Warum kennnt denn keiner AVANIR PH., denn.. - 500 Beiträge pro Seite

[silber-tom]

über jede Bio-Aktie wird hier geschrieben und wenn sie noch so klein ist, aber AVANIR ist eine echte Perle.
Mich wundert das in keinem Board etwas zu diesen Aktie geschrieben steht. Die US-Boards sind voll.
Es wäre schön wenn jemand Infos hier hinein stellen könnte!

Mfg S-T

[silber-tom]

Läuft SUPER

IN US 47 %

mfg s-t

[silber-tom]

KEINER EINE MEINUNG ??????

WAS IST LOS ????

S-T

[mahatma]

Hi silber-tom,
freue dich über diese Seite:
http://www.biospace.com/ct/results.cfm?company=2314
es grüß der kalte Winter in den USA

maha

[silber-tom]

Vielen DANK !!

#####AVANIR Pharmaceuticals develops and commercializes novel therapeutic products for the treatment of chronic diseases. In July of this year, the U.S. Food and Drug Administration approved AVANIR`s first drug product, Abreva™, a topical treatment for cold sores. Abreva™ is the first FDA-approved product in the over-the-counter cold sore treatment category and will be marketed in the U.S. and Canada by SmithKline Beecham, one of the world`s largest consumer healthcare companies. AVANIR, through its subsidiary, Xenerex Biosciences, is commercializing a platform technology for developing monoclonal antibodies and plans to partner with companies to generate monoclonal antibodies to their proprietary disease targets, as well as to produce monoclonal antibodies to its own targets. AVANIR`s product development pipeline includes a drug candidate for the treatment of multiple central nervous system disorders, including emotional lability, neuropathic pain and chronic cough. AVANIR also has a drug discovery program in the advanced pre-clinical stage of development for the treatment of the underlying biological causes of allergy and asthma. The company`s website is www.avanir.com.


Und gleich noch etwas für die Boardteilnehmer #######
Dieses ist eine ``ECHTE PERLE ``


Clinical Trials Search Results
Tradename Developer(s) Partners Indications Current Phase
Abreva AVANIR Pharmaceuticals
SmithKline Beecham
Bristol-Myers Squibb Pharmaceutical Research
Takeda Chemical Industries
Herpes Simplex virus type 1 (oral)
Market
AVP-923 AVANIR Pharmaceuticals
ALS (Lou Gehrig`s disease)
II/III
AVP-923 AVANIR Pharmaceuticals
Pain control
II/III
AVP-923 AVANIR Pharmaceuticals
Lung/Airway Disorder (misc)
II
IgE down regulators AVANIR Pharmaceuticals
Allergies (misc)
Asthma
Pre-Clinical


Fazit ;;;;;;;;;;;;;EINSTEIGEN !!!

mfg s-t

[Sixi]

[img]Avanir Pharmaceuticals Sets Date for Annual Meeting of Shareholders; Company Characterizes 2000 as a `Breakthrough Year`


SAN DIEGO, Jan. 5 /PRNewswire/ -- Avanir Pharmaceuticals (Amex: AVN) today
announced that it has scheduled its 2001 annual meeting of shareholders for
Thursday, March 15, 2001, at 9:00 a.m., Pacific Standard Time, at the
company`s offices, 11388 Sorrento Valley Road, Suite 200, San Diego,
California.
In announcing the date and location for the annual meeting of
shareholders, Gerald J. Yakatan, Ph.D., noted that fiscal 2000 was a
"breakthrough year" for the company in terms of its accomplishments.

Key milestones achieved include:

(1) Obtaining approval from the U.S. Food and Drug Administration for its
first product -- Abreva(TM) -- the first FDA-approved product for the
treatment of cold sores available without prescription. Abreva is
being marketed by SmithKline Beecham Consumer Healthcare, a division
of the newly formed GlaxoSmithKline, one of the world`s largest
marketers of consumer pharmaceutical products. Abreva addresses a
U.S. market of roughly 50 million cold sore sufferers who experience
an average of two to three outbreaks a year. The product is expected
to be Avanir`s first major revenue producer.
(2) Forming a wholly-owned subsidiary company, Xenerex Biosciences, to
provide focus to Avanir`s patented platform technology for producing
fully human monoclonal antibodies. Xenerex intends to commercialize
this technology through partnerships with pharmaceutical and
biotechnology companies and by creating monoclonal antibodies to its
own targets. The company is in active talks with several potential
partners and said the four previously announced demonstration
projects are proceeding as envisioned.
(3) The start of Phase II/III clinical testing to establish efficacy of
AVP-923, a modified form of dextromethorphan, in the treatment of
emotional lability in neurodegenerative diseases. Additional
indications for the compound include neuropathic pain and chronic
cough.

Other projects in the pipeline include a drug discovery program in the
advanced pre-clinical stage of development for the treatment of the underlying
biological causes of allergy and asthma and preclinical work on a cholesterol
lowering compound and an anti-inflammatory compound. These programs represent
the company`s continuing focus on developing novel, small molecule
therapeutics for treating chronic diseases.
Avanir Pharmaceuticals, based in San Diego, is engaged in research,
development, commercialization, licensing and sales of innovative drug
products and antibody generation services. The company`s website is
http://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 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." Preliminary 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 trials results for AVP-923 are unpredictable and outside
of the influence and/or control of the company.



SOURCE Avanir Pharmaceuticals
Web Site: http://www.avanir.com


--------------------------------------------------------------------------------



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[silber-tom]

EEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIINNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSSTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTTEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGGEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEENNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNNN

EINSTEIGEN LEUTE !!!


MFG S-T

[Ronny-D]

Hast du dir auch mal angesehen, welche Umsätze hier zustande kommen. So gut wie keine, oft gar keine.
Wenns kracht´, kommst du aus der Aktie nicht mehr raus.

Auch wenn es vielleicht ein guter Wert ist, so bist du doch
in deinem Handlungsspielraum stark eingeschränkt.
In den USA sieht es auch nicht besser aus. Im Schnitt 50000
Stücke pro Tag. Für Amiverhältnisse kleinkram.

Bio`s sind schon heiß genug !

Gruß

Ronny-D

[silber-tom]

Sehr stabil diese Aktie hält sich sehr gut.

Habe letzte Woche noch einmal nachgelegt (Medx gab es auch einmal unter 5E)
Leute einsteigen!!!

mfg s-t

[sambadobrasil]

eine biotechaktie, die jetzt bereits gewinn macht. hier kann man nichts mehr falsch machen. bin seit märz 00 dabei.
samba

[silber-tom]

JJJJJJJJAAAAAAAAAAAA, dann sind wir jetzt zu zweit.
Ich dachte ich bleib der einzige.
Gratuliere, Top Aktie !!!!!!!

mfg s-t

[Bombenleger]

Hallo Ihr beiden,

kann mir einer genaueres über die Firma sagen.Habe die Firma
mal angeschrieben und um Unterlagen gebeten.
Das schwarze Zahlen geschrieben werden ist nicht schlecht,aber wenn
ich recht sehe sind die guten Präperate noch in den Testphasen.

[silber-tom]

SOURCE: Avanir Pharmaceuticals
Avanir Pharmaceuticals Receives Notice of Allowance of Patent For Potential Allergy and Asthma Treatment Method
SAN DIEGO, March 6 /PRNewswire/ -- Avanir Pharmaceuticals announced today that it received a Notice of Allowance from the U.S. Patent and Trademark Office for claims relating to a method of regulating production of immunoglobulin epsilon (IgE), a primary contributor to the symptoms of allergy and asthma. Avanir`s preclinical research in this area is targeting a novel method of treating allergy and asthma through modulating the body`s synthesis of IgE.

Avanir`s technology involves the use of small molecules in the regulation of IgE. No small molecule drugs are currently available for the treatment of excess IgE, either via neutralization or suppression of synthesis or release. Small molecule drugs that can be taken orally and are capable of suppressing IgE responses could provide a new tool for treating allergy and asthma.

``We are pleased with the continuing development of Avanir`s intellectual property portfolio,`` said Gerald J. Yakatan, Ph.D., president and CEO of Avanir Pharmaceuticals. ``This Patent Office action validates the work of our scientists as we attempt to bring novel approaches to the treatment of important chronic diseases like allergy and asthma.``

Avanir Pharmaceuticals, based in San Diego, is engaged in research, development, commercialization, licensing and sales of innovative drug products and antibody generation services. The company`s website is http://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 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 preclinical IgE modulation program competes with several research approaches and numerous 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.

###########Und die Kassen klingeln weiter ####

Einsteigen mfg s-t

[silber-tom]

Immer noch keiner drin!!!


S-T

[minni]

Patent Issued for Avanir Licensed Product to Help Break Dependence On Habit-Forming Narcotics
SAN DIEGO, April 10 /PRNewswire/ -- Avanir Pharmaceuticals (Amex: AVN - news) announced today that the United States Patent Office issued U.S. Patent No. 6207674 for the use of a combination of dextromethorphan and an oxidase inhibitor (known as AVP-923) for the weaning of patients from narcotics and anti-depressants. The patent was issued to the inventor, Dr. Richard Smith. Avanir has the exclusive worldwide rights to develop and market AVP-923 under a sublicense to granted to Avanir in August of 2000.

The patents claims, among others, that when dextromethorphan and an oxidase inhibitor were administered orally to patients who had become dependent on morphine and anti-depressants, the patients were able to initially reduced their dosages of the narcotics. With additional dosing, the combination allowed patients to terminate all use of morphine and anti-depressants, with minimum withdrawal or other adverse affects.

``The issuance of this patent extends the utility of AVP-923 and reinforces our initial impression of the product as a platform for potential treatments in many different therapeutic areas,`` said Gerald J. Yakatan, Ph.D., president and CEO of Avanir Pharmaceuticals.

The company is currently conducting a Phase II/III trial examining the effect of AVP-923 in the treatment of emotional lability in Amyotrophic Lateral Sclerosis (ALS) patients and a Phase I dose ranging study for the use of AVP-923 in patients with neuropathic pain.

Avanir Pharmaceuticals, based in San Diego, is an emerging diversified biopharmaceutical company engaged in research, development, commercialization, licensing and sales of innovative drug products and antibody generation services. The company`s website is http://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 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``. Research findings and patent claims are not always supportable by evidenced 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.




ich bin seit gestern auch drin, zum 2. Mal
grüsse minni

[silber-tom]

Hallo minni sind wir die einzig SCHLAUEN oder DOOFEN die in AVANIR inves. sind ???

