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The First Botanical Drug by FDA and beyond
US Food and Drug Administration (FDA) approved
a new prescription drug by MediGene AG, Germany in October 2006. The drug, named VeregenTM (Polyphenon®E) is comprised of water extracts of green tea leaves and
green tea components. Veregen is
specifically indicated for the topical treatment of external genital and
perianal warts caused by human papilloma virus. It is the first botanical drug approved
by FDA under the 1962 Drug Amendment, which required that the safety and effectiveness must be
proved prior to the marketing of a drug.
Polyphenon®E Ointment
came as the joint effort of the international pharmaceutical community. In 1997 Epitome Pharmaceuticals Ltd. licensed from Mitsui
Norin Company (Japan), a patented method of treating external
genital warts through the topical application of Polyphenon® E green tea extract (patent valid
until 2017). Epitome then sublicensed this technology to MediGene AG, and
the two collaborated on a multi-centre Phase II trial. MediGene AG submitted the
new drug application to the US FDA in September 2005 and got approved in
October 2006.
The approval is considered a major breakthrough
under FDA regulation. In June
2006, FDA published the “Guidance for Industry – Botanical Drug Products”,
which provides sponsors with guidance on submitting investigational new drug
applications (NDA) for botanical drug products. Unlike synthetic or highly purified drugs, botanical drugs
are complex mixtures of natural constituents. Supplied as an ointment for topical administration,
Polyphenon® E is the first pharmaceutical plant essence which obtained
marketing authorization from FDA. Clinical results confirmed its safety and effectiveness. The approval by FDA is a milestone in
the development of botanical drug and will further promote the research and clinical
application in the future.
There are currently about 60 ~ 70 botanical drugs pending for FDA
approval. Among which, 10 Chinese
medicine products from China have entered NDA stage. For Fufang Dansen Diwan, IND application number has been
assigned, while Kanglaite Injection has completed Phase I clinical
investigation and ready to start Phase II. Sunrecome (also known as Shuangling Gubansan in Chinese) is
now under Phase I Clinical Trial at the University of Chicago. As a topical administrative drug, Polyphenon®
E was able to meet the registration requirements with FDA and got its approval. Also, the two randomized, double-blind,
vehicle-controlled phase III clinical trials had achieved major advancement in
establishing the safety and effectiveness of ointment.
China is rich in botanical drug resources and has a long history in
clinical application. The successful experience of Veregen by MediGene AG demonstrates
that business acumen (in targeting good product leads), good management (from
project management to deal making), protection of intellectual properties (for
value) and business partnerships (for funding, synergy and risk sharing) provide
some essential enabling ingredients to translate research outcome into a
successful botanical product.
Sources: Yi Yao Jing Ji Bao
CHINAMTCM
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