Der Handel mit den CDIs der pSivida Corp. beginnt
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pSivida Corp. (NSDQ:PSDV) is touting a study of a drug-device combination that it says helps slow the advance of a degenerative eye disease called retinitis pigmentosa.
The disease involves the gradual deterioration of the rods and cones that make up the retina. Symptoms begin with night blindness and progress over years or decades to tunnel vision and, often, total blindness. CEO Dr. Paul Ashton told MassDevice that the Watertown, Mass.-based company's Durasert is inserted into the back of the eye, where it slowly releases a steroid called fluocinolone acetonide.
"It's a truly horrible disease," Ashton told us, speaking on his cell phone outside a pub in his native England. "Typically, people get diagnosed in about their 30s and you're normally totally blind by the time you're 50. It's completely untreatable."
Retinitis pigmentosa occurs when the byproducts of normal vision accumulate, he explained.
"Basically, whenever you process a visual image, the rods and cones produce a lot of by-products which, in a normal cell, get cleared. In retinitis pigmentosa, they accumulate. That's what eventually kills the cells and the lights go out. What we've done is use a very small insertable drug delivery device to release a steroid directly into the eye that will just provide some protection and slow down the rates of vision loss. With a condition that takes 20 years to make you blind, if you slow it down by a factor of two, that's pretty good."
The study, published in the journal Investigative Ophthalmology and Visual Science, showed that the Durasert device slowed the disease's progression in rats. The researchers used electroretinography, which measures the electrical response of the rods and cones to light, to chart the effectiveness of the device compared with rats with no device inserted or with a device inserted that contained no steroids.
"The animals that received these implants had preserved vision. The retina, kind of like the camera film, the structure or architecture of the retina was preserved. Normally it goes to hell pretty quick," Ashton said. "In a rat with retinitis pigmentosa, that 'blip' [on the ERG] gets pretty flat pretty quick and eventually flat-lines. We found that those pulses on the ERG were preserved significantly longer in eyes that were receiving implants."
The study showed that the rats with no implants or with the dummy implants suffered a 50 percent to 60 percent reduction in ERG amplitudes four weeks after implantation. Two other groups of rats each received implants containing the FA steroid, one of which received a higher dose. The rats with the lower dose showed a 15 percent rate of amplitude attenuation, while the higher-dose rates showed a 30 percent reduction.
Ashton said pSivida is developing a larger implant for humans, aimed at treating diabetic eye disease, that's in clinical trials now. The company is also working on a treatment for macular edema, he said.
"These devices release drugs very, very slowly. In the human trial, you're looking at devices designed to last for up to three years from a single insertion. The idea is to maintain low therapeutic [drug] levels over a long period of time. Eye diseases are difficult, because eye drops only get to the front of the eye. It's very difficult to get drugs to the back of the eye, the retina, which is where all the damage occurs," Ashton said. "The technology can be used virtually anywhere. If something is small enough and safe enough to be injected into the eye, it can be used anywhere — brains, organs, anywhere."
Quelle: http://www.massdevice.com/news/psivida-aims-slow-retinitis-pigmentosa
Dr. Paul Ashton, CEO of pSivida Corp. said, “We congratulate Alimera on its successful IPO and look forward to Alimera’s filing of the NDA for Iluvien for the treatment of DME.” Alimera has stated that it intends to file the NDA for Iluvien this quarter and to seek priority review, which, if granted, is expected to result in a response from the FDA in the 2010 fourth quarter. If the FDA approves Iluvien for the treatment of DME, pSivida is due to receive a $25 million milestone payment from Alimera. pSivida would also be entitled to receive 20% of the net profits of sales of Iluvien. “pSivida’s focus is the use of our unique technologies to develop therapies for serious unmet medical needs. We target diseases that affect large numbers of people and that represent big commercial opportunities. We believe Iluvien for DME is an example of this,” Dr. Ashton said. He added that pSivida is developing other ophthalmic products, some in partnership with Pfizer, pSivida’s largest shareholder, and some internally. pSivida is also working to adapt its drug delivery platforms to deliver therapeutics outside ophthalmology.
...und das ganze bei z.Zt einer Marktkapitalisierung von nur ca. 90 Mio. $
img_chart_pipeline.jpg (verkleinert auf 96%)
Lese doch tapfer weiter mit bei PSIVIDA.
Halte ich doch schon ewig und freu' mich mal wenn's nun etwas anzieht.
Weiter so!
Auch das Posten!
