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Novartis' Arzerra outpaces Sanofi's Aubagio in MS trial

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Novartis laid out $16 billion for GlaxoSmithKline’s oncology portfolio in 2015 and has spent much of the last four years laboring to make a success of one of the drugs it picked up, Arzerra. It hasn’t had much luck in chronic lymphocytic leukemia (CLL), but it’s hoping fresh phase 3 data will help it forge a new market for the drug: multiple sclerosis.

Friday, Novartis said Arzerra (ofatumumab) had shown it was superior to Sanofi’s MS drug Aubagio in two phase 3 studies in adults with relapsing forms of the disease. The trials included 1,882 patients who either received a monthly injection of Arzerra or once-daily Aubagio pills. Arzerra reduced the rate of relapses, Novartis said.

The company plans to release full data at an MS conference in mid-September and to begin the approval process for Arzerra in MS with regulatory agencies by the end of this year. The drug will carry a different brand name if it is approved in MS.

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RELATED: Novartis, feeling the heat from head-to-head rivals, pulls Arzerra outside the U.S.

If Novartis succeeds with Arzerra in MS, it will be a notable turnaround for a troubled drug. Arzerra was never really a contender in CLL, because shortly after Novartis acquired it from GSK, the drug started to face competition from Johnson & Johnson and AbbVie’s Imbruvica. Arzerra floundered while Imbruvica grew into a $4 billion-a-year hit.

In January 2018, Novartis and partner Genmab stopped marketing Arzerra outside the U.S., citing a lack of market traction due to competition. It didn’t help that J&J and AbbVie ran head-to-head trials showing Imbruvica outperformed Arzerra in CLL in both response rate and survival.

But Novartis always held out hope for Arzerra in MS. A few months after it struck the GSK oncology deal, it paid another $1 billion for full control of the drug in MS. It was viewed as a smart bet at the time, because Novartis’ MS pill Gilenya—the company's best-seller at $3.3 billion a year—was expected to face generic competitors as soon as this year.

Novartis has so far managed to delay those generic rivals to Gilenya, though. In June, a U.S. district judge in Delaware granted a temporary injunction that prevented several generic drugmakers from launching their low-cost versions of the med. The judge cited ongoing patent litigation in federal court.

RELATED: Can Novartis MS blockbuster-to-be break Mayzent break doctors’ ‘circle of denial’?

Luckily, though, Novartis isn’t placing all its MS hopes on Gilenya and Arzerra. In March, the FDA approved Novartis’ Mayzent, the first oral drug for patients with secondary progressive multiple sclerosis. Even though the company will face challenges in educating physicians about how to recognize that particular form of the disease, analysts expect that sales of the drug will ultimately reach blockbuster territory.

Arzerra works against MS by binding to CD20 on the surface of B cells and depleting the cells, which are a major culprit in the disease. The company started the phase 3 trials of the drug in MS in August 2016.

机器翻译

诺华在 2015 年为葛兰素史克的肿瘤产品组合布局了 160 亿美元,在过去四年的大部分时间里,诺华都在努力让其收购的药物之一 Arzerra 获得成功。它在慢性淋巴细胞白血病 (CLL) 方面还没有太多运气,但它希望新的 iii 期数据能帮助它为该药打造一个新市场:多发性硬化症。上周五,诺华公司表示,Arzerra (ofatumumab) 在成人复发型疾病的两项 3 期研究中显示出其优于赛诺菲的 MS 药物 Aubagio。这些试验包括 1882 名患者,他们每月接受一次 Arzerra 注射或每日一次 Aubagio 药丸注射。诺华公司表示,Arzerra 降低了复发率。该公司计划在 9 月中旬的 MS 大会上公布全部数据,并在今年年底与监管机构开始 Arzerra 在 MS 的审批程序。如果在 MS 获得批准,该药物将采用不同的品牌名称。像这样的免费每日通讯?订阅 FiercePharma!生物制药是一个快速增长的世界,每天都有大的想法出现。我们的订户依靠 FiercePharma 作为最新的新闻、分析和数据的必读来源,以及制药公司。今天注册,以获得医药新闻和更新交付到您的收件箱和阅读的走。现在订阅相关内容:诺华公司感受到了竞争对手之间的激烈竞争,将 Arzerra 拉出了美国之外。如果诺华的 Arzerra 在 MS 获得成功,对于一个陷入困境的药物来说将是一个明显的转机。Arzerra 从未真正成为 CLL 的竞争者,因为诺华从 GSK 手中收购后不久,该药就开始面临强生和艾伯维的 Imbruvica 的竞争。当 Imbruvica 以每年 40 亿美元的速度成长时,Arzerra 挣扎着。2018 年 1 月,诺华和合作伙伴 Genmab 停止在美国以外市场销售 Arzerra,理由是由于竞争缺乏市场牵引力。强生和艾伯维开展的头对头试验显示,Imbruvica 在 CLL 缓解率和生存率方面都优于 Arzerra,这无济于事。但诺华公司始终对 Arzerra 在 MS 方面抱有希望。在达成 GSK 肿瘤学交易几个月后,它又支付了 10 亿美元完全控制了 MS 的药物。这在当时被视为一个聪明的赌注,因为诺华的 pill Gilenya 女士——该公司每年 33 亿美元的畅销药——预计最快在今年将面临仿制药竞争者。不过,诺华迄今设法推迟了那些与 Gilenya 竞争的仿制药。六月份,美国特拉华州地区法官批准了一项临时禁令,阻止了几家仿制药生产商推出他们的低成本版本的 med。法官列举了联邦法院正在进行的专利诉讼。相关:诺华 MS blockbuster-tobe break Mayzent 能否打破医生 ‘ 否认圈 ’?不过幸运的是,诺华并没有将所有的 MS 希望都寄希望于 Gilenya 和 Arzerra。今年 3 月,FDA 批准了诺华的 Mayzent,该药是首个用于继发性进展型多发性硬化症患者的口服药物。尽管该公司在教育医生如何认识这种特殊形式的疾病方面将面临挑战,但分析师预计,该药的销售最终将达到重磅炸弹级领域。Arzerra 通过与 B 细胞表面的 CD20 结合并耗尽细胞(这是导致疾病的一个主要罪魁祸首)来对抗 MS。该公司于 2016 年 8 月开始了该药在 MS 中的 3 期试验

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