I had stated: "OPKO's is likely to get to market sooner" this is incorrect.
I thought that Opko had an earlier start to their PIII trial than did VSAR but it turns out that their ongoing PIII trial is for adult GH. Their pediatric program is still in PII (late stage). Hopefully this means VSAR has both first mover and dosing advantages over OPKO's product. The remaining concern is that OPKO had a faster growth rate but that can be explained as per Brian's post above.
Hi Seacrets...I took a little nibble today. I was waiting for the sarcoma data. Funny my first post was asking about that data 1 hour before they released it.
In addition, I do think the once every 2 weeks represents a significant advantage over the weekly. Though it seems OPKO's is likely to get to market sooner so it probably will have first-mover advantage.
Pfizer Inc. and OPKO Health Inc. have partnered to develop and commercialize an OPKO treatment for growth-hormone deficiency that could replace daily injections with weekly ones.
OPKO OPK, +0.49% will receive an upfront payment of $295 million and is eligible to receive up to an additional $275 million if its treatment, hGH-CTP, meets certain regulatory approvals. Pfizer PFE, +0.80% will commercialize the treatment, which it said would be complementary to its existing Genotropin growth-hormone franchise.
Google: "Opko Pfizer growth hormone" and you'll get a bunch of articles
Looks like PFE paid big bucks for rights to the OPKO GH
In addition the Somatotropin Biopartners is definitely out there but I don't see any US activity. There is a Prolor product as well unless that is the same as the OPKO product (I don't think so but both refer to it as "hGH-CTP". The pegylated GH referred to in the study above was being developed by Novo Nordisk but it seems they stopped development.
Can anyone tell me if this data is out yet? I don't see it and I believe the company had suggested 2H14 originally. If it's not out any ideas why?
I think it's clear they won't be alone in the long acting GH market for long. However, I don't see anything about Somatropin Biopartners applying for FDA approval and VSAR seems to be ahead of the other long acting formulations. Seems like they are very likely to be successful in PIII and they have a dosing advantage over S. Biopartners (once every 2 weeks instead of every week).
I think this time around the secondary may be a good time to grab some.
Otsuka is not private. It's a public Japanese company and you can buy it on the OTC market ticker: OTSKF
You can also invest in 2nd generation N (deuterated) by investing in CNCE.
Very interesting...just made a post on the VSAR board. Seems like they will have some competition when they get to market. Not sure on specifics of that yet. Agree there is huge potential there.
Just starting to look into VSAR upon recommendation of a current stock holder (Thanks Brian). Does anyone here have a sense of the competition for long acting GH? I see several possible candidates with one (Somatropin Biopartners) that is already approved in the EU (weekly injection):
28. Péter F, Bidlingmaier M, Savoy C, et al., Three-year efficacy and safety of LB03002, a once-weekly sustained-release growth hormone (GH) preparation, in prepubertal children with GH deficiency (GHD), J Clin Endocrinol Metab, 2012;97:400–407.
29. Palanki MS, Bhat A, Bolanos B, et al., Development of a long acting human growth hormone analog suitable for once a week dosing, Bioorg Med Chem Lett, 2013;23:402–6.
30. de Schepper J, Rasmussen MH, Gucev Z, et al., Long-acting pegylated human GH in children with GH deficiency: a singledose, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics, Eur J Endocrinol, 2011;165:401–9.
Data Show PROLOR's Biobetter Form of hGH has Potential to Reduce Required Dosing Frequency from One Injection Per Day to Two Injections Per Month -- -- Phase I Safety and Tolerability Endpoints Met --
NES-ZIONA, Israel, Feb. 2 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc., (OTC:PBTH) (BULLETIN BOARD: PBTH) today reported positive top-line results from a Phase I study of its longer-acting version of human growth hormone (hGH). The study was designed to measure the potential durability (half-life), overall drug exposure (AUC) and biological efficacy, as well as the safety and tolerability of PROLOR's longer-acting CTP-modified human growth hormone (hGH-CTP).
Somatropin Biopartners receives marketing authorisation in the EU, Norway and Iceland
The European Commission has granted a marketing authorisation to Somatropin Biopartners, a prolonged-release somatropin-containing medicinal product. Somatropin Biopartners allows for a once-weekly injection instead of the currently available therapies
..and thank you for your contributions Sarge...it's been a crazy ride here and the real contributors such as yourself made participation worthwhile
Thank you for the kind words. Also, thanks for your always on-point and relevant information through the years. Finally, thank you for showing us all how to navigate the vagaries of an anonymous world while keeping your grace and humanity.
Will be in touch!
Really? you are still looking for a flaw?
I guess this can't become a precedent at this point so I'll tell you. I bought 1000 shares on 8/30/02 for $1.51 (I don't know how that relates to subsequent splits) and I sold those shares 6/4/2003 for $2.06. Not all my AVNR trades were that good though, as ANYONE WHO DIDN'T MISS THE LAST 4 MONTHS IN AVNR KNOWS....some were MUCH better.
Good luck in your trading Congo.
bon voyage AVNR
thanks jtl...I spoke to Ian Clements (Avanir's IR guy) about the AVP-786 depression trial. They have not yet given any guidance on when it will finish but he noted it's about the same size as their agitation trial and that took 2 years to get data after the first patient was enrolled. He thought that would be a reasonable approximation for depression as well....so something roughly around September 2016
You are correct...I missed the part that dated the prior discussion on October 9. CNCE's pps was higher then.
I started to write the same thing yesterday...but I'm not completely sure.
I assume you are looking at the statement of the pps being higher late in the year compared to earlier discussions? I think that does imply it is not CNCE but discussions were initiated prior to the agitation results so it still could be CNCE (though I agree probably unlikely). Is that what you were looking at and were you able to sort it out more?