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Fina Biosolutions and PATH Contract for Manufacturing Development and Scale-up of EcoCRM

November 15, 2018

ROCKVILLE, Md.--(BUSINESS WIRE)--Nov 15, 2018--Fina Biosolutions LLC announced today it has reached agreement with PATH, a global organization focused on solving some of the world’s most pressing health challenges, under which PATH will provide funding and technical support for the clinical manufacture of FinaBio’s CRM 197, known commercially as EcoCRM ®. As consideration for this support, FinaBio has licensed PATH its CRM 197, a key component in conjugate vaccines. Under the license, PATH receives non-exclusive rights to EcoCRM ® for infectious disease vaccines sold to, or for supply to, low-income countries.

CRM 197 may form a critical component of several important vaccines PATH is supporting against life threatening diseases such pneumonia and meningitis. Consequently, this partnership will support the development of low-cost, critical vaccines, while FinaBio retains worldwide rights to commercialize EcoCRM ®, including exclusive rights outside low income countries and non-infectious disease indications.

“We are pleased to reach this agreement with PATH which advances EcoCRM ® to good manufacturing practice (GMP) production and promotes the development of affordable vaccines for low-income countries a key tenet of our company mission,” FinaBio CEO Andrew Lees said. “We look forward to producing clinical grade CRM 197 as we believe there is a substantial unmet demand for it if priced appropriately.”

“This agreement will allow us to support the development of urgently needed vaccines,” Mark Alderson, director of PATH’s pneumococcus, meningitis, and group B Streptococcus projects said. “It’s just one example of how public-private partnerships can save lives and foster commercial development at the same time.”

FinaBio’s unique pricing model has reduced the cost of CRM 197 by as much as 80%, enabling researchers and developers to produce critical vaccines at a lower cost.

About Fina Biosolutions LLC

Fina Biosolutions (Rockville, MD) is a privately held company providing technology, laboratory, and consulting services in the field of conjugate vaccines. Chemistry developed by Fina Biosolutions’ scientists is used by GSK (Synflorix) and Pfizer (Nimenrix), among others. Fina Biosolutions developed an E. coli expression system that produces a significantly higher yield of CRM 197 than achieved with current methods. The method is covered by US Patent 10093704 and others.

FinaBio markets its CRM 197 under the tradename, EcoCRM ®, for “ E. coli CRM.” Fina Biosolutions’ mission is to promote the development of conjugate vaccines.

About CRM 197

CRM 197 is a genetically detoxified diphtheria toxin widely used in vaccines for pneumococcal and meningococcal diseases, as well as many vaccines currently in development, including Group B Streptococcus, Salmonella, Klebsiella, and malaria. It is used in Pfizer’s pneumococcal vaccine Prevnar 13, the world’s bestselling vaccine and the only pneumococcal conjugate vaccine licensed in the United States. As a component in these vaccines, CRM 197 is chemically linked (“conjugated”) to the antigen of interest to induce a better immune response to the antigen. Conjugate vaccines are among the most complex and expensive pediatric vaccines produced today.

View source version on businesswire.com:https://www.businesswire.com/news/home/20181115005121/en/

CONTACT: Fina Biosolutions LLC

Dr. Andrew Lees, 301 633-0464

ALees@Finabio.com

KEYWORD: UNITED STATES NORTH AMERICA MARYLAND

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY INFECTIOUS DISEASES PHARMACEUTICAL RESEARCH SCIENCE

SOURCE: Fina Biosolutions LLC

Copyright Business Wire 2018.

PUB: 11/15/2018 06:00 AM/DISC: 11/15/2018 06:01 AM

http://www.businesswire.com/news/home/20181115005121/en

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