IDM Pharma Joins NORD to Raise Awareness of Rare Diseases
26 Février 2009 - 2:00PM
PR Newswire (US)
IRVINE, Calif., Feb. 26 /PRNewswire-FirstCall/ -- IDM Pharma, Inc.
(NASDAQ:IDMI) today announced that it is joining the National
Organization for Rare Disorders (NORD) and more than 100 patient
organizations, caregivers, researchers and companies developing
treatments for rare diseases to observe Rare Disease Day on
February 28. The goal of the day is to bring attention to rare
diseases, the challenges encountered by those affected and the
importance of research to develop diagnostics and treatments. IDM
Pharma is currently developing mifamurtide (MEPACT in Europe) for
the treatment of osteosarcoma, a rare bone cancer in children and
young adults. "Osteosarcoma impacts approximately 1,200 newly
diagnosed children and young adults every year in each of the
United States and Europe," said Robert W. Metz, vice president,
commercial operations, IDM Pharma. "Through our participation in
Rare Disease Day, we hope to bring increased attention to the
impact rare diseases -- like osteosarcoma -- have on the lives of
young patients and their families, and help break down the barriers
some patients experience when trying to access proper diagnosis and
treatment." IDM Pharma has developed mifamurtide to treat
non-metastatic, resectable osteosarcoma. The Company is currently
awaiting a final decision on European Marketing Authorization,
anticipated within the first quarter, following the positive
opinion adopted by the Committee for Medicinal Products for Human
Use in December 2008. The submission was based, in part, on the
largest Phase 3 clinical trial ever completed in osteosarcoma,
which enrolled approximately 800 patients and was a National Cancer
Institute (NCI) funded cooperative group study conducted by the
Children's Oncology Group (COG). The study evaluated patient
outcomes with the addition of mifamurtide to three- or four-drug
adjuvant chemotherapy (cisplatin, doxorubicin, and methotrexate,
with or without ifosfamide). Results demonstrated that the addition
of mifamurtide to chemotherapy resulted in approximately a 30
percent decrease in the risk of death with 78 percent of patients
surviving after six years of follow-up after treatment with
mifamurtide. About Osteosarcoma Between two and three percent of
all childhood cancers are osteosarcoma. Because osteosarcoma
usually develops from osteoblasts, it most commonly affects
children and young adults experiencing their adolescent growth
spurt. Boys and girls have a similar incidence rate until later in
their adolescence, when boys are more commonly affected. While most
tumors occur in larger bones, such as the femur, tibia, and
humerus, and in the area of the bone that has the fastest growth
rate, they can occur in any bone. The most common symptom is pain,
but swelling and limited movement can occur as the tumor grows.
Osteosarcoma is an orphan disease with approximately 1,200 new
cases diagnosed in the United States each year. A similar incidence
of the disease exists in Europe. According to the Children's
Oncology Group (COG), the survival of children with osteosarcoma
has remained at 60-65 percent since the mid-1980s. The standard
treatment for osteosarcoma is tumor resection with combination
chemotherapy before and after surgery. About Rare Disease Day
Started in 2008 in Europe, this is the first year that Rare Disease
Day is being observed in the United States, making it a global
activity. The main objective of Rare Disease Day 2009 is to raise
awareness with policy makers and the public of rare diseases and of
their impact on patients' lives. For additional information on the
day, please visit http://www.rarediseases.org/. Mifamurtide U.S.
Regulatory Status As previously announced, in the United States,
the Company continues to work with the COG as well as external
experts and advisors to gather patient follow up data from the
Phase 3 clinical trial of mifamurtide and to respond to other
questions in the non-approvable letter the Company received from
the U.S. Food and Drug Administration (FDA). The Company plans to
submit an amended New Drug Application (NDA) for mifamurtide in
mid-2009 and expects to be in a position to provide an update on
the progress of the filing, including timing, following a meeting
scheduled with the FDA in March. Mifamurtide was granted orphan
drug status in the United States in 2001. The NDA was submitted to
FDA in October 2006 and was accepted for review in December 2006.
About IDM Pharma IDM Pharma is focused on the development of
innovative cancer products that either destroy cancer cells by
activating the immune system or prevent tumor recurrence by
triggering a specific adaptive immune response. IDM Pharma is
dedicated to maximizing the full therapeutic and commercial
potential of its innovative products to address the needs of
patients and the physicians who treat these patients. The Company
believes it has adequate cash resources to support its operations
through the first half of 2009 based on its current development and
operating plans. The Company does not currently have operational
sales and marketing infrastructure for mifamurtide and does not
currently have plans or sufficient funds to secure this capability.
The Company continues to evaluate strategic alternatives, which may
include seeking strategic partners, a merger and/or the sale of all
or part of its operations and assets, or raising additional capital
to secure operational sales and marketing infrastructure for
mifamurtide. For more information about the company and its
products, visit http://www.idm-pharma.com/. Forward-Looking
Statements This press release includes forward-looking statements
that reflect management's current views of future events including
statements regarding the timeframe in which the Company's cash will
be sufficient to meet planned operations, the Company's plans to
collect, analyze and submit additional Phase 3 data and to respond
to other matters raised by the FDA in an amended NDA for
mifamurtide, including the expected timing for submission of the
amended NDA, and the Company's plans to evaluate strategic
alternatives. Actual results may differ materially from the
forward-looking statements due to a number of important factors,
including, but not limited to, the timing of filing an amended NDA
with the FDA, the possibility that additional data from the Phase 3
clinical trial of mifamurtide and other information in any
amendment to the NDA for mifamurtide submitted by the Company may
not provide adequate support for regulatory approval of mifamurtide
in the U.S. within the timeframe expected by the Company, if at
all, whether the Company will be able to complete any potential
strategic transaction on terms acceptable to the Company's
stockholders, how the volatile economic environment will affect the
Company's efforts to complete a strategic transaction, and whether
the cash resources of the Company will be sufficient to fund
operations as planned. These and other risks affecting the Company
and its drug development programs, intellectual property rights,
personnel and business are more fully discussed in the Company's
Quarterly Report on Form 10-Q filed with the SEC for the quarter
ended September 30, 2008 and other periodic reports filed with the
SEC. The Company expressly disclaims any intent or obligation to
update these forward-looking statements, except as required by law.
DATASOURCE: IDM Pharma, Inc. CONTACT: Bob De Vaere, Chief Financial
Officer of IDM Pharma, Inc., +1-949-470-6447; or Molly Rabinovitz
of WeissComm Partners, +1-312-646-6294, , for IDM Pharma, Inc. Web
site: http://www.idm-pharma.com/ http://www.rarediseases.org/
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