Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
OT:Jagman:
"Jag.......that's fine with me, if that is your feeling.
But we do have rules to abide by here, which are quite clear."
If that response were written by the monitor of this board, you can bet everything it would more than likely be applied evenly and fairly to all, not just to a certain few. Beanie again is caught in a lie.
To prove my point, just look at all the deleted posts that were not yours. They stayed on that board until I had them tossed for violating the TOS.
G'day, Mate.
Aussie.
Mind all that this may/will apply nationwide.
Biotech patents an issue for court
http://www.signonsandiego.com/uniontrib/20050421/news_1b21patent.html
Justices hear arguments involving S.D. entities
By Toby Eckert
COPLEY NEWS SERVICE
April 21, 2005
WASHINGTON – The Supreme Court heard arguments yesterday in a patent dispute that pits major players in San Diego's burgeoning biotech sector against one another and holds broad implications for researchers, drug companies and patients nationwide.
The case involves the question of when it is permissible for drug researchers to use a breakthrough that has been patented by someone else.
Some of the justices seemed skeptical of arguments by a New Jersey company that its patent for biological molecules, originally discovered at the La Jolla-based Burnham Institute, should have the kind of broad protection granted by lower courts.
A scientist at the Scripps Research Institute, also in La Jolla, had used the same type of molecules in studies for the German pharmaceutical company Merck KgaA, prompting the court case.
If the court recognizes a fairly broad right to use patented technologies in research, patents developed by biotech companies could lose value and significantly crimp the $26 billion research industry, legal experts said.
A ruling strictly protecting the patents could discourage research into new drugs or halt it in some cases, pharmaceutical companies argue.
"The fallout is going to be highly dependent on exactly what the court does," said John Van Amsterdam, an attorney in Boston who specializes in biotechnology and pharmaceutical patents and is not involved in the case.
The Bush administration and AARP, the nation's largest senior citizens organization, intervened in the case on Merck's side, expressing concerns about the potential impact on drug development and pharmaceutical prices.
The dispute arose from studies done at Scripps, under a contract with Merck, into ways to block the development of blood vessels that feed tumors. The research involved biological molecules known as peptides, which affect how cells attach to surfaces.
The peptides' role had been discovered earlier by researchers at the Burnham Institute, which patented the peptide sequence and ways to use it. Those patents were subsequently acquired by Integra LifeSciences, a New Jersey company.
After learning of the research at Scripps, Integra asked Merck – which is unrelated to the U.S. drug maker of the same name – to pay for a license for the patents. When the two companies couldn't reach an agreement, Integra sued for patent infringement.
A federal court jury in San Diego ruled in favor of Integra, rejecting Merck's argument that the research was allowed under a federal law that protects researchers from infringement charges if their work is "reasonably related to the development and submission of information" to the Food and Drug Administration. The jury awarded Integra damages of $15 million, later reduced to $6.4 million.
The decision was upheld by a federal appeals court, which ruled that the law cited by Merck was intended to hasten the development of generic drugs while patented versions are still on the market. The studies sponsored by Merck involved identifying "new pharmaceutical compounds" and was not solely meant to produce information for the FDA, the court concluded in a 2-1 decision.
E. Joshua Rosenkranz, an attorney for Merck, told the Supreme Court that the lower court rulings "defy the plain language of the statute the Congress passed," which doesn't specifically mention generic drugs.
Merck argued that the lower courts' interpretation would inhibit research and innovation since the infringement exemption would only apply to drugs in clinical trials. But the FDA requires earlier research, such as animal studies, before allowing clinical trials.
"The statute provides a safe harbor for experiments that are related to information sought by the FDA," Rosenkranz said. "No rational drug innovator ever proceeds to clinical trials without conducting that research."
Some justices seemed to be swayed by that argument.
"They are going to want to know before they allow clinical trials whether the drug has some application to cancer rather than the common cold," Justice David Souter said.
The Bush administration took Merck's side, with Assistant Solicitor General Daryl Joseffer arguing that the lower court erred on several legal issues. "The statute is not limited to generic drugs," he said.
But Mauricio A. Flores, an attorney for Integra, argued that there was no error in the lower courts' interpretation of the law.
"The program carried out at Scripps was not reasonably related to the FDA," he told the justices.
The type of research that would have been presented to the FDA before a clinical trail was carried out by Merck in Germany, he said. The work done at Scripps was more experimental.
Some of the justices indicated they were inclined to try to clarify the meaning of the federal law and then return the case to a lower court.
"What we have to focus on is whether the court of appeals was in error in interpreting the scope of the exemption," Justice Sandra Day O'Connor said. "It is open to us to correct that and send it back."
Justice Stephen Breyer called the appeals court decision "pretty foggy."
But Justice David Souter questioned why Merck had agreed to jury instructions concerning the law's interpretation.
Several pharmaceutical and biotech companies filed legal briefs in the case. Biogen Idec, which has a research and manufacturing campus in San Diego County, argued in support of Merck.
"We believe preclinical testing generates information that is essential to the FDA approval process," Biogen Idec spokesman Jose Juves said. "We support a generous and practical reading of the statutory exemption from patent liability in the testing and evaluation of new drugs."
Carlsbad-based Isis Pharmaceuticals Inc. and Invitrogen Corp. sided with Integra. Many of San Diego County's 400 or so biotech and medical device companies have drugs or technologies in early development and remain unprofitable, so revenue from the licensing of intellectual property can be a crucial source of cash, biotech executives argue.
Isis, an unprofitable biotech with over 1,500 patents issued on its novel antisense drugs and technology, has generated $70 million from licensing activities. And that revenue gets ploughed back into research on about a dozen experimental drugs that Isis is developing.
"The essence of Merck's argument is that biotech companies could block drug development, but in fact it is the opposite," said Laura Handley, vice president for patents at Isis. "Biotech companies as a whole generate a substantial amount in licensing deals, and for early-stage innovators that revenue stream is critical for drug development."
Van Amsterdam said he believes the economic stakes of the case are higher for biotech companies, universities and nonprofit research groups that rely on patents to generate revenue.
"In terms of a life or death thing, it's definitely bigger for the small biotechs," he said. "Some of them may find some significant difficulties if the case goes the wrong way. Whereas for big (pharmaceutical companies), they'd have to pay a little more for using a particular patented discovery.
"If you compare the amount of money that it would cost them to fair-and-square pay for the use of certain things, it's probably a very, very small amount compared to the rest of the drug development process."
The court is expected to rule by July.
-----------------------------------------------------------------
Staff writer Penni Crabtree contributed to this report.
G'day, Mates.
Aussie
techizbest, you may try to post without the venom, it's worthless.
When I posted, "Biophan Technologies is a good bet for the future," it was done after spending about an hour checking out the various references on the top of this very board, plus a few of my own resources. It wasn't an off the wall comment. By now, you know very well that is not my character.
You don't know me or, my intentions or, what I give a hoot about. In the future, don't go there.
Maybe you would care to show where it was made mention that any stock was "MY" stock. Not done, so the genre falls in the toilet along with the rest of the post.
And, I don't lie when I post that a company is good or bad, just as I see it as I come across it. Hyping and bashing are not my character against a company or its stock. Have been very accurately known to attack posters that overhype, lie, twist the truth, or use "apples and orange type of posts, or "DUH!" remarks.
Have a g'day.
Aussie
Biotech patents an issue for court
http://www.signonsandiego.com/uniontrib/20050421/news_1b21patent.html
Justices hear arguments involving S.D. entities
By Toby Eckert
COPLEY NEWS SERVICE
April 21, 2005
WASHINGTON – The Supreme Court heard arguments yesterday in a patent dispute that pits major players in San Diego's burgeoning biotech sector against one another and holds broad implications for researchers, drug companies and patients nationwide.
