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How bout a WAR Party this spring boys?
FART gonna run tomoorrow. LOL
Ahhh really now. Is edig ready to move up again> Or is this pos absoloutely finished? Oledie but goodie? Or just plain chit?
WAR
What we at I hub need is a real live WAR Party. Ummmm naw. Wife would never permit it. >LOL
Evo, just thought I'd check the thread before I walk out the door. Bummer. Step away from the puter. Call it a day man. take care of the head and go sit in the sun. Relax man.
WAR
FFFOOOOOOOOOOUUUUUUUUURRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRRR
Later boys and gurls. Orders have been set and it's time for some golf. Have fun
WAR
IVAN from last week. LOL. A ready to goooo I think.
LMAOROTF!!! Everyone sittin back waiting for GERN to break below 6.35 before they jump on it. LOL. 6.33 is the entry.
Gonna short FHRX in the am momo.
WAR
Gern under 6.33/fcel a short if it tags 11.12
dann fly wants to die in a real bad way I guess.
About to go midevil on this farkin fly in my office. Driving me nuts.
EVO: Don't give up. Here's a freebie. PXLW. Wink wink. Do check the charts on it before doing anything.
Wink wink,
WAR
Parole officer sez no go for ole warhorse. I fold.
LOL. WAE
LRCX. This one pays the bills. Gern also looking decent. Could be a slow climb over 8.00 this week.
WAR
PROX: This one has to break over 1.00 soon.
WAR
New here. This one is probably better suited for this thread. FCEl could breakout this week on this news and renewed interest.
(COMTEX) B: FuelCell Energy Receives New Direct FuelCell(R) Component Orde
from MTU CFC Solutions GmbH for 3 Sub-Megawatt Carbo
B: FuelCell Energy Receives New Direct FuelCell(R) Component Order from MTU CFC
olutions GmbH for 3 Sub-Megawatt Carbonate Fuel Cell Power Plants - MTU Commence
Operation of First European Dual Fuel Carbonate Power Plant at Berlin-based Uti
ity Vattenfall/BeWag - RWE Fuel Cells GmbH To Install First European Digester Ga
-Fueled Carbonate Fuel Cell Power Plant at Municipal Wastewater Treatment Facili
y in the City of Ahlen, Germany ( PRNewswire-FirstCall )
DANBURY, Conn., Oct 4, 2004 /PRNewswire-FirstCall via COMTEX/ -- FuelCell
Energy, Inc. (Nasdaq: FCEL) announced today that its European strategic partner,
MTU CFC Solutions, GmbH (a subsidiary of DaimlerChrysler), placed a new order
for the Company's Direct FuelCell(R) (DFC(R)) components for 3 new sub-megawatt
carbonate fuel cell power plants. Delivery is expected in late calendar year
2004 and early calendar year 2005. Announcements of individual power plant sites
utilizing these DFC stacks will be forthcoming, with each customer's request and
authorization.
MTU's branded carbonate fuel cell power plant, the HotModule(R), is based on
FuelCell Energy's Direct FuelCell technology and utilize fuel cells manufactured
by FuelCell Energy's Connecticut manufacturing facility. MTU is currently
operating eight Hot Modules in Germany and Spain, and two additional German
units completed their field trial programs.
"MTU CFC Solutions continues to demonstrate success by operating flexible high
temperature carbonate fuel cell power plants at European customer sites," said
Jerry D. Leitman, Chairman and CEO of FuelCell Energy. "This new order from MTU,
plus the additional siting announcements announced by MTU and its strategic
partner, RWE Fuel Cells, is evidence of a growing interest in clean and
efficient onsite power for commercial and industrial customers."
On September 30, 2004, MTU commenced operation of Europe's first dual fuel
250-kilowatt (kW) carbonate fuel cell power plant for Vattenfall/BeWag, a
Berlin-based utility. This unit will operate on natural gas, methanol from
organic waste/biomass generated from refuse of the city of Berlin, or a mix of
both fuels, the first of its kind in Europe.
