AUS
NZ
UK
CA
USA
FRA
GER
ESP
ITA
NLD
PRT
SWE
GRC
IND
POL
BRA
ZAF
RUS
CHN
UAE
The Australian health care industry has been projected to continue growing actively over the next four-five years period due to Australia's changing patient demographics, rising frequency of several chronic diseases as well as increasing the health insurance coverage by private health insurers.
The health care sector is facing many challenges, a few of them are related to the rising costs, an increasing number of infections, changing patient demographics, evolving consumer expectations, new market entrants and complex health and technology ecosystems.
Coronavirus has inflicted its first big hit on Australian markets, and the health care stocks which are considered as defensive ones have marked their worst session due to this outbreak.
While all the companies are busy posting updates related to the impact of coronavirus outbreak on the business and most of the shares are down due to COVID-19, one health care sector company - Paradigm Biopharmaceuticals is focused towards achieving its set goals.
Paradigm Biopharma stock price remains in green, and its share price has tripled in the value over the previous 12 months.
Moreover, the company is obtaining an Investigational New Drug (IND) filing with the FDA for marketing approval of its Zilosul. The approval process is currently on-track after a successful announcement of a pre-IND meeting with the US Food and Drug Administration on 20 February 2020 and expected to be completed in the fourth quarter of the calendar year 2020.
Let us delve deep and discuss the recent updates of PAR.
Paradigm Biopharmaceuticals Ltd (ASX:PAR)
On 25 February 2020, the stock settled the day’s trade at $3.490, up by 1.453%. However, on 26 February 2020, PAR was trading at $3.290, slipping by 5.731 percent (at AEDT 1:20 PM). The market capitalisation of the stock stood at around $ 690.37 million, with nearly 197.81 million shares outstanding. The 52 weeks high and low price of the stock was noted at $4.500 and $1.084, respectively.
The PAR stock has delivered an outstanding return of 213.48% in last one year, a positive return of 17.11% on year to date basis and 156.62% in the last six months.
PAR’s performance in the past one year is as depicted below:
About Paradigm Biopharmaceuticals
An ASX listed Australian biopharmaceutical company Paradigm Biopharmaceuticals Ltd (ASX:PAR) is focused on drug repurposing and for the treatment of inflammation it provides repurposed pentosan polysulphate sodium (PPS). The company has a strong IP position with many patents and patent applications.
The company engaged in developing solutions for the treatment of bone marrow edema, symptoms in osteoarthritis as well as treatment of pain, mobility and joint function in mucopolysaccharidoses (MPS) patients.
Positive Pre-IND meeting with US FDA
Paradigm unveiled that the company had a positive and informative pre-IND meeting with the US Food and Drug Administration. This meeting was to discuss development as well as market authorisation programs for injectable Pentosan Polysulfate Sodium (iPPS) or Zilosul for symptomatic osteoarthritis treatment.
Moreover, the company will provide additional information to the market by receipt of final minutes from the US FDA. Paradigm also mentioned that the development plans are progressing toward an Investigational New Drug (IND) filing by fourth quarter of the calendar year 2020.
iPPS- Injectable Pentosan Polysulfate Sodium is not currently registered in Australia, but it is was earlier registered in a few European markets as an antithrombotic agent. Currently, iPPS for human use is not available for sale in Australia.
First patient dosed for Zilosul®
According to an ASX announcement dated 18 February 2020, Paradigm disclosed that the first patient for iPPS (Zilosul®) has been dosed in the United States under the Expanded Access Program of FDA. In this program, participants will receive per week two Zilosul® injections across a six weeks duration.
Under the Expanded Access Program, the company will treat ten patients comprised of Ex-NFL Players. Paradigm is expecting last patient’s final dosing to take place in mid-May and to report results to the market by early third quarter in the calendar year 2020.
MPS VI poster at the World MPS Symposium
Paradigm has presented its mucopolysaccharidosis type VI (MPS VI) poster at the MPS World Symposium in Orlando, Florida. Poster presented consequences of the patient focus group, which aimed on identification as well as validation of clinical endpoints, producing the most clinically significant endpoints for MPS patients.
A Patient Centric method is precisely tailored to the unmet clinical needs of MPS patients. This method will certainly assist the company in Recruitment as well as Retention of mucopolysaccharidosis patients in the clinical trial Phase 2/3, and will probably improve iPPS market penetration for the treatment of MPS patients in combination with Enzyme Replacement Therapy (ERT) as the company is taking a step toward commercialisation.
The European Medicines Agency (EMA) and FDA have agreed to a joint Parallel Scientific Advice Submission, and it is expected to start in March.
Half Year Results (Year ended 31 December 2019)
The company updated the market with its half year results on ASX, and the highlights are-
- The company mentioned that revenue from continuing activities has been reported to be $602,301.
- Cash and cash equivalents of Paradigm reported to be approximately $70,933,651.
- For the first half of FY 2020, Paradigm biopharma recorded research and development expenses to be nearly $4,315,825.
Outlook-
- MPS is an orphan indication, and the Paradigm program aims to address the continuing unmet need for residual musculoskeletal symptoms in patients receiving primary treatment for MPS. The application submission will be in March, in line with the date agreed with both regulators, where the company will submit a detailed plan for review of proposed trial design for a pivotal/registration trial within MPS.
Paradigm anticipates the initial feedback from both regulators toward the end of the second quarter of the calendar year 2020.
- The principal investigator and other staff of the company are currently writing the primary manuscript of the Phase 2b clinical trial. Paradigm anticipates the peer reviewed publication of Phase 2b OA/BMEL to be released during the third quarter of the calendar year 2020.
With key milestones achieved in 2019 and a positive outlook for the upcoming years, Paradigm Biopharmaceuticals could achieve a strong position in the health care sector in Australia. It can be observed that it has a well-planned clinical trial for the future to support the continuous growth of the company.
