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SSB-T NR today 83m at .62
Glacier buys GVIC Publications for $9.25-million
2006-03-24 15:42 ET - News Release
See News Release (C-GVC) Glacier Ventures International Corp
Mr. Jonathon Kennedy reports
GLACIER ANNOUNCES EQUITY INVESTMENT IN GVIC PUBLICATIONS LTD.
Glacier Ventures International Corp.'s wholly owned subsidiary, 0747036 B.C. Ltd., has acquired approximately 94.9 per cent of the equity of GVIC Publications Ltd. (formerly Stressgen Biotechnologies Corp.)
Under the transaction, GVIC Publications received shareholder and regulatory approval to be restructured under a plan of arrangement whereby:
all of GVIC Publication's assets and liabilities were transferred to a new biopharmaceutical company that will carry on the former business carried on by Stressgen Biotechnologies; and
0747036 acquired 5,838,284 Class B voting shares and 237,178,557 Class C non-voting of GVIC Publications, representing approximately 40 per cent of the Class B voting shares, 98.19 per cent of the Class C non-voting shares and 94.9 per cent of the equity in GVIC Publications for $9.25-million.
0747036 and Glacier have no interest in the new biopharmaceutical company.
GVIC Publications will now focus on acquiring one or more businesses operating in the information communications sectors. GVIC Publications will seek to raise capital as required to finance such acquisitions.
Glacier acquired the shares of GVIC Publications for investment purposes.
We seek Safe Harbor.
Way to go. I am watching the chart may get some later when it settles down again.
OTG
I bailed with a nice profit in the nick of time. The crash was like watching a spectacular multicar pileup. WOW
I like gnbt long term a lot. It'll take a while to break through the overhead resistance.
Quite the correction today but IMHO that will change to the upside. Also check out RBM-V it is interesting as well. Happy trading.
OTG
SSB-T NR today Sedar plus (see below) 83m at .63
Stressgen loses $19.6-million in 2005
2006-03-22 09:26 ET - News Release
Mr. Gregory McKee reports
STRESSGEN BIOTECHNOLOGIES ANNOUNCES 2005 FINANCIAL RESULTS
Stressgen Biotechnologies Corp. has provided financial results for the year ended Dec. 31, 2005.
For the year ended Dec. 31, 2005, the company reported a net loss from continuing operations of $27.1-million, or 37 cents (31 U.S. cents) per share, compared with a net loss from continuing operations of $31.8-million, or 44 cents (34 U.S. cents) per share for the year ended Dec. 31, 2004. The company had cash and short-term investments of $4.4-million at Dec. 31, 2005. In January, 2006, the company entered into an agreement to reorganize and receive up to $9.25-million in non-dilutive financing.
Stressgen highlights
Corporate and finance:
appointed Gregory M. McKee as the new president, chief executive officer and director;
received approximately $8.72-million from sale of bioreagent business;
implemented two restructurings to focus corporate resources on the advancement of HspE7, lowering burn rate and decreasing operational overhead;
completed equity financings totalling gross proceeds of $3.6-million; and
entered into an agreement to reorganize and receive up to $9.25-million in non-dilutive funding.
Clinical:
showed higher than expected complete responses with HspE7 among women with high-grade cervical dysplasia.
Intellectual property:
granted United States patent covering therapeutic products to treat hepatitis B virus;
granted U.S. patent covering new methods of manufacturing HspE7; and
defeated Antigenics' challenge to European patent, a decision that has been subsequently appealed by Antigenics.
Manufacturing:
completed manufacture of commercial grade HspE7.
"We have made substantial progress in re-invigorating the company in 2005," commented Mr. McKee. "All of the milestones completed in 2005 have strengthened the foundation to support the continued development of HspE7 for human papillomavirus- (HPV) related indications."
CONSOLIDATED STATEMENT OF OPERATIONS
Year ended Dec. 31
(In thousands of dollars)
2005 2004
Revenue
Collaborative
R&D revenue $ 645 $ 700
Operating expenses
Research and
development 20,766 25,913
Selling, general
and admin 5,891 6,247
Restructuring 1,370 -
------- -------
28,027 32,160
------- -------
Operating loss (27,382) (31,460)
------- -------
Other income
(expenses)
Interest income 1,092 777
Net foreign
exchange (loss) (560) (938)
Interest (expense) (37) (96)
------- -------
495 (257)
------- -------
Net (loss) from
continuing
operations before
tax expense (26,887) (31,717)
Income tax
expense, net (187) (128)
------- -------
Net (loss) from
continuing
operations (27,074) (31,845)
Net income from
discontinued
operations 7,460 1,580
------- -------
Net (loss) $(19,614) $(30,265)
======= =======
Basic and diluted
(loss) per
common share
From continuing
operations $ (0.37) $ (0.44)
From discontinued
operations 0.10 0.02
------- -------
$ (0.27) $ (0.42)
We seek Safe Harbor.
APT NR today close 3.04
Alpha Pro Tech, Ltd. Announces 25% Increase in Revenue and 33% Increase in Net Income for Fiscal 2005
2006-03-22 16:00 ET - News Release
NOGALES, Ariz. -- (Business Wire) -- March 22, 2006
Alpha Pro Tech (AMEX:APT) (CHX:APT), a leading
manufacturer of disposable protective apparel and building products,
announced its financial results for the fourth quarter and full-year
period ended December 31, 2005.
Revenues for the three months ended December 31, 2005 increased
9.4% to $7.0 million compared to $6.4 million in the fourth quarter of
2004. New sales of construction supply weatherization products,
including the Engineered Products segment's building wrap and roof
underlayment, totaled $1.2 million for the quarter. Sales for the
Disposable Protective Apparel segment for the quarter were $3.7
million, a 21.1% decrease compared to the $4.7 million reported for
the same period of 2004 as the Company experienced decreased orders
primarily from its largest distributor due to a slowdown in orders
from them to reduce their inventory levels. Although shipments to them
declined in the fourth quarter of 2005, sales to the distributor's end
users remained fairly consistent with prior quarters. Infection
Control segment sales for the fourth quarter increased by 33.4% to
$1.6 million compared to the fourth quarter of last year, which
benefited from increased awareness surrounding Avian Flu. Mask sales
in the fourth quarter were up 36% as compared to the average for the
first three quarters of 2005. Extended care products were relatively
unchanged at $573,000 for the fourth quarter as the Company
experienced similar levels of demand for the Company's Extended Care
Unreal Lambskin products.
Gross profit decreased by 1.0 % to $3.1 million, and represented
44.3% of sales for the fourth quarter of 2005 as compared to a gross
profit of $3.1 million, which represented 48.9% of sales, for the same
period in 2004. The decrease in overall gross margins was directly
related to the contribution of Engineered Products revenue, which
carries lower overall margins than the Company's other segments and
initial manufacturing startup costs in this segment. Excluding
Engineered Products, gross profit margin was 51.7% for the fourth
quarter of 2005, up from gross profit margin of 48.9% for fiscal 2004.
Gross profit in the Engineered Products segment was 25.1% for the
fourth quarter, as compared to 28.2% for the third quarter and 25.2%
for the second quarter of 2005. Gross profit on this product line is
expected to increase to the low to mid 30% range by the second half of
2006 as the Company generates increased sales in this segment and the
joint venture in India becomes fully operational.
Selling, general and administrative expenses increased by 13.2% to
$2.5 million, or 35.7% of sales, for the quarter from $2.2 million, or
34.5% of sales for the quarter ended December 31, 2004. This was
primarily the result of increased Engineered Products expenses,
increased rent and utilities expense, increased travel expenses and
increased factory indirect expenses. Management believes it has the
necessary infrastructure required to substantially grow revenue and
accordingly expects operating expenses to remain fairly stable for the
coming twelve months, despite planned revenue growth.
Income from operations decreased by 40.3% to $478,000 for the
quarter compared to income from operations of $801,000 for the fourth
quarter last year. The decrease was due to a shift in product mix,
which included a higher contribution from our lower-margin engineered
products and a reduction in sales in our core apparel business. Net
income for the fourth quarter was $309,000, or $0.01 per fully diluted
share, compared to net income of $556,000, or $0.02 per fully diluted
share for the quarter ended December 31, 2004.
In 2006 the Company will introduce two new apparel product lines
targeted to the industrial and clean room marketplace. Comfortech(TM),
the first product, has been under development for two years and is a
new technically superior and lower cost line of non-breathable
material used in coveralls, gowns, lab coats and other apparel
products for the pharmaceutical, medical device and lab animal
research markets. The second is the Comfortech Certified(TM) product
line which is targeted for manufacturing facilities and other
applications where reducing bio-contamination is a priority. The
Company has received beta orders for the Comfortech(TM) product during
the first quarter of 2006 and expects to receive initial orders during
the second quarter of 2006. Based on initial customer indications,
management expects both of these products to begin to contribute more
meaningfully to revenue during the second half of 2006.
Al Millar, President of Alpha Pro Tech commented, "We continued to
grow our top line while maintaining the appropriate operating expense
controls to deliver profitable results. During the fourth quarter we
witnessed a decline in orders from our largest apparel distributor,
however, sales to their end users remained fairly consistent with
prior quarters. Based on initial indications, we anticipate this
distributor will return to more normalized ordering patterns in the
latter part of the first quarter of 2006."
For the year ended December 31, 2005, sales increased 25.2% or
$6.3 million to $31.1 million from $24.8 million reported for 2004.
The increase was due primarily to $4.7 million in incremental sales
from Engineered Products, specifically construction supply
weatherization products which was a new segment in 2005 and a $1.7
million or 9.3% increase in sales of Disposable Protective Apparel.
Infection Control segment sales for the year were flat year-over-year
at $5.1 million. Discounting the $600,000 one-time sale of N-95 masks
during the second quarter of 2004, sales in this segment would have
increased approximately 14% on a comparable basis. Extended Care
products decreased by 6.7% or $0.1 million to $1.8 million as the
Company experienced softness in the sale of medical bed pads. This
segment is not expected to be a growth area for the Company.
Gross profit margin decreased to 45.5% for the year from 49.5% for
the same period in 2004. Excluding Engineered Products, gross profit
margin was 49.1% for the year ended December 31, 2005 compared to
49.5% for the same period of 2004, in line with the Company's gross
profit margin for 2004.
Selling, general and administrative expenses increased by 9.8% to
$9.8 million for the year, representing 31.5% of sales, compared to
$8.9 million, or 35.9% of sales, for the year ended December 31, 2004.
The increase in absolute dollars was primarily related to increased
expenses of $802,000 for the Engineered Products segment.
Depreciation and amortization expense decreased by 3.5% to
$499,000 for the year ended December 31, 2005 from $517,000 for the
same period in 2004.
Income from operations increased by 35.4% to $3.9 million for the
year from $2.8 million last year due primarily to an increase in gross
profit of $1.9 million partially offset by an increase in selling,
general and administrative expenses of $0.9 million. Net income for
the year ended December 31, 2005 was up 32.6% to $2.5 million, or
$0.10 per fully diluted share (based on 25.2 million fully diluted
shares) compared to net income of $1.8 million, or $0.08 per fully
diluted shares (based on 24.6 million fully diluted shares) for fiscal
2004.
The balance sheet continues to remain strong with a current ratio
of 6.51 to 1 as of December 31, 2005. Additionally at year end, the
company reported no long-term debt, and shareholders' equity improved
to $18.6 million from $15.7 million on December 31, 2004. As of
December 31, 2005, the Company had cash and cash equivalents of $1.2
million and working capital of $14.2 million. The Company's cash
position increased by $0.9 million from the third quarter, primarily
related to a reduction in accounts receivable. The Company has a $3.5
million dollar line of credit of which almost all is still available.
"We see significant growth opportunities for both our core
Disposable Protective Apparel business in addition to our Engineered
Products Division as we further penetrate each market respectively
with new and innovative products," Mr. Millar continued. "Our Miami
Dade Certification received in October 2005 validates the integrity of
our Engineered Products offering and helps to clear the way for Perma
R to increase sales in the geographic areas where their customers are
located. Additionally, the Comfortech(TM) line of products should
bolster our Disposable Protective Apparel sales in 2006 as we look to
capture incremental market share."
