Aug 07, 2010 - Newly-Published Peer-Reviewed Paper shows Durasert device was neuroprotectant in Retinitis Pigmentosa Model
WATERTOWN, Mass., Apr 07, 2010 (BUSINESS WIRE) --pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of ophthalmic sustained release drug delivery products, today said that a recently-published peer reviewed scientific paper showed that a sustained release Durasert drug delivery device releasing the steroid fluocinolone acetonide (FA) in the back of the eye preserved retinal function in a retinitis pigmentosa model.
Dr. Paul Ashton, CEO of pSivida Corp., who co authored the paper with Inna V. Glymbia, Alexander Kennedy and Gary Abrams of Wayne State University, Kresge Eye Institute in Detroit and Raymond Iezzi of the Mayo Clinic in Rochester, used pSivida's Durasert technology to study the neuroprotective properties of low-dose sustained-release intravitreous FA as a means of reducing retinal neuroinflammation, preventing cell death and preserving retinal function. Retinitis pigmentosa is a hereditary condition that affects approximately 100,000 individuals in the US. There is presently no known cure or effective treatment for the condition, which causes gradual loss of peripheral vision and night vision and eventually most individuals become legally blind.
"This is very encouraging," said Dr. Ashton, "and we intend to pursue further studies using our technologies for the treatment of eye diseases for which there currently are very few effective treatments." pSivida has developed two of the only three FDA approved ophthalmic sustained release drug delivery products, Retisert(R) for the treatment of posterior uveitis and Vitrasert(R) for the treatment of Aids-related CMV retinitis, both of which are licensed to Bausch & Lomb. The company's third product, Iluvien(R) for the treatment of diabetic macular edema is licensed to Alimera Sciences which is conducting Phase III fully recruited trials and expects to submit a New Drug Application to the FDA in the second quarter of this year. If approved, Iluvien will be the first FDA approved drug for the treatment of DME.
pSivida is a world leader in the development of tiny, sustained release, drug delivery products that are administered by implantation, injection or insertion. pSivida's lead development product delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME). This product candidate, formerly known as Medidur(TM) FA for DME, is licensed to Alimera, which is conducting fully-recruited Phase III clinical trials and intends to commercialize the product under the name Iluvien(R). pSivida also has two products approved by the Food and Drug Administration (FDA): Retisert(R) for the treatment of posterior uveitis and Vitrasert(R) for the treatment of AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. under which Pfizer may develop additional ophthalmic products.
pSivida owns the rights to develop and commercialize a modified form of silicon known as BioSilicon(TM), which has potential therapeutic applications. The most advanced BioSilicon product candidate, BrachySil(TM), delivers a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors. pSivida conducted an initial safety clinical trial of BrachySil for the treatment of pancreatic cancer and in October 2009 completed a follow-on dose-ranging clinical trial.
pSivida's intellectual property portfolio consists of 62 patent families, over 100 granted patents, including patents accepted for issuance, and over 200 patent applications. pSivida conducts its operations from Boston in the United States and Malvern in the United Kingdom.
pSivida Corp. (ASX: PVA, NASDAQ: PSDV) released additional positive 24 month safety and efficacy data from the Iluvien Phase III FAME Study for the treatment of Diabetic Macular Edema
-> pSivida's licensing partner, Alimera Sciences intends to file a New Drug Application (NDA) to the FDA in Q2 calendar 2010. There are presently no FDA approved drugs to treat diabetic eye disease.
-> Following the release in late December 2009 of the top-line two year data from the FAME Study, Alimera Sciences raised US$10 million from its investors via the exercise of warrants. Alimera is due to begin monthly principal payments of US$500,000 to pSivida plus quarterly interest payments at 20% annually based on a US$15 million contingent note in April 2010. Alimera is contracted to pay pSivida a US$25m milestone payment upon FDA approval and pay pSivida 20% profits from the sale of Iluvien.
Jan 04, 2010 - pSivida releases positive results from Phase III trials of Iluvien for DME
pSivida Corp. (NASDAQ: PSDV, ASX: PVA, FF: PV3), a drug delivery company with two of the only three ophthalmic sustained release delivery products approved by the FDA for treatment of back of the eye diseases, today reported top-line 24 month results from the Phase III FAME™ study of Iluvien® for the treatment of Diabetic Macular Edema (DME) being conducted by pSivida’s collaborative partner Alimera Sciences.
-> The primary endpoint of the Study was met with a statistically significant number of patients achieving 15 letters or more of vision improvement (three lines on an eye chart) compared to the control groups.
-> A total of 956 patients were enrolled in the Study in centres across the US, Canada, Europe and India.
-> There are currently no FDA approved drug treatments for diabetic eye disease that affects millions of Americans in an unmet market that estimated at + $billion.
