MediWound_NOI.pdf

The Office of Acquisitions Management, Contracts, & Grants (AMCG) anticipates executing an option to Contract number HHSO100201500035C to support the Biomedical Advanced Research and Development Agency’s (BARDA) contract with MediWound Ltd, Yavne, Israel (MW). This contract was awarded competitively in September 2015, under solicitation number 15-100- SOL-00021-- see link below to the full acquisition on FBO. The Government’s need was for at a minimum, an active clinical Phase II study or pilot study that that had the prospective to be an effective, enzymatic debridement product for thermal burn mass casualty preparedness, that would be efficacious within 24 hours of first treatment; with a further requirement that the debridement product had the potential for use in both adults and special populations (e.g. pediatrics, immunocompromised, elderly). One award was made in response to the solicitation. The contract with MW is for the development and procurement of MW’s product for definitive care of thermal burn injuries, which may result from various threats such as the detonation of an improvised nuclear device (IND). The exercising of this option does not materially modify the original scope of work under the option or deviate from the statement of objectives in the solicitation.

The ongoing base period is for the development of their product aimed at US licensure for use in adults; a Phase III clinical trial is current. The option is for a US-based Phase III pediatric trial to potentially make the medical countermeasure available for children aged 0-18 years in response to mass burn casualty public health emergencies. MediWound is conducting a similar pediatric trial in Europe that is ongoing. For that trial, and in preparation for the US trial, MediWound has experienced a significantly lower recruitment rate than what it had assumed. This was due to unforeseen challenges in finding qualified patients. To meet FDA regulations for an adequate patient population, MW will add additional trial sites in the US.

and provide more personnel support to ensure qualified patients are recruited for the trial within a feasible timeframe. As a result of the challenges above, the cost to conduct the trial has increased and the option’s period of performance has been extended from 60 months to 72 months.

MW owns all intellectual property rights for their debridement product and is the only known source that can legally conduct Phase III US pediatric trials to potentially achieve the critical need for an effective, enzymatic debridement product for thermal burn mass casualty preparedness that would be efficacious within 24 hours of first treatment.

All questions concerning this requirement shall be addressed directly to the contractual point of contact, Matthew Rose, at matthew.rose@hhs.gov or by telephone, 202-205-2901.

https://www.fbo.gov/index?s=opportunity&mode=form&id=bcfccf800da38bc07a8 74df807700716&tab=core&_cview=1 https://www.fbo.gov/index?s=opportunity&mode=form&id=bcfccf800da38bc07a874df807700716&tab=core&_cview=1 https://www.fbo.gov/index?s=opportunity&mode=form&id=bcfccf800da38bc07a874df807700716&tab=core&_cview=1 https://www.fbo.gov/index?s=opportunity&mode=form&id=bcfccf800da38bc07a874df807700716&tab=core&_cview=1 https://www.fbo.gov/index?s=opportunity&mode=form&id=bcfccf800da38bc07a874df807700716&tab=core&_cview=1