Schöne Ostern

S-T

[minni]

ich hoffe die Schlauen... immerhin auf den Amiboards ist
ein ziemlich reger Betrieb

[silber-tom]

Hey immer noch keine neuen Ak. bei Avanir, nein nein inv. weiter in Unternehmen die Verluste schreiben. Macht euch schlau.....


s-t

[Kelbi]

Ihr seid nicht die einzigen, heute vor den Zahlen aktuell + 22,90 % auf wieder über 5 USD und endlich mal ein ordentliches Volumen.

Bin mal gespannt wie Zahlen ausfallen werden und welchen Ausblick es gibt.

Gruß

Kelbi

[Kelbi]

29 % und gleich noch ne Neuigkeit hinterher, klingt auch nicht schlecht....(Quelle Yahoo)

Avanir Subsidiary Xenerex Biosciences and Eos Biotechnology Form Antibody Research Collaboration
Companies Will Jointly Discover Antibody Therapies For Selected Cancer-Target Antigens
SAN DIEGO, May 8 /PRNewswire/ -- Xenerex Biosciences, a subsidiary of Avanir Pharmaceuticals (Amex: AVN - news), announced today that it has entered into an antibody generation agreement with Eos Biotechnology. The research collaboration provides for Xenerex to generate fully human monoclonal antibodies to three cancer-target antigens provided by Eos. Eos will evaluate the antibodies generated by Xenerex for potential development of therapeutic treatments for the selected cancers. One of the pioneers in the effective use of the human genome sequence, Eos has discovered many new disease-specific drug targets in several major cancers.

``This collaboration represents an important third-party validation of the potential of our proprietary technology in human antibodies,`` said J. David Hansen, president and chief operating officer of Xenerex Biosciences. ``We are very pleased to have the opportunity to work with an established genomics and bioinformatics company such as Eos. The agreement serves as an important step in broadening the commercialization of our platform for application in multiple diseases.``

``The establishment of research collaborations that utilize our antibody generation expertise is a key element of Avanir`s 2001 growth plan,`` said Avanir`s president and chief executive officer Gerald J. Yakatan, Ph.D. ``The agreement between Xenerex and Eos represents the achievement of an important milestone that is part of that plan.``

``This agreement with Xenerex allows us to collaborate with a company having a novel and unique platform for generating human antibodies,`` stated David Martin, Eos` president and chief executive officer. ``Eos is committed to a high throughput approach to developing therapeutic antibodies against our proprietary, highly-specific disease related targets. Acquiring access to Xenerex technology is important for ensuring success in our drug development process.``

Under terms of the agreement, Xenerex will receive research fees for the use its unique monoclonal antibody technology to generate fully human antibodies and could receive license fee and milestone payments, plus royalty payments on sales of products developed by Eos from the antibodies. Eos will be responsible for manufacturing, product development and marketing of any products developed through the agreement. The financial terms of the agreement were not disclosed.

Eos Biotechnology, Inc., a privately funded biotechnology company in South San Francisco, California, develops, applies and integrates a variety of high- throughput genomics, bioinformatics and biological processes for the creation of novel therapeutic and diagnostic products. Eos technologies are being applied to rapidly and cost-effectively build a pipeline of novel and medically important therapeutics and diagnostics in the areas of oncology, angiogenesis and inflammation, with initial product development efforts focused in the area of therapeutic antibodies. Further information about Eos and its programs is available at http://www.eosbiotech.com .

Xenerex, a subsidiary of Avanir Pharmaceuticals, is a biopharmaceutical company with a customer-focused mission to enable partner companies to develop and commercialize completely human antibody products. The Xenerex technology utilizes human immune system cells engrafted into SCID mice, which do not have their native immune system. The mice are immunized with the target antigen and respond by creating fully human antibodies, which the company evaluates for optimum antibody characteristics against the target.

Avanir Pharmaceuticals, based in San Diego, is an emerging diversified biopharmaceutical company engaged in research, development, commercialization, licensing and sales of innovative drug products and antibody generation services. The company`s website is http://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 like ``estimate,`` ``anticipate,`` ``believe,`` ``plan`` or ``expect`` or similar statements are forward-looking statements. In regard to Avanir Pharmaceuticals and Xenerex Biosciences, risks and uncertainties include risks associated with product discovery and development as well as risks shown in Avanir`s Annual Report on Form 10-K and Form 10-Q and from time-to-time in other publicly available information regarding the companies. 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. Xenerex`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 and future capital requirements. 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 companies disclaim any intent or obligations to update these forward-looking statements.

[silber-tom]

Avanir lebt und d.Z + 30%, ich denke Avanir wird neu entdeckt, schau euch mal das Volumen an.
Heute nur tolle Neuigkeiten, dabei bleiben kaufen, kaufen, kaufen......


Schönen Abend

Silber - Tom

[silber-tom]

AVN Could Be the New Mab Leader
Interesting news in the biotech world has arrived. Eos has signed the first partnership with AVN`s Xenerex which will
compete with MEDX, ABGX and PDLI in making fully human monoclonal antibodies. What`s even more interesting is that
Eos` chairman of the board is Nicholas Pritzker and a major investor in Eos is the Pritker Family`s BCC bank. The Pritzkers are the multibillionairs of Hyatt Hotel fame who were instumental is the growth of MEDX. The Pritzkers
through BCC were one of MEDX`s largest investors. Immediately after the deal with AVN, Eos announced that they were
retuning $5M to MEDX which was in the terms of an already existing deal. One has to assume that the terms of the contract
being changed were in connection with the AVN/Xenerex deal. Why would the Pritzkers lean towards AVN/Xenerex now?
Perhaps this has something to do with it...

"Using immuno-deficient mice, rather than transgenic mice, Xenerex can produce completely human
antibodies faster and cheaper than its
competition, big market players like Abgenix Inc., Medarex Inc. and Cambridge Antibody
Technology plc, Hansen said. "

Bioworld Online,#

KAUFEN !!!!
MFG S-T

[silber-tom]

Leute warumm kennt denn wirklich niemand Avanir, kann doch garnicht sein, denn das Untern. ist doch TOP und MEDX war auch einmal unter 5$



einsteigen mfg s-t

[silber-tom]

Latest News Bin ja der einzige der an diese Geschichte glaubt, aber sagt nicht ihr habt es nicht gewusst.

mfg s-t

--------------------------------------------------------------------------------
AVANIR Subsidiary Xenerex Biosciences Broadens Technology Platform By Licensing Rights to Stem Cell PatentPatent Further Strengthens Technology Platform for Generating Fully Human Antibodies With Complimentary, Novel Approach


SAN DIEGO, Jun 6, 2001 /PRNewswire via COMTEX/ -- Xenerex Biosciences, a
subsidiary of AVANIR Pharmaceuticals (Amex: AVN), announced today that it has
licensed the rights to a patent for grafting adult human stem cells into severe
combined immunodeficient (SCID) mice. The ability to engraft adult human stem
cells, which may respond to unique antigens with unique antibodies, broadens the
company`s technological resources with yet another important option in
generating fully human monoclonal antibodies.

"The addition of this exclusive method extends our technology platform with
another methodology for generating fully human antibodies to a wide array of
infectious diseases and human proteins," said J. David Hansen, president and
chief operating officer of Xenerex Biosciences. "With the addition of this
unique approach we hope to generate B-cells and antibodies, that are difficult
or even impossible to obtain by other methods. We intend to further develop this
technology and are excited by both the synergies and the new opportunities this
patent presents in our pursuit of research collaborations to maximize and
commercialize our expertise in antibody generation."

The patent, U.S. 5994617, "Engraftment of Immune-Deficient Mice With Human
Cells" was originally issued to John Dick, Ph.D. and Suzanne Kamel-Reid, Ph.D.
of The Hospital for Sick Children (HSC) in Toronto, Canada. The patent allows
for the engraftment of diverse sources of adult human cells, including bone
marrow, cord blood and liver cells. These grafts have been found to be capable
of differentiating into B-cells, the cells responsible for antibody production.

Xenerex will be responsible for development of the technology under a license
agreement with HSC Research and Development Limited Partnership and will pay a
royalty to the partnership if products are marketed utilizing this specific
technology. Other terms of the agreement were not disclosed.

The existing patented technology of Xenerex is focused on engrafting mature
human immune system cells into SCID mice and generating human monoclonal
antibodies from immunization of these cells in the mice. The newly licensed
technology gives Xenerex the capability to generate a renewable pool of millions
of human B-cells from the engrafting of the adult human stem cells into SCID
mice. The mice provide an environment for these cells to multiply and
differentiate into human B-cells. These B-cells may then be stimulated to
produce totally human antibodies for a wide array of antigens using Xenerex`s
current technology.

The Hospital for Sick Children is a health care, teaching and research center
dedicated exclusively to children; affiliated with the University of Toronto.
Its mission is to provide the best in family-centered compassionate care, to
lead in scientific and clinical advancement, and to prepare the next generation
of leaders in child health. For more information, please visit www.sickkids.ca.

Xenerex Biosciences, a subsidiary of AVANIR Pharmaceuticals, is a
biopharmaceutical company with a customer-focused mission to enable partner
companies to develop and commercialize completely human antibody products.

AVANIR Pharmaceuticals, based in San Diego, is an emerging diversified
biopharmaceutical company engaged in research, development, commercialization,
licensing and sales of innovative drug products and antibody generation
services. The company`s website is 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 like
"estimate," "anticipate," "believe," "plan" or "expect" or similar statements
are forward-looking statements. In regard to AVANIR Pharmaceuticals and Xenerex
Biosciences, risks and uncertainties include risks associated with product
discovery and development as well as risks shown in AVANIR`s Annual Report on
Form 10-K and Form 10-Q and from time-to-time in other publicly available
information regarding the companies. 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. Xenerex`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 and future capital requirements. 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 companies disclaim any intent or obligations to update
these forward-looking statements.


+++++++++++++Die schreiben Gewinne++++++++++++++++

[Chessmaster]

ooops hallihallo...ich bin in AVN schon seit ca.
1 jahr investiert und du hast recht, es ist
eine echte perle !!
werde demnächst öfter reinschauen
gruß
cm

[silber-tom]

Hier mal ne Meinung aus dem US Board und recht hat er!!


