HHS is tak ing Gilead to court, seek ing dam ages for in fring ing gov ern ment HIV patents


2019-11-08 17:24:52 ENDPOINTS NEWS


Gilead earlier this year fired an opening salvo by marching to the US Patent and Trademark Office and requesting a review of the validity of the patents for HIV preventative treatment or PrEP granted to the HHS since 2015.  On Wednesday, the tactic blew up as the US government retorted by filing a patent infringement lawsuit against the California drugmaker. The suit, filed on behalf of the HHS, alleges that Gilead deliberately violated CDC’s patents, and profited from research funded by million’s of taxpayer dollars and has reaped billions from the sale of its therapies — Truvada and Descovy — as PrEP treatments. The HHS has also claimed that the US drugmaker repeatedly refused to license the patents. Did an obscure Chinese biotech just crack the Alzheimer’s enigma that’s dumbfounded a host of major league drug developers? China’s National Medical Products Administration revealed late Friday that it’s granted conditional approval for Shanghai Green Valley Pharma’s oligomannate capsules to improve cognitive functions in patients with mild-to-moderate Alzheimer’s, finding an overnight oasis in a therapeutic desert. The decision, which followed a fast-track review, was based on a purported Phase III win that the company has yet to dissect in detail. Antifungal drug developer Scynexis, which burst into the zeitgeist as one of the sole US-based companies with a Candida auris therapy in human trials, on Thursday disclosed that the same experimental drug had hit the main goal in a late-stage trial in patients with vaginal yeast infections. The oral drug, ibrexafungerp, was being tested in the 376-patient, placebo-controlled VANISH-303 trial. Patients enrolled had experienced an acute episode of vulvovaginal candidiasis (VVC), with signs and symptoms score of four or greater on a scale of zero to 18. No new drug has been approved for Alzheimer’s since 2003, and researchers endeavoring to change that have been greeted with a graveyard of failed therapies. So when Chinese regulators waved a treatment developed by an obscure biotech through to the market — albeit a conditional approval contingent upon confirmatory data — it makes sense that scientists who woke up to the news were more in doubt than in awe. While several prominent Alzheimer’s experts threw their weight behind the seaweed-derived therapy, oligomannate (GV-971), others contacted by Endpoints News were much more skeptical. As Green Valley Pharma has yet to release full data of the single Phase III trial on which the decision was based, most are taking a wait-and-see stance while the company prepares to launch a second, global trial in early 2020. Among the deluge of questions surrounding the surprise approval, two seem particularly crucial: Did Green Valley offer enough credible evidence to warrant an OK? And did the drug really work as the biotech claimed? Five months after dismal trial results convinced Takeda to scrap an entire Phase III program for their multiple myeloma drug Ninlaro, the Japanese giant announced a different late-stage trial has met its primary endpoint — although they have yet to release any data. Ninlaro improved progression-free survival as a first-line maintenance treatment in a placebo trial of 706 patients who have not received a stem cell transplant and responded to 6-12 months of treatment, Takeda announced. Takeda’s answer to Sanofi’s controversial dengue vaccine is here. The Japanese drugmaker, which is hoping to avert the challenges faced by its French rival to develop a product for the mosquito-borne disease, broke out the numbers from the first tranche of its pivotal trial on Wednesday. The placebo-controlled trial, called TIDES, is testing the impact of two doses of the vaccine — TAK-003 — in preventing dengue fever, triggered by any of the four viral strains, in more than 19,000 patients aged four to 16 years in parts of Latin America and Asia where the disease is endemic. Scientists unfurling the human genome at the turn of the century came across many surprises but perhaps nothing as shocking as the percentage of the genome that didn’t appear to code for anything. Around 2% wrote proteins and the rest appeared to be “junk,” “dark,” or, as the New York Times then put it, “the apparent product of a typing pool of drunken baboons. ” Roche has joined a line of drugmakers retreating from one class of experimental Duchenne muscular dystrophy drugs, dealing another blow to the theory that inhibiting myostatin can slow the muscle-wasting disease. Anyone who specializes in neurosciences R&D has to prepare themselves for some frustration along the way. And the team at Arkuda Therapeutics can tell you all about it. The CEO and co-founder is Gerhard Koenig, who you may recall headed up the team at Quartet Medicines, which worked on neuronal and inflammatory cells, until they folded the shop after running into a blind alley. Before that, he was CSO at Forum, which Deborah Dunsire — now CEO at Lundbeck — had helmed as it tried to break new ground in Alzheimer’s and schizophrenia. It didn’t work out either. But even though Atlas closed the checkbook on Quartet, Bruce Booth never blamed the crew. You want to try something cutting edge here, you pay your money and you take your chances. And sometimes you write off your losses. That’s biotech. So now Koenig and some of the execs he’s known along the way are back, knocking the door on a new approach to neurodegeneration, another high-risk, high-reward play where they are looking to break new ground. And Booth has been bankrolling the incubator work in hopes of seeing a new venture fly. A NASH-focused spinoff of Teva Pharmaceuticals delayed its IPO and Galera priced below its $14-$16 range as the public waters grow murkier. Touting an FGF21 analog cleaved off Teva’s pipeline, 89bio would have gone from Series A to Wall Street in less than a year had they completed the IPO they announced last month. Now, they’re being held up over an “issue” with the SEC and the company’s auditors said it could put the company in jeopardy.
今年早些时候,吉利德(Gilead)向美国专利和商标局( US Patent and Trademark Office )进军,并要求对自2015年以来授予 HHS 的 HIV 预防性治疗或 PrEP 专利的有效性进行审查,从而启动了一项新的销售活动。周三,随着美国政府对加州制药商提起专利侵权诉讼,这一策略遭到反击。 这起代表 HHS 提起的诉讼声称,吉利德(Gilead)故意侵犯了疾病预防控制中心(CDC)的专利,并从纳税人的数百万美元资助的研究中获利,并通过出售 Truvada 和 Descovy 作为 PrEP 治疗获得了数十亿美元的收益。美国卫生与公众服务部还声称,这家美国制药商一再拒绝许可这些专利。 一个默默无闻的中国生物科技公司是否只是破解了阿兹海默症的谜团,而这个谜团却造就了一大批大联盟药物开发商? 中国国家医药产品管理局( National Medical Products Administration )上周五晚些时候透露,有条件批准上海绿谷制药( Shanghai Green Valley Pharma )的寡聚糖脂胶囊,以改善轻度至中度阿尔茨海默症患者的认知功能,发现一片治疗沙漠中的过夜绿洲。这一决定是在经过快速审查后做出的,其依据是据称的第三阶段胜利,该公司尚未对此进行详细分析。 抗真菌药物开发商 Scynxis 周四披露,在一项针对阴道酵母菌感染患者的后期试验中,同样的实验药物达到了主要目标。 Scynxis 是美国唯一一家在人体试验中使用念珠菌疗法的公司之一。 口服药物 ibrexafunerp 正在接受376名患者的安慰剂对照 VANISH-303试验。患者已经历一次急性外阴阴道念珠菌病( VVC ),症状和体征评分为4分或更高的零至18分。 自2003年以来,没有一种新药被批准用于阿尔茨海默氏症,研究人员一直在努力改变这种状况,他们的治疗方法失败了。因此,当中国监管机构动摇了一种由一种晦涩难懂的生物技术开发出来的治疗方法进入市场时——尽管有条件的批准取决于确认数据——有意义的是,那些醒来了解这一消息的科学家更有疑问,而不是敬畏。 尽管几位著名的阿尔茨海默症专家在海藻衍生疗法( GV-971)的背后投下了重注,但 EndpointNews 联系的其他专家则更加怀疑。由于 Green Valley Pharma 尚未公布该决定所依据的单一 III 期试验的全部数据,大多数公司在准备于2020年初启动第二个全球试验的同时采取观望态度。 在围绕这一意外批准的众多问题中,有两个似乎尤为关键:绿谷是否提供了足够可信的证据来证明“确定”是正确的?这种药物真的像生物技术声称的那样有效吗? 在试验结果令人沮丧的5个月后,日本巨人武田(Takeda)公司宣布放弃其多发性骨髓瘤药物尼诺拉罗的整个 III 期项目,该公司宣布另一项后期试验已经达到了主要终点——尽管他们还没有发布任何数据。 武田(Takeda)宣布,在一项针对706名未接受干细胞移植的患者的安慰剂试验中, Ninalaro 改善了无进展生存作为一线维持治疗,并对6-12个月的治疗作出了反应。 武田(Takeda)对赛诺菲(Sanofi)有争议的登革热疫苗的回答就在这里。这家日本制药商希望避免其法国竞争对手为蚊媒疾病开发产品所面临的挑战。该公司周三公布了关键试验的第一批数据。 这项名为 TIDES 的安慰剂对照试验正在测试两剂疫苗 TAK-003在预防登革热方面的影响,这四种病毒株中的任何一种引发了登革热,在拉丁美洲和亚洲部分地区,有19,000名4至16岁的患者感染了这种疾病。 世纪之交,揭开人类基因组面纱的科学家们遇到了许多令人惊讶的事情,但也许并不像基因组中似乎没有编码的比例那么令人震惊。大约2%的人写蛋白质,其余的似乎是“垃圾”,“黑暗”,或者,正如《纽约时报》当时所说的,“喝醉的狒狒的典型产品”。“这是一个很好的选择。” 罗氏(Roche)公司加入了一系列从一类实验性 Duchenne 肌营养不良药物中撤退的制药公司,这对抑制肌动蛋白可以减缓肌肉萎缩疾病的理论又一次打击。 任何专门从事神经科学研究与开发的人,都必须准备好在此过程中遇到一些挫折。Arkuda Therapeutics 的团队可以告诉你所有的事情。 首席执行官兼联合创始人格哈德·科尼格( Gerhard Koenig )可能会记得,他是四方医药( Quarte Medicines )的团队负责人,该公司致力于神经细胞和炎症细胞的研究,直到他们在跑进一条盲道后,把店铺折叠起来。在那之前,他是论坛上的 CSO ,现在担任灵北(Lundbeck)首席执行官的 Deborah Dunsire 在试图打破阿尔茨海默氏症和精神分裂症的新局面时,曾执掌论坛。 这也不算什么。 但即使阿特拉斯关闭了四方核查,布鲁斯布斯从来没有指责船员。你想在这里尝试一些尖端的东西,你支付你的钱和你的机会。有时你会冲销你的损失。 那是生物技术。 因此,现在科尼格和他所熟知的一些高管又回来了,敲门采取了一种新的神经退化方法,这是另一种高风险、高回报的游戏,他们希望在那里开辟新的天地。Booth 一直在资助孵化器的工作,希望看到一只新的创业苍蝇。 一家专注于 NASH 的梯瓦(Teva) Pharmaceuticals 公司推迟了 IPO , Galera 的定价低于14-16美元,因为公共水域变得更加模糊。 如果将 FGF21类似物剥离出梯瓦(Teva)的管道,在不到一年的时间里,如果他们完成上个月宣布的 IPO ,将有89家生物从 A 系列转移到华尔街。现在,他们正因与美国证交会的“问题”而被搁置,该公司的审计人员表示,这可能危及该公司的安全。