AVII - Sector: Healthcare --- Industry: Biotechnology & Drugs

[setravis]

Press Release Source: AVI BioPharma, Inc.


AVI BioPharma and Cook Group Enter Into License Agreement to Develop NEUGENE Drugs for Vascular Diseases
Monday March 13, 9:00 am ET 
Cook to Fund All Clinical Development of Three Products for Cardiovascular Restenosis and Develop Products for Peripheral Vascular Diseases


PORTLAND, Ore.--(BUSINESS WIRE)--March 13, 2006--AVI BioPharma, Inc. (Nasdaq: AVII - News), today announced that it has entered into agreements with Cook Group Inc. (Cook) for Cook's development and commercialization of products for vascular diseases. Cook has specifically licensed AVI's NEUGENE® antisense technology for down-regulating c-myc gene expression in the field of cardiovascular disease. Cook will take over clinical development of AVI's device-related programs for cardiovascular restenosis, including its Resten-NG® drug-eluting stent (DES) program, Resten-MP(TM) microparticle delivery program and its new program for catheter delivery of Resten-NG.


Cook will fully fund the development, clinical and regulatory costs of these programs in the U.S. and Europe leading to commercialization. This funding is expected to result in expenditures by Cook that could reach $100 million.

Cook has also entered into a supply agreement to purchase the drugs for development, clinical studies and commercialization from AVI. Because of the drugs' established Phase II clinical efficacy, AVI has forgone certain near-term milestone payments in favor of a double-digit royalty on worldwide product sales and a commercialization milestone. Cook will purchase 692,003 shares of AVI common stock for $5 million under a stock purchase agreement. Cook will take over AVI's facilities and personnel at its Colorado site. Additional terms of the agreements were not disclosed.

"Based upon promising Phase II clinical data in combating cardiovascular restenosis and progress in our drug-eluting stent and Resten-MP programs, AVI has now partnered its device-related cardiovascular programs with one of the pre-eminent vascular device companies in the world," said Denis R. Burger, Ph.D., chief executive officer of AVI. "Together, Cook's device expertise and AVI's antisense technology become a formidable combination to address vascular diseases on many fronts."

AVI will narrow its internal cardiovascular focus exclusively to its coronary artery bypass graft (CABG) program, which is moving into Phase II clinical trials later this year. This agreement also enables AVI to apply resources more aggressively toward the company's infectious disease program, focusing on hepatitis C and influenza A, including avian influenza type H5N1.

Resten-NG (AVI-4126) is a third-generation antisense agent that targets the key regulatory gene involved in cardiovascular restenosis, the transcription factor referred to as c-myc. It is believed that it regulates the many downstream genes which produce the pathology of restenosis, namely cell migration and adhesion, collagen formation, secretion of extra-cellular matrix, and cell proliferation, among others. The c-myc gene expression is immediately activated by the injury to the vascular lining during angioplasty and stent placement and peaks at 24 to 48 hours before subsiding. NEUGENE antisense drugs are particularly suited to prevent this process because they can be delivered immediately following injury to the angioplasty site by a variety of means including catheter and stent elution, or by systemic delivery using AVI's microparticle delivery system, Resten-MP.

"Based upon our preliminary investigation, we believe that Resten-NG (AVI-4126) has great potential for use on drug-eluting stents to reduce restenosis of stented vessels," said Bill Cook, CEO of Cook Group Inc. "AVI's NEUGENE antisense drug therapies also have potential to treat stenotic vessels systematically via catheter. Our company is honored to be a partner with AVI in the exploration of new, antisense vascular therapies."

Joseph B. Horn, AVI's vice president of cardiology who recently joined AVI from Cook, will be rejoining Cook to advance these programs through clinical development and into commercialization. While at Cook, Horn was responsible for the introduction of Cook cardiology products worldwide. In addition, Horn worked with Cook medical researchers and physicians in the management of clinical studies of new medical devices. Previously, Horn spent eight years as president and CEO for Global Therapeutics, a medical device company that he founded and which was acquired by Cook in 1998.