1. Bought small amount as a member of a stock club & started some research.
2. After gaining confidence in Abreva I felt it was a safe investment.
3. My first personal purchase was in October 2000
4. 10,730 shares & growing
5. Abreva, AVP-923, Future Docosanol uses, IgE, & best of all Xenerex
6. Better than anticipated
7. Stock prices have not reflected good news.
8. year 2001-$17.00/2002-$35.00/2003-$70.00/new products = new estimates
9. Focused on growing a small company with great science.
10. I suppose they could spend more money on hype but i would rather see them concerned with R&D.
11. I think they are doing fine without my suggestions
12. I`ve probably sold another 10,000+ shares to friends
who were confident in AVN and their revenue stream.
13. I read RB`s message board every day. I feel that some
investors are too impatient. The market isn`t going to buy hype. AVN needs earnings & I`m confident they will have them in abundance. Managment has me convinced that they don`t say anything until they are sure. I like that approach.


mfg s-t

[silber-tom]

Neues von AVANIR
Leute einsteigen die schreiben dicke Gewinne ####


AVANIR Subsidiary Xenerex Biosciences and Peregrine Pharmaceuticals Announce Research Collaboration for Solid Tumor Cancer Antibody Therapeutics


SAN DIEGO, Jun 12, 2001 /PRNewswire via COMTEX/ -- Xenerex Biosciences, a
subsidiary of AVANIR Pharmaceuticals (Amex: AVN), and Peregrine Pharmaceuticals,
Inc. (Nasdaq: PPHM) today announced that they have entered into an antibody
research collaboration agreement. The collaboration is designed to discover,
develop and potentially commercialize fully human monoclonal antibody therapies
for the treatment of solid tumor cancers.

Terms of the agreement provide for the transfer of three antigen targets from
Peregrine to Xenerex for the subsequent generation of fully human monoclonal
antibodies, utilizing Xenerex`s antibody generation technology. Xenerex will
receive upfront research fees and could receive milestones and royalties on
future product sales. Peregrine will be responsible for product development,
manufacturing and commercialization of any products developed through the
collaboration. The specific financial terms of the agreement were not disclosed.

"Our opportunity to work with Peregrine is yet another step forward in
validating the unique technology that Xenerex offers to the biopharmaceutical
marketplace," said J. David Hansen, president and chief operating officer of
Xenerex Biosciences. "In partnering with Peregrine, we are expanding the number
and types of proteins to which we can apply our antibody generation
capabilities. Additionally, we are implementing our strategy of continuing to
build our client base with partners also focused on novel treatments and
technologies."

"We look forward to working with Xenerex for the generation of antibodies
against several targets we have identified as being promising for our
therapeutic antibody programs," said Steven King, Peregrine`s Vice President of
Technology and Product Development. "Based on the strength of data from
pre-clinical animal studies using murine antibodies against several different
targets, we felt it was time to begin development of fully human antibodies that
could potentially serve as candidates for clinical studies. We believe that
Xenerex has the ability to efficiently generate these human antibodies. Based on
data from our animal models, we feel that these antibodies have the potential to
be used as unconjugated antibodies for the treatment of a variety of different
solid tumors."

Peregrine Pharmaceuticals is a biopharmaceutical company focused on the
development, commercialization and licensing of unique technologies for the
treatment of cancer, primarily based on its "collateral targeting technologies".
These technologies therapeutically target cell structures and cell types, rather
than surface cancer cells, as a means to attack solid tumors, without causing
damage to surrounding healthy tissue. The company has three collateral targeting
technologies: Tumor Necrosis Therapy (TNT), Vasopermeation Enhancement Agents
(VEA), and Vascular Targeting Agents (VTA). The company`s lead TNT based drug,
Cotara(TM), is currently being studied in the U.S. in a Phase II trial for brain
cancer and five Phase I trials for colorectal, pancreatic, biliary, sarcoma and
liver cancers. The company also has a direct tumor-targeting agent called
Oncolym(R) for the treatment of advanced non-Hodgkin`s B-cell Lymphoma. Oncolym
is being studied in a U.S. Phase I/II.

Xenerex Biosciences, a subsidiary of AVANIR Pharmaceuticals, is a
biopharmaceutical company with a customer-focused mission to enable partner
companies to develop and commercialize completely human antibody products.
Xenerex is building a portfolio of antibody product candidates through
agreements and licenses with biopharmaceutical companies. Xenerex has also
identified targets of its own and is in the process of generating antibody
product candidates for eventual out-licensing or development.

AVANIR Pharmaceuticals, based in San Diego, is an emerging diversified
biopharmaceutical company engaged in research, development, commercialization,
licensing and sales of innovative drug products and antibody generation
services. The company`s website is http://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 like
"estimate," "anticipate," "believe," "plan" or "expect" or similar statements
are forward-looking statements. In regard to AVANIR Pharmaceuticals and Xenerex
Biosciences, risks and uncertainties include risks associated with product
discovery and development as well as risks shown in AVANIR`s Annual Report on
Form 10-K and Form 10-Q and from time-to-time in other publicly available
information regarding the companies. 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. Xenerex`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 and future capital requirements. 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 companies disclaim any intent or obligations to update
these forward-looking statements.
mfg s-t

[silber-tom]

Super Zahlen und alles was das Herz braucht, also EINSTEIGEN!!!!!

mfg S-T

AVN
5.09
+0.00

delayed 20 mins - disclaimer




Thursday August 9, 4:01 pm Eastern Time
Press Release
SOURCE: Avanir Pharmaceuticals
Avanir Pharmaceuticals Reports Third Fiscal Quarter Financial Results
Revenues Increased 391% Over The Prior Year Period Based on Royalties on Sales Of Abreva(TM), the Company`s Lead Product Marketed By GlaxoSmithKline
SAN DIEGO, Aug. 9 /PRNewswire/ -- Avanir Pharmaceuticals (Amex: AVN - news), today reported financial results for the third fiscal quarter and nine months ended June 30, 2001.

``The company continued to make progress in several areas in our third fiscal quarter,`` said Avanir`s President and Chief Executive Officer Gerald J. Yakatan, Ph.D. ``Following our initial visits to current and prospective licensees for docosanol 10% cream in Japan, Korea, Israel and Western Europe, we are negotiating terms with some of the prospective licensees at the present time and expect to make an announcement before the end of the calendar year regarding new licensees and filings by current licensees. Patient enrollments continue in our Phase II/III clinical trial to examine the effect of our drug candidate, Neurodex, in the treatment of emotional lability in Lou Gehrig`s disease (ALS).``

``Our subsidiary, Xenerex Biosciences, recently entered into research collaboration agreements with Eos Biotechnology and Peregrine Pharmaceuticals, Inc.,`` stated Dr. Yakatan. ``We believe these two recent collaboration agreements represent important steps forward in validating the unique technology that Xenerex offers to the biopharmaceutical marketplace. Also during the period, Xenerex added to its intellectual property portfolio by licensing the rights to a patent for grafting adult human stem cells into severe combined immunodeficient (SCID) mice.``

Third Fiscal Quarter Operating Performance

Revenues for the third fiscal quarter ended June 30, 2001 were $799,000, an increase of 391% over revenues of $163,000 in the same period a year ago. Third fiscal quarter 2001 revenues include $509,000 in royalties earned on the sales of Abreva(TM) by GlaxoSmithKline. Royalties on sales of Abreva were lower in the third fiscal quarter as the cold and flu season passed and in-store inventory levels heading into the summer months were reduced. Thus, the spring months making up most of the third fiscal quarter brought lower demand for cold sore products than the winter months in the prior quarter. The balance of the third fiscal quarter revenues primarily came from interest income. For the same period a year ago, the company earned $163,000 in interest income.

Operating expenses for the third fiscal quarter ended June 30, 2001 were $2.8 million compared to $1.6 million as reported for the same period a year ago. The $1.2 million increase in operating expenses over the same period a year ago reflect a $756,000 increase in research and development expenses primarily for the company`s Phase II/III clinical trial for a potential treatment of emotional lability in ALS, $236,000 in expenses related to the launch of Abreva(TM) and slightly higher sales and marketing and administrative expenses as the company explored potential product license arrangements. Research and development expenses for the third fiscal quarter ended June 30, 2001 amounted to $1.4 million, accounting for 50% of total operating expenses, compared to $639,000, or 40% of total operating expenses for the same period a year ago. In addition to its Phase II/III clinical trial for a potential treatment of emotional lability in ALS, the company currently has several research programs underway including a preclinical research program focused on developing a novel treatment for allergy and asthma, and ongoing research within its subsidiary, Xenerex Biosciences, for the development of fully human monoclonal antibodies.

The company`s third fiscal quarter net loss of $2 million or $0.03 per share reflects an increase of $542,000 over the net loss in the same period a year ago. The net loss per share was unchanged from the same period a year ago after rounding to the nearest cent in each of the periods.

Fiscal Year-to-date Results

For the nine months ended June 30, 2001, the company incurred a net loss of $1.6 million or $0.03 per share, an improvement of 80% compared with a net loss of $8 million or $0.16 per share for the same period in fiscal 2000. Excluding litigation settlement costs of $4.1 million in the prior fiscal year and product launch expenses of $728,000 in the current fiscal year, the company reduced its losses by $3 million fiscal year-to-date. The $3 million improvement reflects primarily a $6.6 million or 544% increase in revenues, partially offset by a $3.6 million or 227% increase in research and development expenses, compared with the same period a year ago.

Balance Sheet Highlights

As of June 30, 2001, the company had cash, cash equivalents and investments of $19.1 million, working capital of $18 million and shareholders` equity of $20.8 million, compared with cash, cash equivalents and investments of $21.3 million, working capital of $19.2 million and shareholders` equity of $21.1 million at September 30, 2000. The $1.2 million decrease in working capital during the first nine months of fiscal year 2001 was primarily due to using cash to fund operating losses.

