Takeda to Acquire Inviragen, Inc.
Obtains Promising Vaccine Candidates Against Dengue and Hand, Foot and Mouth
Disease, Advancing Takeda's Commitment to Vaccines and Global Health
OSAKA, Japan and DEERFIELD, Ill. and FORT COLLINS, Colo., May 7, 2013
OSAKA, Japan andDEERFIELD, Ill. and FORT COLLINS, Colo., May 7, 2013
/PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") and
Inviragen, Inc. ("Inviragen") jointly announced today that Takeda, its wholly
owned subsidiary Takeda America Holdings, Inc., and Inviragen, Inc. have
entered into a definitive agreement for Takeda to acquire Inviragen for an
upfront payment of US$35 million, and future payments of up to US$215 million
linked to the progress of clinical development and achievement of key
commercial milestones. Headquartered in Fort Collins, CO, with facilities in
Madison, WI and Singapore, Inviragen is a privately-held biopharmaceutical
company specializing in research and development of innovative vaccines for
emerging infectious diseases, including dengue and hand, foot and mouth
"Takeda has taken another major step toward its goal of establishing a
world-class global vaccine business by acquiring Inviragen and its advanced
vaccine candidate against dengue, a serious mosquito-borne illness that
threatens nearly half of the world's population," said Rajeev Venkayya, M.D.,
executive vice president and head of Takeda's Vaccine Business Division.
"Today's announcement reinforces Takeda's commitment to develop innovative
vaccines to fight some of the world's most important infectious diseases."
Inviragen has created innovative products using its expertise in viral
vaccines. The company's lead candidate, DENVax, is a four-strain recombinant
viral vaccine for the prevention of dengue infection. An administration
schedule of two doses of DENVax over 90 days is currently being evaluated in
Phase 2 clinical trials. In addition to DENVax, Inviragen's pipeline contains
a vaccine candidate to protect against hand, foot and mouth disease (HFMD)
caused by enterovirus 71 (EV71), which has completed Phase 1 clinical testing.
Inviragen has also developed a recombinant vaccine candidate to protect
against chikungunya, currently in preclinical development.
"The acquisition of Inviragen supports Takeda's overall research and
development programs, long-term growth strategy and commitment to improve
health through innovation and new technology," said Tadataka Yamada, M.D.,
Takeda's chief medical and scientific officer and member of the Takeda board
of directors. "Coming less than a year after the acquisition of LigoCyte with
the world's leading norovirus vaccine candidate, this illustrates Takeda's
commitment to its global vaccine business and global public health."
Dengue is the most important mosquito-borne viral illness in the world, and is
one of four World Health Organization (WHO) future vaccine priorities. It is
estimated that about 400 million people worldwide are infected by the dengue
virus each year, of which nearly 100 million develop clinical illness.
Approximately 500,000 people are hospitalized and 20,000, mostly children, die
from severe complications such as hemorrhagic fever. Currently there are only
symptomatic treatments available for dengue and dengue hemorrhagic fever, and
the only means of prevention is through mosquito control. The number of
reported symptomatic dengue infections has increased 30-fold in the past 50
years, and the global footprint of dengue is expanding. HFMD epidemics occur
annually throughout the Asia Pacific region, with millions of cases reported
yearly since 2010. Chikungunya, which is a mosquito-transmitted virus, has
produced epidemics in Africa, India, Asia and Europe. There are no specific
treatments or cures for dengue, HFMD or chikungunya. Takeda will work with
governments and international organizations to ensure that these vaccines
reach the populations that need them around the world.
"This acquisition combines Inviragen's expertise in viral vaccine research and
development and our extensive worldwide network of preclinical and clinical
collaborators with Takeda's resources, product development expertise, and
global reach. Together we are well-positioned to bring these promising vaccine
candidates to the market," said Dan Stinchcomb, Ph.D., Inviragen's chief
executive officer. "Inviragen is pleased to become a part of a leading
pharmaceutical company that is so strongly committed to developing vaccines
that can improve public health worldwide."
Beyond the substantial expansion of Takeda's vaccine pipeline, this
acquisition will enhance Takeda's core vaccine R&D capabilities with
Inviragen's vaccine development center in Singapore, in one of the regions
where Inviragen's vaccines will have the greatest impact. "Inviragen has made
significant progress in developing key vaccines for emerging infectious
diseases in Asia and worldwide, with active support from its international
investor base," said Swee–Yeok Chu, CEO & President EDBI, a strategic
investment firm headquartered in Singapore and a major Inviragen investor.
