In June 2014, TFS and LobSor signed a risk-sharing agreement for the development of LobSor's Advanced Parkinson's disease candidate LECIGel® with the objective to file a Marketing Authorization (MA) in Europe. TFS is under the risk-sharing agreement responsible for the regulatory strategy, clinical development planning and execution including the regulatory MA filing. TFS and LobSor have advanced the program from outlining the regulatory strategy to the first patient dosing in less than 18 months and are planning to file the MA in December 2015. The clinical trial will recruit 15 Parkinson's patients at one investigational site during six weeks and the final study report is expected by September 2015.
No equity transaction is involved in the risk-sharing partnership the commercial upside for both parties relies upon a successful regulatory approval of the MA which is expected in the second half of 2016.
LECIGel, is a proprietary gel formulation for continuous intestinal administration of a levodopa, carbidopa and entacapone with the help of a small and light ambulatory pump system. The intention is to offer a treatment system with an improved safety profile, maintained clinical efficacy, enhanced user convenience, and thus improved Quality Of Life. Adding entacapone to a levodopa/carbidopa formulation, will among other, likely reduce the daily levodopa dose needed with a maintained clinical effect, potentially reducing levodopa related side effects including its adverse metabolic effects. The continuous intestinal delivery, tailored for the individual patient, has shown to secure a smooth levodopa plasma level and thereby offering a true continuous dopaminergic stimulation resulting in a predictable and stable clinical effect.
"It was quite an easy choice to engage TFS in this project. For us, this was the "one-stop-shop" offering a regulatory and clinical solution, aligned with our ambition to have an industrial competent and virtual organization around the LECIGel project. In addition, the risk-sharing agreement gave us the opportunity to gain time to market without an initial and resource consuming financing process" says Mr. Roger Bolsöy, CEO of LobSor. He adds "with the advancements in the project under the risk-sharing agreement it has been easier to, in parallel, obtain external financing for product development, build-up of production capacity and other capital consuming steps of pharmaceutical development".
"We are very pleased with the progress so far and the risk-sharing structure we have in place with LobSor. Entering into a risk-sharing structure is normally not a core business of TFS but we would not shy away if we think the science, the regulatory pathway and the literature would support a high probability of success. We found all these elements to be well-aligned with our expectations when reviewing the opportunity back in early 2014. We are now looking forward to complete the ongoing study and file the MA" says Mr. Daniel Spasic, CEO of TFS.
Information about TFS
TFS International is the largest global independent clinical Contract Research Organization (CRO). Founded in 1996 in Sweden, TFS currently operates in over 20 countries throughout Europe, USA, Canada and Japan and employs more than 700 professionals. TFS core therapeutic areas of expertise are Oncology, Immunology, Dermatology, Ophthalmology, CNS, Cardiology and Endocrinology. Through two business areas, TFS Develop™ and TFS People™, TFS provides services worldwide as end-to-end solutions or tactical functional services. Detailed information about TFS, its business offerings, global locations and recent press releases can be obtained through www.tfscro.com
Information about LobSor Pharmaceuticals
The company's mission is to leverage existing medical and information technologies to develop new, potentially proprietary, patient-tailored therapies and systems. Products will be based on known active substances, components and technologies, but applied in a way that improve the quality of life for patients and provide financial effectiveness for society. LobSor Pharmaceutical is a fully owned subsidiary of Uppsala (Sweden) based LobSor Holding AB.
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