Outlook for the Remainder of 2001

Gregory P. Hanson, Avanir`s chief financial officer, said, ``We expect to receive a $5 million milestone payment from GlaxoSmithKline in each of the next two quarters in addition to ongoing royalties on sales of Abreva(TM), which should enable us to fund operations without accessing our cash reserves. We are encouraged by recent product promotion and merchandising activities that we have seen on Abreva, which should translate into higher royalties in the coming months, as market penetration continues through the summer season.``

``We also expect that our operating costs will continue to increase in the coming quarters, mainly in the areas of clinical and research and development related to the expansion of our development programs,`` continued Hanson. ``Our operating costs could approach $5 million for the fourth fiscal quarter ending September 30, 2001, depending on the rate of progress with Neurodex and other research and development. We do not expect to incur any additional product launch costs for Abreva(TM) as our participation in GlaxoSmithKline`s product launch costs concluded on June 30, 2001.``

Conference Call and Webcast

Avanir Pharmaceuticals will host a conference call with a simultaneous webcast today at 1:30 p.m. Pacific/ 4:30 p.m. Eastern. The conference call, featuring President and Chief Executive Officer Gerald J. Yakatan, Ph.D. and Vice President and Chief Financial Officer Gregory Hanson, will be available live via the Internet by accessing Avanir`s web site at www.avanir.com. The live webcast will also be available at www.companyboardroom.com. Please go to either web site at least fifteen minutes early to register, download and install any necessary audio software. For those who cannot listen to the live broadcast, the online replays will be available for 90 days, or a phone replay will be available through August 16, 2001, by dialing [phone] or [phone] and entering the passcode # 5435300.

About Avanir Pharmaceuticals

Avanir Pharmaceuticals, based in San Diego, is an emerging diversified biopharmaceuitcal company with an FDA-approved drug currently on the market. AVANIR is engaged in research, development, commercialization, licensing and sales of innovative drug products and antibody generation services. The company`s website is http://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 like ``estimate,`` ``anticipate,`` ``believe,`` ``plan`` or ``expect`` or similar statements are forward-looking statements. In regard to financial projections, risks and uncertainties include risks associated with royalties earned on product sales of Abreva(TM) by GlaxoSmithKline, timing of receipt of milestone payments, and results of clinical trials or product development efforts, as well as risks shown in Avanir`s Annual Report on Form 10-K and 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. The company disclaims any intent or obligation to update these forward-looking statements.


AVANIR Pharmaceuticals
Summary Consolidated Financial Information
(Unaudited)

Statement of operations data:

Quarters Ended June 30, Nine Months Ended June 30,
2001 2000 2001 2000

Revenues $798,714 $162,631 $7,812,149 $1,213,646
Expenses
Product launch cost 235,919 -- 728,148 --
Research and
development 1,394,732 638,616 5,165,822 1,581,351
General and
administrative 799,002 758,742 2,620,613 2,684,547
Sales and marketing 360,550 214,336 866,844 465,834
Litigation settlement -- -- -- 4,097,504
Interest 870 874 5,308 346,220
Total expenses 2,791,073 1,612,568 9,386,735 9,175,456
Net loss $(1,992,359) $(1,449,937) $(1,574,586) $(7,961,810)

Net loss
attributable
to common
shareholders $(2,003,151) $(1,605,550) $(1,606,961) $(8,117,423)
Net loss per share:
Basic $(0.03) $(0.03) $(0.03) $(0.16)
Diluted $(0.03) $(0.03) $(0.03) $(0.16)
Weighted average
number of common
shares outstanding:
Basic 57,542,291 55,181,700 57,368,194 50,417,191
Diluted 57,542,291 55,181,700 57,368,194 50,417,191


Balance sheet data:
June 30, September 30,
2001 2000

Cash, cash equivalents and investments $19,096,607 $21,268,242
Working capital $18,048,172 $19,162,545
Total assets $23,200,020 $23,519,237
Total liabilities $1,920,326 $1,922,929
Redeemable convertible preferred stock $498,295 $465,920
Shareholders` equity $20,781,399 $21,130,388

SOURCE: Avanir Pharmaceuticals

[Kelbi]

AVANIR PHARMACEUTICALS RECEIVES $5 MILLION MILESTONE PAYMENT FROM GLAXOSMITHKLINE FOR ABREVA™ LICENSING
Contact Info:
At The Financial Relations Board/BSMG Worldwide:
At Avanir Pharmaceuticals:

Kristen Kopay
Tricia Ross
Haris Tajyar
Patrice Saxon

General Information
Analyst/Investor
Media
Investor Relations

310-996-7458
310-996-7454
310-996-5500
858-622-5202

[e-mail]
[e-mail]
[e-mail]
[e-mail]





Comments on Revenue Growth Target for 2001


San Diego, Sept. 19, 2001 -- Avanir Pharmaceuticals (AMEX: AVN) today announced the receipt of a $5 million dollar licensing milestone payment from GlaxoSmithKline Consumer Healthcare, the consumer product division of GlaxoSmithKline (NYSE:GSK). GlaxoSmithKline is Avanir’s marketing partner in North America for ABREVA™, the first cold sore product approved by the U.S. Food and Drug Administration available to consumers without prescription.

Under the terms of the license agreement with GlaxoSmithKline, Avanir receives up to $25 million in licensing fees plus royalties on sales. This payment brings total milestone payments received to date to $20 million, with the final $5 million expected in the fourth quarter of 2001.

“ABREVA has become a leading treatment for cold sores in the short time it has been available in the market,” said President and Chief Executive Officer Gerald J. Yakatan, Ph.D. “Pairing our licensing fees with increasing royalties from the successful marketing of ABREVA in North America, we expect to generate revenue growth of approximately 30% for fiscal 2001. The revenue generated from ABREVA licensing is in turn reinvested to help fund both our projects in clinical trials and our pre-clinical research.”

Opportunities for future revenue growth beyond fiscal 2001 are expected to come from the international licensing and registration of docosanol in Europe and Asia, research collaborations in other business areas, and the development of additional products in the development pipeline. Avanir’s objective is to have sufficient resources to achieve positive, sustained cash flow from operations by 2005.

ABREVA, Avanir’s lead product, first became available for sale in late 2000. By March of 2001, ABREVA had become the largest selling consumer healthcare product for the treatment of cold sores. In clinical trials, ABREVA was shown to cut healing time in half when compared to a cold sore left untreated. Stress, sunlight, extreme weather temperatures, fatigue, colds and flu are among common cold sore triggers for the estimated 40% of the U.S. population that suffers from cold sores.

Avanir Pharmaceuticals, based in San Diego, is a diversified biopharmaceutical company engaged in research, development, commercialization, licensing and sales of innovative drug products and antibody generation services. The Company’s website is www.avanir.com.

[Kelbi]

Es tut sich wieder was bei Avanir...

ThinkEquity Partners Initiates Coverage on Avanir Pharmaceuticals
MINNEAPOLIS, Dec. 18 /PRNewswire/ -- ThinkEquity Partners initiated coverage of Avanir Pharmaceuticals (Amex: AVN - news) this morning. Cindy Glass, Senior Analyst covering biopharmaceuticals for ThinkEquity Partners, rates the stock a Strong Buy with a $7 price target. Key investment points covered the Research Note include:

Avanir is an emerging specialty pharmaceutical company with one commercialized product, others in Phase II/III trials, and proprietary monoclonal antibody technology.
Near-term milestones include: news on Neurodex clinical performance, additional progress with Xenerex, and other clinical program updates.
Avanir`s Xenerex subsidiary has monoclonal antibody technology that could generate upside given the growing interest in MAb technology, and limited number of companies with capabilities.
Strong Buy rating and $7 price target. Institutional investors can access the complete research note through First Call or by contacting your ThinkEquity Partners institutional salesperson.
About ThinkEquity Partners

ThinkEquity Partners is a research-centric institutional investment boutique focused on the knowledge economy. ThinkEquity Partners is headquartered in Minneapolis with offices in New York, Chicago, and San Francisco.

[Kelbi]

Und noch mehr News, mal sehen wie die Zahlen heute ausfallen...

AVANIR Subsidiary Xenerex Biosciences Advances to Second Stage of Antibody Agreement With Eos Biotechnology
Xenerex Successfully Generates Antibodies to Human Protein Targets
SAN DIEGO, Dec. 18 /PRNewswire/ -- Xenerex Biosciences, a subsidiary of AVANIR Pharmaceuticals (Amex: AVN - news) focused on generating fully human monoclonal antibodies, today announced that it has successfully generated antibodies to the first two cancer-target antigens provided by Eos Biotechnology through the parties` research collaboration agreement. Eos has asked Xenerex to proceed to the next stage of their research agreement, which will provide Eos with more information on selected panels of the antibodies that meet the antibody characteristics defined in the agreement.

``Eos Biotechnology was the first collaborator to utilize our technology for generating fully human antibodies. We are very pleased that we have achieved this key first step and that Eos has decided to move forward using the technology we have developed. We view this as an important substantiation of our unique platform technology since the targets were all human proteins,`` said J. David Hansen, President and Chief Operating Officer of Xenerex Biosciences. ``As important as it is for Xenerex to enter into antibody research and commercialization agreements, it is equally important to successfully deliver viable antibody product candidates to our clients. As we proceed with the first two targets, we are also in the process of providing Eos additional data on a third target to determine if they will select further development.``

Xenerex`s research collaboration with Eos began in May 2001 with an agreement whereby Xenerex will use its proprietary platform technology to generate fully human monoclonal antibody candidates to three cancer targets supplied by Eos. Under terms of the agreement, Xenerex received research fees for the use of its unique monoclonal antibody technology and could receive additional research fees as potential antibody candidates move through the stages of the Research Agreement. Xenerex could also receive license fee and milestone payments during the development phase, plus royalty payments on sales of products developed by Eos from the antibodies. Eos will be responsible for manufacturing, product development and marketing of any products developed through the agreement.

``Today`s announcement speaks directly to the maturation of this valuable antibody generation technology and serves as an important step in the development of our platform,`` said AVANIR`s President and Chief Executive Officer Gerald J. Yakatan, Ph.D. ``Advancing the collaboration between Xenerex and Eos represents an important achievement of a milestone that is part of our overall corporate plan.``

[Kelbi]

AVANIR Pharmaceuticals Reports Fourth Quarter and Fiscal 2001 Year-End Results
*29% Revenue Growth and Fiscal Year Profitability Derived Primarily From Milestone Payments and Abreva(TM) Royalties
*Key Fiscal 2001 Achievements and 2002 Goals Highlighted
SAN DIEGO, Dec. 18 /PRNewswire/ -- AVANIR Pharmaceuticals (Amex: AVN - news) today reported financial results for the fourth quarter and fiscal year ended September 30, 2001.

