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辉瑞杯具了!三大仿制药巨头集体推出Celebrex(西乐葆)仿制药

  1. Celebrex
  2. 仿制药
  3. 西乐葆
  4. 辉瑞

来源:生物谷 2014-12-11 10:04

三大仿制药巨头集体推出Celebrex仿制药,这是继降脂神药立普妥(Lipitor)、蓝色小药丸伟哥(Viagra)之后,辉瑞遭遇的又一次重创!!

2014年12月10日讯 /生物谷BIOON/ --辉瑞杯具了!三大仿制药巨头阿特维斯(Actavis)、梯瓦(Teva)、迈兰(Mylan)集体推出Celebrex(西乐葆)仿制药,这是上市的首批Celebrex仿制药,规格包括50mg、100mg、200mg、400mg胶囊。Celebrex是辉瑞的第4大产品(仅次于Lyrica、Prevnar、Enbrel),在2013的全球销售额约30亿美元(包括美国市场的20亿美元)。此次3大仿制药巨头集体推出Celebrex仿制药,意味着辉瑞又一枚重磅产品的陨落。

目前,尽管辉瑞一直在努力加强研发管线,但似乎在每一个领域都比竞争对手晚了一步。在PCSK9抑制剂领域,业界预测,赛诺菲和合作伙伴Regeneron合作开发的alirocumab很可能成为撬开市场的首个PCSK9抑制剂,其次是安进的evolocumab,最后才是辉瑞的bococizumab。而在肿瘤免疫学领域,辉瑞更是远远落后于其他竞争对手,包括默沙东、百时美施贵宝、罗氏、阿斯利康。辉瑞近日接连与德国默克和比利时iTeos签署合作,开始重金打造自己的免疫肿瘤领域资产。(相关阅读:一个月,两笔重大交易!辉瑞重金打造自家免疫肿瘤领域资产

目前,辉瑞正经历着最严峻的仿制药重创,先是超级“药王”立普妥(Lipitor)2011年底遭遇专利悬崖,之后是神奇的蓝色小药丸——伟哥(Viagra)在各国的专利陆续到期,导致市场份额迅速被仿制药瓜分,品牌药销售呈断崖式直线下跌。

业界认为,这也是为什么辉瑞频繁活动于资本市场侦察并购的原因之一。一些分析师表示,不能排除辉瑞重返并购阿斯利康的可能性。另有一些分析师则认为,总部位于瑞士的全球第三大仿制药巨头阿特维斯(Actavis)可能是辉瑞收购的备选目标,尽管阿特维斯近日才660亿美元抢婚肉毒杆菌制造商艾尔健(Allergan)。

关于西乐葆(Celebrex):

Celebrex是辉瑞的镇痛药品牌,该药可有效治疗多种临床常见的急性疼痛:急性创伤/组织损伤(如急性踝扭伤、急性肩腱炎、滑囊炎),慢性疼痛急性发作(如慢性腰背痛急性发作),术后疼痛;也可有效治疗慢性疼痛,如骨关节炎、类风湿关节炎、强直性脊柱炎。西乐葆®作为新一代非甾体抗炎镇痛药,通过选择性抑制环氧化酶-2 (COX-2)来抑制前列腺素生成,达到抗炎症、镇痛的效果,除了具备抗炎镇痛的显著疗效,由于它不会抑制具有胃肠道保护作用的生理酶——环氧化酶-1(COX-1),与传统非甾体抗炎镇痛药相比,它大大降低了胃肠道不良反应风险。(生物谷Bioon.com)

英文原文:Another Pfizer blockbuster bites the dust as Celebrex generics roll

Look out, Pfizer--the generics are here. Both Teva and Mylan Wednesday launched versions of the company's arthritis med Celebrex, meaning Pfizer is about to watch the sales decline of yet another blockbuster.

Each of the companies is rolling out generics of the $2.56 billion U.S. seller at strengths of 50 mg, 100 mg, 200 mg, and 400 mg, they said. With generics makers usually pricing their products 30% to 80% lower than their branded counterparts, the Pfizer stalwart--its fourth-best seller--is in for a top-line slide.

Pfizer has a March court decision to thank for the impeding hit. Last March, a U.S. patent office reissued a key IP shield on the drug, extending the company's market exclusivity through the end of 2015. But a year later, a U.S. court struck that decision down, opening Celebrex up to generic rivals. Bad news for Pfizer, where Celebrex trails only Lyrica, the Prevnar franchise and Enbrel in the company's sales ranks--and Celebrex generates the vast majority of its global sales in the U.S.

The pharma giant has watched the patent cliff spell doom for a top product more than once, of course. Heavyweight Lipitor saw its sales pummeled by low-cost competition after losing protection. Though Viagra still has a lock on the U.S. market, it's facing generics overseas.

And while the company is working to whip its pipeline into shape, it's lately seemed to be late to every party: Its PCSK9 candidate is currently the furthest away from the market, for example, and it's beginning to dabble in immuno-oncology well behind peers Merck and Bristol-Myers Squibb.

That's one of the reasons the company has been scouting out deals--like the whopper of a proposed merger that AstraZeneca shot down earlier this year. Some analysts say they haven't ruled out the possibility that Pfizer comes back for another pass at its British peer, while others have listed Actavis--despite that company's own recent agreement join forces with Allergan--as a back-up target.

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