據(jù)輝瑞公司方面消息，公司即將向FDA提交關(guān)于其開發(fā)的乳腺癌藥物palbociclib。這也標(biāo)志著輝瑞在收購阿斯利康公司失敗之后，開始嘗試建立自己的腫瘤研發(fā)部門。公司預(yù)期這一藥物將在今年4月13日之前獲得FDA的最終批準(zhǔn)，同時FDA也已經(jīng)表示不需要輝瑞等候FDA下屬的專家委員會建議通過。這一決定暗示palbociclib最終獲得通過的可能性相當(dāng)之高。
時間回到2014年八月份，輝瑞公司在向FDA提交關(guān)于palbociclib的臨床二期研究數(shù)據(jù)后，獲得了FDA的高度評價。所有這些消息都促成了輝瑞公司對palbociclib上市前景的巨大信心。分析人士預(yù)計，palbociclib一旦獲得批準(zhǔn)，其每年銷售額最高可達(dá)到30億-50億美元之多。
事實(shí)上，輝瑞公司此前花費(fèi)超過1千億美元的價格收購阿斯利康的重要原因之一就是希望借此組建自己的腫瘤免疫療法研發(fā)部門。不過，現(xiàn)在來看，沒有阿斯利康的幫助，輝瑞公司仍然朝著預(yù)定目標(biāo)在不斷前進(jìn)。公司先后與默克等公司建立了合作研發(fā)協(xié)議，以試圖在這一領(lǐng)域遙遙領(lǐng)先的諾華、默沙東等醫(yī)藥巨頭?？梢韵胍?，2015年的腫瘤免疫療法市場上，又將出現(xiàn)一場場龍爭虎斗。
詳細(xì)英文報道：
Pfizer ($PFE) appears to be speeding toward a crucial early FDA approval for palbociclib, a breast cancer treatment with blockbuster potential, pivoting from its failed bid for AstraZeneca ($AZN) and building up an oncology pipeline of its own.
The company is expecting to get final word on the drug by April 13,revealing today that the FDA isn't going to require it to go through a panel of agency advisers in the meantime. That makes approval look all the more likely to a few analysts, good news for a treatment that has thus far had a charmed trip through the regulatory process. Pfizer submitted a palbociclib application with only Phase II data back in August, quickly winning the FDA's priority review designation and lining it up for an early approval.
Skipping the advisory panel process, in which independent experts vote whether to recommend approval, could be a sign the agency has already made up its mind, Evercore ISI analyst Mark Schoenebaum wrote in a note to investors. And while the agency could well reject palbociclib anyhow, Schoenebaum believes the news a net positive for Pfizer. Leerink's Seamus Fernandez, who sees this development as a likely prelude to a regulatory OK, figures the drug could be worth between $3 billion and $5 billion a year at its peak.
Approval for palbociclib, which Pfizer plans to market as Ibrance, would help set the stage for what the company hopes will be a bright future in cancer treatments. Pfizer has apparently moved on from last year's pursuit of AstraZeneca, a $118 billion gambit driven largely by the allure of the latter company's immuno-oncology pipeline. In the ensuing months, Pfizer struck a slew of deals to cobble together some promising new assets that could help it catch up with immuno-oncology titans Bristol-Myers Squibb ($BMY), Merck ($MRK) and Roche ($RHHBY) without the need for a big buyout.
Headlining Pfizer's swing into immuno-oncology is a deal with Germany's Merck KGaA, signed in November, under which the U.S. drugmaker will pay $850 million up front and as much as $2 billion more in order to collaborate on up to 20 new cancer immunotherapies. Pfizer also struck a smaller deal with biotech iTeos Therapeutics, handing over a $30 million down payment to get its hands on preclinical drugs that target IDO1 and TDO2, cancer-expressed enzymes that break down tryptophan, which is integral to the immune system's ability to recognize tumors.
The goal is to contend with industry's biggest oncology outfits, reversing its trend of checkered results in cancer R&D and building a sustained presence in the field. Palbociclib, which leads similar therapies from Novartis ($NVS) and Eli Lilly ($LLY), is the first big step forward, and Pfizer could use the victory.
