The Food and Drug Administration (FDA) is a regulatory agency within the United States Health and Human Services Department that is engaged in protecting the public health and well-being by ensuring the safety, effectiveness, as well as security of both human and veterinary medications, vaccinesand other biological formulations.
The FDA is also responsible for the safety and security of electronic radiation-emitting products, food supply, cosmetics, dietary supplements and even for the regulation of tobacco products. Any pharmaceutical or biotech company looking for FDA approval formarketinga new prescription medicine must complete a five-step process including discovery& development, pre-clinical as well as clinical research, FDA review and post-market safety monitoring by FDA.
Moreover, the agency is also an active partner in the COVID-19 response and working closely with government as well as public health partners across the United States Department of Health and Human Services, including its international counterparts.
In this article, we will dig out information fromthe progress report andFDA approvals for drug formulation of four ASX listed healthcare stocks-PAR, RHY, MSB, MVP
Paradigm Biopharmaceuticals Ltd (ASX:PAR)
A health care sector Company,Paradigm Biopharmaceuticals Ltdis centered on repurposing of drug, and for the treatment of inflammation. Also, it offers ZILOSUL®, which is repurposed pentosan polysulphate sodium (PPS). Paradigm has a robust intellectual property (IP) position with many patents along with patent applications. The Company develops solutions for the treatment of bone marrow edema, treatment of mobility, painand joint function inmucopolysaccharidoses patients.
Initiation of treatment with Zilosul®Under the FDA approved EAP
On 24 March 2020, the Company has updated about the dosing of all ten patients with Zilosul® has initiated under the FDA approved Expanded Access Program (EAP) in the US while dodgingthe impact of COVID-19.
In the United States, Paradigm’s staff have assessed the progression of every single patient and observe constant encouraging feedback from patients as they make progress through the course of treatment.
In this program, every patient is first examined for determining their baseline pain scores under the Western Ontario, and McMaster Universities osteoarthritis index, as well as, MRI scans for determination ofBMEL (Bone Marrow Edema Lesions) incidence within the knee joint.
Furthermore, follow-up scans and pain measurements will then be recorded at 6-weeks after completing of the treatment.
It is notable that Paradigmforesees reporting the outcomes of this information in the third quarter of 2020.
Trading halt notification
PAR notified the market on 2 April 2020, that its securities would be placed in trading halt pending a release of an announcement. Also, except Australian Securities Exchange decides otherwise, the shares of the Company would continue to be in trading halt till the earlier of the beginning of normal trading session on 6 April this year or whenever thea notification is given to the market.
Rhythm Biosciences Limited (ASX:RHY)
An ASXlisted healthcare player Rhythm Biosciences Limited is engaged inthe development and commercialisation of a screening and diagnostic test for detection of colorectal carcinoma. The lead product of Rhythm ColoSTAT® is expected to be a simple, affordable, minimally invasive and effective blood test for the early diagnosis and detection of bowel tumor for the international market.
The Company published its half-yearly report on 26 February 2020 for the period concluded 31 December last year. It highlighted that it was expecting to seek approval for ColoSTAT® in the US. Preliminary assessment work is occurring, along with various go-to-market strategies that may involve FDA approval and/or early entry via a CLIA laboratory pathway.
In an ASX announcement dated 2 April this year, RHY revealedthat the antibodies for the main, lead biomarker have now been successfully confirmed, stabilised and established to be capable of reproducing. This lead biomarker is the main biomarker which can distinguish between healthy and cancerous blood samples and makes up the principal ingredient for ColoSTAT®.
Moreover, Rhythm mentioned that it is working with manufacturers, suppliers, consultants, and hospitals for the assessment of any effect the Companyis experiencing on their operations because ofcoronavirus pandemic and how that impacts ongoing R&D of the Company.
Further,RHY mentioned thatit would provide anupdate withregards to the impact of COVID-19 within the upcoming quarterly report.
Mesoblast Limited (ASX:MSB)
A Melbourne headquartered health care sector playerMesoblast Limited is aleader in developing innovative cellular medicines across the globe. The Company has a strong emerging drug pipeline for follow-on indications with three programs currently undergoing Phase 3 clinical studies. Mesoblast’s lead product candidates that are under clinical study-remestemcel-L, Revascor, MPC-06-ID and MPC-300-IV.
Mesoblast has filed an application (biologics license application) to the FDA for approval of its drug candidate RYONCIL™ for treatment of steroid-refractory acute GvHD (graft versus host disease). If approved, RYONCIL is anticipated to be introduced for pediatric steroid-refractory aGVHD in the US in 2020.
Biologics licence application for RYONCIL™ accepted by FDA
On 1 April 2020, Mesoblast disclosed that the US FDAhas accepted for priority review of the Company’s Biologics License Application (BLA) filing for RYONCILTM (remestemcel-L), its allogeneic cell therapy for the treatment of children with SR-aGVHD (steroid-refractory acute graft versus host disease).
Moreover, the Company highlighted that the FDA established a Prescription Drug User Fee Act action date of September 30, 2020, and immediately after approval, the Company will make available RYONCIL in the US region.
Medical Developments International Limited (ASX:MVP)
Australia based, Medical Developments International Limitedis into offering solutions related to emergency medical attention forenhancingoutcomes among patients. MVP is a leader in providing products related to both emergency respiratory and pain reliefto the patients. MVP is engaged in the production of Penthrox®, a fast-acting trauma & emergency pain relief formulation and is utilised in the Hospitals of Australia, along with the Emergency Departments andin additional medical applications.
Penthrox® in the United States
In the United States region, FDA has given clarity to the drug-Penthrox® and Clear pathway forward to open IND or investigational new drug application for-
- Pre-clinical research which imitates human dosing procedureamonganimals;
- Study on human factors;
- Conclusion of PASS in Europeregion;
- Full answers to queries on Penthrox device “whistle”.
Moreover, in the United States, IND approval is aimedtowards the second half of the FY 20 period.
Moreover, MDI plans to submit the non-clinical study protocols to FDA for feedback prior to conducting study and also intends to submit human factor study protocol in FDA meeting briefing pack.
Penthrox® Sales in Australia-
- In Australia, Penthrox® sales in increased by18%;
- New Mundipharma distribution agreement providingsolid sales growth in Australia particularly in General Pharmacies or hospitals;
- Sales for Australian ‘Dr’s Bags’ increased by 54%.
Let us now have a look on the stock information of these four ASX listed health care sector playerson 2 April 2020-
Paradigm Biopharmaceuticals Ltd (ASX:PAR)- The stock of PAR last traded at $1.690on 1 April 2020, with themarket capitalisation of around $334.31million.With almost 197.81 million outstanding shares,the 52 weeks high price of the stock was recorded at $4.500.
Rhythm Biosciences Limited (ASX:RHY)- The RHY stock closed the day’s trade $0.096, surging up by 74.545%,from its last close, with a market capitalisationof $5.54 million. The stock has a 52 weeks high price of $0.220 and a 52 weeks low price of $0.041, with approximately 100.75million shares outstanding.
Mesoblast Limited (ASX:MSB)- MSB stock closed the day’s trade at $1.460, down by3.311% versus last close, with a market capitalisationof $811.28 million. The stock has a 52 weeks high price of $3.210 and a 52 weeks low price of $1.020, with approximately 537.27 million shares outstanding.
Medical Developments International Limited (ASX:MVP)- The MVP stock last traded at $5.620 down by3.932% from its previous close. With almost 65.61 million shares outstanding, the company’s market capitalisationstood at nearly $383.8 million.
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