Notice of Prospective Space Act Agreement and Intent to Transfer Sponsorship of Investigational New Drug Application

Synopsis – Jul 19, 2012
General Information
Solicitation Number: NNJ12ZBH001O
Posted Date: Jul 19, 2012
FedBizOpps Posted Date: Jul 19, 2012
Recovery and Reinvestment Act Action: No
Original Response Date: Aug 03, 2012
Current Response Date: Aug 03, 2012
Classification Code: 99 — Miscellaneous
NAICS Code: 325412

Contracting Office Address

NASA/Lyndon B. Johnson Space Center, Houston Texas, 77058-3696, Mail Code: BH

Description

SUMMARY: The National Aeronautics and Space Administration (NASA) has identified a potential pharmaceutical industry partner named Epiomed Therapeutics, Inc., having its principal place of business in Irvine, California, which is interested in assuming responsibilities for the further development and commercialization of a pharmaceutical dosage form for intranasal administration of scopolamine (INSCOP).

NASA has been actively engaged in the clinical development of this agent and is now seeking a Space Act Agreement (SAA) Partner whose role will include production of the formulation under FDA stipulated GMP GUIDELINES for clinical trials. In the future, an SAA Partner should have sufficient resources to provide the additional corporate pharmaceutical and regulatory expertise necessary to execute effective communication and documentation with the FDA, ensure completion of clinical trials under the existing IND, and, pursue subsequent approval of a New Drug Application (NDA) and successful market release of the new drug. A license to related patent rights may in the future be necessary in order to commercialize drug products arising from the SAA.

INSCOP is currently being investigated in Phase II clinical trials under NASA-sponsored Investigational New Drug (IND) Application No. 33,983 registered with the Food and Drug Administration (FDA). The data contained in this IND, along with the data that will emerge from NASA’s ongoing clinical trials and subsequent work under the SAA, would be available to the SAA Partner. The SAA would give the opportunity to secure FDA approval of a transfer of the IND sponsorship from NASA to Epiomed Therapeutics.

DATES: The prospective Space Act agreement may be entered into unless within fifteen (15) days from the date of this published notice, NASA receives written objections including evidence and argument that establish that the grant of the agreement and transfer of IND sponsorship would not be consistent with applicable policy and procedural guidance, such as NASA Policy Directive (NPD) 1050.1I, “Authority to Enter Into Space Act Agreements;” NASA Advisory Implementing Instruction 1050-1B, “Space Act Agreements Guide;” or other applicable federal law. Competing applications completed and received by NASA within fifteen (15) days of the date of this published notice will also be treated as objections to the grant of the contemplated Space Act agreement.

Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

ADDRESSES: Objections relating to the prospective Space Act agreement may be submitted to Chief Counsel, Office of Chief Counsel, NASA Johnson Space Center, 2101 NASA Parkway, Houston, Texas 77058, Mail Code AL; Phone (281) 483-3021; Fax (281) 483-6936.

FOR FURTHER INFORMATION CONTACT: Harry Gruchala, Attorney-Advisor, Office of Chief Counsel, NASA Johnson Space Center, 2101 NASA Parkway, Houston, Texas 77058, Mail Code AL; Phone (281) 483-1001; Fax (281) 483-6936.

Point of Contact

Name: LaToy J. Jones
Title: Contracting Officer
Phone: 281-244-8023
Fax: 281-483-4066
Email: latoy.j.jones@nasa.gov