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<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>FYI and further dissemination. </span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'> </span></font></p>
<p class=MsoNormal><font size=2 color=navy face="Times New Roman"><span
style='font-size:10.0pt;color:navy'>Freddie Ann Hoffman</span></font><font
size=2 color=navy><span style='font-size:10.0pt;color:navy'>, MD</span></font><font
color=navy><span style='color:navy'> <br>
</span></font><b><font size=5 color=navy face="Tempus Sans ITC"><span
style='font-size:16.0pt;font-family:"Tempus Sans ITC";color:navy;font-weight:
bold'>H</span></font></b><b><font color=navy face="Tempus Sans ITC"><span
style='font-family:"Tempus Sans ITC";color:navy;font-weight:bold'>eteroGeneity,
LLC</span></font></b><font color=navy><span style='color:navy'> <br>
</span></font><font size=2 color=navy><span style='font-size:10.0pt;color:navy'>5611
16th Street, NW</span></font><font color=navy><span style='color:navy'> <br>
</span></font><font size=2 color=navy><span style='font-size:10.0pt;
color:navy'>Washington</span></font><font size=2 color=navy><span
style='font-size:10.0pt;color:navy'>, DC 20011-6809</span></font><font
color=navy><span style='color:navy'> <br>
</span></font><font size=2 color=navy><span style='font-size:10.0pt;color:navy'>Tel.:
202-545-6843</span></font><font color=navy><span style='color:navy'> <br>
</span></font><font size=2 color=navy><span style='font-size:10.0pt;color:navy'>Fax:
202-545-6844</span></font><font color=navy><span style='color:navy'> <br>
</span></font><u><font size=2 color=navy><span style='font-size:10.0pt;
color:navy'><a href="mailto:fhoffman@heterogeneity-LLC.com"
title="mailto:fhoffman@heterogeneity-LLC.com"><font color=navy><span
style='color:navy'>fhoffman@heterogeneity-LLC.com</span></font></a></span></font></u></p>
<p class=MsoNormal><font size=2 color=navy face="Times New Roman"><span
style='font-size:10.0pt;color:navy'><a href="http://www.heterogeneity-LLC.com"
title="http://www.heterogeneity-LLC.com"><font color=navy><span
style='color:navy'>www.heterogeneity-LLC.com</span></font></a></span></font></p>
<div class=MsoNormal align=center style='text-align:center'><font size=3
face="Times New Roman"><span style='font-size:12.0pt'>
<hr size=2 width="100%" align=center>
</span></font></div>
<p class=MsoNormal><b><font size=2 face=Tahoma><span style='font-size:10.0pt;
font-family:Tahoma;font-weight:bold'>From:</span></font></b><font size=2
face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma'> Nancy Moon
[mailto:Nancy@herbalgram.org] <br>
<b><span style='font-weight:bold'>Sent:</span></b> Thursday, November 09, 2006
4:44 PM<br>
<b><span style='font-weight:bold'>To:</span></b> Nancy Moon<br>
<b><span style='font-weight:bold'>Subject:</span></b> PRESS RELEASE - FDA
Approves Special Green Tea Extract as a New Topical Drug for Genital Warts</span></font></p>
<p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size:
12.0pt'> </span></font></p>
<p class=MsoNormal><img width=135 height=246
src="cid:image001.gif@01C70440.2C2A82B0" align=left hspace=12 alt="Text Box: "><b><font
size=2><span style='font-size:10.0pt;font-weight:bold'>[1,302 words]</span></font></b></p>
<p class=MsoNormal><b><font size=5 face="Times New Roman"><span
style='font-size:16.0pt;font-weight:bold'>AMERICAN BOTANICAL COUNCIL</span></font></b></p>
<p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size:
12.0pt'>P.O. Box 144345</span></font>, Austin, TX 78714-4345</p>
<p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size:
12.0pt'>Phone: 512-926-4900 x121; Fax: 512-926-2345</span></font></p>
<p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size:
12.0pt'>Contact: Nancy Moon</span></font></p>
<p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size:
12.0pt'>Email: <a href="mailto:nancy@herbalgram.org"
title="mailto:nancy@herbalgram.org">nancy@herbalgram.org</a></span></font></p>
<p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size:
12.0pt'>Web site: <a href="http://www.herbalgram.org/"
title="http://www.herbalgram.org/">http://www.herbalgram.org/</a></span></font></p>
