It doesn't take a brain implant to see how sustained release platforms will get some traction going forward.
Let's assume that the HSS gig has finally come to some kind of fruition with an implant for osteoarthritis. It could be a pain management implant. Inflammation in and of itself can be painful, so perhaps another anti-inflammatory implant with steroids? Wouldn't the regulatory pathway be a bit easier? I just love this part of where pSivida will be branching out of ophthalmology, arthritis is a great way to branch out. We all could use a couple of implants for inflammation around our joints. I say bring it on.
Good find Terry. This further explains what's been happening at HSS with pSivida. I'm not too concerned that there is a co inventor here. The point is get pSivida technology involved with this hospital. HSS is a major leader in arthritis and sports medicine. This might be the arthritis gig that Paul Ashton has been referring to in his CC's. I say bring it on.
I understand your point here Hernando. But here is the agreement:
We entered into an agreement with pSivida US, Inc. (pSivida) in February 2005, which was subsequently amended and restated in March 2008, for the use of fluocinolone acetonide (FAc) in pSivida’s proprietary delivery device. pSivida is a global drug delivery company committed to the biomedical sector and the development of drug delivery products. Our agreement with pSivida provides us with a worldwide exclusive license to develop and sell ILUVIEN, which consists of a tiny polyimide tube with membrane caps that is filled with FAc in a polyvinyl alcohol matrix for delivery to the back of the eye for the treatment and prevention of eye diseases in humans (other than uveitis). This agreement also provides us with a worldwide non-exclusive license to develop and sell pSivida’s proprietary delivery device to deliver other corticosteroids to the back of the eye for the treatment and prevention of eye diseases in humans (other than uveitis) or to treat DME by delivering a compound to the back of the eye through a direct delivery method through an incision required for a 25-gauge or larger needle. We do not have the right to develop and sell pSivida’s proprietary delivery device for indications for diseases outside of the eye or for the treatment of uveitis. Further, our agreement with pSivida permits pSivida to grant to any other party the right to use its intellectual property (i) to treat DME through an incision smaller than that required for a 25-gauge needle, unless using a corticosteroid delivered to the back of the eye, (ii) to deliver any compound outside the back of the eye unless it is to treat DME through an incision required for a 25-gauge or larger needle, or (iii) to deliver non-corticosteroids to the back of the eye, unless it is to treat DME through an incision required for a 25-gauge or larger needle.
Obviously in the 8 years since Durasert entered Iluvien "FAME" trial, there has been technical progress. So much so that the Durasert platform has blended with the Biosilicon platform, or so it seems to me. The fact that a medley of patents have been applied for on this level does show this pursuit. But pSivida never says a word....right. No......check out the way they communicate. Here's the lowdown from the 10Q....
Our pre-clinical research is primarily focused on our Tethadur and Durasert technology platforms. We are seeking to develop products using Tethadur, part of our BioSilicon™ technology, to provide sustained delivery of peptides, proteins, antibodies and other large biologic molecules. We are also researching the use of our Durasert technology, in some instances in combination with our BioSilicon technology, to provide sustained delivery of therapeutic agents to treat wet and dry Age-Related Macular Degeneration (AMD), osteoarthritis and glaucoma, as well as to provide systemic delivery of biologics.
I've made an inquiry to IR, so we wait....but one thought here Hernando is that the Durasert platform goes back 8 years. There is a lot of water under the bridge in this amount of time. The bioerodible form of Durasert is just being talked about, not fully realized or in a clinical setting; yet. In fact the bioerodible platform wasn't invented yet, so we'll find out who's got rights to what as more clarity comes to light. ALIM has a great product. I lost faith in it after 3 CRL's, but you were right all along in your believing that Iluvien would be the last approved DME drug. The big boys came first.
I think we might need to do that. I just checked with IR pSivida and the breadth of Corticosteroid may only apply only to the " Durasert "platform specifically. I believe you bring a whole lot to this MB Hernando and appreciate your input here. This may be an issue that needs more clarity. Let's try to find out. Can you pursue this on ALIM's end? I'll try to get more on the pSivida end, it's a very important issue.
There have been some mention of this platform. Pfizer's potentially has the Glaucoma insert going with pSivida. My point is however, it might be possible to use steroids in the eye with the bio erodible version of Durasert. ALIM has all the rights to the first "Durasert'' for steroids, but that may not mean for the bioerodible version of the platform. We'll see, but I'm curious if "dry" AMD might benefit from a steroid. I'm still curious about the new chemical entity risk pSivida is passionate about not engaging in. If "dry'' AMD will be a solo venture of pSivida's , then we can be assured that it is an already approved drug. Otherwise, it's a collaboration gig with another company paying for development of the NCE.
