8/18 05:35 EST
当大型医药公司孜孜不倦寻找上亿美元的医药业务以确保业绩增长率时，The Medicines Co(代號:MDCO) 却能够取得理想的市场成绩，每年2-3亿美元的销售额着实令人满意。公司总裁Clive Meanwell表示：“不到10亿美元的产品通常会被大型医药公司拒绝的。”但是抗血凝剂Angiomax今年的销售额将上涨至3亿美元，这又为公司赢得了一次业绩春。近期由FDA批准的Cleviprex主要使用于急性高血压外科手术，也将迎来2亿美元的年销售额。这对于这家位于新泽西州的医药开发公司来说是绰绰有余了。
Cleviprex的获批加上Angiomax取得的一系列利好业绩令The Medicines Co业绩锦上添花。公司在六月季度的营收增长了54%至8670万美元，每股收益为0.08美元。08年上半年的营收增长了35%至1.66亿美元。公司的股价为今年市场低迷注入了一丝活力，由19美元升至23美元。几乎所有的销售额都来自Angiomax抗血栓药品，08年上半年销售额升至1.61亿美元，同比为1.21亿美元。Angiomax销售额的增长主要来自今年两度价格上调。总裁表示明年还将有进一步上调价格的可能性。
08年全年的Angiomax销售额预测为3.2-3.3亿美元。他表示Angiomax的提价仍然是能够为住院病人所接受的。Angiomax是由剑桥大学和Biogen(代號:BIIB)联合研发的。但是FDA一季度对于Angiomax的反响平平，而Biogen也不愿意进行生产。因此The Medicines Co就“肥水不流外人田”地获得了生产此项药品的机会。“FDA对此表示十分理解，Angiomax在治疗血栓方面的功效是毫无疑问的。”
随着Angiomax上市大获全胜之后，公司再度乘胜追击推出了Cleviprex，也获得了大卖，目前公司在着手组建危重病医学基地并开发一系列新药， niche就是其中一支，这种抗血凝剂药品如今已经获得高级认证。但是仍然存在的疑云是，Angiomax专利保护将在2010年到期，但是公司在专利保护延期方面行动落后了，而现存法律是不允许专利保护延期的。目前公司正在游说政府以授权专利保护延期，虽然白宫已经通过了，但是参议院方面仍然存在阻碍。一项分析师怀疑一旦专利保护延期失败，将对公司业绩有不利影响。
同时，随着两大主要市场竞争对手分别大幅降价，公司的Angiomax销售额将下降60-70% 。公司总裁显然对于专利保护申请失败造成的亏损十分不满，并再度游说华盛顿政府以获得支持，但他也接受专利保护截止日期的扩展。“一旦成交，我们将接受。我们的核心消费能力将在2010年专利权到期后面临危机。因此我们将寄以最好的期望，做最坏的打算。”
如果失去了专利保护，公司应该如何找到接替产品呢？总裁表示公司将拓展欧洲市场。他预计新型Cleviprex最终将获得2亿美元的年度销售额，并在 2010年获得FDA批准。分析师预警公司在很大程度上依赖于政府的帮衬，一旦专利保护到期，两大竞争对手将蚕食掉60-70%的销售额；一旦有更多的竞争对手加入分蛋糕的行列，有85-90%的销售额将为他人所享用。
Investor's Business Daily
Drug Company Comes In A Day Late, But Not A Dollar Short
Friday August 15, 6:12 pm ET
Norm Alster Big Pharma looks for billion-dollar drugs to keep growing at rates that please Wall Street.
But Clive Meanwell, president of The Medicines Co. (NasdaqGS:MDCO - News), is content with more modest market success. A nice $200- to $300-million-a-year seller will do.
"Products that won't turn over $1 billion dollars have largely been rejected by Big Pharma," Meanwell said. But he has been able to ride the success of the anticoagulant Angiomax, which will do upward of $300 million in sales this year.
Waiting in the wings is Cleviprex, recently approved by the FDA for acute high blood pressure, often a problem with surgical patients. Cleviprex should prove to be a $200- million-a-year drug in the U.S., Meanwell says.
That's enough for the New Jersey-based The Medicines Co., which licensed the AstraZeneca-developed drug. "Astra Zeneca didn't believe the drug would be a multibillion-dollar product," Meanwell said.
