NEW YORK & SOMERSET, N.J.–(BUSINESS WIRE)–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 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 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 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.
ISEE-G
Contacts
IVERIC bio:
Investor / Media:
IVERIC bio
Kathy
Galante, 212-845-8231
Vice President, Investor Relations and
Corporate Communications
Kathy.galante@ivericbio.com
Press / Media:
Catalent
Chris Halling, +44 (0)7580
041073
chris.halling@catalent.com