Good Trades
Vers
“We are continuing to advance our technologies toward the development of additional products, both partnered through our ongoing collaboration agreement with Pfizer, Inc. and internally. We are excited by the opportunities in our pipeline”
"I am very pleased with the progress on the development side. At the recent ARVO conference, positive results of pre-clinical studies indicated a key step toward the ability to use our bio-erodible technology for the treatment of glaucoma and other degenerative eye diseases. At the conference, there were nine presentations of our technologies, three sponsored by us and our partners and another six by independent researchers," said Dr. Paul Ashton, CEO of pSivida.
“I am also pleased with the significant improvement in our financial condition. After the close of the quarter, the Company received $15.2 million from Alimera Sciences, Inc. in full payment of principal plus accrued and unpaid interest on a conditional note. With this payment, we project fiscal 2010 revenues of approximately $22.8 million and cash and cash equivalents at June 30, 2010 of approximately $17 million, up from approximately $7 million last year,” added Dr. Ashton.
Financial Results
The Company reported a consolidated net loss of $2.7 million, or $0.15 per share, for the quarter ended March 31, 2010, compared to a consolidated net loss of $636,000, or $0.03 per share, for the quarter ended March 31, 2009.
Revenues totaled $515,000 for the three months ended March 31, 2010 compared to revenues of $3.2 million for the three months ended March 31, 2009. The revenue decrease was attributable to the completion on December 31, 2009 of the Company’s performance obligations under its collaboration agreement with Alimera, through which date cash consideration received from Alimera was being amortized to revenue.
For the nine months ended March 31, 2010, the Company reported a consolidated net loss of $4.3 million, or $0.24 per share, compared to a consolidated net loss of $2.0 million, or $0.11 per share, for the nine months ended March 31, 2009. Revenues for the nine months ended March 31, 2010 were $7.3 million compared to revenues of $8.9 million for the nine months ended March 31, 2009.
Cash and cash equivalents totaled approximately $4.0 million at March 31, 2010, a decrease of approximately $1.1 million compared to approximately $5.1 million at December 31, 2009. Over the first 9 months of fiscal 2010, net cash and cash equivalents decreased by $2.9 million.
Corporate Update
Alimera has reported its intent to file an NDA for Iluvien®, licensed by pSivida to Alimera, with the FDA in the second calendar quarter of 2010 and to request Priority Review. If approved, Iluvien would be the first ophthalmic drug therapy for Diabetic Macular Edema, a potentially blinding eye disease that affects more than one million people in the United States alone. Receiving Priority Review status could result in a decision from the FDA by as early as the end of calendar 2010 and, if positive, Alimera has indicated that first sales of Iluvien could be as early as the first quarter of 2011.
“FDA approval of Iluvien would trigger a $25 million milestone payment from Alimera,” explained Dr. Ashton.
“We are continuing to advance our technologies toward the development of additional products, both partnered through our ongoing collaboration agreement with Pfizer, Inc. and internally. We are excited by the opportunities in our pipeline,” concluded Dr. Ashton.
finance.yahoo.com/news/FDA-grants-priority-review-to-apf-1922635914.html
ATLANTA (AP) -- Alimera Sciences Inc. said Monday regulators granted priority review to its potential diabetic macular edema treatment, Iluvien.
The Food and Drug Administration decision sets a six-month review timetable for the drug's application instead of the normal 10 months. That could result in a potential approval in December because the drug's application was submitted at the end of June.
Diabetic macular edema can lead to distorted or loss of vision.
Alimera, which specializes in prescription ophthalmic drugs, is conducting two late-stage trials on Iluvien that involve 956 patients to evaluate its safety and effectiveness.
Shares of Alimera rose 40 cents, or nearly 5 percent, to $8.50 in after-hours trading Monday.
Mal sehen wann die Psi-Aktie reagiert.
www.istockanalyst.com/article/viewiStockNews/articleid/4503628
Sollten deutlich positiv sein, da ja die 1. Meilensteinzahlung im April gekommen.
(RTTNews) - pSivida Corp. (PSDV: News ) reported on Wednesday a profit for fourth quarter, compared to a year-ago loss, helped by higher revenues.
The reported net income for the fourth quarter of $13.07 million or $0.68 per share, compared to a net loss of $534 thousand or $0.03 per share in the year-ago quarter.
Total revenues for the quarter increased to $15.72 million from $3.22 million in the prior-year quarter.
www.rttnews.com/Content/QuickFacts.aspx
nachbörslich +12% auf 4,80 $
The brokerage said Illuvien, Alimera’s advanced product candidate to treat diabetic macular edema (DME) could present a nice adjunctive therapy in DME.
