PARSIPPANY, N.J., Jan. 23, 2013 /PRNewswire/ -- Watson
Pharmaceuticals, Inc. (NYSE: WPI) today announced that it has
completed the acquisition of Belgium-based Uteron Pharma SA for
$150 million in cash up front, and up
to $155 million in potential future
milestone payments. The acquisition of Uteron expands
Watson's Global Brands pipeline of Women's Health products
including two potential near term global commercial opportunities
in contraception and infertility, and one novel oral contraceptive,
projected to launch globally in 2018. Several additional
products in earlier stages of development are also included in the
acquisition. The Company said the transaction is expected to
be minimally dilutive to non-GAAP earnings in 2013 and 2014, and
accretive in 2015.
"This is a strategic acquisition of a solid pipeline, sound
development expertise, and sufficient manufacturing capacity to
generate value for shareholders within the next two years, and
provide the potential of multiple global product introductions
through the latter half of the decade," said Fred Wilkinson, President of Watson Global
Brands and Biosimilars. "We have structured the financials of
the acquisition to reflect the immediate value of the late stage
pipeline, with approximately $45
million in near-term milestones and appropriately balancing
the development risks and investments required to commercialize
these assets, when compared to the longer-term
opportunities.
"The acquisition capitalizes on the growing potential of the
expanded global commercial footprint for our Women's Health Brand
franchise following the Actavis acquisition. As a result of
the Uteron acquisition, Watson welcomes the opportunity to access
resources within the Walloon Region of Belgium, and acquires a valuable source of
research and innovation. We also look forward to expanding
our R & D team with the inclusion of the research and clinical
professionals in Liege, Belgium as
well as continuing their ongoing collaborations with the University
of Liege. This transaction is a first step in fulfilling our
promise to enhance our branded opportunities globally, while
creating near term revenue for Global Brands and further expanding
our Women's Health development portfolio."
Uteron's executive team including Co-CEO and co-founder
Stijn Van Rompay and CSO and
co-founder Professor Jean-Michel
Foidart, will continue to manage Uteron, which will become a
key part of research and development activities of an enlarged and
growing Women's Health business for Watson.
"We believe this transaction provides excellent value for our
shareholders and validates the potential of Uteron Pharma's strong
product pipeline, which is a result of great dedication and hard
work of our extremely talented employee partners. We are
pleased that Watson has committed to long term development of our
product portfolio in the Walloon region and the continued
collaboration with the University of Liege," said Francois
Fornieri, Co-CEO of Uteron Pharma.
"Uteron Pharma has developed a strong pipeline of innovative
products in different stages of development in the area of women's
health, based on strong in-house research capabilities combined
with deep partnerships with other scientific-led groups, such as
Pantarhei Bioscience, which initiated and co-developed Estelle, one
of our pipeline products. Joining forces with Watson provides
an excellent opportunity to advance our product portfolio further
and leverage the global commercial platform of Watson. We
look forward to working together with Watson to bring products to
market which will have a significant impact on women's lives," said
Stijn Van Rompay, Co-CEO of Uteron
Pharma.
Near-Term Product Opportunities
Levosert is an
Intrauterine Device (IUD), designed to initially deliver 20 mcg of
levonorgestrel per day for the indications of long term
contraception and treatment of heavy bleeding. The product is
currently pending approval in several EU countries, for first
indication, with potential launch in 2013, and is in late Phase III
development for the U.S. market, with potential launch in 2014.
A patent portfolio covers this product until 2031.
Watson has marketing rights in Western Europe and other regions and is
partnered with Gedeon Richter in
certain eastern European countries and Medicines360 in the U.S. and
certain other countries. The Uteron manufacturing facility in
Belgium will manufacture product
for Watson as well as provide the capacity to supply to its current
marketing partners.
The second near-term product opportunity, Diafert, is a
non-invasive immunoassay kit for the assessment of oocyte (egg)
quality during in-vitro fertilization (IVF). Diafert
measures the presence of granulocyte colony stimulating factor
(G-CSF) in the individual follicular fluids of corresponding eggs
to determine egg quality. When combined with traditional
embryo morphology assessment by an embryologist in the IVF clinic,
Diafert has the potential to increase implantation success rates,
resulting in fewer treatment cycles of IVF required. Diafert
is expected to obtain CE mark in the EU in the second half of 2013
and launch thereafter. Diafert is expected to be filed and,
if approved, launched in the U.S. in 2014. The patent extends
to 2028, and Watson has sole global marketing rights.
