Intec Pharma CEO says 2019 will be 'a year of ongoing evolution'
Intec Pharma announces that Jeffrey Meckler, vice chairman and CEO of Intec Pharma, has issued a Letter to Shareholders. The letter read, in part, "2018 was a transitional year for Intec Pharma, with advances on both the corporate and clinical fronts that we believe put us in a strong position to potentially achieve multiple value driving milestones in the coming year. We believe 2019 will be a year of ongoing evolution. We expect to broaden our Accordion Pill pipeline opportunities, report data on our late-stage clinical program in Parkinson's disease and continue to make significant commercial, clinical and corporate progress that collectively position us for continued growth and success. Our many accomplishments in 2018 were highlighted by the progress we made with our Phase 3 ACCORDANCE clinical trial of AP-Carbidopa/Levodopa to treat the symptoms of advanced PD patients. In October, we completed enrollment of 462 subjects in this pivotal Phase 3 trial and have now randomized greater than95% of the expected 315 patients into the blinded, randomized portion of the study. Preliminary analysis of the baseline data for the randomized population to date shows: Average age of patients was 63 and 65% of enrolled patients were male; Patients had a diagnosis of PD for 8.8 years on average; The average daily levodopa dose for patients upon entering the blinded portion of the study was in excess of 800 mg and the most common Accordion Pill dose was AP-CD/LD 500mg three times per day; Average daily OFF time for patients upon entering the randomized study was approximately 6.1 hours; Approximately 32% of patients were recruited in the U.S. The Phase 2 pharmacokinetic study of AP-CD/LD 50/500 mg dosed three times per day completed enrollment of 12 advanced PD patients in mid-December. Blood samples from the study are scheduled to be batch analyzed at the PK laboratory in Italy during January 2019...We believe the work we are doing now will be key to the development of a winning commercial strategy - whether we select to partner the product or to launch it ourselves. Importantly, we believe our ongoing market assessment continues to strongly support our value proposition and AP-CD/LD's significant market potential. Most notably, we have invested in the commercial scale manufacture of AP-CD/LD, for which we are in partnership with LTS Lohmann Therapie-Systeme AG, the global leader in formulation and film technology manufacturing for the pharmaceutical industry. We are delighted to report that the new product manufacturing line has passed factory testing and is being installed at LTS' dedicated manufacturing space in Andernach, Germany this week. During 2019, we plan to begin the validation, bridging and stability studies needed for regulatory filing and expect these should put us on track for a submission with the U.S. Food and Drug Administration in mid-to-late 2020. We have a meeting planned with the FDA to discuss our commercial scale manufacturing strategy and will have greater granularity on these requirements and timelines in the second quarter of 2019. We made solid progress with our growing development pipeline and are nearing the initiation of our AP-THC PK study. "