2014年11月26日讯 /生物谷BIOON/ --最新的处方数据表明，吉利德丙肝鸡尾酒Harvoni深受市场欢迎，而该药近日又赢得欧盟批准，有望进一步增加吉利德的整体收入。
吉利德丙肝资产近日获得了一些好消息，丙肝鸡尾酒Harvoni于上周末获得欧盟批准。此前，Harvoni已于今年10月初获FDA批准，随后吉利德在美国强势推出Harvoni，根据最新的美国处方数据，Harvoni销量将超过季度预期，同时将打破丙肝明星药Sovaldi创下的纪录。
今年9月，欧洲药品管理局（EMA）人用医药产品委员会（CHMP）发布积极意见，建议批准Harvoni。通常情况下，CHMP发布积极意见后，EMA会在3个月内做出审查决定。然而，Harvoni却早于预期获得批准，这无疑将进一步推升该药在美国已经很高的销量。上周末，EMA发布批准消息后，吉利德股价上涨近4%。Harvoni的获批，也将有助于保持吉利德在快速发展的丙肝领域中的统治地位。
Harvoni将超过Sovaldi
Harvoni预计将超过丙肝明星药Sovaldi的创记录表现，这反映在2014财年第三季度Sovaldi销售季度环比下降20%。然而，吉利德其实也没有什么可担忧的，该公司只会从Harvoni上市中获益，尽管该药将与Sovaldi自相残杀。据彭博社数据，Harvoni上市第一周的处方量达503例，是Sovaldi上市第一周处方量248例的2倍还多。
此外，Harvoni上市第5周的处方量达到3606例，其中3004例为新写处方（New Written Prescriptions，NWP），处方量每周环比增长37%。花旗集团（Citigroup）预计，根据上周1.02亿美元的销售额，Harvoni的年销售额将达到53亿美元。对于第四季度，业界的共识是14亿美元销售额，花旗集团预期为19亿美元。
治疗周期缩短——容量游戏
击败Sovaldi及其他竞争药物，对于Harvoni而言将是一个容量游戏。Sovaldi售价1000美元一片，通常治疗周期为12周，该药通常处方联合干扰素，12周治疗成本为94500美元。
然而，由于Harvoni更有效，对于最常见的基因型1丙肝患者（约占丙肝病例的45%），该药仅需治疗8周。因此，8周的治疗周期意味着成本将低至63000美元，比任何其他竞争对手的药物治疗成本要低，如强生Olysio，该药与Sovaldi的联合治疗成本为130000美元。因此，尽管Harvoni价格便宜对患者更实惠，但这一优势也将为吉利德带来更大的目标市场。
收入依赖——价格威胁
吉利德丙肝药物销售占该公司总销售额高达83%，使投资者开始关注吉利德对丙肝专营权的高度依赖性。Sovaldi自2013年一上市便改变了丙肝市场格局，使得其他制药商很难与吉利德竞争，尽管Sovaldi价格高昂。
艾伯维（AbbVie）正在开发的丙肝鸡尾酒（ABT-450/利托那韦/ombitasvir/dasabuvir）预计将于本季度获批，该药将与Harvoni类似，治疗周期为12周。业界预测，如果艾伯维鸡尾酒定价较低，将会比Harvoni有优势。如果2者同等疗效，一直以来背负Sovaldi高额账单的患者和医疗服务提供商很可能转向更便宜的治疗药物。
就目前而言，卖方分析师仍然对吉利德保持乐观。花旗集团和FBR资本近日重申立场，对吉利德看好。
英文原文：Gilead Sciences Harvoni Has A Better-Than-Expected Launch
Latest prescription data for Harvoni shows that the hepatitis C drug has been well-received by the market. The recent European approval of the drug is expected to further add to the company‘s overall revenue
Gilead Sciences, Inc. (NASDAQ:GILD) got some good news for its hepatitis C portfolio last week when the European Commission gave the green light to its latest single-regimen hepatitis C tablet, Harvoni. The drug, which was approved in the US October 10, has had a strong launch, with US prescription data indicating that Harvoni sales will surpass expectations for the quarter as well as break the drug’s predecessor Sovaldi’s records.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for Harvoni in late September. It typically takes three months after CHMP’s opinion for the Commission to make a decision regarding a drug. However, in Harvoni’s case, the approval came in earlier than expected, which will only add to the already high sales of the drug from the US.
