Approval of FOSRENOL in the United Kingdom triggers U.S.$3 million payment to AnorMED
September 25 2006 - 1:23AM
PR Newswire (US)
VANCOUVER, Sept. 25 /PRNewswire-FirstCall/ -- AnorMED Inc.
(NASDAQ:ANOR; TSX:AOM) today announced that under the terms of an
existing agreement, AnorMED will receive a U.S.$3 million milestone
payment from Shire Pharmaceuticals Group, plc based on the recent
licensing approval received in the United Kingdom by Shire to sell
FOSRENOL as a treatment for high phosphate levels in the blood,
which occurs in patients undergoing dialysis as a result of chronic
kidney failure. In March 2004, AnorMED sold the global patent
rights for FOSRENOL to Shire. Under the terms of the agreement
Shire agreed to pay AnorMED U.S.$18 million when FOSRENOL was
approved in the United States and U.S.$7 million when FOSRENOL was
approved in the relevant European countries. This agreement was
also extended to include a U.S.$6 million payment to AnorMED upon
regulatory approval in Japan. In consideration of these payments,
Shire's royalty obligations to AnorMED would cease throughout the
world. To date AnorMED has received U.S.$19 million upon U.S. and
E.U. approvals. In addition to the U.S.$3 million milestone payment
on German approval announced last week and the U.S. $3 million
milestone payment on U.K. approval, the Company is eligible to
receive a further U.S.$6 million payment to AnorMED upon regulatory
approval in Japan. More information and where to find it On
September 5, 2006, AnorMED filed with the United States and
Canadian securities regulatory authorities a Directors' Circular
and Tender Offer Solicitation/Recommendation Statement on Schedule
14D-9 in which AnorMED's Board of Directors recommended that
shareholders reject the September 1, 2006 hostile offer from
Dematal Corp., a wholly-owned subsidiary of Genzyme Corporation.
The Circular describes the reasons for the Board's recommendation
that shareholders reject the Genzyme Offer. Investors and
shareholders are strongly advised to read the Directors' Circular
and Tender Offer Solicitation/Recommendation Statement on Schedule
14D-9, as well as any amendments and supplements to those
documents, because they contain important information. Investors
and shareholders may obtain a copy of the Directors' Circular at
http://www.sedar.com/ and the Tender Offer
Solicitation/Recommendation Statement on Schedule 14D-9 from the
SEC website at http://www.sec.gov/. Free copies of these documents
can also be obtained by directing a request to AnorMED's Secretary
at Suite 200 - 20353 64th Avenue, Langley, British Columbia, Canada
V2Y 1N5; telephone (604) 530-1057. Other reports filed by or
furnished by AnorMED to the SEC and applicable securities
commission in Canada may also be obtained free of charge at
http://www.sec.gov/, http://www.sedar.com/ or from AnorMED's
Secretary. More information about AnorMED is available online at
http://www.anormed.com/. YOU SHOULD READ THE DIRECTORS' CIRCULAR OR
TENDER OFFER SOLICITATION/RECOMMENDATION STATEMENT CAREFULLY BEFORE
MAKING A DECISION CONCERNING THE GENZYME OFFER. About AnorMED Inc.
AnorMED is a chemistry-based biopharmaceutical company focused on
the discovery, development and commercialization of new therapeutic
products in the areas of hematology, oncology and HIV, based on the
Company's research into chemokine receptors. The Company's product
pipeline includes MOZOBIL, currently in pivotal Phase III studies
in cancer patients undergoing stem cell transplants; AMD070,
currently in proof-of-principle Phase I/II studies in HIV patients;
and several novel classes of compounds in pre-clinical development
that target specific chemokine receptors known to be involved in a
variety of diseases. Upcoming product announcements AnorMED expects
to release in the first half of 2007, top-line data from two
pivotal Phase III studies for the use of MOZOBIL in cancer patients
undergoing stem cell transplantation. Based on successful results
of these studies, the Company plans to file a new drug application
("NDA") for marketing approval with the FDA in the second half of
2007 and with Canadian and European regulators in 2008. Additional
data relating to MOZOBIL is expected to be presented at the
American Society of Hematology ("ASH") meeting scheduled to be held
in Orlando, Florida from December 9 to 13, 2006. In the next few
months, the Company also expects to initiate clinical studies for
MOZOBIL for use as a chemosensitizer for treatment of leukemia
patients. In February 2007, the Company expects to present updated
clinical data on the development of AMD070 in HIV patients at the
Conference on Retroviruses and Opportunistic Infections ("CROI")
scheduled to be held in Los Angeles, California. FORWARD-LOOKING
STATEMENTS This news release contains forward-looking statements
within the meaning of the United States Private Securities
Litigation Reform Act of 1995, and forward-looking information
within the meaning of applicable securities laws in Canada,
(collectively referred to as "forward-looking statements").
Statements, other than statements of historical fact, are
forward-looking statements and include, without limitation,
statements regarding the Company's strategy, future operations,
timing and completion of clinical trials, prospects and plans and
objectives of management. The words "anticipates", "believes",
"budgets", "could", "estimates", "expects", "forecasts", "intends",
"may", "might", "plans", "projects", "schedule", "should", "will",
"would" and similar expressions are often intended to identify
forward-looking statements, which include underlying assumptions,
although not all forward-looking statements contain these
identifying words. By their nature, forward-looking statements
involve numerous assumptions, known and unknown risks and
uncertainties, both general and specific, that contribute to the
possibility that the predictions, forecasts, projections and other
things contemplated by the forward-looking statements will not
occur. We caution readers not to place undue reliance on these
statements as a number of important factors could cause our actual
results to differ materially from the beliefs, outlooks, plans,
objectives, expectations, anticipations, estimates and intentions
expressed in such forward-looking statements. Although our
management believes that the expectations represented by such
forward-looking statements are reasonable, there is significant
risk that the forward-looking statements may not be achieved, and
the underlying assumptions thereto will not prove to be accurate.
