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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 24, 2008
Pharmion Corporation
(Exact name of Registrant as specified in its charter)
Delaware 000-50447 84-1521333
(State or other jurisdiction of (Commission File Number) (IRS Employer
incorporation) Identification No.)
2525 28th Street, Boulder, Colorado 80301
(Address of principal executive offices) (Zip Code)
720-564-9100
(Registrant's telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the Registrant under any of the
following provisions (see General Instruction A.2 below):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17
CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01 Other Events.
On January 24, 2008, Pharmion Corporation ("Pharmion" or the "Company")
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, aged 65 years or older or ineligible for high dose
chemotherapy. The marketing authorization application 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.
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) 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.
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
in France while the Company seeks an approval. Pharmion is the only provider of
Thalidomide outside of the U.S. 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.
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.
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.
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.
This report 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 EU; 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 EU; 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.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended,
the Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: January 24, 2008 PHARMION CORPORATION
By: /s/ Steven N. Dupont
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Name: Steven N. Dupont
Title: Executive Vice President and
General Counsel