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Thalidomide Pharmion(R) Receives Positive Opinion For Treatment Of First-line Multiple Myeloma From European Medicines Agency
Pharmion Corporation
(Nasdaq: PHRM) announced that the European Medicines Agency (EMEA)
has issued a positive opinion to recommend approval of Thalidomide
Pharmion(R) for use in combination with melphalan and prednisone as first
line treatment for patients with untreated multiple myeloma (MM), aged 65
years or older or ineligible for high dose chemotherapy. The marketing
authorization application (MAA) for Thalidomide Pharmion was submitted to
the EMEA in January 2007.
The EMEA's Committee for Medicinal Products for Human Use (CHMP)
reviewed the application, and its positive opinion will be forwarded to the
European Commission (EC), which generally follows, but is not obligated to
follow, the recommendation of the CHMP, and issues final marketing approval
within two to three months. Once ratified by the EC, a single marketing
authorization would be granted to Pharmion to market Thalidomide Pharmion
for first line multiple myeloma in the 27 member states of the European
Union (EU) as well as Norway and Iceland.
"We are very pleased with this recommendation by the EMEA for the
approval of Thalidomide in the treatment of first line multiple myeloma,
and clearly appreciate that the return of Thalidomide to Europe as an
approved therapy represents a significant step toward the safe distribution
of this important and widely used drug for patients with multiple myeloma,"
said Patrick J. Mahaffy, Pharmion's president and chief executive officer.
"This has been a long and complex process and I would like to thank all of
the participants in the dialogue that has led to this recommendation by the
EMEA, which include European thalidomide groups, patient organizations, the
hematology community and the employees of Pharmion who made this happen. We
have been and will remain committed to managing Thalidomide with the
respect that its history requires."
The Marketing Authorization Application reviewed by the EMEA is based
upon a clinical data package comprised of studies of nearly 1400 patients
in total, including the Intergroupe Francophone du Myelome (IFM) 99-06
survival study. The three-arm study conducted by IFM demonstrated the
superiority of melphalan/prednisone plus Thalidomide (MPT) over standard
therapy of melphalan/prednisone (MP) or a combination of chemotherapies
(vincristine/adriamycin/dexamethasone (VAD)) followed by melphalan and
transplantation (MEL 100) in the treatment of newly diagnosed multiple
myeloma patients, aged 65 to 75 who were ineligible for intensive bone
marrow transplantation. A total of 447 patients were randomized to one of
the three treatment arms. At final analysis, the overall median survival in
the MPT arm was 51.6 months, compared to 33.2 and 38.3 months,
respectively, for the MP and MEL 100 arms. The hazard ratios were 0.59 and
0.69, respectively. Thalidomide treatment was generally well-tolerated by
the majority of patients. The most frequently reported adverse events
associated with MPT included neutropenia, somnolence and constipation. The
Thalidomide combination was also associated with a 5-10% greater risk of
Grade 3 and 4 venous thromboembolism and peripheral neuropathy.
"Our study results demonstrate the profound impact on overall survival
that the addition of Thalidomide to the standard of care can provide to
patients with untreated multiple myeloma," said Professor Philippe Moreau,
Professor of Clinical Hematology at Nantes Faculty of Medicine and Chairman
of the Intergroupe Francophone du Myelome. "This recommendation recognizes
the importance of the study results, opens drug access to all physicians
and patients in Europe and provides great hope for patients with this
devastating disease."
Multiple myeloma, the second most common cancer of the blood, affects
approximately 82,000 people in the EU, and approximately 25,000 people in
the EU are diagnosed with multiple myeloma each year.
Thalidomide Pharmion has been designated as an Orphan Medicinal Product
in the EU for the treatment of multiple myeloma, which, if approved,
entitles the drug to ten years of market exclusivity for the approved
indications.
Thalidomide Pharmion must be prescribed and dispensed through the
Thalidomide Pharmion Pregnancy Prevention Programme, a risk management plan
that includes a number of actions intended to prevent pregnancies in women
being treated with thalidomide and exposure of unborn children to the
medicine. Treatment with Thalidomide Pharmion, only available by
prescription, will be initiated and monitored by a doctor who has
experience in the treatment of multiple myeloma. A clear warning will be
printed on the boxes containing the medicine, indicating that Thalidomide
Pharmion causes birth defects and fetal death. Prior to the launch of
Thalidomide Pharmion, Pharmion will provide healthcare professionals and
patients with educational materials about the treatment-related risks and
the precautions required to ensure the safe use of the product.
Thalidomide Pharmion is approved in Australia, New Zealand, Turkey,
Israel, South Korea, Thailand and South Africa for the treatment of
multiple myeloma after the failure of standard therapies.
