Diminutive Alpharma Takes a Risky Slap At Drug Titan Pfizer
A tiny generic-drug company has launched an assault on the largest pharmaceutical company in the solar system.
On Friday, pint-size Alpharma Inc. took what appears to be a huge risk by beginning to sell the first generic version of Pfizer Inc.'s blockbuster anticonvulsant drug Neurontin. A federal court in New Jersey is still weighing patent issues involving Neurontin.
If Alpharma, with a market value of about $900 million, is found to have transgressed the patents of Pfizer, which has a market capitalization of $225 billion, Alpharma would have to pay treble damages. No wonder the stock of Alpharma fell $1.10, or 6%, to $17.12 a share as of 4 p.m. Friday in New York Stock Exchange composite trading.
But Alpharma, of Fort Lee, N.J., has reasons for taking such risks. The court case that it pre-empted with its early launch has been dragging on. Moreover, another generics maker, Ivax Corp., of Miami, found a way to sidestep the courts with a near-copy of Neurontin -- and already has captured some 20% of the market. Neurontin, generically known as gabapentin, is widely prescribed for a range of psychiatric and pain conditions. It had $2.2 billion in U.S. sales last year. Pfizer will soon launch a successor to Neurontin called Lyrica that will add to the competition. Finally, Alpharma has a muscular ally in its launch -- generic-drug giant Teva Pharmaceutical Industries Ltd. -- which has indemnified it from some of the court penalties should its gamble fail.
An Alpharma spokeswoman declined to comment on the reasons behind the launch.
Also on Friday, New York-based Pfizer was rejected when it asked the court in an emergency hearing to block Alpharma from launching its generic version. A few hours later, Pfizer said it would release its own version of Neurontin through its rarely used generic subsidiary called Greenstone.
Pfizer's release of its own generic is an example of the newest tactic wielded by big branded-drug companies to put pressure on the generic-drug industry. Until recently, the stocks of the generic-drug makers have performed far better than the big drug makers' shares. In the past five years, shares of two of the biggest generics companies, Teva, of Israel, and Mylan Laboratories Inc., of Pittsburgh, have gone up roughly fourfold and more than doubled, respectively. Shares of branded-drug giants Pfizer and Merck have declined a bit during the same period. As concerns over health-care costs mount, generic-drug use has increased with encouragement from insurance companies and government payers such as Medicare and Medicaid.
This year, though, generic-drug stocks have taken a pounding. Wholesalers and retail-drugstore chains, the generics' big customers, have been driving harder bargains. But the biggest cloud over the industry is the trend toward so-called authorized generics.
Here is how the authorized-generics defense works: When a branded drug is about to face a new copycat drug from one generics company, the big pharmaceutical company allows another generics company, or in some cases its own generic-drug subsidiary, to sell an "authorized copy" of the drug.
Why is this a problem? Normally, by law, the generics maker that first challenged a patent on a branded drug would be granted six months of exclusive sales of its copy. The six month period of exclusivity is a key source of profits for generics; prices plunge after six months as several players start selling the drug.
But the authorized copies are allowed to be sold immediately, skirting the six-month restriction on copies. So the authorized copies immediately cut into the rival generic makers' sales. Recent examples include a deal between generics maker Par Pharmaceutical Inc., a unit of Pharmaceutical Resources Inc., and Bristol-Myers Squibb Co. for the diabetes drug Glucophage XR, which had sales of $450 million last year.
Authorized generics have a negative effect on price. When two generics hit the market at the same time, companies have to jostle for market share, which often causes prices to fall. The first generic to market typically only discounts 20% to 30% off the branded price, but another entrant could push that to 40% to 50% off. Analysts and executives fret that the branded companies will start to slash the prices of the authorized generics and ruin the profitability of the market. On Neurontin, "we just don't know how Pfizer will act on price," says Rich Silver, an analyst from Lehman Brothers who doesn't personally own any shares in Pfizer, Alpharma or Teva. "Will they be rational?"
Some branded-drug companies are even bringing back their atrophied generics subsidiaries to put out their own authorized versions. In August, Schering-Plough Corp. put out an authorized generic of its hepatitis drug Rebetol through its Warrick division and gutted the market by coming in at a lower price than expected. "This action...made a potential windfall situation for generic firms into a nonevent," wrote Albert Rauch, an analyst with A.G. Edwards & Sons, in an Aug. 11 research note.
Alpharma isn't the first generic-drug company to make an "at-risk launch." Increasingly, generics companies will start selling a generic copy of a drug after they have won a patent challenge against the branded drug in a lower district court but before an appeal has been decided.
