Cowen Conference Spotlight: Amgen, Bristol-Myers Squibb and Amarin Share Updates

Cowen 卫生保健会议第二天:安进,百时美施贵宝和 Amarin 分享管道开发见解

2019-03-15 20:36:00 BioSpace


标签: 医药/器械 医药 创新药 仿制药
On day two of Cowen and Company’s 39th Annual Health Care Conference, more companies shared insight into pipeline development. BioSpace rounded up a few of the stories. Amgen – During a conversation with investors, David Meline, chief financial officer at Amgen, pointed to the company’s biosimilar pipeline as a potential multi-billion driver for the company. Over the past several years, Amgen has had 10 biosimilars in development, six of which are now in advanced Phase III studies or have been submitted for regulatory approval. The company has launched two biosimilars in Europe, Amgevita, a biosimilar to AbbVie’s Humira, and Kanjinti, a biosimilar to Genentech’s Herceptin. Meline said the company anticipates additional launches in the future. Earlier this year, Amgen also reported positive results from a Phase I/Phase III trial for a biosimilar to Biogen’s Rituxan. Meline also highlighted some of the strengths of the company’s pipeline. He pointed to Omecamtiv Mecarbil, a Phase III product for heart failure and asthma treatment Tezepelumab, which is also in Phase III development. Meline also pointed to the recent approval of Evenity in Japan. The drug was approved for the treatment of osteoporosis in patients at high risk of fracture. The company is also eying potential approval in the U.S. An advisory committee with the U.S. Food and Drug Administration gave an 18 to 1 favorable vote for the medication. Meline also pointed to the company’s BiTE molecules in development, including AMG 420 or BCMA BiTE for multiple myeloma. Meline said the company is “positioned very nicely for long-term growth.” Bristol-Myers Squibb –As Bristol-Myers Squibb continues to move forward with its acquisition of Celgene, BMS CEO Giovanni Caforio and other executives fielded numerous questions about the deal. During a Q&A, Cowen’s Stephen Scala said the company is consistently asked two questions about the merits of the acquisition and whether or not a series of smaller acquisitions would not have been better for BMS than the $74 billion deal for Celgene. Scala said it’s important to give some thought to Caforio’s argument that acquiring Celgene will be transformative for the company and was done so from a position of strength. Caforio said the deal for Celgene, struck in January, “is the right option and the best option for Bristol-Myers Squibb.” Caforio said the deal creates a strong company that is well-positioned for long-term and sustainable growth. He said he is clear about the strategic rationale for the deal and his board of directors understands their fiduciary duties. BMS executives were also clear that they performed their due diligence when it comes to the intellectual property of Celgene, particularly as it relates to that company’s top-selling drug Revlimid. Revlimid brought in nearly $10 