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IDM Pharma Provides Update On Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting Of European Committee For Medicinal Products
IDM Pharma, Inc.
(Nasdaq: IDMI) announced that it met with representatives of the
Committee for Medicinal Products for Human Use (CHMP) and Secretariat of
the European Medicines Agency (EMEA) on September 25th, following the
CHMP's September meeting where CHMP considered the Company's Marketing
Authorization Application (MAA) for mifamurtide (L-MTP-PE) for the
treatment of patients with non-metastatic, resectable osteosarcoma, a rare
and often fatal bone tumor that typically affects children and young
adults.
Based on discussions at that meeting, the Company has been invited to
present to the CHMP Scientific Advisory Group on Oncology (SAG-O) and to
the CHMP to review and address the remaining open issues in its MAA for
L-MTP-PE. These meetings are scheduled to take place in November. The SAG-O
is regularly convened at the request of the CHMP to provide independent
advice on scientific/technical matters relating to oncology products under
evaluation by the CHMP, or on any other scientific issue relevant to the
work of the CHMP that relates to this area. The Company will provide SAG-O
and CHMP information to address the remaining open issues in advance of
these meetings.
"The European review of L-MTP-PE continues to progress," said Timothy
P. Walbert, president and chief executive officer, IDM Pharma. "We are
pleased to report that, in response to the comprehensive information we
submitted in advance of the September CHMP meeting, the CHMP has determined
that the Children's Oncology Group's (COG) Phase 3 trial is compliant with
Good Clinical Practices (GCP) and that the database from this pivotal study
can be reliably used in the evaluation process of the MAA. We also received
feedback from the CHMP that there are no major objections remaining related
to chemistry, manufacturing and controls (CMC)."
Mr. Walbert continued, "While we have satisfactorily addressed issues
related to the positive benefit/risk assessment reached at the oral
explanation meeting with the CHMP in January 2008, we have been invited by
the CHMP to meet with SAG-O and CHMP in November to address certain open
issues arising from the assessment by the Rapporteur and Co-Rapporteur. We
welcome the opportunity to present to both the SAG-O and CHMP to complete
the L-MTP-PE MAA review and we remain confident that L-MTP-PE provides a
significant overall survival benefit for osteosarcoma patients and meets an
important unmet treatment need."
With the final CHMP opinion now anticipated in November, IDM Pharma
expects a final decision from the European Commission in the first quarter
of 2009. If approved for Marketing Authorization by the European
Commission, L-MTP-PE will be the first treatment in more than 20 years
approved for patients with osteosarcoma.
In January 2008, the Company announced that, following presentation of
data at an oral explanation hearing, the CHMP determined in a non-binding
opinion that L-MTP-PE suggested a possible clinical benefit in terms of
survival and granted the Company a clock-stop, or time extension to allow
IDM Pharma additional time to respond to questions regarding the MAA. At
that time, the CHMP requested clarification of the existing data in order
to gain assurance about the quality of the data before drawing any final
conclusions from the data presented. In addition, the Company was required
to address a number of remaining questions relating to CMC.
In April 2008, the European regulatory authorities conducted an
inspection of the COG to assess the quality of the overall survival data
from the 2006 confirmatory database included in the Company's applications
for regulatory approval, and to review GCP compliance of the COG in terms
of patient randomization and stratification, overall survival data
collection, and study monitoring. The Company supported the COG in this
effort.
Following the satisfactory GCP inspection in April and the June CHMP
meeting, the CHMP requested that the Company provide additional data
analyses from the Phase 3 L-MTP-PE trial (INT-0133), in addition to
responding to the remaining CMC questions. The Company provided this
information in accordance with the timeline for preliminary consideration
by the CHMP at its plenary meeting in September and will respond to open
questions ahead of the November SAG-O and CHMP oral explanation hearings.
L-MTP-PE was granted orphan drug status in Europe in 2004. The MAA for
L-MTP-PE was submitted to the EMEA and accepted for regulatory review in
November 2006.
L-MTP-PE 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 L-MTP-PE trial 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 expects to submit the
amended New Drug Application (NDA) in the fourth quarter of 2008.
L-MTP-PE 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. The non-approvable letter was received in August 2007.
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 fewer than 1,000 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, 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 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 each of its innovative products to address the needs of
patients and the physicians who treat these patients.
As previously announced, the Company is evaluating the Company's
research and development programs, including related assets and costs, and
strategic alternatives available to the Company.
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 the Company's belief
that the data from the L-MTP-PE Phase 3 study warrants regulatory approval
in Europe and the United States, the Company's plans to address the
remaining questions with respect to the MAA for L-MTP-PE, including the
Company's plans for completion of data analysis and submission of responses
to the CHMP, the expected timing of a final opinion from the CHMP and
receipt of a final regulatory decision regarding the MAA in the European
Union, as well as the Company's plans to collect, analyze and submit
additional Phase 3 data in an amended NDA for L-MTP-PE, including the
expected timing for such amended NDA, and to respond to other matters
raised by the FDA 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 Company's planned presentation to the CHMP Scientific Advisory
Group on Oncology and the effect of input of that group on the opinion of
the CHMP, whether the European Commission will follow the final opinion of
the CHMP, whether the timing for the final regulatory decision in Europe
will occur as expected by the Company, the possibility that additional data
from the Phase 3 clinical trial of L-MTP-PE and other information in any
amendment to the NDA for L-MTP-PE submitted by the Company may not provide
adequate support for regulatory approval of L-MTP-PE in the United States
within the timeframe expected by the Company, if at all, whether the
Company will be able to manufacture and commercialize L-MTP-PE even if it
is approved by regulatory authorities, whether the Company will be able to
complete any potential strategic transaction on terms acceptable to the
Company's stockholders, 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 June 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.
IDM Pharma, Inc.
http://www.idm-pharma.com
IDM Pharma Oferã Update La Mifamurtide (L-MTP-PE) de reglementare Status septembrie Dupã reuniune a Comitetul European pentru Produse Medicale - IDM Pharma Provides Update On Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting Of European Committee For Medicinal Products - articole medicale engleza - startsanatate