But Alpharma's aggressive move Friday "is a different kind of at-risk launch," Lehman's Mr. Silver says, because no court has actually ruled yet on the patent fight. Mr. Silver doesn't think Alpharma is going out too far on a limb, because no generic maker has ever actually paid damages for launching early.
Moreover, Alpharma's action forced Pfizer to launch its own authorized generic, putting the drug giant in an awkward position in the pending patent litigation: How is Pfizer going to argue to the court that it would be irreparably harmed by a generic if it was putting one out itself?
Alpharma has its risk significantly hedged by the big gun of the generics business, Teva. Although specifics haven't been disclosed, the two generics makers in April reached a deal under which Teva would share the six-month period of exclusive sales that Alpharma gets for being the first generic to market. In exchange, Teva would pay Alpharma certain fees and somehow indemnify Alpharma if it lost the patent case and had to pay damages. As one of the biggest and most profitable of the generics companies, Teva presumably has deep enough pockets to take such a risk. Under the terms of the agreement, Teva on Friday also launched its version of Neurontin.
Rodney Hathaway, portfolio manager of the Heartland Value Plus Fund, doesn't see authorized generics as a big problem. "There is no way the branded companies are going to put the generics out of business with these pre-emptive attacks," he says. Mr. Hathaway's fund holds 350,000 shares of Alpharma, about 1.7% of the fund's assets. He spent the last year buying Alpharma while others worried about manufacturing and pipeline problems. He isn't adding Alpharma now because it is at the fund's limit for the size of its holdings. But he thinks Alpharma and Par Pharmaceuticals are cheap enough to buy.
Alpharma isn't a likely takeover candidate, because some insiders hold shares with extra voting rights. But for the generics industry, a period of consolidation could be on the way.
"Consolidation has been going on, and I expect it to continue," Mr. Hathaway says.
无名之辈Alpharma挑战辉瑞
一家名不见经传的仿制药制药商居然向全球最大的制药公司辉瑞(Pfizer Inc.)发起了挑战。
上周五，小型制药商Alpharma Inc开始销售全球第一款含有辉瑞拳头产品──抗痉挛药Neurontin成分的仿制药。由于同Neurontin有关的专利权问题仍在新泽西州联邦法院的审议之中，Alpharma的这个举动似乎蕴含著巨大的风险。
如果法院判决Alpharma侵犯了辉瑞的专利权，Alpharma将向后者支付3倍的赔偿金。二者的市值简直有天壤之别，Alpharma仅有9亿美元，而辉瑞的市值则高达2,250亿美元。从这一点来看，Alpharma上周五收盘下跌1.10美元至17.12美元，以6%的跌幅报收的结局并不令人感到惊讶。