Thalidomide is currently provided by Pharmion on a named
patient/compassionate use basis in most of the EU and under an Autorisation
Temporaire d'Utilisation (ATU) in France while the Company seeks an
approval. Pharmion is the only provider of Thalidomide outside of the US
with a comprehensive safety program in place.
The Company holds exclusive marketing and distribution rights from
Celgene Corporation for Thalidomide in markets outside of North America,
Japan and certain other Asian countries.
Safety Information
Thalidomide Pharmion warning:
Teratogenic effects.
Thalidomide is a powerful human teratogen, inducing a high frequency of
severe and life threatening birth defects. Thalidomide must never be used
by women who are pregnant or could become pregnant. The conditions of the
Thalidomide Pharmion Pregnancy Prevention Programme must be fulfilled for
all male and female patients
The common adverse reactions associated with the use of Thalidomide in
combination with other anti-myeloma therapies are: deep vein thrombosis,
constipation, peripheral oedema, tremor, dizziness, fatigue, asthenia,
somnolence, peripheral neuropathy, neutropenia, lymphopenia, leucopenia,
anaemia, thrombocytopenia, paraesthesia and dysaesthesia. Serious or severe
reactions associated with Thalidomide use are: deep vein thrombosis and
pulmonary embolism, bradycardia, cerebrovascular accident, peritonitis,
orthostatic hypotension, and severe skin reactions including Stevens
Johnson Syndrome and toxic epidermal necrolysis. Thromboprophylaxis should
be used when Thalidomide is prescribed in combination with other
anti-myeloma therapies. Peripheral neuropathy is a potentially severe,
adverse effect of treatment with Thalidomide that may result in
irreversible damage. Thalidomide may also potentially aggravate existing
neuropathy and should therefore not be used in patients with clinical signs
or symptoms of peripheral neuropathy unless the clinical benefits outweigh
the risks. Symptoms may occur some time after thalidomide treatment has
been stopped and may resolve slowly or not at all. Thalidomide frequently
causes drowsiness, somnolence and sedation. Patients should be instructed
to avoid situations where drowsiness may be a problem.
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a
cancer of the blood in which malignant plasma cells are overproduced in the
bone marrow. Plasma cells are white blood cells that help produce
antibodies called immunoglobulins that fight infection and disease.
However, most patients with multiple myeloma have cells that produce a form
of immunoglobulin called paraprotein (or M protein) that does not benefit
the body. In addition, the malignant plasma cells replace normal plasma
cells and other white blood cells important to the immune system. Multiple
myeloma cells can also attach to other tissues of the body, such as bone,
and produce tumors. The cause of the disease is unknown.
About Pharmion
Pharmion is a leading global oncology company uniquely focused on
acquiring, developing and commercializing innovative products for the
treatment of hematology and oncology patients in the U.S., Europe and
additional international markets. Pharmion has a number of products on the
market including the world's first approved epigenetic drug, Vidaza(R), a
DNA demethylating agent. For additional information about Pharmion, please
visit the company's website at http://www.pharmion.com.
References
1. Facon Thierry, et al. Superiority of Melphalan and Prednisone
chemotherapy plus Thalidomide over Melphalan and Prednisone alone or
reduced-intensity autologous stem cell transplantation in elderly
patients with multiple myeloma: Results of a randomised IFM trial. The
Lancet Vol 370 October 6, 2007, pp 1209-1217
Safe Harbor Statement under the Private Securities Litigation Reform
Act of 1995: This release contains forward-looking statements, which
express the current beliefs and expectations of management. Such statements
are based on current expectations and involve a number of known and unknown
risks and uncertainties that could cause Pharmion's future results,
performance or achievements to differ significantly from the results,
performance or achievements expressed or implied by such forward-looking
statements. Important factors that could cause or contribute to such
differences include the regulatory status and timing of regulatory
approvals for Thalidomide Pharmion; the impact of competition from other
products sold by Pharmion's competitors in the E.U.; the regulatory
environment and changes in the health policies and structure of various
countries; acceptance and demand for new pharmaceutical products and new
therapies, uncertainties regarding Pharmion's ability to enforce market
exclusivities in member states of the E.U.; failure of third-party
manufacturers to produce the product volumes required on a timely basis,
fluctuations in currency exchange rates, and other factors that are
discussed in Pharmion's filings with the U.S. Securities and Exchange
Commission. Forward-looking statements speak only as of the date on which
they are made, and Pharmion undertakes no obligation to update publicly or
revise any forward-looking statement, whether as a result of new
information, future developments or otherwise.
Pharmion Corporation
http://www.pharmion.com
Thalidomide Pharmion (R) primeºte aviz pozitiv pentru tratamentul de primã linie, mielom multiplu de la Agenþia Europeanã a Medicamentului - Thalidomide Pharmion(R) Receives Positive Opinion For Treatment Of First-line Multiple Myeloma From European Medicines Agency - articole medicale engleza - startsanatate