Gilead stock rose nearly 4% November 18 after the EMA approval. Harvoni is an extremely positive development for Gilead and will help the biotech guard its dominant position in the fast-evolving hepatitis C space.
However, the company saw its shares drop Thursday on the back of rumors that Carl Icahn had accumulated a sizeable stake in the company. This had shareholders worried that the activist investor might soon launch an agenda, asking the company to look into further acquisitions. In any case, Mr. Icahn’s interest in the company does reflect significant potential, mainly based on the company’s Harvoni and Sovaldi franchise.
Harvoni is expected to overshadow blockbuster Sovaldi’s performance, as was reflected in the 20% quarter-over-quarter decline in Sovaldi’s third-quarter FY14 sales. However, Gilead doesn’t have much to worry about as it only stands to benefit from Harvoni’s launch even after the cannibalization. According to data from Bloomberg, Harvoni’s prescriptions in the first week were recorded at 503. This was more than double the first-week number for Sovaldi at 248 prescriptions.
Moreover, for the fifth week of Harvoni’s launch, prescriptions were tracked at 3,606; of these, 3,004 were New Written Prescriptions (NWP). This reflects week-over-week growth in prescriptions of 37%. Citigroup Inc (NYSE:C) forecasts annual revenue for the drug to come in at $5.3 billion, based on $102 million sales last week. For the fourth quarter, Harvoni sales consensus stands at $1.4 billion, while Citigroup expects $1.9 billion.
Shorter Duration – Volume Game
Beating sales of Sovaldi and other competitor drugs will be a volume game for Harvoni. Sovaldi is priced at $1,000 per pill and is generally administered for a period of 12 weeks. It is generally prescribed with another interferon, taking the price up to $94,000. Harvoni has been priced higher at $1,125 per pill, and the cost for a 12-week treatment comes in at $94,500.
However, as Harvoni is more effective, it only has to be administered for eight weeks to patients with genotype 1 of the virus. Genotype 1 is the most common virus, estimated to make up over 45% of the cases. Hence, an eight-week treatment means that the cost comes down to $63,000, lower than that of any other rival drugs such as Johnson & Johnson’s (NYSE:JNJ) Olysio, which costs $130,000 for a combo treatment with Sovaldi. So while Harvoni is cheap and more affordable for patients, it also translates into a bigger target market for Gilead.
Revenue Dependency – Price Threat
Investors may have reacted negatively to rumors of Mr. Icahn acquiring a stake in the company, but it does direct attention to Gilead’s high dependence on its hepatitis C franchise, which makes up 83% of the company’s total sales. When Sovaldi was launched in 2013, it changed the dynamics of the hepatitis C market, making it difficult for other pharmaceuticals to compete with Gilead despite the drug’s high price tag.
AbbVie Inc (NYSE:ABBV) is working on a hepatitis C combo regimen (ABT-450, ritonavir, ombitasvir, and dasabuvir), which will be similar to Harvoni and will be an all-oral treatment spanning over 12 weeks. AbbVie’s treatment, which expects approval this quarter, could have an advantage over Harvoni if it is priced lower. Patients and healthcare providers, who have been burdened with high bills from Sovaldi, would most likely be willing to switch to a cheaper treatment if it is equally effective. Express Scripts Holding Company (NASDAQ:ESRX) is reported to have said that it will favor the new drug if it has similar efficacy as Sovaldi with a lower price tag.
For now, sell-side analysts remain optimistic about Gilead. Citigroup and FBR Capital recently reiterated their bullish stance on the company. Of the 32 analysts following the stock, 27 have rated it a Buy, while five have suggested a Hold. The 12-month price target on the stock is $124, compared to Friday’s closing price of $100.58.