"I'm thrilled to be rejoining Cook with the team I've assembled to complete the mission that I started at AVI in the field of cardiology in the near term, and in all areas of vascular medicine in the longer term," Horn said. "Moving AVI's cardiovascular program forward in both Europe and the United States will be my initial priority, and I'm pleased to be surrounded by a talented team of professionals with cutting-edge technology to apply clinically. I believe this is a win-win scenario for both companies"

About Cook Group

The world's largest privately held manufacturer of medical devices with international headquarters in Bloomington, Ind., COOK® (www.cookmedical.com) is a leading designer, manufacturer and global distributor of minimally invasive medical device technology for diagnostic and therapeutic procedures. Since its founding in 1963, Cook has created innovative technologies for drug-eluting and bare metal stents, aortic and vascular endografts, catheters, wire guides, introducer needles and sheaths, embolization coils, medical biomaterials and contract manufacturing of biopharmaceuticals, vena cava filters and other minimally invasive medical devices for radiology, cardiology, urology and OB/GYN, critical care medicine, surgery, gastroenterology, bone access and endovascular therapies.

About AVI BioPharma

AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NEUGENE antisense drugs. AVI's lead NEUGENE antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis, cancer and polycystic kidney disease. In addition to targeting specific genes in the body, AVI's antiviral program uses NEUGENE antisense compounds to combat disease by targeting single-stranded RNA viruses, including West Nile virus, hepatitis C virus, dengue virus, Ebola virus and influenza A virus. AVI has introduced a NEUGENE-based exon-skipping technology called ESPRIT therapy. More information about AVI is available on the company's Web site at http://www.avibio.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the company's Securities and Exchange Commission filings.

Contact:
AVI BioPharma, Inc.
Michael Hubbard, 503-227-0554
[email protected]
or
Cook Group Inc.
Director of Public Relations
David McCarty, 812-339-2235 ext. 2387
[email protected]
or
Investors:
Lippert/Heilshorn & Associates Inc.
Bruce Voss, 310-691-7100
[email protected]
or
Jody Cain, 310-691-7100
[email protected]
or
Press:
Waggener Edstrom Worldwide
Bioscience and Healthcare Practice
Jenny Moede, 503-443-7000
[email protected]

--------------------------------------------------------------------------------
Source: AVI BioPharma, Inc.

[setravis]

bizjournals.com
AVI BioPharma partners to commercialize heart therapies
Monday March 13, 2:36 pm ET


AVI BioPharma Inc. has an agreement with Cook Group Inc. in which Cook will develop and commercialize AVI's treatments for vascular diseases.
Bloomington, Ind.-based Cook will take over clinical development of Portland-based AVI's (NASDAQ: AVII - News) device-related programs for cardiovascular restenosis.


Privately held Cook will fully fund the development, clinical and regulatory costs of these programs in the United States and Europe leading to commercialization. Expenditures by Cook could reach $100 million.

Cook will purchase 692,003 shares of AVI common stock for $5 million under a stock purchase agreement and will take over facilities and personnel at AVI's Colorado site.

AVI will narrow its internal cardiovascular focus exclusively to its coronary artery bypass graft program, which is moving into Phase II clinical trials later this year. This agreement also enables AVI to apply resources more aggressively toward the company's infectious disease program, focusing on hepatitis C and influenza A, including avian influenza type H5N1.

Joseph B. Horn, AVI's vice president of cardiology who recently joined AVI from Cook, will be rejoining Cook to advance these programs through clinical development and into commercialization. While at Cook, Horn was responsible for the introduction of Cook cardiology products worldwide.

