Flexilev MyFID (levodopa/carbidopa microtablets with electronic dosing device) / Navamedic, Orion Corp - LARVOL DELTA

Navamedic and Orion Corporation sign License & Supply Agreement for Flexilev in Europe (PRNewswire) - "Navamedic ASA and Orion Corporation ('Orion') have today signed a license and supply agreement for Flexilev...Through the signed agreement, Orion has been granted the exclusive right to market, distribute, and sell Flexilev in 27 countries in Europe, including the 'big five': Germany, France, Italy, Spain and the UK...The agreement consists of a non-refundable upfront payment of 2mEUR to Navamedic, upon signature of the agreement. Additionally, Navamedic is entitled to milestone payments of up to 3.5 mEUR upon reimbursement approval in key countries, as well as royalty from net revenue and sales milestone payments."

Licensing / partnership • CNS Disorders • Parkinson's Disease

Navamedic and Orion Corporation sign non-binding term sheet for Flexilev in Europe (PRNewswire) - "Navamedic ASA and Orion Corporation ('Orion') have today signed a non-binding term sheet for a licensing- and supply agreement for Flexilev®, including the Orafid dispenser, across Europe, not including Sweden, Norway, Denmark, and Iceland, where Navamedic will market and sell the product....Orion and Navamedic have agreed to enter into a final agreement by the end of the first quarter of 2024....The intended licensing agreement will consist of a non-refundable upfront payment of 2mEUR to Navamedic, upon signature of the agreement. Additionally, Navamedic is entitled to milestone payments of up to 3.5 mEUR upon reimbursement approval in key countries, as well as royalties, and sales milestone payments."

Licensing / partnership • Parkinson's Disease

Sensidose's share rises after offer from Navamedic [Google translation] (BioStock) - "Sensidose develops and sells individualized dosing of drugs for the medical treatment of Parkinson's disease. The pharmaceutical company is in a growth phase and has now received a cash takeover offer from Norwegian Navamedic. The deal has been recommended by the board and with the support of the corporate finance company Eminova. The news of the acquisition caused Sensidose's stock to rise by over 40 percent."

M&A • Stock price • CNS Disorders • Parkinson's Disease

Sensidose granted reimbursement for Flexilev in Finland (Market Screener) - "As part of Sensidose's ongoing geographical expansion, the company last autumn applied for reimbursement for Flexilev with the Finnish Pharmaceutical Price Board....The application has now been granted and the approval is in accordance with the reimbursement in the other Nordic countries....The Finnish authority, Kela, has assessed the clinical data and cost-effectiveness of Flexilev and concluded that the product is cost-effective for patients where standard therapy has not given satisfactory results. In Finland, it is estimated that 16,000 people suffer from Parkinson's disease."

Reimbursement • CNS Disorders • Parkinson's Disease

"Sensidose granted reimbursement for Flexilev in Finland https://t.co/cZTdNoW8aI" (@CisionNews)

Reimbursement • US reimbursement

Sensidose AB interim report 1 January - 30 September 2022 [Google translation] (Cision) - "Sensidose's January-September turnover increased by 9.7% compared to the same period in 2021, which is gratifying given that the third quarter was challenging. The third quarter of 2022 was characterized by declining sales compared to the same period in 2021. A couple of factors explain the loss. In part, the third quarter of 2021 was an unusually strong quarter, but mainly we are now seeing the effect that, due to the production situation regarding MyFID, we were unable to deliver dosing machines to new patients who are waiting to start their treatment in Sweden and Denmark. These two factors caused turnover in these countries to decrease in the third quarter of 2022 compared to 2021."

Commercial • CNS Disorders • Parkinson's Disease

Do Age, Demographics, and Tear Characteristics Affect Outcomes After Rotator Cuff Repair? Results of Over 2000 Rotator Cuff Repairs at 5-Year Follow-up. (PubMed, Orthop J Sports Med) - "Primary outcome measures were the Flexilevel Scale of Shoulder Function (FLEX-SF) and a pain score, collected at baseline, 6, 12, and 24 months, and 5 years...Tear size >4 cm and tendon reducibility correlated with outcome. Even patients with large tear sizes had clinically significant improvement in FLEX-SF scores after repair."

Journal • Pain

Sensidose has submitted an application for subsidy of Flexilev to the Finnish Medicines Price Committee. [Google translation] (Cision) - "As part of the geographical expansion plan, Sensidose has submitted an application for subsidy of the company's Parkinson's drug to the Finnish Medicines Price Committee. The application is a central step in the company's ambition to be able to offer patients in Finland to take part in Sensidose's non-invasive Parkinson's treatment for patients in advanced stages of Parkinson's disease, the so-called failure phase."

Commercial • CNS Disorders • Parkinson's Disease

Sensidose Aktiebolag is preparing capitalization and aiming for listing on the Spotlight Stock Market [Google translation] (Cision) - "Sensidose Aktiebolag...is a pharmaceutical company that develops and sells individualized dosages of tablets for optimal medical treatment of Parkinson's disease. The company's drug Flexilev® in combination with the dosing device MyFID® is currently available on the Scandinavian market. In order to reach new patient groups, Sensidose intends to develop a new dosing device with a planned launch in 2023. To finance the mentioned activities and expand the market for existing product, Sensidose is now preparing for a capitalization before the planned listing on Spotlight Stock Market in the spring of 2022."

Financing • CNS Disorders • Parkinson's Disease

Personalized Medicine Approach in Treating Parkinson's Disease, Using Oral Administration of Levodopa/Carbidopa Microtablets in Clinical Practice. (PubMed, J Pers Med) - "These results suggest that LC-5 therapy is generally well-tolerated, with favorable patient-reported efficacy and user friendliness, as well as the possibility for an individualized, fine-tuned PD treatment. Further studies with a prospective design and larger study population are needed to confirm the results."

Clinical • Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Measurement of scapular prominence in symptomatic dyskinesis using a novel scapulometer: reliability and the relationship to shoulder dysfunction. (PubMed, J Shoulder Elbow Surg) - "The reliability of the scapulometer in patients with shoulder pain is moderate to excellent. Scapular dyskinesis may be a compensatory strategy to avoid shoulder pain and improve shoulder function."

Journal

Computer Adaptive Test Stopping Rules Applied to The Flexilevel Shoulder Functioning Test. (PubMed, J Appl Meas) - "The CT rule resulted in more biased estimates at the higher end of the trait scale and larger standard errors. The SE rules performed well across the trait scale in terms of both measurement precision and efficiency."

Journal

Population pharmacokinetics of levodopa/carbidopa microtablets in healthy subjects and Parkinson's disease patients. (PubMed, Eur J Clin Pharmacol) - "The presented models adequately described the PK of levodopa and carbidopa, following microtablet administration. The developed model may in the future be combined with a pharmacokinetic-pharmacodynamic target and used for individualized dose selection, utilizing the flexibility offered by the microtablets."

Clinical • Journal • PK/PD data

Sensor-based algorithmic dosing suggestions for oral administration of levodopa/carbidopa microtablets for Parkinson's disease: a first experience. (PubMed, J Neurol) - "This study shows that it is possible to use algorithmic sensor-based dosing adjustments to optimize treatment with oral medication for PD patients."

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