EyePoint Pharmaceuticals (vorher: PSIVIDA) startet durch !! (Seite 203)

[wuenschmirwas]

Dann darfst Du aber nicht schreiben:
Jeder Aktionär will endlich wissen was in der Firma los ist.
Sondern:
Wir wollen endlich den Erfolg am Markt.

Ich sehe Psivida im Moment auf dem richtigen Weg. Natürlich noch mit sehr viel Risiken behaftet.
Wäre dies nicht so, wäre der Einstiegspreis für die Aktie sicher nicht mehr interessant weil viel zu hoch.

[N424671]

Zitat von wuenschmirwas: Tut mir leid. Ich verstehe Deinen Beitrag nicht.Nur durch Veröffentlichungen kann man erfahren was in der Firma los ist.

Bei pSivida weiss doch jeder Aktionär was los ist. Nur ein Erfolg im Markt kann diese Aktie in die Höhe bringen

[wuenschmirwas]

Tut mir leid. Ich verstehe Deinen Beitrag nicht.Nur durch Veröffentlichungen kann man erfahren was in der Firma los ist.

[N424671]

Wir warten schon sehr lange auf diesen Erfolg im Markt. Die vielen Veröffentlichungen sind eher Gift für diese Aktie. Jeder Aktionär will endlich wissen, was los ist in der Firma.

[wonner]

pSivida Announces Tech Evaluation Agreement With Leading Global Pharmaceutical Company

WATERTOWN, Mass.--(BUSINESS WIRE)-- pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that it has signed a funded technology evaluation agreement with a leading global pharmaceutical company. The agreement will evaluate pSivida's proprietary Durasert™ technology for this pharmaceutical company's select products in ophthalmology. The Durasert technology system delivers specific quantities of drugs directly to a target site in the body at controlled rates for predetermined periods of time ranging from weeks to months.

"I am very pleased to be entering into a technology assessment agreement in ophthalmology with another Global Pharmaceutical company," said Dr. Paul Ashton, President and CEO of pSivida Corp. "We are transitioning into a Specialty Pharma company developing our own products, while continually looking for ways to use our technology platforms to develop new products. Technology agreements such as this enable us work with major companies further expanding our reach and increasing our shots on goal."

pSivida has developed three of the four sustained release devices for retinal diseases that have been approved in either the US or Europe, the most recent being ILUVIEN®, partnered with Alimera and approved in multiple EU countries. Independently, pSivida is developing an injectable, sustained release product to treat uveitis affecting the back of the eye (posterior uveitis) and an injectable, bioerodible product to treat glaucoma and ocular hypertension in collaboration with Pfizer.

[lson3]

twitter
https://twitter.com/pSividaCorp

[binda]

Vielen Dank. Wo hast Du das her?

[lson3]

The eye space continues to heat up. $2.5B was wiped off Allergan’s market cap following the announcement of a delay in two programs including their Phase II DARPin program for AMD. This is an anti-body type protein targeting VEGF/PDGF that is rumored to be injected into the eye every 3-6 months. If approved could be really tough competition in the multi-billion ocular anti-VEGF market now dominated by Roche’s Lucentis and Regeneron’s Eylea (which are typically injected every 4 to 8 weeks). So, if Phase II trials had gone well, and if Phase III trials had gone well, and if DARPin injected every 6 months ultimately had similar efficacy as Eylea injected every 2 months, it could have been a great drug for AMD/DME. Interestingly Regeneron’s market cap increased $2.5B following news of the delay. Seems like a lot of “ifs” for $2.5B but maybe not. People are realizing that the AMD/DME market is really big. With such a big market and so few players every development is important. Whoever can come up with a sustained delivery system for anti-body type proteins in the eye may do very well indeed.

Regarding our own product in this space, the last month or so has seen a flurry of good news on ILUVIEN, our sustained release insert approved in Europe for chronic DME. A lot of people are asking some of the same questions so here are some clarifications:

1) Yes, ILUVIEN is now on sale in Germany and to private payers in the UK. There aren’t many private payers in the UK so an important piece of news coming up will be the verdict from NICE (the UK government body that determines the price of drugs that the government of UK will pay) on a possible discount on pricing of ILUVIEN by Alimera (termed a Patient Access Scheme or PAS). The exact details of the PAS are confidential so it will be hard for people to discover the exact discount (from the private payers price of £5,500) Alimera is offering the UK government. If it goes through, and we should know in a month or two, please don’t ask me what it is, I’m not allowed to say.
2) Yes, great news that the FDA has accepted the resubmission of ILUVIEN for DME and given a PDUFA date (October 17th). This is the date by which the FDA aims to have completed their review and be able to give a decision (yes, no, or more data please).
3) Yes, I’m optimistic about the revised application, but no, I don’t know what the decision will be.

