San Diego biotech Otonomy isn't biding its time, filing to go public in an $86.3 million IPO just three days after unveiling positive Phase III results for its lead drug.
The company, hardly short on cash after closing a $49 million Series D in April, plans to use its proceeds to wrap up development of its top prospect, AuriPro, and pour the rest into two pipeline treatments for ear-related disorders. Key to each drug is Otonomy's proprietary delivery technology, which uses a thermosensitive polymer to mete out treatment after a single injection.
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 called tympanostomy. The drug met its primary endpoints in two Phase III trials, Otonomy said last week, and now the biotech intends to file for FDA approval in the first half of 2015. If the agency signs off, the company plans to launch the product on its own the following year.
Behind its top prospect, Otonomy has OTO-104, a steroid treatment for a rare inner ear disorder called Ménière's disease that disrupts hearing and balance. That therapy is in the midst of a Phase IIb trial on 140 patients with data expected next year. If those results come back positive, the company plans to roll '104 into Phase III in 2015. Otonomy's third candidate, the preclinical tinnitus treatment OTO-311, is in line to enter the clinic next year, the company said.
|Otonomy CEO David Weber|
Driving Otonomy's efforts is CEO David Weber's belief that the industry is entering a new age for ear treatments. Before the dawn of VEGF-inhibiting therapies, patients with vision-damaging ophthalmic diseases had few treatment options, an unmet need that helped turn drugs like Eylea and Lucentis into blockbusters, Weber has said. Now, a similar storm is brewing for disorders that rob patients of their hearing, he said, and Otonomy is on the cutting edge.
Weber estimates the global market for Otonomy's products at north of $1 billion, and while the biotech is positioning itself to be able to go it alone on the commercial front with AuriPro, it will keep its ears open to partnerships and deeper deals for ex-U.S. marketing, Weber told FierceBiotech earlier this year.
The company, which plans to trade under "OTIC," has raised about $143 million in venture cash since its foundation by Avalon Ventures in 2008, and its backers include OrbiMed Advisors, Novo, TPG Biotech and Domain Associates.
- read the S-1