美国FDA批准一种绿茶的提取物作为治疗外生殖器疣和肛疣的新药
转载自 现代中药网

　　美国食品和药物管理局(FDA)批准将一种绿茶的专用提取物作为一种新的处方药，用于局部（外部）治疗由人类乳头瘤病毒引起的生殖器疣。这种被称为Veregen™ (Polyphenon® E) 新药物是第一种经美国食品和药物管理局根据1962年药品修正案批准的植物（草本）药物，该法案要求所有的药物在投放美国市场前必须经过证明是安全和有效的。

　　这种药物的活性成分Polyphenon® E代表了一种特有的植物化学混合液，取自绿茶树叶的一种部分纯净萃取液。由茶树叶子生产的绿茶是世界上最流行的一种饮料。但是，与用于生产红茶或乌龙茶的茶叶不同的是，用于制造绿茶的叶子并没有经过一个发酵的过程，从而使绿茶保留更多的高抗氧性多酚化合物，即茶多酚。

　　经动物和人体的内部和外部测试，Polyphenon®E已经被证明具有非常重要的药用价值。就美国食品和药物管理局的药物批准程序而言，Polyphenon® E 软膏的安全性和功效在两项前瞻性的随机双盲临床研究中已经得到了证明。该项研究在接近400名患有外生殖器/肛疣的成人中进行，所患疣的数目从2到30个不等。受试人员每天使用药膏三次，直到所有的疣被清除为止。在两组临床实验中，完全清除所有疣所用的平均时间分别是16周和10周。而用药部位的皮肤变化则显示了一些最常见的副作用，包括皮肤红肿，发痒，灼烧，疼痛/不适，溃疡以及局部硬化。

　　在美国，Polyphenon® E Ointment 只能以医生处方的方式来购买。虽然它不能完全治愈疣，（新的疣可能会随着该药膏的使用而产生），但是在医生的指导下，这种新的药物将为疣的治疗增加了另一种业已证明的方案。这种药物由一家德国公司MediGene研发，并将由新泽西州费尔菲尔德的布莱德利医药公司推向美国市场。

　　“这是一次监管的突破。”非赢利的美国植物学会创建者和执行主任马克.布鲁蒙萨尔说。“这是近半个世纪以来的第一次，一种复杂的草本制剂得以作为处方药进入美国市场。”

　　植物药物方面的专家，医学博士弗雷迪.安.霍夫曼说，“一个新的药物行业已经在美国诞生了-或者可以说重生了，那就是多分子植物药物行业。”作为美国食品和药物管理局的前官员，霍夫曼是华盛顿特区HeteroGeneity, LLC的创始人，这家咨询公司主要从事于以植物为基础的药物的推广。

　　“虽然很多美国食品和药物管理局的人并不这么认为，但是对这一药物的批准是该机构一个历史性的里程碑。” 她同时继续表示，“这证明了美国食品和药物管理局不仅仅把植物当做食物和辅食，也认为它们可以作为得到批准的药物来使用。”霍夫曼博士补充说，“这将会极大地激发人们对于植物临床使用方面的认真研究。同时，随着一定的市场需求，药物制造商也更乐意去继续他们产品的医疗适应症的研究。”

　　霍夫曼还认为美国食品和药物管理局的这一决定将会对处理正在激烈进行的争论起关键的作用。目前，人们正在就草药在医学方面的安全使用进行热火朝天的探讨。“健康专家，保险从业者以及消费者必须认识到这种新药并不是一种营养补充或选择性的疗法，而是一种主流的治疗方式。现在，它的安全和功效已经得到了充分的临床证明，并且跟所有化学或生物药物一样获得了美国食品和药物管理局的批准。这一批准实际上为一个新药品行业的建立铺平了道路。”

