SPECIAL NOTICE
99 -- Notice of Intent to Sole Source - Stemnion Inc.
- Notice Date
- 12/5/2011
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- N62645 Naval Medical Logistics Command 693 Neiman Street Ft. Detrick, MD
- ZIP Code
- 00000
- Solicitation Number
- N6264512WM001
- Archive Date
- 12/26/2011
- E-Mail Address
-
NMLC Research Division
(NMLC-Research@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command intends to award a sole source contract under the authority of 6.302-1 to Stemnion, Inc., 100 Technology Drive, Pittsburgh, PA 15219, for the performance of continued research and development efforts in support of the Naval Medical Research Center s cellular combat wound initiative. The contract award builds upon Stemnion s successful completion of pre-clinical animal trials and the appropriate pre-clinical animal safety testing. The latter included multiple toxicology studies that resulted in FDA permission to proceed with a 2009 Phase I human clinical trial using ACCS to demonstrate safety in the treatment of partial thickness burns. The Phase I human trial outcomes demonstrated safety in the treatment regimen and allowed Stemnion to proceed to the next round of clinical trials. Those efforts include: Preparation and Development of Materials for Research and Clinical Trials ACCS Research & Development: formulations for controlled-release, release to specific tissues and to stabilize the ACCS for storage at room temperature. Immunology Ocular Surface Disorder/Dry Eye Clinical Trial The estimated value of this contract is $8.347 Million. The period of performance for this contract is anticipated to be a base period of 18-months. Stemnion controls over 20 patents pending that are directly related to the AMP cell and ACCS cytokine solution therapies that are entering FDA Phase I and Phase II clinical trials. Stemnion is positioning itself to have a first-in-class, FDA-approved product for use in wound healing and, eventually, other clinical applications as well. Although other companies will be able to produce their own products based on their own proprietary technology and cells, it will be very difficult for a company to develop a generic (me-too) version of Stemnion s product for several reasons. The first is that Stemnion s products are very complex biologicals which would be hard to replicate. Secondly, Stemnion s confidential, proprietary process would be difficult if not impossible to copy. Thirdly, the Affordable Care Act provides for 12 years of data exclusivity for new biologics such as Stemnion s products. Therefore, once Stemnion s product is FDA-approved, even if a company were able to make a same or similar product (termed a biosimilar ) it would still have to wait 12 years before being allowed to rely on data generated by Stemnion to obtain FDA approval. This would force a company interested in producing a biosimilar to commit millions of dollars and years of research to generate their own preclinical and clinical data. Based on these unique capabilities and the previous work done with Stemnion. Stemnion is the only company capable of meeting the Government s requirements. 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 and other information sufficient to determine capability to perform the proposed contract effort. All capability statements received by 3:30PM Eastern Time on December 20, 2011, will be considered by the Government. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for purpose of determining whether to conduct a competitive procurement. Capability statements shall be submitted by email ONLY as a Microsoft Word or Adobe PDF attachment to NMLC-Research@med.navy.mil.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6264512WM001/listing.html)
- Record
- SN02633245-W 20111207/111205234022-a89ed0f88d0b86aac8370ef1da157d34 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |