The loss of patent protection on two drugs is forcing Gilead Sciences to terminate about 20 percent of its sales team, according to reports.
California-based Gilead will terminate about 150 long-term members of its sales team, STAT News reported. The two drugs, Ranexa and Letairis, lost protection this year. Ranexa’s patent expired at the end of February and generic drugmakers have lined up with their own products to treat angina. There are also other classes of drugs aimed at the same indication, including generics. Letairis, a treatment for pulmonary arterial hypertension, lost its patent protection last summer. Since then, generics, as well as newer drugs aimed at the same indication, have begun to undercut sales.
Gilead told STAT that the job cuts are unfortunate but necessary in order to cut costs. Gilead is still trying to pivot and recover from the losses it has taken in the hepatitis C arena. Gilead had previously warned its investors of the patent losses and the associated loss of revenue due to generic challenges. The layoffs will become effective July 1, according to the report.
The layoffs are a rough start to the tenure of new Gilead Chief Executive Officer Daniel O’Day, who took over the reins of the company last month. O’Day, a long-time Roche veteran, was tapped for the top spot at the company after former CEO John Milligan announced last summer that he planned to step down. O’Day was the former CEO of Roche Pharmaceuticals. One of O’Day’s primary focuses as CEO is on Gilead’s CAR-T program. Sales of Yescarta (axicabtagene ciloleucel) have been lower than the company would like, which is due to a number of reasons, including the risk of toxicity, cost and logistical issues regarding the process. Yescarta was initially developed by Kite Pharma but Gilead acquired that company in an almost $12 billion deal in 2017. In the United States, Yescarta was the second CAR-T treatment approved.
The sales team layoffs aren’t the only snags that Gilead has hit in the past several months. Prior to O’Day’s taking over, the company’s pivot to developing treatments for nonalcoholic steatohepatitis (NASH) hit a major problem. Its Phase III treatment selonsertib, developed to treat compensated cirrhosis from NASH, failed to meet primary its endpoint in the STELLAR-4 trial.
In addition to the Phase III failure, the company also lost a legal fight over one of its HIV drugs. In February, a California court ruled that personal injury cases against the company would be allowed to proceed. HIV patients and advocates have filed several lawsuits against the Foster City, Calif.-based company claiming the company “suppressed a safer, far less toxic version of the drug in order to maximize profits and extend sales of the first drug, tenofovir disoproxil fumarate (TDF).”
据 STAT 新闻报道，总部位于加州的吉利德（Gilead）将终止其销售团队约150名长期成员。这两种药物， Ranexa 和 Letelairis ，今年失去了保护。Ranexa 的专利在2月底到期，仿制药厂商纷纷推出自己的治疗心绞痛的产品。还有其他种类的药物针对同一适应症，包括仿制药。治疗肺动脉高压的 Letawis 去年夏天失去了专利保护。从那时起，仿制药以及针对相同适应症的新药物开始削弱销售。
吉利德（Gilead）告诉 STAT ，裁员是不幸的，但为了削减成本，这是必要的。吉利德（Gilead）仍在努力从其在丙肝领域遭受的损失中恢复过来。吉利德（Gilead）此前曾警告投资者，由于仿制药的挑战，其专利损失以及相关的收入损失。报告称，裁员将于7月1日生效。
裁员是吉利德（Gilead）首席执行官丹尼尔•奥戴( Daniel O ’ Day )任期的一个艰难开端。奥戴上月接替了该公司的控制权。在去年夏天前首席执行官约翰•米利根( John Milligan )宣布他计划辞职后，长期担任罗氏（Roche）( Roche )老将的欧戴( O ’ Day )被评为该公司最高职位。O ’ Day 曾任罗氏（Roche）制药首席执行官。作为首席执行官， O ’ Day 的主要关注点之一是吉利德（Gilead）的 CAR-T 计划。Yescarta ( axobtagene cioleucel )的销售额低于该公司希望的水平，这是由于一些原因，包括该工艺的毒性风险、成本和物流问题。Yescasta 最初由 Kite Pharma 开发，但吉利德（Gilead）在2017年以近120亿美元收购了该公司。在美国， Yescarta 是第二个批准的 CAR-T 治疗。
销售团队的裁员并不是吉利德（Gilead）过去几个月遭遇的唯一障碍。在 O ’ Day 接管之前，该公司致力于开发非酒精性脂肪性肝炎（ NASH ）的治疗方法遇到了一个重大问题。它的 III 期治疗药物 selonertib ，用于治疗 NASH 的补偿肝硬化，未能达到 STELLAR-4试验的主要终点。
除了第三阶段的失败，该公司还失去了对其一种艾滋病毒药物的法律斗争。今年2月，加州一家法院裁定，针对该公司的人身伤害诉讼将被允许继续进行。艾滋病患者和倡导者已经对加利福尼亚州的福斯特城市提起了几起诉讼。-总部位于美国的公司声称，该公司“为了最大限度地增加利润，延长第一个药物富马酸替诺福韦二吡呋酯（ TDF ）的销售，抑制了一种更安全、毒性更小的药物。”