About Alpha Pro Tech, Ltd.
Alpha Pro Tech develops, manufactures and markets innovative
disposable and limited-use protective apparel products for the
industrial, clean room, medical and dental markets. In addition, Alpha
ProTech Engineered Products, Inc. manufactures and markets a line of
construction weatherization products, including building wrap, roof
underlayment and mold resistant framing sealant. The Company has
manufacturing facilities in Salt Lake City, Utah; Nogales, Arizona;
Janesville, Wisconsin; and Valdosta, Georgia. For more information and
copies of all news releases and financials, visit Alpha Pro Tech's
Website at http://www.alphaprotech.com.
The Private Securities Litigation Reform Act of 1995 ("Act")
provides a safe harbor for forward-looking information made on behalf
of the Company. Forward-looking statements involve risks,
uncertainties and assumptions as described from time to time in
registration statements, annual reports and other periodic reports and
filings of the Company filed with the Securities and Exchange
Commission. All statements, other than statements of historical facts
which address the Company's expectations of sources of capital or
which express the Company's expectations for the future with respect
to financial performance or operating strategies, can be identified as
forward-looking statements. As a result, there can be no assurance
that the Company's future results will not be materially different
from those described herein as "believed," "anticipated," "estimated"
or "expected," which reflect the current views of the Company with
respect to future events. We caution readers that these
forward-looking statements speak only as the date hereof. The Company
hereby expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any such statements to reflect
any change in the Company's expectations or any change in events,
conditions or circumstances on which such statement is based.
-0-
*T
Alpha ProTech, Ltd.
Consolidated Statement of Operations
For the Three Months Ended For the Year Ended
December 31, December 31,
(unaudited)
2005 2004 2005 2004
Sales $ 7,017,000 $ 6,413,000 $31,095,000 $24,841,000
Cost of goods sold,
excluding
depreciation and
amortization 3,908,000 3,274,000 16,948,000 12,555,000
----------- ------------ ----------- -----------
Gross margin 3,109,000 3,139,000 14,147,000 12,286,000
Expenses:
Selling, general
and
administrative 2,507,000 2,214,000 9,796,000 8,925,000
Depreciation and
amortization 124,000 124,000 499,000 517,000
----------- ------------ ----------- -----------
Income from
operations 478,000 801,000 3,852,000 2,844,000
Other income
(expense)
Equity in income
(loss) of
unconsolidated
affiliates (16,000) - (16,000) -
Gain on sale
of assets - - - 7,000
Interest,
net - 11,000 24,000 7,000
----------- ------------ ----------- -----------
Income before
provision for
income taxes 462,000 812,000 3,860,000 2,858,000
Provision for
income taxes 153,000 256,000 1,410,000 1,011,000
----------- ------------ ----------- -----------
Net income $ 309,000 $ 556,000 $ 2,450,000 $ 1,847,000
=========== ============ =========== ===========
Basic net income
per share $ 0.01 $ 0.02 $ 0.10 $ 0.08
=========== ============ =========== ===========
Diluted net income
per share $ 0.01 $ 0.02 $ 0.10 $ 0.08
=========== ============ =========== ===========
Basic weighted
average shares
outstanding 23,731,350 23,435,038 23,684,229 23,215,809
=========== ============ =========== ===========
Diluted weighted
average shares
outstanding 25,522,533 24,608,146 25,247,236 24,624,613
=========== ============ =========== ===========
BALANCE SHEET HIGHLIGHTS
December 31st December 31st
2005 2004
Cash $ 1,163,000 $ 4,875,000
Total Current Assets $ 16,761,000 $ 15,348,000
Net Property and Equipment $ 3,389,000 $ 3,256,000
Total Assets $ 21,871,000 $ 18,789,000
Total Current Liabilities $ 2,576,000 $ 2,437,000
Total Liabilities $ 3,228,000 $ 3,089,000
Shareholder's Equity $ 18,643,000 $ 15,700,000
Total Liabilities and Equity $ 21,871,000 $ 18,789,000
*T
Contacts:
Alpha Pro Tech, Ltd.
Al Millar or Donna Millar, 905-479-0654
e-mail: ir@alphaprotech.com
or
Hayden Communications, Inc. (Investor Relations)
Matthew Hayden or Brett Maas, 843-272-4653
matt@haydenir.com
gnbt is trading in the $4.80s I'm pretty happy with the switch. The june 2002 is $5.24, I'm guessing I can get out in the $5.00-5.00 range.
CVQ-T NR today 102m at 3.47
CV begins trading on TSX; to enter U.S. market
2006-03-22 08:08 ET - News Release
Mr. Gordon Brown reports
CV TECHNOLOGIES-MAKER OF COLD-FX'R'-BEGINS TRADING ON THE TSX
CV Technologies Inc. today began trading its common shares on the Toronto Stock Exchange, trading under the symbol (CVQ), previously used on the TSX Venture Exchange.
CV Technologies was selected the TSX Venture Exchange's top performing company in 2005. CV Technologies president and chief executive officer Dr. Jacqueline Shan says: "This move fulfills a major corporate objective that management had set for this year. We believe our investors will see this as a natural and timely progression in our development. It is part of our business plan and coincides with our announcement at our annual general meeting three weeks ago of our strategy to enter the U.S."
Dr. Shan added, "A listing on the TSX could bring our company more visibility, attract analysts and institutional investors, and offer more stability to the company in the capital markets."
As part of the listing ceremony, Dr. Shan, along with COLD-fX spokesperson Don Cherry and other company executives, launched the trading day on the TSX.
A good move I believe.
OTG
switched from nvax to gnbt
NVAX NR 21/03/06 NR 8.31
Novavax Executes Definitive Agreement for $38 Million Public Offering
2006-03-21 07:50 ET - News Release
MALVERN, Pa., March 21 /PRNewswire-FirstCall/ -- Novavax, Inc. today announced that it has entered into a definitive agreement for a $38 million registered direct offering of 5,205,479 shares of its common stock at a price of $7.30 per share. The shares of common stock will be issued pursuant to an effective shelf registration statement.
Rodman & Renshaw, LLC acted as the exclusive placement agent for the offering. Novavax plans to use the net proceeds from the offering for general corporate purposes, including but not limited to i) clinical development of virus-like particles (VLP) based avian and seasonal influenza vaccines, including the development of appropriate adjuvants, and demonstration of large-scale production capabilities, for such vaccines; ii) internal research and development programs, such as preclinical and clinical testing and studies of our product candidates and the development of new technologies; iii) expansion of and investment in the Company's research and development facilities, including compliance with CGMP (Current General Manufacturing Practices) and GLP (Good Laboratory Practices) rules and regulations and iv) other general corporate purposes. A copy of the final prospectus relating to the offering may be obtained from Dennis Genge, Vice President and Chief Financial Officer, Novavax, Inc., 508 Lapp Road, Malvern, PA 19355, when available.
About Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. The company's technology platforms include the virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasome(R) non-phospholipid vesicles and dendrimer technologies. The company is developing a pandemic flu vaccine against H5N1, H9N2 and other avian influenza viruses and a seasonal flu vaccine against human influenza strains using its VLP and Novasome adjuvant technologies. Novavax's drug delivery technologies include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, ESTRASORB(R). In addition to MNP, Novavax drug delivery technologies include Novasomes and Sterisome(R) solvent and oil free emulsions for subcutaneous depot injection. The company has several products utilizing the MNP technology in various stages of development.
Forward Looking Statements
Statements made in this press release that state Novavax's or management's intentions, hopes, beliefs, expectations, or predictions of the future are forward-looking statements. Forward-looking statements include but are not limited to statements regarding usage of cash, product sales, future product development and related clinical trials and future research and development, including FDA approval. Novavax's actual results could differ materially from those expressed in such forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements. Such factors include, among other things, the following: general economic and business conditions; ability to enter into future collaborations with industry partners, competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; ability to establish and maintain commercial-scale manufacturing capabilities; results of clinical studies; progress of research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; the ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity financing or otherwise; and other factors referenced herein. Additional information is contained in Novavax's annual report on Form 10K for the year ended December 31, 2005 incorporated herein by reference. Statements made herein should be read in conjunction with Novavax's annual and quarterly reports filed with the SEC. Copies of these filings may be obtained by contacting Novavax at 508 Lapp Road, Malvern, PA 19355 Tel 484-913-1200 or the SEC at http://www.sec.gov.
Novavax, Inc.
CONTACT: Kathy Hamilton of Novavax, Inc., +1-484-913-1213,
KHamilton@novavax.com
Web site: http://www.novavax.com/
NVAX NR 20/03/06
Novavax CEO to Present at World Vaccine Congress 2006
2006-03-20 07:00 ET - News Release
MALVERN, Pa., March 20 /PRNewswire-FirstCall/ -- Novavax, Inc. , today announced that Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax, is scheduled to make a presentation at the World Vaccine Congress 2006 in Washington, DC on Tuesday, March 21, 2006. The conference will be held at the Four Seasons Hotel in Washington, DC and Dr. Singhvi will present at 5:50 p.m. ET. Dr. Singhvi's presentation will include a case study on Novavax's potential pandemic virus-like particle (VLP) flu vaccine initiative, a new vaccine platform to address the urgent need for a pandemic flu vaccine which includes:
* Results of pre-clinical studies with an influenza avian (pandemic) H9N2
candidate VLP vaccine
* Novasomes(R) -- a safe, patented adjuvant to help address the need for
antigen sparing
* Rapid, disposable, scalable manufacturing process to meet vaccine needs
for pandemic flu
About Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. The company's technology platforms include the virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes(R), non-phospholipid vesicles and dendrimer technologies. The company is developing a pandemic flu vaccine against H5N1, H9N2 and other avian influenza viruses and a seasonal flu vaccine against human influenza strains using its VLP and Novasome adjuvant technologies. Novavax's drug delivery technologies include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, ESTRASORB(R). In addition to MNP, Novavax drug delivery technologies include Novasomes(R) and Sterisomes(R), solvent and oil free emulsions for subcutaneous depot injection. The company has several products utilizing the MNP technology in various stages of development.
Forward Looking Statements
Statements made in this press release that state Novavax's or management's intentions, hopes, beliefs, expectations, or predictions of the future are forward-looking statements. Forward-looking statements include but are not limited to statements regarding usage of cash, product sales, future product development and related clinical trials and future research and development, including FDA approval. Novavax's actual results could differ materially from those expressed in such forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements. Such factors include, among other things, the following: general economic and business conditions; ability to enter into future collaborations with industry partners, competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; ability to establish and maintain commercial-scale manufacturing capabilities; results of clinical studies; progress of research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; the ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity financing or otherwise; and other factors referenced herein. Additional information is contained in Novavax's annual report on Form 10K for the year ended December 31, 2005 incorporated herein by reference. Statements made herein should be read in conjunction with Novavax's annual and quarterly reports filed with the SEC. Copies of these filings may be obtained by contacting Novavax at 508 Lapp Road, Malvern, PA 19355 Tel 484-913-1200 or the SEC at www.sec.gov.
Novavax, Inc.
CONTACT: Kathy Hamilton of Novavax Inc., Investor Relations,
+1-484-913-1213, khamilton@novavax.com
Web site: http://www.novavax.com//
CVQ-V NR 06/20/06 102m at 3.30
CV Technologies to list on TSX on March 22
2006-03-20 19:02 ET - New Listing
TSX bulletin 2006-0307
An application has been granted for the original listing in the industrial category of 117,418,950 Class A common shares of which 102,013,340 Class A common shares are issued and outstanding, and 15,405,610 Class A common shares are reserved for issuance. The Class A common shares of the company will be listed and posted for trading at the open on Wednesday, March 22, 2006.
Stock symbol: CVQ
Cusip No.: 126664 10 1
Trading currency: Canadian dollars
Designated market-maker: RBC Capital Markets
Other markets: The Class A common shares of the company were listed on the TSX Venture Exchange on July 27, 1998. The Class A common shares will be delisted from the TSX-V on March 22, 2006.