-> pSivida's licensing partner, Alimera Sciences plans to file a new drug application to the FDA in the 2nd quarter of 2010.
-> pSivida is due to receive from Alimera Sciences a US$25m payment upon FDA approval and repayment of a US$15m conditional note. If the note is not repaid by April 2010, Alimera must make principal repayments of $500k + quarterly interest payments calculated at 20% pa. pSivida will also receive 20% of profits from sales of Iluvien for DME.
Oct 22, 2009 - pSivida Announces Completion of BrachySil™ Dose Ranging Study in Pancreatic Cancer
Watertown, MA (22 October 2009) – pSivida Corp. (NASDAQ:PSDV; ASX:PVA; FF:PV3), a leading drug delivery company is pleased to announce the completion of a second pancreatic clinical trial of BrachySil™ (P32 BioSilicon™), a potential new brachytherapy treatment for inoperable pancreatic cancer. Six patients were studied at two centers in the UK (Guy’s and St Thomas’ NHS Foundation Trust and University Hospital, Birmingham). The study was conducted to determine the safety of escalating radiation doses of the BrachySil™ device and to determine an optimum dosing level. Tumor response was also measured as a secondary end point.
The study escalated the absorbed targeted radiation dose by four-fold from the previous study to 400 Gy (Gy or Gray is a unit of absorbed radiation dose due to ionizing radiation). No device related serious adverse events were experienced at the elevated levels and independent dosimetry experts have concluded from the data that 400 Gy is the optimum dose.
The previous safety study presented last year at the American Society of Clinical Oncology-GI showed that BrachySil™ in combination with standard chemotherapy (gemcitabine), was well tolerated with no clinically significant adverse events related to the device. Data in the first study showed disease control in 82% of patients. BrachySil™ is implanted directly into the tumor and was found to be easily deliverable by endoscopic ultrasound.
“BrachySil™ has once again produced encouraging clinical results with 100% of patients experiencing stabilization in tumor growth,” said Dr. Paul Ashton, President and CEO of pSivida Corp. “We are very encouraged by the results of both this dose ranging study and the prior safety study.”
BrachySil™ is a novel oncology product which comprises a combination of BioSilicon™ (a proprietary porous silicon) and the isotope 32Phosphorus, a proven anti-cancer therapeutic. It is hoped this product will provide oncologists with an effective and user-friendly new treatment for this disease which has a high unmet clinical need.
Pancreatic cancer is the fourth most frequent cause of cancer death in the United States, and at least 80% of patients present with inoperable locally advanced or metastatic disease. The median survival for these patients following diagnosis is typically less than six months with standard chemotherapy. Accordingly, there is significant clinical and market demand for effective therapies.
Source: pSivida Corporation
Sep 30, 2009 - pSivida Reports Results from 18-Month Interim Readout of Human PK Iluvien(R) Safety and Efficacy Study
WATERTOWN, Mass., Sep 29, 2009 (BUSINESS WIRE) -- pSivida Corp (NASDAQ: PSDV)(ASX: PVA), a leading drug delivery company that has developed two of the only three products approved by the FDA for the long-term, sustained release delivery of drug to treat chronic back of the eye disease, today reported the interim 18-month safety and efficacy results from the first human pharmacokinetic study (PK Study) of Iluvien(R). The PK trial is being conducted by Alimera Sciences, the licensee for Iluvien.
Dr. Paul Ashton, CEO of pSivida, said: "We are encouraged with the results we see from this small, 37-patient PK study, particularly as it relates to the safety profile. The lower incidence of elevated IOP with Iluvien in the PK study compared to the higher incidence shown in the data for studies of Retisert(R) (one of our FDA-approved, surgically inserted products which uses the same steroid), is very promising. In this PK study, we see an increase in efficacy in the high dose group and a decrease in efficacy in the low dose group in the results at 18 months as compared to 12 months. While the efficacy data is encouraging, these are very small patient numbers. Data from the almost 1000 patient Phase III FAME(TM) trial is due at the end of the year, which will give us a clearer picture of the relative efficacy of Iluvien dosages."
This present 36-month, open-label, Phase II study is designed primarily to assess systemic exposure of the corticosteroid, fluocinolone acetonide (FA), after administration of Iluvien in patients with DME. Secondarily, the PK Study is designed to provide information on the safety and efficacy of Iluvien in a DME patient population. A total of 37 subjects were enrolled in the PK Study, 20 patients on the low dose of Iluvien (an approximate 0.23 micrograms (ug) per day dose), and 17 patients on the high dose of Iluvien (an approximate 0.45ug per day dose).
In the 18-month interim readout, data again demonstrated no adverse events related to intraocular pressure (IOP) in low dose patients, and a similar level of increased IOP in the high dose patients as reported at 12 months. No patients receiving the low dose of Iluvien experienced IOP increases of 30 millimeters of mercury (mmHg) or greater at any time point, while 29 percent of the patients receiving the high dose of Iluvien experienced IOP increases of 30mmHg or greater at some time point.
