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.
ーーー
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.
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
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.
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.
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.
ーーー
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
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
In addition to today’s
submission to the FDA, the companies have already initiated rolling
submissions across the globe including in Australia, Canada, Europe,
Japan and the U.K., and plan to submit applications immediately to
other regulatory agencies around the world
Based on current projections,
the companies expect to produce globally up to 50 million doses in
2020 and up to 1.3 billion doses by the end of 2021; the companies
will be ready to distribute the vaccine within hours after
authorization
BNT162b2 demonstrated a
vaccine efficacy rate of 95%, with no serious safety concerns
observed to date
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
COMIRNATY is the first
COVID-19 vaccine to be granted FDA approval
Approval is based on a
comprehensive submission package including six-month efficacy and
safety data after second dose
More than 1.2 billion Pfizer-BioNTech
doses have been delivered to more than 120 countries or territories
around the world since December 2020
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.
It is approved as a 2-dose series for
prevention of COVID-19 in individuals 16 years of age and older
It is also authorized under Emergency
Use Authorization (EUA) to be administered for emergency use to:
prevent COVID-19 in individuals 12
through 15 years, and
provide a third dose to individuals
12 years of age and older who have been determined to have certain kinds
of immunocompromise
The Pfizer-BioNTech COVID-19 Vaccine has
received EUA from FDA to:
prevent COVID-19 in individuals 12 years
of age and older, and
provide a third dose to individuals 12
years of age and older who have been determined to have certain kinds of
immunocompromise
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:
had a severe allergic reaction after a
previous dose of this vaccine
had a severe allergic reaction to any
ingredient of this vaccine
Individuals should tell the vaccination
provider about all of their medical conditions, including if they:
have any allergies
have had myocarditis (inflammation of
the heart muscle) or pericarditis (inflammation of the lining outside the
heart)
have a fever
have a bleeding disorder or are on a
blood thinner
are immunocompromised or are on a
medicine that affects the immune system
are pregnant, plan to become pregnant,
or are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an
injection
The vaccine may not protect everyone.
Side effects reported with the vaccine
include:
There is a remote chance that the
vaccine could cause a severe allergic reaction
A severe allergic reaction would
usually occur within a few minutes to one hour after getting a dose of
the vaccine. For this reason, vaccination providers may ask individuals
to stay at the place where they received the vaccine for monitoring
after vaccination
Signs of a severe allergic reaction
can include difficulty breathing, swelling of the face and throat, a
fast heartbeat, a bad rash all over the body, dizziness, and weakness
If an individual experiences a
severe allergic reaction, they should call 9-1-1 or go to the nearest
hospital
Myocarditis (inflammation of the heart
muscle) and pericarditis (inflammation of the lining outside the heart) have
occurred in some people who have received the vaccine. In most of these
people, symptoms began within a few days following receipt of the second
dose of the vaccine. The chance of having this occur is very low.
Individuals should seek medical attention right away if they have any of the
following symptoms after receiving the vaccine:
chest pain
shortness of breath
feelings of having a fast-beating,
fluttering, or pounding heart
Side effects that have been reported
with the vaccine include:
severe allergic reactions;
non-severe allergic reactions such as rash, itching, hives, or swelling
of the face; myocarditis (inflammation of the heart muscle);
pericarditis (inflammation of the lining outside the heart); injection
site pain; tiredness; headache; muscle pain; chills; joint pain; fever;
injection site swelling; injection site redness; nausea; feeling unwell;
swollen lymph nodes (lymphadenopathy); diarrhea; vomiting; arm pain
These may not be all the possible side
effects of the vaccine. Serious and unexpected side effects may occur. The
vaccine is still being studied in clinical trials. Call the vaccination
provider or healthcare provider about bothersome side effects or side
effects that do not go away
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.
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.