"Takeda is an excellent partner to bring these important vaccines to the next
stage of development."
To preserve continuity and build upon Inviragen's success, Takeda will
integrate the Inviragen team into Takeda's Vaccine Business Division. Pending
the satisfaction of customary closing conditions, the deal is expected to
close in the next few weeks.
Key Strategic Benefits
Takeda expects the acquisition of Inviragen will:
oEnable Takeda to develop a highly-promising vaccine against dengue, which
the World Health Organization calls "the most important mosquito-borne
viral disease in the world."
oGrow Takeda's product pipeline with vaccine candidates that protect
against HFMD and chikungunya.
oExpand Takeda's current technical capabilities, which include virus-like
particle and cell culture technologies, with Inviragen's live-virus and
inactivated virus vaccine capabilities.
oContribute to Takeda's overall research and development programs,
long-term growth strategy and commitment to improve the health of people
and communities everywhere.
1.Acquiring companies: Takeda America Holdings, Inc. and Takeda
Pharmaceutical Company Limited
2.Shareholders of Inviragen, Inc.: EDBI, Charter Life Sciences, Venture
Investors, and Phillip Private Equity
4.Number of fully diluted common and preferred stock equivalent to common
outstanding shares: 39,035,439
5.Acquisition amount: US$35 million
a.In addition to this acquisition amount, the deal consideration
includes with future contingent consideration based on the progress
of development projects and commercial milestones up to US$215
6.Planned date of completion: Pending the satisfaction of customary closing
conditions, the deal is expected to close within 14 days.
7.Legal advisor to Takeda: Morgan, Lewis & Bockius LLP
8.Financial advisor to Inviragen: Torreya Partners LLC
9.Legal advisor to Inviragen: Wilson Sonsini Goodrich & Rosati
Profile of Inviragen Inc.:
1.Corporate Name: Inviragen, Inc.
2.Headquarters: Fort Collins, CO, U.S.A.
3.Wholly owned subsidiary: Inviragen (Singapore) Pte.Ltd., Singapore
4.Representative: Dr. Dan Stinchcomb, Co-founder and CEO
5.Year of establishment: 2005
6.Common Stock Equity: US$777
7.Additional Paid-in Capital: US$1,979,995
9.Number of employees: Approximately 50 employees.
10.Relationship with Takeda: No matters to report regarding capital, personal
and transactional relationship between Takeda and Inviragen.
The impact from this acquisition on Takeda's consolidated financial statements
of fiscal 2013 is expected to be minimal.
About Dengue Fever
Nearly half of the world's population live in countries that have frequent
dengue outbreaks. The four dengue viruses (DEN‐1, DEN‐2, DEN‐3 and DEN‐4) are
spread by the mosquito, Aedes aegypti, which is found throughout tropical and
subtropical regions. Recent estimates suggest that dengue viruses cause
approximately 100 million cases of clinical illness and over 2 million cases
of severe dengue disease leading to more than 20,000 deaths every year. For
more information on dengue fever, please refer to the World Health
Organization (WHO), Centers for Disease Control and Prevention (CDC), and
Dengue Vaccine Initiative (DVI) web sites.
About Hand, Foot and Mouth Disease (HFMD)
Hand, foot and mouth disease is a disease common in children throughout the
world and is endemic in the Asia Pacific region where its incidence has been
increasing steadily over the past two decades. Although the disease is
typically of short duration, there has been an increase in severe HFMD cases
associated with EV71. HFMD epidemics have been reported in most Asian
countries, particularly Singapore, Taiwan, Malaysia, Thailand, Japan, Korea,
Vietnam, Hong Kong and China.
About Chikungunya and the CHIKV Virus
Chikungunya Virus (CHIKV) is transmitted via mosquito and can cause fever,
headache, fatigue, nausea, vomiting, muscle pain, rash and joint pain in those
infected. Approximately 30% of patients showing clinical signs experience
incapacitating joint pain, or arthritis that may persist for weeks, months, or
in some cases years. On rare occasions, CHIKV infection may lead to neurologic
and hepatic disease with high illness and mortality rates. CHIKV is considered
endemic in 34 countries in Europe, Australia, Asia and Africa.
About Inviragen, Inc.
