Just so that everyone is on the same page.....
Watertown, MA, USA (June 14, 2011) – Drug delivery company pSivida Corp (NASDAQ: PSDV, ASX: PVA) today announced it amended and restated its Research and Development Agreement with Pfizer Inc. (NYSE: PFE) to focus solely on the development of a long-term, sustained-release implant to deliver latanoprost for patients with ocular hypertension and glaucoma. The proposed implant is a bioerodible version of pSivida’s proprietary Durasert™ technology system and is designed to be injected into the subconjunctival space of the eye.
Under this revised agreement, Pfizer will make an initial payment of $2.3 million. pSivida will, with technical assistance from Pfizer, have the right to develop the glaucoma product candidate through Phase II clinical trials. At that point, Pfizer may exercise its option for an exclusive, worldwide license to develop and commercialize the product candidate in return for a $20 million payment, double-digit royalty payments on any sales of the product and additional development, regulatory and sales performance milestone payments of up to $146.5 million. If Pfizer does not exercise its option, pSivida will retain the right to develop and commercialize the glaucoma product on its own or with a partner. As part of the amended agreement, pSivida regains all rights to its intellectual property in ophthalmic applications previously included in the original Research and Collaboration Agreement other than that required for the latanoprost implant.
“Pfizer is an excellent partner, and we are pleased to be entering into this new stage of our relationship involving development of a potentially enhanced glaucoma product,” said Dr. Paul Ashton, President and CEO of pSivida. “The $2.3 million payment from Pfizer comes on top of the approximately $7.0 million in R&D support we have already received from Pfizer since we first started our partnership in 2007. We believe that regaining rights to intellectua
Prxl. I read about them too. For Glaxo to be on board already with a license deal says a lot. Sure will be something to keep an eye on as the trial moves forward. It's interesting that they didn't mention biologic delivery in the way they described the technology. I'm sure they'll be touting it, if they indeed can. Good find. It shows the field of drug delivery and the nano structured silicon field growing in attention.
Read my new post with a quote from IR, it explains the issue. Your inference regarding Ashton it seems is pure " blather", go run with that. Question it? .....contact pSivida IR.
Hey guys. Great threads about Glaucoma and how different companies are going after it. We've all been wondering why the heck has there been a delay in the PFE/ PSDV collaboration. Bev reads the threads as well, but cannot in anyway post to clarify all the things we get wrong......which can be abundant. So, I ran it by her and she was quick to clarify it. She was not sure if pSivida got 2.5 Million exactly from PFE, or was it less. She was going to check, though I believe it was 2.5 M. Here is her clarification that explains why there might have been a delay in the progress. Naturally, you can bother her with anything you all feel I didn't get right. It may have been all about the money. This is a quote from Bev in an email....
Pfizer has already paid pSivida monies toward this – they funded early development as a result of the old agreement, and I believe there was a $2.5 million payment at the time that the revised Pfizer agreement was announced.
pSivida is responsible for running the phase one and phase two trials – they incur costs – Pfizer does not pay anything toward this. At the end of the Phase 2 trial, Pfizer has the option to pick up the project – if they decide to exercise that option, then they pay pSivida $20 million and they would be responsible for phase 3 and commercialization, with milestone payments along the way – if the product were to get to approval as a Pfizer product, then there is a double digit royalty.
If, at the end of the phase 2 Pfizer decides not to exercise their option, then pSivida can do whatever they want with the product – that could be develop on their own or license out – whatever. That would end Pfizer’s involvement in the project.
Also, I don’t think we’re talking about a three year product here – I think they would consider something a bit shorter term since the idea on this product is to release the latanaprost on a sustained basis to help with the biggest problem in glaucoma – compliance. The drugs work just fine a
Kool. You're right here. I don't want to see money spent at all. Ashton did mention Glaucoma in the CC, so I don't know what he meant by that. Wouldn't a three year glaucoma treatment fit nice in the market with Durasert as the platform?
Billy, Thanks. This platform has such vast potential that it's mind boggling. The energy that the Big's are putting into proteins and antibodies is staggering. These are very fragile molecules that need protection for sustained release. We now see (from Terry's post regarding patent apps) that pSivida has discovered how to further protect these molecules with coatings, apparently made with Durasert polymers. We can't think short term here. In 3 years we'll see a zero behind current valuation SP. Management is building a very good foundation for the technology first. That is the value driver.
JD, I played the last CC again today. Paul did mention that glaucoma was one of the things they were very interested in. He was responding to a question from Ladenberg regarding the pipeline. Might this mean they're changing the focus a bit? It could have been all about cash management, and before the milestone pSivida was lighter on cash.
Billy, I think PFE owns around 8% of the outstanding stock. Regarding the Latanoprost work....I contacted Beverly of pSivida IR. If you heard the last CC, you heard Paul Ashton addressing glaucoma as one of the potential IND's that might be pending. along with dry and wet AMD. In my communication with Beverly, she mentioned the possibility that with the big cash influx that came with the Iluvien milestone, that there might be more emphasis now put on glaucoma. So the question is, will this be the Latanoprost glaucoma gig they have with PFE? I believe it is, but we'll again have to wait and see if in fact this is true. The income has put things that were on the back burner , now on the front burner. That's what cash does for biotech's.
DR, don't know but it was oversold for some time. Maybe someone got a whiff of some news. What a great entry point either way. How do you get a thumbs down for asking a question?