　　对于是否这种新的植物药物或多分子药物会有更多的成本优势比起各种合成或生物产品，霍夫曼博士认为现在判定还为时过早。“在人们确定这种药物比起其他药物更能节省成本之前，我们需要有更多的植物药物获得批准。”她补充说，“但是，在其他国家和文化中，人们传统上，历史上甚至目前都将植物当作食物和添加剂，这一事实将有助于缩短视其在美国为药物的进程。” 美国食品和药物管理局将植物药物定义为一种专门含有来自植物，藻或真菌成分的产品。和传统的由单一化学成分构成的药物不同，植物药物含有复杂的自然生成的化学混合物。为了更好地评估草药混合物，美国食品和药物管理局在2004年6月发布了《植物药品研究指南》，它为潜在的植物药品制造商提供了一些具体的建议，描述了植物药品的应用过程，并就化学合成产品如何满足美国食品和药物管理局严格的“新药物”评审过程的要求提供了一些指导意见。

　　关于生殖器疣治疗药软膏

　　生殖器疣治疗药软膏 15%是一种经批准的植物药物，用于局部治疗成人外生殖器疣或肛疣。由人类乳头瘤病毒（类型6或类型11）引起的外生殖器疣是一种世界范围内最常见和传播最快的性病。科学家预计，每年有多达一百万的新生殖器疣患者得到确诊。在美国，大约一千四百万人感染了人类乳头瘤病毒，而在欧洲感染这一病毒的人数达到了一千五百万。 

　　生殖器疣治疗药软膏是全球研发的成果。1997年，一家私有的加拿大公司（位于新斯科舍省的哈利法克斯），Epitome制药公司从三井农林株式会社（日本东京）得到授权，获准使用一种具有专利权的治疗方式，既通过应用Polyphenon® E绿茶萃取物来治疗外生殖器疣。该项专利有效期一直到2017年。后来，Epitome制药公司又将这一专利技术授权给德国慕尼黑的MediGeneAG公司，并与之在两项二期多中心试验中进行合作。2003年，MediGene公司将这一专利许可扩大，使之包括对乳头状瘤病毒引起的增生的治疗。2004年，MediGene AG公司进行了两项三期试验，一项在欧洲进行，另一项则在美国。根据试验结果，2005年9月，MediGene AG公司向美国食品和药物管理局递交了一份新药物申请，申请对该药物进行药物评估和研究。2005年9月初，美国食品和药物管理局接受了这一新药物申请。据报道，MediGene AG公司计划在2006年底向欧洲递交申请，以获得进入欧洲市场的许可。MediGene AG公司是第一家其药物在美国获得市场许可的德国生物技术公司。 MediGene AG公司预计生殖器疣治疗药软膏的最高潜在销售额将达到每年一亿美元。这种药物将由MediGene AG公司在美国的合作伙伴布莱德利医药公司（纽约证券交易所：BDY）进行市场销售。该公司预期在2007年下半年开始销售这种产品。该公司的两个下属子公司将负责销售Polyphenon.E软膏15%，其中Doak Dermatologics 将向皮肤病科医生推销该产品，而布莱德利的另一家子公司，Kenwood Therapeutics将负责向产科和妇科医生推广该外用疗法。 

　　关于MediGene AG

　　MediGene AG是一家公开上市的生物制药公司（精华标准：MDG），其总部位于德国慕尼黑附近的马丁斯里德镇，并在英国牛津和美国圣地亚哥设有子公司。MediGene AG是第一家将药物投放该市场的德国生物制药公司，第二种药物也已经通过了美国食品和药物管理局（FDA）的审批。同时，公司的第三种药物，用于治疗红斑痤疮的OraceaTM，最近获得了美国药物公司CollaGenex的许可，投放于欧洲市场。此外，还有几种药物的研究目前正处于临床发展阶段。MediGene还拥有各项创新平台技术 。公司的核心竞争力主要来自于在抗癌和自体免疫治疗方面的研究和开发。因此，MediGene AG将重点关注在较高医疗需求方面的适应症及其所带来的经济机会。 

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 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. 

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.

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. 

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.

“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 E® Ointment

Polyphenon EÒ 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 EÒ 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 patent for which extends through 2017. Epitome sublicensed the technology to MediGene 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 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 EÒ 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 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. 

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