"Unlike other fuel cells, the HotModule can be run with other hydrocarbon- based
fuels, such as biogas, sewage gas, landfill gas, industrial residue gases and
methanol as well as natural gas," said Michael Bode, CEO of MTU CFC Solutions.
"This presents us with completely new possibilities by converting this gas,
which normally goes to waste, or, at best, is used in thermal applications. This
offers a highly efficient possibility to utilize these gases to produce power."
Additionally, RWE Fuel Cells GmbH, stakeholder in MTU CFC Solutions, announced
on June 30, 2004, the signing of an agreement for the installation of a 250-kW
carbonate fuel cell power plant for a municipal wastewater treatment facility in
the City of Ahlen, Germany. This will be the first carbonate fuel cell to
operate on anaerobic digester gas in Europe.
FuelCell Energy delivered its first commercially available DFC300A power plant
in January 2003. Through mid-September 2004, over 48 million kilowatt hours of
electricity has been generated from power plants incorporating its DFC
technology at customer sites throughout the world.
About Direct FuelCells
Direct FuelCells efficiently generate clean electricity at distributed customer
locations, including hospitals, schools, universities, hotels and other
commercial and industrial facilities, as well as in grid-support applications
for utility customers. Direct FuelCells operate similar to large, continuously
operating batteries except they utilize a fuel to generate electricity, such as
natural gas or digester gas from wastewater treatment facilities. DFC power
plants are hydrogen generators, and because of this are ready today and do not
require the creation of a hydrogen infrastructure. This high-efficiency
technology generates more electric power from less fuel and with less carbon
dioxide emissions than traditional combustion methods. The sub-megawatt fuel
cell power plant is a collaborative effort using Direct FuelCell(R) technology
of FuelCell Energy and the Hot Module(R) balance of plant design of MTU CFC
Solutions, GmbH, a subsidiary of DaimlerChrysler.
About FuelCell Energy, Inc.
FuelCell Energy, Inc., based in Danbury, Connecticut, is a world leader in the
development and manufacture of high temperature hydrogen fuel cells for clean
electric power generation. The Company has developed commercial distribution
alliances for its carbonate Direct FuelCell products with MTU CFC Solutions in
Europe; Marubeni Corporation in Asia; Enbridge Inc. in Canada; Caterpillar, PPL
Energy Plus, Chevron Energy Solutions, Alliance Power and LOGANEnergy in the
U.S. FuelCell Energy developed its patented Direct FuelCell technology for
stationary power plants with the U.S. Department of Energy through its Office of
Fossil Energy's National Energy Technology Laboratory.
FuelCell Energy is also developing next generation high temperature fuel cell
products, such as a diesel fueled marine Ship Service Fuel Cell, a
combined-cycle DFC/Turbine(R) power plant and solid oxide fuel cells for
applications up to 100 kilowatts. More information is available at
http://www.fuelcellenergy.com.
About MTU CFC Solutions GmbH
The company MTU CFC Solutions, which has its registered offices in Ottobrunn
near Munich, Germany, was set up in January 2003 as a 100% subsidiary of MTU
Friedrichshafen GmbH. The company is the world's leading developer of fuel cells
for use in high-temperature fuel cell installations and currently employs about
85 people. MTU CFC Solutions is engaged in the design, development, testing and
construction of fuel cell facilities delivering 200 kilowatts up to roughly
three megawatts of power for the supply of decentralized energy through coupled
power-heat-(cold) co-generation. Since July 2003, RWE Fuel Cells GmbH, Essen,
has held a 25.1 % share in MTU CFC Solutions. More information is available at
http://www.mtu-friedrichshafen.com/cfc/en/cfcs/cfcs.htm.
About RWE Fuel Cells GmbH
RWE Fuel Cells, a wholly-owned subsidiary of RWE AG, Essen, Germany (one of the
largest enterprises in Europe and a leading international utility in the areas
of energy and water), works on the development and marketing of products and
services based on fuel cells as well as other small distributed energy plants,
such as micro gas turbines and Stirling engines. RWE Fuel Cells exclusively
focuses on stationary fuel cells for commercial, industrial and private uses. It
currently has a staff of 28 employees. More information is available at
http://www.rwe.com/generator.aspx/rwe-world/fuel-
cells/id=1838/fuel-cells-home.html.
