chief executive officer, Abbott.
"The combined business will have a powerful pipeline ready to deliver
next-generation medical technologies and offer improved efficiencies for health
care systems around the world."
"Today's announcement is an exciting next chapter for St. Jude Medical, bringing
together two industry leaders with a shared passion for innovation, culture and
patients," said Michael T. Rousseau, St. Jude Medical president and chief
executive officer. "Our combined scale will expand the global reach,
competitiveness and impact of our medical device innovation for physicians and
hospitals. This transaction provides our shareholders with immediate value and
the opportunity to participate in the significant upside potential of the
combined organization. I'd like to thank our 18,000 employees whose hard work
and commitment help us deliver leading medical technologies to patients around
the world."
The acquisition of St. Jude Medical will advance Abbott's strategic and
competitive positions:
Aligned with healthcare and demographic trends: Cardiovascular medical devices
are important tools to address the growing health and economic burden of
cardiovascular disease (CVD). In the U.S. alone, more than 40 percent of adults
are expected to have one or more forms of CVD by 2030. The combined business
will have one of the broadest portfolios of devices and an industry-leading
pipeline to help healthcare systems provide better care for patients while
increasing efficiencies and reducing costs.
Leadership positions in core businesses: With combined annual sales of
approximately $8.7 billion, Abbott's cardiovascular business and St. Jude
Medical will hold the No. 1 or 2 positions across large and high-growth
cardiovascular device markets and will compete in nearly every area of the
market – with an aggregate market opportunity of $30 billion.
Well-managed diversity to deliver reliable, sustainable growth: St. Jude Medical
further diversifies and enhances sources of future growth for Abbott – the
combined pipelines are expected to bring numerous new medical device products to
key markets this year, including:
St. Jude Medical's EnSite Precision™ next-generation cardiac mapping system used
to visualize and navigate catheters in the heart during ablation procedures;
first-to-market MultiPoint™ Pacing technology advances quadripolar technology
and provides additional options for cardiac resynchronization therapy patients
who are not responsive to other pacing options; Proclaim™ Elite recharge-free
Spinal Cord Stimulation System and Prodigy™ Chronic Pain System, which are used
for treating chronic pain and are MRI safe, upgradeable, and feature its
proprietary Burst technology.
Abbott's FreeStyle® Libre, a sensor-based glucose monitoring system for people
with diabetes that eliminates routine finger sticks; Tecnis® Symfony, a
first-in-kind continuous range of vision intraocular lens for the treatment of
people with cataracts; and Absorb™, the world's first bioresorbable coronary
stent.
Strong positions in the world's largest and fastest-growing geographies: St.
Jude Medical has strong and leading positions around the world, strengthening
Abbott's global scale, infrastructure and capabilities.
Financial Impact of Transaction
The acquisition of St. Jude Medical is expected to be accretive to Abbott's
adjusted earnings per share in the first full year after closing and increasing
thereafter, with approximately 21 cents of accretion in 2017 and 29 cents in
2018.(1) The combination is anticipated to result in annual pre-tax synergies of
$500 million by 2020, including both sales and operational benefits. One-time
deal-related costs and integration costs will be provided at a future date.
St. Jude Medical's net debt of approximately $5.7 billion will be assumed or
refinanced by Abbott. Abbott intends to fund the cash portion of this
transaction with medium- and long-term debt.
The transaction, which has been approved by the boards of directors of St. Jude
Medical and Abbott, is subject to the approval of St. Jude Medical shareholders
and the satisfaction of customary closing conditions, including specified
regulatory approvals. The transaction is expected to close in the fourth quarter
of 2016.
Separate Equity Issuance to Balance Capital Structure
Separately, Abbott expects to issue $3 billion of common stock in the secondary
market to rebalance its capital structure, with timing to be determined.
Financing for the St. Jude Medical transaction and the previously announced
Alere Inc. acquisition contemplates financing capacity to close both
transactions.