Published March 13, 2006 by The Business Journal


Headline News Link....http://finance.yahoo.com/q/h?s=AVII

[setravis]

I feel the market is going to rally this week, JMHO of course...
but if I am right about the market rallying this week, this one will fly.
Back above the 50-dma

Technicals
Gap Up
Percentage Gainer

Last Price Quote is:
-0.27%below 13-day EMA
6.51%above 50-day EMA
RS Rating: 98 

Fundamentals
Key Data:
Market Cap (M): $284.11 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/08/2006
Last Analyst Rating: Mkt Outperform

[rickjust]

hi,
i hope your right .bought this morning at 692 .
too high?
max

[setravis]

hi,
i hope your right .bought this morning at 692 .
too high?
max

I hope I'm right too....all is JMHO
I think you picked a nice time to enter Rickjust .
Good luck with your trade my friend.....Let's make some mooola!!!!

[rickjust]

hi,
sold this morning break even. didn't like the small gap up on low volume. seems often an indication of todays action.
glta
maxi

[setravis]

AP
Investors Buy Into Bird Flu
Monday March 20, 4:48 pm ET 
Bird Flu Vaccine Maker Shares Jump on Heightened Fears


NEW YORK (AP) -- As U.S. health and government officials nervously wait for the bird flu to land on U.S. soil, investors wasted no time in buying up shares of companies working on avian flu vaccines and treatments.

Shares of companies such as Novavax and Generex Biotechnology Corp., both of which hit new year-highs, must have seemed particularly attractive investments given the FDA's announcement on Monday that it has prohibited the use of human antiviral drugs on animals.

Hemispherx Biopharma Inc. shares, which have traded between $1.25 and $4.05 over the last year, closed up 44 cents, or 13 percent, at $3.87 on the American Stock Exchange. AVI Biopharma Inc. shares, which have traded between $2.05 and $9.20 over the last year, closed up 48 cents or nearly 8 percent, at $6.82.

Meanwhile, Generex shares rose 39 cents to close at $3.33 on the Nasdaq. Earlier in the session, they set a new 52-week high of $3.33.

Carrington Laboratories Inc. shares surged up 56 cents, or 8.5 percent, to close at $7.18 on the Nasdaq.

Novavax Inc. shares, which have traded between 70 cents and $7.55 over the last year, soared 95 cents, or 13 percent, to close at $8.31 on the Nasdaq.

Poultry producers as well traded higher, albeit much more modestly. Tyson Foods Inc. shares closed up 19 cents at $13.55 on the New York Stock Exchange, while Smithfield Foods Inc. shares rose 59 cents, to $28.70, also on the NYSE. Pilgrim's Pride Corp. shares were up 16 cents, at $22.32 also on the Big Board.

Another big beneficiary from the bird flu scare was pork producer Premium Standard Farms Inc., which saw its shares shoot up $1.48, or 8.5 percent, to $18.93 on the Nasdaq.

Over the weekend, avian flu infections were found in Israel, and another suspected case of avian flu was found in Egypt.

Health officials have warned that it may only be a matter of time before the avian flu hits the U.S.

[setravis]

A great vehicle to use as a speculative investment in a rally.
Looks like a pullback opportunity in this speculative stock, IMHO... 

Volume: 2,088,430
Avg Vol (3m): 3,173,730

Technicals
Last Price Quote is:
-1.38%below 13-day EMA
2.53%above 50-day EMA
RS Rating: 97 

Fundamentals
Key Data:
Market Cap (M): $280.13 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/08/2006
Last Analyst Rating: Mkt Outperform

 

[setravis]

Volume: 4,130,026
Avg Vol (3m): 3,199,410

Technicals
Close Above the 50-day EMA

Last Price Quote is:
2.46%above 13-day EMA
6.33%above 50-day EMA
RS Rating: 98 

Fundamentals
Key Data:
Market Cap (M): $280.13 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/08/2006
Last Analyst Rating: Mkt Outperform

[setravis]

Symmetrical Triangle (continuation) Pattern .........Breakout !! 
AVII announces break through on Avian Flu......
MACD and Stochastic have bottomed.