The case involves the question of when it is permissible for drug researchers to use a breakthrough that has been patented by someone else.
Some of the justices seemed skeptical of arguments by a New Jersey company that its patent for biological molecules, originally discovered at the La Jolla-based Burnham Institute, should have the kind of broad protection granted by lower courts.
A scientist at the Scripps Research Institute, also in La Jolla, had used the same type of molecules in studies for the German pharmaceutical company Merck KgaA, prompting the court case.
If the court recognizes a fairly broad right to use patented technologies in research, patents developed by biotech companies could lose value and significantly crimp the $26 billion research industry, legal experts said.
A ruling strictly protecting the patents could discourage research into new drugs or halt it in some cases, pharmaceutical companies argue.
"The fallout is going to be highly dependent on exactly what the court does," said John Van Amsterdam, an attorney in Boston who specializes in biotechnology and pharmaceutical patents and is not involved in the case.
The Bush administration and AARP, the nation's largest senior citizens organization, intervened in the case on Merck's side, expressing concerns about the potential impact on drug development and pharmaceutical prices.
The dispute arose from studies done at Scripps, under a contract with Merck, into ways to block the development of blood vessels that feed tumors. The research involved biological molecules known as peptides, which affect how cells attach to surfaces.
The peptides' role had been discovered earlier by researchers at the Burnham Institute, which patented the peptide sequence and ways to use it. Those patents were subsequently acquired by Integra LifeSciences, a New Jersey company.
After learning of the research at Scripps, Integra asked Merck – which is unrelated to the U.S. drug maker of the same name – to pay for a license for the patents. When the two companies couldn't reach an agreement, Integra sued for patent infringement.
A federal court jury in San Diego ruled in favor of Integra, rejecting Merck's argument that the research was allowed under a federal law that protects researchers from infringement charges if their work is "reasonably related to the development and submission of information" to the Food and Drug Administration. The jury awarded Integra damages of $15 million, later reduced to $6.4 million.
The decision was upheld by a federal appeals court, which ruled that the law cited by Merck was intended to hasten the development of generic drugs while patented versions are still on the market. The studies sponsored by Merck involved identifying "new pharmaceutical compounds" and was not solely meant to produce information for the FDA, the court concluded in a 2-1 decision.
E. Joshua Rosenkranz, an attorney for Merck, told the Supreme Court that the lower court rulings "defy the plain language of the statute the Congress passed," which doesn't specifically mention generic drugs.
Merck argued that the lower courts' interpretation would inhibit research and innovation since the infringement exemption would only apply to drugs in clinical trials. But the FDA requires earlier research, such as animal studies, before allowing clinical trials.
"The statute provides a safe harbor for experiments that are related to information sought by the FDA," Rosenkranz said. "No rational drug innovator ever proceeds to clinical trials without conducting that research."
Some justices seemed to be swayed by that argument.
"They are going to want to know before they allow clinical trials whether the drug has some application to cancer rather than the common cold," Justice David Souter said.
The Bush administration took Merck's side, with Assistant Solicitor General Daryl Joseffer arguing that the lower court erred on several legal issues. "The statute is not limited to generic drugs," he said.
But Mauricio A. Flores, an attorney for Integra, argued that there was no error in the lower courts' interpretation of the law.
"The program carried out at Scripps was not reasonably related to the FDA," he told the justices.
The type of research that would have been presented to the FDA before a clinical trail was carried out by Merck in Germany, he said. The work done at Scripps was more experimental.
Some of the justices indicated they were inclined to try to clarify the meaning of the federal law and then return the case to a lower court.
"What we have to focus on is whether the court of appeals was in error in interpreting the scope of the exemption," Justice Sandra Day O'Connor said. "It is open to us to correct that and send it back."
Justice Stephen Breyer called the appeals court decision "pretty foggy."
But Justice David Souter questioned why Merck had agreed to jury instructions concerning the law's interpretation.
Several pharmaceutical and biotech companies filed legal briefs in the case. Biogen Idec, which has a research and manufacturing campus in San Diego County, argued in support of Merck.
"We believe preclinical testing generates information that is essential to the FDA approval process," Biogen Idec spokesman Jose Juves said. "We support a generous and practical reading of the statutory exemption from patent liability in the testing and evaluation of new drugs."
Carlsbad-based Isis Pharmaceuticals Inc. and Invitrogen Corp. sided with Integra. Many of San Diego County's 400 or so biotech and medical device companies have drugs or technologies in early development and remain unprofitable, so revenue from the licensing of intellectual property can be a crucial source of cash, biotech executives argue.
Isis, an unprofitable biotech with over 1,500 patents issued on its novel antisense drugs and technology, has generated $70 million from licensing activities. And that revenue gets ploughed back into research on about a dozen experimental drugs that Isis is developing.
"The essence of Merck's argument is that biotech companies could block drug development, but in fact it is the opposite," said Laura Handley, vice president for patents at Isis. "Biotech companies as a whole generate a substantial amount in licensing deals, and for early-stage innovators that revenue stream is critical for drug development."
Van Amsterdam said he believes the economic stakes of the case are higher for biotech companies, universities and nonprofit research groups that rely on patents to generate revenue.
"In terms of a life or death thing, it's definitely bigger for the small biotechs," he said. "Some of them may find some significant difficulties if the case goes the wrong way. Whereas for big (pharmaceutical companies), they'd have to pay a little more for using a particular patented discovery.
"If you compare the amount of money that it would cost them to fair-and-square pay for the use of certain things, it's probably a very, very small amount compared to the rest of the drug development process."
The court is expected to rule by July.
-----------------------------------------------------------------
Staff writer Penni Crabtree contributed to this report.
G'day, Mates.
Aussie
akula, very glad you didn't say your $.0002 cents worth. LOL.
G'day, mate.
Aussie
Biophan Technologies is a good bet for the future. Strongly looking at every aspect of it.
OT: This board may also want to take a good look at the AVN IHub bord and also consider that stock.
G'day, Mates.
Aussie
"OT": Two of my prior posts were for some reason were deleted. They were about the newly elected Pope Benedict XVI. Only to inform the board of such a great worldly event in a most timely manner --up to the second, in fact. If for some reason they offended anyone, then I certainly do apologize for that. It wasn't intended at all. However, believe me that doesn't appear to be the case. All who post on here are also members of the Raging Bull Avanir posting board where the same messages were posted in the exact same manner. It's obvious that board wasn't offended and accepted it as good, quality, timely news as did two other posting boards.
Just amazes one how on other boards they can post non-stock stuff and it stays. Something as important as a newly elected Pope is treated as sacrilegious to the TOS. Strange, strange world.
drbio45, I know you, as the board monitor, had nothing to do with it. Thank you.
G'day, Mates.
Aussie
Much obliged.
Have a g'day.
Aussie
Slow morning. AVN has 45,800 trades and the PPS is just bouncing between $2.58 and $2.59.
Needs a little news.
G'day, Mates.
Aussie
Jagman, taking a real serious look over it. Thanks.
Sure wish it had options.
G'day, Mate.
Aussie
Don't own any shares, just saw Jagman's post on another board and thought I'd just say G'day to all.
Good luck to this new board and with your investment.
G'day, Mates.
Aussie
The FDA has granted AVANIR's NDA a Priority Review, which is an accelerated six-month review timeline.
I don't see that to mean any more than what the December 16, 2004, PR already gave us, which was:
Per the Prescription Drug User Fee Act (PDUFA), the FDA’s goal is to complete priority reviews within 6 months compared to 10-12 months for a standard PDUFA review."
Both are BW PRs.
G'day, Mate.
Aussie
The Yahoo board is all in titters about the FDA approval and whether the review has been further accelerated. There are a few posts about, "AVN...PRIORITY REVIEW- GRANTED BY THE FDA."