This news release contains forward-looking statements, including statements
regarding the Company's plans and expectations regarding the development and
commercialization of its fuel cell technology. All forward- looking statements
are subject to risks and uncertainties that could cause actual results to differ
materially from those projected. Factors that could cause such a difference
include, without limitation, the risk that commercial field trials of the
Company's products will not occur when anticipated, general risks associated
with product development, manufacturing, changes in the utility regulatory
environment, potential volatility of energy prices, rapid technological change,
and competition, as well as other risks set forth in the Company's filings with
the Securities and Exchange Commission. The forward-looking statements contained
herein speak only as of the date of this press release. The Company expressly
disclaims any obligation or undertaking to release publicly any updates or
revisions to any such statement to reflect any change in the Company's
expectations or any change in events, conditions or circumstances on which any
such statement is based.
SOURCE FuelCell Energy, Inc.
CONTACT: Investor and Media - Steven P. Eschbach, CFA, FuelCell Energy
Inc., +1-203-825-6000, seschbach@fce.com
(FCEL)
http://www.prnewswire.com
Copyright (C) 2004 PR Newswire. All rights reserved.
-0-
KEYWORD: Connecticut
INDUSTRY KEYWORD: OIL
*** end of story ***
FCEL news: (COMTEX) B: FuelCell Energy Receives New Direct FuelCell(R) Component Orde
from MTU CFC Solutions GmbH for 3 Sub-Megawatt Carbo
B: FuelCell Energy Receives New Direct FuelCell(R) Component Order from MTU CFC
olutions GmbH for 3 Sub-Megawatt Carbonate Fuel Cell Power Plants - MTU Commence
Operation of First European Dual Fuel Carbonate Power Plant at Berlin-based Uti
ity Vattenfall/BeWag - RWE Fuel Cells GmbH To Install First European Digester Ga
-Fueled Carbonate Fuel Cell Power Plant at Municipal Wastewater Treatment Facili
y in the City of Ahlen, Germany ( PRNewswire-FirstCall )
DANBURY, Conn., Oct 4, 2004 /PRNewswire-FirstCall via COMTEX/ -- FuelCell
Energy, Inc. (Nasdaq: FCEL) announced today that its European strategic partner,
MTU CFC Solutions, GmbH (a subsidiary of DaimlerChrysler), placed a new order
for the Company's Direct FuelCell(R) (DFC(R)) components for 3 new sub-megawatt
carbonate fuel cell power plants. Delivery is expected in late calendar year
2004 and early calendar year 2005. Announcements of individual power plant sites
utilizing these DFC stacks will be forthcoming, with each customer's request and
authorization.
MTU's branded carbonate fuel cell power plant, the HotModule(R), is based on
FuelCell Energy's Direct FuelCell technology and utilize fuel cells manufactured
by FuelCell Energy's Connecticut manufacturing facility. MTU is currently
operating eight Hot Modules in Germany and Spain, and two additional German
units completed their field trial programs.
"MTU CFC Solutions continues to demonstrate success by operating flexible high
temperature carbonate fuel cell power plants at European customer sites," said
Jerry D. Leitman, Chairman and CEO of FuelCell Energy. "This new order from MTU,
plus the additional siting announcements announced by MTU and its strategic
partner, RWE Fuel Cells, is evidence of a growing interest in clean and
efficient onsite power for commercial and industrial customers."
On September 30, 2004, MTU commenced operation of Europe's first dual fuel
250-kilowatt (kW) carbonate fuel cell power plant for Vattenfall/BeWag, a
Berlin-based utility. This unit will operate on natural gas, methanol from
organic waste/biomass generated from refuse of the city of Berlin, or a mix of
both fuels, the first of its kind in Europe.
"Unlike other fuel cells, the HotModule can be run with other hydrocarbon- based
fuels, such as biogas, sewage gas, landfill gas, industrial residue gases and
methanol as well as natural gas," said Michael Bode, CEO of MTU CFC Solutions.
