Fosamprenavir calcium

Produced in the U.S., the generic anti-fungal drug is fully substitutable for Noxafil® LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi announced today it has introduced Posaconazole Injection, a generic substitute for Noxafil®, for use in treating or preventing serious fungal infections in adults and children who have an increased chance of getting these infections due to a weakened immune system. Now available in the U.S., Posaconazole Injection is the newest addition to Fresenius Kabi’s portfolio of more than 30 anti-infective molecules. This press release features multimedia. View the full release here: Fresenius Kabi Posaconazole Injection, a generic substitute for Noxafil® (Photo: Business Wire) Available in a 300 mg per 16.7 mL vial, Posaconazole Injection is used to treat invasive aspergillosis, a serious fungal infection, in adults and teenagers 13 years of age and older. It is also used to prevent invasive aspergillus and candida infections in patients who are severely immunocompromised, including adults and pediatric patients age 2 or older. “The introduction of Posaconazole Injection reflects Fresenius Kabi’s ongoing commitment to expanding our portfolio of affordable generic options for the treatment and/or prevention of life-threatening infections,” said John Ducker, president and CEO of Fresenius Kabi USA. Posaconazole Injection is produced at the company’s pharmaceutical production site in Grand Island, New York. Fresenius Kabi has invested nearly $1 billion to expand and update its U.S. pharmaceutical production and distribution network. More than 70 percent of the product units shipped in the U.S. by Fresenius Kabi are drugs listed on the FDA’s Essential Medicines List. “We are doubling our U.S. manufacturing capacity to enhance the resilience of our supply chain, which helps assure fast, reliable service for our customers and the patients they serve,” said Lindsey Thomas, senior vice president of marketing of Fresenius Kabi USA. “Our investments will help patients gain access to the treatments they need – when and where they need them most.” Learn more about Fresenius Kabi’s commitment to strengthening its domestic supply chain at MoreInAmerica.com. About Fresenius Kabi Fresenius Kabi ( ) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn. References *Noxafil® is a registered trademark of Merck Sharp & Dohme LLC. About Posaconazole Injection Posaconazole is an azole antifungal indicated as follows: Posaconazole injection is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older. Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: Posaconazole injection: adults and pediatric patients 2 years of age and older. IMPORTANT SAFETY INFORMATION Posaconazole is contraindicated in persons with known hypersensitivity to posaconazole or other azole antifungal agents. Coadministration of Posaconazole with the following drugs is contraindicated; Posaconazole increases concentrations and toxicities of: Sirolimus CYP3A4 substrates (pimozide, quinidine): can result in QTc interval prolongation and cases of torsades de pointes (TdP) HMG-CoA Reductase Inhibitors Primarily Metabolized through CYP3A4 Ergot alkaloids Venetoclax: in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) at initiation and during the ramp of phase Calcineurin-Inhibitor Toxicity: Posaconazole increases concentrations of cyclosporine or tacrolimus; reduce dose of cyclosporine and tacrolimus and monitor concentrations frequently. Arrhythmias and QTc Prolongation: Posaconazole has been shown to prolong the QTc interval and cause cases of TdP. Administer with caution to patients with potentially proarrhythmic conditions. Do not administer with drugs known to prolong QTc interval and metabolized through CYP3A4. Electrolyte Disturbances: Monitor and correct, especially those involving potassium (K+), magnesium (Mg++), and calcium (Ca++), before and during Posaconazole therapy. Hepatic Toxicity: Elevations in liver tests may occur. Discontinuation should be considered in patients who develop abnormal liver tests or monitor liver tests during treatment. Renal Impairment: Posaconazole injection should be avoided in patients with moderate or severe renal impairment (creatinine clearance <50 mL/min), unless an assessment of the benefit/risk to the patient justifies the use of Posaconazole injection. Concomitant Use with Midazolam: Posaconazole can prolong hypnotic/sedative effects. Monitor patients and benzodiazepine receptor antagonists should be available. Vincristine Toxicity: Concomitant administration of azole antifungals, including Posaconazole, with vincristine has been associated with neurotoxicity and other serious adverse reactions; reserve azole antifungals, including Posaconazole, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options. Venetoclax Toxicity: Concomitant administration of Posaconazole with venetoclax may increase venetoclax toxicities, including the risk of tumor lysis syndrome, neutropenia, and serious infections; monitor for toxicity and reduce venetoclax dose. Adult Patients: Common adverse reactions in studies with Posaconazole in adults are diarrhea, nausea, fever, vomiting, headache, coughing, and hypokalemia. Pediatric Patients: Common adverse reactions (incidence >20%) receiving 6 mg/kg Posaconazole injection in a study in pediatric patients are pyrexia, febrile neutropenia, vomiting, mucosal inflammation, pruritus, hypertension, hypokalemia, and stomatitis. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or . Drug Interactions: Interaction Drug Interaction Rifabutin, phenytoin, efavirenz Avoid coadministration unless the benefit outweighs the risks Other drugs metabolized by CYP3A4 Consider dosage adjustment and monitor for adverse effects and toxicity Digoxin Monitor digoxin plasma concentrations Fosamprenavir Monitor for breakthrough fungal infections Pregnancy: Based on animal data, may cause fetal harm. Pediatrics: Safety and effectiveness in patients younger than 2 years of age have not been established. Severe Renal Impairment: Monitor closely for breakthrough fungal infections. This Important Safety Information does not include all the information needed to use Posaconazole Injection safely and effectively. Please see the full prescribing information for Posaconazole Injection available at .

