Novasep and Celladon Execute MYDICAR API Supply Agreement
March 24 2015 - 4:05PM
Celladon Corporation (Nasdaq:CLDN), a clinical-stage cardiovascular
gene therapy company and Novasep, a leading supplier of services
and technologies for the life sciences and chemical industries,
today announce that they have signed a Development, Manufacturing
and Supply Agreement pursuant to which, if supported by upcoming
MYDICAR clinical data, Novasep would manufacture MYDICAR drug
substance through 2018 with extension options through 2020.
The contract follows an earlier letter agreement concerning the
initial process transfer of MYDICAR and pre-validation studies,
which was signed in December 2014. The new agreement continues the
work necessary for Novasep to achieve GMP production of MYDICAR
drug substance.
MYDICAR is an innovative, genetically-targeted enzyme
replacement therapy based on AAV1/SERCA2a that is being developed
for advanced heart failure and has been granted Breakthrough
Therapy Designation by the US Food and Drug Administration (FDA).
MYDICAR is currently being tested in human clinical trials,
including a Phase IIb study in the USA and Europe referred to as
CUPID2, the top-line results of which are expected to be announced
in late April 2015.
"We are very pleased to have the option to partner with Novasep
to prepare for and commence commercial manufacturing of MYDICAR
drug substance," said Dr. Krisztina Zsebo, CEO of
Celladon. "Novasep has demonstrated technical excellence and a
real commitment to helping advance the MYDICAR program."
"This agreement validates the trusted relationship Novasep has
established with Celladon," said Andrew Brennan, Novasep General
Manager, US Operations. "The relationship represents a partnership
in every sense of the word and, I believe, is a model for future
development and commercial supply agreements in the fast growing
gene therapy space."
Under the terms of the agreement, Novasep and Celladon would
conduct the process transfer, development, facility retrofitting
and scale-up activities necessary to carry out production of
MYDICAR drug substance in a 2000L bioreactor at an enhanced
bioproduction plant in Seneffe, Belgium. GMP operations are planned
to start in Q4 2016 and continue through 2018. An option to extend
through 2020 will be determined based on Celladon's requirements
for the MYDICAR drug substance. Celladon has the right to terminate
the agreement, exercisable for a specified period of time following
the un-blinding of the data from the CUPID2 study, if Celladon
concludes in good faith that the CUPID2 data is such that Celladon
does not require production of MYDICAR drug substance at the
Novasep facility.
"Celladon has impressed us with their strategic approach in
building a robust supply chain for a challenging biopharmaceutical.
Celladon is preparing for potential fast track development, which
makes Novasep's technical expertise and dynamic business processes
an excellent match," said Michel Spagnol, Chairman of the Board and
CEO of Novasep. "We are thrilled to be part of a team that is
striving to enable the treatment of many patients suffering serious
heart disease by Celladon's innovative viral vector based
therapy."
About Celladon
Celladon is a clinical-stage biotechnology company applying its
leadership position in the field of cardiovascular gene therapy to
develop novel therapies for diseases with tremendous unmet medical
needs. Celladon's lead programs target SERCA enzymes which are a
family of enzymes that play an integral part in the regulation of
intra-cellular calcium in all human cells. Calcium dysregulation is
implicated in a number of important and complex medical conditions
and diseases, such as heart failure, vascular disease, diabetes and
neurodegenerative diseases. MYDICAR, the Company's most advanced
product candidate, uses gene therapy to target SERCA2a, which is an
enzyme that becomes deficient in patients with advanced heart
failure. Celladon's CUPID2 trial is a 250 patient Phase 2b clinical
trial evaluating the efficacy of MYDICAR in reducing the frequency
of, or delaying heart failure-related hospitalizations. This
randomized, double-blind, placebo-controlled, multinational trial
is evaluating a single intracoronary infusion of MYDICAR versus
placebo added to a maximal, optimized heart failure regimen in
patients with New York Heart Association class III or IV symptoms
of chronic heart failure due to systolic dysfunction, known as
HFrEF. The Company has received Breakthrough Therapy designation
from the FDA for this MYDICAR program and expects to report results
from the Phase 2b clinical trial in late April 2015. In addition,
the Company conducts research and development on its mSCF gene
therapy program for cardiac diseases. Celladon has also identified
a number of potential first-in-class compounds addressing novel
targets in diabetes and neurodegenerative diseases with its small
molecule platform of SERCA2b modulators. For more information,
please visit www.celladon.com.
About Novasep
Novasep is a global provider of cost-effective and sustainable
manufacturing solutions for life sciences molecules and fine
chemicals. Novasep's unique offering includes process development
services, purification equipment and turnkey processes, contract
manufacturing services and complex active molecules to serve
pharmaceutical, biopharmaceutical, fine chemical, food and
functional ingredients as well as fermentation and chemical
commodities industries.
http://www.novasep.com
Celladon Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Such statements include, but are not limited to,
references to the potential future GMP production and commercial
supply of MYDICAR drug substance at the Novasep facility; the
expected timing of CUPID2 data; the impact of Breakthrough Therapy
designation on MYDICAR development and the potential for a
fast-track development schedule; and Celladon's decision and
ability to proceed under the agreement following the un-blinding of
CUPID2 data and commit to a long-term supply arrangement with
Novasep. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. These
forward-looking statements are based upon Celladon's current
expectations and involve assumptions that may never materialize or
may prove to be incorrect. Actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of various risks and
uncertainties, which include, without limitation, risks and
uncertainties associated with the process of conducting product
development activities and clinical trials and obtaining regulatory
approval to commercialize product candidates, Celladon's reliance
on third parties, the need to raise additional funding when needed
in order to conduct our business, and the degree of future market
acceptance of MYDICAR by physicians, patients, third-party payors
and others in the medical community. These and other risks and
uncertainties are described more fully in Celladon's filings with
the Securities and Exchange Commission, including without
limitation its Form 10-Q for the quarter ended September 30,
2014. All forward-looking statements contained in this press
release speak only as of the date on which they were made. Celladon
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
CONTACT: Novasep
Andrew Lloyd & Associates
Carol Leslie
carol@ala.com
UK and US: +44 1273 675 100
FR: +33 156 54 07 00
Celladon
Fredrik Wiklund
Vice President, Corporate Development and Investor Relations
(858) 432-7215
fwiklund@celladon.com
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