Incorporation: The issuer was incorporated under the Business Corporation Act of Alberta on June 29, 1992. Effective Oct. 1, 1997, the issuer amalgamated with Corsayre Capital Co. on the Alberta Stock Exchange. Effective June 30, 1998, the issuer and HerbTech Inc., a former wholly owned subsidiary of the issuer, amalgamated and continued as CV Technologies Inc.
Fiscal year-end: Sept. 30
Nature of business: The issuer is a health sciences and technology company, founded in 1992 and headquartered in Edmonton, Alta. The issuer has developed, commercialized and patented a proprietary technology used to discover and biologically standardize natural products that deliver consistent, verifiable and provable health benefits. The issuer's lead product, COLD-fX, is designed to prevent and treat colds and flu by strengthening the immune system.
Transfer agent and registrar: Computershare Trust Co. of Canada at its principal offices in Toronto and Calgary
Dividends: The company will consider paying dividends if/as and when the financial position would allow the payment of dividends.
CVQ-V NR today 102m at 3.00
CV Technologies to list on TSX March 22
2006-03-20 09:49 ET - News Release
Dr. Jacqueline Shan reports
CV Technologies Inc. has received approval to begin trading of its common shares on the Toronto Stock Exchange beginning Wednesday, March 22, 2006. The company will continue to trade under the symbol CVQ. CVQ will be delisted from the TSX Venture Exchange at the close of trading Tuesday, March 21, 2006.
CV Technologies was selected the TSX Venture Exchange's top performing company in 2005. CV Technologies president and chief executive officer Dr. Jacqueline Shan says: "This move fulfills a major corporate objective that management had set for this year. We believe our investors will see this as a natural and timely progression in our development. It is part of our business plan and coincides with our announcement of our strategy to enter the U.S. at our annual general meeting three weeks ago.
"A listing on the TSX could bring our company more visibility, attract analysts and institutional investors and offer more stability to the company in the capital markets."
As part of the listing ceremony this Wednesday, Dr. Shan, along with other company executives, will launch the trading day on the TSX at 9:30 a.m. Wednesday.
We seek Safe Harbor.
Remember GNBT seems to be about a day behind NVAX.
Good luck with your trades.
NVAX - Correction
/C O R R E C T I O N -- Novavax, Inc./
2006-03-16 09:04 ET - News Release
In the news release, Novavax Receives Additional Government Funding for IV/AIDS Vaccine Research, issued earlier today by Novavax, Inc. over PR Newswire, the headline should read "Novavax Receives Additional Government Funding for HIV/AIDS Vaccine Research" rather than "IV/AIDS Vaccine Research" as incorrectly transmitted by PR Newswire.
Novavax, Inc.
DDS-T NR today 43m at 7.75
Globe says former Labopharm chair settles with OSC
2006-03-17 07:05 ET - In the News
The Globe and Mail reports in its Friday edition that Ian Lennox has reached a settlement with the Ontario Securities Commission on accusations of illegal insider trading. The Globe's Janet McFarland writes in the Business Ticker column that Mr. Lennox is the former chairman of pharmaceutical company Labopharm. The OSC announced Thursday that Mr. Lennox has agreed to pay $32,000 plus $5,000 in costs. Mr. Lennox has also agreed to take a governance course at the University of Toronto's Rotman School of Management. Mr. Lennox was accused of buying 25,000 shares of Labopharm last August while in possession of undisclosed information about a new partnership agreement. Labopharm stock closed off four cents at $7.75 Thursday in Toronto. The stock has a 52-week trading range of $9.75 to $2.50. The stock began a significant advance in early November, peaking at the end of January. The United States Food and Drug Administration agreed to review Labopharm's filing to sell a once-daily version of the pain reliever tramadol in late January. The Globe reported on Jan. 31 that National Bank Financial analyst Andre Uddin said the the likelihood of FDA "approval is very good." The stock has since fallen $2.45.
kool otg. Can't keep my paws of the calculator figuring out how much I've made off nvax. lol Ummmm mph, big bearish engulfing candlestick bitch. lol The sweet part of the bowl is tasting a little sour the last 2 days. Hopefully it'll turn around soon.
GNBT NR today 2.45
Generex Biotechnology Receives Patent in Mexico
2006-03-16 09:00 ET - News Release
TORONTO -- (MARKET WIRE) -- 03/16/06
http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=113474&ProfileId=051205&am...
Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery, announced today that it has been granted a patent by the Mexico National Registry of Patents titled "Proteinic Drug Delivery System Using Aerosolized Membrane-Mimetic Amphiphiles." The patent, an extant United States Patent registered by the Company, relates to an improved delivery system for the administration of large-molecule pharmaceuticals, particularly through the oral and nasal membranes.
The patent covers formulations for the delivery of peptidic drugs, vaccines, and hormones and enhances the Company's existing drug delivery platform patent portfolio.
"We are pleased to augment our Latin American patent protection as we continue with our Generex Oral-lyn(TM) commercialization efforts in the region," said Rose Perri, the Company's Chief Operating Officer. Generex Oral-lyn is the Company's flagship product, a proprietary oral insulin spray product which has been approved by the Ecuadorian Ministry of Public Health for the treatment of Type-1 and Type-2 diabetes.
The Company currently holds an aggregate of 71 patents (19 of which are United States patents) and has an aggregate 58 patent applications pending in various jurisdictions.
About Generex
Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Generex Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.
For more information, visit the Generex Web site at www.generex.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
Contact:
Shayne Gilliatt
Generex Biotechnology Corporation
Phone: (800) 391-6755
and (416) 364-2551
Ed Lewis
CEOcast, Inc.
Phone: 1 (212) 732-4300
CJC-T NR today 47M at 1.24
ConjuChem loses $9.73-million in Q1
2006-03-16 09:13 ET - News Release
Mr. Lennie Ryer reports
CONJUCHEM ANNOUNCES FISCAL 2006 FIRST QUARTER FINANCIAL RESULTS
ConjuChem Inc. has provided its financial results for its first quarter of fiscal 2006, ended Jan. 31, 2006.
"ConjuChem is making solid progress on the clinical front as 2006 advances. Subsequent to quarters end, we received clearance from the FDA to conduct a phase I/II trial for the treatment of Type 2 diabetes using our proprietary PC-DAC: Exendin-4 compound. At the same time, our phase II study for DAC:GRF for the treatment of HIV-related Lipodystrophy remains ongoing," said vice-president and chief financial officer Lennie Ryer. "We look forward to updating shareholders on these two lead programs as the year progresses."
The company's net loss for the quarter ended Jan. 31, 2006, was $9.7-million, or 20 cents per share, compared with $11.3-million, or 26 cents per share, for the quarter ended Jan. 31, 2005. The decrease in the net loss is mainly attributable to a decrease in net research and development expenses of $1.7-million.
The company recorded interest income on cash, short and long-term investments of $80,886 for the quarter versus $137,775 in the same period last year. The decrease in interest revenue was a result of lower rates of return on invested funds caused by a general decrease in market interest rates combined with a reduction in the funds available for investment.
Net research and development expenses amounted to $6.1-million for the quarter ended Jan. 31, 2006, compared with $7.9-million in the same period last year. The decrease is largely attributable to reduced costs of the clinical development programs compared with the prior fiscal year.
General and administrative costs for the quarter ended Jan. 31, 2006, were $1.2-million compared with $929,442 for the same period last year. The increase in general and administrative expenses is attributable to increased costs of insurance coverage and non-recurring expenses incurred to recruit and relocate ConjuChem's new president and chief executive officer.
As of Jan. 31, 2006, the company had cash and cash equivalents of $9.9-million and a working capital position of $7.5-million.
Subsequent to quarter-end, ConjuChem announced a corporate reorganization transaction which will strengthen its financial position by adding an extra $6.4-million of gross proceeds to ConjuChem's balance sheet. The transaction, which will monetize accumulated tax losses, in no way changes the fundamental business of the company and is non-dilutive for its shareholders.
Outlook
ConjuChem anticipates releasing preliminary data from its phase I/II trial for the treatment of Type 2 diabetes using its proprietary PC-DAC:Exendin-4 compound by midyear. A maximum of 68 patients will be enrolled in this randomized, double-blind, single escalating dose study with patient dosing to begin by mid-March. The company's placebo-controlled, double-blind phase II study in which DAC:GRF is administered once weekly for the treatment of HIV-related Lipodystrophy remains continuing. ConjuChem expects to report preliminary data from this trial in the fourth quarter of 2006.
STATEMENT OF OPERATIONS AND DEFICIT
Three months ended Jan. 31
2006 2005
Revenues
Contract
revenue $239,123 $32,989
Interest
income 80,886 137,775
------------ ------------
320,009 170,764
Expenses
Research
and
development 6,214,332 8,027,938
Investment
tax credits (75,000) (150,000)
------------ ------------
Net
research
and
development
expenses 6,139,332 7,877,938
General and
admin
expenses 1,203,960 929,442
Amortiz-
ation of
property,
plant and
equipment 72,814 93,704
Amortiz-
ation of
intangible
assets 14,486 10,391
Amortiz-
ation of
deferred
financing
fees 8,722 8,722
Non-cash
stock
compens-
ation 1,183,343 1,280,198
Financial
charges 3,673 3,501
Foreign
exchange
(gain) loss 184 96,179
Accretion
in carrying
value of
convertible
senior
unsecured
notes 1,425,799 1,204,650
------------ ------------
10,052,313 11,504,725
------------ ------------
Net (loss) $(9,732,304) $(11,333,961)
============ ============
(Deficit),
beginning
of period $(200,918,066) $(157,056,878)
Opening
adjustment
for stock-
based
compen-
sation - (5,343,453)
------------ ------------
(Deficit),
end of
period $(210,650,370) $(173,734,292)
============ ============
Basic and
diluted
(loss) per
share $(0.20) $(0.26)
We seek Safe Harbor.
HEB NR 3.22
New Research From Hemispherx Biopharma Leverages Recent Studies to Identify Factors in Breakdown of Immune System; May Help Prevent Spread of Avian Flu
2006-03-16 08:25 ET - News Release
PHILADELPHIA -- (Business Wire) -- March 16, 2006
Company Website: http://www.hemispherx.net
Hemispherx Biopharma, Inc.:
-- Results to be Presented at the VIII International Symposium on
Respiratory Viral Infections March 16-19 in Hawaii
-- Japanese Researchers Initiate Primate Studies With
Co-administration of Hemispherx Biopharma's Ampligen and H5N1
Vaccine
The results of new studies to be presented at the VIII
International Symposium on Respiratory Viral Infections on March 16-19
represent a major step forward in leveraging research that identifies
the gene that is believed to have caused the immune system to shut
down and led to the devastating Spanish flu epidemic of 1918, which is
estimated to have killed 100 million people. These studies have
critical implications because some researchers believe the current
spread of the H5N1, or avian flu, virus may have similar underlying
causes. The findings, to be presented by Dr. William Mitchell,
Professor of Pathology at Vanderbilt University and a member of the
Board of Directors of Hemispherx Biopharma, provide further evidence
that Hemispherx Biopharma's Alferon LDO (Low-Dose Oral), a new
delivery form of an anti-viral with prior regulatory approval for a
category of sexually transmitted diseases, has tremendous potential in
resisting the spread of avian flu by stimulating genes that induce the
production of immune compounds that are key building blocks in the
body's defense system.
Researchers in this area have recently focused on TNF, a naturally
occurring immune substance (or "lymphokine") as the instigator of the
massive tissue damage to lung cells. The new research included
analysis of avian flu virus specimens recently recovered in the frozen
arctic tundra from victims of the 1918 avian flu epidemic. These
studies suggest that the interferon system, the body's primary line of
defense, broke down first, leading to the aberrant and ultimately
self-destructive release of TNF.
In recent healthy human volunteer tests conducted in Hong Kong and
Philadelphia, patients were given graded doses of Alferon LDO for two
minutes' exposure. Blood samples were then taken to determine which
components of the immune system had been activated. It was found that
the interferon gene activity normally suppressed or killed by the
virus were instead enhanced several times over. By contrast, the TNF
gene battery normally enhanced by viral infection was instead sharply
suppressed by the brief Alferon LDO exposure.
