Genzyme and Bone Care International Announce Merger Agreement ------------------------------------------------------ Genzyme to
2005年5月4日 - 11:21PM
PRニュース・ワイアー (英語)
Genzyme and Bone Care International Announce Merger Agreement
------------------------------------------------------ Genzyme to
Acquire Bone Care, Adding Complementary Therapy to Renagel;
Accelerates Commercial Entry into Earlier Stages of Chronic Kidney
Disease CAMBRIDGE, Mass. and MADISON, Wis., May 4
/PRNewswire-FirstCall/ -- Genzyme Corporation (NASDAQ:GENZ) and
Bone Care International (NASDAQ:BCII) announced today that they
have signed a definitive merger agreement under which Genzyme will
acquire Bone Care in an all cash transaction valued at $33.00 per
fully diluted share, or approximately $600 million, net of Bone
Care's cash of $119 million. With the close expected in the third
quarter of the year, Genzyme expects the transaction to be neutral
in 2005, and accretive beyond. Genzyme will provide specific advice
upon completion of purchase accounting. The acquisition of Bone
Care brings Genzyme a complementary line of products and a
profitable commercial organization that will strengthen and
diversify Genzyme's renal business. Bone Care's Hectorol(R)
(doxercalciferol), a line of vitamin D2 pro-hormone products, is
used to treat secondary hyperparathyroidism in patients on
dialysis, where it can be used in tandem with Genzyme's Renagel(R)
(sevelamer hydrochloride) and other phosphate binders. Hectorol is
available in intravenous form for patients on hemodialysis, and in
oral forms primarily used by patients with earlier stage chronic
kidney disease (CKD). It is the first and only vitamin D2 analog
approved to treat the continuum of chronic kidney disease. Sales of
Hectorol reached $59 million for the nine months ended March 31,
2005. Based on strong third quarter sales, Bone Care increased its
revenue guidance on April 26 to a range of $82-$83 million for
fiscal year 2005, ending June 30, 2005. "We are tremendously
excited for the opportunity to bring these products to Genzyme,"
said Henri A. Termeer, Genzyme's chairman and chief executive
officer. "The addition of the Bone Care organization and the
Hectorol brand will solidify and strengthen our growing renal
business, while further broadening our overall product portfolio.
This important therapy for patients with earlier stages of chronic
kidney disease will provide Genzyme with valuable commercial
experience and speed our entry into this much larger market." Paul
Berns, Bone Care's president and chief executive officer, said:
"Genzyme has recognized the potential of our strong growth platform
and the value our employees bring to patients, clinicians and
shareholders. We believe that this merger is a tremendous
opportunity to optimize Bone Care's global business potential."
Strong Strategic Fit The use of Renagel and Hectorol are each
supported by a large and growing body of clinical evidence. Both
products are well positioned in the National Kidney Foundation's
(NKF) K/DOQI guidelines for Bone Metabolism and Disease in Chronic
Kidney Disease. Renagel, the only calcium-free, metal-free
phosphate binder, controls serum phosphorus levels in patients with
CKD on hemodialysis. The NKF's K/DOQI guidelines recommend
sevelamer hydrochloride as a first-line treatment option to reduce
phosphorus. Renagel has an established safety profile, is not
systemically absorbed and provides phosphorus control without the
concerns of calcium or metal accumulation. Renagel is used by more
than 350,000 people worldwide. Hectorol capsules are a unique
pro-hormone vitamin D2 analog formulation indicated for the
treatment of secondary hyperparathyroidism in patients with CKD
stages 3, 4, and 5. Hectorol treats secondary hyperparathyroidism,
a condition that impacts a significant number of patients with
earlier stages of CKD. This condition, if left untreated, can
result in bone disease, muscle weakness, reduced immunity,
cardiovascular disease and increased mortality. Genzyme estimates
that more than 500,000 patients in the United States with CKD stage
3 and stage 4 have elevated PTH levels above K/DOQI targets. Beyond
Renagel's current indication for patients on hemodialysis (stage 5
CKD), Genzyme is developing a next generation sevelamer for use in
hyperphosphatemic patients in earlier stages of chronic kidney
disease. Genzyme has begun enrolling patients in a short-term
clinical trial of sevelamer carbonate to evaluate the product's
equivalence to Renagel, and anticipates launching a study later
this year to evaluate sevelamer carbonate's potential to benefit
hyperphosphatemic patients with earlier stage chronic kidney
disease. Genzyme intends to integrate Bone Care into its own renal
operations in the United States. Genzyme will also begin immediate
work on the registration of Hectorol outside of the United States,