``Our greatest success in fiscal 2001 was the strong performance of Abreva(TM), our first commercialized product and the only over-the-counter (OTC) cold sore medicine approved by the U.S. Food & Drug Administration,`` stated Gerald J. Yakatan, Ph.D., President and Chief Executive Officer of AVANIR Pharmaceuticals. ``Abreva already leads its product category in sales as the number one pharmacist recommended cold sore treatment in the OTC market. The combined effect of earning milestone payments and royalties from our licensing partner GlaxoSmithKline contributed substantially to our growth this past year, which included a 29% increase in revenues. Importantly, our financial achievements enabled us to make significant progress with other product development programs currently in our pipeline.``

Dr. Yakatan continued, ``We continue to make progress toward goals established in four broad areas:


-- Expanding our docosanol (Abreva) franchise throughout the world,
including working with our licensees to advance regulatory approvals
in Canada, Korea and Israel. We have also signed three letters of
intent to license docosanol in China, Southern Europe, and selected
countries in the Middle East;

-- Completing over 60% of enrollment for our clinical trials of our next
potential drug Neurodex(TM) (formerly AVP-923) for the treatment of
emotional lability in patients with Lou Gehrig`s disease;

-- Expanding our product development pipeline, by acquiring a technology
for targeting macrophage migration inhibitory factor (MIF), which we
believe will be useful in our drug discovery program for novel
therapeutic intervention of a number of inflammatory diseases; and

-- Establishing two research collaborations through our antibody
generation services company, Xenerex Biosciences. We have made solid
progress on developing antibodies to a number of our partners` cancer
target antigens as well as beginning development work on our own
targets."


``What makes our accomplishments even more significant is that we were able to do so while achieving positive cash flow from our operating activities -- exceeding our goal of breakeven that we had set for fiscal 2001,`` continued Dr. Yakatan.

Fourth fiscal quarter operating performance

Revenues for the fourth fiscal quarter ended September 30, 2001, were $6 million compared to revenues of $9.5 million in the same period a year ago. Fourth fiscal quarter 2001 revenues included a $5 million milestone payment and $774,000 in royalties earned on sales of the cold sore product Abreva(TM) by GlaxoSmithKline. Royalties on sales of Abreva trended higher in the fourth quarter of fiscal 2001 as stores began to increase inventory levels in anticipation of the approaching cold and flu season. For the same period a year ago, revenues included a $9 million milestone payment that the Company earned on obtaining approval by the U.S. Food and Drug Administration (FDA) for Abreva.

Operating expenses for the fourth fiscal quarter ended September 30, 2001 were $4.2 million compared to $2.1 million as reported for the same period a year earlier. Operating expenses for the fourth fiscal quarter 2001 included a $917,000 charge related to purchased in-process research and development expense, representing in-process technologies acquired from Ciblex Corporation. AVANIR intends to use the knowledge gained from the acquisition to develop a novel approach to regulating a number of inflammatory diseases. Excluding one-time charges related to purchased in-process research, fourth fiscal quarter 2001 operating expenses increased by $1.2 million over the same period a year ago. Research and development (R&D) expenses increased by $1.3 million, primarily due to Neurodex and the Company`s ongoing Phase II/III clinical trial for a potential treatment of emotional lability in patients with amyotrophic lateral sclerosis (ALS) or Lou Gehrig`s disease. R&D expenses for the fourth fiscal quarter ended September 30, 2001, amounted to $2.1 million, or 49% of total operating expenses, compared to $793,000, or 38% of total operating expenses for the same period a year ago. The Company also is currently engaged in several other research programs including preclinical research focused on developing a novel treatment for allergy and asthma and ongoing research programs within its subsidiary Xenerex Biosciences for the development of fully human monoclonal antibodies.

Net earnings attributable to common shareholders for the fourth fiscal quarter ended September 30, 2001, amounted to $1.8 million, or $0.03 per share, compared with net earnings of $7.2 million, or $0.13 per share ($0.11 per share on a fully diluted basis), for the same period a year ago. Lower milestone payments (by $4 million) and the one-time charge of $917,000 related to purchased in-process research in the current quarter primarily accounted for lower net earnings compared with net earnings for the same period a year earlier, although royalties from Abreva sales in the current quarter provided a partial offset.

Fiscal year results

Revenues for fiscal 2001 were $13.8 million compared to revenues of $10.7 million in fiscal 2000. Fiscal 2001 revenues included $10 million in milestone payments and $2.5 million in royalties earned on sales of Abreva by GlaxoSmithKline. Revenues for fiscal 2000 included $10 million in milestone payments from GlaxoSmithKline primarily from obtaining approval from the FDA for Abreva.

Operating expenses for fiscal 2001 were $13.6 million compared to $11.3 million as reported for fiscal 2000. Operating expenses increased by $6.4 million over the same period a year ago excluding $4.1 million in litigation settlement costs in fiscal 2000. Fiscal 2001 expenses included a charge of $917,000 for purchased in-process research related to the acquisition of the MIF technology. R&D expenses increased by $4.9 million over the prior year, primarily for the Company`s ongoing Phase II/III clinical trial for a potential treatment of emotional lability in ALS patients. Increases in sales and marketing and administrative expenses reflect efforts to pursue and obtain three letters of intent from international companies interested in licensing docosanol and overall general corporate growth in operations. R&D expenses for fiscal 2001 amounted to $7.2 million, accounting for 53% of total operating expenses, compared to $2.4 million, or 21% of total operating expenses for fiscal 2000. Spending on research programs in fiscal 2001 included $2.3 million for Neurodex clinical development and clinical trials, $1.4 million related to allergy and asthma research, $1.3 million related to monoclonal antibody research at Xenerex Biosciences, and $1.1 million related to laboratory operating costs, with the balance related to clinical and regulatory affairs and other smaller research programs.

For fiscal 2001, net earnings attributable to common shareholders amounted to $190,000 or breakeven on a per share basis, representing a $1 million or $0.02 per share improvement over the net loss of $802,000 in fiscal 2000. The improved net earnings in fiscal 2001 were primarily due to earning $2.5 million in royalties from sales of Abreva by GlaxoSmithKline in the current year.

Total milestone payments and royalties earned by AVANIR since the inception of its license agreement for Abreva with GlaxoSmithKline for the North American market (March 2000 to September 30, 2001) amounted to $22.5 million, including $20 million in milestone payments and $2.5 million in royalties. In November 2001, AVANIR received an additional and final milestone payment of $5 million, which will be included in AVANIR`s first quarter revenues for fiscal year 2002.

Balance sheet highlights

As of September 30, 2001, AVANIR had cash and investments of $21.9 million, net working capital of $16.4 million and shareholders` equity of $24 million, compared with cash and investments of $21.3 million, net working capital of $19.2 million and shareholders` equity of $21.1 million at September 30, 2000.

Goals for 2002

Dr. Yakatan commented, ``Our goals for 2002, which are intended to increase shareholder value in the long term, presently include:

-- Advancing our docosanol franchise in other major markets, including
the establishment of international marketing licenses and regulatory
filings in Europe and Asia;

-- Expanding our clinical trials programs for Neurodex into multiple
indications, including completing Phase II/III clinical trials for the
treatment of emotional lability in ALS patients, initiating a similar
trial in patients with multiple sclerosis, and initiating a Phase II
trial to determine efficacy of the drug in neuropathic pain;

-- Placing a new chemical entity into the clinical trials process, with
particular emphasis on filing with the FDA for an investigational new
drug for our lead anti-IgE compound, designed to be orally taken for a
potentially novel treatment of allergy and asthma; and

-- Establishing additional research collaborations with major
pharmaceutical companies for our technologies, particularly our
antibody generation services technology at Xenerex."


Outlook for first fiscal quarter ending December 31, 2001

``Prospects for revenues in our first fiscal quarter ending December 31, 2001, appear to be similar to our most recently completed quarter ended September 30, 2001,`` stated Gregory P. Hanson, Vice President and Chief Financial Officer of AVANIR. ``Already in the first quarter of fiscal 2002 we have earned a final $5 million milestone fee. Additionally, we expect Abreva sales to generate royalties near the level of our most recently completed quarter. We expect that R&D expense will continue to trend higher as we expand our development efforts on established programs in the pipeline. Also, we expect that marketing, sales and general and administrative expenses will grow at a modest rate to support operations.``

The Company

AVANIR Pharmaceuticals, based in San Diego, is a diversified biopharmaceutical company engaged in research, development, commercialization, licensing and sales of innovative drug products and antibody generation services. AVANIR`s subsidiary, Xenerex Biosciences, is engaged in research collaborations with partner companies for developing and commercializing completely human antibody products to target antigens. For more information on the Company, visit www.avanir.com and www.xenerex.com .

Conference Call and Webcast

Management will host a conference call with a simultaneous webcast today at 1:30 p.m. Pacific/ 4:30 p.m. Eastern to discuss fourth fiscal quarter and year-end 2001 operating performance and outlook. The call/webcast will feature President and Chief Executive Officer Gerald J. Yakatan, Ph.D., Vice President and Chief Financial Officer Gregory Hanson and J. David Hansen, President and Chief Operating Officer of Xenerex Biosciences. The webcast will be available live via the Internet by accessing AVANIR`s web site at www.avanir.com or CCBN`s www.companyboardroom.com . Please go to either web site at least ten minutes early to register, download and install any necessary audio software. Replays of the webcast will be available for 90 days, or a phone replay will be available through December 27, 2001, by dialing [phone] and entering the passcode # 5710623.

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 like ``estimate,`` ``anticipate,`` ``believe,`` ``intend,`` ``plan,`` or ``expect`` or similar statements are forward-looking statements. In regard to financial projections, risks and uncertainties include risks associated with royalties earned on product sales of Abreva(TM) by GlaxoSmithKline, and results of clinical trials or product development efforts, as well as risks shown in AVANIR`s Annual Report on Form 10-K and 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. The company disclaims any intent or obligation to update these forward-looking statements.