但Alpharma敢向强大的辉瑞发起挑战自有它的理由。首先，该公司提前推出仿制药为其赢得了先机，而法庭何时能就上述专利权作出判决依然遥遥无期。而且，在推出Neurontin的仿制药方面早有先例：迈阿密的另一家仿制药制造商Ivax Corp.已经推出了和Neurontin几乎一模一样的一种仿制药并占据了20%左右的市场，而且它还找到了一条规避法院审查的途径。Neurontin是一种广泛用于治疗精神和疼痛症状的处方药，去年在美国市场上的销售额达到22亿美元。辉瑞不久便会推出名为“Lyrica”的新一代Neurontin，相信这块市场的竞争会更加激烈。最后，Alpharma身后还有一个实力雄厚的后台──仿制药巨头Teva Pharmaceutical Industries Ltd.。一旦输掉官司，那么Teva将向Alpharma施以援手。
Alpharma的发言人拒绝对推出Neurontin仿制药的理由发表评论。
上周五，辉瑞要求召开紧急听证会以阻止Alpharma推出其仿制药产品的请求被法院驳回。在遭遇这一挫折数小时之后，辉瑞便罕见地宣布准备通过其仿制药子公司Greenstone将Neurontin推向市场。
辉瑞推出自己的仿制药产品是大型原研制药厂商最近所惯用的一个伎俩。他们通过这种手段来向仿制药制造商施加压力。仿制药制造商的股价走势一直远远好于原研制药厂商，这种局面直到最近才有所改变。过去5年来，最大的两家仿制药公司以色列的Teva和匹兹堡的Mylan Laboratories Inc.的涨幅分别比原研制药厂商的走势强出近3倍和1倍多，而同期辉瑞和默克(Merck)却是在小幅下跌。这是因为由于人们对医疗保健成本的忧虑加重，以及保险公司和美国老年保健医疗制度(Medicare)、联邦医疗保险计划(Medicaid)等政府医疗保险计划的鼓励，人们已更普遍地使用仿制药。
不过，仿制药类股今年的走势遭到重创，原因是仿制药制造商的大客户──批发商和零售连锁药店加大了讨价还价的力度。但最大的冲击还在于原研制药生产商为了应对仿制药层出不穷的局面祭出了“授权仿制药”这个法宝。
一旦原研制药生产商认为仿制药公司即将推出一种仿制药会对其构成威胁时，大型制药公司便会授权另一家仿制药公司、有时候是通过旗下仿制药子公司销售得到授权的仿制药。
这其中有何奥妙呢？通常，根据法律，首先挑战原研制药专利的仿制药生产商会获得6个月的仿制药独家销售权。6个月的独家销售权是仿制药获利的关键；在6个月后随著多家公司开始销售这种药物，价格就会下跌。
但授权仿制药允许立刻销售，而不受6个月的仿制药限制期的约束。因此，授权仿制药可以立刻降低仿制药竞争对手的销售额。比如，最近Pharmaceutical Resources Inc.旗下的仿制药生产商Par Pharmaceutical Inc.与百时美施贵宝公司(Bristol-Myers Squibb Co., BMY, 又名:必治妥施贵宝)之间关于糖尿病药物Glucophage XR的交易就是这样。Glucophage XR去年的销售额为4.5亿美元。
授权仿制药会给价格带来负面影响。当两种仿制药同时上市时，它们会争夺市场占有率，这常常会带来价格下跌。第一种面市的仿制药通常仅会比原研制药便宜20%-30%，但后来者则会低出40%-50%。分析师及业内人士担心，原研制药公司将开始降低授权仿制药的价格，以降低仿制药市场的赢利能力。雷曼兄弟(Lehman Brothers)的分析师西尔弗(Rich Silver)说：“就Neurontin而言，我们不清楚辉瑞会对价格作出何种反应，他们是否会保持理性。”他本人不持有辉瑞、Alpharma或Teva的股票。
部分原研制药公司甚至通过自己的仿制药子公司推出本公司的授权仿制药。8月份时，先灵葆雅公司(Schering-Plough, Corp., SGP)通过旗下Warrick部门推出了肝炎治疗药物Rebetol的授权仿制药，价格也低于市场预期。A.G. Edwards & Sons的分析师劳赫(Albert Rauch)在8月11日的研究报告中称，这种做法使得仿制药公司一无所得。
Alpharma并不是首家刀口舐血的公司。越来越多的仿制药公司在级别较低的地区法院批准生产某种仿制药之后就开始推出其产品，而此时原研制药公司对这一裁决正在提起上诉。
但雷曼兄弟的西尔弗说，Alpharma上周五的积极举措是一种不同类型的刀口舐血，因为实际上还没有哪家法院对围绕Neurontin的专利纠纷作出过裁决。西尔弗认为Alpharma此举并非冒进，因为此前尚没有仿制药生产商因提前将产品推向市场而付出过代价。
而且，Alpharma的做法迫使辉瑞推出自己的授权仿制药，使得该公司在即将进行的专利诉讼中处于尴尬境地：如果辉瑞也推出自己的仿制药，那它又怎么解释它本身受到的伤害呢？
另一家仿制药生产商Teva很大程度上分担了Alpharma的风险。尽管详细情况尚未披露，但4月两家仿制药生产商达成协议，对于Alpharma推向市场的第一种仿制药，Teva将享有6个月的独家销售权。作为交换，Teva将向Alpharma支付一定费用，并在专利纠纷败诉的情况下补偿Alpharma部分费用，以助其赔偿损失。作为最大，利润额最高的仿制药公司之一，Teva有足够的能力承担这一风险。根据协议条款，Teva上周五也推出了自己的Neurontin。
Heartland Value Plus基金的投资组合经理哈撒维(Rodney Hathaway)认为授权仿制药并不是什么大问题。他说，原研制药公司不会通过这种先发制人的做法让仿制药消失。哈撒维的基金持有35万股Alpharma股票，约占该基金总资产的1.7%。他在去年其他人还担忧Alpharma的生产和新产品永续规划时就买进了该股。哈撒维最近没有增持Alpharma，因为对它的持股已经达到该基金规定的上限。但他认为Alpharma和Par Pharmaceuticals价格仍很低，可以买进。
Alpharma不太可能成为收购目标，因为部分内部人士持有具有额外投票权的股份。但对仿制药行业来说，整合期可能已经开始。
哈撒维说：“整合已经开始，我预计还会持续。”
