Biotech Stocks Facing FDA Decision In January 2019

盘点2019年1月即将送审药企,默克、安进等蓄势待发

2018-12-26 06:32:25 RTTNews

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Starpharma Starpharma’s (SPHRY.OB) New Drug Application for VivaGel BV is under priority review by the FDA – with a decision expected in early January. VivaGel BV is a non-antibiotic, water-based vaginal gel for the treatment of bacterial vaginosis and prevention of recurrent bacterial vaginosis. The global market for bacterial vaginosis treatment is estimated to be roughly US$750 million, and about US$1 billion for prevention of recurrent bacterial vaginosis. The product is already approved in Europe and Australia. VivaGel BV is licensed to Mundipharma in Europe, and to Aspen Pharmacare in Australia where it is marketed under the brand name Fleurstat. Antibiotics like Flagyl, Cleocin oral or vaginal suppositories, vaginal gel MetroGel-Vaginal, and Solosec are some of the other approved medications for bacterial vaginosis. In the U.S., VivaGel BV is licensed to ITF Pharma. Starpharma is entitled to receive up to US$101 million from ITF Pharma in regulatory approval and commercialization milestones in addition to escalating double-digit royalties on sales. SPHRY.OB closed Friday’s (Dec.21, 2018) trading at $9.55, down 3.44%. Merck Merck & Co. Inc. (MRK) has sought FDA approval for the expanded use of its blockbuster cancer drug Keytruda as a monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer in patients whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations. The regulatory agency’s decision on the proposed new indication is expected on January 11, 2019. Keytruda, co-developed and co-commercialized with AstraZeneca, is already approved for the treatment of melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high cancer, gastric cancer, cervical cancer, hepatocellular carcinoma, and Merkel cell carcinoma. The drug fetched revenue of $3.81 billion for Merck in full year 2017, and $5.02 billion in the first nine months of 2018. MRK closed Friday’s (Dec.21, 2018) trading at $72.90, down 0.80%. Exelixis The FDA decision on Exelixis Inc.’s (EXEL) supplemental New Drug Application for Cabometyx tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma is expected on January 14, 2019. Hepatocellular carcinoma (HCC), the most common type of liver cancer, is the fastest-rising cause of cancer-related death in U.S. It is the second-leading cause of cancer death worldwide, accounting for more than 700,000 deaths and nearly 800,000 new cases each year. Cabometyx, available in 3 strengths of 20mg, 40mg and 60mg, is already approved in the United States for the treatment of patients with advanced renal cell carcinoma. The drug is also approved in the European Union, Norway, Iceland, Australia, Switzerland, South Korea, Brazil and Taiwan for the treatment of advanced renal cell carcinoma (RCC) in adults who have received prior VEGF-targeted therapy, and in the European Union for previously untreated intermediate- or poor-risk advanced RCC. Cabometyx generated $324.0 million in net product revenue in full year 2017, and $428.3 million in the first nine months of 2018. EXEL closed Friday’s (Dec.21, 2018) trading at $17.72, down 3.70%. Amgen Amgen Inc. (AMGN) and UCB’s investigational drug Evenity, proposed for the treatment of osteoporosis in postmenopausal women at high risk for fracture, is all set to be reviewed by an FDA panel on January 16, 2019. Evenity was turned down by the FDA last July, with the companies being asked to submit the efficacy and safety data from an additional phase III active-comparator study, dubbed ARCH. In the ARCH study, treatment with Evenity for 12 months followed by Merck & Co.’s (MRK) Fosamax significantly reduced the incidence of new vertebral, clinical and non-vertebral fractures in postmenopausal women with osteoporosis at high risk for fracture, compared to Fosamax alone. However, the rate of cardiovascular serious adverse events was higher in patients treated with EVENITY compared to Fosamax (2.5 percent Evenity versus 1.9 percent Fosamax at 12 months), raising a concern. The companies resubmitted the Biologics License Application for Evenity to the FDA with the required data in July of this year. Before the regulatory agency takes a final decision, the Biologics License Application is slated to be reviewed by a panel of outside experts on the above-mentioned date, i.e. on January 16, 2019. AMGN closed Friday’s (Dec.21, 2018) trading at $180.21, down 2.57%. Lexicon Pharmaceuticals An FDA panel is slated to review Zynquista (sotagliflozin), an investigational oral treatment as an adjunct therapy to insulin for adults with type 1 diabetes, on January 