Volume: 12,131,051..........
Avg Vol (3m): 3,283,420

Technicals
Most Actives
Gap Up
Percentage Gainer

Last Price Quote is:
13.57%above 13-day EMA
15.41%above 50-day EMA
RS Rating: 98 

Fundamentals
Key Data:
Market Cap (M): $293.83 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/08/2006
Last Analyst Rating: Mkt Outperform

[setravis]

Press Release Source: AVI BioPharma, Inc.


AVI BioPharma Reports Successful Inhibition of Multiple Subtypes of Influenza A Using NEUGENE Antisense Therapeutic
Thursday March 30, 9:00 am ET 
Preclinical Results by Four Independent Laboratories Summarized and Presented at Keystone Symposia: Advances in Influenza Research


PORTLAND, Ore.--(BUSINESS WIRE)--March 30, 2006--AVI BioPharma, Inc. (Nasdaq:AVII - News), today announced the presentation of research results titled "Inhibition of Multiple Subtypes of Influenza A Virus in Cell Culture with Morpholino Oligomers" at the Keystone Symposia conference "Advances in Influenza Research: From Birds to Bench to Bedside." The symposium will be held March 28 to April 2, 2006, in Steamboat Springs, Colo.


"Our presentation summarizes the results from AVI's collaborations with four independent research laboratories from around the world," said Patrick L. Iversen, Ph.D., senior vice president of research and development at AVI. "The key finding here is that our NEUGENE® therapeutics continue to show efficacy against all strains of influenza A, including H5N1, the avian influenza strain that is currently causing global concern as a potential pandemic pathogen."

The poster presentation includes results generated by researchers at the Massachusetts Institute of Technology, Cambridge, Mass.; Mahidol University, Bangkok, Thailand; the Public Health Agency of Canada, Winnipeg, Manitoba; and Oregon State University, Corvallis, Ore.

The summary results show that AVI's NEUGENE agents targeting a highly conserved region in the genetic start-site of influenza A viruses were highly effective in inhibiting replication of multiple influenza A subtypes, including H1N1, H3N2, H3N8, H5N1 and H7N7. This suggests that a single NEUGENE agent could be developed to inhibit replication of multiple strains of Influenza A virus.

Based on these findings, as well as the results generated by additional studies in other viruses, AVI plans to file an IND application with the FDA later this year for the treatment of influenza A virus using NEUGENE antisense drugs.

About Influenza A Viruses

Influenza, or flu, is a contagious respiratory illness caused by influenza viruses. On average 5 percent to 20 percent of the U.S. population are infected with the flu each year, resulting in 36,000 deaths. Influenza A virus is an enveloped negative-strand RNA virus, with eight genome segments that code for 10 proteins. Influenza strains are subtyped according to the antigenic and genetic nature of their surface glycoproteins: hemagglutinin (HA or H) and neuraminidase (NA or N). Fifteen H and nine N subtypes have been identified, with three associated with widespread human disease (H1N1, H2N2 and H3N2). In addition, several subtypes of avian influenza virus -- H5N1, H7N7 and H9N2 -- can infect and cause disease in humans.

The current influenza pandemic in birds throughout Asia and in Eastern Europe is caused by the H5N1 subtype. It is thought that co-infection of man or certain animals (such as pigs) with both H1N1 and H5N1 can lead to a reassortment or recombination of viral particles, resulting in the emergence of virus with dangerous public health properties, namely new antigens to which the human population does not have immunity and which have the ability to spread from person to person. It is believed that emergence of avian flu by this general mechanism may have led to the worldwide pandemics of 1918, 1957 and 1968.

About AVI BioPharma

AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NEUGENE antisense drugs. AVI's lead NEUGENE antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis, cancer and polycystic kidney disease. In addition to targeting specific genes in the body, AVI's antiviral program uses NEUGENE antisense compounds to combat disease by targeting single-stranded RNA viruses, including West Nile virus, hepatitis C virus, dengue virus, Ebola virus and influenza A virus. AVI has introduced a NEUGENE-based exon-skipping technology called ESPRIT therapy. More information about AVI is available on the company's Web site at http://www.avibio.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the results of research and development efforts, the results of preclinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the company's Securities and Exchange Commission filings.