"This presents us with completely new possibilities by converting this gas,
which normally goes to waste, or, at best, is used in thermal applications. This
offers a highly efficient possibility to utilize these gases to produce power."
Additionally, RWE Fuel Cells GmbH, stakeholder in MTU CFC Solutions, announced
on June 30, 2004, the signing of an agreement for the installation of a 250-kW
carbonate fuel cell power plant for a municipal wastewater treatment facility in
the City of Ahlen, Germany. This will be the first carbonate fuel cell to
operate on anaerobic digester gas in Europe.
FuelCell Energy delivered its first commercially available DFC300A power plant
in January 2003. Through mid-September 2004, over 48 million kilowatt hours of
electricity has been generated from power plants incorporating its DFC
technology at customer sites throughout the world.
About Direct FuelCells
Direct FuelCells efficiently generate clean electricity at distributed customer
locations, including hospitals, schools, universities, hotels and other
commercial and industrial facilities, as well as in grid-support applications
for utility customers. Direct FuelCells operate similar to large, continuously
operating batteries except they utilize a fuel to generate electricity, such as
natural gas or digester gas from wastewater treatment facilities. DFC power
plants are hydrogen generators, and because of this are ready today and do not
require the creation of a hydrogen infrastructure. This high-efficiency
technology generates more electric power from less fuel and with less carbon
dioxide emissions than traditional combustion methods. The sub-megawatt fuel
cell power plant is a collaborative effort using Direct FuelCell(R) technology
of FuelCell Energy and the Hot Module(R) balance of plant design of MTU CFC
Solutions, GmbH, a subsidiary of DaimlerChrysler.
About FuelCell Energy, Inc.
FuelCell Energy, Inc., based in Danbury, Connecticut, is a world leader in the
development and manufacture of high temperature hydrogen fuel cells for clean
electric power generation. The Company has developed commercial distribution
alliances for its carbonate Direct FuelCell products with MTU CFC Solutions in
Europe; Marubeni Corporation in Asia; Enbridge Inc. in Canada; Caterpillar, PPL
Energy Plus, Chevron Energy Solutions, Alliance Power and LOGANEnergy in the
U.S. FuelCell Energy developed its patented Direct FuelCell technology for
stationary power plants with the U.S. Department of Energy through its Office of
Fossil Energy's National Energy Technology Laboratory.
FuelCell Energy is also developing next generation high temperature fuel cell
products, such as a diesel fueled marine Ship Service Fuel Cell, a
combined-cycle DFC/Turbine(R) power plant and solid oxide fuel cells for
applications up to 100 kilowatts. More information is available at
http://www.fuelcellenergy.com.
About MTU CFC Solutions GmbH
The company MTU CFC Solutions, which has its registered offices in Ottobrunn
near Munich, Germany, was set up in January 2003 as a 100% subsidiary of MTU
Friedrichshafen GmbH. The company is the world's leading developer of fuel cells
for use in high-temperature fuel cell installations and currently employs about
85 people. MTU CFC Solutions is engaged in the design, development, testing and
construction of fuel cell facilities delivering 200 kilowatts up to roughly
three megawatts of power for the supply of decentralized energy through coupled
power-heat-(cold) co-generation. Since July 2003, RWE Fuel Cells GmbH, Essen,
has held a 25.1 % share in MTU CFC Solutions. More information is available at
http://www.mtu-friedrichshafen.com/cfc/en/cfcs/cfcs.htm.
About RWE Fuel Cells GmbH
RWE Fuel Cells, a wholly-owned subsidiary of RWE AG, Essen, Germany (one of the
largest enterprises in Europe and a leading international utility in the areas
of energy and water), works on the development and marketing of products and
services based on fuel cells as well as other small distributed energy plants,
such as micro gas turbines and Stirling engines. RWE Fuel Cells exclusively
focuses on stationary fuel cells for commercial, industrial and private uses. It
currently has a staff of 28 employees. More information is available at
http://www.rwe.com/generator.aspx/rwe-world/fuel-
cells/id=1838/fuel-cells-home.html.
