10/27 01:54 EST
想知道研发新药的成本昂不昂贵，问问Alexion PharmaceuticalsALXN#就知道了。这是一家位于美国康涅狄格州的药物研发公司，15年来已经斥资7.29亿美元进行不同规模的药物研发，主要研究治疗罕见或潜在的致命性血液紊乱疾病药物。去年，公司研发的新药Soliris获批，可以进入美国和欧洲市场进行销售。公司的销售额增长是显而易见的，Soliris作为公司的核心获批产品，公司于周四发布了Soliris连续七个季度营收100%以上的增长率，这是公司连续二个季度利润大涨的丰收季节了。公司因此提高了08年全年的业绩预测，显示对全年业绩增长的信心。Cowen&Co.Soliris分析师Rachel Mc-Minn表示：“对于公司来说，接下来要做的就是稳定运营和高效管理，除此以外别无他法。”
作为治疗阵发性睡眠性血红蛋白尿症（又名PNH）的药物，Soliris是目前唯一获得正式批准的药物。PNH是一种极为罕见的、导致患者全身虚弱并攻击自身血红蛋白细胞的紊乱疾病。患者将出现复发性疼痛、疲劳、肾脏病变以及其它问题。国家健康局数据显示此种疾病的患病率是100万名之中有1到5名。但是 Alexion公司已经未雨绸缪，提前为此做好准备。公司表示目前此种疾病的患病率与日俱增，尤其是在欧洲和美国地区，患者数量已经达到8K到10K名。医生通过监测能够及早发现疾病，在超过15个国家已经有患者开始使用Soliris治疗自己的疾病。
Soliris能够降低血块的数量，维护肾脏正常功能，并回复机体健康。FDA已经在07年3月批准了Soliris上市。欧洲相关监管机构也在今年六月批准此项药物。公司目前站在努力向澳大利亚和日本市场进军。公司总裁兼COO表示：“已经有越来越多国家的内科医生开始使用我们的药物为患者提供治疗。” 公司预计今年在荷兰和英国市场的营收将大涨，因为这些国家的保险商和国家保荐机构已经同意为此种药物支付费用。一年的药物共供应成本为389K。但是公司表示此种药物还能够适用于其它疾病的治疗，包括哮喘病等。公司以及Soliris已经获得了2008年最佳生物科技Galen Prize奖项。
大赛主席Gerald Weissmann表示：“这对于公司的潜在影响是巨大的，事实上公司在药物开发方面的实力无与伦比。”但是此种药物在其它疾病治疗方面的效果目前尚不可知。公司表示将于12月份在American Society of Hematology上发布有关的资料。公司还将开发新药，分析师表示：“很显然，公司的长期发展战略是形成有效地研发管道。”公司成立于1992年，是由耶鲁大学研究院组建的。公司于1996年上市，500名主要员工均来自美国和欧洲。
公司三季度Soliris的销售额达到7120万美元，上个季度货运营收达到530万美元。本季度公司发布的营收为7650万美元。一年前的销售额仅为 2210万美元。周四发布的季报中，每股收益达到0.29美元，同比为亏损0.28美元。公司还提高了08年下半年业绩预测，预测销售额将上涨至 2.56-2.58亿美元。Thomson Reuters分析师预期公司今年的每股收益将上涨0.08美元，09年每股收益将达到0.8美元。
Investor's Business Daily
Biotech Firm's Sales Explode On Drug To Treat Rare Blood Disorder
Friday October 24, 6:07 pm ET
Kevin Harlin Developing new drugs is expensive. Just ask Alexion Pharmaceuticals.
The Cheshire, Conn., drug discovery company has spent a cumulative $729 million over 15 years of research, working mostly on a drug to treat a rare and potentially fatal blood disorder.
Last year, the company finally won critical regulatory approvals to market its drug, Soliris, in the U.S. and Western Europe.
Sales have taken off.
Thanks to Soliris, Alexion's (NasdaqGM:ALXN - News) sole approved product, the company on Thursday reported its seventh consecutive quarter of triple-digit revenue growth. It was the company's second straight profitable quarter.
Alexion increased its revenue guidance and now expects to show its first annual profit in 2008.
"They're doing nothing but executing solidly here," said Rachel McMinn, an analyst at Cowen & Co.
Soliris, the trade name for the drug eculizumab, is the only substance approved to treat paroxysmal nocturnal hemoglobinuria, or PNH.
PNH is a rare, debilitating disease that causes the body to attack its own red blood cells. Patients can suffer recurring pain, fatigue, kidney disease and other problems. The National Institutes of Health thinks that the disease afflicts only one to five people out of a million.
But the company thinks there are 8,000 to 10,000 people in the U.S. and Western Europe with the condition.
The company says awareness of the disease is growing. As that happens, doctors are able to correctly diagnose it more often. There are paying customers in more than 15 countries.
The drug can reduce instances of blood clots, protect kidney function and restore quality of life, the company says.
FDA Nod
Soliris won Food and Drug Administration approvals in March 2007. European regulators cleared it that June. Alexion is now working on approvals in Australia and hopes to begin clinical trials in Japan.
"Simply put, more physicians in more countries are treating more new PNH patients with Soliris," David Keiser, president and chief operating officer, told analysts on a conference call.
Revenue is expected to increase in places such as the Netherlands and Great Britain, where insurers and national health services have agreed to pay for the drug. A year's supply costs about $389,000.
But the company says the drug also shows promise for treating an array of other maladies, including asthma, lupis and age-related macular degeneration.
It's that promise that won Alexion and Soliris the prestigious Galen Prize for best biotechnology product of 2008, according to Gerald Weissmann, the chairman of the award committee.
"It's got enormous impact and potential, and the fact that they've developed this drug is remarkable," said Weissmann, director of the Biotechnology Study Center at New York University's School of Medicine.
But just how useful the drug will be on other conditions isn't clear yet.
The company says it will present some early data at the American Society of Hematology annual meeting in December.
And it's not clear what Alexion will come up with to follow Soliris. It's working on an antibody that could fight such cancers as chronic lymphocytic leukemia, multiple myeloma and ovarian cancer, for instance.
But success there is far from certain, and a long way off.
"Clearly, longer-term, you'd like to see a pipeline developed," McMinn said.
The company was founded in 1992 by Yale University researchers. It went public in 1996. It employs about 500 people, mostly in the U.S. and Europe.
The company sold $71.2 million worth of Soliris in the third quarter and recognized $5.3 million in revenue from shipments made in previous quarters.
That $76.5 million was all the revenue Alexion reported that quarter. A year earlier, it had just $21.8 million in Soliris sales. Some contract revenue brought total income that quarter to $22.1 million.
Earnings Report
Thursday, Alexion reported earnings per share of 29 cents, ex-items, compared with a per-share loss of 28 cents in the year-ago quarter.
Alexion also upped its guidance for the rest of the year. It now expects Soliris sales to be between $256 million and $258 million. It had previously called for sales of $235 million to $245 million.
The higher guidance factors in growing patient numbers and a weaker euro.
The company reported a loss of $1.27 per share last year. Analysts surveyed by Thomson Reuters think it could show an 8-cents-per-share profit this year and an 80-cents-per-share profit in 2009.
In February, the company settled a patent dispute over the technology behind Soliris, paying $10 million to the Oklahoma Medical Research Foundation.
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