I agree, I don't see this moving up if required to do a P3, big or small. In fact I think the assumption that we will need to do a P3 is stifling the price right now.
That's the thing, they will need a partner in the EU if they go it alone. I never denied a partnership in Europe would be necessary. There is no way they can market Z otherwise. As for the great U.S of A, we're going it alone, at least for a while.
Did anyone expect a partnership to be named at the time of filing? So to answer your question, I guess not having a partner could be an indication of keeping the options open for a potential suitor to determine how to handle the EU market. Then again, it could just mean they have not come to agreement with anyone yet. EU could take a while to develop.
It blows my mind how many small start up bios are out there. It seems like every week I hear about 10 more.
Just have to hold your nose on days like today or go play golf in a foot of F'ing snow.
Is it 4 yet?
Can I a drink over here?
Goose , Grey Goose.......leave the bottle
Not knowing who is financing this group makes it difficult to speculate their intention for the future. They are risk conservative but they are hungry for winners over there. They are a relatively young as a company with no approved drugs. I would say they are not an acquisition/IPO candidate for now.
Also, KERX does not have the money to even think about another company . Seriously. They need to pour all resources into a successful launch of Z and that's exactly what they will do. The size of the prize is yet to be determined but they will be a player.
As for Shield, it's a reminder to all that DD should not be confined to reading company websites and conference call transcripts.
ST10 for the treatment of iron deficiency
ST10 is an oral ferric iron therapy for the treatment of iron deficiency that is in Phase 3 development as an effective oral alternative to parenteral (IV) iron in ferrous intolerant patients. GI absorption of ST10 is at least as good as ferrous products at a significantly lower daily dose and it is not affected by gastric pH, so can be co-prescribed with widely used acid-reducers.
The British National Formulary states: "parenteral iron does not produce a faster response than oral iron provided the oral iron is taken reliably and is absorbed adequately."
ST10 aims to deliver these benefits and so provide a compelling alternative to prescribers, patients and payors as well as removing the hypersensitivity risk of IV infusions.
ST10 has an existing library of early clinical data clearly demonstrating effectiveness and key pivotal trial results of ST10 are expected towards the end of 2013.
ST10 is currently being tested in the core markets of iron deficiency anaemia in inflammatory bowel disease and chronic kidney disease. It also has the potential to be used across a wide range of indications where iron deficiency is frequently seen, for example:
To improve fatigue symptoms in iron-deficient women
Treatment of post-bariatric surgery iron-deficiency
Treatment of iron deficiency in the elderly
Treatment of iron deficiency associated with restless leg syndrome
Treatment of functional iron deficiency in patients undergoing chemotherapy
To correct/prevent iron deficiency in rapidly growing children
To correct iron deficiency in CHF (NYHA I-IV)
These additional primary and secondary care label expansion opportunities will further enhance the excellent commercial opportunity that ST10 provides.
PT20 for the treatment of hyperphosphatemia
Invented in the UK and exclusively licensed from the Medical Research Council, PT20 is a novel iron-based phosphate binder being developed for the treatment of hyperphosphataemia related to dialysis-dependent or dialysis-independent chronic kidney disease (CKD). Hyperphosphataemia is a life-threatening complication of CKD, the incidence of which is itself increasing across the world as obesity levels rapidly rise.
As Tonelli et al suggested in 2010 "...the ideal phosphate binder would avidly bind dietary phosphate, have minimal systemic absorption, few side effects, a low pill burden ...” (N Engl J Med 2010;362:1312-24).
PT20 acts as a ‘phosphate sponge’ and data from early in vitro and in vivo studies on PT20 suggest it exhibits higher specificity and efficacy than market leading phosphate binders.
In addition, the low systemic absorption and the well-tolerated nature of the base ferrihydrite indicate a very good side effect profile should be expected.
Pivotal trials of PT20 are expected to commence during 2014.
You have just appeared out of nowhere.....born today. Happy B-day.
Your best source for info is to go to their website and start from there, but you knew that. Then review the board. Pretty impressive pedigree , these guys. Look into their consultants and you will see a familiar name. You are long kerx and this is what brings you out of the woodwork? Concerned?
IMO they are a potential threat . Will it prevent us from bringing Z to market? No. Will it temper some of these crazy price projections? Probably. Could the EMA have a bias to a UK company and thus have some affect on our approval path for KERX in the EU? I have already opined on that.