This news release contains forward-looking statements, including statements
regarding the Company's plans and expectations regarding the development and
commercialization of its fuel cell technology. All forward- looking statements
are subject to risks and uncertainties that could cause actual results to differ
materially from those projected. Factors that could cause such a difference
include, without limitation, the risk that commercial field trials of the
Company's products will not occur when anticipated, general risks associated
with product development, manufacturing, changes in the utility regulatory
environment, potential volatility of energy prices, rapid technological change,
and competition, as well as other risks set forth in the Company's filings with
the Securities and Exchange Commission. The forward-looking statements contained
herein speak only as of the date of this press release. The Company expressly
disclaims any obligation or undertaking to release publicly any updates or
revisions to any such statement to reflect any change in the Company's
expectations or any change in events, conditions or circumstances on which any
such statement is based.
SOURCE FuelCell Energy, Inc.
CONTACT: Investor and Media - Steven P. Eschbach, CFA, FuelCell Energy
Inc., +1-203-825-6000, seschbach@fce.com
(FCEL)
http://www.prnewswire.com
Copyright (C) 2004 PR Newswire. All rights reserved.
-0-
KEYWORD: Connecticut
INDUSTRY KEYWORD: OIL
*** end of story ***
OK now. Spouses are either in or out. Which is it. I vote leave them at home, if you can... lol. I need to know so I can get my permission slip signed. LOL
Is this anything like the CMKX shareholders party? LOL
That can't be good for war churak.
Right. But for some reason I think this r/s is a decent deal. Guess no one wants to chance it. Oh well. I'll load up and see what happens in oct.
Can CORV ever find a bottom? Am I missing something with that pos?
never mind. Going back to bed.
IVAN moving up. Check the charts. FWIW
Going long BURP. LMAOROTF!!! Thanks folks. make da money!
WAR
BURP!
Heey, tanks for lvts. That was alot of fun today. Owe you one. Hope everyone is well.
WAR
BIOM. Seems like they are solidifying each tick up. This one should'nt come back to this range until it tests 2.00. If anyone has another opinion please post it.
Thanks, WAR
Steppin out for the afternoon. Can hardly wait to see where it goes. Probably in the chitter. LOL
Thanks for VLTS. Will hold BIOM for morning gappage.
BCON LOL
Here weeee goooo. BIOM. Watch them take it down to 1.51
Pound her down , come on. You can do it.
BIOM: LMAOROTF looky those wonderful mm's taking it under 1.60. LOL. Fill that gap now so we can run. Love to see it fall as low as 1.51
They sure seem to be trying. LOL. Watch her bounce.
DISCLAIMER: Usally whenever I post a stock pick. I do so with the intention of providing folks enough time to do some dd. Almost always. You should be able to buy on a pullback and not chase them. You need to watch for that pullback. Study who is running the show mmm wise. Study how it's moving. Evaluate the volume and make a decision. Never rush to pull the trigger. Most of my calls take a little time to develope. I'm not talking days here. But I am saying time your entrys so you buy low and sell high.
WAR
KCS. Possible mayjor breakout in the works. Needs to break that 15 imaginary wall.
WAR
ALso,
(COMTEX) B: FDA grants fast track status for BLP25 Liposome Vaccine ( Cana
a NewsWire )
B: FDA grants fast track status for BLP25 Liposome Vaccine ( Canada NewsWire )
EDMONTON, AB, Sep 29, 2004 (Canada NewsWire via COMTEX) -- Biomira Inc.
(Nasdaq: BIOM) (TSX: BRA) and Merck KGaA of Darmstadt, Germany today announced
that the U.S. Food & Drug Administration (FDA) has granted Fast Track status to
the investigation of BLP25 Liposome Vaccine (L-BLP25) for its proposed use in
the treatment of non-small cell lung cancer (NSCLC).
The FDA's Fast Track programs are designed to facilitate the development and
expedite review of drugs that are intended to treat serious or life-threatening
conditions and that demonstrate the potential to address unmet medical needs.
With Fast Track designation, there may be more frequent interactions with the
FDA during the development of a product and eventually a company may be eligible
to file a U.S. biologics license application (BLA) on a rolling basis as data
becomes available. This permits the FDA to review a filing as it is received,
rather than waiting for the entire document prior to commencing the review
process. Due to the nature of these types of products, BLAs filed with Fast
Track status are generally eligible for priority review, which could decrease
the typical review period.