While all the ILUVIEN news is great, we are focused right now on developing our own product for posterior uveitis. We view the economic opportunity here to be in the same size range for us as DME. In the US there are about 175,000 people with posterior uveitis. That’s about 5 times fewer people than those that have DME, but with uveitis we’d have all of the profits from sales whereas in DME we’d get 20% of Alimera’s profits (if it’s approved). And while we are optimistic about the upcoming PDUFA date for ILUVIEN in the US, we are also optimistic in the longer term about our chances of approval in uveitis.

One final thing on ILUVEIN for DME that people keep bringing up is the profit split. Details of our profit split with Alimera are as follows. We are entitled to 20% of the profits on ILUVIEN sales by Alimera on a quarter by quarter country by country basis. Profit is essentially net sales minus cost of goods minus commercialization costs (i.e. sales and marketing). COGS is a known number as is the sales costs (Alimera is using Quintiles as a sales force for hire so we know how much per country per quarter). Marketing costs are budgeted per country per quarter and are transparent. So profit in, say, Q4 in Germany cannot be affected by, say, launch costs in say France in that quarter. Under the agreement Alimera is allowed to recoup 20% of pre-profit commercialization costs in a given country by reducing our percentage of profit from 20% to 16% until they have recouped those costs. For example, if Alimera had incurred a total of $5M in commercialization expenses before the product has a profitable quarter in that country, then Alimera could reduce our profit split in subsequent quarters from 20% to 16% until $1M (i.e. 20% of $5M) has been recouped and thereafter our profit split would go back up to 20%. In Alimera’s 10-K they indicate approximately $5-6M in commercialization expenses that could be off-set against pSivida’s profit split. So one would think that our profit split could be 16% until Alimera recoups approximately $5-6M. However commercialization expenses can only be off-set against profits on a country by country basis. If the whole $5-6M in commercialization expenses were all directed sales in Germany then yes, our profit split in Germany would be 16% until Alimera had recouped $5-6M (i.e. 20% of its commercialization expenses). But in reality most of the commercialization expenses incurred to date have not been in Germany and these expenses can only be recouped against profit in the country in which they were incurred. Thus US commercialization expenses cannot be off-set against profit in Germany, France or wherever. And to answer another question, commercialization expenses in any country cannot be off-set against the $25M we’d be due on US approval.

That’s a lot of detail but hopefully the profit split with Alimera is now clear. We are of course very pleased with the progress in the EU, are working hard to get the uveitis phase III started in the US and also on Tethadur, our protein/peptide sustained delivery system.

More updates to come.

[lson3]

The eye space continues to heat up. $2.5B was wiped off Allergan’s market cap following the announcement of a delay in two programs including their Phase II DARPin program for AMD. This is an anti-body type protein targeting VEGF/PDGF that is rumored to be injected into the eye every 3-6 months. If approved could be really tough competition in the multi-billion ocular anti-VEGF market now dominated by Roche’s Lucentis and Regeneron’s Eylea (which are typically injected every 4 to 8 weeks). So, if Phase II trials had gone well, and if Phase III trials had gone well, and if DARPin injected every 6 months ultimately had similar efficacy as Eylea injected every 2 months, it could have been a great drug for AMD/DME. Interestingly Regeneron’s market cap increased $2.5B following news of the delay. Seems like a lot of “ifs” for $2.5B but maybe not. People are realizing that the AMD/DME market is really big. With such a big market and so few players every development is important. Whoever can come up with a sustained delivery system for anti-body type proteins in the eye may do very well indeed.

