2014年11月24日讯 /生物谷BIOON/ --如果你要问近两年生物医药产业药物研发哪家强？相信99%的分析人士都会提到吉利德公司的Sovaldi。这种药物能够在仅仅数月中将90%的丙肝患者治疗痊愈，因为在上市的短短一段时间内就席卷了整个丙肝医药市场，成为了这一领域当之无愧的霸主。而Sovaldi的拥有者吉利德公司也凭此跻身一线药物研发公司，风光一时无两。
不过，众多生物医药巨头并不甘心丙肝药物市场里任凭吉利德公司一家独大。最近艾伯维公司传来消息，欧盟医药相关管理机构建议批准艾伯维公司开发的一种治疗丙肝的鸡尾酒疗法。如果这一消息属实，那么很快丙肝医药市场将迎来一种足以与Sovaldi抗衡的药物。
艾伯维公司开发的这种新药主要包括两个部分。第一部分是每日服用的Viekirax，其主要成分包括NS5A抑制剂ombitasvir和NS3/4A阻断剂paritaprevir以及ritonavir三种；第二部分是一天两次的药物Exviera，主要靶向NSB5蛋白。而这些蛋白都在丙肝病毒的传播和复制中起到了重要作用。在此前艾伯维公司披露的研究数据显示，无论丙肝患者的基因型类型，艾伯维的鸡尾酒疗法都能对患者起到显着作用。而在美国，FDA预计将于十二月中旬宣布对艾伯维这种药物的最终审核结果。这也使得艾伯维公司将在2014年末与Sovaldi和Harvoni（一种NS5A抑制剂和Sovaldi联用的疗法）短兵相接。
据分析人士预计，艾伯维的这一鸡尾酒疗法一旦上市，其销售额最高可达300亿美元。不过目前艾伯维公司尚未透露这一疗法的价格，其市场接受度如何仍属未知之数。
详细英文报道：
AbbVie ($ABBV) is one step closer to challenging Gilead Sciences' ($GILD) dominance in the hepatitis C market, securing a likely European approval for its rival combo treatment as it awaits a U.S. nod.
The European Medicines Agency has recommended approval for AbbVie's three-agent combination, which, like Gilead's competing Harvoni, uses a cocktail of antivirals to halt viral replication and cure more than 90% of hep C patients. The EMA generally approves medicines about three months after such a recommendation, putting AbbVie on track for an early 2015 launch in Europe.
Once approved, AbbVie's drug would be marketed in two parts: once-a-day Viekirax, which combines the NS5A inhibitor ombitasvir with a fixed-dose combo of paritaprevir and ritonavir that blocks NS3/4A; and twice-daily Exviera, which targets NSB5. Each targeted protein is essential to the spread of hep C, and, in pivotal trials on thousands of patients, AbbVie's multi-pill combination has eradicated the virus in patients with all genotypes without the need for painful interferon injections.
In the U.S., AbbVie expects a final FDA decision on its combination by mid December, and the company plans to mount a commercial launch by year's end. That'll put it head to head with Gilead and Harvoni, an all-oral combination of the blockbuster Sovaldi and the NS5A inhibitor ledipasvir that won stateside approval last month. Gilead's single-pill treatment picked up EU clearance just this week, putting it in line for global sales of up to $10 billion a year, analysts say.
Peak sales estimates for AbbVie's entry hover around $3 billion a year, but the prospect of a price war could well shift the balance of power. Harvoni carries a sticker price of $94,500 for a 12-week regimen, giving AbbVie the chance to chip away at Gilead's market share by undercutting that figure. The company has thus far stayed silent on price, and analysts are divided on whether the company will or should price Viekirax and Exviera at a discount.
Enanta Pharmaceuticals ($ENTA), a Massachusetts biotech, co-developed the cocktail alongside AbbVie and, under a 2006 deal between the two, is guaranteed double-digit royalties on all sales of the combo.