Navigation Links
IVERIC bio Enters into Strategic Manufacturing Relationship with Catalent’s Paragon Gene Therapy for Orphan Inherited Retinal Diseases
Date:6/18/2019

IVERIC bio, Inc. (NASDAQ: ISEE) and Catalent Biologics, today announced that they have entered into an agreement for production and manufacturing of GMP-grade adeno-associated virus (AAV) vector for IVERIC bio’s gene therapy product candidates, IC-100 for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP) and IC-200 for the treatment of BEST1 related retinal diseases. IVERIC bio expects to initiate Phase 1/2 clinical trials for IC-100 in 2020 and IC-200 in the first half of 2021. IVERIC bio has engaged Paragon Gene Therapy, part of Catalent Biologics, to provide materials for preclinical activities and its planned Phase 1/2 clinical trials for both product candidates.

“We fully appreciate the importance of having a world-class manufacturing infrastructure in place as we continue to build and advance our gene therapy pipeline for inherited retinal diseases,” stated Mr. Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. “Our relationship with Catalent secures access to state-of-the-art manufacturing capabilities and capacity that we believe will enable us to enter into the next phase of gene therapy development with our product candidates IC-100 for RHO-adRP and IC-200 for BEST1 related retinal diseases.”

“We are extremely pleased to partner with IVERIC bio as they advance their portfolio of AAV gene therapies for orphan inherited retinal diseases,” added Pete Buzy, President of Paragon Gene Therapy. “We look forward to a strong relationship with the goal of achieving IVERIC bio’s gene therapy AAV manufacturing milestones for the production of clinical material.”

“We believe that AAV gene therapy is the future of drug development for orphan inherited retinal diseases,” stated Keith Westby, Chief Operating Officer of IVERIC bio. “When building a gene therapy franchise the selection of an experienced manufacturer is a critical component. We believe Paragon’s specialized expertise in AAV vector manufacturing and the addition of their new world-class commercial-scale facility will positively impact the advancement of our gene therapy pipeline. We look forward to collaborating closely with the Paragon team.”

About IVERIC bio
IVERIC bio is a biotechnology company with a focus on the discovery and development of novel gene therapy solutions to treat orphan inherited retinal diseases with unmet medical needs. Vision is Our Mission. For more information on the Company’s gene therapy and other programs, please visit http://www.ivericbio.com.

About Catalent
In May 2019, Catalent, Inc. announced that it had completed the $1.2 billion acquisition of Paragon Bioservices, Inc., a leading viral vector development and manufacturing partner for gene therapies.

Paragon’s unique and differentiated scientific, development, and manufacturing capabilities, will fundamentally enhance Catalent’s biologics business and end-to-end integrated biopharmaceutical solutions and allow Catalent to capitalize on strong industry tailwinds in the potentially $40 billion addressable market for gene therapies.

Catalent is the leading global provider of advanced delivery technologies, and development and manufacturing solutions for drugs, biologics, gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 11,000 people, including over 1,800 scientists, at more than 30 facilities across five continents, and in fiscal year 2018 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com.

More products. Better treatments. Reliably supplied.™

IVERIC bio Forward-looking Statements
Any statements in this press release about IVERIC bio’s future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about IVERIC bio’s strategy, future operations and future expectations and plans and prospects for IVERIC bio, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. In this press release, IVERIC bio’s forward looking statements include statements about the implementation of its strategic plan, including its transition to a gene therapy focused company, the timing, progress and results of clinical trials and other research and development activities, including manufacturing activities, the potential utility of its product candidates and the potential for its business development strategy, including any potential in-license or acquisition opportunities. Such forward-looking statements involve substantial risks and uncertainties that could cause IVERIC bio’s development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the initiation and the conduct and design of research programs and clinical trials, establishment of manufacturing capabilities, availability of data from these programs, reliance on university collaborators and other third parties, expectations for regulatory matters, need for additional financing and negotiation and consummation of in-license and/or acquisition transactions and other factors discussed in the “Risk Factors” section contained in the quarterly and annual reports that IVERIC bio files with the Securities and Exchange Commission. Any forward-looking statements represent IVERIC bio’s views only as of the date of this press release. IVERIC bio anticipates that subsequent events and developments will cause its views to change. While IVERIC bio may elect to update these forward-looking statements at some point in the future, IVERIC bio specifically disclaims any obligation to do so except as required by law.