<p class=MsoNormal><i><font size=3 face="Times New Roman"><span
style='font-size:12.0pt;font-style:italic'> </span></font></i></p>
<p class=MsoNormal><i><font size=3 face="Times New Roman"><span
style='font-size:12.0pt;font-style:italic'>Editor’s Note: Mark Blumenthal
is available for interviews. Please contact Nancy Moon per above.</span></font></i></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> </span></font></p>
<p class=MsoNormal><b><font size=2 face="Times New Roman"><span
style='font-size:11.0pt;font-weight:bold'> </span></font></b><b><font
size=5><span style='font-size:16.0pt;font-weight:bold'>FOR IMMEDIATE RELEASE</span></font></b></p>
<p class=MsoNormal style='text-align:justify'><b><i><font size=7
face="Times New Roman"><span style='font-size:36.0pt;font-weight:bold;
font-style:italic'>News Release</span></font></i></b></p>
<p class=MsoNormal><b><font size=5 color=black face="Times New Roman"><span
style='font-size:16.0pt;color:black;font-weight:bold'>FDA Approves Special Green
Tea Extract as a New Topical Drug for Genital Warts</span></font></b></p>
<p class=MsoNormal><b><font size=4 color=black face="Times New Roman"><span
style='font-size:14.0pt;color:black;font-weight:bold'>Expert Says Development
Marks the Birth of a “New Industry”</span></font></b></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>Austin</span></font><font color=black><span
style='color:black'>, Texas</span></font><font color=black><span
style='color:black'>. (November 9, 2006) Last week the U.S. Food and Drug
Administration (FDA) approved a special extract of green tea as a prescription
drug for the topical (external) treatment of genital warts caused by the human
papilloma virus (HPV). The new drug, called Veregen™ (Polyphenon®
E) Ointment is the first prescription botanical (herbal) drug approved by FDA
under the “new” drug amendments of 1962 that required drugs to be
proven both safe and effective prior to being marketed in the U.S. </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>The active drug ingredient, Polyphenon</span></font><font
color=black face=Symbol><span style='font-family:Symbol;color:black'>Ò</span></font><font
color=black><span style='color:black'> E, represents a proprietary mixture of
phytochemicals produced from a partially purified water extract of green tea
leaves. Green tea, brewed from the leaves of the tea plant (<i><span
style='font-style:italic'>Camellia sinensis</span></i>), is one of the most
popular beverages worldwide. Unlike leaves used for black or oolong teas,
leaves used to prepare “green” tea do not undergo a fermentation
process. Therefore, green tea retains higher levels of highly antioxidant
polyphenolic compounds known as catechins.</span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>Polyphenon® E has been shown to have
significant pharmacological activities when tested both internally and
externally in animals and humans. For FDA drug approval, the safety and
efficacy of Polyphenon® E Ointment were studied in two prospective, randomized,
double-blind clinical studies in nearly 400 adults with external genital and
anal warts ranging in number from 2 to 30. Test subjects applied the ointment
three times daily until complete clearance of all warts. In each of these
clinical trials, the median time to clear warts completely was 16 weeks and 10
weeks, respectively. Changes in the skin over the site of use were the most
commonly reported side effects and included redness, itching, burning,
pain/discomfort, ulceration, swelling, and local hardening of the
skin. </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>Polyphenon® E Ointment will be available
in the United States only by prescription. While not a cure (new warts
may develop following the ointment therapy), this new drug adds another proven
intervention to be used in the treatment of warts, under the guidance of a
physician. The drug was developed by MediGene, a German company, and will be
marketed in the United States by Bradley Pharmaceuticals of Fairfield, NJ.</span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>“This is a regulatory breakthrough,