17, 2019. Zynquista, developed by Sanofi (SNY) in partnership with Lexicon Pharmaceuticals Inc. (LXRX) is an oral dual inhibitor of SGLT-1 and SGLT-2, proteins that influence how the intestines and kidneys absorb and eliminate sugar (glucose) resulting in improved glucose control and additional clinical benefits. The final decision of the FDA on Zynquista is expected on March 22, 2019. In clinical trials, Zynquista lowered blood glucose and helped patients with type 1 diabetes (T1D) lose weight and control blood pressure. However, the drug candidate was associated with higher rates of diabetic ketoacidosis, a potentially life-threatening complication. According to GlobalData Healthcare, Zynquista is expected to reach peak U.S. sales of $1.3 billion in 2024. LXRX closed Friday’s (Dec.21, 2018) trading at $6.34, down 8.65%. Immunomedics Immunomedics Inc.’s (IMMU) Biologics License Application for Sacituzumab govitecan, which is under priority review by the FDA, has a decision date of January 18, 2019. Sacituzumab govitecan is proposed for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior treatments. Triple negative breast cancer is a type of breast cancer whose cells don’t have receptors for the hormones oestrogen and progesterone, and protein Her2. It is said to be more aggressive and difficult to treat. Also known as IMMU-132, Sacituzumab govitecan is a novel first-in-class antibody-drug conjugate (ADC) that delivers a lethal payload of moderately-toxic chemotherapeutic SN-38 to TROP-2-expressing cells. Trop-2 is a cell-surface glycoprotein expressed on more than 90% of triple-negative tumors. If approved, Sacituzumab govitecan would be the first and only ADC approved for the treatment of metastatic triple-negative breast cancer. IMMU closed Friday’s (Dec.21, 2018) trading at $15.04, up 6.14%. Sanofi The FDA decision on Sanofi’s (SNY) request to expand the age indication of flu vaccine Fluzone Quadrivalent of 0.5-mL dose to include children 6 through 35 months of age is slated for January 28, 2019. Currently, only individuals aged 36 months and older can be administered a 0.5-mL dose. For children aged between 6 and 35 months, the approved dose of Fluzone Quadrivalent is 0.25-mL. Fluzone Quadrivalent is effective against four different strains of flu - two influenza A viruses and two influenza B viruses. SNY closed Friday’s (Dec.21, 2018) trading at $42.32, down 2.06%. Aquestive Therapeutics Aquestive Therapeutics Inc.’s (AQST) APL-130277, proposed as an intermittent therapy to overcome episodic off periods in Parkinson's disease, awaits the FDA decision on January 29, 2019. APL-130277 is a sublingual film formulation of Apomorphine, a non-ergot dopamine agonist. Sunovion Pharmaceuticals Inc. is Aquestive Therapeutics’ partner and sponsor of APL-130277. If approved, APL-130277 is expected to bring in peak sales of $700 million. Oral Levodopa is the “Gold Standard” therapy for Parkinson's disease. Over time, as the disease progresses, the medication fails to work optimally, resulting in the re-emergence of symptoms (motor and non-motor) otherwise controlled by it. These periods are referred to as OFF episodes. OFF episodes are characterized, in part, by tremor, stiffness or slow movement. These episodes may disrupt a person’s ability to perform everyday activities and may be burdensome for patients, family and caregivers. AbbVie Inc.’s Duopa, which is administered using a small, portable infusion pump that delivers carbidopa and levodopa directly into the small intestine; Apokyn, an injectable drug; Deep brain stimulation and Surgical treatment are some of the currently available treatment options for Parkinson disease patients with OFF periods. Acorda Therapeutics Inc.’s (ACOR) Inbrija was approved as recently as December 21, 2018 for the treatment of OFF episodes in people with Parkinson’s disease taking a carbidopa/levodopa regimen. AQST closed Friday’s (Dec.21, 2018) trading at $6.51, down 5.65%. Alkermes After being turned down by an FDA panel in November, Alkermes plc’s (ALKS) New Drug Application for ALKS 5461 awaits the final decision on January 31, 2019. Proposed for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies, ALKS 5461 is a once-daily, oral investigational fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist, in the form of a sublingual tablet. The panel had voted 21 to 2 that the drug’s benefit-risk profile is not adequate to warrant its approval. The regulatory agency usually follows the decisions of its panels, although it is not mandatory. If approved, the Company expects ALKS 5461, which has a novel mechanism of action, to be a "blockbuster". ALKS closed Friday’s (Dec.21, 2018) trading at $28.45, down 4.40%.
