2014年12月10日訊 /生物谷BIOON/ --輝瑞杯具了!三大仿製藥巨頭阿特維斯(Actavis)、梯瓦(Teva)、邁蘭(Mylan)集體推出Celebrex(西樂葆)仿製藥,這是上市的首批Celebrex仿製藥,規格包括50mg、100mg、200mg、400mg膠囊。Celebrex是輝瑞的第4大產品(僅次於Lyrica、Prevnar、Enbrel),在2013的全球銷售額約30億美元(包括美國市場的20億美元)。此次3大仿製藥巨頭集體推出Celebrex仿製藥,意味著輝瑞又一枚重磅產品的隕落。
目前,儘管輝瑞一直在努力加強研發管線,但似乎在每一個領域都比競爭對手晚了一步。在PCSK9抑制劑領域,業界預測,賽諾菲和合作夥伴Regeneron合作開發的alirocumab很可能成為撬開市場的首個PCSK9抑制劑,其次是安進的evolocumab,最後才是輝瑞的bococizumab。而在腫瘤免疫學領域,輝瑞更是遠遠落後於其他競爭對手,包括默沙東、百時美施貴寶、羅氏、阿斯利康。輝瑞近日接連與德國默克和比利時iTeos籤署合作,開始重金打造自己的免疫腫瘤領域資產。(相關閱讀:一個月,兩筆重大交易!輝瑞重金打造自家免疫腫瘤領域資產)
目前,輝瑞正經歷著最嚴峻的仿製藥重創,先是超級「藥王」立普妥(Lipitor)2011年底遭遇專利懸崖,之後是神奇的藍色小藥丸——偉哥(Viagra)在各國的專利陸續到期,導致市場份額迅速被仿製藥瓜分,品牌藥銷售呈斷崖式直線下跌。
業界認為,這也是為什麼輝瑞頻繁活動於資本市場偵察併購的原因之一。一些分析師表示,不能排除輝瑞重返併購阿斯利康的可能性。另有一些分析師則認為,總部位於瑞士的全球第三大仿製藥巨頭阿特維斯(Actavis)可能是輝瑞收購的備選目標,儘管阿特維斯近日才660億美元搶婚肉毒桿菌製造商艾爾健(Allergan)。
關於西樂葆(Celebrex):
Celebrex是輝瑞的鎮痛藥品牌,該藥可有效治療多種臨床常見的急性疼痛:急性創傷/組織損傷(如急性踝扭傷、急性肩腱炎、滑囊炎),慢性疼痛急性發作(如慢性腰背痛急性發作),術後疼痛;也可有效治療慢性疼痛,如骨關節炎、類風溼關節炎、強直性脊柱炎。西樂葆®作為新一代非甾體抗炎鎮痛藥,通過選擇性抑制環氧化酶-2 (COX-2)來抑制前列腺素生成,達到抗炎症、鎮痛的效果,除了具備抗炎鎮痛的顯著療效,由於它不會抑制具有胃腸道保護作用的生理酶——環氧化酶-1(COX-1),與傳統非甾體抗炎鎮痛藥相比,它大大降低了胃腸道不良反應風險。(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.