said Mark Blumenthal, Founder and Executive Director of the nonprofit American
Botanical Council.</span></font> <font color=black><span style='color:black'>“It
is the first time a complex herbal preparation has come to market as a prescription
drug in the U.S. in more than half a century.”</span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>Freddie Ann Hoffman, MD, an expert on this
botanical drug process, said, “A new drug industry has just been born --
perhaps ‘reborn’ -- in the United States: the <i><span
style='font-style:italic'>polymolecular </span></i>botanical drug
industry.” Dr. Hoffman is a former FDA official and is founder of
HeteroGeneity, LLC, a Washington, D.C.-based consulting firm advising companies
seeking to market botanically-based drugs. </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>“Though many within the FDA may not
yet recognize it as such, this approval represents an historic milestone for
the agency, she continued. “It is proof that FDA can deal with botanicals
-- not only as foods and dietary supplements, but also as approved
medicines.”</span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>Dr. Hoffman added, it “will
hopefully stimulate more serious research efforts regarding the clinical uses
of botanicals. Manufacturers should also now be more willing to pursue a
medical indication for their products, along with appropriate marketing
claims.”</span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>Hoffman also views FDA’s action as
pivotal in addressing the nexus of an ongoing debate regarding the safe use of
herbals for medical conditions. “Health professionals, insurance
carriers, and consumers themselves must realize that this new drug is not a
nutritional supplement or an ‘alternative’ therapy, but a mainstream
therapy fully supported by clinical evidence of safety and efficacy equal to
that of any chemical or biotechnology drug approved by FDA in the U.S. today. This approval indeed paves the way for a new pharmaceutical industry.”</span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>Whether or not a new class of botanical--
or “polymolecular”-- drugs will have cost benefits over synthetic
or biotechnology products, Dr. Hoffman finds this too early to assess.
“We will need to see more drug approvals before anyone can speculate on
cost-savings of this drug class over others.” She adds, “The fact,
however, that botanicals find their uses out of learnings gleaned of other
countries and cultures – from traditional, historical and even current
use as foods and supplements-- should shorten their pathway to drug approval in
the US.”</span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>FDA defines a “botanical” as a
product that exclusively contains ingredients from plants, algae or fungi. In
contrast to most conventional pharmaceutical drugs comprised of one single
chemical, botanicals contain complex mixtures of naturally-occurring chemicals.
In order to more appropriately evaluate herbal mixtures, in June 2004 the FDA
published <i><span style='font-style:italic'>Guidance for Industry for
Botanical Drugs</span></i>, a new policy providing advice for potential
botanical drug manufacturers, describing both the application process and
providing recommendations as to how chemically complex products might satisfy
the requirements of FDA’s rigorous “new drug” review process.
</span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> </span></font></p>
<p class=MsoNormal><b><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black;font-weight:bold'>About Polyphenon E®
Ointment </span></font></b></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>Polyphenon E</span></font><font
color=black face=Symbol><span style='font-family:Symbol;color:black'>Ò</span></font><font
color=black><span style='color:black'> Ointment, 15% is a botanical drug
approved as a topical treatment of external genital and anal warts in adults.
External genital warts, caused by human papilloma viruses (HPV type 6 or 11),
are one of the most common and fastest-spreading venereal diseases worldwide.