In this trial, a subset of 11 patients in the high dose group and 13 patients in the low dose group met the visual acuity inclusion criteria of the nearly 1000 patient Phase III FAME trial. Of the 11 patients in the high dose group, six patients or 55 percent had an improvement in best corrected visual acuity (BCVA) of 10 letters or greater from baseline and four patients or 36 percent of the high dose patients had an improvement in BCVA of 15 letters or greater over baseline.
Of the 13 patients in the low dose group meeting the visual acuity criteria of the FAME trial, three patients or 23% percent had an improvement in BCVA of 10 letters or greater from baseline, while no patients showed an improvement in BCVA of 15 letters or greater from baseline at this time point. Iluvien is an investigative, extended release intravitreal insert currently under development for the treatment of Diabetic Macular Edema (DME). Each Iluvien insert is designed to provide a sustained therapeutic effect of up to 36 months, for the low dose Iluvien, and up to 24 months, for the high dose of Iluvien. Iluvien is inserted into the patient's eye with a 25-gauge needle, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists. An NDA for Iluvien is expected to be filed with the FDA early in 2010 by Alimera.
Sep 10, 2009 - pSivida closed on NASDAQ yesterday at a 52 week high of US$3.32 on 156k volume
1 PSDV (NASDAQ) = 1 PVA (ASX) = 1 PV3 (FF)
pSivida's Iluvien treatment for Diabetic Macular Edema (DME) is scheduled to complete Phase III clinical trials in October, with results expected in December. There are presently no FDA drug approved treatments for DME, a blinding disease that results from diabetes and inflicts millions of Americans.
pSivida is a world leader in the development of miniaturized, injectable, drug delivery systems for the eye. pSivida has two products approved by the Food and Drug Administration (FDA): Retisert® to treat uveitis and Vitrasert® for treating AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. pSivida has one product in fully recruited Phase III clinical trials: Iluvien™, which delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME), formerly known as Medidur FA for DME. pSivida has licensed certain drug delivery technology to Alimera Sciences, Inc. for the development of Iluvien and certain other ophthalmic products. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. under which Pfizer may develop additional ophthalmic products.
pSivida owns the rights to develop and commercialize a modified form of silicon known as BioSilicon™, which has potential therapeutic applications. The most advanced BioSilicon product candidate, BrachySil™, delivers a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors. pSivida completed an initial safety and efficacy clinical trial of BrachySil for the treatment of pancreatic cancer and has commenced a dose-ranging clinical trial.
pSivida’s intellectual property portfolio consists of 45 patent families, over 100 granted patents, including patents accepted for issuance, and over 200 patent applications. pSivida conducts its operations from Boston in the United States and Malvern in the United Kingdom.
Mar 13, 2009 - pSivida Corp. Reports Favourable 12-Month Interim Safety and Efficacy Results from IluvienTM Human PK Study
Watertown, MA - March 13, 2009 - pSivida Corp. (NASDAQ:PSDV)(ASX:PVA)(FF:PV3), a leading drug delivery company, today reported the interim 12-month safety and efficacy results from the first human pharmacokinetic study (PK Study) of IluvienTM. The study is being conducted by the Company's licensing partner Alimera Sciences. Iluvien is an intravitreal insert being developed for the treatment of diabetic macular edema (DME).
This 36-month, open-label, Phase II study, running concurrently with the pivotal Phase III FAMETM Study (Fluocinolone Acetonide in Diabetic Macular Edema), is designed primarily to assess systemic exposure of the corticosteroid, fluocinolone acetonide (FA), after administration of Iluvien in patients with DME. Secondarily, the PK Study is designed to provide information on the safety and efficacy of Iluvien in a DME patient population. A total of 37 subjects were enrolled in the PK Study 20 patients on the low dose of Iluvien (an approximate 0.23 micrograms (ug) per day dose), and 17 patients on the high dose of Iluvien (an approximate 0.45ug per day dose).
In the 12-month interim readout, no adverse events related to intraocular pressure (IOP) were seen in low dose patients, and 23.5% of the high dose patients experienced IOP increases of 30mm of mercury (mmHg) or greater at some time point and one of those patients required surgery to address their elevated IOP. For comparative purposes, in published results from clinical studies of DME patients using sustained release intravitreal FA in Bausch & Lomb Incorporated's product Retisert® (a surgically implanted intravitreal drug delivery device containing 0.59 mg FA approved for the treatment of chronic non- infectious posterior uveitis), 35% of the patients experienced IOP increases of 30 mmHg or greater at some time point during the first year.
