对于投资者来说,更快的食物和药物管理和应用基因组织对药物发展的进步的组合会产生有趣的可能性。
乍一看,投资者可能预计药品公司的利润机会会缩小。After all, genomics can lead to personalized drugs that would be sold only to the limited number of people with a particular genetic mutation — the polar opposite of the drug industry’s classic model of mass-market blockbusters, usually defined as $1 billion or more in annual sales.
然而,在某种程度上,价格较高的价格可以弥补买方数量的损失。复杂的生物药物可以在每年50,000美元到超过120,000美元的任何地方,而标准名牌丸为350美元至1,200美元。但这些价格如此争议,许多保险公司BALK,进一步复杂化任何预测。保险公司可能会成功迫使折扣。没有保险的患者可能会跳过所需的药物。
许多医疗保健投资者正在寻求利基。Michael Gregory,他在与达拉斯对冲基金公司高地资本管理相关约2亿美元的卫生保健基金中,喜欢所谓的孤儿药物,这些药物治疗疾病,甚至基于Nongenomics的产品有限。自1983年孤儿药物法案以来,FDA一直向这些产品的制造商提供诱因,包括税收抵免和七年专属营销权利。
孤儿药是在最新的处方药用户费(PDUFA)中挑选的少数地区之一,其中包括将“外展向工业”和患者团体增加,以编写涵盖“非传统临床”的新指南发展计划“并鼓励”审稿人“的灵活性和科学判断。”5月初,即使在最新的PDUFA通过之前,FDA也批准了Selelyso,来自辉瑞伙伴关系的孤儿药,用于治疗Gaucher病,一种影响肝脏和脾脏的稀有遗传疾病。
“FDA内的活动会导致我们重新考虑有利地追求孤儿毒品的公司的机会,”格雷戈里说。他还指出,孤儿药品价格甚至可以超过生物制剂,有时每年每件患者排名500,000。
At Great Point Partners, a Greenwich, Connecticut–based investment firm with about $400 million in assets, co-founder Jeffrey Jay says the FDA’s tougher stance on cholesterol drugs like Merck & Co.’s niacin product Tredaptive prompted him to shift away from the cardiovascular market, despite its huge size, and toward targeted niche drugs. The most obvious target is cancer. One company Jay singles out is Ariad Pharmaceuticals of Cambridge, Massachusetts, which is working on a drug for a type of leukemia in patients with a particular genetic mutation. Ariad has finished clinical trials and is awaiting FDA approval; Jay expects the new drug to hit the market next year.
FDA的肿瘤科传统上,甚至在基因组学的出现之前,甚至在基因组学的出现之前都有声誉,因为癌症药物几乎按照定义符合原子能机构的特殊加速考虑:致命疾病的药物,患有少数或没有有效治疗的致命疾病。原子能机构的其他武器具有相反的声誉 - 应得的或不适合效率低下或严格。其中:代谢和内分泌产物的分歧;肺,过敏和风湿病学产品;和神经内科。
Depending on the specific personnel, “there are about 20 or 25 percent of cases where the FDA doesn’t act rationally, where some bureaucrat gets in there,” says Nathan Fischel, who runs $80 million in health-care-focused hedge funds at Los Angeles–based Dafna Capital Management. One of Fischel’s favorite companies is Discovery Labs in Warrington, Pennsylvania, whose synthetic drug Surfaxin was approved in March for treating respiratory distress syndrome in premature infants.
在纽约运行小型同名对冲基金的Michael Krensavage表示,FDA的变化没有改变他的基本,深价战略,虽然“他们当然确实使事情更有趣,并且可能更有利可图。”如果有的话,他认为,“Biotech股正在讨厌邦克斯”,以期预期自11月以来的纳斯达克生物技术指数的50%涨幅所示。为了他的部分,Krensavage等着看那个泡沫坍塌。