Biomira submitted a Fast Track application to the FDA, which included
encouraging results from a controlled, randomized Phase IIb study in Stage IIIB
and IV NSCLC patients. Results from the Phase IIb study will be presented at the
European Society of Medical Oncology meeting (ESMO) to be held in Vienna,
Austria, on November 1.
A recent letter received from the FDA stated, "We have reviewed your request and
concluded that it meets the criteria for the Fast Track designation. Therefore,
we are designating as a Fast Track Drug Product development program the
investigation of Liposomal Vaccine in the extension of survival among patients
with unresectable stage 3a and locoregional stage 3b non-small cell lung cancer
following first line chemotherapy. We look forward to working with you to
expedite the development and review of this promising proposed use of the
product."
"Fast Track designation for L-BLP25 for the treatment of these patients is an
important step in the development of this product candidate and may help us
bring this potentially promising drug to patients more quickly," said Alex
McPherson, MD, PhD, President and CEO of Biomira. "This is a significant
milestone for the Company, highlighting the importance of product candidates
such as L-BLP25 to one day address a sizeable unmet need in this patient
population. We believe our vaccine will be able to provide a new treatment
option for men and women with NSCLC that has the potential to both extend and
improve the quality of their lives."
L-BLP25 is a synthetic MUC1 peptide vaccine, designed to induce an immune
response to cancer cells. L-BLP25 incorporates a 25-amino acid sequence of the
MUC1 cancer mucin, encapsulated in a liposomal delivery system. The liposome
enhances recognition of the cancer antigen by the immune system and facilitates
better delivery.
Biomira and Merck KGaA continue to explore opportunities for early registration
for this product candidate with other regulatory agencies. Plans are also
underway for a confirmatory Phase III study.
About Lung Cancer
Lung cancer is the leading cause of cancer-related mortality for both sexes in
North America. In 2004, approximately 174,000 new cases of lung cancer will be
diagnosed in the U.S. - 54 per cent of them in men and 46 per cent in women.
Approximately 160,000 people will die of this disease in the U.S. alone in 2004.
In Canada, the mortality percentages are slightly higher for men - 57 per cent
of deaths from lung cancer will occur in men and 43 per cent will be in women.
NSCLC accounts for approximately 75 to 80 per cent of all primary lung cancers.
At the time of diagnosis, only 25 per cent of patients are potentially curable
by surgery.
The Companies
Biomira is a biotechnology company specializing in the development of innovative
therapeutic approaches to cancer management. Biomira's commitment to the
treatment of cancer currently focuses on the development of synthetic vaccines
and novel strategies for cancer immunotherapy. We are The Cancer Vaccine
People(TM).
Merck is a global pharmaceutical and chemical company with sales of EUR 7.2
billion in 2003, a history that began in 1668, and a future shaped by 28,300
employees in 56 countries. Its success is characterized by innovations from
entrepreneurial employees. Merck's operating activities come under the umbrella
of Merck KGaA, in which the Merck family holds a 74 per cent interest and free
shareholders own the remaining 26 per cent. The former U.S. subsidiary, Merck &
Co., has been completely independent of the Merck Group since 1917. Merck KGaA
has built a strategic oncology portfolio by developing and in-licensing product
candidates in four areas - monoclonal antibodies, therapeutic vaccines,
immunocytokines and angiogenesis inhibitors.
EMD Pharmaceuticals Inc., the U.S. affiliate of Merck KGaA, is a fully
integrated pharmaceutical company with an initial emphasis on launching new
products in oncology. Located in Durham, N.C., EMD focuses on meeting patient
and physician needs with pioneering pharmaceutical products and services.
This release may contain forward-looking statements. Various factors could cause
actual results to differ materially from those projected in forward-looking
statements, including those predicting the timing or attainment of regulatory or
product approvals and whether or not the timing may be expedited, the timing of
clinical trials approvals, the timing of clinical trials, the efficacy of
products or the availability of capital. Although the Company believes that the
forward-looking statements contained herein are reasonable, it can give no
assurance that the Company's expectations are correct. All forward-looking
statements are expressly qualified in their entirety by this cautionary
statement.
