V ClinBio Partners with Camargo for Strategic 505(b)(2) Development of Transformative Prodrug Technology Platform

CINCINNATI, March 6, 2018 /PRNewswire/ -- V ClinBio Inc., an innovative biopharmaceutical company focused on transforming existing compounds into differentiated new therapeutics, today announced that it has entered into service agreements with Camargo Pharmaceutical Services, LLC ("Camargo"). Camargo will provide end-to-end regulatory consulting and strategic development services including pre-Investigational New Drug (pre-IND) meeting planning and preparations through New Drug Applications (NDA) submissions, for V ClinBio's two (2) proprietary medications, CLX-106 and CLX-103, for the treatment of relapsing-remitting multiple sclerosis (RRMS) and ulcerative colitis (UC), respectively. After receiving data from initial proof-of-concept trials in humans, V ClinBio plans to implement clinical plans for both CLX-106 and CLX-103.

Both CLX-106 and CLX-103 utilize the proprietary Synergix drug delivery platform, which generates novel prodrugs of approved therapies and conjugates them with long chain fatty acids. This approach targets two critical points in a disease more efficiently than can be achieved by co-administration or independent dosing of multiple therapies and allows for development via the US 505(b)(2) regulatory pathway. Camargo is a highly experienced global strategist specializing in drug and fixed-dose combination product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act. Over the last decade, Camargo has established an unrivaled track record with 505(b)(2) IND and NDA preparations and submissions, including participation in more than 1,100 FDA meetings and more than 200 FDA, NDA, and ANDA approvals.

"With our rich pipeline of products, we are excited to partner with Camargo to bring these two promising medical advancements to patients with RRMS and UC respectively," said Bob Oliver President & CEO of V ClinBio. "The management team at V ClinBio determined that our best path to market with our lead compounds CLX-103 and CLX-106 would be the 505(b)(2) regulatory pathway, and as such, our aim was to collaborate with a leader in the field."

"Our goal at Camargo is to develop and execute a strategic roadmap for the 505(b)(2) regulatory pathway and drive commercial success for our partners," said Ken Phelps, President and CEO of Camargo Pharmaceutical Services. "We are excited to work with V ClinBio on the regulatory strategy employing innovative technologies with FDA-approved pharmaceuticals that address the unmet needs of patients worldwide."

About CLX-106 & CLX-103

CLX-106, a patented novel formulation of MMF conjugated to icosapentaenoic acid for the treatment of RRMS and psoriasis, has demonstrated a highly differentiated profile compared with other MMF prodrugs in development. MMF is an approved RRMS therapy that achieved global sales of over $4 billion in 2016.

CLX-103 is a novel, patented prodrug molecular conjugate of mesalamine, eicosapentaenoic acid and caprylic acid designed to offer incremental benefits over the currently approved 5-ASA formulations for the treatment of ulcerative colitis.  In 2016, mesalamine therapeutics generated more than $4.8 billion in annual sales globally.

About V ClinBio

V ClinBio is an innovative biopharmaceutical company, spearheaded by former Otsuka America CEO, and Wyeth and J&J senior executive, Bob Oliver, which is driving the development of novel drug products for treatment of immune and other related diseases. V ClinBio develops New Molecular Entities (NMEs) using incremental innovation and prodrug technology targeted to provide better pharmacokinetic, pharmacodynamics, physicochemical properties, and to enable the development of known agents for both existing and new indications. With our expanded collaboration and financial investment with Cellix Bio, we have access to the group’s entire portfolio of asset development and patents. Our collective technology has the potential to increase efficacy, tissue distribution, safety, compliance and synergic/additive pharmacology of conjugate components. Our focus is to develop a robust pipeline of new medicines addressing unmet medical needs across diverse therapeutic areas including neurology, inflammation and metabolic diseases.

About Camargo Pharmaceutical Services

Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six Agency meetings a month, Camargo works with product developers across more than 25 countries. For more about Camargo Pharmaceutical Services, visit https://CamargoPharma.com

SOURCE Camargo Pharmaceutical Services, LLC

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