AVANIR Pharmaceuticals
Summary Financial Information

Quarters Ended Years Ended
September 30, September 30,
Statement of
operations data: 2001 2000 2001 2000
Revenues $6,016,592 $9,473,380 $13,828,741 $10,687,026
Expenses
Cost of sales -- 261,603 728,148 261,603
Research and
development 2,061,666 792,600 7,227,488 2,373,951
Purchased
in-process
research 917,097 -- 917,097 --
General and
administrative 861,122 643,441 3,481,735 3,327,988
Sales and marketing 367,760 226,141 1,234,604 691,975
Litigation settlement -- -- -- 4,097,504
Interest 1,239 170,068 6,547 516,288
Total expenses 4,208,884 2,093,853 13,595,619 11,269,309
Net earnings
(loss) 1,807,708 $7,379,527 233,122 $(582,283)
Net earnings
(loss)
attributable
to common
shareholders $1,796,849 $7,160,004 189,888 $(801,806)

Basic net
earnings (loss)
per share $0.03 $0.13 -- $(0.02)
Diluted net
earnings (loss)
per share $0.03 $0.11 -- $(0.02)
Weighted average
number of common
shares outstanding 57,794,901 55,855,567 57,475,748 51,784,214
Weighted average
diluted number
of common shares
outstanding 62,017,795 64,205,372 63,980,738 51,784,214


September 30, 2001 September 30, 2000
Balance sheet data:
Cash and investments $21,851,236 $21,268,242
Net working capital $16,415,701 $19,162,545
Total assets $27,053,953 $23,519,237
Total liabilities $2,592,488 $1,922,929
Redeemable convertible
preferred stock $502,903 $465,920
Shareholders` equity $23,958,562 $21,130,388

SOURCE: AVANIR Pharmaceuticals

[Kelbi]

REPEAT/Peregrine Pharmaceuticals Announces the Initiation of Human Antibody Generation Against Two Additional Antigen Targets With Xenerex Biosciences
TUSTIN, Calif.--(BW HealthWire)--Dec. 20, 2001--Peregrine Pharmaceuticals Inc. (Nasdaq:PPHM - news) today announced that it has initiated human antibody generation against two additional targets with Xenerex Biosciences, a wholly owned subsidiary of Avanir Pharmaceuticals (AMEX:AVN - news).

Both of these antibodies are being developed to potentially be used as fully human monoclonal antibody therapies for the treatment of solid tumors. The initiation of antibody generation against the new targets will complete the transfer of three targets from Peregrine to Xenerex under the terms of an agreement signed in June 2001.

``We are very pleased with the progress that Xenerex has made on the generation of human antibodies against the first target we provided them earlier this year,`` said Steven King, Peregrine`s vice president of technology and product development.

``Because of the nature of the antigen, we anticipated that it might be difficult to generate antibodies against the target. Xenerex`s system has proven to be quite robust, so we are confident to move additional targets into their system for the generation of fully human antibodies.``

Work on generating antibodies against the two additional targets will commence immediately.

Xenerex Biosciences has a proprietary technology that enables rapid generation of fully human antibodies of high affinity and specificity to essentially any antigenic disease target or human protein. The technology combines the antigenic stimulation of donated human lymphoid cells with the grafting of the cells into severe combined immunodeficient (SCID) mice.

This technology mimics the in vivo human antibody response as it generates multiple antibodies to an antigenic target with various combinations of affinities and specificities characteristics.

The Xenerex system is able to take advantage of the unique in vivo cellular interactions, which occur in the human immune system that result in natural affinity maturation. This is the process by which the immune system generates antibodies of high specificity and affinity. The technology therefore is capable of duplicating many aspects of the human immune system, resulting in the generation of fully human antibodies.

``Xenerex has developed a novel system for the rapid generation of fully human monoclonal antibodies, which gives antibody development companies an exciting new option for the generation of new therapeutic targets,`` said Edward Legere, Peregrine`s president and CEO.

``The generation of fully human antibodies is a critical milestone in our anti-vascular and anti-angiogenesis programs. Once human antibodies are generated, we can test them for suitability for advancement into human clinical trials as new therapies for solid tumor cancers and possibly other maladies.

``We look forward to continuing to expand our therapeutic pipeline through our sponsored research and in collaboration with companies such as Xenerex Biosciences.``

[Kelbi]

So, das sollte euch doch mal zu denken geben, bei Überschreiten des massiven Widerstands bei 5 USD siehts auch da ganz gut aus...

AVANIR Pharmaceuticals Signs Collaborative Research and Development Agreement With Chinese Pharmaceutical Company
Agreement Is Significant Step Toward Marketing Docosanol in China
SAN DIEGO, Jan. 16 /PRNewswire/ -- AVANIR Pharmaceuticals (Amex: AVN - news) announced today the signing of a collaborative research and development agreement with Shanghai New Asiatic Pharmaceutical Company, Ltd., a division of Shanghai Pharmaceutical Co., Ltd., the largest state-owned pharmaceutical conglomerate in the People`s Republic of China. The agreement is considered a preliminary step in the process toward marketing AVANIR`s docosanol 10% cream in the People`s Republic of China, including Hong Kong and Macau, for the treatment of cold sores and other topical viral indications.

``This collaboration is the first step in forging a relationship with a leading Chinese pharmaceutical company, Shanghai New Asiatic Pharmaceutical Company, a pioneer in that market,`` said Gerald J. Yakatan, Ph.D., AVANIR`s Chief Executive Officer and President. ``The competitive landscape in the People`s Republic of China is ripe for new entrants, especially for effective over-the-counter treatments. We look forward to developing a solid partnership and to the prospect of tapping into the vast potential we believe exists in that region of the world.``

There are approximately 1.3 billion people in the People`s Republic of China. As in other parts of the world, potentially 80% of the population carries the virus that causes cold sores. Approximately 20% or roughly 260 million people will have outbreaks of at least one cold sore episode per year. Historically, cold sores have not been treated in China except with the use of herbal products. ``AVANIR`s China initiative could open the door to many new opportunities to access this market, potentially the largest pharmaceutical market in the world,`` said Dr. Ming-Wei Wang of SiniWest Holdings, Inc. who facilitated this deal.

Under the collaborative research and development agreement, Shanghai New Asiatic Pharmaceutical Company will be exploring other indications or uses for AVANIR`s docosanol 10% cream beyond cold sores and fever blisters. These additional indications include genital herpes or HSV-2 and herpes zoster, also known as shingles. Terms of the agreement provide for Shanghai New Asiatic to conduct and finance all aspects of product development deemed necessary for regulatory approvals for all three indications. AVANIR will provide all pertinent clinical, pre-clinical, regulatory and manufacturing information, along with related know-how and assistance, for Shanghai New Asiatic`s product development and regulatory efforts. AVANIR will retain sole and exclusive title to all products that may be developed within the scope of the agreement.

``After having gone through the challenges and changes of the past 70 years, we have built Shanghai New Asiatic into a modern and multiple-placing base for pharmaceutical products in accordance with the operations of the modern enterprise system and the standards of current good manufacturing practices (cGMP),`` said Mr. Hong Yi Bian, Vice President of Shanghai New Asiatic. ``Our motto is `Quality Creates Value, Innovation Builds the Future,` which is our way of conveying our belief that well known brands are an enterprise`s soul, while quality is its life. In conjunction with that, we look forward to working with AVANIR Pharmaceuticals on this new collaboration.``

Established in 1926, Shanghai New Asiatic Pharmaceutical Company is one of the pioneers of the pharmaceutical industry in China and has evolved into a modern company with five joint venture and holding company relationships with pharmaceutical companies throughout China and the world. Shanghai New Asiatic currently manufactures and markets 120 products in China. Shanghai New Asiatic is a division of the Shanghai Pharmaceutical Co., Ltd., the largest state-owned pharmaceutical conglomerate in China, with vast experience in working with multi-national companies. The parent company, Shanghai Pharmaceutical Co., Ltd., has over 45 major joint ventures with various multi-national pharmaceutical companies and is in the forefront in distributing new pharmaceutical products to the People`s Republic of China.

[Kelbi]

Tja, wieder nicht geschafft über die 5 USD, aber bei den Indikatoren ist im Moment m.M. wenig Luft nach oben. Aber man kriegt hier eine Aktie die mit Sterncells kooperiert(Stammzellenforschung), eine eigene Produktpipeline mit 5 Kandidaten hat, von denen einer bereits durch die FDA zugelassen wurde und auch noch sehr erfolgreich ist. Desweiteren ist Avanir auch in der Antikörperforschung tätig. Das einzig negative ist die m.E. im Moment zu dünne Cashposition. Aber das könte sich mit ordentlichen Lizenzvereinbarungen für Abreva(das zugelassene Produkt) auch schnell ändern. Siehe heute....

Ich bin kein Molekularbiologe etc. aber vieleicht könte sich ja mal jemand, nicht nur unter charttechischen Gesichtspunkten, von euch, mal mit der Firma beschäftigen...

Gruß

Kelbi

[Kelbi]

So die positiven News setzen sich fort, rechne aber nicht damit das sich das im Kurs niederschlägt, bei dem Umfeld...AVANIR Pharmaceuticals` Subsidiary, Xenerex Biosciences, And DNAX Research, Inc. Enter Antibody Research Collaboration Agreement
SAN DIEGO, Jan. 23 /PRNewswire-FirstCall/ -- Xenerex Biosciences, a subsidiary of AVANIR Pharmaceuticals (Amex: AVN - news), announced today that it has entered into a research collaboration agreement to generate fully human antibodies for DNAX Research Inc. of Palo Alto, California. DNAX Research is Schering-Plough Corporation`s (NYSE: SGP - news) biotechnology center for immunology and molecular biology. The research agreement provides for Xenerex to generate fully human monoclonal antibodies to two target antigens provided by DNAX, which will then evaluate the antibodies for potential development as therapies for human diseases.

Under terms of the agreement, Xenerex will receive research fees for the use of its proprietary monoclonal antibody technology to generate antibodies to the antigen targets. The agreement provides DNAX with an option to enter into a commercial license agreement that could provide Xenerex with additional milestone payments and royalties on future product sales resulting from the collaboration. The financial terms of the agreement were not disclosed.

``Our collaboration with DNAX illustrates the growing interest of leading pharmaceutical companies in the potential capabilities of our proprietary human antibody technology,`` said J. David Hansen, President and Chief Operating Officer of Xenerex Biosciences. ``The collaboration provides an important opportunity for us to further demonstrate the viability of our technology and the successful commercialization of our platform for application in multiple diseases.``

Xenerex Biosciences has developed proprietary platform technology that is capable of generating fully human antibodies to multiple targets, including human targets, and is building a portfolio of antibody product candidates through agreements and licenses with biopharmaceutical companies. The Xenerex technology utilizes human immune system cells engrafted into severe combined immunodeficient (SCID) mice, which do not have their native immune system. The mice are immunized with the target antigen and respond by creating fully human antibodies, which the company evaluates for optimum antibody characteristics.