星法马公司 FDA正在对星法马公司的VivaGel BV新药申请进行优先审查,预计将在1月初作出决定。 VivaGel BV是一种非抗生素、水性阴道凝胶, 用于治疗细菌性阴道病和预防反复出现的细菌性阴道病。 据估计,全球细菌性阴道病治疗市场约为7.5亿美元,用于预防反复出现的细菌性阴道病的市场约为10亿美元。 该产品已经在欧洲和澳大利亚获得批准。VivaGel BV在欧洲被授权给萌蒂制药有限公司,在澳大利亚被授权给阿斯潘药品公司,在澳大利亚以Fleurstat旗下品牌销售。 甲硝唑、氯林可霉素口服或阴道栓剂、阴道凝胶MetroGel-Vaginal和Solosec等抗生素是其他一些批准用于治疗细菌性阴道病的药物。 在美国, VivaGel BV被授权给ITF 制药公司。 除了销售额增加两位数的特许权使用费外,星法马公司有权从ITF 制药公司获得高达1.01亿美元的监管审批费用和商业化里程碑。 星法马公司以9.55美元的价格结束了上周五(2018年12月21日)的交易,下跌了3.44%。 默克 默克公司(MRK)已寻求FDA批准,将其畅销的癌症药物派姆单抗作为一线疗法,用于局部晚期或转移性非鳞状或鳞状非小细胞肺癌的治疗,这些患者的肿瘤表达PD-L1而无EGFR或ALK基因组肿瘤畸变。 监管机构将于2019年1月11日对拟议新适应症做出决定。 与阿斯利康共同开发和共同商业化的派姆单抗已被批准用于治疗黑色素瘤,非小细胞肺癌,头颈部鳞状细胞癌癌,经典霍奇金淋巴瘤,原发性纵隔大B细胞淋巴瘤,尿路上皮癌,微卫星不稳定性癌,胃癌,宫颈癌,肝细胞癌和梅克尔细胞癌。 该药在2017年全年为默克公司带来了38.1亿美元的收入,2018年前9个月的收入为50.2亿美元。 默克公司以72.90美元的价格结束了周五 (2018年12月21日) 的交易, 下跌了0.80%。 Exelixis公司 FDA将于2019年1月14日就Exelixis公司 (EXEL)补充新药物应用于尼莫单抗片剂作出决定,以治疗之前接受过治疗的晚期肝癌患者。 肝细胞癌(HCC)是最常见的肝癌类型,是美国上升最快的癌症相关死亡原因。它是全球第二大癌症死亡原因,每年导致70多万人死亡,新增病例近80万例。 尼莫单抗有20mg、40mg、60mg三种剂量,在美国已被批准用于晚期肾癌患者的治疗。 在欧盟、挪威、冰岛、澳大利亚、瑞士、韩国、巴西和台湾,该药物也被批准用于治疗先前接受过VEGF针对治疗的成人的晚期肾细胞癌(RCC),以及在欧盟用于先前未治疗的中危或低危晚期肾细胞癌。 尼莫单抗在2017年全年的净产品收入为3.24亿美元,2018年前9个月为4.283亿美元。 EXEL以17.72美元 的价格结束了周五 (2018年12月21日) 的交易, 下跌了3.70%。 安进 安进公司(AMGN)和UCB用于治疗骨折风险高的绝经后妇女的骨质疏松症的研究药物Evenity,将于2019年1月16日由FDA专家组审查。 去年7月,FDA拒绝了Evenity,要求两家公司提交来自另一项名为ARCH的III期活性比较器研究的疗效和安全性数据。 在ARCH研究中,默克公司的Fosamax联合均匀治疗12个月,与单独使用Fosamax相比,显著降低绝经后骨质疏松症患者骨折高风险的椎体新骨折、临床骨折和非椎体骨折的发生率。 然而,与Fosamax治疗相比,接受EVENITY治疗的患者心血管严重不良事件的发生率更高(12个月时的时间为 2.5%,Fosamax为1.9%),这引起了人们的关注。 今年7月,两家公司向FDA重新提交了生物制剂许可证申请,并提供了所需的数据。在监管机构做出最终决定之前,生物制品许可证申请将在上述日期,即2019年1月16日,由外部专家小组进行审查。 AMGN周五收盘报180.21美元,下跌2.57%。 Lexicon 制药 2019年1月17日,FDA将对Zynquista (sotagliflozin)进行审查,这是一种用于成人I型糖尿病胰岛素辅助治疗的实验性口服治疗药物。 Zynquista是赛诺菲(Sanofi, SNY)与Lexicon 制药合作开发的一种口服SGLT-1和SGLT-2双抑制剂,这两种蛋白质会影响肠道和肾脏吸收和清除糖(葡萄糖)的方式,从而改善血糖控制,并带来额外的临床效果。 FDA对Zynquista的最终决定预计将于2019年3月22日做出。 