ASX Health Stocks: MVP’s ‘green whistle’ has finally got to Phase 3 in the US after FDA decision
Health & Biotech
Health & Biotech
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The ASX 200 Health Index (XHJ) is trading lower by 0.27% at the time of writing, compared to the broader index which is falling by 0.56%.
Pain relief specialist Medical Development International (ASX:MVP) announced that the US FDA has unconditionally lifted the agency’s clinical hold on its lead product, Penthrox.
Commonly known as the green whistle, Penthrox is an analgesic used by paramedics and ambulances to administer emergency pain relief.
The latest FDA move means that MVP can immediately begin preparing for its Phase III US clinical trial, a critical step towards bringing Penthrox closer to licensure in the US market.
As anticipated, the two-year trial will be conducted on a targeted trauma and associated pain patient group, with recruitment expected to commence in late 2022.
CEO Brent MacGregor said: “We are thrilled with this news which allows us to move forward quickly with preparations for our clinical trial.”
“After years of hard work, our team is buoyed by the prospect of bringing the many benefits of Penthrox to the US market. This will strongly complement our growing Penthrox success in Europe, and fully supports our further investment in the product.”
CAR-T specialist AdAlta (ASX:1AD) announced that it’s been granted a Chinese patent for its lead program, AD-214.
The new patent protects the i-body sequence used in AD-214, sequences similar to this, and pharmaceutical compositions and derivatives containing these i-body sequences.
AD-214 is being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other human fibrotic diseases for which current therapies are sub-optimal.
Results from the Phase 1 clinical studies suggested that the AD-214 molecule fully engaged its target receptor in humans, with no dose limiting safety issues.
Patents are granted on a country-by-country basis, and China is the fifth country to grant patent protection under this application, following Australia (two patents), US (two patents), Japan and Singapore.
AdAlta says it’s currently pursuing patent claims in other major markets including the European Union and India.
“China is now the second largest (and fastest growing) pharmaceutical market in the world after the US representing 11% of the global prescription drug market, says “AdAlta CEO, Dr Tim Oldham.
“IPF is included in the Chinese Rare Diseases List, including it as part of China’s plan to increase availability of drugs for rare diseases. Patent protection for AD-214 in this important market is anticipated to further increase the already significant interest from potential China partners.”
Sigma Healthcare (ASX:SIG) says it expects underlying EBITDA for the financial year ending 31 January to exceed previous guidance.
The improved financial performance primarily reflects the rapidly evolving Covid-19 environment, and the sudden increased demand for Rapid Antigen Tests (RATs) as a diagnostic tool, which resulted in significant volume growth in the month leading up to the FY close.
Underlying EBITDA is now expected to be 10% to 15% up on last year, compared to the previous guidance provided on 6 December 2021 of around 10% down.
Reported NPAT is expected to be a loss of $5m to $10m for the year, largely impacted by the SaaS accounting policy change (in excess of $30m) in the current year.
Sigma’s full year results are scheduled for announcement on 29 March.