Though the firm is often labeled a biotech, both drugs are made by "conventional chemistry," Meanwell notes.
FDA Approval
The approval of Cleviprex, along with the growing success of Angiomax, has been a winning parlay for The Medicines Co. In its June quarter, the company grew revenue by 54% to $86.7 million. GAAP earnings per share came in at 8 cents, up from just two cents a year before. For the first six months of 2008, revenue grew by 35% to $166 million. Shares of The Medicines Co. have bucked the market downturn this year, rising from just over $19 to a recent price above $23.
Nearly all of its sales derive from Angiomax, used to stop clotting during cardiac surgery. The drug is an alternative to heparin. In the first six months of 2008, Angiomax sales jumped to over $161 million. That's a healthy bump from $121 million in the first half of 2007. Much of the growth came from two price hikes.
Meanwell says there is a good chance of a further price hike in the next year. For all of 2008, the firm expects Angiomax sales of $320 million-$330 million. He believes the drug offers enough value to hospital customers to command price hikes.
Angiomax was developed by Cambridge, Mass-based Biogen (NasdaqGS:BIIB - News). But the FDA was at first cool to the drug. And Biogen thought it would be costly to produce. Meanwell convinced Biogen to license the drug to The Medicines Co.
He also set about trimming production costs and cajoling the FDA. The FDA withheld approval because Angiomax was no more effective than heparin in trials. Meanwell convinced the FDA the new drug had fewer side effects, such as bleeding.
"The FDA was quite receptive" to that pitch, Meanwell said. "It's very much the safer alternative to heparin" agreed Jason Kantor, an analyst with RBC Capital.
With Angiomax winning market acceptance and Cleviprex on deck, The Medicines Co. is building a niche in critical care medicine. Meanwell hopes to expand on that niche with new drugs. Cangrelor, for example, is an anticoagulant now in advanced trials.
But there are clouds on the horizon. Angiomax patent protection is due to expire in late 2010. Angiomax might have had over four more years of generic-proof life but for a tardy FDA filing.
The company was one day late in filing for an extension. Under existing law, the extension was denied. The company has been lobbying Washington to allow the Patent Office freedom to grant the extension. The House has passed such a provision, but the Senate has not.
Some analysts doubt that it will pass this session. "On balance, the world remains skeptical this will happen," said analyst Kantor.
"Right now, there are low odds they'd be successful," said Biren Amin, a senior analyst with Stanford Group.
The Medicines Co. could face competition from generics very swiftly if the patent expires at the end of 2010, says Amin. He believes at least two generic makers have plans to enter the market. The impact of generics would be dramatic. With two new rivals slashing prices, Angiomax could suffer "60% to 70% sales erosion," Amin said.
Meanwell is clearly frustrated by the loss of years of patent protection for a one-day filing mistake. That's akin to losing your house for sending in a mortgage payment one day late, he reasons.
Meanwell has lobbied to win political support for a Washington fix. He would accept a compromise that upholds the sanctity of deadlines, but eases the penalty. Asked if he would be willing to accept a loss of one year in patent protection, he replied: "If that was the deal, I would take it."
But he's not counting on any breaks. "Our core assumption is the patent will expire in late 2010," he said. He summed up his approach: "Let's plan for the worst and hope for the best."
European Expansion
But how will the company replace the hundreds of millions in sales it stands to lose to generics? Meanwell suggests the company can make up the slack if needed.
He has built up marketing in Europe. In time, he predicts, Angiomax can do $100 million in European revenue. He also expects newly approved Cleviprex eventually will be a $200- million-a-year drug. He hopes that Cangrelor will win FDA approval by 2010.
Much of the stock's relative strength this year derives from hope that Washington will approve a fix to the patent issue, Amin says.
"The stock has moved on legislative speculation," he said. Amin believes there is risk in the stock. Should the company fail to get legislative relief, generics would shred Angiomax sales.
Two generic rivals would eat up "60% to 70%" of sales. But if there are five or more generic rivals, "it could be 85%-90% sales erosion," he warned.
So Meanwell continues to scout for new midsize drug prospects scorned by Big Pharma.
"We have a staff of eight looking for new products," he said.
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