FluidCrystal® extended release formulation of zilucoplan
achieved rapid and sustained pharmacodynamic inhibition of
complement C5 in non-human primates, supporting at least once
weekly dosing
CAMBRIDGE, Massachusetts and
LUND, Sweden, July 16, 2019 /PRNewswire/ -- Ra Pharmaceuticals,
Inc. (Nasdaq: RARX) and Camurus AB (Nasdaq STO: CAMX) today
announced an exclusive worldwide license agreement for the use of
Camurus's proprietary FluidCrystal® (FC) technology to develop,
manufacture, and commercialize a long-acting formulation of
zilucoplan, Ra Pharma's complement component 5 (C5) inhibitor in
development for the treatment of multiple complement-mediated
disorders.
"Ra is committed to delivering convenient and accessible
products for managing C5-mediated diseases. Building on the
strength of our daily formulation, which offers a quick, low volume
injection and room temperature storage, the FluidCrystal® extended
release (XR) formulation of zilucoplan has the potential to control
disease for at least seven days from a single subcutaneous dose
without the need for intravenous loading, on-body infusion devices,
tissue-degrading enzymes, or permeation enhancers. The promising
data from our pre-clinical studies conducted with Camurus, the
potential for cost-effective manufacturing, and Camurus's proven
late-stage regulatory experience with FluidCrystal® were compelling
reasons to add the FluidCrystal® technology into our zilucoplan XR
life-cycle extension program," said Doug
Treco, Ph.D., President and Chief Executive Officer of Ra
Pharma.
In pre-clinical testing, a single dose of the FC XR formulation
of zilucoplan in non-human primates rapidly achieved and maintained
target levels of complement inhibition for at least seven days
without the need for an intravenous loading regimen.
"The partnership with Ra Pharma follows the successful
completion of a feasibility study of the FluidCrystal® extended
release zilucoplan injection, which met formulation,
pharmacokinetic, and tolerability target specifications," said
Fredrik Tiberg, President & CEO
of Camurus. "We look forward to the next phase of our collaboration
with Ra Pharma and initiating clinical development of a new
promising product candidate based on our unique FluidCrystal®
technology."
Under the agreement, Camurus will receive an upfront payment of
$2 million and is eligible to receive
up to $14.5 million in development
milestones and other license payments, up to $55 million in sales milestones, and tiered
single digit royalty payments on product sales related to the FC XR
formulation of zilucoplan.
About Zilucoplan
Ra Pharma is developing zilucoplan and zilucoplan extended
release (XR) for generalized myasthenia gravis (gMG),
immune-mediated necrotizing myopathy (IMNM), and other
tissue-based, complement-mediated disorders with high unmet medical
need. The product candidates are designed for convenient
subcutaneous (SC) self-administration. Zilucoplan is an
investigational, synthetic, macrocyclic peptide discovered using Ra
Pharma's powerful proprietary drug discovery technology. The
peptide is designed to bind complement component 5 (C5) with
sub-nanomolar affinity and allosterically inhibit its cleavage into
C5a and C5b upon activation of the classical, alternative, or
lectin pathways.
About FluidCrystal® Injection Depot
The FluidCrystal® injection depot delivers therapeutic levels
of drug substance over selected extended periods – from days to
months – from a single injection. The FluidCrystal® injection depot
offers a liquid solution that transforms into a controlled release,
biodegradable liquid crystal gel matrix in situ on contact with
minute quantities of aqueous fluid at the injection site. Medicines
based on the FluidCrystal® injection depot can be administered by
the patients themselves or by healthcare professionals, without
time-consuming and complicated reconstitution procedures. The
technology is validated by approvals of Buvidal® in the EU and
Australia and by the Brixadi™
tentative approval in the US and has been studied in more than 20
completed clinical trials. FluidCrystal® is a registered trademark
of Camurus AB.
About Ra Pharmaceuticals
Ra Pharmaceuticals is a clinical-stage biopharmaceutical
company focused on leading the field of complement biology to bring
innovative and accessible therapies to patients with rare diseases.
The Company discovers and develops peptides and small molecules to
target key components of the complement cascade. For more
information, please visit:
www.rapharma.com.
About Camurus
Camurus is a Swedish science-led biopharmaceutical company
committed to developing and commercialising innovative and
differentiated medicines for the treatment of severe and chronic
conditions. New drug products with best-in-class potential are
conceived based on the company's proprietary FluidCrystal® drug
delivery technologies and its extensive R&D expertise. Camurus'
clinical pipeline includes products for the treatment of cancer,
endocrine diseases, pain and addiction, which are developed
in-house and in collaboration with international pharmaceutical
companies. The company's shares are listed on Nasdaq Stockholm
under the ticker CAMX. For more information, visit
www.camurus.com.
Ra Pharmaceuticals, Inc.
Investors:
Ra Pharmaceuticals, Inc.
Natalie Wildenradt, 617-674-9874
nwildenradt@rapharma.com
Media:
Argot Partners
David Rosen, 212-600-1902
david.rosen@argotpartners.com
Camurus AB
Fredrik Tiberg
President & CEO, Head of R&D
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com
Fredrik Joabsson
Chief Business Development Officer
Tel. +46(0)70-776-17-37
ir@camurus.com
This information is information that Camurus AB is obliged to
make public pursuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of
the managing director, at 8:00 am CET
on 16 July 2019.
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/camurus-ab/r/ra-pharmaceuticals-and-camurus-announce-exclusive-license-agreement-for-fluidcrystal--extended-relea,c2864037
The following files are available for download:
https://mb.cision.com/Main/13456/2864037/1078056.pdf
|
Press
release.pdf
|