Lund, Sweden, 8 October 2018
TFS collaboration with Lobsor Pharmaceuticals AB, on the development of Lecigon®, has resulted in marketing authorization of Lecigon® in Sweden.
TFS International is thrilled with the announcement that Lecigon®, a new therapeutic system for symptomatic treatment of Advanced Parkinson’s Disease (APD), has been granted marketing authorization in Sweden. Lecigon® is a pharmaceutical gel formulation containing a combination of levodopa/carbidopa and entacapone for continuous infusion into the small intestine through a newly developed lightweight pump. The combination of lower dosage and lighter pump is designed to significantly improve patient convenience and quality of life.
TFS contributed to this success through its collaboration with Lobsor Pharmaceuticals AB under a risk-sharing partnership, performing the regulatory strategy, clinical development planning and execution and Marketing Authorization (MA) filing.
“Together with Lobsor, we are very proud of this accomplishment. A big thanks to our joint teams for their hard work achieving this significant milestone”, said Dr János Filakovský, Chief Executive Officer. “This is another example of how TFS partners with customers to provide tailored flexible solutions to accelerate new innovative treatment development”.
“Our ultimate goal is improving patient care, this great achievement speaks to our capability and experience to handle a drug-device combination product application in Europe and globally, in a complex regulatory environment to bring further treatment options for patients in this unmet medical need area”, said Dr Bassem Saleh, Chief Medical and Scientific officer and Head Clinical Development Services.
Ulf Rosén and Roger Bolsöy, Founders of Lobsor: “The market authorization in Sweden is a big achievement for a small company like Lobsor and the risk-sharing partnership with TFS has been an important part of the success. The partnership presented the opportunity to move the project forward in a pace otherwise not possible for us.”
Information about TFS
TFS was founded in 1996 and has grown to become the leading global mid-size clinical CRO focusing on small and mid-size life science customers. TFS employs more than 700 professionals throughout 21 countries and currently delivers clinical research services in more than 40 countries. We can provide end-to-end solutions or flexible single services. Our partnering approach with customers is based on our four business principles – commitment, flexibility, value creation and global reach. Our core therapeutic specialties are Oncology, Immunology, Dermatology, Ophthalmology, CNS, Cardiology and Endocrinology.
Detailed information about TFS, and its business offerings can be obtained through www.tfscro.com
Information about Lobsor Pharmaceuticals AB
Lobsor Pharmaceuticals is a privately held company based in Uppsala, Sweden founded 2013 by Ulf Rosén. In 2014, Roger Bolsöy joined as Co-founder to run the development project. It is a fully owned subsidiary to Lobsor Holding AB. Lobsor has signed a collaboration agreement with NordicInfu Care for market insights in the development phase, in addition to sales, marketing and distribution in the Nordic market. In addition, Lobsor is now exploring various commercial routes forward to ensure that the treatment will be made available for patients in the European market and the rest of the world. For more information go to www.lobsor.com
For further information, please contact:
Andrew Copestake, Chief Commercial Officer
Phone: +46 (0)40 280 18 00