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Star Rizin
Senior Poster
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From one side of the pond to the other...
saweet!!! Merry Christmas!!!
SPL:AU
AUDSTARPHARMA ORD (Australia)
Last [Tick] $0.685[+]
Change $0.055
% Change 8.73%
Bid $0.660
Bid Size 8,500
Ask $0.685
Ask Size 24,150
Open $0.645
Volume 188,592
Day High $0.690
Day Low $0.630
Previous Close $0.630
Prev. Close Date 12/22/2009
Market Status Open(closes in 53min
USA.....
Last [Tick] $5.8900[+]
Change $0.3900
% Change 7.09%
Bid $5.00
Bid Size 500
Ask $5.10
Ask Size 500
Open $5.7000
Volume 3,200
Day High $5.8900
Day Low $5.7000
Previous Close $5.5000
Prev. Close Date 12/22/2009
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Edited by - Star Rizin on 01/09/2010 07:12:43
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Star Rizin
Senior Poster
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The VivaGel coated condom - which has a simpler regulatory path than drugs - is expected to generate royalty revenues, commencing in CY 2011.
VivaGel is in clinical trials. The gel aims to protect women from sexually transmitted infections (HIV,HSV-2, HPV, bacterial vaginosis). It is in clinical development with US$26M National Institute of Health support.
Dendrimers – there are multiple partnerships already in place:
– Drug delivery (Lilly/Elanco, GSK/Stiefel and various confidential )
– Medical technology (Siemens, Aldrich, Merck, Qiagen)
– Agrochemical deal with multi-billion dollar US Co.
– Other opportunities: Industrial, cosmetic, water treatment
Looking ahead Jackie Fairley saw the following as Value Drivers for Starpharma:
Advance VivaGel®-Coated Condom to market:
- Complete co-development with SSL plc
- Regulatory filings and approvals for VivaGel -coated condoms
- Commencement of royalty revenue – currently estimated for CY11
Advance VivaGel through clinical development:
- Start and complete Phase-2 dose-ranging study for Bacterial Vaginosis
- Phase-3 clinical study for Bacterial Vaginosis leading to product registration
- Complete IIa trials and advance Herpes/HPV/HIV efficacy trials
Expand dendrimer-based commercial relationships and programs:
- Advance existing collaborations - pharmaceuticals, diagnostics, agrochemicals
- Potential sales of first agrochemical product
- Establish new, “no downside" licensing partnerships – medical and industrial
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huntw3
Nano Newbie
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| So here's the question I would like some insight on. In early 2009 SPHRY praised the initially positive PRO 2000 microbicide results, saying that the active ingredient in PRO 2000 is similar to the active ingredient in Vivagel. The PRO 2000 clinical trial outcome that was announced 10-14 days ago was completely negative - there was no disernible difference between PRO 2000 and placebo. Not a peep from SPHRY on this outcome. One could argue that the dendrimer-based application will be more effective than PRO 2000, or one could argue that the PRO 2000 result make a positive Vivagel trial outcome less likely. Until there is better visibility into how Vivagel is different from PRO 2000, there will be some doubt about Vivagel's viability. This is my only concern currently about this stock. |
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Star Rizin
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Good point!
Why dont you contact the company and see if they will come off any information.. My experience is they are pretty tight-lipped about this kind of thing though.. we will likely just have to wait it out. Vivagel is by no means a "sure-thing" .. however, it does appear today, that the condom coating will be going to market in the next 12-18 months..
And, SPL also appears to be putting multiple deals in place w other companies so that.. regardless of what ultimately happens with Vgel.. they will be capitalizing on the commercialization of dendrimers!
-although.. I have not studied/perused the available information, though, I would guess that.. structurally, Pro200 and Vgel are similar, but that (naturally) Vgel is superior in the way the adhesive or bonding properties.. I would also guess that.. if one was to compare Vgel and Pro200 side by side on initial studies that.. Vgel in Phase 1 to Pro 2000 phase 1.. is superior.. the Vgel studies that show active inhibition of most all strains of HSV is.. unchallanged or equivocated by any other microbicide in testing .. then or now.
