RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
As of Jan.31, 2021, Pfizer (PFE -3.5%) has supplied 65M doses globally out of which 29M doses supplied to U.S. government.
While continuing to work closely with the U.S. government on production, release and future shipping schedules, Pfizer expects to deliver 200M doses to the country by May end.
By 2021 end, the company can potentially deliver ~2B doses based on the updated 6-dose label, expansion at current facilities, and contingent upon adding more suppliers and contract manufacturers.
In the last week of January, Pfizer/ BioNTech planned to speed up COVID-19 vaccine supply.
Funded by the National Institutes of Health, the open-label, multi-center study involving 100 patients with mild-to-moderate Alzheimer’s disease is currently in progress to evaluate the long-term safety and tolerability of simufilam.
The analysis has summarized the clinical data at the midway point of enrollment, i.e., the first 50 patients who have completed at least 6 months of drug treatment.
After six months of simufilam treatment, cognition scores have risen 1.6 points on ADAS-Cog11, a 10% mean improvement from baseline to month 6. Dementia-related behavior, such as anxiety, delusions, and agitation, has also improved by 1.3 points on the Neuropsychiatric Inventory, a 29% mean improvement from baseline to month 6.
With no drug-related serious adverse events, simufilam has demonstrated a safety profile consistent with prior human studies despite mild or transient adverse events.
The company expects the trial data and prior clinical results support for simufilam in a Phase 3 trial for Alzheimer’s disease which is scheduled for 2H 2021.
For comparison, the recent data readout by Eli Lilly (NYSE:LLY) for Donanemab included a statistically significant decline by 32% in the Integrated Alzheimer’s Disease Rating Scale (iADRS) relative to placebo. iADRS combines the cognitive measure ADAS-Cog13 and functional measure ADCS-iADL.
The TRAILBLAZER-ALZ trial is a randomized, placebo-controlled, double-blind, multi-center Phase 2 involving 272 patients with early symptomatic Alzheimer’s disease.
Subject to regulatory clearances, the transaction is expected to complete by Q2 2021.
The deal includes MMM Holdings, LLC (“MMM”) and its Medicare Advantage (“MA”) plan MMM Healthcare, LLC as well as affiliated companies and Medicaid plan.
With more than 267K MA members and over 305K Medicaid members, MMM is the ninth-largest MA plan in the country and the second-largest Medicaid plan in Puerto Rico, a statement from the company said.
The financial terms of the transaction were not disclosed, and Anthem’s 2021 EPS guidance remains unchanged post-acquisition.
In Q4 2020, the top-line of Anthem rose ~16% YoY despite a decline of ~41% YoY in the net income.