Arecor Therapeutics PLC Arecor: positive Hikma FDA pre-IND meeting (6326L)
07 Septembre 2023 - 8:00AM
UK Regulatory
TIDMAREC
RNS Number : 6326L
Arecor Therapeutics PLC
07 September 2023
Arecor Therapeutics plc
("Arecor" or the "Group")
ARECOR ANNOUNCES POSITIVE PRE-IND MEETING WITH FDA FOR NOVEL
READY-TO-USE MEDICINE AT307 LICENSED TO HIKMA
- Positive feedback from pre-IND meeting with FDA confirms
Hikma's continued development of AT307 under the 505(b)(2)
regulatory pathway
- Abbreviated 505(b)(2) submission offers an efficient and
streamlined development pathway with reduced risk
Cambridge, UK, 7th September 2023: Arecor Therapeutics plc (AIM:
AREC), the biopharmaceutical group advancing today's therapies to
enable healthier lives, is pleased to announce further progress
from Hikma in the development of ready-to-use ("RTU") injectable
medicine AT307, following a recent positive pre-investigational new
drug application (pre-IND) meeting between Hikma and the US Food
and Drug Administration (FDA).
In January 2023, Arecor transferred all rights and
responsibility for future development and commercialisation of
AT307 to Hikma as part of an earlier co-development and license
agreement in which Arecor used its proprietary drug formulation
technology platform, Arestat(TM), to develop a novel RTU
formulation of an existing therapeutic product.
Based on positive feedback from a pre-IND meeting held with the
FDA, Hikma has communicated to Arecor its intention to continue
development of AT307 in the US using the FDA's 505(b)(2) regulatory
pathway. This pathway provides companies with an abbreviated
regulatory review process when evidence of safety and clinical
efficacy generated for an originator product is deemed suitable to
be relied upon in new marketing applications.
Sarah Howell, Chief Executive Officer at Arecor, said: "We are
very pleased with this confirmatory news that Hikma is able to
pursue an abbreviated 505(b)(2) approval pathway for AT307,
providing an opportunity to progress the development and regulatory
review process and bring this medicine to patients more rapidly
than through a traditional new drug approval route. This also
further validates a fundamental assumption within our business that
the abbreviated 505(b)(2) pathway can be utilised across our
specialty hospital portfolio where we are developing enhanced,
ready-to-use and ready-to-administer formulations of existing
therapeutic products."
Bill Larkins, President of Injectables at Hikma, said: "The
FDA's feedback supports our intention to pursue a 505(b)(2) pathway
to market for AT307, so we can bring this important new
ready-to-use treatment option to patients. It also further
demonstrates the strength of the Hikma and Arecor strategic
partnership where we are leveraging our respective strengths to
bring this important treatment option to patients and healthcare
providers and further position our business for continued long-term
growth. We look forward to advancing AT307 through further
development and to continuing our highly productive strategic
collaboration with Arecor."
Under the terms of Arecor's 2020 co-development and license
agreement with Hikma, the Group is eligible to receive development
milestone payments in addition to future recurring revenue from
royalty payments upon commercialisation.
-ENDS-
For more information, please contact:
Arecor Therapeutics plc www.arecor.com
Dr Sarah Howell, Chief Executive Tel: +44 (0) 1223 426060
Officer Email: info@arecor.com
Susan Lowther, Chief Financial Officer Tel: +44 (0) 1223 426060
Email: info@arecor.com
Mo Noonan, Communications Tel: +44 (0) 7876 444977
Email: mo.noonan@arecor.com
Panmure Gordon (UK) Limited (NOMAD
and Broker)
Freddy Crossley, Emma Earl (Corporate Tel: +44 (0) 20 7886 2500
Finance)
Rupert Dearden (Corporate Broking)
Consilium Strategic Communications
Chris Gardner, David Daley, Lindsey Tel: +44 (0) 20 3709 5700
Neville Email: arecor@consilium-comms.com
Notes to Editors
About RTU and RTA medicines
Ready-to-use (RTU) and ready-to-administer (RTA) medicines are
becoming increasingly important to enable fast, safe and effective
treatment of patients at point of care in a hospital setting. These
RTU and RTA new stable liquid product formulations improve safe
medication practices and simplify care by eliminating the need for
reconstitution. The lack of a RTU or RTA version of a product is
usually due to technical challenges in developing stable and
efficacious liquid formulations.
Arecor has demonstrated its capability to leverage the
Arestat(TM) platform to reformulate existing products into RTU and
RTA injectables. This market thus offers Arecor the opportunity to
deliver differentiated products and with it's partners target
market share in a valuable, but often competitive space.
About Arecor
Arecor Therapeutics plc is a globally focused biopharmaceutical
group transforming patient care by bringing innovative medicines to
market through the enhancement of existing therapeutic products. By
applying our innovative proprietary formulation technology
platform, Arestat(TM), we are developing an internal portfolio of
proprietary products in diabetes and other indications, as well as
working with leading pharmaceutical and biotechnology companies to
deliver enhanced formulations of their therapeutic products. The
Arestat(TM) platform is supported by an extensive patent portfolio.
For further details please see our website, www.arecor.com
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