Read the full story at https://www.prweb.com/releases/iveric_bio_enters_into_strategic_manufacturing_relationship_with_catalents_paragon_gene_therapy_for_orphan_inherited_retinal_diseases/prweb16383283.htm.


'/>"/>
Source: PRWeb
Copyright©2019 Vocus, Inc.
All rights reserved


Related biology technology :

1. Bio-Tech Firm PathSensors Enters Fast-Growing Chinese Pathogen Detection Market
2. MMJ International Holdings Enters Cannabis Study Agreement with BioInformatics and Genomics Center (BIG) at the University of Buffalo, New York
3. Research Centers of America Adopts Verified Clinical Trials Biometrics Research Subject Database Registry to Prevent Duplicate Enrollment in Clinical Trials
4. Inspirata to Exhibit at CANCERSCAPE 2017 in Washington DC to Help Community Cancer Centers Better Bridge the Gap Between Pathology and Precision Medicine
5. Northwest Kidney Centers Announces Intention to Grant $15 Million to Jumpstart UW Medicines Center for Dialysis Innovation
6. Immunomedics Enters into Exclusive Global Licensing Agreement with Seattle Genetics for Sacituzumab Govitecan (IMMU-132) with Potential Payments of up to Approximately $2 Billion, Plus Royalties
7. Enteris BioPharma Enters Agreement with Sanofi to Develop Investigational Oral Therapeutic for Type 2 Diabetes
8. FireflySci Enters Fiber Optic Probe Market With Several New Offerings
9. Back Pain Centers Of America Calls For Award Submissions For Excellence In Spine Health
10. Sharp Edge Labs Enters into Drug Discovery Collaboration with Sumitomo Dainippon Pharma
11. Velocity Products Announces Pending Introduction of Intelligent Toolholder and End Mill Assemblies for Okuma Machining Centers at IMTS 2016.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/17/2019)... ... September 17, 2019 , ... ... Director, Project and Clinical Supplies Management, Asia Pacific (APAC) will present at the ... Singapore, on Sept. 25-26, 2019. , On Thursday, Sept. 26, at 10:10 a.m., ...
(Date:9/17/2019)... ... ... When a lot of researchers think of Visikol, they think of the ... tissues through the use of confocal and light sheet microscopy. However, over the last ... focused contract research organization and today offers 3D tissue imaging as a ...
(Date:9/11/2019)... ... 2019 , ... Suvoda LLC , a SaaS provider ... management, today announced its new technology partnership with Veeva Systems , a ... Veeva Vault EDC and our IRT will enable sponsors and CROs to run ...
(Date:9/8/2019)... ... 2019 , ... The Blavatnik Family Foundation and ... and six Finalists of the 2019 Blavatnik Regional Awards for Young Scientists ... Jersey, and Connecticut since 2007, the Blavatnik Regional Awards recognize outstanding researchers in ...
Breaking Biology Technology:
(Date:10/10/2019)... SAN DIEGO (PRWEB) , ... October 09, 2019 ... ... their merger-acquisition of Nanosens Innovations, Inc., the creators of CRISPR-Chip™. Cardea first ... announcement of their Early Access Program for the Genome Sensor™. Built with CRISPR-Chip ...
(Date:10/8/2019)... ... October 08, 2019 , ... ... announcing a collaboration with the National Research Council of Canada (NRC) to ... in nanofabrication and lab-on-a-chip technologies and in manufacturing, LIFT will offer a ...
(Date:10/8/2019)... ... October 07, 2019 , ... The future of medicine in the 21st ... in people living longer, healthier lives. But it will be up to each individual ... Hood, MD, PhD, Chief Strategy Officer and Co-Founder of the Institute for Systems Biology ...
Breaking Biology News(10 mins):