在临床试验中,Zynquista降低了血糖,帮助了I型糖尿病患者减肥并控制了血压。然而,这种候选药物与糖尿病酮症酸中毒(一种潜在的危及生命的并发症)的高发病率有关。 根据GlobalData Healthcare的数据,Zynquista预计将在2024年达到13亿美元的峰值。 lxrx 上周五 (2018年12月21日) 收盘交易, 价格为6.34 美元, 下跌8.65%。 Immunomedics Immunomedics公司(IMMU)申请Sacituzumab govitecan生物制剂许可证的日期是2019年1月18日,FDA正在对该许可证进行优先审查。 Sacituzumab govitecan用于治疗以前至少接受过两次治疗的转移性三阴性乳腺癌(mTNBC)患者。 三重阴性乳腺癌是一种乳腺癌,其细胞中没有雌激素、黄体酮和Her2蛋白受体。据说它更具有攻击性,很难治疗。 Sacituzumab govitecan也被称为IMMU-132,是一种新型的一级抗体-药物偶联物(ADC),可将中毒性化疗药物sn38的致命载荷传递给表达trop -2的细胞。Trop-2是三阴性肿瘤中90%以上表达的细胞表面糖蛋白。 如果获得批准,Sacituzumab govitecan将成为首个也是唯一一个获批用于治疗转移性三阴性乳腺癌的ADC。 IMMU immu 上周五 (2018年12月21日) 收盘价为 155. 04, 上涨6.14%。 赛诺菲 FDA关于SNY要求将0.5 毫升流感疫苗的年龄指标扩大到包括6至35个月的儿童的决定定于2019年1月28日做出。 目前,只有36个月及以上的人可以服用0.5 ml的剂量。对于6-35个月的儿童,核准的氟酮四价剂量为0.25 ml。 氟酮四价对四种不同的流感病毒株-两种A型流感病毒和两种B型流感病毒有效。 SNY周五(2018年12月21日)收盘价为 $42.32 美元, 下跌2.6%。 Aquestive 制药 Aquestive制药公司(Aquestive Therapeutics Inc.)的APL-130277被提议作为一种间歇性疗法,用于治疗帕金森病的间歇性发作,等待2019年1月29日FDA的决定。 APL-130277是一种舌下膜制剂, 是一种非多巴胺激动剂。 Sunovion制药公司是Aquestive公司的合作伙伴, 也是APL-130277的赞助商。 如果获得批准,APL-130277预计将带来7亿美元的最高销售额。 口服左旋多巴是帕金森病的“黄金标准”疗法。随着时间的推移,随着病情的发展,药物并没有达到最佳的疗效,导致症状(运动和非运动)的再次出现,而不是由它控制。这些时期被称为间歇期。 间歇期的部分特征是震颤、僵硬或缓慢运动。这些事件可能会干扰一个人进行日常活动的能力,对病人、家人和护理人员来说可能是一种负担。 艾伯维公司(AbbVie Inc.)的Duopa使用一种小型便携式输液泵给药,这种输液泵 能将碳化物多巴和左旋多巴直接送入小肠;Apokyn,一种注射用药物;脑深部刺激和手术治疗是目前帕金森病患者的一些治疗选择。 Acorda 制药公司(Acorda Therapeutics Inc.)位于布里亚,直到2018年12月21日才被批准用于治疗服用carbidopa/levodopa方案的帕金森病患者的非发作期。 AQST周五(2018年12月21日)收盘报6.51美元,下跌5.65%。 Alkermes公司 去年11月,Alkermes plc (ALKS)申请ALKS 5461新药被FDA专家组拒绝,等待2019年1月31日的最终决定。 建议用于对标准抗抑郁治疗反应不足的患者进行重度抑郁症的辅助治疗,ALKS 5461是一种每日一次的口服研究固定剂量丁丙诺啡组合,一种部分μ阿片受体激动剂和κ-阿片受体拮抗剂 和samidorphan,一种μ-阿片受体拮抗剂,以舌下片剂的形式存在。 专家组以21票赞成、2票反对的结果认为,该药物的收益-风险组合不足以证明其获得批准。 监管机构通常遵循其小组的决定,尽管这不是强制性的。 如果获得批准,公司预计具有新颖作用机制的ALKS 5461将成为“重磅炸弹”。 ALKS周五收盘(2018年12月21日),价格为28.45美元,下跌4.40%。

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