There is no basis to believe anything has changed. I read the latest PR and it doesn't disagree with the information we've already received.
The January 12, 2005 stated, "... “We look forward to starting this Phase III trial in the first half of 2005.” And, in the disclosure part of the PR it states, "For example, AVANIR can provide no assurances that it will submit a new drug application for Neurodex for neuropathic pain, and that when and if filed, it will be accepted by the FDA. Further, we can provide no assurances that Neurodex will be successful in its clinical studies, that it will receive regulatory approval, or that even if such regulatory clearance is received, that AVANIR will be able to market Neurodex successfully." Neither indicates any difference in the acceleration of the process.
The December 16, 2004 stated. "The U.S. Food and Drug Administration (FDA) offered a “rolling” review of a new drug application (NDA) for Neurodex and also indicated that Neurodex would qualify for a priority review when the submission is complete. AVANIR expects to complete its submission in the first half of 2005." Only time frame actually mentioned is when Avanir will finish its submission.
In the same PR, a couple paragraphs down it gives the only timeframe we are aware of specifically, "Per the Prescription Drug User Fee Act (PDUFA), the FDA’s goal is to complete priority reviews within 6 months compared to 10-12 months for a standard PDUFA review."
Looks like June or early July is about it.
IMO.
Updated: 03:19 PM EDT
AVANIR Pharmaceuticals to Present at the White Mountain Capital 3rd Annual Biotechnology Conference
SAN DIEGO--(BUSINESS WIRE)----AVANIR Pharmaceuticals (AMEX:AVN) will be presenting at the White Mountain Capital Biotechnology Conference on Tuesday, April 19th in New York. AVANIR's President and Chief Executive Officer Dr. Gerald J. Yakatan will be presenting a corporate overview at the investor conference at 1:30 p.m. Eastern time.
The presentation will focus on AVANIR's lead product candidate, Neurodex(TM), for the treatment of two central nervous system (CNS) disorders, pseudobulbar affect and diabetic neuropathic pain. AVANIR has successfully completed two pivotal Phase III trials with Neurodex for the treatment of pseudobulbar affect, a neurological disorder that affects approximately one million people in the U.S. AVANIR began submission of a "rolling" new drug application (NDA) to the U.S. Food and Drug Administration (FDA) at the end of 2004 and expects to submit the final module in mid-year 2005. The FDA has granted AVANIR's NDA a Priority Review, which is an accelerated six-month review timeline.
AVANIR is also in the process of initiating a pivotal Phase III clinical trial for Neurodex in the treatment of diabetic neuropathic pain under a Special Protocol Assessment from the FDA.
AVANIR Pharmaceuticals is a drug discovery and development company focused on treatments for chronic diseases. Our product candidates address therapeutic markets that include central nervous system and cardiovascular disorders, inflammation, and infectious disease. The Company's first commercialized product, Abreva(R), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.
The information contained in this press release, including any forward-looking statements contained herein, should be reviewed in conjunction with the company's most recent Annual Report on Form 10-K and other publicly available information regarding the company. Copies of such information are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the company's business and technology. Forward-looking statements often contain such words like "estimate," "anticipate," "believe," "plan" or "expect". Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are unpredictable and outside the influence and/or control of the company. The Company disclaims any intent or obligation to update these forward-looking statements.
AVANIR Pharmaceuticals Patrice Saxon, 858-622-5202 (Investor Relations) psaxon@avanir.com
04/18/2005 13:57 ET
© Business Wire 2003
G'night, Mates.
Aussie
http://www.mountauburn.caregroup.org/healthnews/healthday/050415HD525036.htm
Drug Fights MS-Linked Emotion Disorder
Individuals affected by 'pseudobulbar effect' cannot control laughing, crying
FRIDAY, April 15 (HealthDay News) -- A new drug may help control laughing and crying spells in multiple sclerosis (MS) patients with a condition called pseudobulbar effect, which leaves them unable to control their emotions, says a U.S. study.
The drug, called AVP-923, "is the first drug designed specifically for this condition. The only treatment now is antidepressants, which can have unpleasant side effects," researcher Dr. Hillel Panitch, a neurologist at the University of Vermont College of Medicine, said in a prepared statement.
The pseudobulbar effect can also occur in people with other kinds of neurological disorders, including Alzheimer's disease, stroke, brain injury and amyotrophic lateral sclerosis (ALS).
The 12-week study included 150 MS patients with pseudobulbar effect. They received either a placebo or AVP-923, which is a combination of the drugs dextromethorphan hydrobromide and quinidine sulfate.
Of the patients taking the drug, 84 percent reported improvement in their condition, compared to 49 percent of those who took the placebo. The patients taking the medication had 46 percent fewer emotional episodes than those on placebo and reported overall improvement in quality of life, quality of relationships and the amount of pain they experienced.
Dizziness was a common side effect reported by those taking the drug.
The study, funded by Avanir Pharmaceuticals, which is developing AVP-923, was presented April 14 at the annual meeting of the American Academy of Neurology in Miami Beach.
More information
The U.S. National Institute of Neurological Disorders and Stroke has more about MS.
SOURCE: American Academy of Neurology, news release, April 14, 2005
Copyright © 2005 ScoutNews LLC. All rights reserved.
Health News Provided By:
G'day, Mates.
Aussie
NEWS! NEWS! NEWS!
http://biz.yahoo.com/bw/050414/145635.html?.v=1
Press Release Source: AVANIR Pharmaceuticals
AVANIR's Pivotal Neurodex Clinical Trial Data Presented at American Academy of Neurology Meeting Thursday April 14, 1:30 pm ET Data on the Treatment of PBA in MS Patients Selected as a ``Highlight of the Meeting''
SAN DIEGO--(BUSINESS WIRE)--April 14, 2005--AVANIR Pharmaceuticals (AMEX:AVN - News) announced that data from its Phase III clinical trial examining Neurodex(TM) in the treatment of pseudobulbar affect (PBA) in patients with multiple sclerosis (MS) were presented today at the 2005 Annual Meeting of the American Academy of Neurology (AAN) in Miami, Florida. Dr. Hillel Panitch, Professor of Neurology at the University of Vermont College of Medicine and Director of the Multiple Sclerosis Center at Fletcher Allen Health Care in Burlington, Vermont, presented the results of the trial. Additionally, a summary of the data has been selected for presentation at the AAN's "Scientific Program Highlights Plenary Session" on Friday, April 15th at 5:15 pm.
ADVERTISEMENT
"Neurodex is the first drug designed specifically to treat PBA," reported Dr. Panitch, one of the 22 investigators who participated in the trial. "The only treatment option available to patients now is antidepressants, which can have a number of undesirable side effects. Based on the study data, patients enrolled in the trial showed improvement as early as the first week after starting treatment."
In the double-blind study, 150 MS patients with PBA were randomized to receive either placebo or Neurodex on a 12 hour dosing schedule for 90 days. In his presentation, Dr. Panitch stated that 84% of patients treated with Neurodex reported that their condition improved, compared to 49% of those given a placebo. The study participants kept a diary tracking the number of laughing/crying episodes they experienced each day. Dr. Panitch noted that Neurodex-treated patients reported 46% fewer laughing and/or crying episodes than those on placebo during the three-month trial. Neurodex-treated patients also reported overall improvement in their quality of life, quality of relationships, and in the amount of pain they experienced.
Of the side effects reported in 5% or more of the patients, a statistically significant difference between Neurodex and placebo was observed only for dizziness. In the Neurodex group, 14% of patients withdrew from therapy due to adverse events, compared to 11% discontinuing in the placebo group. The majority of reported side effects were mild to moderate in intensity.