Again, thats not to say Vgel is a "shoe-in".. I just think the initial data r a little more.. promising, favorable.. as does the rest of the market .. considering the recent rally in share price!
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Edited by - Star Rizin on 12/26/2009 20:32:01 |
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stoway
Nano Newbie
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| Agree StarRizin -my limited knowledge suggests that Vivagel is very different - it is Dendrimer instead of Polymer based - with as you say a bonding / delivery structure which is more advanced - atleast I hope it is!!!. |
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Star Rizin
Senior Poster
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HUNTW3: FROM BEN ROGERS re your PRO2000 Trial Results Concern.
"Whilst the PRO2000 result is disappointing for the microbicide
community, it does not indicate problems for SPHRY. VivaGel has a
very different activity profile in rigorous clinical testing, and is
also highly active against clinically relevant strains of HPV.
We do not consider the PRO2000 result to have diminished the prospects
for VivaGel.
Thank you for your interest".
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huntw3
Nano Newbie
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StarRizin:
Thanks for the company followup. I would not expect them to say anything different. The proof will be in the phase 3 results. PRO2000 had good initial results, which is what made its failure in Nov. 2009 so disappointing. On the other hand, if Vivagel does help prevent HIV, it's better for Starpharma not to have a competitor in the field.
Separately, it is odd that Rogers mentions "clinically relevant strains of HPV", not bacterial vaginosis, which is the focus of the $15.6 million capital raise. I guess the BV results are considered too important to release publicly, as compared to the HPV results, which were announced in April 2008. |
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Star Rizin
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Not sure I follow you..
BRogers mentions "clinically relevant strains" I believe bc we were asking the question about PRO 2000 -which was being developed as a "preventative" microbicide similar (potential competitor) to Vivagel or. to one indication of what Vgel is being developed for. However, the Bact Vag is an entirely different application.. in development as a "treatment" not a a preventative.. and therefore not really relevant as a comparison to Pro2000 .. though, you are correct.. very little information has been released around the efficacy of Vgel as a treatment for BV.. those results will be out in antoher 15 months.. we hope! :-)
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Star Rizin
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SPL7013 is the sodium salt of a sulfonated dendrimer that has potent antiviral properties. VivaGel®, a topical gel containing 3% (wt/wt) SPL7013, is in development as a vaginal microbicide. BufferGel® is a Carbopol®-based acidic buffering gel that enhances the natural protective action of the vagina to produce a broad-spectrum microbicidal environment. The positive attributes of both gels were combined into a combination vaginal microbicidal gel having dual mechanisms of action. A 3% (wt/wt) SPL7013 combination gel, pH 3.7, was developed and fully characterized and was shown to have more than twofold greater acidic buffering capacity than BufferGel. Ultracentrifugation experiments demonstrated that SPL7013 was not sequestered or entropically trapped in the viscous gel, thereby confirming, along with viral challenge studies, that SPL7013 has sufficient mobility in the viscous gel to exert antiviral properties.
Keywords: microbicide; vaginal; dendrimer; ultracentrifugation; diffusion; Carbopol®
http://www.informaworld.com/smpp/77023174817843205/content~db=all~content=a906184903
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Vivagel.Durex
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http://www.azonano.com/news.asp?NewsID=9865
Although the result from the completed clinical study is not statistically significant and is insufficient to enable registration, it is an important milestone for the product category. PRO2000 gel was also shown to have a good safety profile, no different from the placebo. These findings are significant for Starpharma, given that the active ingredient in PRO2000 gel is in many respects similar to that of VivaGel(R).
"Given the similarity of the two products, this is excellent news for Starpharma. Importantly, VivaGel(R) has a number of differentiating factors including its activity in HIV, HSV-2 (genital herpes) and all clinically relevant strains of human papillomavirus, and its lack of absorption into the bloodstream," said CEO Dr Jackie Fairley.
The completed study also showed that another candidate microbicide, BufferGel(R), which relies on a fundamentally different mechanism of action, was not effective in reducing the risk of HIV infection |
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Starpharma ....
