Update on Traumakine drug substance manufacturing

RNS Number : 4268O

Faron Pharmaceuticals Oy

02 October 2019

 

Faron Pharmaceuticals Oy

("Faron" or the "Company")

Update on Traumakine drug substance manufacturing

TURKU - FINLAND, 02 October 2019 - Faron Pharmaceuticals Oy (AIM: FARN), the clinical stage biopharmaceutical company, announces that further to the update provided in the H1 2019 interim results in relation to the active pharmaceutical ingredient ("API") manufacturing process for Traumakine, Rentschler Biopharma SE ("Rentschler") has sent Faron a letter in which Rentschler states that it terminates the agreement concerning the API manufacturing. It is the Company's understanding that this relates to the fact that significant upgrading of the API manufacturing process would be required prior to MAA/BLA approval for Traumakine.

The Company is exploring various options for future API manufacturing. This termination has no impact on the currently on-going clinical advice process with FDA/EMA, which focuses on the structure of the next Traumakine clinical study.

For more information please contact:

Faron Pharmaceuticals Oy

Dr Markku Jalkanen, Chief Executive Officer

[e-mail] 

Panmure Gordon (UK) Limited, Nomad and Broker

Emma Earl, Freddy Crossley (Corporate Finance)

James Stearns (Corporate Broking)

Phone: [phone]

Consilium Strategic Communications

Mary-Jane Elliott, David Daley, Lindsey Neville

Phone: [phone]

E-mail: [e-mail]

Westwicke Partners, IR (US)

Chris Brinzey

Phone: [phone]

E-Mail: [e-mail]

About Faron Pharmaceuticals Ltd

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage. Clevegen, its precision immunotherapy, is a novel anti-Clever-1 antibody with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. Currently in phase I/II clinical development as a novel macrophage checkpoint immunotherapy for patients with untreatable solid tumours, Clevegen has potential as a single-agent therapy or in combination with other immune checkpoint molecules. Traumakine, the Company's pipeline candidate to prevent vascular leakage and organ failures, has completed a phase III clinical trial in Acute Respiratory Distress Syndrome (ARDS) and progressing in phase II trial for the Rupture of Abdominal Aorta Aneurysm ("RAAA"). Plans for its future development are being finalised to avoid interfering steroid use together with Traumakine. Faron is based in Turku, Finland. Further information is available at www.faron.com

 

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