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Serum Institute of India Private Limited has achieved

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Paullee   Wednesday, 01/08/20 08:12:30 AM
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Serum Institute of India Private Limited has achieved World Health Organization (WHO) prequalification for PNEUMOSIL®, containing CRM197 produced in Pfenex Expression Technology
GlobeNewswire GlobeNewswire•January 8, 2020
SAN DIEGO, Jan. 08, 2020 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) today announced that Serum Institute of India Private Limited (Serum Institute) achieved World Health Organization (WHO) prequalification for Pneumosil, a 10-valent pneumococcal conjugate vaccine. Pneumosil contains the recombinant carrier protein CRM197 produced by Serum Institute under a license to the Pfenex Expression Technology®.

Under the agreement with Serum Institute, Pfenex is eligible to receive annual fees, milestone payments, and a tiered low single digit royalty based on net sales for all products developed by Serum Institute that use the CRM197 carrier protein produced via the Pfenex Expression Technology.

“Our partnership with Serum Institute continues to be successful. We are thrilled to have played a part in their mission to help ensure that children of low- and middle-income countries have access to lifesaving vaccines at a sustainable price,” said Eef Schimmelpennink, Chief Executive Officer of Pfenex.

“I am extremely pleased to see the WHO PQ of Pneumosil. This could help pave the way for saving lives by using a highly cost-effective Pneumococcal vaccine. For this vaccine, we have used Pfenex Expression Technology for the manufacturing of recombinant CRM197 (rCRM197) co-developed with Pfenex. I am also pleased to note that our next product in the pipeline which utilizes rCRM197 is also in late stage clinical development,” said Adar Poonawalla, Chief Executive Officer of Serum Institute of India.

Pneumosil covers over 71% invasive pneumococcal disease (IPD) causing serotypes, and targets the Indian Universal Immunization Programme and Asian, African and other countries under the Gavi Advanced Market Commitment (AMC).

A second product being developed by Serum Institute which also utilizes CRM197 as one of its carrier proteins and is subject to the Pfenex Expression Technology license is a thermostable Pentavalent Meningococcal Conjugate Vaccine (A, C, Y, W-135, X). This product is currently in a Phase 3 clinical study and is also targeted for developing countries.

About CRM197

Pfenex CRM197 is a non-toxic mutant of diphtheria toxin having a single amino acid substitution of glutamic acid to glycine at position 52. CRM197 is a well-defined protein and functions as a carrier for polysaccharides and haptens, making them immunogenic. It is utilized as a carrier protein in several approved conjugate vaccines for diseases such as Streptococcus pneumoniae, Haemophilus influenzae b and Neisseria meningitidis. Pfenex CRM197 is a recombinant, soluble form produced by the Pfenex Expression Technology® platform. CRM197 is currently being used by vaccine development focused pharmaceutical partners, including Merck and the Serum Institute of India Private Ltd., (SIIPL). In 2018, Merck announced that it had initiated multiple Phase 3 clinical studies of PCV-15 (V114), an investigational polyvalent conjugate vaccine for the prevention of pneumococcal disease. SIIPL who is developing a 10-valent pneumococcal conjugate vaccine, Pneumosil recently achieved World Health Organization Prequalification (PQ).

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