REG - Arecor Therapeutics - Arecor: positive Hikma FDA pre-IND meeting

Arecor TherapeuticsAnnouncement

07/09/2023 07:00

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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™, 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 (http://www.arecor.com/)
 Dr Sarah Howell, Chief Executive Officer        Tel: +44 (0) 1223 426060

                                                 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 Finance)  Tel: +44 (0) 20 7886 2500

 Rupert Dearden (Corporate Broking)

 Consilium Strategic Communications
 Chris Gardner, David Daley, Lindsey Neville     Tel: +44 (0) 20 3709 5700

                                                 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™ 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™, 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™
platform is supported by an extensive patent portfolio. For further details
please see our website, www.arecor.com (http://www.arecor.com)

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