Mid Stage Development Candidate
Currently in end of
Phase II clinical studies, the Estelle contraceptive product is
being developed for global markets, with anticipated launch in
2018. Estelle contains a novel natural estrogen, estetrol,
which the Company believes will provide a prolonged half-life, a
higher safety margin, less interference with liver and metabolic
functions and an improved side effect profile. Estelle is
being studied in combination with a progestin and will be marketed
in a convenient dosing regimen. The product has patent
protection until 2025 in the U.S. and 2027 in the E.U.
Early Stage Development Opportunities
As part of the
acquisition, Watson acquires multiple potential products in early
stage development; including Vaginate, being developed for the
potential treatment of vaginal infections, Colvir, which is being
studied for the treatment of premalignant Human Papilloma Virus
(HPV) lesions of the uterine cervix and other product opportunities
in Women's Health.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. (NYSE: WPI) is a global,
integrated specialty pharmaceutical company focused on developing,
manufacturing and distributing generic, brand and biosimilar
products. The Company has global and U.S. headquarters in
Parsippany, New Jersey, USA, and
international headquarters in Zug, Switzerland.
Watson is the world's third-largest generics pharmaceutical
manufacturer, with more than 750 products marketed globally through
operations in more than 60 countries. Watson's global branded
pharmaceutical business develops and markets products principally
in Urology and Women's Health, and is committed to developing
and marketing biosimilars products in Women's Health, Oncology and
other therapeutic categories. In addition, Watson is the
fourth-largest U.S. generic pharmaceutical product distributor
through its Anda, Inc. business, and also develops and out-licenses
generic pharmaceutical products outside of the U.S. through its
Medis third-party business. Watson has announced that it will
adopt a new global name – Actavis – effective in 2013.
For press release and other company information, visit Watson
Pharmaceuticals' Web site at http://www.watson.com.
About Uteron
Uteron Pharma, a spinoff of the University of Liege, headquartered in Liege (Belgium), is a development-based company
dedicated to female healthcare. Uteron has a diversified
portfolio of innovative products in different stages of
development. The product development portfolio includes a hormonal
IUD, a next generation oral contraceptives containing natural
estrogen, a new generation of biochemical tests that will
significantly increase in-vitro fertilization success rates, and
pharmacologic treatments for cervical dysplasia. Its first product
is expected to be launched in selected EU countries in 2013.
The company operates a GMP approved, 3000 square meter facility
in Grace-Hollogne (Liege),
Belgium. This is a multi-use site;
it serves as a production facility for the Levosert hormonal
intrauterine device (IUD), as well as a production and quality
control facility which provides support for the clinical trials and
R&D activity.
The Uteron group employs a multidisciplinary staff of
approximately 60 employees and consultants. Uteron also interacts
actively with the University of Liege.
Forward-Looking Statement
Any statements contained in this press release that refer to
future events or other non-historical facts are forward-looking
statements that reflect Watson's current perspective of existing
trends and information as of the date of this release. Except as
expressly required by law, Watson disclaims any intent or
obligation to update these forward-looking statements. Actual
results may differ materially from Watson's current expectations
depending upon a number of factors affecting Watson's business.
These factors include, among others, integration of the Uteron
acquisition and the ability to recognize the anticipated synergies
and benefits of the Uteron acquisition; the anticipated size of the
markets and anticipated demand for Uteron's products; the impact of
competitive products and pricing; risks of fluctuations in foreign
currency exchange rates; the risks and uncertainties normally
incident to the pharmaceutical industry; risks that the carrying
values of assets may be negatively impacted by future events and
circumstances; the timing and success of product launches; the
difficulty of predicting the timing or outcome of product
development efforts and regulatory agency approvals or actions, if
any; market acceptance of and continued demand for Watson's and
Uteron's products; costs and efforts to defend or enforce
intellectual property rights; difficulties or delays in
manufacturing; the availability and pricing of third party sourced
products and materials; successful compliance with governmental
regulations applicable to Watson's and Uteron's facilities,
products and/or businesses; changes in the laws and regulations
affecting among other things, pricing and reimbursement of
pharmaceutical products; and other risks and uncertainties detailed
in Watson's periodic public filings with the Securities and
Exchange Commission, including but not limited to Watson's
Quarterly Report on Form 10-Q for the quarter ended September 30, 2012 and Watson's Annual Report on
Form 10-K for the year ended December 31,
2011. Except as expressly required by law, Watson disclaims
any intent or obligation to update these forward-looking
statements.
CONTACTS:
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Investors:
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Lisa
DeFrancesco
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(862)
261-7152
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Media:
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Charlie
Mayr
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(862)
261-8030
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SOURCE Watson Pharmaceuticals, Inc.