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Inhaled insulin flops, but field may hold promise
吸入型胰岛素重创，前景依然在
Sun Apr 13, 2008 2:48pm EDT
By Deena Beasley
LOS ANGELES (Reuters) - Inhaled insulin may be a debacle that pharmaceutical companies want to put behind them as quickly as possible, but many companies are still working to develop drugs that are delivered through the lungs.
洛杉矶（路透社），尽管吸入型胰岛素对于制药公司而言是一场希望早日结束的灾难，但是许多公司依然坚持不懈地开发这类通过肺部释放的药物。
Asthma has been treated with inhalants for decades, and inhaled drugs now under development include treatments for other pulmonary diseases, like cystic fibrosis or infections of the lung, as well as a faster-onset version of an existing migraine drug.
吸入法治疗哮喘已经运用了十多年，目前在研的有治疗其他肺部疾病如囊肿性纤维化或肺部感染吸入型药物，也有早期治疗偏头痛的药物的速效吸入剂。
"This is a way to deliver high concentrations of medication to the target organ," said Kevin Corkery, senior director of the pulmonary business unit at Nektar Therapeutics, which last week abandoned its Exubera inhalable insulin program after onetime partner Pfizer Inc said clinical trials found increased cases of lung cancer.
Nektar公司肺部事务部主要负责人Kevin Corkery说：“这是一种使药物在靶器官附近高浓度释放的给药方式。” 当其曾经的伙伴辉瑞宣布临床试验显示吸入型胰岛素Exubera有增加肺癌的风险后，该公司于上周也中止了该品种的开发进程。
Nektar, known before 2003 as Inhale Therapeutic Systems, is developing inhalable dry powder versions of anti-infectives for treating pneumonia in the lung as well as aerosolized forms of antibiotics for patients with cystic fibrosis, a genetic disease in which the body produces a thicker-than-normal mucus that clogs the lungs and other organs.
2003年前以吸入给药系统著称的Nektar，现正在开发治疗肺炎的吸入干粉给药系统和抗囊肿性纤维化的抗生素喷雾剂，囊肿性纤维化是一种遗传性疾病，体内产生了一种稠粘液造成肺部和其他器官的阻塞。
Pfizer had already decided last year to stop marketing Exubera, which had only marginal sales despite the pitch of being more convenient than traditional insulin injections. The decision cost the company a $2.8 billion pretax charge.
尽管Exubera比传统的注射胰岛素更加方便，但是因为销售不佳，Pfizer仍然于去年决定停止Exubera的市场销售，这一决定致使28亿美元（扣税前）付之东流。
After the world's largest drugmaker acknowledged its product was never going to see the blockbuster sales it once hoped, Eli Lilly and Novo Nordisk this year also ended inhaled insulin development programs.
当世界最大的制药公司承认其产品从来没有成为期望中的重磅炸弹后，礼来和诺和诺德今年也结束了吸入型胰岛素的研发计划。
Tiny MannKind Corp remains a notable holdout, repeating this week that it remains committed to its experimental inhaled insulin, Technosphere, which it believes holds advantages over the other products.
引人注目的是，MannKind公司依然坚持着。这周，他们重申，将继续致力于开发吸入型胰岛素Technosphere，并相信该产品优于其他产品。
"The safety issues related to inhaled insulin really center on the fact that it is a growth factor going into the lung," said Tim Nelson, chief executive at MAP Pharmaceuticals Inc, which is developing an inhalable migraine drug and an asthma drug for toddlers and preschoolers.
MAP 制药公司的主要负责人Tim Nelson 说：“与吸入型胰岛素相关的安全性问题集中在它是肺的生长因子这一事实上。”该公司正在开发供蹒跚学步的孩子和学龄前儿童用的抗偏头痛吸入剂和抗哮喘吸入剂。
Insulin and related substances called insulin-like growth factors have been shown to increase the risk of developing cancer.
