Second Traumakine manufacturing site established

RNS Number : 8543D

Faron Pharmaceuticals Oy

05 February 2018

 

Faron Pharmaceuticals Ltd

("Faron" or the "Company")

Faron establishes second Traumakine^® manufacturing site

TURKU - FINLAND, 05 February 2018 - Faron Pharmaceuticals Ltd ("Faron") (AIM: FARN), the clinical stage biopharmaceutical company, announces that it has signed an agreement with a second contract manufacturing organization, Lyocontract GmbH, for additional commercial scale manufacturing of Faron's wholly owned product Traumakine (drug product FP-1201-lyo), for the treatment of Acute Respiratory Distress Syndrome (ARDS).

Lyocontract, based in Ilsenburg, Germany, will provide a second independent manufacturing facility for Traumakine, to complement the primary site currently operated by Rentschler Biopharma SE under a separate manufacturing and supply agreement. These two manufacturing sites will support Faron's commercial preparations for Traumakine in the event of positive results from the pivotal pan-European INTEREST trial in patients with moderate and severe ARDS. Data from this trial continue to be expected during the first half of 2018.

A single production batch at Lyocontract will contain 120,000 vials of FP-1201-lyo equalling approximately 20,000 Traumakine treatments. Faron anticipates that it will have approximately 100,000 available treatments for distribution in global markets by mid 2019, assuming that Traumakine is granted the necessary regulatory approvals.

ARDS is a severe orphan disease with a reported mortality rate of approximately 30-45%^1,2,3, for which there is currently no approved pharmacological treatment. It is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia (e.g. following a pandemic influenza), sepsis, or significant trauma. Faron estimates there are around 300,000 plus annual cases in Europe and US alone. Faron completed the recruitment of 300 patients with moderate and severe ARDS for the pan-European pivotal trial INTEREST in December 2017.

Dr Markku Jalkanen, CEO of Faron, said: "We are very pleased to secure additional manufacturing for Traumakine drug product FP-1201-lyo as we continue to prepare for commercialization. This will enable us to provide Traumakine supply for early access programs as well as for later market demand in the event of product approval. Lyocontract has already sucessfully produced several pilot batches of FP-1201-lyo ahead of data readout from the recently completed INTEREST trial in ARDS.

"We look forward to the data becoming available during the first half of 2018 and, following recent positive FDA advice which expedites Traumakine's potential route to U.S. markets, we continue our goal of becoming a global leader in organ protection and control of harmful immune suppression and work on bringing Traumakine to patients as expediously as possible."

For more information please contact:

Faron Pharmaceuticals Ltd

Dr Markku Jalkanen, Chief Executive Officer

[e-mail] 

Consilium Strategic Communications

Mary-Jane Elliott, Matthew Neal, Philippa Gardner, Lindsey Neville

Phone: [phone]

E-mail: [e-mail]

Westwicke Partners, IR (US)

Chris Brinzey

Phone: [phone]

E-Mail: [e-mail]

Panmure Gordon (UK) Limited, Nomad and Broker

Freddy Crossley (Corporate Finance)

Tom Salvesen (Corporate Broking)

Phone: [phone]

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 focusing on acute organ traumas, vascular damage and cancer immunotherapy. The Company's lead candidate Traumakine, to prevent vascular leakage and organ failures, is currently the only treatment for Acute Respiratory Distress Syndrome (ARDS) undergoing Phase III clinical trials and in 2017 received advice from US FDA to proceed directly to BLA submission following completion of EU and Japanese Phase III studies.  There is currently no approved pharmaceutical treatment for ARDS. An additional European Phase II Traumakine trial is underway for the Rupture of Abdominal Aorta Aneurysm ("RAAA"). Faron's second candidate Clevegen is a ground breaking pre-clinical anti-Clever-1 antibody. Clevegen has the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development. This novel macrophage-directed immuno-oncology switch called Tumour Immunity Enabling Technology ("TIET") may be used alone or in combination with other immune checkpoint molecules for the treatment of cancer patients. Faron is based in Turku, Finland. Further information is available at  www.faron.com

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1 JAMA. 2016 Feb;315(8):788-800

2 Intensive Care Med. 2011;37(12):1932

3 N Engl J Med. 2005;353(16):1685

 

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