"These new studies are highly significant to our understanding of
how the body reacts to virus attacks, a critical component in building
adequate defenses against the spread of avian flu," said Dr. William
Mitchell. "We believe that taken collectively, the latest findings
represent tremendous progress in this critical area."
Dr. Mitchell will also be presenting ongoing findings from trials
on The TLR3 Agonist, Poly I: Poly C12U, Provides Nasal Adjuvant
Activity to a Vaccine Directed Against Highly Pathogenic H5N1 Avian
Influenza Virus and Synerginistic Inhibition of Avian Influenza Virus
(H5N1) by PolyI: Poly C12 U Combined with Oseltamivir or Zanamivir.
(All three trials were recently presented at the ASM Biodefense
Conference.)
Dr. Mitchell will announce that the co-administration of
Hemispherx Biopharma's experimental immunotherapeutic Ampligen, a
specifically configured double-stranded RNA, may help enable
substantial reductions in an H5N1 vaccine dose, as well as provide
cross-protection against mutated strains of the H5N1 virus. These
results come from a conclusive mouse study conducted in collaboration
with the National Institute of Infectious Diseases in Japan. In
collaboration with Hemispherx Biopharma, the Institute has initiated
the next phase of studies with primates.
Finally, additional research to be presented suggests the
effectiveness of Tamiflu and Relenza, the only two drugs formally
recognized for combating bird flu, can be boosted up to 100 times. Lab
studies reveal that 50 to 100 times less Tamiflu may be used in
conjunction with Ampligen to achieve full inhibition with no
multiplication of the virus, and no host cell damage.
"The latest research offers further evidence that we are on the
right path to identifying the factors that cause the immune system to
break down, which has grave implications in the event of a pandemic,"
said Dr. William A. Carter, M.D., Chairman and CEO of Hemispherx
Biopharma. "We're also encouraged that our experimental
immunotherapeutics Ampligen and Alferon offer tremendous potential
against the global spread of the H5N1 virus."
About Hemispherx Biopharma
Hemispherx Biopharma, based in Philadelphia, is a
biopharmaceutical company engaged in the manufacture and clinical
development of new drug entities for treatment of viral and
immune-based chronic disorders. Hemispherx Biopharma's flagship
products include Alferon(R) and the experimental
immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). Alferon(R)
is approved for a category of STD infection, and Ampligen(R) and
Oragens(TM) represent experimental nucleic acids being developed for
globally important viral diseases and disorders of the immune system.
Hemispherx's platform technology includes large and small agent
components for potential treatment of various chronic viral
infections. Hemispherx has in excess of 140 patents comprising its
core intellectual property estate, a fully commercialized product
(Alferon(R) N) and GMP certified manufacturing facilities for its
novel pharma products. For more information please visit
www.hemispherx.net
www.hemispherx.net
Information contained in this news release other than historical
information, should be considered forward-looking and is subject to
various risk factors and uncertainties. For instance, the strategies
and operations of Hemispherx involve risk of competition, changing
market conditions, change in laws and regulations affecting these
industries and numerous other factors discussed in this release and in
the Company's filings with the Securities and Exchange Commission. Any
specifically referenced investigational drugs and associated
technologies of the company (including Ampligen(R), Alferon(R) LDO and
Oragens) are experimental in nature and as such are not designated
safe and effective by a regulatory authority for general use and are
legally available only through clinical trials with the referenced
disorders. The forward-looking statements represent the Company's
judgment as of the date of this release. The Company disclaims,
however, any intent or obligation to update these forward-looking
statements. Clinical trials for other potential indications of the
approved biologic Alferon(R) do not imply that the product will ever
be specifically approved commercially for these other treatment
indications.
Contacts:
Hemispherx Biopharma, Inc.
Dianne Will, 518-398-6222
ir@hemispherx.net
or
Media:
Neale-May & Partners
Digs Majumder, 212-213-5400 x206
digs@nealemay.com
NVAX NR 7.00
Novavax Receives Additional Government Funding for IV/AIDS Vaccine Research
2006-03-16 07:00 ET - News Release
MALVERN, Pa., March 16 /PRNewswire-FirstCall/ -- Novavax, Inc. , announced approval today from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), of an additional commitment of approximately $1.0 million to fund the third year of a 4 1/2 year research program. Novavax is developing a novel HIV/AIDS virus-like particle (VLP) vaccine as part of an NIH Integrated Preclinical/Clinical AIDS Vaccine Development Program comprised of scientists from the University of Alabama at Birmingham, Emory University, and Harvard Medical School. All three institutions are working with Novavax in a collaboration to accelerate HIV/AIDS vaccine development.
Dr. Gale Smith, Vice President of Vaccine Development, explains, "We believe the only realistic solution to the global HIV/AIDS pandemic is an effective vaccine. Novavax is extremely pleased to be working with such an acknowledged group of world leaders in developing a novel HIV/AIDS vaccine. Our research is based on our insect cell technology for the production of recombinant virus particles that mimic HIV-1, but without the risk of infection." According to Dr. Beatrice Hahn, one of the principal investigators at the University of Alabama at Birmingham, "Globally circulating strains of HIV-1 are extraordinarily variable, and this diversity poses a major obstacle to AIDS vaccine development. Currently, all candidate vaccines are derived from contemporary HIV-1 isolates, often selected solely based on availability. With VLP vaccines produced by Novavax, we are now testing whether consensus immunogens can elicit broadly cross-reactive immune responses and thus protect against a wide range HIV-1."
In the first two years of the program, Novavax developed a process to manufacture HIV-1 VLPs from consensus sequences of the HIV-1 envelope glycoprotein, the principle target for virus neutralization. These synthetic genes were shown to be incorporated into particles that are structurally similar to HIV-1. Scientists at UAB, Emory, and Harvard discovered that the novel HIV/AIDS VLP vaccines induced a range of immune responses and antibodies in small animals and non-human primates that neutralized both laboratory strains and acute, contemporary HIV-1 isolates. The objectives for the team during 2006 are to maximize efficiency of incorporation of the HIV-1 envelope glycoprotein into particles. Novavax then plans to begin preparations for human clinical trials of an improved HIV/AIDS VLP vaccine.
About HIV/AIDS Pandemic
According to a 2005 report from the World Health Organization (WHO), HIV/AIDS has killed more 25 million people, making it one of the most destructive epidemics in recorded history. HIV claimed the lives of more than half a million children and about 3.1 million people overall in 2005. In the United States alone, more than 40,000 become infected with HIV annually.
About Virus-Like Particle (VLP) Technology
Novavax's virus-like particle (VLP) vaccines use recombinant DNA technology to produce antigenic structures that mimic a virus to produce a protective immune response without the risk of infection or disease. Viral proteins can self-assemble into VLPs when over-expressed in certain cells. The use of VLP technology has already been proven with the success of the hepatitis B vaccine and more recently with developmental human papillomavirus vaccines. This is the first time that VLP technology has been applied to create a potential HIV/AIDS vaccine and is the same technology Novavax is using to produce influenza VLP vaccines that are readily adaptable and could be scaled up to meet a surge in demand during a pandemic.
About Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. The company's technology platforms include the virus-like particle (VLP) manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes(R), non-phospholipid vesicles and dendrimer technologies. The company is developing a pandemic flu vaccine against the H5N1, H9N2 and other avian influenza viruses and a season flu vaccine against human influenza strains using its VLP and Novasome adjuvant technologies. Novavax's drug delivery technologies include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, ESTRASORB(R). In addition to MNP, Novavax drug delivery technologies include Novasomes(R) and Sterisomes(R), solvent and oil free emulsions for subcutaneous depot injection. The company has several products utilizing the MNP technology in various stages of development.
Forward Looking Statements
Statements made in this press release that state Novavax's or management's intentions, hopes, beliefs, expectations, or predictions of the future are forward-looking statements. Forward-looking statements include but are not limited to statements regarding usage of cash, product sales, future product development and related clinical trials and future research and development, including FDA approval. Novavax's actual results could differ materially from those expressed in such forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements. Such factors include, among other things, the following: general economic and business conditions; ability to enter into future collaborations with industry partners, competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; ability to establish and maintain commercial-scale manufacturing capabilities; results of clinical studies; progress of research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; the ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity financing or otherwise; and other factors referenced herein. Additional information is contained in Novavax's annual report on Form 10K for the year ended December 31, 2005 incorporated herein by reference. Statements made herein should be read in conjunction with Novavax's annual and quarterly reports filed with the SEC. Copies of these filings may be obtained by contacting Novavax at 508 Lapp Road, Malvern, PA 19355 Tel 484-913-1200 or the SEC at www.sec.gov.
Novavax, Inc.
CONTACT: Kathy Hamilton, Investor Relations of Novavax Inc.,
+1-484-913-1213, khamilton@novavax.com
ONC-T NR today 36m at 5.85
Oncolytics to present Reolysin data at conference
2006-03-16 06:45 ET - News Release
An anonymous director reports
ONCOLYTICS BIOTECH INC.'S RESEARCH COLLABORATORS TO PRESENT REOLYSIN(R) CLINICAL TRIAL DATA AT ASCO CONFERENCE
Research collaborators with Oncolytics Biotech Inc. are scheduled to deliver two poster presentations covering Reolysin clinical trial data at the American Society of Clinical Oncology (ASCO) annual meeting, to be held June 2 to 6, 2006, in Atlanta, Ga. The data cover interim results of Oncolytics's phase I systemic administration trial being conducted in the United Kingdom, and final results of Oncolytics's Canadian phase I recurrent malignant glioma trial.
A poster entitled, "A phase I study of a wild-type reovirus (Reolysin) given intravenously to patients with advanced malignancies," is scheduled to be presented by Dr. Johann S. de Bono of the Royal Marsden Hospital and the Institute of Cancer Research, U.K.
A poster entitled, "A phase I trial of intratumoral (i.t.) administration of reovirus in patients with histologically confirmed recurrent malignant gliomas (MGs)," is scheduled to be presented by Dr. P.A. Forsyth of the University of Calgary and the Alberta Cancer Board.
We seek Safe Harbor.
APT NR today
Alpha Pro Tech, Ltd. to Announce 2005 Fourth Quarter and Year End Results on March 22, 2006
2006-03-15 11:32 ET - News Release
NOGALES, Ariz -- (Business Wire) -- March 15, 2006
Alpha Pro Tech (AMEX:APT)(CHX:APT), a leading
manufacturer of products designed to protect people and environments,
including disposable protective apparel and construction supply
weatherization products, announced today that it will have a
conference call regarding its 2005 fourth quarter and year end
financial results, which ended on December 31, 2005.
The conference call will take place at 4:30 p.m. Eastern Time, on
Wednesday, March 22, 2006. Anyone interested in participating should
call 800-811-0667 if calling within the United States or 913-981-4901
if calling internationally. There will be a playback available until
April 5, 2006. To listen to the playback, please call 888-203-1112 if
calling within the United States or 719-457-0820 if calling
internationally. Please use pin number 4323280 for the replay.
This call is being web cast by ViaVid Broadcasting and can be
accessed at Alpha Pro Tech's website at www.alphaprotech.com. The web
cast may also be accessed at ViaVid's website at www.viavid.net. The
web cast can be accessed until April 22, 2006 on either site.
To access the web cast, you will need to have the Windows Media
Player on your desktop. For the free download of the Media Player
please visit:
http://www.microsoft.com/windows/windowsmedia/en/download/default.asp.
About Alpha Pro Tech, Ltd.
Alpha Pro Tech, Ltd. develops, manufactures and markets innovative
disposable and limited-use protective apparel products for the
industrial, clean room, medical and dental markets. In addition, Alpha
ProTech Engineered Products, Inc. manufactures and markets a line of
construction weatherization products, including building wrap, roof
underlayment and mold resistant framing sealant. The Company has
manufacturing facilities in Salt Lake City, Utah; Nogales, Arizona;
Janesville, Wisconsin; and Valdosta, Georgia. For more information and
copies of all news releases and financials visit Alpha Pro Tech's
Website at http://www.alphaprotech.com.