VIEW ADDITIONAL COMPANY-SPECIFIC INFORMATION:
http://www.newswire.ca/en/releases/orgDisplay.cgi?okey=76826
CONTACT: For further information: Biomira Company Contacts: Bill Wicks
n,
Manager, Public Relations, (780) 490-2818; Jane Tulloch, Dire
tor, Investor
Relations, (780) 490-2812; U.S. Media Contact: Daniel Budwick
BMC
Communications, (212) 477-9007 X14;
To request a free copy of this organization's annual report,
lease go to
http://www.newswire.ca and click on reports(at)cnw.
News release via Canada NewsWire, Calgary 403-269-7605
Copyright (C) 2004 CNW, All rights reserved
-0-
KEYWORD: EDMONTON, AB
INDUSTRY KEYWORD: MTC
BIO
HEA
SPM
*** end of story ***
BCON. Could this pig breakout here?
(COMTEX) B: FDA grants fast track status for BLP25 Liposome Vaccine ( Cana
a NewsWire )
B: FDA grants fast track status for BLP25 Liposome Vaccine ( Canada NewsWire )
EDMONTON, AB, Sep 29, 2004 (Canada NewsWire via COMTEX) -- Biomira Inc.
(Nasdaq: BIOM) (TSX: BRA) and Merck KGaA of Darmstadt, Germany today announced
that the U.S. Food & Drug Administration (FDA) has granted Fast Track status to
the investigation of BLP25 Liposome Vaccine (L-BLP25) for its proposed use in
the treatment of non-small cell lung cancer (NSCLC).
The FDA's Fast Track programs are designed to facilitate the development and
expedite review of drugs that are intended to treat serious or life-threatening
conditions and that demonstrate the potential to address unmet medical needs.
With Fast Track designation, there may be more frequent interactions with the
FDA during the development of a product and eventually a company may be eligible
to file a U.S. biologics license application (BLA) on a rolling basis as data
becomes available. This permits the FDA to review a filing as it is received,
rather than waiting for the entire document prior to commencing the review
process. Due to the nature of these types of products, BLAs filed with Fast
Track status are generally eligible for priority review, which could decrease
the typical review period.
Biomira submitted a Fast Track application to the FDA, which included
encouraging results from a controlled, randomized Phase IIb study in Stage IIIB
and IV NSCLC patients. Results from the Phase IIb study will be presented at the
European Society of Medical Oncology meeting (ESMO) to be held in Vienna,
Austria, on November 1.
A recent letter received from the FDA stated, "We have reviewed your request and
concluded that it meets the criteria for the Fast Track designation. Therefore,
we are designating as a Fast Track Drug Product development program the
investigation of Liposomal Vaccine in the extension of survival among patients
with unresectable stage 3a and locoregional stage 3b non-small cell lung cancer
following first line chemotherapy. We look forward to working with you to
expedite the development and review of this promising proposed use of the
product."
"Fast Track designation for L-BLP25 for the treatment of these patients is an
important step in the development of this product candidate and may help us
bring this potentially promising drug to patients more quickly," said Alex
McPherson, MD, PhD, President and CEO of Biomira. "This is a significant
milestone for the Company, highlighting the importance of product candidates
such as L-BLP25 to one day address a sizeable unmet need in this patient
population. We believe our vaccine will be able to provide a new treatment
option for men and women with NSCLC that has the potential to both extend and
improve the quality of their lives."
L-BLP25 is a synthetic MUC1 peptide vaccine, designed to induce an immune
response to cancer cells. L-BLP25 incorporates a 25-amino acid sequence of the
MUC1 cancer mucin, encapsulated in a liposomal delivery system. The liposome
enhances recognition of the cancer antigen by the immune system and facilitates
better delivery.
Biomira and Merck KGaA continue to explore opportunities for early registration
for this product candidate with other regulatory agencies. Plans are also
underway for a confirmatory Phase III study.
