How can Pfenex enable the improvement and/or development of protein based therapeutics and vaccines?
The institutional knowledge possessed by the Pfenex scientific team which has been accumulated over the past 17 years and over 60 collaborations, including with 12 of the 15 top pharmaceutical companies in the world, is leveraged on every product development program we embark upon.
The comprehensive capability of Pfenex including the production platform, analytical capability and pilot scale production facility as well as our experienced scientific team will be leveraged on our partnered programs.
Pfenex is seeking co-development partnerships wherein our technology platform is uniquely enabling. The Pfenex platform has routinely demonstrated success in producing a broad range of highly complex proteins where legacy platforms have failed.
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Our Current Partners
Pfenex has granted Alvogen the exclusive rights to commercialize Pfenex’s lead drug candidate, PF708, a teriparatide, which is being developed as a therapeutic equivalent candidate to Eli Lilly & Company’s Forteo®/Forsteo®, in the United States, Europe, Middle East and North Africa and the Rest of World outside of the countries licensed to NT Pharma including, Hong Kong, Mainland China, Malaysia, Singapore and Thailand. PF708 is being developed via the 505(b)(2) regulatory pathway in the United States and the New Drug Application (NDA) has a Prescription Drug User Fee Act (PDUFA) goal date of October 7, 2019.
Alvogen is a global, privately owned pharmaceutical company focused on developing, manufacturing and selling generic, brand, over-the counter (OTC) and biosimilar products for patients around the world. With commercial footprint in over 35 markets, Alvogen’s key regions include the U.S. and emerging markets in the CEE and APAC regions.
China NT Pharma Group Company Limited (NT Pharma)
Pfenex has granted NT Pharma the exclusive rights to commercialize Pfenex’s lead drug candidate, PF708, a teriparatide, which is being developed as a therapeutic equivalent candidate to Eli Lilly & Company’s Forteo®/Forsteo®, in Hong Kong, Mainland China, Malaysia, Singapore and Thailand.
NT Pharma is a technology-based pharmaceutical company which is principally engaged in the investment, research and development, manufacturing and sales of pharmaceutical products in the People’s Republic of China (“China” or “PRC”) and countries overseas, with its products covering therapeutic areas of severe illness such as oncology, orthopedics, Central Nervous System (“CNS”), hepatology and respiratory system. The Group also owns several sales and distribution companies with around 1,000 sales professionals and R&D specialists. The Group has an extensive promotion network in China, covering nearly 10,000 hospitals.
Jazz Pharmaceuticals plc
Pfenex granted Jazz Pharmaceuticals worldwide rights to develop and commercialize multiple early stage hematology product candidates including a recombinant crisantaspase, JZP-458 (PF743), a potential treatment option for patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginase products and PF745, a recombinant crisantaspase with half-life extension. For JZP-458 (PF743) a Phase 1 study of healthy volunteers was completed in 2019, and a single-arm, pivotal Phase 2/3 study is planned for initiation later in 2019. The agreement also includes an option for Jazz Pharmaceuticals to negotiate a license for a recombinant pegaspargase product candidate with Pfenex.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ), a global biopharmaceutical company, is dedicated to developing life-changing medicines for people with limited or no options. As a leader in sleep medicine and with a growing hematology/oncology portfolio, Jazz has a diverse portfolio of products and product candidates in development and is focused on transforming biopharmaceutical discoveries into novel medicines.
Merck & Co, Inc.
Merck & Co., Inc. currently has a license agreement for the use of Pfenex Expression Technology to produce the carrier protein CRM197 for use in conjugate vaccines they are developing. Merck is currently conducting multiple Phase 3 studies with their 15-valent Pneumococcal vaccine, PCV-15 (V114), and CRM-197 produced via the Pfenex production strain is used a component of the PCV-15 (V114) vaccine.
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases.
Serum Institute of India Pvt. Ltd
Serum Institute of India Private Limited (SIIPL) currently has a license agreement for the use of Pfenex Expression Technology to produce the carrier protein CRM197 for use in conjugate vaccines they are developing. SIIPL is developing a 10-valent Pneumococcal vaccine, Pneumosil® that has completed Phase 3 clinical studies and as of January 2019 is in the WHO Prequalification process. SIIPL is also developing a thermostable Pentavalent Meningococcal Conjugate Vaccine (A, C, Y, W-135, X) that is currently being evaluated in a Phase 3 clinical study. In addition, SIIPL is Pfenex’s exclusive supplier of pre-clinical grade and cGMP grade CRM197 which Pfenex sells to vaccine developers globally, see www.CRM197.com for more information.
Serum Institute of India Pvt. Ltd. is the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses) which includes Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. Vaccines manufactured by SIIPL are accredited by the World Health Organization, Geneva and are being used in around 140 countries across the globe in their national immunization programs, saving millions of lives throughout the world.
The Biomedical Advanced Research and Development Authority
Supported by a $143.5MM advanced development contract Pfenex is collaborating with BARDA on the development of two novel anthrax vaccine candidates.
The Biomedical Advanced Research and Development Authority (BARDA) is established within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.