[MPWG] ABC Press Release: FDA Approves NDA for Botanical Prescription Drug

Thu Nov 9 19:46:47 CST 2006

FYI and further dissemination. 

Freddie Ann Hoffman, MD 
HeteroGeneity, LLC 
5611  16th Street, NW 
Washington, DC  20011-6809 
Tel.:  202-545-6843 
Fax:  202-545-6844 
 <mailto:fhoffman at heterogeneity-LLC.com> fhoffman at heterogeneity-LLC.com

 <http://www.heterogeneity-LLC.com> www.heterogeneity-LLC.com

  _____  

From: Nancy Moon [mailto:Nancy at herbalgram.org] 
Sent: Thursday, November 09, 2006 4:44 PM
To: Nancy Moon
Subject: PRESS RELEASE - FDA Approves Special Green Tea Extract as a New
Topical Drug for Genital Warts

Text Box: [1,302 words]

AMERICAN BOTANICAL COUNCIL

P.O. Box 144345, Austin, TX 78714-4345

Phone: 512-926-4900 x121; Fax: 512-926-2345

Contact: Nancy Moon

Email: nancy at herbalgram.org

Web site: http://www.herbalgram.org/

Editor's Note: Mark Blumenthal is available for interviews. Please contact
Nancy Moon per above.

 FOR IMMEDIATE RELEASE

News Release

FDA Approves Special Green Tea Extract as a New Topical Drug for Genital
Warts

Expert Says Development Marks the Birth of a "New Industry"

Austin, Texas. (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 VeregenT
(PolyphenonR 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.   

The active drug ingredient, Polyphenon* 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 (Camellia
sinensis), 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.

PolyphenonR 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 PolyphenonR 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.   

PolyphenonR 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.

"This is a regulatory breakthrough, said Mark Blumenthal, Founder and
Executive Director of the nonprofit American Botanical Council. "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."

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 polymolecular 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. 

"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."

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."

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."

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."

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 Guidance for Industry for
Botanical Drugs, 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. 

About Polyphenon ER Ointment 

Polyphenon E* 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. 

Polyphenon E* 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), a patented method
of treating external genital warts through the topical application of
Polyphenon E* green tea extract, the he patent for which extends through
2017. Epitome sublicensed the technology to MediGene
<http://www.medigene.com/englisch/index_e.php>  AG 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.   

MediGene predicts peak sales potential for PolyphenonR 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* 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.

About the American Botanical Council

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 HerbalGram, a peer-reviewed quarterly journal. ABC is also the
publisher of The ABC Clinical Guide to Herbs, 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  <http://www.herbalgram.org/default.asp?c=mobotbook> The
Identification of Medicinal Plants: A Handbook of Morphology of Botanicals
in Commerce, a guide to the macroscopic identification of botanical
materials for industry quality control laboratories. More information is
available at  <http://www.herbalgram.org/> http://www.herbalgram.org/.

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