米医薬品・医療器具大手のアボット・ラボラトリーズは、米医療機器メーカーのセント・ジュード・メディカルを総額約250億ドル(約2兆7000億円)で買収すると発表した。需要拡大が見込める心血管治療分野を強化する。2016年10〜12月期中の手続き完了を見込む。
アボットはセント・ジュード1株につき、現金46.75ドルとアボット0.8708株、1株当たり85ドル相当を支払う。
セント・ジュードは年間売上高は約59億ドル、従業員数は約1万8000人。ペースメーカーや血管を広げて血流を助けるカテーテル器具など、心血管治療関連の医療器具で業界大手。
アボットの医療器具事業は年間売上高が50億ドル。そのうち30億ドル程度を心血管治療関連が占める。同社は米国など主要市場で肥満や高齢化により同分野の医療用品の需要が伸びると見ており、セント・ジュード取り込みで品ぞろえを強化する。
セント・ジュード・メディカルについて
セント・ジュード・メディカルは、世界中の患者様の命を救い生活を改善する費用対効果の高い医療技術開発することで、最も治療費のかかり、蔓延する疾患への治療に変革をもたらすことに取り組むグローバル医療機器メーカーです。「カーディアック・リズム・マネジメント(不整脈疾患の診断及び治療に用いる医療機器)」、「心房細動」、「心臓血管」、および「ニューロ・モジュレーション(慢性疼痛・神経障害)」の4つの分野に注力しています。米国ミネソタ州セントポールに本社を置き、全世界で事業を展開するグローバル企業です。日本では東京都港区の本社ならびに日本全国に営業拠点を置き、日本で35年以上にわたり患者様の疾患治療に最新のテクノロジーとソリューションを提供しています。
---
昨年、セント・ジュードはThoratecを買収した。アボットは実質的に2社を統合することになるのです。
2015 年 10 月 8 日
セント・ジュード・メディカルがThoratecを買収
2015年10月8日、世界的な医療機器メーカーであるセント・ジュード・メディカルは、重症心不全(HF)治療における補助人工心臓(Mechanical
Circulatory Support)技術の世界的リーダーであるThoratecの買収を完了いたしましたので、お知らせいたします。
この買収により、最も広く使用され大規模試験も行われている左心補助人工心臓(LVAD)のHeartMate II®、次世代機器のHeartMate
3™、HeartMate PHP™、およびその他の補助製品が、市場をリードするセント・ジュード・メディカルの心不全製品ラインナップに追加されます。以上の製品を加えることで、セント・ジュード・メディカルは今後、最も包括的な心不全治療用製品ラインを提供して参ります。
買収に関して、セント・ジュード・メディカルのCOOであり、次期社長兼CEOのマイケル・T・ルソーは次のように述べています。「セント・ジュード・メディカルは、心不全治療をリードする2社が統合すること、また現在、心不全分野全体において医師および患者様への革新的ソリューション提供にユニークなポジションを確立している弊社のフランチャイズ展開を推進できることを嬉しく思っております。これを機に、この治療費がかかり、蔓延する疾患の治療に対する世の中の見方が変化していくことを信じています。また、このThoratec社員の皆様を歓迎いたします。」
取得する現金を除いた正味買収金額は約33億米ドルです。買収契約に基づき、買収完了時の発行済みThoratec株式に対して、1株当たり$63.50(利息なし)の現金を受け取る権利が付与されました。セント・ジュード・メディカルは、この買収により、2016年の1株当たりの調整後利益が向上すると予測しています。
必要となる法的な要求事項をすべて満たし、2015年10月7日にThoratecの株主承認を得た後、買収は完了となります。なお、合併完了に伴い、Thoratecの普通株はナスダック市場への上場を廃止します。
セント・ジュード・メディカルの財務顧問はバンクオブアメリカ・メリルリンチ、法律顧問はギブソン・ダン&クラッチャー法律事務所です。Thoratec社の財務顧問はグッゲンハイム証券会社、法律顧問はレイサム・アンド・ワトキンス法律事務所です。また、センタービュー・パートナーズ社は、買収に関して、Thoratec取締役会に公正な立場から意見提供を行いました。
左心補助人工心臓について
ドナーから提供される心臓が不足していることから、研究者たちは、心不全患者における心室ポンプ機能を助け、心負荷を低減するVADの開発を行ってきました。左室機能を助けるデバイスを左心補助人工心臓(LVAD)といい、右室機能を助ける機器を右心補助人工心臓(RVAD)といいますが、多くの患者様で補助を必要とするのは左室のみであるため、LVADがVAD治療の大半を占めています。
HeartMate II LVADは、患者様自身の心臓の近くに植え込みを行い、弱った左室のポンプ機能を補助する設計となっており、肺から全身へ酸素の豊富な血液を行き渡らせるポンプの機能を担います。また、心不全患者において長期間の心臓補助を行うように設計されており、世界中の試験登録および市販使用により、これまでに21,000例の患者様がHeartMate
II VADの植込み手術を受けています。本デバイスは、2008年に移植待機患者を対象として(移植までのブリッジとしての使用(Bridge-To-Transplantation))、また、2010年に心移植の対象ではない患者を対象として(長期在宅治療としての使用(Destination
Therapy))米国食品医薬品局(FDA)の承認を受けました。HeartMate II VADの植込み手術は、米国、欧州、日本、アジア太平洋、オーストラリア、カナダおよびラテンアメリカといった世界中の365以上の医療施設で行われています。
HeartMate 3 VADは治験中の長期使用LVADであり、有害事象率を低下させ、外科的留置をより容易にするために設計され磁気浮上型である、Full
MagLev™フローテクノロジーを使用しています。本機器は幅広い進行性心不全患者を対象としており、心移植の適応とならない患者様における長期補助使用に関する臨床試験が進行中です。また、移植待機患者を対象とした短期補助についても評価を行う予定です。さらに、2015年第4四半期中には、欧州でCEマークの取得が見込まれています。現在、MOMENTUM
3 U.S. IDE試験の被験者登録が進められています。
FDA grants emergency use authorization for fastest available molecular point-of-care test for novel coronavirus.
Abbott has received emergency use
authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the
fastest available molecular point-of-care test for the detection of novel