Regarding our own product in this space, the last month or so has seen a flurry of good news on ILUVIEN, our sustained release insert approved in Europe for chronic DME. A lot of people are asking some of the same questions so here are some clarifications:

1) Yes, ILUVIEN is now on sale in Germany and to private payers in the UK. There aren’t many private payers in the UK so an important piece of news coming up will be the verdict from NICE (the UK government body that determines the price of drugs that the government of UK will pay) on a possible discount on pricing of ILUVIEN by Alimera (termed a Patient Access Scheme or PAS). The exact details of the PAS are confidential so it will be hard for people to discover the exact discount (from the private payers price of £5,500) Alimera is offering the UK government. If it goes through, and we should know in a month or two, please don’t ask me what it is, I’m not allowed to say.
2) Yes, great news that the FDA has accepted the resubmission of ILUVIEN for DME and given a PDUFA date (October 17th). This is the date by which the FDA aims to have completed their review and be able to give a decision (yes, no, or more data please).
3) Yes, I’m optimistic about the revised application, but no, I don’t know what the decision will be.

While all the ILUVIEN news is great, we are focused right now on developing our own product for posterior uveitis. We view the economic opportunity here to be in the same size range for us as DME. In the US there are about 175,000 people with posterior uveitis. That’s about 5 times fewer people than those that have DME, but with uveitis we’d have all of the profits from sales whereas in DME we’d get 20% of Alimera’s profits (if it’s approved). And while we are optimistic about the upcoming PDUFA date for ILUVIEN in the US, we are also optimistic in the longer term about our chances of approval in uveitis.

One final thing on ILUVEIN for DME that people keep bringing up is the profit split. Details of our profit split with Alimera are as follows. We are entitled to 20% of the profits on ILUVIEN sales by Alimera on a quarter by quarter country by country basis. Profit is essentially net sales minus cost of goods minus commercialization costs (i.e. sales and marketing). COGS is a known number as is the sales costs (Alimera is using Quintiles as a sales force for hire so we know how much per country per quarter). Marketing costs are budgeted per country per quarter and are transparent. So profit in, say, Q4 in Germany cannot be affected by, say, launch costs in say France in that quarter. Under the agreement Alimera is allowed to recoup 20% of pre-profit commercialization costs in a given country by reducing our percentage of profit from 20% to 16% until they have recouped those costs. For example, if Alimera had incurred a total of $5M in commercialization expenses before the product has a profitable quarter in that country, then Alimera could reduce our profit split in subsequent quarters from 20% to 16% until $1M (i.e. 20% of $5M) has been recouped and thereafter our profit split would go back up to 20%. In Alimera’s 10-K they indicate approximately $5-6M in commercialization expenses that could be off-set against pSivida’s profit split. So one would think that our profit split could be 16% until Alimera recoups approximately $5-6M. However commercialization expenses can only be off-set against profits on a country by country basis. If the whole $5-6M in commercialization expenses were all directed sales in Germany then yes, our profit split in Germany would be 16% until Alimera had recouped $5-6M (i.e. 20% of its commercialization expenses). But in reality most of the commercialization expenses incurred to date have not been in Germany and these expenses can only be recouped against profit in the country in which they were incurred. Thus US commercialization expenses cannot be off-set against profit in Germany, France or wherever. And to answer another question, commercialization expenses in any country cannot be off-set against the $25M we’d be due on US approval.

That’s a lot of detail but hopefully the profit split with Alimera is now clear. We are of course very pleased with the progress in the EU, are working hard to get the uveitis phase III started in the US and also on Tethadur, our protein/peptide sustained delivery system.

More updates to come.

[Peter_02]

@speculatitis,
die Großanleger kann man auf der Homepage von PSI ansehen.
Was meinen Sie denn, wann ist wer ein Großanleger bei ca 48 Mio € Marktkapitalisierung.

Möchtest Du ernst genommen werden oder belächelt ?

Die Beiträge zeugen nicht von Sachkenntnis
Ich meine 20 % sind gut bei fast 0 Risiko.

Was ist denn Ihre fachliche Meinung, wenn es bei der alten Gewinnsplittung 50/50 geblieben wäre, wie lange, seit 2009 hätte PSI seinen Anteil an den Forschungskosten aus Eigenmitteln denn bezahlen können.

Die Gewinnerwartungen aus der Vermarktung von Illuven wurde von Alimera bereits veröffentlicht.


@speculatitis, warum so unsachlich und ohne Kenntnis ?
Eigeninterresse ?