研究表明，被称为类胰岛素生长因子的胰岛素及相关化合物有增加癌变的风险
IMPAIRED LUNG FUNCTION
肺功能损害
In addition, Exubera has always been associated with slight impairment of lung function, requiring physicians to carefully screen and monitor patients for lung disease like asthma and emphysema.
此外，Exubera还与轻微损害肺功能有关，要求医师密切监测患有哮喘和肺气肿等肺病的病人。
Nelson said MAP's products do not hold that kind of risk.
Nelson说，MAP的产品不存在这种风险。
The company expects results late this year from a pivotal-stage trial of a low-dose aerosol form of a steroid used to treat asthma in children too young to use inhalers.
公司有望在今年晚些时候完成一项重要的临床试验，即针对尚不能使用吸入剂的的小儿而开发的低剂量类固醇喷雾剂用于治疗哮喘病。
Nelson said MAP's technology will deliver about half as much steroid to children under age 5 in three to four minutes, compared with the 10- to 15-minute process they are now subject to.
Nelson说，与现在治疗需要10到15分钟时间相比，对于5岁以下的儿童，MAP的技术可实现在3到4分钟内释放一半量的类固醇。
The active ingredient in MAP's migraine drug, known as MAP0004, is dihydroergotamine, which has been used intravenously for 60 years by hospitals for treating severe migraines. The IV infusion can cause nausea and cardiovascular problems, but MAP's inhaled drug is not associated with those side effects, Nelson said.
MAP的抗偏头痛药物的活性成分，代号为MAP0004，是双氢麦角胺，已经在医院中作为静脉用药用于治疗严重的偏头痛近60年。Nelson说，静脉滴注会引发恶心和心血管问题，而MAP的吸入药物则没有这些副作用。
He also said MAP0004 works to calm migraine pain in as fast as 10 minutes, compared with 45 minutes to two hours for commonly-prescribed migraine pills.
他说，MAP0004最快能在十分钟内缓解偏头痛，而常规的治疗偏头痛的药片则需要45分钟到2小时。
"We're treating migraine upstream ... there is a much broader spectrum of efficacy," Nelson said.
“我们治疗偏头痛是逆流方式..，具有广泛的疗效。” Nelson 说。
The first Phase III results from the company's migraine program are also expected in late 2008.
公司偏头痛药物的3期临床试验的第一阶段有望在2008年晚些时候结束。
Morgan Stanley has estimated peak annual sales for MAP0004 of around $250 million and said UDB could see sales of $500 million a year.
摩根史坦利投资公司预计MAP0004的年销售额约2.5亿美元，而UDB则认为可达到5亿美元。
Corkery said Nektar and partner Bayer AG are talking with U.S. regulators about the design of a Phase 3 trial of its aerosolized powder form of the antibiotic amikacin.
Corkery 说，Nektar及其伙伴德国拜耳公司正在与US当局讨论阿米卡星干粉喷雾剂的3期临床设计问题。
The company is also working on an inhaled version of vancomycin for treating antibiotic-resistant, hospital-acquired pneumonia.
公司正在研制万古霉素的一种吸入剂型用于治疗耐药性医院获得性肺炎。
Nektar has partnered with Novartis and Bayer, respectively, to develop inhalable dry powder versions of anti-infectives tobramycin and ciprofloxacin for cystic fibrosis patients.
Nektar分别与诺华和拜耳开发治疗囊肿性纤维化的抗感染的托普霉素和环丙沙星的干粉吸入剂型。
Meanwhile, Gilead Sciences Inc, the world's second-most highly valued biotech company, is slated to hear in September whether the U.S. Food and Drug Administration will approve its application for cystic fibrosis drug aztreonam lysine for inhalation.
同时，吉里德科技公司，世界第二大最具价值的生物科技公司，预计今年9月听证FDA是否同意其治疗囊肿性纤维化的氨曲南赖氨酸吸入剂的申请。
Analysts have estimated that Gilead's drug will see sales of more than $500 million a year.
分析人士估计吉里德科技公司的年销售额有望超过5亿美元。
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