Contacts:
Alpha Pro Tech, Ltd.
Al Millar or Donna Millar, 905-479-0654
ir@alphaprotech.com
or
Hayden Communications, Inc.
Matthew Hayden, 843-272-4653 (Investor Relations)
matt@haydenir.com
Brett Maas, 843-272-4653 (Investor Relations)
AEMD NR today
The Treatment of H5N1 Avian Influenza Report: Released by Aethlon Medical
2006-03-15 16:05 ET - News Release
SAN DIEGO -- (Business Wire) -- March 15, 2006
Aethlon Medical, Inc. (OTCBB:AEMD), a pioneer in
developing therapeutic devices for infectious disease, disclosed this
afternoon that Chairman and CEO, James A. Joyce, has authored a report
entitled; The Treatment of H5N1 Avian Influenza. The content of the
report follows:
Summary
The intent of this paper is to analyze how current options for
treating H5N1 Avian Flu infection may influence the commercialization
of the Aethlon Hemopurifier(TM), a therapeutic device targeted to
modulate the immune response and capture circulating H5N1 virus. In
the face of an accelerating pandemic, the present void in effective
H5N1 treatments may dictate that the Hemopurifier(TM), initially
proposed as a treatment for drug resistant patients, evolves into an
important first-line treatment role. Mounting evidence explaining why
H5N1 is often fatal to those infected with the virus reinforces the
opportunity of the Hemopurifier(TM) as an essential weapon in the
treatment arsenal against Avian Flu.
The Threat
Scientists are increasingly worried that the H5N1 strain of Avian
Flu will mutate into a form easily passed between humans, triggering a
global pandemic. It already is unprecedented as an animal illness in
its rapid expansion, and has cost 300 million farmers more than $10
billion during its initial spread through poultry around the world.
World Health Organization (WHO) officials claim the H5N1 strain of
Avian Flu poses a greater challenge to the world than any other
infectious disease, including AIDS. WHO officials confirm that 101 of
180 people have died H5N1 infection as of March 15(h), 2006.
In the face of such dire news, researchers are unraveling the
mystery of why the H5N1 strain of the Avian Flu virus is so lethal. It
appears that H5N1 hyper-activates the immune response, a frightening
trait inherent in the worst pandemic killer known to man, the Spanish
Flu of 1918, which caused the deaths of over 40 million people. To
provide perspective, it has taken 25 years for AIDS related deaths to
rise to such levels. In the case of H5N1 infection, viral sepsis
leading to major organ failure is often the cause of death. This is
triggered when the immune system over-responds to infection by
releasing a cascade of inflammatory cells and chemicals in what is
known as a "Cytokine Storm". As a result, the likelihood of death in
individuals with robust immune systems equals or exceeds the immune
compromised who are normally most susceptible to regular seasonal flu
strains. Unfortunately, antiviral drugs are unable to shut off a
cytokine storm once it has been triggered.
Current Treatments
Antiviral drugs being stockpiled as part of a global strategy to
treat Avian Flu have no therapeutic value once the cytokine storm has
been triggered. At present, only one antiviral, oseltamivir (Tamiflu)
is known to offer some level of effectiveness against the H5N1 strain
of Avian Flu. However, Tamiflu is indicated as a treatment for normal
household varieties of influenza if administered within 48 hours of
first symptoms. The treatment window for an ultra-virulent H5N1 strain
is likely to narrow considerably. Reports already indicate the potency
of Tamiflu against the avian flu virus is reduced, even when taken
after 24 hours of the first symptoms of the disease. H5N1 resistance
to Tamiflu is already being reported in Southeast Asia.
Prolonged incubation combined with a short antiviral treatment
window also concerns researchers. Dr. Tim Uyeki, a medical
epidemiologist with the influenza branch of the Centers for Disease
Control and Prevention (CDC) quoted the following to the Wall Street
Journal; "Patients aren't presenting (symptoms) early in the illness.
If the cytokine storm has already been triggered, antiviral drugs
aren't going to turn it off."
A successful global strategy against H5N1 will, at a minimum, have
to rely on therapeutics that can modulate the overproduction of
cytokines. The March 2, 2006 issue of The Lancet reported that
researchers at the well-regarded Karolinska Institute in Stockholm are
proposing the use of chemotherapy to kill off excess immune cells as a
means to curb the cytokine storm leading to viral sepsis in H5N1
patients. While the concept may seem radical, researchers are likely
to agree that any treatment able to damp down the immune system might
be helpful. Unfortunately, taming the immune system without destroying
defenses against infection has yet to be demonstrated with drugs.
Until other treatments surface, health officials from the United
States and other nations continue a strategy of stockpiling Tamiflu.
To date, the Department of Health and Human Services (HHS) has ordered
12.4 million doses of Tamiflu, and expects to have a stockpile of 20
million doses by the end of 2006. Adjunctive antiviral therapies able
to increase Tamiflu effectiveness will need to surface if these
stockpiles are to offer any hope of widespread benefit. Regardless,
the effectiveness of Tamiflu and other antiviral drugs ends once the
cytokine cascade is triggered.
The Hemopurifier(TM) to Treat Avian Flu
The Hemopurifier(TM) is presently the only proposed treatment for
H5N1 Avian Flu that simultaneously targets the clearance of H5N1 and
the modulation of the cytokine storm. The deployment of the
Hemopurifier(TM) as a treatment for Avian Flu is consistent with a
corporate strategy to evolve the Hemopurifier as a broad-spectrum
treatment for drug and vaccine resistant pathogens. In this context,
the Hemopurifier(TM) was recently awarded the 2006 Technology
Innovation Award by global industry researcher, Frost & Sullivan.
Specific to H5N1 infection, the Hemopurifier(TM) represents a novel
extracorporeal method to mimic and boost the immune response, which
should improve the effectiveness of antiviral drugs when deployed as
an adjunctive therapy. Once a cytokine storm has been triggered, the
Hemopurifier could serve as the first and perhaps only option for
treating H5N1 infected patients. Attributes and considerations for
deploying the Hemopurifier(TM) as a treatment for pandemic flu,
include:
-0-
*T
1. Rapid Clearance of H5N1 - The affinity agents immobilized
within the Hemopurifier(TM) have broad-spectrum capabilities to
capture envelope viruses by binding to glycosolated proteins
that reside on their surface. In the case of H5N1, the virus
capture is directed at two major surface glycoproteins, the
hemagglutinin (HA) and neuraminidase (NA), which are available
binding sites, even in the case of viral mutation. As compared
to normal influenza, longer periods of incubation and
accessibility to circulating virus appear to be the norm in
H5N1 infection. The ability to clear H5N1 virus and viral
fragments prior to cell and organ infection, would decrease
cytokine production, inhibit disease progression, and improve
the effectiveness of Tamiflu and other antiviral drugs.
2. Broad Clearance of Cytokines - The structure of the
Hemopurifier(TM) vastly improves the potential to clear the
full spectrum of deleterious cytokines, as compared to
Hemofiltration techniques indicated as an adjunct treatment for
cytokine induced sepsis since 1990. In fact, the
Hemopurifier(TM) may be an ideal method to modulate cytokine
production, as the pores of the Hemopurifier(TM) fibers are
large enough to allow both cytokines and cytokine aggregates,
unable to be cleared in Hemofiltration, to be separated and
captured from circulation. Non-human studies to document the
capture of cytokines, prevalent in autopsy reports of H5N1
induced deaths, have been initiated by Aethlon researchers.
3. Expedited Regulatory Path - Under the Bioterrorism Act of 2002,
pandemic flu therapies can be developed and financed by the
Project BioShield Act. The guidelines require clinical trials
to only demonstrate safety in man, as traditional efficacy
studies are not plausible or ethical in the case with
pathogenic influenza. Thus, the FDA is permitted to accept
efficacy data from animal models related to drug and vaccine
submissions. In the absence of an animal model, the
Hemopurifier(TM) is positioned to demonstrate the capture of
viruses and cytokines from human blood through closed loop
studies that replicate human treatment. An Avian Flu Industry
Report published by Griffin Securities, suggests that these
regulatory provisions not only provide an accelerated path to
approval, but could also provide government funding for
stockpiling, representing large commercial opportunities for
companies developing Avian Flu therapies.
4. Human Safety Observations - H5N1 Avian Flu is not a call to
arms to initiate drug and vaccine research programs. It's a
siren to deliver therapeutics that are in late stage
development and can be delivered to market. The proposed
treatment of H5N1 with the Aethlon Hemopurifier(TM) would be
based on treatment protocols already established in a human
safety study currently being administered to renal failure
patients co-infected with the Hepatitis-C virus. To date, no
material adverse events have been observed in these patients.
Upon completion of this study, Aethlon will submit the safety
data as part of regulatory submissions to the Food and Drug
Administration (FDA) in an effort to pursue the treatment of
H5N1 Avian Flu and other drug and vaccine resistant viral
conditions. The Company may also seek to commercialize the
Hemopurifier(TM) through regulatory agencies outside of the
United States.
*T
In closing, the ominous threat of an H5N1 pandemic; the absence of
a vaccine; an evolving resistance to a single drug option; and, a
post-infection immune response that triggers a highly fatal cytokine
storm; provides organizations with innovative therapeutics, the
opportunity to demonstrate effectiveness on a global stage. Those who
execute and deliver therapeutics to the market will play an important
role in saving the lives of individuals infected with H5N1 pandemic
influenza.
About Aethlon Medical
Aethlon Medical is developing the first medical device to treat
infectious disease. The device, known as the Hemopurifier(TM), is a
broad-spectrum treatment countermeasure against drug and vaccine
resistant bioweapons, naturally evolving pandemic threats such as H5N1
Avian Flu, and chronic infectious disease targets including
Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). Aethlon
has also initiated research on a second generation Hemopurifier(TM)
that targets the capture of growth factors inherent in the spread of
Cancer. More information on Aethlon Medical and the Hemopurifier(TM)
technology can be found at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and
involve risks and uncertainties. Such forward-looking statements
involve assumptions, known and unknown risks, uncertainties and other
factors which may cause the actual results, performance or
achievements of Aethlon Medical, Inc to be materially different from
any future results, performance, or achievements expressed or implied
by the forward-looking statements. Such potential risks and
uncertainties include, without limitation, the Company's ability to
raise capital when needed, the Company's ability to complete the
development of its planned products, the ability of the Company to
obtain FDA and other regulatory approvals permitting the sale of its
products, the Company's ability to manufacture its products and
provide its services, the impact of government regulations, patent
protection on the Company's proprietary technology, product liability
exposure, uncertainty of market acceptance, competition, technological
change, and other risk factors. In such instances, actual results
could differ materially as a result of a variety of factors, including
the risks associated with the effect of changing economic conditions
and other risk factors detailed in the Company's Securities and
Exchange Commission filings.
Contacts:
Aethlon Medical, Inc.
Jeff Richardson, 858-459-7800 x302
jrichardson@aethlonmedical.com
or
James A. Joyce, 858-459-7800 x301
jj@aethlonmedical.com
GNBT NR today
Generex Biotechnology to Present Its Avian Influenza Vaccine Program at DNA Forum in London
2006-03-14 08:30 ET - News Release
TORONTO -- (MARKET WIRE) -- 03/14/06
http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=113081&ProfileId=051205&am...
Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that Dr. Douglas Powell, Ph.D., Director of Immunobiology at Antigen Express, Inc., the Company's wholly owned immunotherapeutics subsidiary, will present the Antigen Express H5N1 avian influenza vaccine program at the upcoming Third Annual DNA Vaccines Forum to be held in London, UK, March 17 - 18, 2006.
The strategy employed by Antigen Express focusing on the development of its novel H5N1 avian influenza vaccine utilizes small portions of the H5 protein that are modified to enhance antigen-specific stimulation of T-helper cells. Upon infection, such T-helper cell responses enhance the speed and strength of neutralizing antibody production. It is anticipated that the vaccine being developed will both impart some level of protection on its own and enhance the activity of other types of avian influenza vaccines, including DNA vaccines.