Contact:
AVI BioPharma, Inc.
Michael Hubbard, 503-227-0554
[email protected]
or
Lippert/Heilshorn & Associates Inc. (Investor Contacts)
Bruce Voss, 310-691-7100
[email protected]
or
Jody Cain, 310-691-7100
[email protected]
or
Waggener Edstrom Worldwide (Press Contacts)
Bioscience and Healthcare Practice
Andie Long, 202-326-0791
[email protected]

--------------------------------------------------------------------------------
Source: AVI BioPharma, Inc.

[setravis]

AVI BioPharma reports successful research results of Influenza virus, shows efficacy against Avian (AVII) 6.59 : Co announces presentation of research results titled "Inhibition of Multiple Subtypes of Influenza A Virus in Cell Culture with Morpholino Oligomers". Co's Senior VP of Research comments, AVI. "The key finding here is that our NEUGENE therapeutics continue to show efficacy against all strains of influenza A, including H5N1, the avian influenza strain that is currently causing global concern as a potential pandemic pathogen."

[setravis]

AP
AVI BioPharma Up Bird Flu Trial Plan
Thursday March 30, 1:54 pm ET 
AVI BioPharma Inc. Shares Rise on Plans to Apply to the FDA for a Flu Drug Trial This Year


PORTLAND, Ore. (AP) -- Shares of AVI BioPharma Inc. jumped Thursday after the biotech company said it plans to file papers with the Food and Drug Administration this year to begin clinical trials of its Neugene line of antisense drugs.


AVI BioPharma rose 79 cents, or 12 percent, to $7.38 in afternoon trading on the Nasdaq at more than double their average volume. Shares have traded between $2.05 and $9.20 over the past 52 weeks.

The company said it will base the application on lab studies showing that Neugene antisense drugs are effective in stopping the replication of influenza viruses, including the bird flu virus strain H5N1. Antisense drugs interfere with genetic processes to stop the manufacture of harmful proteins.

Shares of other biotechnology companies developing products to fight bird flu, such as Hemispherx Biopharma Inc. and Novavax Inc., also rose.

Shares of Hemispherx BioPharma rose 10 cents, or 2.8 percent, to $3.66 on the American Stock Exchange, and Novavax shares grew by 33 cents, or 4.4 percent, to $7.84 on the Nasdaq.

[la-onda]

AVI BioPharma Stock Flies High On Bird Flu Test Results
Friday , March 31, 2006 00:19 ET

Mar 31, 2006 (financialwire.net via COMTEX) -- March 31, 2006 (FinancialWire) AVI BioPharma, Inc. (NASDAQ: AVII) cracked the top 25 volume leaders on the NASDAQ exchange. It led percentage gainers with 15.78% on volume of 12,151,176, over three times its average, closing at $7.63 on the news that its Neugene agents were effective in inhibiting replication of multiple influenze A subtypes.
The research results were presented at the Keystone Symposia in Steamboat Springs, Colorado, scheduled March 28
Based on the findings, as well as the results generated by additional studies in other viruses, AVI plans to file an IND application with the FDA later this year for the treatment of influenza A virus using NEUGENE antisense drugs.
The summary results show that a single Neugene agent could be developed to inhibit replication of multiple strains of Influenza A virus.

AVI BioPharma was enrolled in Investrend Research's unique and pioneering professional analyst program, which facilitates independent analysts to provide financial coverage for shareholders and investors in companies that otherwise would have little or no analyst following. Enrollment in standards-based research is an important measure of a company's commitment to transparency and Good Governance, but its research has grown stale in the absence of recent access to the company by an Investrend Research analyst.

[setravis]

Technicals
MACD - Bullish

Last Price Quote is:
9.14%above 13-day EMA
13.49%above 50-day EMA
RS Rating: 98 

Fundamentals
Key Data:
Market Cap (M): $400.06 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 05/08/2006
Last Analyst Rating: Mkt Outperform

Bird Flu Still Flying