Illuvien, assuming usage as 2nd line therapy to lasers can generate peak sales of at least $250 million by 2016, the brokerage said.
“Ultimately, we can envision ALIM as a potential takeout target,” Rodman & Renshaw said.
Illuvien, a tiny, intravitreal insert, is being studied as a way to deliver fluocinolone acetonide, a corticosteroid, to the retina for up to three years to treat DME.
DME, a complication of diabetic retinopathy, is a disease affecting the macula, the part of the eye responsible for central vision. In the U.S., diabetic retinopathy causes about 12,000 to 24,000 new cases of blindness each year, making diabetes the leading cause of new cases of blindness in adults aged 20 to 74.
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There are no ophthalmic drug therapies currently approved by the US Food and Drug Administration (FDA) for the treatment of DME.
Rodman & Renshaw said DME represents a serious long-term ocular complication of diabetes and laser photocoagulation is the only approved therapy.
FDA has given priority review for Illuvien and Prescription Drug User Fee Act date is Dec 30, 2010.
“We try to bolster our case for Illuvien approval by highlighting that Allergan got approval for Ozurdex in retinal vein occlusion even though the trial failed and there was no efficacy signal at 6-months,” the brokerage said. Illuvien, relatively, is showing a much better signal than laser therapy at 24-months.
Shares of Alpharetta, Georgia-based Alimera Sciences ended Friday’s regular trading session at $10.89 on the Nasdaq.
Kulmbach (aktiencheck.de AG) - Nach Einschätzung der Experten vom Anlegermagazin "Der Aktionär" weist die pSivida-Aktie (ISIN US74440J1016/ WKN A0Q4DQ) ein ausgeglichenes Chance/Risiko-Verhältnis auf.
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Die US-Gesundheitsbehörde FDA wolle am 29. Dezember 2010 ihre Entscheidung über eine Zulassung des von Alimera Sciences (ISIN US0162591038/ WKN A0Q78Q) einlizensierten Augenmedikaments Iluvien bekannt geben. Sollte diese positiv ausfallen, könne pSivida mit einer Meilensteinzahlung von 25 Mio. USD sowie einer Gewinnbeteiligung von 20% rechnen.
Risikobereite Anleger können bei dieser Zulassungsspekulation auch direkt auf Alimera Sciences setzen, dürften aber mit der am Börsenwert gemessen kleineren pSivida-Aktie einen höheren Hebel haben, so die Experten von "Der Aktionär. Es werde ein Kursziel von 6,00 Euro gesehen. Ein Stopp sollte bei 3,20 Euro platziert werden. (Ausgabe 50)
(13.12.2010/ac/a/a)
Wer in Bio-Nano-Tech investiert (als Privatmann) sollte sehr gute Geduld mitbringen.
Drücken wir uns allen die Daumen dass es noch eine schöne Jahresendmeldung von der FDA für uns gibt und dann auf zu neuen Höhen.
In diesem Sinne
Frohes Zocken
Vers
kommt dann geht in den nächsten Monaten die Post ab.....nur meine Meinung.
aber erst mal ruhig Weihnachten.. bis dann
Jetzt hoffe ich drauf, dass die mir mittlerweile sehr symphatische Firma PSIVIDA es allen zeigt und vielleicht sind ihre Technologien so gut, dass es zu Weltpatenten reicht.
Ich drücke uns schwer die Daumen
Frohe Weihnachten
Vershjelm
Sah doch so gut aus?
Ich glaube die FDA hat einen Formfehler entdeckt bei einem Antrag.
Oder ist es mehr?
FZ
Vers
Wie ich bereits geschreiben hatte (bzgl. böser Überraschung), bin ich bei 4,75€ VOR der Entscheidung raus und stehe aktuell an der Seitenlinie.
Allerdings ist der CRL (zumindest lt. Pressemitteilung) nicht so negativ zu werten, da keine neunen Studien verlangt wurden, sondern "nur" die kompletten 36-Monats-Ergebnisse. Das zeigt auch die Kurserholung nach dem "Schock".
Meiner Meinung nach wird es noch ca. 1-2 Monate dauern, bis hier wieder Schwung reinkommt. Ich halte das Unternehmen trotzdem für sehr aussichtsreich, da ja noch andere Sachen in der Pipeline sind.
Mögliche Kurs-Katalysatroren 2011
- Zusammenarbeit mit Pfizer seit ca. 3 Jahren (News sollten auch bald folgen)
- Zulassung von Iluvien doch noch in 2011
- evtl. Übernahme der Company
Happy Trading und auf gute Gewinne!