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This excerpt taken from the BIIB 10-K filed Feb 6, 2009. ZEVALIN
In 2008, 2007, and 2006 sales of ZEVALIN were $4.8 million,
$16.9 million, and $17.8 million, respectively. The
decrease in total ZEVALIN sales in 2008 as compared to 2007 is
primarily due to the sale of the rights to market, sell,
manufacture, and develop ZEVALIN in the U.S. to CTI during
the fourth quarter of 2007. Beginning in 2008, ZEVALIN product
revenue consists only of ZEVALIN sales to Schering AG.
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This excerpt taken from the BIIB 10-Q filed Oct 21, 2008. ZEVALIN
In the three months ended September 30, 2008, compared to
the three months ended September 30, 2007, sales of ZEVALIN
decreased from $4.4 million to $2.5 million, due to
the sale of the rights to market, sell, manufacture and develop
ZEVALIN in the U.S. to CTI during the fourth quarter of
2007.
In the nine months ended September 30, 2008, compared to
the nine months ended September 30, 2007, sales of ZEVALIN
decreased from $14.2 million to $5.0 million,
primarily due to the sale of the rights to market, sell,
manufacture and develop ZEVALIN in the U.S. to CTI during
the fourth quarter of 2007.
This excerpt taken from the BIIB 10-Q filed Jul 22, 2008. ZEVALIN
In the three months ended June 30, 2008, compared to the
three months ended June 30, 2007, sales of ZEVALIN
decreased from $4.3 million to zero, due to the sale of the
rights to market, sell, manufacture and develop ZEVALIN in the
U.S. to CTI during the fourth quarter of 2007.
In the six months ended June 30, 2008, compared to the
three months ended June 30, 2007, sales of ZEVALIN
decreased from $9.9 million to $2.5 million, primarily
due to the sale of the rights to market, sell, manufacture and
develop ZEVALIN in the U.S. to CTI during the fourth
quarter of 2007.
This excerpt taken from the BIIB 10-Q filed Apr 23, 2008. ZEVALIN
In the three months ended March 31, 2008, compared to the
three months ended March 31, 2007, sales of ZEVALIN
decreased from $5.6 million to $2.4 million, primarily
due to the sale of the rights to market, sell, manufacture and
develop ZEVALIN in the United States to CTI during the fourth
quarter of 2007.
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This excerpt taken from the BIIB 10-K filed Feb 14, 2008. Zevalin
In December 2007, we sold the U.S. marketing, sales,
manufacturing and development rights of ZEVALIN to Cell
Therapeutics, Inc., or CTI, for an upfront purchase price of
$10.0 million and up to an additional $20.0 million in
milestone payments. In addition, we also will receive royalty
payments on future sales of ZEVALIN. As part of the overall
arrangement, we have entered into a contract with CTI to supply
ZEVALIN product through 2014 and a related services and security
agreement under which CTI has agreed to reimburse us for costs
incurred in an ongoing randomized clinical trial for ZEVALIN
with respect to aggressive non-Hodgkin’s lymphoma. The
$10.0 million upfront payment will be recognized in our
results of operations over the term of the supply agreement.
This excerpt taken from the BIIB 10-Q filed Oct 23, 2007. ZEVALIN
In the three months ended September 30, 2007, compared to
the three months ended September 30, 2006, sales of ZEVALIN
were unchanged. In the nine months ended September 30,
2007, compared to the nine months ended September 30, 2006,
sales of ZEVALIN increased 2.2%, due to higher international
sales offset by lower domestic sales. In August 2007 we entered
into an agreement to sell the rights to market, sell,
manufacture and develop ZEVALIN in the United States to CTI. We
expect this agreement to close in the fourth quarter of 2007.
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This excerpt taken from the BIIB 10-Q filed Jul 24, 2007. ZEVALIN
In the three months ended June 30, 2007, compared to the
three months ended June 30, 2006, sales of ZEVALIN
decreased 2.3%, due to lower domestic sales offset by higher
international sales. In the six months ended June 30, 2007,
compared to the six months ended June 30, 2006, sales of
ZEVALIN increased 4.2%, due to higher
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international sales offset by lower domestic sales. We expect
future domestic sales of ZEVALIN to decline due to decreased
commercial effort as a result of our planned divestiture of this
product line.
This excerpt taken from the BIIB 10-Q filed May 3, 2007. ZEVALIN
For the three months ended March 31, 2007, compared to the
three months ended March 31, 2006, the cost of product
revenue for ZEVALIN increased $2.5 million, or 114.0%, due,
principally, to the increased write-off of unmarketable
inventory.
This excerpt taken from the BIIB 10-K filed Feb 21, 2007. ZEVALIN
For 2006 compared to 2005, cost of product revenue for ZEVALIN
decreased $6.7 million, or 29.2%, due, principally, to the
impairment of certain capitalized patents in 2005 and decline in
sales volumes. For 2005 compared to 2004, cost of product
revenue for ZEVALIN increased $3.8 million, or 20.0%, due
to inventory write-offs and impairments.
This excerpt taken from the BIIB 10-K filed Mar 3, 2006. ZEVALIN
The ZEVALIN therapeutic regimen, which features ZEVALIN, is a
radioimmunotherapy that is approved for the treatment of
patients with relapsed or refractory low-grade, follicular, or
transformed B-cell NHL, including patients with RITUXAN relapsed
or refractory non-Hodgkin’s lymphoma. In 2005, sales of
ZEVALIN in the U.S. generated revenues of
$19.4 million as compared to revenues of $18.7 million
in 2004. ZEVALIN is approved in the EU for the treatment of
adult patients with CD20¡ follicular B-cell NHL who are
refractory to or have relapsed following RITUXAN therapy. We
sell ZEVALIN to Schering AG for distribution in the EU, and
receive royalty revenues from Schering AG on sales of ZEVALIN in
the EU. Rest of world product sales for ZEVALIN in 2005 were
$1.4 million as compared to $4.3 million in 2004. The
$4.3 million rest of world product sales in 2004 relates to
ZEVALIN sold to Schering AG in 2003 and 2004, recognition of
which had been deferred.
Radiation therapy plays an important role in the management of
B-cell lymphomas due to the sensitivity of
B-cell
tumors to radiation. Traditional radiation therapy consists of
an external beam of radiation focused on isolated areas of the
body or areas with high tumor burden. The ZEVALIN therapeutic
regimen combines a monoclonal antibody with a radioisotope.
Following intravenous infusion, the monoclonal antibody
recognizes and attaches to the CD20 antigen. This allows ZEVALIN
to specifically target B-cells, destroying the malignant NHL
B-cells and also normal B-cells.
ZEVALIN therapy consists of two kits: an imaging kit for
use with indium-111 and a therapeutic kit for use with
yttrium-90. The ZEVALIN therapeutic regimen can be completed on
an outpatient basis in approximately seven to nine days and
includes:
We are working with third party investigators to expand the
quality and quantity of data available about ZEVALIN. ZEVALIN is
being investigated in a variety of lymphoma subtypes including
diffuse B cell lymphoma, mantle cell lymphoma and follicular
non-Hodgkins’ lymphoma. ZEVALIN is also being studied in a
number of different treatment strategies including combinations
with front-line and salvage chemotherapy regimens as part of
autologous and allogeneic stem cell transplantation in both
indolent and aggressive lymphoma subtypes and in combination
with investigational agents.
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