billion last year for Celgene, but it will be facing patent challenges in the next several years, which will cause it to lose revenue-driving steam. A shareholder vote that will finalize the acquisition is set for next month, April 12. Amarin Corporation – John Thero, president and CEO of Amarin Corporation said things seem to be getting more dire in the cardiovascular space as it relates to public health burdens. In November, Ireland-based Amarin released data that showed its fish-oil-based drug Vascepa reduced the relative risk reduction of adverse cardiovascular events by 25 percent, including a 20 percent reduction in cardiovascular death. Trial data showed that patients receiving Vascepa in addition to statin therapy saw a risk reduction of 31 percent to experiencing a heart attack, a 28 percent risk reduction for stroke, and a 20 percent risk reduction in CV-related death. Vascepa has already been approved to treat patients with triglyceride levels higher than 500 milligrams per deciliter, triple normal levels. Results from the REDUCE-IT study will be used as an attempt to expand the labeling indication for the drug, Thero said. “We are on track for soon submitting a sNDA to the FDA seeking a label expansion from our current triglyceride lowering indication to one for a prevention of cardiovascular events beyond cholesterol management,” Thero said.
在 Cowen 和公司第39届年度卫生保健会议的第二天,更多的公司分享了对管道开发的见解。生物空间概括了一些故事。 安进-在与投资者的对话中,安进(Amgen)首席财务官戴维•梅林( David Meline )指出,该公司的生物生物仿制药管道可能成为该公司数十亿美元的潜在驱动因素。在过去几年中,安进(Amgen)公司已经开发了10种生物仿制药类似物,其中6种目前正在进行 III 期高级研究或已提交监管机构批准。该公司在欧洲推出了两种生物类似物, Amgevita ,一种是艾伯维(AbbVie)的 Humira 的生物生物仿制药物,另一种是基因泰克(Genentech)的 Herceptin 的生物类似物 Kanjinti 。梅琳说,公司预计未来还会有更多的产品上市。今年早些时候,安进(Amgen)还报告了百健(Biogen)公司 Rituxan 的生物生物仿制药物 I / III 期试验的积极结果。 Meline 还强调了该公司管道的一些优势。他指的是 Omecamdiv Mecarbil ,一种治疗心脏衰竭和哮喘的 III 期产品 Tezepeumab ,也在 III 期开发中。梅琳还指出,最近日本批准了《晚报》。该药物被批准用于治疗骨折高危患者的骨质疏松。该公司也在寻求在美国的潜在批准。美国食品药品监督管理局(Food and Drug Administration)的一个咨询委员会对该药物投了18比1的赞成票。Meline 还指出该公司正在开发的 BiTE 分子,包括 AMG 420或 BCMA BiTE 用于多发性骨髓瘤。 梅琳表示,该公司“在长期增长方面处于非常有利的地位”。 百时美施贵宝-随着百时美施贵宝继续推进收购新基(Celgene),百时美施贵宝(BMS)首席执行官 Giovanni Caforio 和其他高管对这笔交易提出了许多问题。考恩的斯蒂芬·斯卡拉( Stephen Scala )在一次问答中表示,公司一直被问及两个问题:收购的价值,以及一系列规模较小的收购对百时美施贵宝(BMS)的影响,是否会比新基(Celgene)740亿美元的收购更好。斯卡拉说,考虑到卡弗里奥的论点很重要,即收购新基(Celgene)对公司来说是变革性的,而且是从实力的角度来考虑的。 Caforio 表示,1月份达成的新基(Celgene)交易“是百时美施贵宝的正确选择和最佳选择。”Caforio 表示,这笔交易创造了一个强大的公司,为长期和可持续的增长做好了准备。他表示,他对这笔交易的战略理由很清楚,他的董事会理解他们的信托责任。 百时美施贵宝(BMS)的高管们也很清楚,在涉及新基(Celgene)的知识产权时,他们履行了尽职调查的职责,尤其是与该公司的畅销药品 Revlimd 有关的知识产权。去年, Revlimed 为新基(Celgene)带来了近100亿美元的收入,但它将在未来几年面临专利挑战,这将导致它失去收入驱动的动力。 将于下月(4月12日)完成收购的股东投票。 Amarin 公司—— Amarin 公司总裁兼首席执行官 John Thero 说,心血管领域的情况似乎越来越糟糕,因为它与公共卫生负担有关。11月,爱尔兰的 Amarin 发布的数据显示,其鱼油药物 Vacepa 将心血管不良事件的相对风险降低了25%,包括心血管死亡减少了20%。试验数据显示,除了他汀类药物外,接受 Vacepa 治疗的患者患心脏病的风险降低了31%,中风的风险降低了28%,心血管相关死亡的风险降低了20%。 Vacepa 已经被批准用于治疗甘油三酯含量高于每升500毫克,是正常水平的三倍的患者。Therro 说,来自 REDUCE-IT 研究的结果将被用来扩大该药物的标签适应症。 “我们即将向 FDA 提交一份 sNDA ,寻求从目前的甘油三酯降低适应症扩展到预防胆固醇管理之外的心血管事件,”西奥说。