The meeting will focus on the latest advances involving DNA vaccine technology as well as clinical experiences and regulatory issues. All vaccines that are currently approved for human use are inactivated or attenuated (weakened) viruses or recombinant protein vaccines. DNA vaccines are a promising new approach with the potential to prevent many infectious diseases such as H5N1 influenza, anthrax and plague. Although a number of DNA vaccines are currently in clinical trials, none have been approved for use in humans. One of the challenges facing the use of DNA vaccines is that the responses generated in humans may be insufficient to prevent infection. To address this issue, scientists have investigated numerous methods to enhance the immunogenicity of DNA vaccines including the use of novel adjuvants and cytokines. For many diseases, including influenza, the generation of neutralizing antibodies produced by B lymphocytes is sufficient to protect against infection. The CD4 T cell response is essential for generating high levels of neutralizing antibodies in addition to eliciting memory T and B cell responses that provide protection against future infections. CD4 T cells recognize MHC class II epitopes presented on the surface of antigen presenting cells. Dr. Douglas Powell and Dr. John Zinckgraf at Antigen Express have demonstrated that immunization of mice with MHC class II epitopes derived from the H5N1 influenza hemagglutinin protein coupled to the proprietary Ii-Key peptide greatly enhances the CD4 T cell responses to a DNA vaccine encoding the H5N1 influenza hemagglutinin protein and may be used as a strategy to increase the immunogenicity of DNA vaccines.
One of the major challenges facing immunization with many of the currently available vaccines is the need for refrigeration, often referred to as maintenance of the cold chain. This is a particularly difficult problem in developing countries with limited medical resources. One of the advantages of a vaccine utilizing peptides and DNA is that both of these components can be lyophilized, stored at ambient temperatures and reconstituted "on-site" with saline. "We have promising data in an animal model suggesting that we will be able to achieve levels of immunity consistent with protection from H5N1," said Dr. Powell. The company has recently completed a pre-IND meeting with the FDA and hopes to enter human clinical trials of its peptide vaccine against H5N1 later this year.
About Generex
Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world. Antigen Express is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutics for the treatment of malignant, infectious, allergic, and autoimmune diseases.
For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
Contact:
Shayne Gilliatt
Generex Biotechnology Corporation
Phone: (800) 391-6755 and (416) 364-2551
Ed Lewis
CEOcast, Inc.
Phone: 1 (212) 732-4300
VAS-T NR today 84m at 2.69
FP/wire say Vasogen holders take hike after test fails
2006-03-14 08:52 ET - In the News
The Financial Post reports in a Bloomberg dispatch Tuesday shares of Vasogen plunged Monday. The unbylined item says the hit came on news its Celacade therapy for treating inflammation failed to help patients with an artery disease walk farther in a treadmill test. Shares on the Toronto Stock Exchange were down 86 cents to $2.69 on volume of 1.2 million shares. The trial of 553 patients with peripheral artery disease missed its main goal of bolstering endurance. The technology did succeed in "significantly" reducing levels of high sensitivity C-reactive protein (hs-CRP), a substance tied to the risk of heart failure, stroke and heart attacks. "The ability to impact hs-CRP levels represents an exciting new feature of our technology," David Elsley, chief executive officer, said in a statement. The stock was already well down in the 12 months preceding Monday's announcement. Monday's decline is the biggest since Aug. 30, 2005, when shares fell nearly half after Vasogen said Celacade did not work against hardening of the arteries. Nigel deGruyther, a health-care analyst at Toronto-based Research Capital, rates the shares a "speculative buy" and does not own any.
Here is a daily 3 month chart of MPH-T
Great chart. They will do well IMHO.
otg: mph is hitting the sweet part of the cup?/saucer bottom?
VAS-T NR today 84m at 3.55
Vasogen Celacade phase III does not meet end point
2006-03-13 05:53 ET - News Release
Mr. Glenn Neumann reports
VASOGEN ANNOUNCES RESULTS FROM PHASE III Simpadico TRIAL IN PERIPHERAL ARTERIAL DISEASE - STUDY DID NOT MEET PRIMARY ENDPOINT - - CELACADE SIGNIFICANTLY REDUCED C-REACTIVE PROTEIN, A WIDELY RECOGNIZED MARKER OF SYSTEMIC INFLAMMATION AND CARDIOVASCULAR RISK -
Vasogen Inc. has released the results from the 553-patient phase III Simpadico trial of its Celacade technology (Celacade) in peripheral arterial disease (PAD). While the Simpadico study did not reach the primary end point of change in maximal treadmill walking distance, Celacade significantly reduced high sensitivity C-reactive protein (hs-CRP), a prespecified end point and a widely recognized marker of systemic inflammation associated with increased cardiovascular risk, including heart failure, stroke and heart attack.
The results are being presented today at a late-breaking clinical trial session of the 55th annual scientific session of the American College of Cardiology in Atlanta, by Dr. Jeffrey Olin, professor of medicine at the Mount Sinai School of Medicine, director of vascular medicine at the Zena and Michael A. Wiener Cardiovascular Institute in New York, and principal investigator and chairman of the steering committee for the Simpadico trial.
"We are obviously disappointed that Celacade was not shown to improve walking distance in PAD, one of the most difficult end points in which to demonstrate a therapeutic benefit," stated Dr. Olin. "It is very interesting to note, however, the finding of a significant reduction in C-reactive protein, a well-recognized inflammatory marker that is associated with increased risk of cardiovascular events. Given this finding, and the fact that otherwise successful therapies have failed to demonstrate a walking distance improvement in PAD, I look forward to the results of the ongoing trial of Celacade in chronic heart failure, where inflammation plays an important role."
Measurement of hs-CRP was included in Simpadico as a prespecified endpoint to assess the impact of Celacade on systemic inflammation. The mean levels of hs-CRP at baseline were well matched at 4.15 milligrams per litre and 4.81 milligrams per litre in the placebo, and Celacade groups, respectively, and these levels are consistent with a patient population at moderate-to-high risk for cardiovascular and PAD events. Mean hs-CRP was reduced by 0.93 milligram per litre in the Celacade group, while it increased by 0.50 milligram per litre in the placebo group (p equals 0.008, placebo versus Celacade, baseline to end of study). A majority of patients were on antiplatelet therapy (82.1 per cent placebo, 77.5 per cent Celacade), predominantly aspirin, and were receiving lipid-lowering therapy (81.3 per cent placebo, 79.8 per cent Celacade), predominantly statins, which are known to reduce hs-CRP levels in cardiovascular conditions, providing evidence that Celacade significantly reduces hs-CRP levels on top of anti-inflammatory pharmaceuticals.
"The high sensitivity C-reactive protein results from the Simpadico study provide compelling evidence that our Celacade technology produces a significant anti-inflammatory effect," said Dr. Jay Kleiman, chief medical officer and head of cardiovascular development for Vasogen. "Although Celacade did not improve walking distance in this study, the clinically significant reduction of a recognized inflammatory marker that is linked to cardiovascular disease risk has important implications for chronic heart failure and other cardiovascular conditions."
The Simpadico study screened 947 patients and randomized 553 subjects. The modified intention-to-treat (mITT) population (n equals 535) that was used for primary data analysis consisted of all patients randomized who received at least one study treatment and had at least one postrandomization treadmill test. The placebo (n equals 273) and Celacade (n equals 262) groups were well balanced for all important baseline characteristics, including demographics, maximal treadmill walking distance (absolute claudication distance, ACD; 321 metres placebo, 303 metres Celacade), smoking history, concomitant medical conditions and medications.
The percentage increase in ACD between baseline and 26 weeks in the mITT group (the primary end point) was not significantly different between Celacade and placebo groups. Similarly, there were no significant differences in the pain-free treadmill walking distance (initial claudication distance, ICD) between the two groups.
The study was also designed to investigate the impact of Celacade on additional prespecified end points, including PAD-related and cardiovascular outcome events. In a time-to-first-event analysis, 84 patients experienced a PAD-related or cardiovascular outcome event during the course of the study, 46 in the placebo group and 38 in the Celacade group. In a similar analysis of only PAD-related outcome events, 20 patients experienced an event, 14 in the placebo group and 6 in the Celacade group. Fifteen of these patients progressed to critical limb ischemia, 12 in the placebo group and 3 in the Celacade group (p equals 0.03).
While changes in quality of life and ankle-brachial index (ABI) did not reach significance in the mITT group, exploratory analysis in the per-protocol group (patients with no major protocol violations and who received a predesignated number of treatments, n equals 416), showed significant changes in several of these measures. Quality-of-life analysis (SF-36, v2), showed a significant difference between Celacade and placebo in the physical functioning (p equals 0.03) and Social Functioning (p equals 0.05) Scores. On the walking impairment questionnaire (WIQ), Celacade was also associated with significant improvements in the distance (p equals 0.02) and Speed (p equals 0.03) domains. There was also a small, but statistically, significant (p equals 0.04) improvement in ABI at 26 weeks in the Celacade group.
Celacade was shown to be well tolerated in this patient population, who were receiving standard-of-care medications for atherosclerosis and PAD, including statins, beta-blockers, anti-platelet agents and ACE-inhibitors. As previously reported in Stockwatch, study treatments were terminated early, based on a recommendation by the study's external safety and efficacy monitoring committee, due to an absence of a sufficiently strong efficacy signal and an observation of an imbalance in the distribution of malignancy cases. An independent review of these cases was conducted at study end by a recognized expert in medical oncology who was not aware of treatment group allocations (blinded). This review concluded that the number and types of malignancies identified in both study arms were consistent with that expected in the study population (18 expected, 40 per cent lung), which is known to be at higher risk for developing malignancy (91 per cent current or ex-smokers, mean age of 67 and predominantly male). The review also confirmed that, although there was no formal screening at baseline for malignancy, there was evidence that indicates a clear prestudy diagnosis of malignancy in eight cases (one placebo, seven Celacade) leaving 10 cases (two placebo, eight Celacade); a distribution that was not statistically different. Of note, the data and safety monitoring board for the recently completed ACCLAIM trial of Celacade involving 2,400 patients has conducted regular reviews and has not expressed any concerns regarding safety.
"The ability to impact hs-CRP levels represents an exciting new feature of our technology, and I look forward with increased enthusiasm to the results from our ACCLAIM trial in heart failure, and to exploring new areas in cardiovascular disease," stated David Elsley, president and chief executive officer of Vasogen. "I would like to thank Dr. Jeff Olin and the members of the steering committee, the central end points committee, the external safety and efficacy monitoring committee, and the clinical investigators for their considerable efforts in the Simpadico program. Most importantly, I thank the patients, without whose dedicated participation in clinical research, no medical advances would be possible."
PTI-T NR today 92m at 6.72
Globe/CP say Patheon brass roasted by angry holders
2006-03-10 08:26 ET - In the News
The Globe and Mail reports in a Canadian Press dispatch Friday executives of Patheon outlined plans to turn around the troubled drug maker at its annual meeting Thursday, but that did not prevent questions from angry shareholders. The unbylined item says last week, the Mississauga-based company reported its first quarterly loss since its inception in 1974. At the meeting, executives said they intend to cut costs, bring in new business and improve efficiency. But some shareholders were not convinced. They hammered chief executive officer Robert Tedford and other executives with questions about Patheon's sliding stock price. They also wanted to know more about the company's Puerto Rican purchase, operational issues at its Canadian plants, and disclosure. "Right now, we're in a period in which we're not getting the growth which we expected. The business doesn't always go up in a straight line," Mr. Tedford said. "Yeah, but yours is going straight down," a shareholder countered. This was one of a handful of heated exchanges. Patheon shres fell eight cents to $6.72 on the Toronto Stock Exchange.
