Minapharm Pharmaceuticals S.A.E has announced today that the German regulatory authority BfArM (Federal Institute for Drugs and Medical Devices) approved a phase 1 clinical trial for its biosimilar teriparatide in Germany. The product has been submitted for approval to the Egyptian health authorities and expected to be marketed under the name Bonosome rDNA.
The planned trial is a single center, double-blind, randomized, single dose, fixed-dose, 2-way cross over study of Bonosome rDNA and its reference product FORSTEO® (Eli-Lilly) in healthy female adult volunteers. Primary objectives are the demonstration of pharmacokinetic equivalence between Bonosome rDNA and FORSTEO®. Secondary objectives comprise pharmacokinetic and pharmacodynamic comparison between both products as well as safety and tolerability parameters.
Bonosome rDNA represents the first product from an impressive biosimilar pipeline at Minapharm Pharmaceuticals subjected to international clinical development.
“This approval of a first European clinical application for a product from our portfolio demonstrates Minapharm’s regional market leadership. The establishment of an internationally rewarded development platform is a landmark milestone bridging to a new strategic era of quality affordable biopharmaceuticals for Africa, the Middle East and beyond, and capitalizes on two decades of research, development and commercialization of genetically engineered medicines”
said Dr. Wafik Bardissi, CEO and Chairman of the Board at Minapharm Pharmaceuticals.
Dr. Jan Rohde, Director R&D Operations and Project Management at Minapharm Pharmaceuticals added: “The research and development group showed a high degree of dedication, expertise and competence over the past years and having achieved this unconditional clinical trial approval for our biosimilar teriparatide from BfArM makes me very proud of the process R&D team. At the same time, we feel well prepared for the next steps and upcoming products of our impressive development pipeline.”
Minapharm Pharmaceuticals, headquartered in Cairo with its production facilities in the Tenth of Ramadan city, is among the leading prescription medicine companies in Egypt and the Middle East. The company is specialized in the manufacture and marketing of innovative pharmaceuticals and through its subsidiary Rhein-Minapharm-Biogenetics, in the research, development and manufacturing of biopharmaceuticals. Its biotech subsidiary is focusing on the core therapeutic areas of endocrinology, oncology, autoimmunity and hematology. With 12 therapeutic biopharmaceuticals already marketed and several in the pipeline, Minapharm’s competence lies in decreasing time to market without compromising ethical and safety standards.
By combining its expertise in pharmaceuticals and leadership in biopharmaceuticals, Minapharm, along with its worldwide strategic alliances, contributes significantly to the quality of life of many people in the region. Minapharm employs a collective workforce of over 1000 and is listed on the Cairo and Alexandria stock exchange (Symbol: MIPH).
For more information on Minapharm and its products please visit www.minapharm.com and www.rhein-minapharm.com