About Lung Cancer
Lung cancer is the leading cause of cancer-related mortality for both sexes in
North America. In 2004, approximately 174,000 new cases of lung cancer will be
diagnosed in the U.S. - 54 per cent of them in men and 46 per cent in women.
Approximately 160,000 people will die of this disease in the U.S. alone in 2004.
In Canada, the mortality percentages are slightly higher for men - 57 per cent
of deaths from lung cancer will occur in men and 43 per cent will be in women.
NSCLC accounts for approximately 75 to 80 per cent of all primary lung cancers.
At the time of diagnosis, only 25 per cent of patients are potentially curable
by surgery.
The Companies
Biomira is a biotechnology company specializing in the development of innovative
therapeutic approaches to cancer management. Biomira's commitment to the
treatment of cancer currently focuses on the development of synthetic vaccines
and novel strategies for cancer immunotherapy. We are The Cancer Vaccine
People(TM).
Merck is a global pharmaceutical and chemical company with sales of EUR 7.2
billion in 2003, a history that began in 1668, and a future shaped by 28,300
employees in 56 countries. Its success is characterized by innovations from
entrepreneurial employees. Merck's operating activities come under the umbrella
of Merck KGaA, in which the Merck family holds a 74 per cent interest and free
shareholders own the remaining 26 per cent. The former U.S. subsidiary, Merck &
Co., has been completely independent of the Merck Group since 1917. Merck KGaA
has built a strategic oncology portfolio by developing and in-licensing product
candidates in four areas - monoclonal antibodies, therapeutic vaccines,
immunocytokines and angiogenesis inhibitors.
EMD Pharmaceuticals Inc., the U.S. affiliate of Merck KGaA, is a fully
integrated pharmaceutical company with an initial emphasis on launching new
products in oncology. Located in Durham, N.C., EMD focuses on meeting patient
and physician needs with pioneering pharmaceutical products and services.
This release may contain forward-looking statements. Various factors could cause
actual results to differ materially from those projected in forward-looking
statements, including those predicting the timing or attainment of regulatory or
product approvals and whether or not the timing may be expedited, the timing of
clinical trials approvals, the timing of clinical trials, the efficacy of
products or the availability of capital. Although the Company believes that the
forward-looking statements contained herein are reasonable, it can give no
assurance that the Company's expectations are correct. All forward-looking
statements are expressly qualified in their entirety by this cautionary
statement.
VIEW ADDITIONAL COMPANY-SPECIFIC INFORMATION:
http://www.newswire.ca/en/releases/orgDisplay.cgi?okey=76826
CONTACT: For further information: Biomira Company Contacts: Bill Wicks
n,
Manager, Public Relations, (780) 490-2818; Jane Tulloch, Dire
tor, Investor
Relations, (780) 490-2812; U.S. Media Contact: Daniel Budwick
BMC
Communications, (212) 477-9007 X14;
To request a free copy of this organization's annual report,
lease go to
http://www.newswire.ca and click on reports(at)cnw.
News release via Canada NewsWire, Calgary 403-269-7605
Copyright (C) 2004 CNW, All rights reserved
-0-
KEYWORD: EDMONTON, AB
INDUSTRY KEYWORD: MTC
BIO
HEA
SPM
*** end of story ***
Covered KCS. This one looks to breakout above 15.00. 14.95 the majic number.
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Harbs. You might like this one. BIOM. Just grsnted fast track status for cancer vaccine. Currently doing the morning gap fill on pull back. Could be interesting. Check the news on it. Looks devent for a run.
Volume is heavy could be a great intraday flippozoid
Check the chart, huge gap to fill eventually. Love em like this
KCS: If it can close above 14.92 a mayjor breakout could occur. However. Depending on the action, it might be a double top and a fantastic short opportunity. Which way will she go? LMAOROTF
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FREE Condom day in Boston, if I'm not mistaken. LOL
Hurracanes are one thing. But your wifes azz getting fat. Now thats another. LOL. Stop it gurls. Just joking.
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Glas to hear lance and our buds infla have come throught this last storm OK. Man you suys sure have had an exciting summer vacation. With ckmx and storms and all. LMAO
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