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Request for Information for the award of commercial sublicense agreements for a generic version of cefiderocol

Closing date: 30.06.2025

1. Summary

GARDP’s Business Development Department is in charge of in- and out-licensing activities related to GARDP portfolio.
GARDP has obtained a license from Shionogi & Co., Ltd. to manufacture and commercialize a generic version of cefiderocol (“Product”) in a territory comprising 135 countries (“Territory”, see Annex 1).
The Product is a first-in-class antibiotic for the treatment of serious Gram-negative bacterial infections that may be resistant to other antibiotic treatments.
GARDP intends to commercialize the Product in 1-gram vials for injection through the support of commercial sublicensee(s) (“Commercial Sublicensee(s)”) in a phased manner based on a prioritization of countries in the Territory (“Prioritized Countries”, see Section 4).
Through this “Request for Information for the award of commercial sublicense agreements for a generic version of cefiderocol”, GARDP is seeking to select Commercial Sublicensee(s) to commercialize the Product in Prioritized Countries, in alignment with GARDP’s Access Strategy and Priorities (https://gardp.org/wp-content/uploads/2023/11/Access_Strategy_And_Priorities_20231117.pdf).

2. Background

In 2022, Shionogi & Co., Ltd. (“Shionogi”) and GARDP announced the signature of a license and technology transfer agreement (“License Agreement”).
The License Agreement’s purpose is to ensure access to cefiderocol across the Territory. Cefiderocol is included in the World Health Organization (“WHO”) Model List of Essential Medicines and targets a number of Gram-negative WHO priority pathogens. It was approved by the US Food and Drug Administration in 2019 and by the European Medicines Agency in 2020.
In 2023, GARDP and India-based Orchid Pharma Ltd signed a manufacturing sublicense agreement (“Manufacturing Sublicense Agreement”) to have cefiderocol manufactured. The Manufacturing Sublicense Agreement encompasses important access, environmental and stewardship provisions, including cost-plus pricing, with a commitment to lower the costs based on volumes to help keep the Product affordable for patients and health systems in low-resource settings. The sublicense access plan, constituting a part of the Manufacturing Sublicense Agreement, also stipulates that Orchid will submit the Product to the WHO medicines prequalification (PQ) programme.

3. The Product

The originator of the Product is Shionogi. It commercializes the Product in Japan under the brand name Fetroja.
The Product is the first and only siderophore cephalosporin antibiotic for the treatment of serious Gram-negative infections. It has a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore. In addition to entering cells by passive diffusion through porin channels, cefiderocol binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria. These mechanisms allow cefiderocol to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells. Cefiderocol has also demonstrated in-vitro activity against certain bacteria that contain problematic resistant enzymes such as ESBLs, AmpC, and serine- and metallo-carbapenemases. Data from multinational surveillance studies for cefiderocol demonstrated potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant A. baumannii, P. aeruginosa, Enterobacterales and S. maltophilia. Cefiderocol has no clinically relevant in vitro activity against most Gram-positive bacteria and anaerobic bacteria.

4. Scope of Work

GARDP is looking for Commercial Sublicensees to commercialize the Product in one or more Prioritized Countries. The commercial sublicenses will be granted on a non-exclusive basis.

The Prioritized Countries are:

  • Latin America: Mexico, Brazil, Panama & Guatemala
  • Sub-Saharan Africa: South Africa, Kenya, Nigeria, Zambia, Zimbabwe, Botswana, Namibia & Etiopia
  • Middle East & North Africa: Egypt & Jordan
  • Asia: Bangladesh, Pakistan & Sri Lanka
  • Eastern Europe: Georgia

The commercialization of the Product shall comprise following activities:
i) Commercial Strategy: prepare and implement a country-wise commercial strategy for the Product in the country(ies) where it commercializes the Product (“Sublicensed Countries”), including but not limited to the positioning, affordable access-oriented pricing, distribution, logistics, life cycle management.

ii) Market Intelligence generation: generate market intelligence in the Sublicensed Countries, including but not limited to the market potential, competition, optimal pricing, with a focus on public health access, and distribution channels for the Product.

iii) Distribution and Logistics: implement an import, distribution and logistics strategy in the Sublicensed Countries, supported by an effective ordering and forecasting process, to ensure cost effective, affordable, timely and uninterrupted availability of the Product to patients. In addition to the distribution of the Product through own/contracted distribution network, facilitate the supply of Product, within the Sublicensed Countries, to International Procurement Agency(s), using the Commercial Sublicensee’s label.