Pseudobulbar affect is a disinhibition syndrome of the motor expression of emotion and is characterized by uncontrollable laughing or crying in a manner that is out of context to the basic social setting. PBA affects patients with neurological conditions such as ALS or Lou Gehrig's disease, Alzheimer's disease, MS, stroke and traumatic brain injury.
AVANIR is currently developing Neurodex(TM) for the treatment of two different indications, PBA and diabetic neuropathic pain. AVANIR has completed Phase III clinical testing of Neurodex for the treatment of PBA, and began submission of a new drug application (NDA) for this indication to the U.S. Food and Drug Administration (FDA) in December 2004. The submission is being done on a "rolling" basis, which allows AVANIR to submit the NDA in modules that can be evaluated by the FDA as they are submitted. The NDA will receive priority review upon completion of submission.
If approved, Neurodex would be the first drug indicated to treat PBA. In a market survey commissioned by AVANIR, IMS Health estimated the potential market for drugs that treat PBA to be approximately $500 million in 2006, the year in which Neurodex may enter the market if approved by the FDA. Beginning in mid-2005, AVANIR intends to conduct a Phase III clinical trial for the treatment of diabetic neuropathic pain under a Special Protocol Assessment from the FDA.
AVANIR Pharmaceuticals is a drug discovery and development company focused on developing and commercializing novel therapeutic products for the treatment of chronic diseases. Our product candidates address therapeutic markets that include central nervous system and cardiovascular disorders, inflammation, and infectious disease. The Company's first commercialized product, Abreva®, is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.
AVANIR press releases and presentations, including any forward-looking statements contained therein, should be reviewed in conjunction with the Company's most recent Annual Report on Form 10-K, subsequent quarterly reports on Form 10-Q and other publicly available information regarding the Company. Copies of such information are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the Company's business and technology. Forward-looking statements often contain such words as "estimate," "anticipate," "intend," "plan" or "expect" and actual results may differ from these forward looking statements. The Company can make no assurances regarding the timing of completion of its rolling submission of a new drug application for Neurodex(TM), whether the FDA will accept the Company's new drug application for Neurodex or whether the FDA will ultimately approve Neurodex for commercialization. Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are unpredictable and outside the influence and/or control of the company. Even if Neurodex is approved for commercialization, the Company can make no assurances that it, or any of its marketing partners, will be able to successfully commercialize Neurodex. The Company disclaims any intent or obligation to update these forward-looking statements.
Contact:
AVANIR Pharmaceuticals
Patrice Saxon, 858-622-5202 (Investor Relations)
psaxon@avanir.com
Source: AVANIR Pharmaceuticals
G'day, Mates.
Aussie
From another AVN board.
This is from Freerealtime.com
http://quotes.freerealtime.com/rt/frt/T?IM=quotes&symbol=AVN&type=Quote&SA=quotes/Quote
AVANIR PHARMACEUTICALS - American Stock Exchange: AVN
Real-time ECN Quote*
Last Change (%) After Hours Chg (%)** Trade Time
2.63 0.11 (4.37) 0.11 (4.37) 13:54
Bid Ask
1.88(20) 0(0)
Ask
Not saying it will open up $.11, as the after hours last figure rarely agrees with the opening call. Just got to hope.
G'day, Mates.
Aussie
http://freerealtime.brand.edgar-online.com/fetchFilingFrameset.aspx?FilingID=3600866&Type=HTML
FORM 4.
STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES
Class A Common Stock 4/8/2005 P 900000 (1) A $2.2 8775000
That makes it two very significant insider buys in this short month. WOW!
G'day, Mates.
Aussie
This was the deal announced on April 6th.
AVANIR Completes $17.1 Million Sale of Common Stock
Tuesday April 12, 5:10 pm ET
SAN DIEGO--(BUSINESS WIRE)--April 12, 2005--AVANIR Pharmaceuticals (AMEX:AVN - News) announced that on April 8, 2005, it completed the previously announced sale of 7,770,000 shares of Class A common stock in a registered direct offering at a price of $2.20 per share. The offering raised gross offering proceeds of approximately $17.1 million and net offering proceeds of approximately $15.8 million, after deducting commissions and offering fees and expenses.
All of the shares were sold by AVANIR Pharmaceuticals. The shares were offered under the Company's effective shelf registration statement on Form S-3. CIBC World Markets Corp. acted as sole bookrunning placement agent, and Leerink Swann & Co. acted as co-placement agent in connection with this transaction.
AVANIR Pharmaceuticals, based in San Diego, is a drug discovery and development company focused on the development of treatments for chronic diseases.
The information contained in this press release, including any forward-looking statements contained herein, should be reviewed in conjunction with the company's most recent Annual Report on Form 10-K and other publicly available information regarding the company. Copies of such information are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the company's business and technology. Forward-looking statements often contain such words like "estimate," "anticipate," "believe," "plan" or "expect." The Company disclaims any intent or obligation to update these forward-looking statements.
Contact: AVANIR Pharmaceuticals
Patrice Saxon, 858-622-5202 (Investor Relations)
psaxon@avanir.com
Source: AVANIR Pharmaceuticals
G'day, Mates.
Aussie
Huge inside buying:
http://www.netsteering.com/cgi-bin/getRecord.cgi?hotBuys+0
G'day, Mates.
Aussie
AVANIR Pharmaceuticals to Release Phase III Clinical Data at American Academy of Neurology
8 April 2005, 07:30am ET
SAN DIEGO, April 8, 2005 -- AVANIR Pharmaceuticals (Amex: AVN) will be releasing the second pivotal Phase III clinical trial data on AVP-923 for pseudobulbar affect in multiple sclerosis (MS) patients at the annual meeting of the American Academy of Neurology in Miami, FL.
The data will be presented by Hillel Panitch, MD, an investigator in the double-blind, placebo controlled study. Dr. Panitch is Professor of Neurology at the University of Vermont College of Medicine and Director of the Multiple Sclerosis Center at Fletcher Allen Health Care in Burlington, Vermont.
Pseudobulbar affect (PBA) is an affective disinhibition syndrome characterized by episodes of involuntary crying and/or laughing. PBA occurs secondary to neurological damage caused by diseases such as multiple sclerosis (MS); amyotrophic lateral sclerosis (ALS); dementias, including Alzheimer's disease (AD); and neurological injuries, such as stroke and traumatic brain injury (TBI). Prevalence of PBA is significant: estimates suggest 10%-20% of patients with the underlying diseases may be affected.
Mentioned Last Change
AVN 2.41 0.04dollars or (1.68%)
The study being presented is the second of two studies that have been completed as part of Phase III clinical trials. The international, multi-site study took place across 18 sites in the U.S. and four sites in Israel.
Dr. Panitch will make the following presentations:
Media Briefing -- Wednesday April 13, 10-11 am EDT
Press Interview Room #107,
Miami Beach Convention Center
ARTICLES ARE EMBARGOED UNTIL 1:30 EDT APRIL 14,
2005
Scientific Platform
Session -- Thursday April 14, 1:30 pm EDT
Room A101-105, Miami Beach Convention Center
Media contacts:
Patrice Saxon, AVANIR, (858) 622-5202
Jamie Cleghorn, IMS, (312) 242-4706
TO ARRANGE AN INTERVIEW WITH DR. PANITCH:
Jamie Cleghorn, IMS, (312) 242-4706
About AVP-923:
AVANIR is currently developing AVP-923 for the treatment of two clinical indications, pseudobulbar affect and diabetic neuropathic pain. AVANIR has completed Phase III clinical testing of AVP-923 for the treatment of pseudobulbar affect, and began submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in December 2004. The submission is being done on a "rolling" basis, which allows AVANIR to submit the NDA in modules, which can then be evaluated by the FDA as they are submitted. The FDA has indicated that AVP-923 would qualify for a priority review when the submission is complete. If approved, AVP-923 would be the first drug indicated to treat pseudobulbar affect. In a market survey commissioned by AVANIR, IMS Health estimated the potential market for drugs that treat pseudobulbar affect to be approximately $500 million in 2006, the year in which AVP-923 may enter the market if approved by the FDA. Beginning in mid- 2005, AVANIR also intends to begin a Phase III clinical trial for the treatment of diabetic neuropathic pain under a special protocol assessment from the FDA.
