Apeptico and Mediolanum sign a Research & Development Cooperation and License Agreement for APEPTICO’s therapeutic peptide Solnatide

Apeptico Forschung und Entwicklung GmbH and Mediolanum farmaceutici S.p.A. today announce the signing of a Research & Development Cooperation and License Agreement for Apeptico’s compound solnatide. Solnatide is a therapeutic peptide developed by Apeptico for the activation of alveolar liquid clearance, ready to enter into phase IIb clinical development for different life-threatening pulmonary indications.

Under the Agreement, Apeptico will receive an up-front research & development payment in cash, development milestones, and will supply Mediolanum the finished pharmaceutical product. In return, Mediolanum will receive an exclusive license for solnatide for various European markets.
Commenting on the agreement, Bernhard Fischer, CEO of Apeptico, stated: "We are very pleased that we could attract Mediolanum, a highly dynamic European pharmaceutical company, to license this exciting project. I am convinced that Apeptico’s know-how in this area, together with the vision and the marketing capabilities of Mediolanum, are the best way forward to bring an innovative therapy to patients.”
Commenting on the deal, Mr. Alessandro Del Bono, CEO of Mediolanum farmaceutici, said “2016 has been a very fruitful year for Mediolanum, particularly in regard to its efforts and achievements in R&D. We are delighted that we have been able to sign this agreement with Apeptico, a company at the forefront of innovation in the area of peptide-based treatments of pulmonary diseases. The addition of solnatide to our development pipeline is in line with our search for innovative solutions for the management of medical conditions with high-unmet medical need.
Mrs. Cristina Del Bono, Licensing & Business Development Director of Mediolanum added “We are proud to collaborate with Apeptico in their effort to bring to the market a new option for the treatment of patients affected with ARDS and PGD, two life-threatening conditions for which no satisfactory cure exists today. Beside in ARDS and PGD, Solnatide has received the orphan designation by the EMA also in high altitude pulmonary edema (HAPE) and pseudohypoaldosteronism type 1b, other two extremely severe conditions. Being the second deal that Mediolanum strikes in the orphan drug sector, it confirms and consolidates Mediolanum’s will to be a strong player in this area, too.”
About Apeptico Forschung und Entwicklung GmbH

Apeptico is a privately held biotechnology company based in Austria, developing peptide-based products targeting chronic and life-threatening diseases. The peptide molecules correspond to validated, pharmacodynamic active structures and domains of well-known proteins and biopharmaceuticals. Apeptico makes use of its technology platforms PEPBASE(TM) and PEPSCREEN(TM) to significantly reduce cost and shorten time to market of its drug candidates.
About solnatide
APEPTICO’s proprietary therapeutic molecule solnatide (INN) is a synthetically manufactured structural equivalent to a domain of a human protein. Solnatide is being developed by Apeptico for the treatment of various forms of life-threatening pulmonary oedema. Liquid and dry powder formulations of solnatide can be directly administered into the lung by inhalation of aerosol particles with 5 micrometres diameter or less. Apeptico has successfully completed two phase IIa randomized controlled trials with orally inhaled solnatide, one for the treatment of patients with Acute Respiratory Distress Syndrome (ARDS) and one for the treatment of patients with primary graft dysfunction (PGD) following lung transplantation. Assessments for the treatment of high altitude pulmonary oedema (HAPE), pseudohypoaldosteronism type 1b (PHA type 1b) as well as severe cardiogenic pulmonary oedema are also underway.
About Mediolanum farmaceutici S.p.A.
Mediolanum farmaceutici SpA is a privately owned pharmaceutical company, headquartered in Milan. Founded by Mr. Rinaldo Del Bono in 1972, it has meanwhile grown to a 500 staff group and reached a consolidated turnover of around 200 million Euros. The Group also includes NeopharmedGentili Srl, a marketing company of pharmaceuticals in Italy, born from the merger of the two companies Neopharmed and Istituto Gentili, acquired from Merck Group; Cristalfarma Srl, a company that develops and commercializes food supplements from botanical sources in Italy; and the subsidiary Laboratoires Leurquin Mediolanum SA in France. In its 45 years’ history, Mediolanum has submitted applications for more than 90 inventions, obtaining nearly 700 patents, and fully developed four new pharmaceutical products. Its current R&D pipeline comprises four projects. Beside the project with Apeptico on solnatide, Mediolanum’s R&D pipeline includes GX-301, an immunotherapeutic vaccine in phase 2 for the treatment of prostate cancer; PP-001, a new small molecule entering clinical phase 1 for the treatment of uveitis, in collaboration with the Austrian company, Panoptes; and ACT-017, a humanized Fab in the preclinical phase of development for the treatment of acute ischemic stroke, in collaboration with the French company, Acticor. From a commercial point of view, Mediolanum’s core business is focused on the vascular and cardio-metabolic area, including diabetes, the osteo-articular area and pneumology/allergology.

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