Merck Receives Priority on Pneumococcal Vaccine, Offers Reassurance on Keytruda


2021-01-14 03:01:10 BioSpace


Ken Frazier, CEO of Merck, pictured above. (Spencer Platt/Getty Images) Merck announced the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) for V114, its 15-valent pneumococcal conjugate vaccine, for priority review. This coincided with the JP Morgan Annual Healthcare Conference where, as usual, the company’s chief executive officer, Ken Frazier, was questioned on how the company was preparing for loss of patent protection for its uber-blockbuster checkpoint inhibitor, Keytruda (pembrolizumab). The BLA for V114 has a target action date of July 18, 2021. It is also being reviewed by the European Medicines Agency (EMA). The BLA and priority review are built on data from Phase II and III clinical trials in adults, including healthy adults and ones at increased risk, such as HIV patients, people with chronic medical conditions, and people 65 years of age and older. V114 is a 15-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease in adults. It is made up of pneumococcal polysaccharides from 15 serotypes conjugated to a CMR197 carrier protein and includes serotypes 22F and 33F, which are linked to invasive pneumococcal disease in older adults globally and are not in the pneumococcal conjugate vaccine currently on the market. “Invasive pneumococcal disease in adults is on the rise in many countries, driven by highly-invasive serotypes including serotype 3, which is included in the currently licensed pneumococcal conjugate vaccine, as well as serotypes not included, such as serotypes 22F and 33F,” said Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. In the other news, Frazier downplayed the company’s concerns over patent protection for Keytruda. The drug’s sales grew from $55 million in 2014 to $7.2 billion in 2018, and are projected to rake in $24.3 billion in 2026, according to EvaluatePharma. “The concerns around the Keytruda (loss of exclusivity), although they’re valid, I think they’re a little bit overstated,” Frazier said at the JP Morgan conference, having earlier said that “we see it as not as big an issue as I think some investors may see it.” The questions about this at JP Morgan typically revolve around what mergers and acquisitions the company may make to bolster their pipeline in preparation for sales losses if and when biosimilars to Keytruda hit the market. Frazier, speaking on the M&A activity, said the company needs “to continue to focus on getting the best external science we can, both in oncology and outside oncology, to diversify our portfolio, and we’re going to continue to focus on that.” And Frazier defends the company, noting that Merck had 120 deals in 2020 alone, but none of them are the type of big, transformational deals major shareholders are apparently looking for. “I think what people are saying is, “We’d like to see you do something bigger and later-stage,” Frazier said. And he may have been referring to Gilead Sciences’ $21 billion acquisition of Immunomedics when he noted that biopharma deals have had “very large prices” and that, “Right now, biotech’s at an all-time high. If you’re going to try to acquire those assets right now, you’re going to pay a very steep price, and then a premium on top of it. And on top of that, anytime somebody’s going after something, it turns into a bidding war.” Merck is also working on various coformulations, combinations and dosing regimens for Keytruda to extend its patent life. In his presentation at JPM, Frazier noted the company’s key growth drivers, Keytruda, Levima, Lynparza, animal health, and their expectations for growth for Gardasil after a slow start. “The good news for us is, as we look at that portfolio and what’s coming behind it, we feel that our revenue growth prospects still remain underappreciated between now and 2024. We are also increasingly having a better line of sight to what’s coming through our pipeline, both before the Keytruda LOE (loss of exclusivity) and after the Keytruda LOE. So we continue to feel good about that. We have the firepower to do business development.” Most Read Today
默克公司首席执行官肯·弗雷泽,上图。(斯宾塞·普拉特/盖蒂图片) 默克公司宣布,美国食品和药物管理局(FDA)已接受其15价肺炎球菌结合疫苗V114的生物制剂许可申请(BLA),进行优先审查。这与JP摩根年度医疗保健会议不谋而合,在会议上,该公司首席执行官肯·弗雷泽像往常一样,被问及该公司如何准备应对其超级重磅检查点抑制剂Keytruda(pembrolizumab)失去专利保护的问题。 V114的BLA的目标行动日期为2021年7月18日。欧洲药品局(EMA)也在审查这一方案。BLA和priority review建立在成人II期和III期临床试验的数据基础上,包括健康成人和风险增加的成人,如HIV患者,慢性疾病患者和65岁及以上的人。 V114是一种15价肺炎球菌结合疫苗,用于预防成人侵袭性肺炎球菌疾病。它由15种血清型肺炎球菌多糖与CMR197载体蛋白结合而成,包括血清型22F和33F,这两种血清型与全球老年人的侵袭性肺炎球菌疾病有关,目前市场上的肺炎球菌结合疫苗中没有这种疫苗。 默克研究实验室高级副总裁兼全球临床开发主管,首席医疗官Roy Baynes说,在许多国家,成人侵袭性肺炎球菌疾病呈上升趋势,其驱动因素是包括血清型3在内的高侵袭性血清型,该血清型包括在目前许可的肺炎球菌结合疫苗中,以及血清型22F和33F等未包括在内的血清型。 在另一则新闻中,弗雷泽淡化了公司对Keytruda专利保护的担忧。根据EvaluatePharma的数据,这些药物的销售额从2014年的5500万增长到2018年的72亿,预计2026年将达到243亿。 弗雷泽在摩根大通会议上表示:“对Keytruda(失去排他性)的担忧,虽然是有道理的,但我认为有些言过其实了,”此前他曾表示,我们认为这不像一些投资者认为的那样是个大问题。 摩根大通对此的疑问通常围绕着公司可能会进行哪些并购,以支持他们的生产线,为一旦Keytruda的生物仿制药上市时的销售损失做准备。弗雷泽在谈到并购活动时说,公司需要继续专注于获得最好的外部科学,包括肿瘤学和肿瘤学以外的科学,以使我们的投资组合多样化,我们将继续专注于这一点。 弗雷泽还为默克辩护,他指出,默克仅在2020年就有120宗交易,但其中没有一宗是大股东显然想要的那种大的,具有变革性的交易。 弗雷泽说:“我认为人们所说的是,我们希望看到你做一些更大,更晚的事情。” 他可能指的是Gilead Sciences 210亿收购Immunomedics的交易,他指出生物制药的交易价格非常高,目前生物技术处于历史最高水平。如果你现在就打算收购这些资产,你将付出非常高昂的价格,然后再加上溢价。最重要的是,任何时候有人想要买东西,就会变成一场竞标战。 默克公司还在为Keytruda研制各种共配方,组合和剂量方案,以延长其专利寿命。 弗雷泽在JPM的演讲中提到了公司的主要增长动力,Keytruda,Levima,Lynparza,animal health,以及他们对Gardasil在缓慢起步后的增长预期。 对我们来说,好消息是,当我们审视这一投资组合及其背后的情况时,我们觉得从现在到2024年,我们的收入增长前景仍然被低估。在Keytruda LOE之前(失去独占性)和Keytruda LOE之后,我们对通过我们管道的产品也越来越有一个更好的视线。所以我们继续对此感到良好。我们有能力发展业务。 今天阅读最多的