Cenexi to Become Preferred Drug Product Supplier for France and the European Union
09/02/2022 — BURLINGAME, Calif. & FONTENAY-SOUS-BOIS, France — (BUSINESS WIRE)
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ and Cenexi, a French CDMO specializing in the formulation, analytical development, and manufacture of complex molecule drugs, announced a collaboration aimed at making Cenexi a preferred supplier of lenzilumab in France and the European Union. The initial step of the collaboration includes the execution of a Master Supply Agreement (“MSA”) providing for Cenexi to provide aseptic fill and finish services for lenzilumab for the next five years.
Under the terms of the agreement, Humanigen will transfer the technology and knowledge to Cenexi to allow them to establish drug product processes utilizing their state-of-the-art high speed filling line at their Herouville-Saint-Clair facility in Normandy. Humanigen and Cenexi will enter into discussions to potentially expand the agreement to other services Cenexi offers. These include labeling and packaging, importation of bulk drug substance and quality release of materials in France and throughout Europe. Humanigen plans to include the Cenexi Normandy site in certain of its future regulatory filings for lenzilumab for COVID-19 and other indications. The companies will collaborate to secure potential funding and investment in capital equipment from AD Normandie, the regional authority and the Government of France, the national authority. In addition, Cenexi will assist Humanigen as it seeks an advanced purchase agreement for lenzilumab in France.
“The goal of the collaboration with Cenexi is to further our efforts to establish a supply of lenzilumab made in Europe,” commented Cameron Durrant, chief executive officer of Humanigen. “Cenexi is an ideal partner for sterile filling and with their strong base of resources and aggressive growth plan, we may expand our collaboration beyond the typical customer/vendor relationship. We may work with Cenexi to become our preferred partner for multiple services and to establish a stable and secure supply chain for lenzilumab in France and Europe longer-term.”
In 2021, French authorities modified existing regulations to provide for early access to unauthorized medicinal products. The early access authorization (autorisation d’acces precoce of “AAP”) allows for a manufacturer to supply product to a cohort of individuals for a specific use, for example, lenzilumab for COVID-19. Humanigen plans to file a request for AAP with the Haute Authorite de Sante in February 2022.
“Cenexi desires a leadership position in France to assist in establishing a strong supply chain for COVID-19 and for future pandemics. Since 2004, Cenexi has been at the forefront of bringing critical medicines to patients and we continue to build on our strong reputation for value, high quality, flexibility and timeliness,” commented Christophe Durand, chief executive officer of Cenexi. “Our partnership with Humanigen will use our core competencies of sterile filling and to potentially expand into to an end-to-end solution for lenzilumab in France and other countries in Europe.”
Pending positive results from the NIH-sponsored ACTIV-5/BET-B study, Humanigen plans to amend the Emergency Use Authorization application in the United States. For the European Union, Humanigen anticipates submission of a Conditional Marketing Authorization with a request for Accelerated Approval in the third quarter of 2022.
Lenzilumab is an investigational product and is not approved or authorized in any country.
Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’. Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. In addition, Humanigen is progressing a Phase 1 program focused on another proprietary monoclonal antibody, ifabotuzumab, in solid tumors.
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Cenexi, a major French CDMO operating in Europe with 1,500 employees and some €200 million in turnover (2021), is experiencing steady growth with four production sites (Fontenay-sous-Bois, Osny, and Hérouville-Saint-Clair in France and Braine-l’Alleud in Belgium) and a center of expertise dedicated to new product introduction.
Created in 2004, the Cenexi Group is positioned on the very dynamic international market for drugs with major therapeutic indications, drawing on its spirit of innovation and its extensive expertise in the manufacture and development of products.
The Group’s new management team has revitalized the company, in particular, by strengthening its sterile expertise which already represents 70% of its business.
Cenexi has the facilities to produce many pharmaceutical forms and has strong expertise in cytotoxic, hormonal, and narcotic drugs.
Humanigen Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements, including, without limitation, statements regarding our objectives to establish manufacturing capabilities for lenzilumab in Europe; statements regarding the potential benefits of our agreement with Cenexi; statements regarding our anticipated future regulatory filings following completion of the ACTIV-5/BET-B trial; and other statements regarding our plans relating to lenzilumab and ifabotuzumab.
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to continue our business as a going concern; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the “Risk Factors” sections of our latest annual and quarterly reports and other filings with the SEC.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.
Timothy E. Morris COO & CFO