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突发:美股Achaogen抗生素新药上市不到一年,公司破产

传播正能量的 药融圈 2020-08-31


这种情况未来在中国也会比较常见;产品未上市,泡泡还可以再多一点,促进新药研发环境。


看看哪些公司会去接手该Achaogen, Inc. (Nasdaq: AKAO)(阿超基因)资产,盘它,盘活它!



1


2018年6月,美国FDA批准新一代氨基糖苷类抗生素Plazomicin用于治疗成人复杂性尿路感染,包括由肠杆菌科细菌、假单胞菌属等引起的肾盂肾炎,而不推荐用于治疗血流感染。



FDA批准依据是2个3期临床试验的相关数据:EPIC(009项目)和CARE(007项目)。在EPIC试验中,191例使用Plazomicin与197例使用美罗培南的患者相比,结果表明Plazomicin治疗复杂性尿路感染的疗效非劣效于美罗培南。



在CARE(007项目)试验中,纳入研究对象为碳青霉烯类耐药肠杆菌科细菌引起的医院内获得性肺炎/呼吸机相关性肺炎和/或血流感染患者,与粘菌素相比,经Plazomicin治疗的患者具有较低的死亡率或严重疾病相关并发症的发生率。与其他氨基糖苷类抗菌药物类似,Plazomicin可能引起中度肾毒性,一般停药后可恢复。


2


2019年4月15日, Achaogen, Inc. (Nasdaq: AKAO)(阿超基因)宣布近期公司将展开申请破产程序。



3.公司披露原文:


SOUTH SAN FRANCISCO, Calif.April 15, 2019 (GLOBE NEWSWIRE) -- Achaogen, Inc. (Nasdaq: AKAO), a biopharmaceutical company developing and commercializing innovative antibacterial agents to address multi-drug resistant (MDR) gram-negative infections, announced today that it has filed a voluntary petition under Chapter 11 of the Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware (the Court). Achaogen has also filed a motion seeking authorization to pursue an auction and sale process under Section 363 of the U.S. Bankruptcy Code.

Achaogen has filed a series of motions with the Court seeking to ensure the continuation of normal operations during this process. Achaogen has the support of its secured lender, Silicon Valley Bank, which has made a $25 millionfinancing commitment to fund the Company’s operations through the auction and sale process. The Company believes that this commitment provides it with sufficient liquidity to continue to meet its operational and financial obligations to patients, physicians, suppliers and employees.

“The Achaogen Board of Directors and management team have thoroughly assessed our strategic options and financial situation and unanimously agree that this structured sale process represents the best possible solution for the Company,” said Blake Wise, CEO of Achaogen. “We continue to believe ZEMDRI® (plazomicin) has the potential to be a valuable component of a portfolio of anti-infective or hospital products and an important life-saving medicine for patients.”

来源:

http://investors.achaogen.com/node/10806/pdf;

https://www.zemdri.com/efficacy/epic-study-design。


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