iv) Regulatory:

  • update and implement the regulatory strategy and liaison with regulatory authorities at regional and country levels;
  • submit regulatory dossiers to the regulatory authorities intended for obtaining regulatory approvals for the Product in the Sublicensed Countries, and provide regulatory support in these countries.

v) Pharmacovigilance:

  • comply with all applicable laws and regulations in the Sublicensed Countries, including but not limited to risk management systems, drug safety and pharmacovigilance;
  • enter into Safety Data Exchange Agreement(s) with GARDP and Shionogi prior to Product commercialization; manage the PV database and reporting to GARDP and Shionogi for the Product distributed by the Commercial Sublicensee and/or other appointed entities (International Procurement Agency etc.) within the Sublicensed Countries.

v) Market Access and Sublicensed Country(ies) Business Plans: develop country specific business plans to be approved by GARDP, for each Sublicensed Country, which shall include:

  • registration requirements and timing;
  • identification of local stakeholders and partners,
  • in-country efficient logistics structure, including a pre-launch centralized stockpiling in order to ensure timely and uninterrupted availability of the Product to the patients;
  • pricing considerations: distribution margins, differentiation between private & public market.

vi) Information Reporting to GARDP: report to GARDP on a quarterly basis via a country-wise report in writing covering topics including but not limited to net sales data, inventory report, regulatory activities undertaken, completed/ in-progress work towards commercialization plan, local medical affairs plan and ESG matters.

5. Requirements for Participants
The participants to this RFI (“Participants”) are requested to list their countries of interest among the Prioritized Countries and:

  1. Demonstrate a viable plan as well as prior experience in the successful commercialization of injectable antibiotic products, preferably for hospital infections;
  2. Demonstrate they have an established marketing and distribution network within the countries of interest;
  3. Demonstrate their ability to manage the product’s regulatory responsibilities at national level;
  4. Agree to comply with the substantial terms of the commercial sublicense agreement template provided by GARDP.

6. Instructions to Participants
a. Participants are requested to provide the following:
i. Form A (Annex 3) completed and signed by an authorized representative of the Participant;
ii. Compliance self-declaration (Annex 4) signed by an authorized representative of the Participant;
iii. RFI Questionnaire (Annex 5) completed;
iv. A word/powerpoint document describing the Participant’s current strategy & operations in the countries of interest and the proposed commercial strategy for the Product in these countries.v. Financial stability confirmation: past 3 years basic financial statements (P&L, balance sheet, cash flow statement).

b. Response submission
i. All responses shall be submitted in English via email with the subject line RFI Response_Cefiderocol to: kprabhakar@gardp.org with cc to: pbhat@gardp.org
ii. Responses received after the deadline will not be considered.
iii. The timeline of the RFI is as follows:

c. Costs of preparing documents
All costs associated with the preparation of the responses to the RFI and participation in general will be borne by the Participants.

d. Confidentiality
Information which the Participants consider to be proprietary should be clearly marked as such. All such information will be treated as confidential and used by GARDP for this RFI assessment purposes only.

e. No disclosure
Information relating to the examination, clarification and evaluation of the Participants’ responses to this RFI shall remain internal to GARDP.

f. Future Sublicense Agreement
As mentioned hereabove, future Commercial Sublicensees are required to comply with all substantial terms of the commercial sublicense agreement template that will be provided by GARDP. The final Sublicense Agreement will be finalized during the negotiation process after selection of the Participant(s).

7. Additional Information
GARDP reserves the right to request additional information from, or arrange interviews with Participants, visit the Participants’ premises and facilities, and conduct an audit to verify the information provided.

8. Selection process
GARDP will assess each eligible response based on selection criteria that include the overall quality of the commercialization plan provided, timelines, corporate capabilities, proposed geographical coverage, commitment to access and antibiotic stewardship, and demonstrated expertise with similar products. GARDP anticipates that several Participants will be identified for further discussions to refine their responses.
GARDP may engage with a third party to perform a quality audit of the selected Participants.
GARDP anticipates an award of commercial sublicense agreement(s) post completion of evaluation and audits (if required). The final evaluation results and award information will remain confidential and proprietary to GARDP.

 

Due/closing date: June 30 2025

 

RFI Questionnaire 

RFI Instructions Document