ASX Health Stocks: Botanix to get FDA approval by June; 4DMedical partners with global player, Philips
Botanix Pharma (ASX:BOT) was up 5% this morning after its resubmission of the New Drug Application (NDA) for Sofdra has been accepted by the US FDA as a complete response.
The FDA also confirmed that the resubmission of the Sofdra NDA is a Class 2 response (i.e. a 6-month review period from resubmission), with the result that approval remains targeted for late June 2024.
With the resubmission accepted as complete and target approval timing confirmed, Botanix says its commercial activities will ensure a rapid Sofdra launch.
“We are pleased that FDA has confirmed that the resubmission of the Sofdra NDA is acceptable as a complete response and that the anticipated approval date in late June 2024 remains on target,” said Botanix CEO, Dr Howie McKibbon.
“This clarity means that our commercialisation activities in preparation for launch can be appropriately designed to ensure a rapid launch of Sofdra, following successful approval from FDA.”
In December, Botanix completed resubmission of the NDA for Sofdra, a drug that treats primary axillary hyperhidrosis.
The resubmission was originally planned for Q1 2024, but the Botanix team had accelerated the process and filed earlier than expected.
The resubmission of the Sofdra NDA is in response to an FDA complete response letter announced in September 2023.
The only deficiency identified in that letter was the paper insert in the product carton that instructs the patient how to use the product safely and effectively.
No efficacy, safety, pharmacology, non-clinical or chemistry, or other manufacturing and controls (CMC) issues were identified, and so no additional clinical studies are required to support the resubmission and approval of Sofdra.
Botanix has been ramping up its commercial launch preparation activities in recent weeks, and is focused on engaging US payers (insurers) around contracting and pricing for the product.
4DMedical (ASX:4DX) announced that it has signed a commercial agreement with Koninklijke Philips (NYSE: PHG), known globally as Philips.
The agreement will establish a collaboration to evaluate Veterans suffering from deployment-related respiratory disease (DRRD), interstitial lung disease (ILD), and other respiratory illnesses within the U.S. Department of Veterans Affairs (VA).
Philips and 4DMedical will combine their efforts to seek contracts from the VA to offer 4D lung imaging as a critical solution for Veterans exposed to those burn pits and airborne hazards while on deployment.
Philips has long-established and significant existing partnerships with both the VA and the Department of Defence (DoD) going back 45 years.
4DX believes that having an unparalleled relationship with a global healthcare company will provide an unprecedented opportunity to accelerate 4DMedical’s go-to-market activities in North America.
“The size and reach of Philips will dramatically accelerate the scaling of our offering within the VA,” said 4DMedical CEO and founder, Andreas Fouras.
“I am incredibly excited by the reach this will give our technology, and importantly, the impact this will have for millions of Veterans and their caregivers.”
Pharmacy and health food group, Vitura Health (ASX:VIT), has signed a technology and product supply services agreement with WholeLife Pharmacy.
WholeLife currently works in partnership with one of the nation’s leading holistic health clinics, One Health Clinics Australia based in Cairns, which also provides face-to-face and telehealth consultations to 14,000 patients nationwide.
Under the terms, Vitura will provide WholeLife, including its franchisees, with a WholeLife branded version of Vitura’s CanView platform for exclusive use by WholeLife’s network of pharmacies, doctors and practitioners.
Canview is Vitura’s online platform that delivers prescribing, dispensing and medication management solutions for plant medicine.
The agreement will be a win-win for both companies, as the WholeLife branded version of CanView is expected to increase the volume of products prescribed through the CanView platform, as well as the number of patients and prescribers registered on it.