A Closer Look At PSivida Thu. September 10, 2009; Posted: 08:49 AM Stocks RSS You too can increase your ETF trading!
Look up the PowerRating of PSDV and see how it has performed over the past week as well as the current proprietary PowerRating.
(RTTNews) - Shares of pSivida Corp. (PSDV | Quote | Chart | News | PowerRating), a drug delivery company with a primary focus on ophthalmology and oncology, set a new intra-day high of $3.58 for the year and then pulled back to close at $3.32 on Wednesday. At the Rodman & Renshaw Annual Health Care Conference in New York, September 10, Paul Ashton, president and chief executive officer of pSivida will make a presentation.
The company's lead development product --Iluvien for the treatment of diabetic macular edema is under two phase III trials. The trials, dubbed FAME study (Fluocinolone Acetonide in Diabetic Macular Edema), are being conducted in partnership with privately-held Alimera Sciences Inc.
Iluvien is an injectable, non-erodable, intravitreal implant designed to release the drug fluocinolone acetonide, or FA, for up to three years. According to pSivida, Iluvien is small enough to be injected into the back of the eye with a 25 gauge needle creating a self-sealing hole and the insertion procedure is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.
Diabetic macular edema, or DME, for which pSivida is testing Iluvien, is a common diabetes complication, which causes retinal blood vessels in a diabetic's eyes to deteriorate and leak.
In March, the company reported favorable 12-month interim safety and efficacy results from a 36-month, open-label, phase II study, which is running concurrently with the pivotal phase III trials. The 12-month results of the phase II study revealed that there were no adverse events related to intraocular pressure, or IOP, in low dose patients, and only 23.5% of the high dose patients experienced IOP increases of 30mm of mercury (MMHG | Quote | Chart | News | PowerRating) or greater at some time point.
According to pSivida, Iluvien compares favorably with Retisert as it has the potential to offer a very important safety advantage. Published results from clinical studies of DME patients who used Retisert show that 35% of the patients experienced IOP increases of 30 mmHg or greater at some time point during the first year.
Retisert, developed by pSivida was approved by the FDA in April 2005 for treating Uveitis, an intra-ocular inflammatory disease and is marketed under license by Bausch & Lomb.
The interim results presented in March also revealed that 27.3% of the high dose patients had an improvement in best corrected visual acuity, or BCVA of 15 letters or greater over baseline and 23.1% of the low dose patients had an improvement in BCVA of 15 letters or greater over baseline. The efficacy data of interim phase II results is from the subgroup of patients with the same visual acuity inclusion criteria as the larger phase III FAME trial.
The phase III FAME study consists of two 36-month, doublemasked, randomized, multicenter trials and top line data from the FAME study is expected by the end of this year. pSivida expects to file a New Drug Application for Iluvien for diabetic macular edema in early 2010.
pSivida has licensed certain of its drug delivery technology to Alimera for the development of Iluvien and certain other ophthalmic products. If Iluvien gets FDA approval, pSivida is entitled to receive a $25 million milestone payment and, upon commercialization, is eligible to receive a 20% profit share from Alimera Sciences as per the terms of the licensing and collaboration agreement.
There is currently no FDA approved drug therapy for treating DME and the only FDA approved method for treating DME involves laser photocoagulation therapy, which can leave irreversible blind spots. Genentech's FDA-approved wet AMD treatment Lucentis is also being investigated as a potential treatment of DME. According to experts, DME represents a vast market potential in excess of $1 billion.
In addition to diabetic macular edema, Iluvien is also being evaluated as a potential treatment for wet and dry age-related macular degeneration. Alimera is conducting a phase II clinical trial with Iluvien in wet and dry age-related macular degeneration.
pSivida has two products approved by the FDA -- Retisert for the treatment of uveitis and Vitrasert for the treatment of AIDS-related cytomegalovirus retinitis. The company has licensed both these products and the technologies underlying them to Bausch & Lomb Inc.
The company has three primary drug delivery technologies -- Durasert, BioSilicon and CODRUG.
-- Durasert portfolio includes the FDA-approved Retisert and Vitrasert as well as product candidates Iluvien and Medidur. Medidur is under pre-clinical trials for Retinitis Pigmentosa.
-- BrachySil, which is in development for the treatment of solid tumors, uses the BioSilicon technology. BrachySil is a medical device containing beta-emitting phosphorous 32-P that is administered under a local anesthetic via direct, intraturmoral injection using a fine gauge needle with ultrasound or CT guidance.
The company is currently conducting a dose ranging clinical trial with BrachySil in pancreatic cancer. Enrollment of the dose ranging clinical trial was completed in March of this year. The study is designed to determine the safety of escalating radiation doses of the BrachySil device, with tumor response as a secondary endpoint.
pSivida believes that BrachySil has the potential to treat other solid tumors, and it has plans to investigate other tumor indications, such as liver metastases.
-- CODRUG system allows for the simultaneous release of two or more drugs at the same controlled rate over a predetermined period of time.
pSivida added Durasert technology system and CODRUG technology system to its roster with the acquisition of Control Delivery Systems Inc. in December 2005. BioSilicon technology was discovered and developed by QinetiQ, one of the major shareholders of pSivida.
The company's major shareholders include Pfizer Inc. (PFE | Quote | Chart | News | PowerRating), ORBIS Investment Management (Australia) Pty Limited, MidSummer Investment Ltd and QinetiQ, the largest research agency in Europe. pSivida has an exclusive worldwide Collaborative Research and License Agreement with Pfizer for certain of its technologies, including the technology underlying the Medidur drug delivery device, in certain ophthalmic applications. Under the terms of the agreement, which was inked in April 2007, pSivida is eligible to receive up to $153.5 million in development and sales related milestones from Pfizer.
pSivida reported its third-quarter results on May 14. For the third-quarter ended March 31, 2009, the company's consolidated net loss narrowed to $636 thousand or $0.03 per share from $5.5 million or $0.30 per share in the comparable year-ago quarter. Total quarterly revenue, which includes revenue from collaborative research & development and royalty income, surged to $3.16 million from a mere $542 thousand in the year-ago quarter.
As of March 31, 2009, the company had total cash of $8 million and zero debt on its balance sheet. With the company, reducing its operating cash burn, it is expected that there is no requirement to raise money to fund its operations prior to FDA approval of Iluvien.
Given the recent positive developments related to pSivida's investigational products as well as its financials, PSDV is worth taking a closer look.
For comments and feedback: contact [email protected] Copyright(c) 2009 RTTNews.com, Inc. All Rights Reserved
PVA Price at posting:
$4.75 Sentiment: None Disclosure: Not Held
