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.
Amazon’s (NASDAQ:AMZN) move had been anticipated for quite a while, given the many reported internal discussions and acquisition of PillPack in 2018, but the latest news is likely to shake CVS (NYSE:CVS), Walmart (NYSE:WMT), Rite Aid (NYSE:RAD) and Walgreens (NASDAQ:WBA).
Amazon Pharmacy will allow customers in the U.S. to order prescription medications for home delivery, including free delivery for Amazon Prime members.
It’s great timing for a launch as Americans are increasingly relying on getting their medicines via mail to avoid getting exposed to COVID-19, and that shift may become permanent.
Amazon Pharmacy will accept most forms of insurance, but could offer savings for people without insurance as well, while customers can also use flexible spending accounts or health savings accounts to buy prescriptions.
How will it work? Doctors can send prescriptions directly to Amazon Pharmacy – which has tools to verify that a physician legitimately ordered each prescription – or patients can request a transfer from existing retailers.
Customers over the age of 18 will have access to the pharmacy service this week in 45 states. Hawaii, Illinois, Kentucky, Louisiana and Minnesota are not yet included.
Amazon Prime customers get free two-day delivery (shipping may still take up to five days the first time a customer orders, as it takes time to transfer a medication). Customers who don’t have Prime can get free delivery within five days, or they can pay $5.99 to upgrade to two-day delivery.
The pilot delivery program is being closely watched as the vaccine must be shipped and stored at -70 degrees Celsius (minus 94°F), significantly below the standard for vaccines of 2-8 degrees Celsius (36-46°F).
Rhode Island, Texas, New Mexico, and Tennessee were picked due to their differences in overall size, diversity of populations, immunization infrastructure, and urban/rural settings.
Pfizer (NYSE:PFE) notes that the four states will not receive vaccine doses earlier than other states by virtue of the pilot, nor will they receive any differential consideration.
The company expects to have enough safety data on the vaccine from the ongoing large scale late-stage trials by the third week of November before proceeding to apply for emergency use authorization from the FDA.
In addition to the single-dose regimen ENSEMBLE study, Johnson & Johnson (NYSE:JNJ) unit, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. The company is investigating multiple doses and dosing regimens to evaluate its long-term efficacy.
The big pharma’s vaccine, JNJ-78436735, is currently in a major 60,000-subject Phase 3 known as ENSEMBLE assessing whether it can prevent coronavirus infections with a single shot.
Phase 3 ENSEMBLE 2 trial will study the safety and efficacy of a two-dose regimen of the investigational Janssen vaccine candidate versus placebo for the prevention of COVID-19 in up to 30,000 participants, running parallel to its ongoing ENSEMBLE phase 3.
J&J is already running a one-shot-and-done program, which puts it at an advantage over rivals Pfizer/BioNTech and Moderna, which need two.
While some drugmakers have been set back by the challenge of manufacturing enough doses, J&J is well on its way to producing 1B doses of its COVID-19 vaccine in 2021 and is looking ahead to 2022, said Paul Lefebvre, vice president of strategic initiatives and COVID-19 vaccine supply chain at J&J’s Janssen unit, in an interview.
Back in April, J&J signed on New Jersey-based CDMO Catalent to lock down manufacturing capacity at its Bloomington, Indiana plant, to hit a manufacturing goal set by January.
In July, Maryland’s Emergent Biosolutions joined the fold, inking a five-year pact to churn out drug substance.
Also, Johnson & Johnson signed on Michigan’s Grand River to meet its 100M dose supply order with the U.S. for $1B, or $10 per dose. Elsewhere, J&J is relying on its own sites in Europe to make drug substance.
J&J just this week finalized a deal to provide up to 200M doses to Europe, with the option to sell another 200M shots at a later date should the vaccine pass muster in clinical trials.
Separately, Johnson & Johnson is shipping 30M doses to the U.K.
The drugmaker also teamed up with Aspen Pharmacare to manufacture J&J’s vaccine at its facility in Port Elizabeth, South Africa, and Biological E in August agreed to manufacture the shot in India.
With those partnerships in place, J&J feels confident it can meet its lofty supply goals.
“The sheer speed of execution is challenging, and also the sheer volume that we need to produce. I think every manufacturer is facing the same challenges,” Lefebvre said.
Meanwhile, J&J’s shot could have a storage and distribution edge over the likes of those from Pfizer and BioNTech, Lefebvre thinks.
Also, J&J has pledged 500M doses to low-income markets starting in mid-2021.
With the completion of the acquisition, MyoKardia shares have ceased trading on Nasdaq and the company now a wholly-owned subsidiary of Bristol Myers.
Through the transaction, BMY gains mavacamten, a potential cardiovascular medicine for the treatment of obstructive hypertrophic cardiomyopathy.
A NDA for mavacamten for obstructive HCM is expected to be submitted in Q1 2021.
Milestone Scientific (NYSEMKT:MLSS): Q3 GAAP EPS of -$0.02 beats by $0.02.
Revenue of $1.25M (-34.2% Y/Y) beats by $0.07M.