Promore Pharma AB, a Swedish biopharmaceutical developer of therapeutic peptides, today announced that a manufacturing agreement has been entered with APL for the production of investigational medicinal product for its LL-37 Phase IIb trial in patients with hard-to-heal leg ulcers. APL was selected from several potential partners in a competitive process.
Promore Pharma has signed an agreement with APL regarding the manufacturing of investigational medicinal product for its LL-37 Phase IIb trial in patients with venous leg ulcers (VLU). The trial will be conducted in Europe with a planned start for patient enrolment in 2018. VLU constitutes the largest category of all chronic, or hard-to-heal, ulcers and represent significant challenges to patients and healthcare systems since they are frequent, costly to manage, recurring, and may persist for months or years. Standard treatment consist of compression bandaging and there are no approved pharmaceutical products for VLUs. Only in the US the costs for VLUs are estimated at a minimum of USD 14 billion annually.
“APL is a proud service provider to Promore Pharma. We are glad to have been selected to continue the partnership with Promore Pharma, when the company now enters into the next phase in the development of this important product” said Eva Sjökvist Saers, CEO of APL.
"It is satisfactory to have come so far in our development initiative on LL-37” said Jonas Ekblom, President and CEO of Promore Pharma. “To secure our supply chain of investigational medicinal product for the clinical trial is a key activity and this means we are able to further commit to an ambitious product development schedule. The development has proceeded according to plan and we are very happy about our continued work with APL whom we have learned to know as a high-quality provider of manufacturing services and support”, he continued.
LL-37 is based on a human antimicrobial peptide that stimulates several processes in wound healing. In the Phase IIa study conducted in patients with venous leg ulcers, LL-37 showed good efficacy. The product candidate can be combined with the standard wound care treatments and can be applied by nurses or potentially by the patient alone. The development of LL-37 focuses initially on venous leg ulcers but the company sees good potential in developing LL-37 for also diabetic foot ulcers.
For more information, please contact:
Eva Sjökvist Saers, CEO APL
Phonel: +4610 - 447 96 10
Jonas Ekblom, CEO Promore Pharma
Phone: +4673 - 677 75 40
Promore Pharma in brief:
Promore Pharma is a biopharmaceutical company specialized in the development of therapeutic peptides for the bioactive wound care market. The company’s aim is to develop two first-in-category products for indications where very few efficacious prescription pharmaceuticals are available, thus, addressing high unmet medical needs. Promore Pharma has two projects, PXL01 and LL-37, in late stage clinical phase. PXL01, that will be used for prevention of post-surgical adhesions and scars, is being prepared for clinical phase III-studies in patients undergoing tendon repair surgery in the hand and LL-37 that is prepared for a clinical phase IIb study in patients with venous leg ulcers. The product candidates can also be deployed for other indications, such as preventing dermal scarring and treatment of diabetic foot ulcers. The company is listed on Nasdaq First North with Redeye AB as Certified Adviser.
APL is a leading Scandinavian contract manufacturer in the Life Science sector with resources for development, manufacturing and analysis of pharmaceuticals. The company is also one of the largest manufacturers of extemporaneous pharmaceuticals in Europe. They offer their services to biotech and pharmaceutical companies, Swedish healthcare and pharmacies. APL has more than 30 years of experience in pharmaceutical development and manufacturing, 580 employees and an annual turnover of about 150 M EUR.
APL är en av Europas största tillverkare av extemporeläkemedel. Vi är ledande kontraktstillverkare inom Life Science i Skandinavien och etablerad partner för tjänster och produkter till apotek. Med våra 489 medarbetare och fyra produktionsanläggningar har vi resurser för utveckling, analys och tillverkning av läkemedel. APL bidrar till läkemedel som förbättrar och räddar liv. Läs mer på www.apl.se.