PTI-T NR today 92m at 6.80
Globe says Corus, others get greedy with stock options
2006-03-09 08:22 ET - In the News
See In the News (C-CJR) Corus Entertainment Inc
The Globe and Mail reports in its Thursday, March 9, edition that Corus Entertainment executive chairwoman Heather Shaw earned $1.5-million with Corus stock options 18 months ago. The Globe's Derek DeCloet, in the Vox column, writes that investors who bought shares five years ago, just after the Nelvana deal, have not made a cent. Mr. DeCloet is not meaning to single out Ms. Shaw, but is merely showing "the absurdity of granting stock options with no strings attached." For instance, he calculates that if Corus shares rise five cents a year, the value of Ms. Shaw's options tops $3.1-million by March, 2012. Warren Buffett was right when he said fixed-price options are "a royalty on the passage of time." If an executive in a stagnant company has options that expire in 10 years, he will make a bundle as long as the company buys back shares. Mr. Buffett says good companies should grant options with strike prices adjusted for retained earnings. Mr. DeCloet points out that Onex, Biovail, Patheon, Cott and CanWest Global are all prolific stock options issuers
MS-T NR today 62m at 3.46
Globe says BioMS may be on tail of MS treatment
2006-03-08 08:58 ET - In the News
The Globe and Mail reports in its Wednesday, March 8, edition that BioMS Medical has revealed impressive phase II trial results for its multiple sclerosis treatment. The Globe's Omar El Akkad writes that BioMS may gain access to an untapped health care market worth about $8-billion. The phase II trial shows BioMS's drug, MBP8298, slows the progression of MS for five years in later-stage patients with two common immune response genes. About three-quarters of MS patients have those genes. The trial involved a two-year treatment and five-year follow-up on 20 patients. The University of Alberta and BioMS analyzed the results. Rodman & Renshaw analyst Elemer Piros says the delay in progression of MS is very notable. Usually, an MS patient will reach paraplegia in 25 years. Chairman Clifford Giese founded BioMS when his MS struck his wife. The company has the only phase III trial of a secondary progressive MS treatment in the world. Nearly half of MS patients suffer from secondary progressive MS. Management says, if phase III is as positive as phase II, BioMS will seek regulatory approval for MBP8298 by late 2008. BioMS shares jumped to $3.46 on the Toronto Stock Exchange on March 7.
GNBT NR todat 2.02
Generex Biotechnology Announces Positive Preliminary Results in a Long-Term Clinical Trial of Generex Oral-lyn(TM) in Juvenile Patients With Type-1 Diabetes Mellitus (DM)
2006-03-08 08:45 ET - News Release
TORONTO -- (MARKET WIRE) -- 03/08/06
http://media.marketwire.com/attachments/200603/MOD-248856_JuvenilestrialMar06Chart1.jpghttp://media.marketwire.com/attachments/200603/TN-248857_JuvenilestrialMar06Chart2.jpghttp://media.marketwire.com/attachments/200603/MOD-248857_JuvenilestrialMar06Chart2.jpghttp://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=112475&ProfileId=051205&sourceType=1" target="_blank">http://media.marketwire.com/attachments/200603/TN-248856_JuvenilestrialMar06Chart1.jpghttp://media.m...
Generex Biotechnology Corporation (NASDAQ: GNBT), a leader in the area of buccal drug delivery, announced today positive preliminary results (10 weeks) of a long-term (six month) clinical trial of Generex Oral-lyn, the Company's proprietary oral insulin spray product, in juvenile patients with Type-1 diabetes mellitus (DM).
Generex previously reported the successful replacement, during a 12-day period, of subcutaneously (s.c.) injected pre-prandial regular insulin with Generex Oral-lyn in 10 adult patients with Type-1 DM. The objective of this new study is to document the effects of replacing the lunchtime dose of s.c. injected regular insulin with Generex Oral-lyn in juvenile type-1 DM patients. A comparison between the two different insulin preparations was done initially (3-4 weeks), followed by a six month replacement period with Generex Oral-Lyn at lunchtime. The results of the first ten weeks of the trial are referenced here. As in the previous study, this new study involves a Generex Oral-lyn split-dose treatment, i.e. the application of Generex Oral-lyn spray both before and after each meal. Generex believes that this approach offers a new diabetes treatment paradigm by offering improved efficacy (as Generex Oral-lyn is better at mimicking the healthy body's natural insulin production) and patient compliance (no painful injections) resulting in greater metabolic stability thereby better controlling diabetes and reducing the complications associated with it. Treatment of adolescents with Type-1 DM is challenging and Generex chose to replace the lunchtime dose because it is this dose that is most frequently associated with non-compliance.
This new study is taking place at the Institute of Endocrinology IEMYR in Quito, Ecuador, under the supervision of Dr. Jaime Guevara-Aguirre M.D., the principal Investigator of the study. All of the participants in the study were referred to IEMYR for treatment. The participants are: (a) 24 adolescents (12 males, 12 females) with a mean age of 14.7 years and a mean Body Mass Index (BMI) of 21.7, and (b) five young adults (two males, three females) with a mean age of 20.6 years and a mean BMI of 23.0. The mean age of the entire participant group is 15.7 years and the mean duration of the diabetes mellitus is 6.8 years.
Because the study participants were referred to IEMYR in varying states of diabetic control, it was necessary to metabolically stabilize them using standardized therapy prior to the commencement of the study. Upon referral to IEMYR, each participant received a schedule of baseline insulin glargine in addition to thrice-daily pre-prandial injections of regular insulin. Metabolic stability was achieved by intense monitoring of glucose levels, adjustments to the insulin schedule, and implementation of proper dietary measures. Glucose was monitored frequently (six-point glucose daily profiles for 20 days). Fructosamine and glycosylated hemoglobin (HbA1c) were obtained at the commencement of the stabilization program and after 20 days.
The 29 subjects (2 new subjects were incorporated shortly after the commencement of the study) were metabolically stabilized in a very short period of time (20 days) as documented by important and statistically significant improvements in the six-point daily glucose profiles (p < 0.0005), as well as in protein glycosylation parameters: Fructosamine (p < 0.0001), and HbA1c (p < 0.0001). The decrement in the last two parameters displayed strong correlation. These results were attributed to the improvement in previous insulin schedules, enhanced nutritional advice, and intense glucose monitoring.
After stabilization and an initial four weeks with regular insulin at lunchtime, Generex Oral-lyn replaced the lunchtime injected insulin. The following 10-week results were obtained:
Stabilization Phase s.c. Regular Generex
Insulin Phase Oral-lyn Phase
N Mean SD N Mean SD N Mean SD
27 172.1 75.2 27 172.1 75.2 29 140.4 35.5
27 139.7 50.1 29 140.4 35.5 29 143.3 39.9
Change -32.4 -31.7 2.9
< .0005 < .0001 p =
0.490
The investigators concluded that during the first two and one-half months of this ongoing six-month trial, replacement of subcutaneous injections of regular insulin by Generex Oral-lyn at lunchtime in adolescent and young adult patients with Type-1 DM was associated with overall adequate glycemic control and similar fructosamine and glycosylated hemoglobin (HbA1c) concentrations.
Generex believes that Generex Oral-lyn can make a significant contribution to the achievement and maintenance of metabolic stabilization by providing a safe, simple, fast, effective, flexible, and familiar alternative to pre-prandial insulin injections. As a pain-free and convenient method of insulin delivery, Generex Oral-lyn will allow individual patients to "fine tune" and then maintain their metabolism resulting in an improved quality of life. Accordingly, Generex Oral-lyn provides the opportunity for the establishment of a new and more effective diabetes treatment paradigm.
About Generex
Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.
For more information, visit the Generex Web site at www.generex.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
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Contact:
Shayne Gilliatt
Generex Biotechnology Corporation
Phone: (800) 391-6755 and (416) 364-2551
Ed Lewis
CEOcast, Inc.
Phone: 1 (212) 732-4300
AEMD NR today .47
Aethlon Medical To Provide Corporate Update at the North America Investing & Partnering in Biotech Conference
2006-03-07 13:30 ET - News Release
SAN DIEGO -- (Business Wire) -- March 7, 2006
Aethlon Medical, Inc., (OTCBB:AEMD) a pioneer in
developing therapeutic devices for infectious disease, announced today
that its Chairman and CEO, James A. Joyce, will provide a corporate
update on March 13th at the North America Forum for Investing &
Partnering in Biotech and Medtech Conference. The venue for the
conference is the Fairmont Copley Plaza Hotel in Boston,
Massachusetts. Mr. Joyce's presentation is scheduled to begin at
4:20pm EST. A "live" web-cast link to the presentation will be
disclosed in a separate news release prior to the conference.
Additional conference details can be accessed at
www.sachsforum.com/boston06.html.
About Aethlon Medical
Aethlon Medical is developing the first medical device to treat
infectious disease. The device, known as the Hemopurifier(TM), is a
broad-spectrum treatment countermeasure against drug and vaccine
resistant bioweapons, naturally evolving pandemic threats such as H5N1
Avian Flu, and chronic infectious disease targets including
Hepatitis-C (HCV) and the Human Immunodeficiency Virus (HIV). More
information on Aethlon Medical and the Hemopurifier(TM) technology can
be found at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and
involve risks and uncertainties. Such forward-looking statements
involve assumptions, known and unknown risks, uncertainties and other
factors which may cause the actual results, performance or
achievements of Aethlon Medical, Inc to be materially different from
any future results, performance, or achievements expressed or implied
by the forward-looking statements. Such potential risks and
uncertainties include, without limitation, the Company's ability to
raise capital when needed, the Company's ability to complete the
development of its planned products, the ability of the Company to
obtain FDA and other regulatory approvals permitting the sale of its
products, the Company's ability to manufacture its products and
provide its services, the impact of government regulations, patent
protection on the Company's proprietary technology, product liability
exposure, uncertainty of market acceptance, competition, technological
change, and other risk factors. In such instances, actual results
could differ materially as a result of a variety of factors, including
the risks associated with the effect of changing economic conditions
and other risk factors detailed in the Company's Securities and
Exchange Commission filings.
Contacts:
Aethlon Medical, Inc.
Jeff Richardson, 858.459.7800 x302
jrichardson@aethlonmedical.com
James A. Joyce, 858.459.7800 x301
jj@aethlonmedical.com
GNBT NR today 2.24
Generex Biotechnology Completes Positive Pre-NDS Meeting With Health Canada for Generex Oral-lyn(TM)
2006-03-03 08:45 ET - News Release
TORONTO -- (MARKET WIRE) -- 03/03/06
http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=111920&ProfileId=051205&am...
Generex Biotechnology Corporation (NASDAQ: GNBT) announced today that on March 1, 2006 the Company concluded a positive Pre-New Drug Submission (NDS) meeting with the Regulatory Affairs Division of the Biologics and Genetic Therapeutics Directorate of Health Canada in respect of Generex Oral-lyn(TM), the Company's proprietary oral insulin spray product for the treatment of diabetes.
The purpose of the Pre-NDS meeting was to review the current status of Generex Oral-lyn(TM) with a view to determining what will be required for a successful New Drug Submission which will allow Generex Oral-lyn(TM) to be marketed and distributed in Canada.
"The informed and vigorous engagement of the Health Canada representatives in our meeting was most gratifying," said Anna Gluskin, Generex President & Chief Executive Officer. "We now have clearly defined objectives in a roadmap to a successful New Drug Submission for Generex Oral-lyn(TM) and we will move expeditiously to achieve those objectives and prepare the NDS." The NDS will include all clinical data, bio-statistical analyses, sample batches, chemistry, manufacturing and controls (CMC), production schedules, and medical device licensing."
The Company expects that the NDS documentary package, together with the April, 2005 approval of Generex Oral-lyn(TM) by the Ecuadorian Ministry of Public Health, will advance similar filings for regulatory approvals with the United States Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA).
About Generex
Generex is engaged in the research and development of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist(TM) device. The Company's flagship product, oral insulin (Oral-lyn(TM)), which has been approved for commercial sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes, is in various stages of clinical trials around the world.
For more information, visit the Generex website at www.generex.com.
Safe Harbor Statement: This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plans," "intends," "believes," "will," "estimates," "forecasts," "projects" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
Contact:
Shayne Gilliatt
Generex Biotechnology Corporation
Phone: (800)391-6755 and (416)364-2551
Ed Lewis
CEOcast, Inc.