Why are you still holding then? You seem disenchanted to say the least, so you find some comfort in bashing the management that's brought the whole technology this far?. Iluvien is going to pay all the bills for pSivida going forward. Tethadur isn't priced in to the SP anyway. Any level of success sends the company to much higher levels. I'm sticking around for it either way. When the data comes out, and it will be good, I get to pull this post back up and shove it up your &^%. That's going to be fun.
The post that Terry made last week regarding polymer coating patent applications fully explains a potential delay in releasing Tethadur data. I'm including it here for the clod heads that are dying to sell once we reach four bucks again. In the meantime, these skin coating polymers are clearly used in conjunction with the erodible nano structured ''pSi'' tubes. pSivida is doing it for reasons that obviously include duration of release. Imagine that......wanting a more sustained duration of release for biologics. No market there bone heads. Great find Terry:
" As a supplement to the background information on this patent, NewsRx correspondents also obtained the inventors' summary information for this patent: "An injectable drug delivery device includes a core containing one or more drugs and one or more polymers. The core may be surrounded by one or more polymer outer layers (referred to herein as 'coatings,' 'skins,' or 'outer layers'). In certain embodiments, the device is formed by extruding or otherwise preforming a polymeric skin for a drug core. The drug core may be co-extruded with the skin, or inserted into the skin after the skin has been extruded, and possibly cured. In other embodiments, the drug core may be coated with one or more polymer coatings. These techniques may be usefully applied to fabricate devices having a wide array of drug formulations and skins that can be selected to control the release rate profile and various other properties of the drugs in the drug core in a form suitable for injection using standard or non-standard gauge needles. The device may be formed by combining at least one polymer, at least one drug, and at least one liquid solvent to form a liquid suspension or solution wherein, upon injection, such suspension or solution under goes a phase change and forms a gel. The configuration may provide for controlled release of the drug(s) for an extended period.
JD, If there were news of substance volume would spike and there would be covering. No news, which is what this little company is famous for, allows for the manipulation by the 876K shorts. This is not huge short interest, but they'd be scrambling to cover and then jump back at the top of the next spike. It's what they do and in the case of pSivida, they've done it historically pretty well. One day though...........
I've been on this MB board for a long time. I didn't freak out on the first, second or third Iluvien CRL's. I invested in pSivida for one reason; the Bio silicon platform. This is what "pSi" means; it means nano structured silicon. Many investors in this company are rattled by the 25% drop in SP post Iluvien " approval". I'm not happy either. I wish we were trading much higher. Investors have also been anticipating pre-clinical data that defines, kind of, sort of where we are with this pipeline that's been touted as so promising. Tblow has spouted that the in vivo data is somehow bad and that Ashton is scrambling to find something that works. Not so. Ashton came from his former company (CDS) acquired by pSivida for his technical prowess. He is pSivida. His former company was acquired for roughly the MC of pSivida "right now"; 105 Mil. He brings to the table immense skill and is developing this nano structured bio silicon with the same development team they've had for years. pSivida is working with huge companies, showing how their technology works. It's long been understood in the science community that nano structured pure silicon that is electro chemically etched can be used as a drug delivery vehicle. In vivo studies have been done extensively in rabbit eyes and found to be " VERY WELL TOLERATED''. Please, Google "nano structured silicon" and do some DD through the many abstracts available . These were not done by pSivida....they just "OWN ALL THE PATENTS" to the technology. I promise you when pre-clinical data is out for this platform, it will make huge waves in the science community. For the whiners on this MB, go buy some P&G, you deserve each other.
Did you take chemistry in college? Tethadur is very simple chemistry. It's electrochemically etched pure silicon to form hollow tubes that can be charged to receive a biologic of an opposite charge; on the micron level (solar panels-get it?) Oh, the pure silicon is inert. It won't react to anything. It can be heated, chemically or heat treated and yet it still won't react. Pure silicon has a melting point of 3400 degrees F. Now, wrap your little brain around the fact that it's Bio Erodible in this form, creates silicic acid and is excreted through your kidneys naturally and with great ease by your body. You still don't get it do you? Stop thinking so short here. Expand your time horizon to include 15'. I'm going to rip you a new one with every single Tethadur accomplishment. Now, you just *&^ me off.
Alimera might be getting some legs with Summer Street Buy rating and PT. Finally, analysts are picking up on Iluvien as a real competitor to the Ozurdex - Dexamethasone 4 month treatment. Anything good with Alimera might drag us up with them, while we wait for pipeline data. So, though we all hoped we'd be in a better SP place at years end, other investors have an opportunity to jump in on the cheap with both companies. Let's hope that continues.
Agreed. I'm not that kind of investor. I use different vehicles for solidifying my financial future; like good real estate. I'm good for the long haul in PSDV. But yes, I wish Data were out. I invested in this company for their Biosilicon platform, now it's backed up with Iluvien. Good data and the resulting clinical advancement will make pSivida a worthwhile investment. I'm sticking around and continuing to pick up shares on the cheap. It is a fair question as to how low it will go. Either way, when the management comes out with it, it will be very good. I guarantee it.
Flex, It might be world peace that comes first. Data is pushed back to most likely 15', more than 6 months late. What would be the reason for that.......? Don't know, so yeah, world peace is looking more likely to happen first.