Approval of FOSRENOL in Germany triggers U.S.$3 million payment to AnorMED
19 September 2006 - 12:00AM
PR Newswire (US)
VANCOUVER, Sept. 18 /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 Germany 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.
"We are pleased with the further marketing approval granted for
FOSRENOL, which was the first product discovered by AnorMED
approved for marketing," said Paul Brennan, AnorMED's Acting
President and Vice President of Business Development. "Our
productive R&D team continues to be a valuable asset for our
Company and has generated a substantial product pipeline for future
development and commercialization." 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, the Company is eligible to receive a further
U.S.$3 million milestone payment upon the first approval in one of
four additional specified E.U. countries and a 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 a
U.S.$3 million milestone payment from Shire Pharmaceuticals Group,
plc based on the recent licensing approval received in Germany 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
further U.S.$3 million milestone payment from Shire upon the first
approval in one of four additional specified E.U. countries and 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.$3 million milestone payment 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 one of four additional specified E.U. countries and 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.$3
million milestone payment from Shire pursuant to the terms of the
March 2004 agreement; FOSRENOL may not be approved in one of the
four specified E.U. countries and 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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