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Health & Biotech
LTR Pharma (ASX:LTP) announced that it has achieved manufacturing validation for its upcoming pivotal clinical study for its lead product, SPONTAN.
All essential criteria for the pivotal FDA clinical study have been met – including stability testing, quality control checks, product purity and packaging integrity.
By testing the chemical stability of SPONTAN over three specified periods, whilst assessing packaging integrity and confirming purity of the active ingredients, LTR Pharma has now met key US FDA requirements to be considered a pivotal study.
LTR Pharma chairman, Lee Rodne, said this achievement has been underpinned by a comprehensive suite of quality control checks as mandated by the FDA.
“Each check was meticulously designed to evaluate the chemical stability of SPONTAN over specified time periods, assess the integrity of its packaging, and verify the purity of our nasal spray formulation,” said Rodne.
“We are optimistic about the potential impact of SPONTAN in the market and look forward to sharing our progress as we move closer to initiating the clinical trial.“
Patient recruitment for the bioequivalence study is now due to commence this month.
SPONTAN is an innovative nasal spray treatment for erectile dysfunction. The nasal cavity is a highly vascular part of the body supporting even and rapid absorption of the drug, empowering it to work within 10 minutes or less.
AFT Pharmaceuticals (ASX:AFP) announced that Maxigesic IV, the patented intravenous form of pain relief medicines, has today been launched in the US by its licensee, Hikma Pharmaceuticals.
The launch of the medicine, under the brand Combogesic IV, is the first patented, NZ-developed medicine with clinical studies in the world’s largest healthcare market.
The first commercial sale of the medicine in the US is expected in the coming weeks, a milestone that will trigger a US$6 million licensee fee to AFT.
AFT expects its share of this licence fee to accrue in the current financial year.
Maxigesic IV has been billed as a significant innovation for the management of pain, offering effective pain relief as well as an alternative to opioid analgesics.
“The launch also represents a beachhead for the commercialisation of Maxigesic in the US and potentially our broader portfolio of medicines,” said AFT co-founder and CEO, Dr Hartley Atkinson.
“Our next goal is the finalisation of plans to launch Maxigesic Rapid, a prescription-only tablet. We have been working on setting up AFT representation in North America in order to support commercialisation with identified partners.”
Allegra Medical Technologies (ASX:AMT) has taken the decision to not proceed with its formal submission to the US FDA as previously planned.
The decision was taken following recent communication with the FDA, resulting in Allegra recognising the need for additional information to support its submission.
Following that communication, Allegra has opted to voluntarily withdraw its submission to the FDA.
Allegra said its limited working capital and the additional expense required in obtaining that supporting data meant that an FDA submission was not feasible.
Allegra has now thoroughly explored all available options, and after careful consideration, the preferred option is to go to the market to seek a buyer for all of its intellectual property relating to the Sr-HT-Gahnite and Sr-HT.
This includes worldwide patents and all registered patents and application for patents in relation to the bio ceramic material, including the spinal fusion cage (also called Cervical Spinal Cage).
Undertaking this process and any subsequent sale will be subject to the required ASX and regulatory approvals.
Allegra owns the patent to the 3D-printed Sr-HT and Sr-HT-Gahnite orthopaedic devices.
These versatile Sr-HT materials are unique, and are made from highly porous, bio-ceramic that contains strontium and zinc ions.
Allegra had produced the Cervical Spinal Cage device, a scaffold used in orthopaedic surgery, from these materials.
Health & Biotech
Health & Biotech
Health & Biotech