G'day, Mates.
Aussie
"Regulation National Market System, or Reg NMS" which was tentatively approved in December was approved by the SEC yesterday. This is good news for investors. It means a stock trader can no longer ignore a better price in favor of sending a customer's order to a preferred market, which might allow a faster execution.
It requires brokers to obtain the best possible price for customers orders even if it means going to another market and takes longer.
Republican Chairman William H. Donaldson believes it should strengthen the confidence of all types of investors in the U.S. equity markets.
Proponents say the rule would save investors$321 million each year by ensuring that investors receive the best price for their stock. Commission studies said as many as ninety-eight thousand trades per day did not receive the best price on the exchanges and markets.
G'day, Mates.
Aussie
Filed Pursuant to Rule 424(b)(2)
http://freerealtime.brand.edgar-online.com/fetchFilingFrameset.aspx?FilingID=3591309&Type=HTML
Class A Common Stock
We are offering 7,770,000 shares of our Class A common stock directly to investors. In connection with this offering, we will pay fees to our placement agents, CIBC World Markets Corp. and Leerink Swann & Co.
G'day, Mates.
Aussie
Form S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
http://freerealtime.brand.edgar-online.com/fetchFilingFrameset.aspx?FilingID=3590544&Type=HTML
EXPLANATORY NOTE
This Registration Statement on Form S-3 relates to the public offering of Class A common stock of Avanir Pharmaceuticals contemplated by the Registration Statement on Form S-3 (File No. 333-114389), declared effective on April 28, 2004 by the Securities and Exchange Commission (the “Prior Registration Statement”), and is filed pursuant to Rule 462(b) promulgated under the Securities Act of 1933, as amended, solely to increase the dollar amount of securities registered under the Prior Registration Statement by $2,850,000, which represents 20% of the remaining amount of securities available for issuance under the Prior Registration Statement. The contents of the Prior Registration Statement, including all exhibits thereto, are incorporated herein by reference.
G'day, Mates.
Aussie
OT: Learn to Respect Shorts
By Stephen D. Simpson, CFA
April 4, 2005
Now, if my friend were to write for The Motley Fool or post his discoveries on message boards, would his diligent research be respected? Of course not. He'd be shouted down amidst slander and profanity, and he would no doubt be accused of being a "manipulator" if the stock subsequently went down.
Instead of benefiting from someone else's hard work, and perhaps saving themselves from a sharp decline in their own portfolio, they would just dismiss him out of hand and throw his insights on the scrap heap.
Definitely the type of behavior from FASC longs.
Maybe one of you kind posters would be so nice as to put this post on the board for them, as I do believe it would interest a couple over there.
http://aol.fool.com/news/commentary/2005/commentary05040404.htm?logvisit=y&source=eptaollnk30810....
IMO.
G'day, Mates.
Aussie
Don't know this poster from Yahoo. Some of you may. So you have to make your own judgement as to the validity of the post. FWIW, it does sound good. IMO.
Called Patrice
by: j_b_118 04/04/05 12:38 pm
Msg: 334183 of 334236
Talked to Patrice on Friday. I’d called her Thursday evening and she called me back twice on Friday until she got a hold of me. FWIW, IR has always been very responsive to returning my phone calls and spending whatever time it takes to discuss my questions (30-60 min). My subjective recollection of our conversation (I didn’t take notes):
My specific complaint was the lack of a clear press release detailing the development/marketing decisions relative to Neurodex. We respectfully disagreed whether a press release was appropriate on this point. I let her know that I didn’t think wading through and then piecing together responses to analyst questions during webcast conferences or slides posted from the ASM was the kind of clarity I was expecting for a decision of this magnitude. She said they didn’t think a press release was necessary because it wasn’t much of a departure from what had been the general plan all along*, and they thought it was clear from all those presentations and the ASM. The issue did come up in staff meeting and we may or may not see anything more specific. I encouraged more specific guidance in this respect, and reiterated that what I had seen did not meet my expectations.
*(They were and always will be open to deals if the right one comes along. They would like a deal, but not unless it gives fair value.)
The SPA for PIII pain was important b/c it means the FDA will accept a trial that is small enough that they can manage it in-house, and they won’t need to go outside for co-development. This was news to me. They will likely sign on to get some specialized co-promotion to cover areas their own sales force won’t (family practice etc.), although I don’t recall if that was relative to PBA, pain or both. Bottom line, I’m not expecting any Neurodex deals until after approval at the soonest, although one could always drop in.
She did say that she didn’t want me going away thinking that there isn’t any chance of any deals before Neurodex is approved. The real in-house excitement re: deals is re: pipeline. My opinion: If we’re going to see a deal before YE05 it will be for a product(s) in the pipe, and she conveyed enthusiasm about that, although again, this is my subjective recollection.
Europe Abreva is pretty lame b/c there is already a GSK OTC product. Japan is still an active possibility, but realistically they are really tough about letting OTC stuff on the market. I’m not expecting anything there anytime soon, but if it gets approved it should be a lot stronger than Europe. Avanir DOES expect to again participate at some point in the royalty stream from the N.American Abreva deal, although we didn’t get into how much or when.
G'day, Mates.
Aussie
AVANIR Pharmaceuticals Invites Investors to the Future Leaders in the Biotech Industry Conference WebcastAVANIR Pharmaceuticals Invites Investors
SAN DIEGO--(BUSINESS WIRE)----AVANIR Pharmaceuticals (AMEX:AVN) will be presenting at the 12th Annual Future Leaders in the Biotech Industry Conference on April 7, 2005 in New York. President and Chief Executive Officer Gerald J. Yakatan, Ph.D. will provide a corporate update 3:50 p.m. Eastern time.
The live webcast of the presentation will be accessible through AVANIR's website at http://:www.avanir.com. It is recommended that viewers log on to the website 10 minutes early to register and download any necessary software. If you are unable to listen to the live webcast, a recorded replay of the presentation will be available within 24 hours of the presentation through May 8, 2005.
AVANIR Pharmaceuticals is a drug discovery and development company focused on treatments for chronic diseases. Our product candidates address therapeutic markets that include central nervous system and cardiovascular disorders, inflammation, and infectious disease. The Company's first commercialized product, Abreva(R), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.
The information contained in this press release, including any forward-looking statements contained herein, should be reviewed in conjunction with the company's most recent Annual Report on Form 10-K and other publicly available information regarding the company. Copies of such information are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the company's business and technology. Forward-looking statements often contain such words like "estimate," "anticipate," "believe," "plan" or "expect". Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are unpredictable and outside the influence and/or control of the company. The Company disclaims any intent or obligation to update these forward-looking statements.
AVANIR Pharmaceuticals Patrice Saxon, 858-622-5202 psaxon@avanir.com
04/04/2005 12:46 ET
© Business Wire 2003
Subject: Saturday Research - from RB
Date: 4/4/2005 12:10 P.M. Eastern Daylight Time
From: Aussie
PJ is a good solid poster on RB and Yahoo. Here is the results of his time spent on Saturday digging up information.
G'day, Mates.
Aussie
By: pj_columbia
02 Apr 2005, 12:24 PM EST
Msg. 34155 of 34157
Jump to msg. #
Saturday Research
(I also posted this over on Yahoo, but with all the noise over there it will probably get lost quickly. Any comments on this are most welcome!
