Northwest Biotherapeutics Announces MOU for Collaboration With the Saudi Pharmaceutical Industries and Medical Appliance Company
Rhea-AI Summary
Northwest Biotherapeutics (OTCQB: NWBO) has entered into a non-binding Memorandum of Understanding with Saudi Pharmaceutical Industries and Medical Appliance Company (SPIMACO) to pursue a collaboration to bring DCVax-L for glioblastoma to Saudi Arabia under a contemplated revenue-sharing model.
According to Northwest Biotherapeutics, SPIMACO would interface with the Saudi Food and Drug Authority and be expected to act as commercial partner for marketing, sales and distribution, while the company supplies DCVax-L, provides regulatory data and scientific support, and retains all intellectual property. The MOU also contemplates negotiating license and technology transfer agreements to enable localized manufacturing in Saudi Arabia and possible future expansion to other indications and GCC countries. Northwest Biotherapeutics notes it has completed a 331-patient Phase III DCVax-L trial for glioblastoma, published results in JAMA Oncology, and has a marketing authorization application under review in the UK.
Positive
- Non-binding MOU with SPIMACO to pursue DCVax-L in Saudi Arabia
- Contemplated revenue sharing model with SPIMACO as commercial partner
- Plan to negotiate license and technology transfer for localized DCVax-L manufacturing
- Completed Phase III trial of DCVax-L in 331 glioblastoma patients
- MAA for DCVax-L commercial approval in the UK currently under review
Negative
- MOU is non-binding and collaboration depends on definitive agreements
- Commercialization of DCVax-L in Saudi Arabia still requires SFDA regulatory approval
- Company cites ongoing need to raise additional capital as a key risk factor
AI-generated analysis. How Rhea-AI works. Not financial advice.
SPIMACO is One of the Largest Saudi Pharma Companies and a Leader in 21 Markets Across the MENA Region
The MOU establishes a general framework for discussions for the potential collaboration regarding the approval, commercialization, supply and technology transfer of the Company's DCVax®-L product for glioblastoma brain cancer (Product) in
The collaboration is based upon a revenue sharing model. Subject to the execution of definitive agreements, the parties currently contemplate that SPIMACO would be responsible for interfacing with the Saudi Food and Drug Authority (SFDA), including the application for approval of DCVax-L for glioblastoma, and would be expected to serve as the Company's commercial partner responsible for marketing, sales and distribution. The Company will provide the data and documentation for regulatory purposes, and will provide scientific support. The Company will also produce and supply the DCVax-L products. The Company retains all ownership of all intellectual property.
The MOU also recognizes that localization and technology transfer are key parts of the contemplated collaboration. Under its Vision 2030 national plan,
Prof. Ahmed Aljedai, Vice Chairman and Managing Director of SPIMACO, said: "Strategic partnerships are a key enabler of SPIMACO's long-term growth and transformation. This Memorandum of Understanding with Northwest Biotherapeutics reflects our commitment to collaborating with global innovators to strengthen our capabilities in biopharmaceuticals, advance innovation and knowledge transfer, and support the continued development of
Linda Powers, the Company's CEO, commented: "We are excited to join forces with SPIMACO as a leader in
About SPIMACO
Saudi Pharmaceutical Industries and Medical Appliances Corporation (SPIMACO) is one of the largest pharmaceutical companies in
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products that are designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company's lead program involves DCVax®-L treatment for glioblastoma (GBM). GBM is the most aggressive and lethal form of primary brain cancer, and is an "orphan disease." The Company has completed a 331-patient Phase III trial of DCVax-L for GBM, presented the results in scientific meetings, published the results in JAMA Oncology and submitted a MAA for commercial approval in the UK. The MAA is currently undergoing review. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and plans to pursue Phase II trials this year. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning plans for DCVax® are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes and decisions, risks related to the Company's ability to achieve timely performance of third parties, risks related to whether the Company's products will be viewed as demonstrating safety and efficacy, risks related to the Company's ongoing ability to raise additional capital, and other risks included in the Company's Securities and Exchange Commission ("SEC") filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company's results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual plans, results or timelines to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACTS
Northwest Biotherapeutics
Dave Innes
804-513-6758
dinnes@nwbio.com
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SOURCE Northwest Biotherapeutics, Inc.