Phone: 1 (212)732-4300
NVAX NR today 5.77
Novavax and Bharat Biotech Announce Strategic Alliance for Pandemic Influenza Vaccine Development
2006-03-06 07:00 ET - News Release
HYDERABAD, India and MALVERN, Pa., March 6 /PRNewswire-FirstCall/ -- Novavax, Inc. and Bharat Biotech International Limited (BBIL), today jointly announced a strategic alliance to pursue the rapid development of pandemic influenza vaccine for India and certain other south Asian markets. Under the terms of the agreement, BBIL will fund 100% of the pre-clinical and clinical studies for these markets and assist in developing an efficient manufacturing process for the Virus-Like Particle (VLP) based influenza vaccine. BBIL will be responsible for the sale and distribution of the vaccine in India and other surrounding countries. Novavax will receive unrestricted access to all pre-clinical and clinical data generated by BBIL and will receive a double digit royalty on all future sales located within BBIL's geographic territories.
Cases of avian influenza (Bird Flu) in poultry and humans have been occurring sporadically throughout the world, prompting the World Health Organization to call avian flu the greatest concern to human health. There are at least 16 Hemagglutinin and 9 Neuraminidase genes within various subtypes of influenza viruses known to circulate in wild waterfowl, each with the potential to infect and cause severe disease in poultry and humans. Three avian influenza subtypes (H9N2, H7N7, and H5N1) have transmitted to humans in recent years and are considered major threats for a pandemic outbreak.
Novavax's Virus-Like Particle Vaccines use recombinant DNA technology to produce antigenic structures that mimic a virus to produce a protective immune response without the risk of infection or disease. Viral proteins can self-assemble into VLPs when over-expressed in certain cells. The use of VLP technology has already been proven with the success of the Hepatitis B vaccine. In addition, the developmental Human Papilloma Virus vaccines are also based on VLP technology. This is the first time that VLP technology has been applied to create an influenza virus vaccine. The technology is a particularly good fit for addressing pandemic influenza because it obviates the reliance on the supply of embryonated eggs for the production of the vaccine. Novavax has recently adopted a manufacturing process that reduces contamination risk and produces high, cost-effective yields of the influenza VLP vaccine (See Press Releases dated September 13, 2005 and February 28, 2006). In addition, this technology can be used to rapidly create vaccines against emerging threats or new strains of existing pathogens.
Commenting on the agreement, Dr. M.K. Bhan, Secretary, Department of Biotechnology, Government of India said, "This is a very positive development. In the spirit of combining global expertise to collectively combat the threat posed by the rapidly spreading avian influenza virus, the department of biotechnology and the Government of India stand ready to provide all enabling support to ensure the success of this partnership between Novavax and BBIL".
Dr. Rahul Singhvi, President and CEO of Novavax said, "We are delighted that BBIL has chosen Novavax's VLP and Novasome(R) adjuvant technologies to develop, produce, and distribute a vaccine against H5N1 and other strains of avian influenza for the Indian population. BBIL has established itself as a leader in adopting innovative vaccine technologies as evidenced by their collaborations with Wyeth and Acambis. We believe that by leveraging the clinical, process and manufacturing capabilities of BBIL, we will be able to expedite the development and regulatory approval of our VLP-based pandemic influenza vaccines around the world".
Dr. Krishna M. Ella, Chairman and Managing Director of Bharat Biotech International Ltd, said "We are extremely pleased to announce this unique partnership between Novavax and BBIL, with the guidance and support of the Department of Biotechnology, Government of India. This agreement between our companies is bigger than just business. It is an attempt to bring together capabilities of two different organizations across the world to address the global public health and economic threat posed by pandemic influenza. Novavax's VLP technology is clearly one of the most effective in addressing emerging strains of the virus and BBIL's proven capabilities in process development, clinical development, and manufacturing infrastructure will help expedite the availability of a VLP-based vaccine for pandemic influenza to the Indian public and the world at large. By joining hands with Novavax, BBIL would be making, in a modest way, its contribution to the cause of Public Health in India and the Developing World".
This alliance will be overseen by a Steering Committee chaired by Dr. Richard Klausner, eminent scientist and Former Executive Director of the Bill and Melinda Gates Foundation and Former Director of the US National Cancer Institute. Dr. Klausner is a special advisor to both the Government of India and to Novavax, Inc. Commenting on this agreement, Dr. Klausner said "I am heartened by this partnership between Novavax and BBIL. I have had a chance to work with each of these organizations and I know the principals in both firms well. These organizations and their management teams are serious in their commitment and are uniquely suited to develop a vaccine against pandemic influenza. I am confident that by combining their mutual capabilities and by working closely with the Department of Biotechnology, Government of India, they will be more effective in arriving at a solution for the good of public health worldwide".
About Virus-Like Particle (VLP) Technology
Novavax's VLP vaccine technology utilizes recombinant DNA to present components of the influenza virus in three-dimensional virus-like structures optimized to elicit a protective immune response without the risk of infection and without the addition of chemical adjuvants. Using the proprietary process associated with this VLP technology, Novavax intends to further develop vaccines which can be produced aseptically, thereby reducing contamination risk, while achieving high, cost-effective yields.
About Novavax, Inc.
Novavax is focused on creating differentiated, value-added pharmaceutical and vaccine products and technologies. The Company's platforms include the virus-like particle manufacturing technology utilizing the baculovirus expression system in insect cells, as well as novel vaccine adjuvants based on Novasomes and dendrimers. The Company is developing vaccines against the H5N1 and other strains of avian influenza and human seasonal influenza viruses using its VLPs and Novasomes. Novavax's drug delivery platforms include the micellar nanoparticle (MNP) technology which is the basis for the development of its first FDA-approved product, Estrasorb(R). In addition to MNP, Novavax drug delivery technologies include Novasomes (paucillamellar non-phospholipid vesicles) and Sterisomes(R) (subcutaneous depot injection). The company has several products utilizing the MNP technology in various stages of development.
About Bharat Biotech International Inc.
Bharat Biotech International Limited based in Hyderabad, India, is a privately held, multidimensional biotechnology company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics. Bharat is engaged in developing next-generation vaccines and biotherapeutics through innovative and collaborative research. Bharat's state-of-the-art manufacturing plant is the largest of its kind in Asia-Pacific. The first bio-pharma facility in the country to be audited and approved by Korean Food & Drugs Administration (KFDA), it sprawls over a picturesque campus at Genome Valley, Hyderabad. Built with an investment of over INR 1000 million, the facility's manufacturing, control procedures and protocols, conform to the stringent standards laid down by internationally recognized institutions such as USFDA, UKMCA, and WHO. Bharat has set new benchmarks in Innovation and Quality that epitomizes the tremendous progress of Indian biotechnology in the global arena.
Forward Looking Statements
Statements made in this press release that state Novavax's or management's intentions, hopes, beliefs, expectations, or predictions of the future are forward-looking statements. Forward-looking statements include but are not limited to statements regarding usage of cash, product sales, future product development and related clinical trials and future research and development, including FDA approval. Novavax's actual results could differ materially from those expressed in such forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from those expressed or implied by such forward-looking statements. Such factors include, among other things, the following: general economic and business conditions; ability to enter into future collaborations with industry partners, competition; unexpected changes in technologies and technological advances; ability to obtain rights to technology; ability to obtain and enforce patents; ability to commercialize and manufacture products; ability to establish and maintain commercial-scale manufacturing capabilities; results of clinical studies; progress of research and development activities; business abilities and judgment of personnel; availability of qualified personnel; changes in, or failure to comply with, governmental regulations; the ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity financing or otherwise; and other factors referenced herein. Additional information is contained in Novavax's annual report on Form 10K for the year ended December 31, 2004 and quarterly reports on Form 10Q for the quarters ended March 31, 2005 and June 30, 2005 and September 30, 2005 incorporated herein by reference. Statements made herein should be read in conjunction with Novavax's annual and quarterly reports filed with the SEC. Copies of these filings may be obtained by contacting Novavax at 508 Lapp Road, Malvern, PA 19355 Tel 484-913-1200 or the SEC at www.sec.gov.
Novavax, Inc.
CONTACT: Kathy Hamilton, Investor Relations of Novavax Inc.,
+1-484-913-1213, khamilton@novavax.com; or Dr. V. Krishna Mohan, President
of Bharat Biotech International Inc, +91-40-2348-0567,
kmohan@bharatbiotech.com
Web site: http://www.novavax.com//
QLT.T NR today 91m at 8.38
QLT Eligard injunction stays put for now
2006-03-07 05:12 ET - News Release
Ms. Tamara Hicks reports
QLT UPDATES ON THE U.S. ELIGARD(R) PATENT LITIGATION; TEMPORARY SUSPENSION OF ELIGARD SALES IN THE U.S. BY SANOFI-SYNTHELABO
The Court of Appeal has informed QLT Inc.'s subsidiary, QLT USA Inc., that the injunction against promoting, manufacturing, selling and offering for sale Eligard has been stayed pending its decision to grant a permanent stay of the injunction. Also, QLT USA's marketing partner for Eligard in the United States, Sanofi-Synthelabo Inc., has advised QLT USA that it is suspending sales of Eligard in the United States until the expiry of TAP Inc.'s patent, United States patent No. 4,728,721, on May 1, 2006.
As mentioned in QLT's news issued in Stockwatch on Feb. 22, 2006, Sanofi-Synthelabo informed QLT USA that, unless the court explicitly permits the continued sale of Eligard, or a licence is granted, it may elect to suspend Eligard sales in the United States until the '721 patent expires.
On Feb. 27, 2006, the United States District Court for the Northern District of Illinois Eastern Division granted an injunction enjoining QLT, Sanofi-aventis and their subsidiaries from promoting, manufacturing, selling and offering for sale QLT USA's Eligard product in the United States until the '721 patent expires on May 1, 2006.
QLT USA and Sanofi-Synthelabo intend to continue to vigorously defend this case, and to seek an appeal of the adverse judgment in the Court of Appeals.
We seek Safe Harbor.
Good chart. Sage feel free to post updates. Thanks.
I've noticed that we often have an up day in the medicals when everything else is down LOL Good for my pf.
The amex pharma index, $drg is long term bullish.
PTI-T NR today 92m at 6.67
Globe/CP say Patheon posts third quarter loss
2006-03-06 08:40 ET - In the News
The Globe and Mail reports in a Canadian Press dispatch Saturday a pack of troubles continued to plague Toronto drug maker Patheon in the first quarter. The unbylined item says the firm posted a big loss and its battered stock took a hit. The woes will not end for some time, Patheon said Friday, with lower growth expected for the near term. Patheon confirmed projections that production problems at its plants in Puerto Rico and elsewhere would hamper its bottom line. Patheon reported a loss of $11.5-million (U.S.) or 12.4 U.S. cents a share in the quarter. That compares with a profit of $6-million (U.S.) or 8.7 U.S. cents for the same period last year. Revenue rose 3 per cent to $157.9-million (U.S.), from $153.9-million (U.S.), below the company's expectations. Patheon shares fell 21 Canadian cents to $6.67 (Canadian).
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Symbol Close St Pr Chg ca:CVQ 3.44 4.15 -0.71 ca:DDS 9.93 7.11 2.82 ca:LOR 0.36 0.30 0.06 ca:MPH 1.71 1.44 0.27 ca:NRI 0.42 0.62 -0.20 ca:ONC 3.9 5.07 -1.17 ca:PTI 7.22 8.10 -0.88 ca:QLT 0.14 7.27 -7.13 ca:SSB 0.43 0.60 -0.17 ca:VAS 2.19 2.35 -0.16 us:AEMD 0.43 0.47 -0.04 us:APT 2.46 2.62 -0.16 us:HEB 2.67 2.19 0.48 us:EMFP 1.8 0.72 1.08 us:NVAX 5.28 3.98 1.30 us:GNBT 1.87 0.90 0.97 ca:RBM 0.81 0.57 0.24 ca:IEX 0.40 0.56 -0.16
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