Did a little browsing on the Rodman and Renshaw report that Mucho so graciously forwarded. Noticed that R&R expects a 10 million share increase in our float sometime this quarter. That makes sense, we gotta get at least enough $$ on hand to make it through next year so we don't get that dreaded "Going Concern" statement in the next 10K. Would like to see it done in the $3 range vice where we are now, but I have a feeling that's why we're down here in the 2s, so whomever is getting those 10 million shares will get them as cheaply as possible.
Good news this week with Punk Ziegel picking up coverage on us. I checked both the R&R site as well as Punk's site and did not see an overlap in names. Thought I saw some speculation from Nirv earlier in the week that someone from R&R could have moved to Punk. I guess that's still possible, but you'd think they would have announced that - or at least updated their web site.
Also saw we had 8 jobs still posted on the AVN web site. Since I know of no one who's departed, this is 8 new positions, and not all of them are related to sales. So, we're still a growing company. Wish we'd see evidence of that in our stock price! Not sure what it's gonna take to get us moving from here. Looked like any possibility of good news is going to get us moving in the right direction.
PJ
Powerful Spiritual Leader Dies After Long Struggle
14:02PM ET update: Vatican confirms Pope John Paull II has died.
VATICAN CITY (April 2) - Pope John Paul II remained in ''very serious'' condition Saturday after developing a high fever, but he was responding to members of his staff, the Vatican said.
http://aolsvc.news.aol.com/news/article.adp?id=20050224055909990001&ncid=NWS00010000000001
He is with God now.
Aussie
Jagman, thanks for the reply and I agree with you 100%, they are totally clueless.
G'day, Mate.
Aussie
Some of you may remember this from the last webcast:
"GERALD YAKATAN: Good try. ELMER PIRUS: Yes, I spent too much time thinking of this question. GERALD YAKATAN: When I said that other people are coming out and a lot have interest in neuropathic pain, that doesn't mean that we wouldn't talk to somebody about P.B.A. or haven't been. But I think that really what I want to do is -- to be honest, make a pretty big deal out of that decision one way or the other. Because you remember, it would be a big step to move forward to commercialization. You have been an R&D company, and if you're going to become a commercialization company, there are additional skill sets that are required, there are additional things to understand and to be able to accomplish. We want to carefully sit through all of those possibilities and understand we are positioned for success, regardless of which way we go. [b}As I said, I will comment on it before the end of this quarter. I have an annual meeting coming up, that's an important milestone meeting for us. And that's before the end of the quarter. I think you can look for us to give you some guidance around that time. ELMER PIRUS: OK. Thank you very much."
IMO, there should be something coming from the company soon.
G'day, Mates.
Aussie
Not much happening with this stock. Still watching it and hope for you longs it pans out.
G'day, Mates.
Aussie
AVN has new coverage.
http://www.investorshub.com/boards/post_new.asp?board_id=2452
AVANIR Pharmaceuticals (AVN) At 4:01PM ET: 2.33 0.03 (1.30%)
Upgrades & Downgrades History
UPGRADES & DOWNGRADES HISTORY
Date Research Firm Action From To
30-Mar-05 Punk, Ziegel & Co Initiated Buy
G'night.
Aussie
On the 9th I had sold shares bought in at $.0135. Sold it $.0145.Becase of the impending lawsuit. Stocks always go down on such news -- whether its a good suit or not.
Now the stock is at $.009. Wouldn't be a bad time to get back in. It goes back up to $.0135 or higher, that would be nice.
Thinking of putting a bid in for $.007.
G'day, Mates.
Aussie
AVANIR's Anthrax Antibody Data Presented at 2005 ASM Biodefense Research Meeting
SAN DIEGO--(BUSINESS WIRE)----AVANIR Pharmaceuticals' (AMEX:AVN) anti-anthrax monoclonal antibodies have demonstrated an ability to protect against the most lethal form of anthrax toxins in animal models. Data from additional studies conducted by Johnny W. Peterson, Ph.D., of the University of Texas Medical Branch were presented today in a poster entitled "Human Monoclonal Antibodies to Protective Antigen with and without Ciprofloxacin Protect Mice and Guinea Pigs against Inhalation Anthrax" at the 2005 American Society for Microbiology (ASM) Biodefense Research Meeting being held this week in Baltimore, Maryland.
"Human anti-PA monoclonal antibodies supplied by AVANIR Pharmaceuticals have been shown to protect against lethal infection in mice and guinea pigs challenged with B. anthracis spores instilled into the respiratory tract," said Dr. Peterson. "Our research indicates delay in death and survival is significantly increased by co-administration of antibodies with low levels of ciprofloxacin."
The in vivo tests on passive immunization with AVANIR human monoclonal antibodies are being conducted in small animal models established at the University of Texas Medical Branch in Galveston under contract from the National Institute of Allergy and Infectious Disease (NIAID), a division of the National Institutes of Health. "AVANIR's human monoclonal antibodies to protective antigen (PA), such as AVP-21D9, have high specificity and very desirable binding properties, and offer considerable promise for the rapid development of products useful as adjuncts to current antimicrobial prophylaxis and therapy against inhalation anthrax," continued Dr. Peterson.
Antibodies that neutralize anthrax toxins may augment existing treatment options. Currently, a vaccine and antibiotics are the treatment options available for the prevention or treatment of anthrax exposure. Both approaches have limitations. The anthrax vaccine takes weeks following the first doses before immunity is established, and requires multiple injections over a period of months, in addition to annual boosters, to reach and maintain its protective effect. Antibiotics, the standard treatment of anthrax infection, are effective in killing anthrax bacteria, but have no effect on the anthrax toxins.
"These data indicate that AVP-21D9 may provide the necessary immediate protection before other treatment regimens take effect," concluded Dr. Peterson.
AVANIR Pharmaceuticals is a drug discovery and development company focused on treatments for chronic diseases. Our product candidates address therapeutic markets that include central nervous system and cardiovascular disorders, inflammation, and infectious disease. The Company's first commercialized product, Abreva(R), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.
Except for the historical information presented herein, matters discussed in this press release contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Statements that are not historical facts, including statements that are preceded by, followed by, or that include such words as "estimate," "anticipate," "believe," "plan" or "expect" or similar statements are forward-looking statements. Risks and uncertainties for AVANIR Pharmaceuticals include risks associated with product discovery and development, our dependence on government grants to subsidize the development of our anthrax antibodies, as well as risks shown in AVANIR's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q and from time-to-time in other publicly available information regarding the company. Copies of such information are available from AVANIR upon request. Such publicly available information sets forth many risks and uncertainties related to AVANIR's business and technology. Avanir's monoclonal antibody technology competes with several technologies used by large pharmaceutical and biotechnology companies and is subject to a number of uncertainties, including risks associated with the success of clinical trials, the progress of research and product development programs, the regulatory approval process, competitive products, future capital requirements and commercialization risks, particularly with drug candidates being developed for the U.S. federal government. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance, or that even if such regulatory clearance were received, that such products would ultimately achieve commercial success. The company disclaims any intent or obligations to update these forward-looking statements.
AVANIR Pharmaceuticals Patrice Saxon, 858-622-5202 (Investor Relations) psaxon@avanir.com
03/22/2005 14:00 ET
© Business Wire 2003
G'day, Mates.
Aussie
AVANIR Presents Data on Novel Mechanism of Action at the American Academy of Allergy, Asthma and Immunology National Meeting
SAN DIEGO--(BUSINESS WIRE)----AVANIR Pharmaceuticals (AMEX:AVN) today announced that data on AVP-13358 was presented at the 2005 national meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI). The poster "A Small Molecule Compound (AVP-13358) in Phase I Clinical Development Suppresses Experimental Allergy in Animals Via a Distinctly Novel Mechanism" describes a unique activity profile for AVP-13358.