Terry, If this is correct and an ongoing process to collaborate with pSivida, we must assume that
Neuron will be picking up the tab for development. It certainly is a new chemical entity, which means a collaboration agreement. Perhaps an upfront payment and milestones with a percentage split. It would be a long time to develop it through PIII. Looking forward to what might happen with it.
I'm wrong here Terry, Corticosteroids are licensed to ALIM with Durasert in the eye, perhaps if pSivida has a different platform; like a bio erodible version then maybe that opens up Fa. So, there might be a different drug other than Fa. Somehow pSivida is looking at an approved drug somewhere for the "Dry'' indication. We'll hear when we hear. It will make news and there should be some pre clinical stuff coming sometime on the Tethadur front. We've just got to be patient.
Terry, I'm not sure that it's going to be that Neuron Drug. That would be a NCE risk and pSivida's not into that.
They may partner on something with a NCE, but they won't go it alone with it; too expensive. I'm beginning to think that we may be going at Dry with Fa, with Durasert, as the devise is FDA approved for Iluvien and soon Medidur for Uveitis. There are some what if's here, but I think the management has had this angle for some time. We'll see, but perhaps we'll get some direction in the upcoming CC.
Durasert will be the key going forward. Although the Tethadur platform is waiting for data, the Durasert platform will be progressing with marketable product pursuits. I always thought that Tethadur would be first. But if pSivida has an idea for Dry AMD, I bet it's a good one. This is where you trust the management.
MLV says pSivida is going after "Dry" AMD"; we heard this from Paul in the last CC. Well, that's four times the market size of "wet" AMD. So, my question is why haven't other big pharma gone after this indication before? I don't know....maybe a sustained release platform that delivers a continuous drug, like Fa, to a specific place in the back of the eye. Oh, gee,.......who can do that? We know the drug is efficacious, we know Durasert delivers up to 3 years. I think everyone in big pharma is watching. This is why we are now a "SPECIALTY PHARMA" because can tackle the sustained release issues better than anyone. The Kansas City Star story was a specialty fit for a specialty patient; the crew put it together in four weeks.
The 50 day is about to cross the 200 day MA. Something to watch besides the paint drying. If doc. retina was right about the March 1st Iluvien launch, then perhaps it will awaken the sleeping microcaps.
This has long been topic on this pSivida MB. Finally, the reality is setting in for drug companies that have had carte blanche to dictate their pricing power. Interestingly, pSivida' s model through sustained release faces this head on. By potentially providing the platforms to better deliver, over time, the same approved drugs in the marketplace. Hence, the "biobetter" chapter in drugs has now reached the front page for big pharma. Who didn't see this coming?
''When pressed on how they could counter the growing pressure from insurers, large drugmakers say they are relying on strategies long employed in the marketplace, focusing research on diseases that don't have adequate treatments and finding ways to differentiate their products from competitors in terms of effectiveness and convenience.
But some industry experts believe they will have to become far more selective even when entering a new treatment area. The hepatitis C example shows how insurers have been able to play just two competitors off one another to wrest a discount.
Gilead Chief Operating Officer John Milligan said that in recent weeks, more health plans are asking the company to drop its hepatitis C drug price more in line with AbbVie in order to keep both drugs on their reimbursement lists.
"Payers are starting to move beyond hand-wringing to real action," said Glen Giovannetti, head of global life sciences at Ernst & Young. "We are starting to see (pharmaceutical) companies deciding which therapeutic options they want to compete in."
Nils Behnke, a partner with Bain & Co's global healthcare and strategy practices, noted that even for the most new promising classes of medications, there are often three or four companies pursuing similar development programs.
"Companies that were heavily into specialty indications thought they were immune, but it is now clear that they are not," he said."
Hernando, That is the million dollar question. At what point does the antiVEGF patients become refractory, 12 months-18? And what are those percentages?
No news blues. So, if and when Iluvien US gets announced , will that get the ball rolling? How about a distribution agreement to get Iluvien launched in the EU, so many countries have OK'd the implant from ALIM, but no distribution as yet. Something has to give and the calendar slips by. With the saga of getting FDA approval, one would think ALIM would be chomping at the bit to share in Iluvien's distribution, especially in the EU.
Well then, now would be good time to exit, wouldn't it? I mean, before it goes to penny land. For that matter, you'd make good chunk of change shorting it to those levels. Just some of my thoughts.