3 months ago during the 4th qtr CC, Rob introduced 4 new Triferic indications for the 1st time.
One was a new orphan indication, or one that treats a small population of people with a rare disease with few or no other alternatives. If approved by the FDA, Rockwell will get a 7-year market exclusivity to market Triferic with little or no competition.
Rob initially said this:
"We also are pursuing potential new drugs and drug products for development. Additionally, we are initiating clinical programs for delivering iron via Triferic and TPN total parenteral nutrition solution, PD, parenteral dialysis solution and an orphan indication."
Then this in reply to a Stifel Q:
"Well, no. The money we will spend on the clinical part for Triferic, for TPN and PD and this orphan indication that I mentioned. That will be strictly for Triferic."
Then Rob said this on 5/7/15 CC
" We're moving forward on clinical programs for Triferic delivery via TPN solution and PD solution, as well as an orphan indication for patients who are iron resistant."
A new orphan indication for patients who are iron resistant. Hmmmm
Triferic is going to be transformative in treating anemia in dialysis patients.
Triferic is the most significant advancement in dialysis in 25 years
$83.6 million in cash. No debt. Strong financial position to launch 2 drugs
“…both drugs on track for commercial launch in the July/August timeframe.”
“For Triferic, we continue to work diligently on numerous pre-launch initiatives. Our activities at the moment are focused on the manufacturing and marketing aspects of the launch, which involves the making of API and the scale-up and CMO redundancy required, as well as our communications with customers and our efforts to educate and to establish brand awareness around Triferic.“
‘…we have spent time interacting with and educating physicians and providers, and their feedback continues to be very positive.”
“Securing at least two suppliers to produce the estimated demand for the market is a must; this redundancy is critical and we have achieved it with both drugs.”
New Business Development
“..Multiple potential licensing partners..”
“..not only Triferic for iron delivery in hemodialysis patients outside the US, but also indications beyond the hemodialysis setting, both in the US and globally.”
Our goal is to:
1) Secure the highest value partner
2) Most favorable economics
3) In each partnered territory
4) For each indication.
New Triferic Markets
“We are moving forward on clinical programs for Triferic delivery via TPN (total parenteral nutrition) solution and PD (Peritoneal Dialysis) solution, as well as an orphan indication for patients who are iron resistant.”
“We also intend to use the Triferic technology in other indications, such as cancer and oral delivery.”
“We are also pursuing regulatory approval for Triferic in several countries outside the US.”