Previous data have shown that AVP-13358 exhibits a profile that inhibits the generation of important mediators associated with development of allergy and asthma. These mediators include IgE antibodies, the cytokine IL-4, and the IgE receptor CD23. AVANIR has now identified a common pathway to account for the unique profile of AVP-13358. The pathway involves regulation of certain proteins located in a sub-cellular organelle known as the Golgi. AVANIR believes suppression of these proteins with AVP-13358 inhibits the secretion of IgE and IL-4 and the expression of CD23, and thus may "quiet" the hyperactive cells typically found in the airways of allergy and asthma sufferers. These data support a decidedly novel mechanism of action, and provide a theoretical basis of action for the AVANIR compounds.
"Other than the inhibitors of leukotrienes, there have been no new drugs with novel mechanisms of actions approved for the treatment of asthma in the last 30 years," said Jagadish Sircar, Vice President of Drug Development for AVANIR. "Asthma is a multi-factorial disorder and a drug that inhibits multiple mediators may offer advantages over more specific agents. Corticosteroids suggest this is a valid approach, however, the use of steroids is limited by their toxicity. Theoretically, AVANIR's compounds may not have similar limitations because they target hyper-responsive cells while leaving constitutive cellular processes relatively unperturbed."
The abstract accepted for presentation at the AAAAI meeting was published in the February 2005 supplement to the Journal of Allergy and Clinical Immunology.
AVANIR Pharmaceuticals is a drug discovery and development company focused on treatments for chronic diseases. Our product candidates address therapeutic markets that include central nervous system and cardiovascular disorders, inflammation, and infectious disease. The Company's first commercialized product, Abreva(R), is marketed in North America by GlaxoSmithKline Consumer Healthcare and is the leading over-the-counter product for the treatment of cold sores. Further information about AVANIR can be found at www.avanir.com.
The information contained in this press release, including any forward-looking statements contained herein, should be reviewed in conjunction with the Company's most recent Annual Report on Form 10-K and other publicly available information regarding the Company. Copies of such information are available from the company upon request. Such publicly available information sets forth many risks and uncertainties related to the Company's business and technology. Forward-looking statements often contain such words like "estimate," "anticipate," "believe," "plan" or "expect." Our IgE modulation program competes with other research approaches and compounds under development by large pharmaceutical and biotechnology companies. Preclinical research findings are not always supportable by evidence obtained from subsequent clinical trials. Final review decisions made by the FDA and other regulatory agencies concerning clinical trial results are unpredictable and outside the influence and/or control of the Company. AVANIR disclaims any intent or obligation to update these forward-looking statements.
AVANIR Pharmaceuticals Patrice Saxon, 858-622-5202 (Investor Relations) psaxon@avanir.com
03/22/2005 11:27 ET
© Business Wire 2003
Merix Pharmaceutical Sues GlaxoSmithKline for Deceptive Promotion of Popular Herpes and Cold Sore Drugs
Lawsuit Underscores Ongoing Controversy Over Pharmaceutical
Marketing Excesses
CHICAGO, March 21 /PRNewswire/ -- In a case that pits a leading pharmaceutical company against one of the behemoths of the pharmaceutical industry, Merix Pharmaceutical Corporation has filed a complaint against GlaxoSmithKline, L.P. for false advertising and unfair competition in its campaign to promote drugs for herpes and cold sores.
The case was filed in the United States District Court for the Northern District of Illinois, Eastern Division, and charges that advertising claims made by GlaxoSmithKline (GSK) are false and misleading, using unreliable test data to promulgate advertising claims in an intentional effort to deceive doctors and the public.
GSK's false claims for its Abreva and Valtrex products violate multiple Illinois laws as well as the federal Lanham Act, according to the lawsuit. The lawsuit alleges that the claims directly and severely harm Merix, which manufactures RELEEV, a competing over-the-counter product for herpes and cold
sore treatment, as well as consumers. Merix is seeking preliminary and permanent injunctive relief to halt the GSK campaign.
According to the Merix suit, the false advertising threatens immediate and severe damage to the RELEEV brand. Merix has made a longstanding and careful investment in the goodwill that the brand enjoys in the marketplace.
The suit alleges that public disclosures of GSK's own research undermine the claims that it makes for both Abreva and Valtrex for healing herpes symptoms and cold sores. According to the lawsuit, some studies have even shown that the active ingredient in Abreva, an over-the-counter ointment,
could not out-perform a placebo, yet, in its $100 million ad campaign, GSK publicly claims that it is just as effective as a prescription drug. Abreva sells at a similar price as RELEEV.
The lawsuit also alleges that GSK's claims for Valtrex, an oral prescription drug, are similarly unsupportable. The suit claims that GSK has no basis to conclude from any testing that was done that Valtrex has any effect beyond the itching and tingling phase once a herpes outbreak has actually occurred. Yet, as the lawsuit alleges, GSK now makes the broad claim
one-day cold sore treatment.
"We are confident the court will agree that this matter requires immediate action, not only to protect Merix, but to protect the marketplace as well," said Meryl Squires, president of Merix Pharmaceutical Corporation.
For more information and copies of the filing, please contact:
Ronald Rothstein, Esq.
Winston & Strawn LLP
Telephone: (312) 558-7464
Email: rrothstein@winston.com
Leslie Valenza
Telephone: (202) 973-1320
Email: lvalenza@levick.com
SOURCE Merix Pharmaceutical Corporation
Paul, thanks again for another excellent report.
G'day, Mate.
Aussie
Another report taken from the RB board.
By: reason911
19 Mar 2005, 01:47 PM EST
Msg. 34128 of 34128
Jump to msg. #
First of all, please do your own DD and that the following is to the best of my knowledge. If you want more info, contact the company like I did.
James Glavin spoke first. He introduced all there. I was surprised to learn that Gilbert Stevely from AMEX was there with AVN’s specialist Brad Mills (I was told by other investors that the AMEX had recognized AVN due to the % change in AVN. I asked them were they there only to visit AVN and he said no that they were visiting other companies in the area. Gilbert was real cordial and the typical “we love having your company on AMEX” conversation occurred with the typical response “we love being on AMEX” followed up with “if there is anything we can do for AVN…”). Glavin also stated that there were 97 million shares outstanding but I thought that there were 99 but perhaps he did not include the 2M from Dr. Yakatan? All proposals were approved.
Then Dr. Yakatan spoke. He first talked about the retiring of Susan Golding and his friend and tennis partners, Jim Glavin. I found it interesting that Susan left right after she received her present and did not stay for the meeting (she whispered to Jim before she left that she thanked him for the opportunity etc…). I think that her leaving after she received her departing gift displayed her attitude with AVN in that she did not have much to participation in AVN. IMO it was best that she left the BOD. Glavin at least stayed for the rest of the meeting. He also stated that some BOD members were surprised how active the ASM is because they have gone to other ASM for other companies and sometimes only one or two shareholders show up. (IMO, this lack of involvement is sad and could explain why the BODs of most companies get away with so much).
The presentation is basically the same that you have heard all before. AVN’s belief is that a pharm company needs to have a portfolio & pipeline of products and thus prevent it from being a one-product company. To limit the exposure by the FDA rejection process, they use already know products in a new manner to create a new product.
There are three items the company is focusing in on: Neurology, Inflammation and Cardiovascular. Of course he was talking about Neurodex for Neurology. He displayed the logo that they have developed. He stated that they felt that they would know from the FDA 9 months from now if the FDA will accept it. AVN expects to send the final report by the middle of the year and because it is a Fast Track application, the FDA must reply no latter than 6 months after it is received (of course there is always the possibility of acceptance earlier than that). IF it is approved, then AVN will show that they can replica the process for developing a product and guiding it through the FDA approval process. This will also show that AVN is not a “one horse” company. He went over the facts about Dex being absorbed ECT... which you all have heard before.
