Vivagel™ has been approved by 40 regulators worldwide except US. Australian TGA marketing approval as curative treatment for BV was in October 2017 and later as preventative - the TGA delegates report noted that a non antibiotic medical device would avoid antibiotic resistance issues of the previous treatment. And we know that WHO is concerned about over prescribing antibiotics and their accumulation via food chain.
The application with the US FDA stalled and is still stalled in 2024. US is an enormous market and would have been very profitable for patented SPL’s Astodrimer sodium BV treatment and availability of non antibiotic BV treatment has not been resolved there. Bacterial vaginosis is a common condition in US made worse by frequent douching. Visiting doctors and specialists for antibiotic scriptsis common.That treatment is profitable for the antibiotic manufacturer and the doctors / health insurers too. As shown below all commonly scripted antibiotics are made by Pfizer. ie Pfizer antibiotics are serious competitor treatments for Starpharma’s Astodrimer sodium BV treatment.
From 2017 Pfizer would have had SPL.AX Astodrimer sodium products on its radar
In the U.S., the primary antibiotics used to treat bacterial vaginosis (BV) include:
1. **Metronidazole**:
- FLAGYL - U.S. Medical Information Page - patient information, ways to contact Pfizer Medical & other resources.
- **Oral**: 500 mg twice daily for 7 days.
- **Topical** (gel): 0.75% once or twice daily for 5 days.
2. **Clindamycin**:
- CLEOCIN T® (clindamycin) | Pfizer Medical Information - US. I
- **Topical** (cream): 2% applied at bedtime for 7 days.
- **Oral**: 300 mg twice daily for 7 days.
3. **Tinidazole**:
- **Oral**: 2 g once daily for 2 days or 1 g once daily for 5 days.
These antibiotics are usually effective in treating BV, but treatment can vary based on the individual's health and medical history. ie REPEAT treatments are often needed.Always follow a healthcare provider's recommendation for proper use.
Thus on regulatory acceptance of very useful VivaGel and commencement of marketing the share price of SPL rose rapidly in 2017 and then reflected disappointment that major Bacterial vaginosis market US FDA was delaying consideration.
Similarly rising shareprice with adaption of Astodrimer sodium Vivagel at the beginning f the pandemic to be effective nasal spray in 2020.Mid 2020 saw rise to same level as 2017.
After that
Regulatory approval EU EMA (UK included) Nov 2020.
Manufacturing begins Belgium Feb 2021 for European distribution
Sales Lloyd’s Pharmacy UK begin late March 2021 - huge sales surge occurred with largest sales the pharmacy had ever had- anticipated Covid prevention and treatment panacea
BUT MID MARCH 2021 PFIZER WHICH ALREADY HAD ASTODRIMER SODIUM ON ITS RADAR FROM US VIVAGEL 2017 WANTED TO CONTROL TREATMENTS MARKET as well as mRNA vax market.
PF-07321332 Paxlovid phase 1 trial began March 2021 as antiviral protease inhibitor - successful trials could lead to expensive novel medicine to treat covid in first 5 days.The same market target of Viraleze except they knew Paxlovid would be too expensive to be a preventative and mRNA was likely to provide the world with vaccination and repeated booster vax additional profits..
Was SPL shareprice rising as world preventive/treatment targeted by SPL or could it be blocked to allow Pfizer to donate that market… we see the share price decline rapidly.
Morrison PM (& secret 2nd Health Minister) in Viraleze country of origin did a mystery deal which didn’t involve “banning AstraZeneca!!”.He had overnight meeting with CEO Pfizer Inc Bourla, to obtain early and more mRNA VAX.By June 2021,UK MHRA established as regulator 1 Jan 2021 ie post BREXIT - questions SARS-CoV-2 claims on Viraleze packaging and effects 6months withholding from sales in UK pharmacies; May 2021 SPL announces to media Viraleze to be used by Oz swim team in Tokyo Olympics - Chanel 7 report on FB… (were there plans to compare COVID results with other teams not using Viraleze. Olympics began 8 July 2021 but there would be no announcements & no publicity about Australian Viraleze because on 2 July TGA (Country of Origin) bans and fines and blocks Australians from seeing Viraleze website. No media would date to mention effectiveness of Viraleze Shareprice continues to plunge.
Pfizer now has no competition from effective antiviral nasal spray Viraleze and phase 2/3 PF-07321332 Paxlovid continues to get Paxlovid to market by end of 2021 and provisional approved in Australia 22 January 2022
- PAXLOVID has been available in the U.S. since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain consistent with the EUA. More than 11.6 million treatment courses of PAXLOVID have been prescribed in the U.S. to date.
So yes the small peak in 2017/8 And the big peak in 2021 are associated with full on Pfizer competition
