Reiterates 2008 Annual Financial Guidance
DUBLIN, Calif., July 1 /PRNewswire-FirstCall/ -- SuperGen Inc. (Nasdaq:
SUPG), a pharmaceutical company dedicated to the discovery, rapid
development and commercialization of therapies for solid tumors and
hematological malignancies, today commented on the preliminary efficacy
data from a trial, initiated in 2002, comparing Dacogen(R) (decitabine) for
Injection to best supportive care (BSC) in elderly patients with
myelodysplastic syndromes (MDS). The data did not demonstrate a
statistically significant advantage of Dacogen treatment on median survival
compared to BSC, the primary endpoint of the study. However, response rates
were similar to those observed in other clinical trials of Dacogen in
patients with MDS. The trial, conducted by the European Organisation for
Research and Treatment of Cancer (EORTC), administered Dacogen on a
three-day dosing schedule in which the number of treatment cycles was
limited. MDS is a potentially life-threatening group of bone marrow
diseases that limit the production of functional blood cells.
Subsequent to database lock and the completion of data analysis,
comprehensive results of the study, including secondary efficacy endpoints
and safety data, will be presented by EORTC at an upcoming scientific
forum.
2008 Annual Financial Guidance Update
The Company reiterates its 2008 annual financial guidance provided
during the 2008 first quarter financial conference call on April 28, 2008.
As indicated in the 2008 first quarter financial conference call, the
Company expects to report royalty revenue for 2008 in a range from $32
million to $35 million. Also, the Company continues to estimate a loss from
operations for 2008 in a range from $17 million to $19 million.
The Company's financial position at March 31, 2008 included
approximately $91 million in unrestricted cash, cash equivalents and
marketable securities and no debt.
Study Design
This Phase 3 open-label, randomized, multicenter, controlled trial
evaluated overall survival of patients receiving Dacogen plus BSC versus
BSC only. The study involved 233 elderly patients, greater than or equal to
60 years of age, with predominantly high-risk or Intermediate-2 type MDS.
Patients included in the trial had primary or secondary MDS, with or
without previous therapy with growth factors, immunosuppressive agents or
hydroxyurea. In order to participate in the study, patients had to have
bone marrow blast counts between 11 and 30 percent. Patients with blast
counts below 10 percent were required to have had poor prognosis
cytogenetics in order to be eligible for randomization.
About MDS
Myelodysplastic syndromes, or MDS, is a bone marrow disorder
characterized by the production of poorly functioning and immature blood
cells. People with MDS may experience a variety of symptoms and
complications, including anemia, bleeding, infection, fatigue and weakness.
Those patients with high-risk MDS may experience bone marrow failure, which
may lead to death from bleeding and infection. Over time, MDS can progress
to acute myelogenous leukemia (AML). The Aplastic Anemia and MDS
International Foundation currently estimates that up to 30,000 new cases of
MDS are diagnosed annually in the Unites States.
About Dacogen(R)
Dacogen(R) (decitabine) for Injection was developed through a pivotal
Phase 3 study by SuperGen and partnered to MGI PHARMA, INC. (acquired by
Eisai Co., Ltd.). MGI PHARMA subsequently sublicensed all Dacogen rights
outside of North America to Janssen-Cilag, a Johnson & Johnson Company.
Dacogen was approved by the U.S. Food and Drug Administration on May 2,
2006 and is indicated for the treatment of patients with MDS, including
previously treated and untreated, de novo and secondary MDS of all
French-American-British (FAB) subtypes (refractory anemia, refractory
anemia with rings sideroblasts, refractory anemia with excess blasts,
refractory anemia with excess blasts in transformation, chronic
myelomonocytic leukemia), and Intermediate-1, Intermediate-2, and High-Risk
International Prognostic Scoring System (IPSS) groups.
Ongoing Clinical Studies
Eisai Inc. is conducting a series of clinical trials in the service of
Dacogen's development to further understand the optimal treatment for MDS
and related conditions. Currently, more than 30 clinical studies of Dacogen
are being conducted, including a Phase 3 pivotal trial to evaluate Dacogen
in patients with AML.
About SuperGen
Based in Dublin, Calif., SuperGen, Inc. is a pharmaceutical company
dedicated to the discovery, rapid development and commercialization of
therapies for solid tumors and hematological malignancies. SuperGen is
developing a number of therapeutic anticancer products focused on kinase
and cell signaling inhibitors and DNA methyltransferase inhibitors. For
more information about SuperGen, please visit http://www.supergen.com.
About Eisai Inc.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a
research-based human health care company that discovers, develops and
markets products throughout the world. Eisai focuses its efforts in three
therapeutic areas: neurology, gastrointestinal disorders and
oncology/critical care. Established in 1995 and ranked among the top-20
U.S. pharmaceutical companies (based on retail sales), Eisai Inc. began
marketing its first product in the United States in 1997 and has rapidly
grown to become an integrated pharmaceutical business with fiscal year 2007
(year ended March 31, 2008) sales of approximately $3 billion, including
the results of the acquisition of MGI PHARMA. For more information about
Eisai, please visit http://www.eisai.com.
Forward-Looking Statements
This news release contains certain "forward-looking" statements within
the meaning of the Private Securities Litigation Reform Act of 1995. These
statements are typically preceded by words such as "believes," "expects,"
"anticipates," "intends," "will," "may," "should," or similar expressions,
and include statements regarding our financial guidance, our expected
operating loss and royalty revenue for 2008. These forward-looking
statements are not guarantees of future performance and involve a number of
risks and uncertainties that may cause actual results to differ materially
from the results discussed in these statements. Factors that might cause
the company's results to differ materially from those expressed or implied
by such forward- looking statements include, but are not limited to, the
ability to discover, develop and move target compounds into clinical
development, the results of clinical trials, decreases in our royalty
revenue or increases in our operating costs and other risks and
uncertainties detailed from time to time in the Company's filings with the
Securities and Exchange Commission including its most recently filed Form
10-Q and 10-K. SuperGen, Inc. undertakes no duty to update any of these
forward-looking statements to conform them to actual results.
Contacts:
Timothy L. Enns
SuperGen, Inc.
SVP, Corporate Communications & Business Development
Tel: (925) 560-0100
E-mail: tenns@supergen.com
Mary M. Vegh
SuperGen, Inc.
Manager, Investor Relations
Tel: (925) 560-2845
E-mail: mary.vegh@supergen.com
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