Inviragen is focused on developing vaccines to protect against infectious
diseases worldwide. Inviragen's vaccine to protect against dengue fever is in
Phase 2 clinical testing. A vaccine designed to protect children from hand,
foot and mouth disease has completed Phase 1 clinical testing. Vaccines to
protect against chikungunya and Japanese encephalitis, which affect millions
of individuals in Asia, are in development. Vaccines in preclinical research
stages include vaccines to protect against new forms of influenza and a
combination plague/smallpox vaccine for biodefense. Founded in 2005 with
offices in Colorado, Wisconsin and Singapore, Inviragen's investors include
EDBI (through Bio*One Capital, Singapore), Charter Life Sciences (Sunnyvale,
CA), Venture Investors (Madison, WI), and Phillip Private Equity (Singapore).
See www.inviragen.com for more details.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its
main focus on pharmaceuticals. As the largest pharmaceutical company in Japan
and one of the global leaders of the industry, Takeda is committed to strive
towards better health for patients worldwide through leading innovation in
medicine. Additional information about Takeda is available through its
corporate website, www.takeda.com.
Takeda's Vaccine Business Division
Takeda has a proven track record of manufacturing and supplying vaccines in
Japan for more than sixty years. Takeda's global vaccine business division was
launched in January 2012 to build upon this success, and is headquartered in
Deerfield, Illinois. The company acquired LigoCyte Pharmaceuticals and its
norovirus vaccine candidate, as well as its proprietary virus-like particle
vaccine platform and several preclinical vaccine candidates in October 2012.
EDBI is a leading strategic investment firm headquartered in Singapore with a
worldwide presence investing to drive growth opportunities within the
knowledge and innovation-intensive sectors of Biomedical Sciences (through its
subsidiary Bio*One Capital), Clean Technologies, Internet & Digital Media, as
well as key industries in Singapore. As a value adding investor, EDBI creates
sustainable and synergistic partnerships with its portfolio companies,
leveraging on its extensive networks and experience to facilitate the
companies' growth in Asia and the world, through their operations in
Please visit: www.edbi.com.
This press release contains "forward-looking statements." Forward-looking
statements include all statements other than statements of historical fact,
including plans, strategies and expectations for the future, statements
regarding the expected timing of filings and approvals relating to the
transaction, the expected timing of the completion of the transaction, the
ability to complete the transaction or to satisfy the various closing
conditions, future revenues and profitability from or growth or any
assumptions underlying any of the foregoing. Statements made in the future
tense, and words such as "anticipate," "expect," "project," "continue,"
"believe," "plan," "estimate," "pro forma," "intend," "potential," "target,"
"forecast," "guidance," "outlook," "seek," "assume," "will," "may," "should,"
and similar expressions are intended to qualify as forward-looking statements.
Forward-looking statements are based on estimates and assumptions made by
management that are believed to be reasonable, though they are inherently
uncertain and difficult to predict. Investors and security holders are
cautioned not to place undue reliance on these forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause
actual results or experience to differ materially from that expressed or
implied by the forward-looking statements. Some of these risks and
uncertainties include, but are not limited to: required regulatory approvals
for the transaction may not be obtained in a timely manner, if at all; the
conditions to closing of the transaction may not be satisfied; the transaction
may not be consummated; the anticipated benefits of the transaction may not be
realized; the transaction could disrupt relationships with employees,
licensees, customers and other business partners or governmental entities;
future sales could be adversely affected by competition or other factors; and
integration costs may exceed current expectations. In addition, the combined
business could be adversely affected by industry, economic or political
conditions outside of Inviragen's or Takeda's control, including general
economic conditions in Japan, the United States and worldwide; competitive
pressures and developments; applicable laws and regulations; the success or
failure of product development programs; actions of regulatory authorities and
the timing thereof; changes in exchange rates; and claims or concerns
regarding the safety or efficacy of marketed products or product candidates in
The forward-looking statements contained in this press release speak only as
of the date of this press release, and neither Inviragen nor Takeda undertake
any obligation to revise or update any forward-looking statements to reflect
new information, future events or circumstances after the date of the
forward-looking statement. If one or more of these statements is updated or
corrected, investors and others should not conclude that additional updates or
corrections will be made.
SOURCE Takeda Pharmaceutical Company Limited
Contact: Takeda Pharmaceutical Company Limited, Corporate Communications
Dept., +81-3-3278-2037, or Julia Ellwanger, Takeda Pharmaceuticals
International Inc., +1-224-554-7681, email@example.com; or Aline
Schimmel, Inviragen, Inc., +1-312-238-8957, firstname.lastname@example.org
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