with particular focus on Europe and Asia. Presently, Hectorol is
only sold in North America. "This transaction provides a great
strategic opportunity for Genzyme to expand our renal business
further, and to raise the visibility of both product lines with
nephrologists and renal patients throughout the world," said John
P. Butler, president, Genzyme Renal. In addition to Renagel,
Genzyme developed and now markets Fabrazyme, an enzyme replacement
therapy for Fabry disease, a degenerative disorder that can lead to
kidney failure; and Thymoglobulin, a polyclonal antibody product
used to treat rejection of a kidney transplant. Genzyme is also
investigating future treatments focused on polycystic kidney
disease, and working to improve renal patient care through support
of basic research, disease awareness initiatives and treatment
access programs. Bone Care has an active development program for
Hectorol and other vitamin D analogs in CKD and a range of other
diseases, including psoriasis and cancers of the prostate, breast
and colon. Financial Terms Genzyme's acquisition of Bone Care will
take the form of a merger, with shareholders receiving $33.00 per
share. As of March 31, 2005, Bone Care had approximately $119
million in cash and equivalents. Genzyme has access to more than
$1.5 billion in cash and equivalents, including an undrawn line of
credit. The transaction has been approved by the boards of
directors of both companies, and is subject to approval by Bone
Care's shareholders and clearance under the Hart-Scott-Rodino
Antitrust Improvements Act. The transaction is expected to be
completed in the third quarter of 2005. Genzyme will issue revised
financial guidance after completion of purchase accounting. About
Renagel (sevelamer hydrochloride) Renagel is indicated for the
control of serum phosphorus in patients with chronic kidney disease
(CKD) on hemodialysis. Renagel is contraindicated in patients with
hypophosphatemia or bowel obstruction. In a 52-week study, the most
common side effects included vomiting, nausea, diarrhea, and
dyspepsia. Drug-drug interactions may occur with some medications
and should be taken into consideration when instructing patients
how to take Renagel. For more information about Renagel, including
complete prescribing information, please visit
http://www.renagel.com/. About Hectorol(R) (doxercalciferol)
Hectorol(R) is indicated for the treatment of secondary
hyperparathyroidism in patients with Stage 3 or Stage 4 chronic
kidney disease and patients with stage 5 chronic kidney disease on
dialysis. Hectorol(R) should not be given to patients with a
tendency towards hypercalcemia or evidence of vitamin D toxicity.
Overdosage of any form of vitamin D, including Hectorol(R), is
dangerous. Acute hypercalcemia may exacerbate tendencies for
cardiac arrhythmias and seizures and may potentiate the action of
digitalis drugs. Chronic hypercalcemia can lead to generalized
vascular calcification and other soft-tissue calcification. The
principal adverse effects of treatment of Hectorol(R) are
hypercalcemia, hyperphosphatemia, hypercalciuria, and
oversuppression of iPTH. Oversuppression of iPTH may lead to
adynamic bone syndrome. About Bone Care Bone Care is a specialty
pharmaceutical company engaged in the discovery, development and
commercialization of innovative therapeutic products to treat the
unmet medical needs of patients with debilitating conditions and
life- threatening diseases. The company's current commercial and
therapeutic focus is in nephrology, utilizing Hectorol, a novel
vitamin D hormone therapy, to treat secondary hyperparathyroidism
in patients with moderate to severe chronic kidney disease and
end-stage renal disease. In addition to chronic kidney disease, the
company is developing vitamin D hormone therapies to treat
hyperproliferative disorders such as cancer and psoriasis. About
Genzyme One of the world's leading biotechnology companies, Genzyme
is dedicated to making a major positive impact on the lives of
people with serious diseases. Founded in 1981, Genzyme has grown
from a small start-up to a diversified enterprise with annual
revenues exceeding $2 billion and more than 7,000 employees in
locations spanning the globe. With many established products and
services helping patients in more than 80 countries, Genzyme is a
leader in the effort to develop and apply the most advanced
technologies in the life sciences. The company's products and
services are focused on rare inherited disorders, kidney disease,
orthopedics, cancer, transplant and immune diseases, and diagnostic
testing. Genzyme's commitment to innovation continues today with a
substantial development program focused on these fields, as well as
heart disease and other areas of unmet medical need. Safe Harbor
Statement This press release contains forward-looking statements,