``The establishment of research collaborations that utilize our antibody generation expertise is a key element of AVANIR`s development strategy and growth plan,`` said AVANIR`s President and Chief Executive Officer Gerald J. Yakatan, Ph.D. ``This research collaboration with the DNAX subsidiary of the Schering-Plough Corporation is a measure of significant progress for the Company and represents a prominent milestone for Xenerex.``

DNAX is a wholly-owned subsidiary of Schering-Plough Corporation of Kenilworth, New Jersey, a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide.

Xenerex, a subsidiary of AVANIR Pharmaceuticals, is a biopharmaceutical company with a customer-focused mission to enable partner companies to develop and commercialize completely human antibody products. The company`s website is http://www.xenerex.com .

[Kelbi]

So hier mal für die Experten, eine kleine Auswahl der Pipeline von Avanir in Worten(stammt von der Homepage der Firma) Würde mich mal interessieren was jemand davon hält, der sich damit auch fachlich auskennt.....



NEURODEX



A patented formulation of dextromethorphan and enzyme inhibitor to treat central nervous system disorders

Development Stage:

AVANIR PHARMACEUTICALS has an investigational new drug (IND) in place for Neurodex and has completed early Phase I clinical trials to establish safety of the drug combination, dextromethorphan and enzyme inhibitor. Phase II/III clinical trials in the first indication, emotional lability, began in fourth quarter 2000.

Product Description:

The product is a patented, orally administered combination of dextromethorphan and an enzyme inhibitor that sustains therapeutic doses of dextromethorphan on a twelve hour dosing schedule. The two drugs are not available as a single oral formulation and there are no formulations of the enzyme inhibitor available at the low dosage required for this product. The ability of the enzyme inhibitor to extend dextromethorphan blood levels may expand the drug`s utility and enable its use in multiple therapeutic areas.

Patents:

Neurodex is patented for the use of the drug delivery technology. In addition, specific patents have been issued using the product technology for four separate indications with a fifth patent pending. A European patent covering the use and all the indications has already been filed.

How the Drug Delivery Technology Works:

Dextromethorphan is a widely used cough medicine. However, the body metabolizes it so rapidly that the higher levels of this drug necessary to be beneficial in other indications are never achieved for most people. With the addition of an inhibitor of the enzyme that metabolizes dextromethorphan, higher drug concentrations can be maintained. This expands the pharmacological usefulness of the drug, allowing more of a given dose to breech the blood-brain barrier and extending its therapeutic effect.

Scientific Rationale:

Neurodex provides controlled therapeutic blood levels of dextromethorphan by inhibiting its oxidative first pass metabolism. The enzyme inhibitor, a well-known drug used for an unrelated therapeutic indication, is used at extremely low doses to inhibit the cytochrome P450-2D6 enzyme responsible for metabolism of dextromethorphan. The enzyme inhibitor is present in the product at 1/20th to 1/40th its normal therapeutic daily dose. Through the use of an enzyme inhibitor, dextromethorphan can be effective in treating neurologic disorders even at doses as low as the adult over-the-counter dosage recommendation (30 mg) for cough suppression.

First Indication: Emotional Lability in Central Nervous System Disorders

Disease Description:

In neurodegenerative disorders, one of the symptoms frequently experienced by the patient can be loss of emotional control. Although not physically harmful, the condition has a significant effect on the health of both patients and their caregivers.

The basic mechanisms underlying the loss of emotional control, as a result of neurodegenerative diseases, are unclear. The discovery of the effectiveness of Neurodex in treating emotional lability rests on empirical observation by neurologists active in treating this disorder.

Potential Patient Population:

Medical reports on the incidence of emotional lability estimate that up to 50% of Lou Gehrig`s disease (Amyotrophic Lateral Sclerosis or ALS) patients and 25% of Multiple Sclerosis (MS) and Alzheimer`s Disease patients are effected by the loss of emotional control. In stroke patients, the incidence is 20% within the first year of stroke with one-half of those patients recovering emotional control within the first year. Combined effected patient populations from all four diseases result in a patient pool up to 1,000,000 patients per year.

Currently, there is no product approved by the U.S. Food and Drug Administration (FDA) for the treatment of emotional lability. The FDA has indicated that if the Company successfully performs clinical studies for emotional lability in at least two of the neurodegenerative diseases, a broad general indication for emotional lability could be obtained.

Development Stage:

AVANIR PHARMACEUTICALS has an investigational new drug application in place for Neurodex and has completed early Phase I clinical trials that show the product is well-tolerated. Phase II/III clinical trials, the first in an a series of studies intended to examine the efficacy of Neurodex in the treatment of emotional lability in neurodegenerative diseases began in December of 2000. It is estimated that it will take one year to complete the trial.

Approximately 100 patients with Lou Gehrig`s disease are participating in the double-blind, controlled, multicenter study. For more detailed information regarding this trial, go to www.clinicaltrials.gov.

Pending positive results from the clinical trial in ALS patients, AVANIR plans to initiate a pivotal Phase III trial that will be conducted in multiple sclerosis patients in 2002. An open-label study will follow the MS trial that will enroll patients with symptoms of emotional lability occurring in any of the following conditions: stroke, Alzheimer`s disease, ALS and MS.

Second Indication: Neuropathic Pain

Disease Description:

Neuropathic pain is defined as pain related to peripheral or central nervous system injury. It includes peripheral nerve injury such as that caused by diabetes, human immunodeficiency virus (HIV), cancer and postherpetic neuralgia, as well as central nervous system injury, such as that caused by spinal injury or stroke.

Over-stimulation of glutamate receptors and the resulting injury to the neurons is considered to be a contributing factor to the symptoms associated with neuropathic pain. Antagonists of glutamate are thought to be neuroprotective.

The rationale for using dextromethorphan in these neurodegenerative disorders is that dextromethorphan is an antagonist of the N-methyl-D-aspartate (NMDA) receptor, a subtype of the glutamate receptor. Dextromethorphan acts at the phencyclidine binding site and is a sigma receptor antagonist. It may act on the N-type calcium channel, although that is still uncertain. Thus, appropriate sustained blood levels of dextromethorphan is a potential therapeutic solution to a common and painful symptom complex.

Potential Patient Population:

Published reports indicate that there are approximately seven million diabetics who suffer from diabetic neuropathy.

Neuropathic pain is treated by several different pharmacological agents with varying degrees of success. Narcotic analgesics, including morphine, are important agents. Anticonvulsive agents (such as Neurontin, Tegretol and Dilantin), tricyclic antidepressants, non-steroidal anti-inflammatory agents, and capsaicin cream are also used to treat neuropathic pain.

A significant commercial advantage for Neurodex will be that neuropathic pain patients, such as the large number of patients who suffer from diabetic neuropathy, will be able to avoid products that contain narcotics.

Development Stage:

The usefulness of dextromethorphan in treating neuropathic pain has been observed in both controlled and uncontrolled studies. AVANIR has completed a Phase I dose-ranging study and intends to begin a Phase II trial to determine efficacy in patients with diabetic neuropathy by the end of this year.

Third Indication: Chronic Cough

Dextromethorphan is well established as an effective and widely used non-narcotic cough suppressant that is effective for short periods after each dose. The drawback to the use of dextromethorphan has been the rapid metabolism of the agent and resulting low blood levels. The metabolite does possess many of the same therapeutic actions as dextromethorphan but does not cross the blood-brain barrier as readily as dextromethorphan. Antitussive agents must cross the blood-brain barrier if they are to exert their centrally active cough suppressing effect. Effective levels of dextromethorphan are therefore critical to the use of dextromethorphan as an effective non-narcotic alternative for patients with chronic cough.

Neurodex directly addresses these exact drawbacks to expanded use of dextromethorphan. Because the combination contains an enzyme inhibitor and will be a prescription product, the company will position the use of this product for chronic cough most often associated with pulmonary disease, cancer, and respiratory infections.

Potential Patient Population:

AVANIR believes Neurodex could find wide utility for the treatment of chronic cough typically caused by smoking, post-nasal drip, asthma, gastro esophageal reflux and chronic bronchitis, as well as intractable cough which is typically associated with lung cancer. While it is estimated that 11% of the approximately 30 million physician office visits each year involve the treatment of cough, the company estimates the treatable patient pool for chronic and intractable cough indication is much narrower, but could be as high as 500,000 patients.

Potential Benefits of this Technology:

Market leverage comes from the opportunity to use the same components and early development efforts for at least three distinct indications. Therefore all pharmacology and toxicology issues, as well as early Phase I clinical results, can be leveraged across all three indications to speed up the development timetable. Each primary indication for the product has significant commercial potential.

Because dextromethorphan is a drug that has been widely used for many years, the toxicology of the drug is well-known. This contributes to lower product development costs and presumably decreases the time it will take to navigate the regulatory process. The ability of the enzyme inhibitor to extend dextromethorphan`s therapeutic life may expand the drug`s utility and enable its use as a potent, non-narcotic analgesic.






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© 2002 Avanir Disclosure

[Kelbi]

AVANIR Pharmaceuticals Expands Docosanol Distribution Through Licensing Agreement With Biopharm Group
SAN DIEGO, Jan. 30 /PRNewswire-FirstCall/ -- AVANIR Pharmaceuticals (Amex: AVN - news) today announced the establishment of a license agreement with Biopharm Group to manufacture and market docosanol 10% cream in Egypt, select countries of the Middle East and the Gulf Cooperative Council. AVANIR will receive milestone payments and royalties on sales of the product in those areas.

``By selecting strategic partners that are well positioned in their own sector, we are able to effectively penetrate new markets,`` said Gerald J. Yakatan, Ph.D., AVANIR`s Chief Executive Officer and President. ``Through this out-licensing strategy, we continue to expand our distribution in international markets and look forward to working with Biopharm Group in that endeavor.``

The licensing agreement with Biopharm is another step in AVANIR`s plans for out-licensing docosanol throughout the world. Currently, the Company`s marketing partners include GlaxoSmithKline in North America, Shanghai New Asiatic Pharmaceutical Company, Ltd. in the People`s Republic of China, Boryung Pharmaceuticals in South Korea and CTS Chemical Industries in Israel.