创新药企的发展，总是要经历积年累月无穷无尽的失败，突然间命运垂青，才会大有进展，否则就有可能永恒的黑暗笼罩。这样的节奏在其他任何领域都只会令人发疯，但在创新药领域却是成长必经的。也正因此，回看美国过去百年发展，从Biotech成长为Big pharma的药企寥寥无几。每一家完成跃迁的药企，背后都有一些对难而正确的事的坚持。而能坚持下来的，最终都会慢慢活成Biopharma的样子。福泰制药就是其中的一家。与大部分Biotech一样，在成立的前十几年，福泰制药的药物研发屡战屡败、屡败屡战。从最开始的免疫抑制剂再到HIV，再到丙肝的抗病毒疗法，福泰制药经过了20年的试错，终于找到了囊性纤维化这片应许之地。抓住囊性纤维化机会的福泰制药疯狂迭代产品，革自己的命，最后形成了绝对的垄断。如今，福泰制药已经是一家市值近千亿美金的Biopharma。福泰制药的成功，再次向我们展示了创新药研发本质：在一个细分领域深耕到极致后，就能带来巨大的财富。二十年的失败之路如果用一个词语，来描述福泰制药上市前三十年的境遇，“艰难”一词或许颇为合适。因为和大部分Biotech一样，如今市值近千亿美元的福泰制药，在成立后的十几年时间里，一款创新药也没有研发出来。1989年，福泰制药成立之初便立项的重点产品强力免疫抑制剂FK-506，在烧掉公司大部分融资之后，以失败告终。直到1999年，经历十年的挣扎后，福泰制药终于迎来首个商业化的药物，治疗HIV的Agenerase。不过，对于福泰制药来说，这首款上市的药物象征意义大于实际意义。因为，Agenerase已经是市场上第五个上市的HIV蛋白酶抑制剂，并且还存在着难以吞咽的问题。在这样的情况下，Agenerase注定无法带给福泰制药足够的回报。虽然在2003年，福泰制药推出了改进版fosamprenavir，但依然无力拯救公司的持续亏损。在看清自己在HIV领域难以获得成功后，2008年福泰把这两款HIV药物卖出，彻底退出HIV领域。转眼来到2011年，这一年，福泰制药治疗慢性丙肝的替拉瑞韦，于上市首年销售额超过5亿美金，远超过市场预期。福泰制药也因为这款药物，首次实现了盈利。本以为公司命运能够就此出现惊天逆转，但没想到造化弄人。2013年，吉利德推出了一款丙肝神药 Sovaldi，能够彻底治愈丙肝。随着这一强劲对手的出现，福泰制药的盈利希望戛然而止。福泰制药不得不在2014年黯然离开乙肝领域。来自囊性纤维化领域的机会辛辛苦苦二十年，一朝回到解放前，毫无疑问福泰制药是不幸的。但与当时大部分Biotech相比，福泰制药又是幸运的。在乙肝领域失败后，福泰制药在另一个领域获得空前的成功，那就是囊性纤维化领域。囊性纤维化是一种常染色体隐性遗传病，由囊性纤维化跨膜电导调节因子（CFTR）基因突变引发，现在已知该基因约有2000种突变。这一疾病会导致粘液在患者的肺部聚集，造成感染和肺部损伤。过去，囊性纤维化的治疗以控制症状为主，大部分患有这种疾病的人寿命只有40年，几乎是一种绝症。而当时，囊性纤维化患者群体并不大，美国大约仅有三万患者，与此同时治疗药物研发难度又很大，所以几乎没有药企愿意深耕这一领域。即便如今成功的福泰制药，在囊性纤维化上的成就，也属于无心插柳柳成荫。将时间拉回到2001年5月，彼时福泰制药以5.92亿美元的价格收购了即将倒闭的Aurora。希望加强其开发和销售新的高通量筛选(HTS)的实力。在收购完成后，福泰制药发现了这家公司有遗留资产需要处理，其中就包括Aurora和囊性纤维化基金会的合作。本来，福泰制药对这一遗留项目没有抱太大的期望，但因为囊性纤维化基金会的资助资金无需任何未来回报，是一种成本较低的融资形式，所以这一项目还是被保留了下来。命运的齿轮，自此开始转动。2008年，福泰制药的囊性纤维化团队研发的增效剂Kalydeco，在临床试验中期数据显示，用药2周后和安慰剂相比，最高剂量的患者肺功能改善了10%。随着这一积极数据的出炉，福泰制药开始重视起来这一项目，囊性纤维化药物研发开始提速。