Pfizer Inc. PFE 0.22%-BioNTech SE – ADR BNTX 0.52% is first among coronavirus vaccine developers to secure authorization for emergency use of candidate BNT162b2, with the first approval granted by U.K. regulators.
Scale-Down Previously Disclosed: An analyst at BofA Securities shrugged off a Thursday report in The Wall Street Journal that hinted at manufacturing constraints, resulting in a modest pullback in Pfizer shares.
The report said the company was forced to scale back its manufacturing plans for 2020 from 100 million doses initially to 50 million doses due to difficulties in scaling up the raw material supply chain.
The reduction was already communicated in the second week of November, BofA's Tazeen Ahmad said in a Friday note.
Pfizer and its German manufacturing partner BioNTech had reiterated to BofA their manufacturing goal of 50 million doses by the year-end and up to 1.3 billion doses by the end of 2021, the analyst said.
"While production is scaling up at an unprecedented pace, we remain confident in the partnership given PFE's expertise and valuable know-how in the vaccine space."
What to Expect From Adcom Meeting: The FDA's Vaccines and Related Products Advisory Committee is set to meet between 9 a.m. and 6 p.m. Dec. 10.
The committee will likely discuss the overall efficacy and safety profile; the age range of eligible subjects when approved; expectations to satisfy full approval; and the timing of when the placebo arm in the positive Phase 3 study will be notified and offered the vaccine, Ahmad said.
BofA estimates non risk-adjusted sales of $9.1 billion for BTN162b2 in 2021.
Upcoming Pfizer Catalysts: The FDA's goal is granting emergency use authorization one week after the Dec. 10 Adcom meeting, the analyst said.
The European Medicines Agency's Committee For Medicinal Products for Human Use is expected to conclude its assessment during a Dec. 29 meeting at the latest, according to BofA.
EU approval could be forthcoming if the data submitted is robust enough to reach conclusions on the safetyand efficacy standards set forth by the EMA, the sell-side firm said.
As the pandemic drags on there are increasing concerns about “Long COVID” – where symptoms persist long after the initial infection has been fought off.
PureTech has joined the effort to find ways to treat the scarring and inflammation that are thought to cause the ongoing symptoms such as shortness of breath and fatigue.
After promising results in an early stage study, the company has begun a phase 2 trial of its LYT-100 (deupirfenidone) in Long COVID respiratory complications and related sequela.
LYT-100 is wholly owned by PureTech, which is already being developed for conditions involving inflammation and fibrosis and disorders of lymphatic flow.
The rationale for treating inflammation and scarring comes from a growing body of evidence from patients recovering from SARS-CoV-2 infection and previous experience with the closely related Severe Acute Respiratory Syndrome (SARS) virus.
PureTech referred to an Italian study showing that more than 40% of COVID-19 survivors reported shortness of breath an average of 60 days following symptom onset.
LYT-100 is based on the already-approved small molecule drug pirfenidone but with the addition of deuterium its half-life has been extended to improve tolerability, allow for less frequent dosing, and potentially increase its efficacy.
It is treated as a new chemical entity and as such fresh trials are needed to establish whether it is safe and effective.
The primary endpoint of the trial will be the six-minute walk test distance.
Secondary endpoints will include pharmacokinetics, inflammatory biomarkers, imaging and patient-reported outcomes and shortness of breath.
The study is to begin in the US and Europe and results are expected in the second half of next year.
PureTech also plans a phase 2a proof-of-concept study testing LYT-100 in patients with breast cancer-related upper limb secondary lymphedema this quarter.
The company is also planning studies to test LYT-100 in idiopathic pulmonary fibrosis (IPF).
https://pharmaphorum.com/news/puretech-begins-trial-of-potential-long-covid-drug-as-cases-mount/
Responses observed in 32% (10/31) of evaluable patients treated at clinically active dose levels-including 1 CR, 3 cPRs and 6 uPRs -
- Disease control rate at 12 weeks is 74% (23/31) and 10 patients remained on treatment -
- Dose-expansion has been initiated to explore 4.3 & 5.2 mg/kg in less heavily pre-treated patient population -
To access the live virtual event on Thursday, Dec. 3, at 2pm PT (5pm ET), please click here. An archived webcast of the event will be available on the Investor section of the company's website at ir.sutrobio.com for approximately 30 days.
https://finance.yahoo.com/news/sutro-biopharma-announces-encouraging-interim-213000411.html
Danish pharmaceutical company Novo Nordisk A/S said Friday that it has submitted a new drug application to the U.S. Food and Drug Administration for its semaglutide weight-loss drug.
"Obesity is associated with a wide range of serious complications, yet many healthcare providers still do not have sufficient medical options available to help people with this chronic disease," said Novo Nordisk Chief Scientific Officer Mads Krogsgaard Thomsen.
Semaglutide is a glucagon-like peptide-1 drug, or GLP-1, that helps enhance the production of insulin and regulate appetite.
Novo Nordisk said it expects the review of its application to complete in six months.