GlaxoSmithKline launched docosanol 10% cream (marketed as ABREVA(TM) in the United States) in November of 2000 and has the rights in Canada to market the product, which is pending approval from the Canadian regulatory agency. Boryung and CTS Chemical also anticipate receiving regulatory approval on docosanol from their respective agencies this year. Biopharm will be responsible for filing for marketing approval with the various regulatory agencies throughout the licensed territory in advance of marketing the product.

ABREVA is the only cold sore product approved by the U.S. Food and Drug Administration (FDA) available without prescription and cuts healing time in half versus untreated outbreaks. During its first year on the market in the United States, ABREVA has captured the number one position in dollar sales and the number three position in unit sales for lip remedies in the over-the-counter market.

``We are happy to be partnering with AVANIR Pharmaceuticals to manufacture and market docosanol products in our territory. We look forward to a mutually successful relationship in introducing our first FDA-approved drug in the region,`` said Osama Kandil, Ph.D., Chairman and Chief Executive Officer of the Biopharm Group.

[Chessmaster]

hallo zusammen....
was ist eurer meinung nach vom kursverfall der letzten
tage zu halten.
günsige gelegenheit zum verbilligen oder stinkt
bei AVN etwas.
ich kann jedenfalls nichts negatives im qu. report
erkennen.
ist "german guy" aus dem yahoo-board hier
auch anwesend ?

[Kelbi]

AVANIR Pharmaceuticals Completes Phase II/III Clinical Trial of Neurodex for Emotional Lability
SAN DIEGO, June 12 /PRNewswire-FirstCall/ -- AVANIR Pharmaceuticals (Amex: AVN - News) announced the completion of a Phase II/III clinical trial investigating the safety and effectiveness of Neurodex in treating emotional lability in 116 patients with amyotrophic lateral sclerosis (ALS). Emotional lability, also known as pseudobulbar affect or pathological laughing or crying, is a symptom complex experienced by an estimated one million patients with neurological conditions such as ALS or Lou Gehrig`s disease, Alzheimer`s disease, multiple sclerosis (MS), stroke and traumatic brain injury. Neurodex is the first drug product in clinical development specifically intended to treat emotional lability.

Neurodex is a patented, orally administered combination of dextromethorphan (DM) and an enzyme inhibitor that sustains elevated levels of DM in the human body. Results of a pilot study showed that the combination of DM, known to be an NMDA receptor antagonist, and an enzyme inhibitor resulted in higher and prolonged dextromethorphan blood levels (Clinical Pharmacology & Therapeutics, 1992; 51:647-55). Patients in the Phase II/III clinical trial were treated orally twice a day, on a twelve-hour dosing schedule.

"While dextromethorphan is considered to be neuroprotective, the therapeutic dilemma has been that its rapid metabolism requires extremely high doses to attain optimum therapeutic benefit," said AVANIR President and Chief Executive Officer Gerald J. Yakatan, Ph.D. "We believe Neurodex allows for improved delivery by increasing blood levels for an extended timeframe with small doses. Side effects of Neurodex may be fewer than with high doses of dextromethorphan alone."

ALS involves loss of upper motor neurons in the brain, which control lower motor neurons. The term pseudobulbar palsy is used to describe uncontrolled activity of the lower motor neurons of the bulbar (brainstem) region and is a phenomenon that seems to cause laughing and crying not necessarily associated with emotions. The loss of the upper motor neurons also results in loss of control of these physical manifestations of emotion. Episodes of uncontrolled laughing and crying can be embarrassing and even frightening to patients and their caregivers.

To determine suitability for inclusion in the trial, patients were assessed for pseudobulbar affect by clinical observation and a survey called the CNS Lability Scale (CNS-LS). The CNS-LS is a validated survey that measures frequency and severity of emotional lability-related episodes. The double-blind, controlled, multi-center clinical trial studied three patient groups consisting of patients taking Neurodex, patients taking dextromethorphan alone, and patients taking the enzyme inhibitor alone. Endpoints of the study include a comparison to baseline of average CNS-LS scores between the Neurodex and other treatment groups and comparison of the number of emotional lability episodes. The Phase II/III trial was conducted at eighteen study sites in the U.S. including Baylor College of Medicine, the University of Wisconsin at Madison, the University of California at San Francisco, the University of Miami, Columbia-Presbyterian Medical Center, Penn Neurological Institute, Northwestern Medical School and Massachusetts General Hospital.

"We anticipate obtaining final data and releasing the results of this study in July," continued Dr. Yakatan. "If successful, we plan to initiate a pivotal Phase III clinical trial with MS patients. An open-label safety study will follow the MS trial and will include patients with symptoms of emotional lability occurring in stroke, Alzheimer`s disease, ALS or MS."

AVANIR has the exclusive license to develop, manufacture and market Neurodex for four potential indications: emotional lability, neuropathic pain, chronic cough and weaning drug-dependent patients from narcotics and anti-depressants. AVANIR intends to initiate a Phase II clinical trial examining Neurodex in the treatment of neuropathic pain later this year. Neurodex is protected by six issued U.S. patents.

[Kelbi]

AVANIR Pharmaceuticals Announces Positive Results of Phase II/III Clinical Trial of Neurodex for Emotional Lability
Study Achieved Statistical Significance in Primary Efficacy Factor
SAN DIEGO, June 20 /PRNewswire-FirstCall/ -- AVANIR Pharmaceuticals (Amex: AVN - News) announced the results of a Phase II/III clinical trial investigating the safety and effectiveness of Neurodex in the treatment of pseudobulbar affect (also known as emotional lability, or pathological laughing or crying) in subjects with amyotrophic lateral sclerosis (ALS). The double blind, controlled, multicenter clinical trial had three treatment arms that compared Neurodex to each of its two active components, dextromethorphan and an enzyme inhibitor.

The primary efficacy variable for the study was change from baseline in a subject`s score on the CNS-Lability Scale (CNS-LS). The CNS-LS is a validated, published scale that measures the severity and frequency of a subject`s episodes of pathological laughing and/or crying. This endpoint of the study in the intent-to-treat population was statistically significant (p less than or equal to 0.0042) in favor of Neurodex when compared to either of the other two treatment arms. Secondary efficacy endpoints and other aspects of the study are being evaluated and will be reported at a later date.

"The results of this trial are very encouraging and validate the Company`s decision to quickly advance this important drug candidate into a Phase II/III clinical trial," said AVANIR President and Chief Executive Officer Gerald J. Yakatan, Ph.D. "The successful outcome of the trial further demonstrates AVANIR`s core strengths of drug discovery and development and our ability to design and execute effective clinical trials."

Emotional lability is a symptom experienced by an estimated one million patients with various neurological conditions including ALS, Alzheimer`s disease, multiple sclerosis (MS), stroke and traumatic brain injury (TBI). Neurodex is the first drug candidate in clinical development specifically intended to treat emotional lability.

Neurodex is a patented, orally administered combination of dextromethorphan and an enzyme inhibitor. The enzyme inhibitor allows for sustained, elevated levels of dextromethorphan in the body. In this Phase II/III study of Neurodex, subjects were treated twice a day on a 12-hour dosing schedule.

"The data from this study are robust and favor Neurodex over the other treatment arms," said James E. Berg, AVANIR`s Vice President of Clinical and Regulatory Affairs. "This trial was conducted by leading clinical investigators in ALS research and treatment. Their dedication to this first ever multicenter study of pseudobulbar affect may one day result in an approved treatment for this distressing symptom."

Pseudobulbar affect is a phenomenon that causes laughing and crying not necessarily associated with emotion. Neurodegenerative diseases such as ALS, Alzheimer`s disease and MS involve the loss of control of upper motor neurons which control the lower motor neurons. The term pseudobulbar palsy is used to describe uncontrolled activity of the lower motor neurons of the bulbar (brainstem) region that results in episodes of uncontrolled laughing and crying that can be both embarrassing and frightening to patients and their caregivers.

"Positive clinical data from this initial clinical trial of Neurodex provides us with the scientific rationale to move forward with its clinical development in other disease states and conditions," continued Dr. Yakatan. "We will initiate a second pivotal clinical trial of Neurodex in MS patients suffering from pseudobulbar affect later this year. An open label trial of Neurodex in patients with pseudobulbar affect is also planned for later this year. Additionally, we intend to initiate an open label, dose-ranging Phase II study examining Neurodex in the treatment of diabetic neuropathic pain this year."

Management will host a conference call with a simultaneous webcast on June 20, 2002, at 1:15 p.m. Pacific/ 4:15 p.m. Eastern Time, to discuss today`s press release. The call/webcast will feature President and Chief Executive Officer Gerald J. Yakatan, Ph.D., Vice President of Clinical and Regulatory Affairs James E. Berg, and Vice President and Chief Financial Officer Gregory Hanson. The webcast will be available live via the Internet by accessing AVANIR`s web site at www.avanir.com or CCBN`s www.companyboardroom.com . Please go to either web site at least ten minutes early to register, download and install any necessary audio software. Replays of the webcast will be available for 90 days, and a phone replay will be available through June 27, 2002, by dialing 888-266-2086 or 703-925-2435 and entering the passcode 6068300.

[Kelbi]

Dow Jones Business News
Avanir Pharmaceuticals Creates Anthrax Antibody
Tuesday February 11, 10:15 am ET


SAN DIEGO (Dow Jones)--Avanir Pharmaceuticals has created an antibody that neutralizes the key toxin in anthrax with the use of its Xenerex technology.
In a press release Tuesday, the drug discovery and development company said it plans to use Xenerex to generate human antibodies to the remaining two toxins of anthrax.

ADVERTISEMENT


Avanir noted that BioThrax, the only anthrax vaccine approved by the Food and Drug Administration, requires six injections given over 18 months. On the other hand, the company said its own antibody candidate could, either alone or in combination with other antibodies, provide immediate immunity to individuals who have been exposed to anthrax or suspect they have been exposed.

Avanir said the antibody has demonstrated high affinity and the capability to neutralize the protective antigen anthrax toxin. The company is moving forward in its preclinical development plan.

Shares of Avanir were up 26.4%, or 23 cents a share, to $1.10 on Nasdaq volume of 139,500 shares. Average daily volume is 119,147 shares.

Company Web site: http://www.avanir.com

-Lisa Reynolds; Dow Jones Newswires; 201-938-5400

Heute +81 %

Allerdings auch ausgehend von Ständen in der Nähe der ATL`s