including statements about the completion of a merger transaction
between Genzyme and Bone Care and the timing thereof, the expected
impact on Genzyme's earnings, 2005 revenue guidance for Hectorol,
plans to initiate a sevelamer carbonate study and the timing
thereof, integration of Bone Care's operations and the Hectorol
sales and marketing operations, and plans for registration of
Hectorol outside the U.S. These statements are subject to risks and
uncertainties that could cause actual results to differ materially
from those projected in these forward-looking statements. These
risks and uncertainties include, among others, the possibility that
the transaction is not completed; the possibility that the
transaction does not obtain FTC clearance on terms acceptable to
the companies; the possibility that other closing conditions are
not met, including receipt of Bone Care shareholder approval; the
actual timing and content of submissions to and decisions made by
regulatory authorities, including those outside of U.S. in regards
to Hectorol; the ability to attract and retain qualified sales
forces; the accuracy of the companies' information concerning the
CKD marketplace, including growth projections; and the risks and
uncertainties described in reports filed by Genzyme and Bone Care
with the Securities and Exchange Commission under the Securities
Exchange Act of 1934, as amended, including without limitation the
information under the heading "Factors Affecting Future Operating
Results" in Genzyme's Annual Report on Form 10-K for the year
ending December 31, 2004, and under the heading "Contingencies" in
Bone Care's Quarterly Report on Form 10-Q for the quarter ended
December 31, 2004. We caution investors not to place substantial
reliance on the forward-looking statements contained in this press
release. These statements speak only as of the date of this press
release, and we undertake no obligation to update or revise the
statements. Bone Care will file with the Securities and Exchange
Commission (the "SEC"), and furnish to its shareholders, a proxy
statement soliciting proxies for the meeting of its shareholders to
be called with respect to the proposed merger. Bone Care
shareholders are advised to read the proxy statement when it is
finalized and distributed to them because it will contain important
information. Bone Care shareholders and other interested parties
will be able to obtain, without charge, a copy of the proxy
statement (when available) and other relevant documents filed with
the SEC from the SEC's website at http://www.sec.gov/. Bone Care
shareholders and other interested parties will also be able to
obtain, without charge, a copy of the proxy statement and other
relevant documents (when available) by directing a request by mail
or telephone to Bone Care International, 1600 Aspen Commons,
Middleton, WI, 53562, telephone: 608-662-7800, or from Bone Care's
website, http://www.bonecare.com/. Bone Care and certain of its
directors, executive officers and other members of management and
employees may, under SEC rules, be deemed to be "participants" in
the solicitation of proxies from Bone Care shareholders with
respect to the proposed merger. Information regarding the people
who may be considered "participants" in the solicitation of proxies
will be set forth in Bone Care's proxy statement relating to the
proposed merger when it is filed with the SEC. Information
regarding certain of these people and their beneficial ownership of
Bone Care common stock as of October 12, 2004 is also set forth in
Bone Care's proxy statement for its 2004 Annual Meeting of
Shareholders, which was filed with the SEC on October 25, 2004.
Conference Call Information There will be a joint conference call
today at 10:15 am ET to discuss the proposed merger between Genzyme
Corporation and Bone Care. If you would like to participate, please
call 719-457-2656. A replay of this call will be available from
2:45 pm. ET on May 4, 2005, to midnight ET on May 11, 2005, by
calling 719-457-0820. Please refer to reservation number 8494364.
This call will also be webcast live at the investor section of
http://www.genzyme.com/. Genzyme's press releases and other company
information are available at http://www.genzyme.com/ and by calling
Genzyme's investor information line at 1-800-905-4369 within the
United States or 1-703-797-1866 outside the United States. Media
Contact, Genzyme: Investor Contact, Genzyme: Dan Quinn Sally Curley
(617) 768-6849 (617) 768-6140 Media Contact, Bone Care: Brian
Hayden (608) 662-7800 DATASOURCE: Genzyme Corporation CONTACT:
Media Contact: Dan Quinn, +1-617-768-6849, or Investor Contact:
Sally Curley, +1-617-768-6140, both of Genzyme; Brian Hayden of
Bone Care, +1- 608-662-7800 Web site: http://www.genzyme.com/
Company News On-Call: http://www.prnewswire.com/comp/104284.html
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