Award notice for continued studies into developing aFDA-approved pharmaceutical to treat noise-induced hearing loss (NIHL).

The Naval Medical Logistics Command (NMLC) intends to award a sole source contract under the authority of FAR 6.302-1 to Otologic Pharmaceutics Inc. (OPI); Oklahoma City, OK, 73104, to continue the Navy’s studies into developing a FDA-approved pharmaceutical (HNP-1010) to treat noise-induced hearing loss (NIHL). The proposed research is a continuation of several previous studies performed by OPI and funded by the Office of Naval Research (ONR). In previous work, OPI completed the research and development to demonstrate that their lead compound, HPN-1010, is effective in preventing NIHL in animals. A large amount of work has already been completed in support of a FDA Investigational New Drug (IND) application.

This work will complete the toxicology, pharmacokinetic, animal efficacy and dose optimization studies of HPN-1010 and will significantly accelerate the commercialization of this technology thereby accelerating the development of safe and effective hearing health solutions to the warfighter. The estimated value of the contract is $688,600.00.



No other vendors are capable of performing this work because OPI is the only company that has the medication being tested in the study (NHPN-1010). They are the sole manufacturer of the medication and have a patent pending. The proprietary nature of the medicine means that there are no other companies who have or could obtain the medicine except OPI.



This Notice of Intent is not a request for competitive proposals and no solicitation document exists for this requirement.

However, parties interested in responding to this notice will need to submit technical data, including cost, sufficient to determine capability. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.



All capability statements received by 9:00 AM Eastern Time, 6 JUNE 2012 will be considered by the Government. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to NMLC-Research@med.navy.mil.