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(Alliance News) - Faron Pharmaceuticals Oy on Wednesday said Rentschler Biopharma SE has terminated its agreement to manufacture the active ingredient in Traumakine.
Shares in Faron were down 4.5% at 96.00 pence in London in midday trading.
Traumakine is being developed by Faron as a treatment for acute respiratory distress syndrome, where a patient's lungs become very inflamed as a result of a injury or an infection. The syndrome causes difficulty breaching and those who develop it are typically admitted to intensive care and put on a ventilator.
Drug developer Faron announced in its half-year results on September 23 that the process being used to make Traumakine's active ingredient would need "significant upgrading" for Faron to ever obtain a biologics license application in the US or marketing authorisation application in the EU.
Faron said it understood Rentschler's decision to terminate the agreement relates to the need for upgraded manufacturing to make Traumakine's active ingredient.
The firm said it is "exploring various options" to make the active ingredient in the future and the termination will not hurt its "clinical advice process" with the Us Food & Drug Administration or European Medicines Agency and is focused "on the structure of the next Traumakine clinical study".
Within its interim results announcement, Faron also disclosed that it had closed its phase 2 Inforaaa study of Traumakine's effect on mortality for patients with surgically operated Ruptured Abdominal Aorta Aneurysm.
While the patients demonstrated a good response to the drug, the high use of corticosteroids among study patients hindered implementation of the study's protocol.
Previous studies have found that taking corticosteroids reduces the action of Traumakine's active ingredient, but such steroids are often the standard of treatment for the patient population Faron is studying. The firm is thus seeking advice on how to structure a trial to account for this problem.
By Anna Farley; annafarley@alliancenews.com
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