Here are 3 press releases, another one on STEMGEN and a couple from Coulter
showing financials and a stock offering to gear up for Bexxar.
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Thursday July 30, 10:45 pm Eastern Time
U.S. FDA panel backs Amgen's Stemgen
BETHESDA, Md., July 30 (Reuters) - Amgen's latest drug Stemgen (ancestim)
won the backing of federal advisers on Thursday, paving the way to U.S.
Food and Drug Administration (FDA) approval.
The panel agreed that the drug produced enough good cells in patients to
ensure a transplant would work, but said Amgen did not prove its claim that
Stemgen reduced the number of procedures needed to get the cells.
Some panelists were worried about safety.
``You haven't proven there's enough benefit to outweigh the risks of
anaphylaxis,'' said panelist Abby Meyers of the National Organization for
But other panelists recommended approval anyway.
The FDA generally follows its panels' advice.
The drug, also called stem cell factor, helps mobilize young blood cells,
normally found in the marrow, into the bloodstream so they can be more
They are kept outside the body while the patient undergoes high-dose
The cells are then reinfused to give the patient a headstart on rebuilding
immunity. Only about 12,000 of these procedures are done each year, usually
in very sick patients.
Two growth factors, Amgen's Neupogen (filgrastim) and Immunex's Leukine
(GM-CSF), are FDA approved for helping mobilize these early blood cells.
Amgen tested Stemgen in combination with Neupogen, with the goal of
increasing the number of cells available for harvest and improving chances
the re-implanted cells will survive.
In three studies in breast and bone cancer and lymphoma, the combination
produced better results than Neupogen alone, said Amgen. It reduced the
number of procedures (called aphereses) necessary to harvest cells and
increased the number of cells available in a majority of patients.
FDA medical reviewer Richard Steffen said the agency saw no difference.
``We feel that adding SCF to G-CSF has a small but negligible effect on
reducing the number of aphereses to reach the target,'' he said.
The agency had safety concerns, saying 33 of 654 patients studied overall
had ``anaphylactic'' reactions to Stemgen, with 76% of those reactions
Amgen said the reactions were not caused by the same biological mechanism
as anaphylaxis, and said symptoms could be minimized with antihistamine and
other drug treatment.
About 81 percent of patients had reactions at the injection site and 15
percent had mild to moderate allergic reactions including rashes and
itching elsewhere on their bodies.
Friday July 31, 7:59 am Eastern Time
Coulter 2.4 mln shares are priced at $25
PALO ALTO, Calif., July 31 (Reuters) - Coulter Pharmaceutical Inc. said
Friday its public offering of 2.4 million shares was priced at $25 a share.
All of the shares were sold by the company, Coulter said in a statement.
The offering was managed by the investment firms BT Alex. Brown Inc.,
Hambrecht & Quist LLC, Pacific Growth Equities Inc., and Piper Jaffray
Inc., the company said.
Coulter had about 13.4 million shares outstanding at the end of the second
The company anticipates that proceeds of the offering will be used to
support the potential commercialization of Bexxar, including costs
associated with establishing sales and marketing capabilities and
pre-launch inventory in anticipation of potential product launch, as well
as to support clinical and manufacturing development costs.
Bexxar is in Phase III clinical trials for the treatment of non-Hodgkin's
lymphoma, Coulter said.
The balance of the net proceeds of the offering is expected to be used
primarily in the company's other research and development programs and for
general corporate purposes.
Friday July 31, 7:35 am Eastern Time
Company Press Release
Coulter Pharmaceutical Reports Second Quarter Results
PALO ALTO, Calif.--(BW HealthWire)--July 31, 1998--Coulter Pharmaceutical
Inc. (NASDAQ:CLTR - news) today reported a net loss of $8,348,000, or $0.62
per share, for its second quarter ended June 30, 1998, compared to a net
loss of $4,994,000, or $0.50 per share, for the quarter ended June 30, 1997.
The company reported a net loss of $18,613,000, or $1.39 per share, for the
six months ended June 30, 1998. For the same period in 1997, the company
reported a net loss of $8,800,000, or $1.05 per share.
The increase in net loss for both the second quarter and year-to-date 1998
periods was primarily due to an increase in operating expenses to reflect
the company's ongoing support of significant clinical and commercialization
development activities for the potential launch of Bexxar(TM) (iodine I 131
tositumomab), its lead investigational cancer therapy for the treatment of
non-Hodgkin's lymphoma. Cash, cash equivalents and short-term investments
were approximately $56 million at June 30, 1998.
Coulter Pharmaceutical Inc. is engaged in the development of novel drugs
and therapies for the treatment of people with cancer. The company is
developing a family of cancer therapeutics based upon two drug discovery
programs: therapeutic antibodies and targeted oncologics.
The company's most advanced investigational product candidate, Bexxar(TM)
(iodine I 131 tositumomab), consists of a monoclonal antibody conjugated
with a radioisotope. The company is gathering data from a Phase III
investigational trial for the treatment of non-Hodgkin's lymphoma and
intends to file a Biologic License Application for Bexxar by the end of 1998.
The company currently is developing a tumor-activated peptide pro-drug
version of doxorubicin to treat certain solid tumor cancers.
Except for the historical information contained herein, the matters
discussed in this news release are forward-looking statements that involve
risks and uncertainties, including uncertainties related to product
development, uncertainties related to the need for regulatory and other
government approvals, dependence on proprietary technology, uncertainty of
market acceptance of Bexxar(TM) or the company's other product candidates
and other risks detailed from time to time in the company's filings with
the Securities and Exchange Commission (SEC). In particular, see ``Risk
Factors'' in the company's Registration Statement on Form S-3, as amended,
filed with the SEC on July 10, 1998.