AVN expecting HUGE herpes cream NEWS THIS WEEK!
AVN expecting HUGE herpes cream NEWS THIS WEEK!
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Posted by AVN's monomice herpes cream are COMING!
on July 11, 2000 at 07:49:56:
Those shorting AVN should sink next week as AVN SOARS! They are scared shitless
because they didn't cover their shorts! AVN will FLY HIGH and the
Those short AVN should crash...ha, ha, ha, ha! THE WEEK OF JULY 10th is
(DOW JONES) DJN: =DJ Avanir Pharma Up 11%;Co. Awaits FDA Labeling Verdict
By K. Maxwell Murphy
NEW YORK (Dow Jones)--Avanir Pharmaceuticals (AVN) shares added Wednesday
Tuesday's gains, even though there was no news from the company.
Avanir spokeswoman Patrice Saxon told Dow Jones Newswires the movement could
be based on speculation the Food and Drug Administration would rule on the
labeling of its docosanol cold sore cream, approved by the FDA June 1.
Saxon said Avanir expects to have the final word on labeling for what she
calls the first cure for cold sores to debut over-the-counter "any day now,
through the week of July 10."
Here's the cream approval notice:
Thursday June 1, 8:32 am Eastern Time
Company Press Release
SOURCE: Avanir Pharmaceuticals
FDA Gives Avanir Approvable Letter on Docosanol;
Over-the-Counter Cold Sore Product to be Marketed
by SmithKline Beecham
SAN DIEGO, June 1 /PRNewswire/ -- AVANIR Pharmaceuticals (Amex: AVN - news)
announced that the U.S. Food
Drug Administration (FDA) has notified the company that its new drug application
(NDA) for docosanol 10% cream is
approvable for marketing in the United States.
When final labeling is approved by the FDA, the cream will be the first FDA-approved
product in the cold sore market able
be sold without prescription. Docosanol 10% cream is intended as a topical treatment
for oral-facial herpes commonly
as cold sores or fever blisters, and will be the company's first FDA-approved product.
``We are delighted by the FDA's decision,'' said Gerald J. Yakatan, Ph.D., AVANIR's
chief executive officer and president.
``It is the culmination of a long development program and great news for our
shareholders and the nation's 50 million cold
sufferers. We are well down the road with the FDA on labeling and will continue to
work towards a mutually agreeable label
a timely manner.''
AVANIR recently signed an agreement with SmithKline Beecham Consumer
Healthcare (NYSE: SBH - news) for
manufacturing and marketing rights to docosanol in the U.S. and Canada. AVANIR
will receive up to $25 million in licensing
fees plus royalties from the licensing agreement.
``FDA's decision to allow docosanol to go directly to the over-the-counter (OTC)
market provides us access to the largest
segment of cold sore sufferers,'' noted Dr. Yakatan. ``SmithKline Beecham's expertise
and experience in the OTC area
enable us to maximize this opportunity and consequently, shareholder value.''
Eighty percent of adults in the United States are carriers of herpes simplex 1 (HSV-1)
infection. Each year, 20 to 40 percent
these develop symptomatic episodes, characterized by the formation of a blister on
the upper or lower lip. The number of
treatable episodes ranges from 100 to 130 million outbreaks annually.
Avanir Pharmaceuticals, based in San Diego, California, develops novel therapeutic
products for the treatment of chronic
diseases. In addition to docosanol, the company's product development pipeline
includes an option to in-license a drug for
treatment of emotional lability in neurodegenerative diseases, expected to enter
Phase II/III clinical trials this year. The
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. Other areas of development include our
recently patented fully human monoclonal
antibody technology and further clinical development on docosanol in additional
indications. AVANIR is also engaged in
preclinical work on a lipid lowering compound and an anti-inflammatory compound.
The company's website is
SmithKline Beecham (NYSE: SBH - news) -- one of the world's leading healthcare
companies -- discovers, develops,
manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines
and health-related consumer products.
company information, visit SmithKline Beecham on the World Wide Web at
Of further interest about AVN...
Rituxin (from IDPH)
was the first FDA approved drug for cancer (in the US) utilizing monoclonal
This could have important significance to AVN if
they developed it using "monomouse" technology. AVN who owns 100% of the patent
equally with IDPH has stated that
they have a verbal agreement with IDPH to commercialize "monomice" technology. If
brought to the market, "monomouse"
technology may compete
with ABGX's "xenomouse" and MEDX's "humabmouse". Both ABGX and MEDX
became high flying stocks this year
based on the mouse
technology. AVN, which still sells for less than $3 per share, feels that their technology
is superior to that of ABGX and
MEDX. AVN has stated that they will announce plans to commercialize "monomouse"
technology within 30-60 days or
sooner. AVN has also recently been approved for the first over the counter herpes
cream using n-docosanol. The product
will be marketed by SBH upon final labeling approval. In addition, AVN has the
exciting IgE technology in the pipeline
which may help bring relief someday to millions of allergy sufferers. The possibility of
developing IgE and monoclonal
antibodies could make a perfect combination. This puts AVN in company with
Genentech (DNA) who have similiar
technology using humanized antibodies.