Otonomy耳部疾病药物AuriPro即将进入上市申报阶段

总部位于美国圣迭戈的Otonomy生物技术公司最近宣布公司开发的用于降低耳部疾病感染手术术后综合征药物AuriPro（OTO-201）已经完成临床三期研究，并达到了预期目标。公司CEO David Weber表示将开始着手进行该药物在美国市场上市的审批流程，同时公司也表示希望寻找到共同开拓海外市场的合作伙伴。AuriPro是一种长效型环丙沙星，能够减少患者术后服用抗生素的频率。为了开发AuriPro，公司今年融资4900万美元。

作为一家成立于2008年的生物技术公司，Otonomy公司至今已经融资1亿4千3百万美元，其投资者包括了Avalon Ventures, RiverVest Venture Partners和Aperture Venture Partners等著名投资公司。

详细英文报道：

Privately held Otonomy is touting positive late-stage results for its investigational ear treatment, gearing up for an FDA application just months after raising $49 million in venture cash.

AuriPro, formerly OTO-201, is a sustained-release formulation of the antibiotic ciprofloxacin designed to reduce postoperative complications in pediatric patients undergoing tube-placement surgery. In two Phase III trials, the treatment did just that, Otonomy said, meeting its primary endpoint of 15-day freedom from ear drainage in patients aged 6 months to 17 years old.

Now the San Diego biotech is preparing for a regulatory filing, CEO David Weber said, and the company is planning to launch AuriPro in the U.S. on its own, keeping an eye out for partners who can help move the product overseas.

About 1 million such tube placements are conducted in the U.S. each year, Otonomy figures, and the majority of patients require inconvenient, twice-daily administrations of antibiotic ear drops for 7 days. AuriPro is designed to provide a single-dose solution to procedural after effects, and the company believes it can shoulder its way onto the market with a specialist sales force targeting ear, nose and throat specialists.

Otonomy has $49 million in fresh financing to get it there, in April closing a round that brought in new investors including Jennison Associates, Perceptive Advisors and Federated Kaufmann Funds, alongside repeat backers like OrbiMed, Novo, TPG Biotech and Domain Associates.

Beyond AuriPro's launch, that funding will help speed along OTO-104, a Phase III steroid treatment for an inner ear disorder called Ménière's disease that disrupts hearing and balance. Otonomy also has a preclinical tinnitus drug that will soon make its way into clinical trials thanks to the new funding, the company said.

The company has raised about $143 million since its foundation in 2008, and the Otonomy's investors include Avalon Ventures, RiverVest Venture Partners and Aperture Venture Partners.