Atharosclerosis Platform – (I know I spelt it wrong). Internally developed novel orally active small molecule AVP 26542. Again, you can read the PR about this product would not only prevent the cholesterol from building up but also help decrease the cholesterol already in the body to levels that are normal. The status is that they are in Partnership discussion and are hoping to file IND by the end of 2005.
Inflammation Platform – Talked about Asthma and that most people do not know that this is an inflammation symptom AVN want to regulate the MIF. They completed initial Phase I, which was well tolerated, and that Phase Ib, will begin using multiple rising doses to begin in 2005 but most of the information is the same in prior PR. They hope to file IND in 2005.
CNS Platform - to have Proprietary drug with Neuroprotective properties, and have dual mechanism of action, which leads to better regulation to decrease glutanate (?). The exciting thing is that they are finding new ways that it may apply to other conditions. They expect it to be $500M market. Completed 2 trials for efficacies and found that there is statistically significant data. NDA started in Dec 2004 & should be completed by June 2005. Priority review with 6 months reply.
Neuropathic Pain. There is an unsatisfied market. It is a question not of if NP will replace current products, but that which other products will it be used with because most current products are used together with other drugs. Phase III. They received from FDA a design protocol and if it works, then FDA will accept because of their participation in the design.
Commercialization of Neurodex – They are looking at a copromotion strategy. (1) Avanir to deploy targeted sales force to meet and educate doctors of the products. Many doctors use a variety of names for the same symptom so they need to be educated in this area. (2) Partner with larger sales force. In addition, they have put together Key Opinion Leaders in the research community to help promote Neurodex. AVN took out their 1st ad for Neurodex in March 05 in the American Journal of Geriatric Psychiatry for the potential mechanism. They can’t take out an ad for the actual product until FDA approves it.
Dr. Yakatan recapped the major events for 2005.
1) They plant to attend the American Academy of Neurology to present some data on MS. AVN has been selected as one of the highlight products/development for the meeting. This will be in April. They are excited about this because the Academy selected them (they usually only select two or three of all the presenters) and also the Academy is a nonbiased endorsement.
2) By the middle of the year, AVN expects to file the NDA for Neurodex.
3) By the middle of the year, starting Phase III trials for Neuropathic pain.
4) By the middle of the year, phase I trials for asthma.
5) By the end of year, IND for arteriosclerosis and Inflammation
6) By the end of the year, response by FDA on Neurodex.
Then the questions (I am sorry that I did not get all the questions or how they were phrased and the exact response but there were only about 5 questions and I was very tired from the busy week trying to get away from work so I can attend the ASM, traveling to the ASM and being up all night).
Q) How do you evaluate the marketing for PBA?
A) They prepared to have a partner and their own sales force.
Q) I was upset about the stock price and dilution of shares. Part of the reason for the stock price is due to the delays and the fact that AVN hoped to have partners by now. Worried about the fact that AVN now has exclusive rights to a third product, yet AVN has Abreva and Xenerex which both have not been fully utilized and these areas are a source of expense for the company and we do not want to have a third product and not have a revenue generating partners. I reminded him that in the 2001 AMS that all we heard about was Xenerex and now we barely know of it. Now it seems that more shares will be issued before the end of the year and during the time of 5 years, the shares authorized have gone from 57M to 100M which is a maximum authorized thus perhaps giving weight to a RS (then Yak corrected the share authorized is 200M).
A) Yak stated that he had understood the concerns and that some of the things have not been met. He also stated that he did not entirely understand Wall street and what drives the market. He told the rest of the audience what the three questions were. He does not want further dilution especially since he is now the biggest shareholder after the Irysis deal (IMO a very big plus for AVN). They are working on obtaining partners and next month he is going to Canada for the product lunch for Abreva. (At this time I did not know that there was a delay due to GSK. Later he said that GSK delayed their lunch due to the fact that they did not want to jeopardize the USA market due to perceived conflicts between the two regulatory agencies of the both countries and the chance that Canada might take away some of the USA market. Canada will only contribute about 10% of the total expected N. American market. I asked why GSK would buy a product to delay launch and he said that AVN also could not understand why GSK would purchase the rights and drag their feet. Therefore, AVN did some research and “fixed” the problem that GSK was concerned about. In addition, I asked if the company that was sold the rights for N. American is disappointed with the lack of Canada product launch. He said no. They felt that Abreva would only hit $$$ market while AVN thought it would hit a higher $$$$ market (Thus the clause that after a certain sales goal, AVN will share in the royalty). Without the Canadian market, the company has already hit the sales goal expected. Of course I pointed out that this couldn’t happen if GSK does not do a product launch, which he agreed to). He also stated that they are working on Japan and Europe. There are delays due to the fact that the product will be OTC and the long regulatory red tape that goes with it (things that have already been discussed). He said that the issuance of shares is typical of biotech companies.
In addition, he stated that they changed their business model for Xenerex because there was very little money in it due to the fact that they would have a long process over things they could not control for the companies that they were producing antibodies for. There are only two ways to fund the research and that is through partners or issuing shares. I asked for which route he is going to choose and he responded that they would be issuing new shares. Yak stated that things will be different next year and I interrupted and reminded him that he told me that last year, then the audience laughed. He said something to this response but I did not hear it.
Q) What is the status of the anthrax antibodies?
A) Biodefense is not a reasonable option due to the fractured government organization fighting. Some departments feel that spending money on treatments is a waste of money and should be used elsewhere. Yet despite this, they are pressing for a response. (Later on, a group talked to David Hansen and he stated that working with the gov’t is a strange situation. Even if you have a better product, the gov’t won’t necessarily purchase is. The NIH has different procedure and some feel that a preventive measure (vaccine) is better that a treatment (antibodies). He also stated that the gov’t tends to go for companies who can take the entire product from A-Z even if the product is not the better product. He did say that we still can keep all the research that is being done and any knowledge that is learned from these various antibodies even if the gov’t or company does not choose to pursue AVN’s antibodies).
Q) What is AVN shooting for sales for Neurodex?
A) The company is gearing towards their own sales for and as of now there is no way to really compare it due to it being a new product and a new marketing potential. (In later discussions, Dr. Yakatan stated that he is waiting for the FDA approval before he begins the activation of the sales for and the building of inventories because he has worked for other companies where they started building up inventories only to have the FDA reject it. Since AVN has such a tight budget, there is no need for additional expenditures until the approval. The use of the sales force would take about 3-4 months after the FDA approval. He also stated that the could have a partner right now but that partner would take about 50% of the revenue from sales and he did not feel that this was a good deal)
Q) Explain more about the Cox 2 inhibitor for pain.
A) No drug currently for pain. It will be significant because it is different and the data shows it is significant for pain (I lost some of the more detailed aspect of it because I started to drift off).
Q) I asked about AVN’s strategy for developing already known products but from the presentation it seemed that both asthma and inflammation is not being developed from any currently know drug.
A) That is correct in that this is a novel target for both of these areas.
Q) Elaborate more on what Xenerex is doing.
A) Xenerex is developing antibodies against resistant bacteria due to the overuse of many doctors and thus these new strains are harder to fight because of the response to drugs already on the market.
Q) How is AVN cholesterol different?
A) Different from Pfizer in that it is different target & mechanism. He stated that Pfizer purchased a company that is developing drug for this area but that the drug would have to be provided through an injection. AVN is different in that you do not need to inject and that is will be a small molecule and thus taken orally.
More to follow soon…
Have a g'day.
Aussie
Paul, great job. Thanks very much.
G'day, Mate.
Aussie