到了2011年，福泰制药公布Kalydeco的积极临床III期数据，在2012年1月底，FDA批准这款药物上市。凭借着年费用31万美元的高昂定价，2013年Kalydeco的销售额就达到了3.71亿美元。福泰制药的苦日子，总算是熬到头了。一条难以跨越的护城河福泰制药是囊性纤维化治疗领域的拓荒者，也是颠覆者。首个治疗药物Kalydeco的成功，将福泰制药带到了成功的方向上。其注意到囊性纤维化领域的巨大市场，并开始加大投入，以期待获得更大的回报。Kalydeco属于CFTR强化剂，能够打开细胞表面损坏的CFTR通道大门，但对于CFTR蛋白损坏严重、甚至都不能到达细胞表面的病人，仅有CFTR强化剂无法发挥作用。当时Kalydeco针对的是g551d突变的患者，这只能帮助6%的美国囊性纤维化患者。而福泰制药的目标是，覆盖更多的囊性纤维化患者。为此，公司后续又成功开发出CFTR矫正剂。2015年，Orkambi获批上市，2018年Symdeko获批上市，2019年Trikafta获批上市。CFTR矫正剂可以重新折叠变异的CFTR蛋白并使之能够转运到细胞表面。CFTR强化剂和CFTR矫正剂组成二联疗法以及三联疗法，使得福泰制药的囊性纤维化药物覆盖患者的比例从5%提升至90%，同时疗效也得到提升。一项包含超过16000名美国患者的真实世界研究显示，通过Trikafta治疗能够降低87%的肺移植风险、减少77%的肺部恶化情况、降低74%的死亡风险。通过不断迭代产品，福泰制药已经在囊性纤维化病领域占据了绝对的统治地位。如今，囊性纤维化疾病患者的预期寿命不断增长，这一疾病已经从当初的绝症慢慢转变为一种慢性疾病，也成为了福泰制药的摇钱树。作为囊性纤维化的唯一玩家，2022年，上述4款囊性纤维化药物，为其贡献了89.31亿美元收入。如今，福泰制药市值接近千亿，跻身全球三十大药企排行榜，是为数不多，从Biotech成功跨越成Bio pharma的美国药企。自我革命造就的千亿帝国看到这里，你可能会有疑问，囊性纤维化这么大的市场，难道就没有其他药企来与福泰制药竞争吗？当然有。艾伯维对囊性纤维化市场一直虎视眈眈，并开启了三药联用治疗囊性纤维化的临床试验。一度，艾伯维都被视为福泰制药的一大威胁。不过，遗憾的是，艾伯维针对囊性纤维化布局的产品，接连出现失败，为此艾伯维不得不终止了所有囊性纤维化的临床试验。艾伯维的失败，也凸显出囊性纤维化领域的研发并不容易。而福泰制药通过一次次药物迭代，不仅在产品层面铸造了护城河，还在技术层面留下了深厚的积累。凭借着这些优势，尽管已经覆盖了90%的患者，福泰制药还在囊性纤维化领域努力迭代。目前，福泰制药正在与Moderna合作开发VX-522，这是一种囊性纤维化的mRNA疗法，旨在通过使肺部细胞产生功能性CFTR蛋白，这能为囊性纤维化患者带来变革性的益处，甚至从源头上治疗这种疾病。由此不难看出，福泰制药这一千亿Biopharma的养成秘诀，可以概括为一句话：在被别人颠覆前，先颠覆自己。在过去的几十年间，福泰制药与大部分大药企不同，它的管线并没有太丰富，目前绝大多数管线都设定在罕见病领域上，比如抗胰蛋白酶缺乏症、血红蛋白病、介导性肾病、进行性肌营养不良症等。当然，它最为重要的管线依然集中在囊性纤维化领域。在囊性纤维化领域，福泰制药不等被竞争对手颠覆，便通过新的产品线去颠覆自己的已有产品线，以保证更多更具竞争力的产品不断脱颖而出，最终实现自己在行业内遥遥领先的产品代际优势。这种“颠覆性迭代能力”，也是它能够从Biotech跨越为Biopharma，坐稳千亿市值的关键。事实上，在创新药领域，颠覆与被颠覆的剧情不断发生。第三代ADC药物颠覆第二代ADC药物的生命，第三代EGFR颠覆第二代EGFR的生命......这也提醒了每家药企，无论在大航海时代你们将创造什么，真正需要做的是，全力以赴奔跑。因为，你往往无法知道自己正处在哪一种情况，只有保持奔跑、不断颠覆自己，才能最大程度避免被别人颠覆的悲剧。