Fantastic clarification added on the Investor Hub:
https://investorhub.pharmaust.com/announcements/6270398
The article in The WestAustralian quoted PharmAust CEO Dr Michael Thurn as saying: “Based on thenumbers of patients out there with MND, this drug could be a blockbuster. Itcould be a drug that makes more than $1 billion in sales.”
PharmAust clarifies thatthis is not a forecast nor revenue projection. The Company is continuingdevelopment of the drug (monepantel) including the forthcoming global pivotalregistration Phase 2/3 clinical study scheduled to start mid-2024, and any potentialsales of the drug will be subject to these study outcomes, regulatory approvaland various pharmaceutical reimbursement schemes.
The quote was provided basedon the potential for sales of monepantel for the treatment of motor neuronedisease (MND) / amyotrophic lateral sclerosis (ALS), should it be approved inmajor regulatory jurisdictions such as the United States (US) and Europe.Relevant data on MND/ALS including the prevalence of disease, size of marketand the list price of recently approved drugs for orphan diseases and MND/ALSare summarised as follows:
- In the US and western Europe it is estimated there is more than 37,000 and 56,000 patients with MND/ALS, respectively, and more than 268,000 globally (1)
- The MND/ALS treatment market was more than USD $9 billion in 2022 and is estimated to each USD $23 billion by the end of 2035 (2)
- In 2021 the median treatment cost was USD $218,872 for orphan drugs (range USD $237 to USD $1,272,021) (3)
- The last three drugs (QalsodyTM, Radicava®, and RelyvrioTM) that received US Food and Drug Administration (FDA) approval for the treatment of MND/ALS each have an annual cost of between USD $150,000 to USD $200,000 (4)
- RelyvrioTM, referenced in the recent media coverage, generated USD $381 million in sales during 2023, its first year from launch (5)
To the extent that the quotecould be considered a financial forecast, PharmAust retracts the statement asit does not have a reasonable basis for the targeted sales figure at thisstage. Investors should not rely on the revenue target mentioned in the articleas a basis for investment decision on the Company.
1-Park J, Kim J-E and SongT-J (2022) The Global Burden of Motor Neuron Disease: An Analysis of the 2019Global Burden of Disease Study. Front. Neurol. 13:864339. doi:10.3389/fneur.2022.864339
2-https://www.researchnester.com/reports/motor-neuron-disease-treatment-market/37813-Althobaiti H, Seoane-Vazquez E, Brown LM, Fleming ML, Rodriguez-Monguio R.Disentangling the Cost of Orphan Drugs Marketed in the United States.Healthcare (Basel). 2023 Feb 13;11(4):558. doi: 10.3390/healthcare11040558.PMID: 36833091; PMCID: PMC9957503.4-https://endpts.com/biogen-prices-new-als-drug-at-more-than-14k-per-dose/
5-https://edition.cnn.com/2024/03/08/health/als-drug-relyvrio-fails-trial/index.html
All fully referenced - very well reasoned and professional.
Cheers
Densy
(20min delay)