Promore Pharma AB announced that it will assume responsibility for the manufacturing of the investigational medicinal product for the clinical Phase III trial for PXL01 and at the same time, the company regains the global manufacturing rights for the commercial product. In March 2016, Promore Pharma entered into an agreement with PharmaResearch Products Ltd. ("PRP") regarding development collaboration on PXL01, complemented by a manufacturing agreement in January 2017. In accordance with the agreements, PRP has contributed to the financing of the Phase III clinical trial on PXL01 through milestone payments as well as manufacturing of investigational medicinal product for the trial.

In cooperation with Promore Pharma, PRP has been working intensively to prepare the manufacturing. Since the clinical trial will be conducted primarily in Europe, the parties have now agreed that Promore Pharma will assume responsibility for the manufacturing of investigational medicinal product to facilitate control of manufacturing and product supply for the trial. At the same time, Promore Pharma regains the global manufacturing rights for the commercial product.

The development of PXL01 is initially aiming at preventing postsurgical adhesions after tendon repair surgery in the hand. Postsurgical adhesions constitute a substantial clinical problem after most surgical procedures, and particularly in conjunction with hand surgery. Flexor tendon injuries and repair result in adhesion formation around the tendon, which restricts the gliding function of the tendon, leading to decreased digit mobility and impaired recovery of normal hand function.

Promore Pharma is preparing for a clinical Phase III study in EU and India. The trial is planned as a randomized, double-blinded study including 500-600 patients with flexor tendon injuries in the hand, where a single administration event of PXL01 at two different doses will be compared with placebo. The company aims to start recruitment to the trial in 2018.