Forward-looking statements in this news release include, but are
not limited to, statements about: AnorMED's expectation that it
will receive U.S.$6 million in milestone payments from Shire
Pharmaceuticals Group, plc based on the recent licensing approvals
received in Germany and the U.K. by Shire to sell FOSRENOL as a
treatment for high phosphate levels in the blood; AnorMED's
expectation that it is eligible to receive a U.S.$6 million payment
upon regulatory approval in Japan; AnorMED's expected release, in
the first half of 2007, of top-line data and successful results
from two pivotal Phase III studies for the use of MOZOBIL in cancer
patients undergoing stem cell transplantation; AnorMED's plans to
file a NDA for marketing approval with the U.S. FDA in the second
half of 2007, and with Canadian and European regulators in 2008;
AnorMED's expectation that in the next few months it will initiate
clinical studies for MOZOBIL for use as a chemosensitizer for
treatment of leukemia patients; AnorMED's expectation that it can
clinically develop its second product, AMD070, now in Phase I/II
clinical trials in HIV patients; AnorMED's expectation that it will
present additional data relating to MOZOBIL at the ASH meeting to
be held in Orlando, Florida from December 9 to 13, 2006; and
AnorMED's expectation that it will present updated clinical data on
the development of AMD070 in HIV patients at the CROI meeting to be
held in Los Angeles, California in February 2007. With respect to
the forward-looking statements contained in this news release, the
Company has made numerous assumptions regarding, among other
things: AnorMED's ability to collect the U.S.$6 million in
milestone payments from Shire pursuant to the terms of the March
2004 agreement; AnorMED's ability to receive further milestone
payments from Shire upon approvals for FOSRENOL in Japan; AnorMED's
ability to release, in the first half of 2007, top-line data from
its two pivotal Phase III studies for the use of MOZOBIL in cancer
patients undergoing stem cell transplantation; AnorMED's ability to
file a NDA for marketing approval with the U.S. FDA in the second
half of 2007, and with Canadian and European regulators in 2008;
AnorMED's ability to initiate its clinical studies for MOZOBIL for
use as a chemosensitizer for treatment of leukemia patients in the
next few months; AnorMED's ability to clinically develop its second
product, AMD070, now in Phase I/II clinical trials in HIV patients;
AnorMED's ability to present additional data relating to MOZOBIL in
December 2006; and AnorMED's ability to present updated data on the
development of AMD070 in HIV patients in February 2007. The
foregoing list of assumptions is not exhaustive. Actual results or
events could differ materially from the plans, intentions and
expectations expressed or implied in any forward-looking
statements, including the underlying assumptions thereto, as a
result of numerous risks, uncertainties and other factors
including: AnorMED may not be able to collect the U.S.$6 million in
milestone payments from Shire pursuant to the terms of the March
2004 agreement in connection with the recent licensing approvals
received in Germany and the U.K.; FOSRENOL may not be approved in
Japan, and AnorMED may not be eligible to receive further milestone
payments from Shire for FOSRENOL; AnorMED may not have the ability
to release, in the first half of 2007, top-line data from its two
pivotal Phase III studies for the use of MOZOBIL in cancer patients
undergoing stem cell transplantation; AnorMED may not have the
ability to file a NDA for marketing approval with the U.S. FDA in
the second half of 2007, and with Canadian and European regulators
in 2008; AnorMED may not have the ability to initiate its clinical
studies for MOZOBIL for use as a chemosensitizer for treatment of
leukemia patients in the next few months; AnorMED may not have the
ability to clinically develop its second product, AMD070, now in
Phase I/II clinical trials in HIV patients; AnorMED may not have
the ability to present additional data relating to MOZOBIL in
December 2006; AnorMED may not have the ability to present updated
data on the development of AMD070 in HIV patients in February 2007;
AnorMED may not be able to develop and obtain regulatory approval
for MOZOBIL in stem cell transplant indications and any future
product candidates in its targeted indications; AnorMED may not be
able to establish marketing and sales capabilities for launching
MOZOBIL in stem cell transplant indications; the costs of any
future products in AnorMED's targeted indications may be greater
than anticipated; AnorMED relies on third parties for the continued
supply and manufacture of MOZOBIL; AnorMED may face unknown risks
related to intellectual property matters; AnorMED may face
competition from other pharmaceutical or biotechnology companies;
and further equity financing may substantially dilute the interests
of our shareholders. Although we have attempted to identify the
forward-looking statements, the underlying assumptions, and the
risks, uncertainties and other factors that could cause actual
results or events to differ materially from those expressed or
implied in the forward-looking statements, there may be other
factors that cause actual results or events to differ from those
expressed or implied in the forward-looking statements. We
undertake no obligation to revise or update any forward-looking
statements as a result of new information, future events or
otherwise, after the date hereof, except as may be required by law.
CONTACT: Company Contact: Kenneth Galbraith, Chairman and Interim
CEO, Tel: (604) 889-5320; or Kim Nelson, Ph.D., Manager, Investor
Relations, Tel: (604) 532-4654, Cell: (604) 614-2886, Email: ;
Media Contact: Karen Cook, James Hoggan & Associates, Tel:
(604) 739-7500, Email: DATASOURCE: AnorMED Inc. CONTACT: Company
Contact: Kenneth Galbraith, Chairman and Interim CEO, Tel: (604)
889-5320; or Kim Nelson, Ph.D., Manager, Investor Relations, Tel:
(604) 532-4654, Cell: (604) 614-2886, Email: ; Media Contact: Karen
Cook, James Hoggan & Associates, Tel: (604) 739-7500, Email:
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