Scientists estimate that as many as 1 million new cases of genital warts are
diagnosed in the United States each year. Approximately 14 million people in
the United States and 15 million people in Europe are infected with HPV. </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>Polyphenon E</span></font><font
color=black face=Symbol><span style='font-family:Symbol;color:black'>Ò</span></font><font
color=black><span style='color:black'> Ointment is a product of global
development. In 1997, Epitome Pharmaceuticals Ltd., a privately owned Canadian
company (Halifax, Nova Scotia) licensed from Mitsui Norin, Ltd. (Tokyo, Japan)</span></font><font
color=blue><span style='color:blue'>,</span></font><font color=black><span
style='color:black'> a patented method of treating external genital warts
through the topical application of</span></font><font color=navy><span
style='color:navy'> </span></font><font color=black><span style='color:black'>Polyphenon
E</span></font><font color=black face=Symbol><span style='font-family:Symbol;
color:black'>Ò</span></font><font color=black><span style='color:black'> green
tea extract, the he patent for which extends through 2017. Epitome sublicensed
the technology to </span></font><font color=blue><span style='color:blue'><a
href="http://www.medigene.com/englisch/index_e.php" target="_blank"
title="http://www.medigene.com/englisch/index_e.php
www.medigene.com">MediGene
AG</a></span></font><font color=black><span style='color:black'> of Munich, Germany, which collaborated in two multi-center Phase II clinical trials. In
2003 MediGene extended its license to include the treatment of hyperplasia
caused by papilloma viruses. In 2004 MediGene conducted two Phase III trials,
one in Europe and another in the Americas. Based on these trial results,
MediGene submitted a New Drug Application (NDA) to the FDA Center for Drug Evaluation and Research in September 2005. FDA accepted the NDA for filing in
early December 2005. MediGene reportedly plans to submit European marketing
authorization applications for the drug before the end of 2006. MediGene is the
first German biotech company to obtain marketing authorization for a drug in
the United States. </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'> </span></font></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>MediGene predicts peak sales potential for
Polyphenon® E Ointment of up to $100 million annually. The drug will be
commercialized in the United States by MediGene’s marketing partner,
Bradley Pharmaceuticals, Inc. (NYSE: BDY), which is expected to launch the
product during the second half of 2007. Both Bradley operating units will
market Polyphenon E</span></font><font color=black face=Symbol><span
style='font-family:Symbol;color:black'>Ò</span></font><font color=black><span
style='color:black'> Ointment, 15%, with the Doak Dermatologics subsidiary
promoting the drug to dermatologists, and Bradley's Kenwood Therapeutics
division marketing this topical therapy to obstetric and gynecological
physicians.</span></font></p>
<p class=MsoNormal><b><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black;font-weight:bold'> </span></font></b></p>
<p class=MsoNormal><b><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black;font-weight:bold'>About the American
Botanical Council</span></font></b></p>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt;color:black'>Established in 1988, the American
Botanical Council (ABC) is the leading nonprofit, member-based international
organization working to educate consumers, healthcare professionals,
researchers, educators, industry, and the media on the safe and effective use
of herbs and medicinal plants products. ABC is located on a 2.5 acre site in Austin, Texas where it publishes <i><span style='font-style:italic'>HerbalGram</span></i>,
a peer-reviewed quarterly journal. ABC is also the publisher of <i><span
style='font-style:italic'>The ABC Clinical Guide to Herbs</span></i>, a continuing
education and reference book, which contains extensive monographs on the safety
and efficacy of 29 popular herbs, including green and black tea. ABC also just
published <i><span style='font-style:italic'><a
href="http://www.herbalgram.org/default.asp?c=mobotbook"
title="http://www.herbalgram.org/default.asp?c=mobotbook"><font color=black><span
style='color:black'>The Identification of Medicinal Plants: A Handbook of
Morphology of Botanicals in Commerce</span></font></a></span></i>, a guide to
the macroscopic identification of botanical materials for industry quality
control laboratories. More information is available at <a
href="http://www.herbalgram.org/" title="http://www.herbalgram.org/"><font
color=black><span style='color:black'>http://www.herbalgram.org/</span></font></a>.</span></font></p>
<p class=MsoNormal><font size=2 color=black face="Times New Roman"><span
style='font-size:11.0pt;color:black'> </span></font></p>
<p class=MsoNormal align=center style='text-align:center'><font size=2
color=black face="Times New Roman"><span style='font-size:11.0pt;color:black'>###</span></font></p>
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12.0pt'> </span></font></p>
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12.0pt'> </span></font></p>
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