coronavirus (COVID-19), delivering positive results in as
little as five minutes and negative results in 13
minutes.
What makes this test so different is where it can be used: outside the four
walls of a traditional hospital such as in the physicians' office or urgent care
clinics.
The new Abbott ID NOW COVID-19 test runs on Abbott's ID
NOWTM platform—a lightweight box (6.6 pounds and the size of a
small toaster) that can sit in a variety of locations.
Because of its small size, it can be used in more non-traditional places where
people can have their results in a matter of minutes, bringing an alternate
testing technology to combat the novel coronavirus.
We're ramping up production to deliver 50,000 ID
NOW COVID-19 tests per day, beginning next week, to
the U.S. healthcare system.
This comes on the heels of our announcement last week of the availability of the
Abbott RealTime SARS-CoV-2 EUA test under FDA EUA, which runs on m2000 RealTime
molecular system for centralized lab environments. Combined with ID NOW, Abbott
expects to produce about 5 million tests in April.
Testing remains a crucial step in controlling the novel COVID-19 pandemic.
Continuing to supply healthcare providers with new technologies to help curb the
spread of infection is a top priority for public health officials and healthcare
providers.
Taking molecular testing to the front lines
Molecular point-of-care testing for COVID-19 offers healthcare workers rapid
results in more settings where people show up for care. Molecular testing
technologies help detect the presence of a virus by identifying a small section
of the virus' genome, then amplifying that portion until there's enough for
detection. This process can cut testing wait time from hours, if not days, to as
little as five minutes for positive results and 13 minutes for negative results.
When not being used for COVID-19 testing, ID NOW is the leading molecular
point-of-care platform for Influenza A&B, Strep A and respiratory syncytial
virus (RSV) testing. Our platform holds the largest molecular point-of-care
footprint in the U.S. and is already widely available in physicians' offices,
urgent care clinics, and hospital emergency departments across the country.
"Through the incredible work of teams across Abbott, we expect to deliver 50,000
COVID-19 tests per day to healthcare professionals on the front lines, where
testing capabilities are needed most," said Chris Scoggins, senior vice
president, Rapid Diagnostics, Abbott. "Portable molecular testing expands the
country's capacity to get people answers faster."
The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been
authorized by the FDA under an emergency use authorization for use by authorized
laboratories and patient care settings. The test has been authorized only for
the detection of nucleic acid from SARS-CoV-2, not for any other viruses or
pathogens, and is only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use of in vitro
diagnostic tests for detection and/or diagnosis of COVID-19 under Section
564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is
terminated or revoked sooner.