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丙肝领域,Achillion能否撼动吉利德霸主地位?

  1. Achillion
  2. 丙肝
  3. 吉利德
  4. 鸡尾酒

来源:生物谷 2015-04-03 15:29

Achillion开发的丙肝鸡尾酒8周和6周疗程均实现100%治愈率,正在开发4周疗程。

2015年4月3日讯 /生物谷BIOON/ --目前,生物技术巨头吉利德(Gilead)已奠定了自身在丙肝治疗领域的统治地位,这得益于该公司成功商业化推出的丙肝明星药物Sovaldi及新一代全口服丙肝鸡尾酒Harvoni,这2个药物在2014年带来了124亿美元的销售额,使其成功实现“鲤鱼跳龙门”跻身《2014年全球制药巨头收入排行Top15》榜单前10。然而,有分析师表示,吉利德的统治地位不会立刻面临威胁,然而该公司仍需要保持警觉。

最近,有传言称,吉利德在丙肝市场的份额可能会受到新的竞争对手Achillion制药公司的冲击。Achillion是美国的一家小型生物技术公司,目前也正在开发一种丙肝治疗药物,其优势在于能够以更短的治疗疗程治愈丙肝。据估计,目前全球丙肝感染者已达1.5亿人,患者群体如此庞大也难怪所有制药公司均想涉足。而吉利德可能面临的挑战还不仅仅来自Achillion,美国制药巨头默沙东(Merck & Co)也在开发另一种全口服丙肝鸡尾酒疗法。

据了解,Achillion公司在临床上推进最快的是丙肝药物ACH-3102,目前正处于II期临床。根据已发布的数据,ACH-3102/Sovaldi组合疗法8周和6周疗程,均实现了100%的治愈率,目前正在调查4周疗程的疗效。如果成功,ACH-3102/Sovaldi组合疗法将成为丙肝治疗领域疗程最短的全口服鸡尾酒。

此外,Achillion也正在尝试调查ACH-3102与其他丙肝药物的组合疗法,包括其内部在研的ACH-3422。业界目前正拭目以待Achillion能否带来同样强劲的疗效数据,以及如果成功,是否会对吉利德的霸主地位构成严重威胁。

不过,业界认为,Achillion可能需要数年的时间才能将其丙肝药物推向市场,同时也存在根本无法上市的可能性。因为Achillion开展的相关临床试验中,患者仅十多个。而根据大多数专家的意见,这些研究患者数量太少,还不足以得出药物疗效的结论。同时,还没有数据证明ACH-3422/ACH-3102组合能带来ACH-3102/Sovaldi组合的强劲疗效。有分析认为,Achillion意图超越吉利德的野心也很可能挫败,因为吉利德也正在开发一款疗程更短的丙肝药物GS5816/Sovaldi,该药预计将在2016年登陆市场。

近日,巴克莱(Barclay)分析师就在一份报告中指出,Achillion在丙肝市场实现有意义的差异化的机会很少。换句话说,巴克莱认为,Achillion的投资者在作一个危险的赌注。不过,投资者可不这么认为,在过去的12个月里,受投资者追捧Achillion公司的股价已上涨214.7%。(生物谷Bioon.com)

英文原文:Does Gilead Sciences, Inc. Face Imminent Threat From Achillion Pharmaceuticals, Inc.?

Gilead’s dominance in the hepatitis C market may not be in any immediate danger. The company, nonetheless, will need to be on its toes when it comes to thwarting competition in the hepatitis C space

Gilead Sciences, Inc. (NASDAQ:GILD) has established itself as a leader in the hepatitis C market, thanks to the successful launch of its hepatitis C drug Sovaldi, which can be used to treat different genotypes of the virus. Sovaldi’s launch was later followed by a newer, more advanced version of the drug named Harvoni.

The company raked in sales of $12.4 billion last year; however, there is speculation that Gilead's revenue share in the hepatitis C market may be threatened by a relatively new entrant in the market by the name of Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN). It is a small biotech company that is also working on a hepatitis C drug, which could reduce the time taken for patients to recover from the disease.

Hepatitis C impacts over 150 million people across the world, and because of the sheer size of the patient population and the fact that this disease can cause fatality in patients, it is no surprise that a cure for this disease is something that all drug-makers want to lay their hands on. Gilead may face competition not only from Achillion, but also from companies such as Merck & Co., Inc. (NYSE:MRK), which is also working on its own version of a hepatitis C drug.

Achillion's most advanced hepatitis C drug is ACH-3102, which is currently undergoing Phase II trials. The company reported last year that it was able to see a 100% cure rate in the patients who took the pill in combination with Sovaldi, in a matter of eight weeks. The drug-maker reported past February that Sovaldi and ACH-3102 combination cured 100% of patients upon six weeks of therapy. The company is now studying the effectiveness of the drug when it is taken for four weeks. The trial, if successful, would mean that the company's drug could be the shortest treatment plan to cure hepatitis C in patients.

Moreover, Achillion is also trying to test the efficacy of ACH-3102 when used with potential alternatives for Sovaldi, including an in-house option by the name of ACH-3422. Investors will certainly have to wait it out to see whether Achillion is able to deliver the same results, and, if so, whether it will pose a serious threat to Gilead's dominance.

However, it could take years for Achillion to launch a therapy into the market. There is also the possibility of the drug never reaching the marketing stage as up until now, the company has only run trials involving a dozen patients. As per most experts, the number is too small for a conclusion on the drug's efficacy. There's also little data proving that ACH-3422 could yield results as potent as the ACH-3102 and Sovaldi combination. Furthermore, Achillion’s efforts to beat Gilead may be thwarted by the fact that Gilead is also developing cutting-edge follow-up hepatitis C therapies. The company is expected to launch a new drug for hepatitis C, one that will utilize GS5816 alongside sofosbuvir by 2016.

Barclays' analysts wrote in a report on March 5, 2015 that they see little opportunity for Achillion to meaningfully differentiate itself in the hepatitis C market. In other words, Barclays views investment in Achillion as a risky bet. The company, nonetheless, has seen its stock price increase 214.7% in the past 12 months. The stock price gains, however, have been in the negative so far this year, with Achillion losing 18.5% of its value to now be worth $10.01 apiece.

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