"We are extremely pleased that the 12 month interim safety analysis of Iluvien is consistent with the results that were seen at the 3 and 6 month readouts," said Dr. Paul Ashton, President and Chief Executive Officer of pSivida Corp. "The lower incidence of IOP changes in high dose Iluvien patients compared to the published clinical data on Retisert and the lack of IOP adverse events in low dose patients is encouraging and indicates that Iluvien has the potential to offer a very important safety advantage in the delivery of FA."
Efficacy data from the subgroup of patients with the same visual acuity inclusion criteria as the larger Phase III FAME trial revealed that 27.3% of the high dose patients had an improvement in best corrected visual acuity (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. Previously published results from a clinical study of Retisert® in DME patients, showed similar efficacy. In the Retisert trial (in 197 patients), 17% had an improvement in BCVA of 15 letters or greater over baseline at 12 months.
"The 12-month Iluvien efficacy data is very encouraging," said Dr. Ashton. "The safety and efficacy results to date in this study continue to be consistent with our expectations regarding Iluvien and we look forward to reporting future results as they become available".
Data from the PK Study will continue to be evaluated with interim analysis conducted at months 18, 24, 30 and 36. Except for the month 18 and final month 36 analysis, when the database will be fully locked, interim evaluations will be based on unaudited data. The last patient was enrolled in this study at the end of February 2008.
About IluvienTM
Iluvien is an intravitreal insert being developed for the treatment of DME. DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. Each Iluvien insert is designed to provide a sustained therapeutic effect, up to 36 months for the low dose and up to 24 months for the high dose. Iluvien is inserted into the patient's eye with a 25-gauge needle, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.
About pSivida Corp.
pSivida is a world leader in the development of miniaturized, injectable, drug delivery systems for the eye. pSivida has two products approved by the Food and Drug Administration (FDA): Retisert® to treat uveitis and Vitrasert® for treating AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. pSivida has one product in fully recruited Phase III clinical trials: Iluvien™, which delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME), formerly known as Medidur FA for DME. pSivida has licensed certain drug delivery technology to Alimera Sciences, Inc. for the development of Iluvien and certain other ophthalmic products. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. under which Pfizer may develop additional ophthalmic products.
pSivida owns the rights to develop and commercialize a modified form of silicon known as BioSilicon™, which has potential therapeutic applications. The most advanced BioSilicon product candidate, BrachySil™, delivers a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors. pSivida completed an initial safety and efficacy clinical trial of BrachySil for the treatment of pancreatic cancer and has commenced a dose-ranging clinical trial.
pSivida’s intellectual property portfolio consists of 45 patent families, over 100 granted patents, including patents accepted for issuance, and over 200 patent applications. pSivida conducts its operations from Boston in the United States and Malvern in the United Kingdom.
Mar 04, 2009 - pSivida Corp: Enrollment complete in BrachySil™ Dose Ranging Study
Watertown, MA – March 5, 2009 – pSivida Corp. (NASDAQ: PSDV, ASX: PVA,
FF: PSI), a leading drug delivery company today announced the completion of
enrollment of the BrachySil™ (P32 BioSilicon™) dose ranging clinical trial.
Dr Paul Ashton, President and CEO of pSivida Corp. said, “We are very pleased
to be progressing BrachySil™ as a potentially effective treatment for pancreatic
cancer, a devastating disease for patients and their families”.
The dose ranging study, conducted in the UK at Guy's and St Thomas' NHS
Foundation Trust, London and University Hospital, Birmingham is designed to
assess the safety of escalating radiation doses of the BrachySilTM device. Patient
survival and tumor response are secondary end points.
This dose ranging study follows a safety study of BrachySilTM in patients with
inoperable pancreatic cancer. This first study had shown BrachySilTM in
combination with standard chemotherapy (gemcitabine) was well tolerated with
no clinically significant adverse events related to the device. The data also
showed disease control in 82% of patients and an overall median survival of
people in the study of 309 days. BrachySilTM was also found to be easily
deliverable by endoscopic ultrasound. This was presented at ASCO (American
Society of Clinical Oncology)-GI.
Pancreatic cancer is the fourth most frequent cause of cancer death, and at least
80% of patients present with inoperable locally advanced or metastatic disease.
The median survival for these patients following diagnosis is typically less than
178 days with standard chemotherapy. Accordingly, there is significant clinical
and market demand for more effective therapies.
Dec 11, 2008 - pSivida Corp.: pSivida New Clinical Trial for Drug Delivery Device in AMD
Drug delivery company pSivida Corp (News) (NASDAQ: PSDV)(ASX: PVA)(FF: PV3) today announced that a clinical trial has begun using its MedidurTM delivery technology to treat a form of dry-Age related Macular Degeneration (dry-AMD).
Medidur is a tiny intravitreal insert designed to be administered by an eye care professional, using a proprietary 25-gauge inserter in a minimally invasive, outpatient procedure.
This application of Medidur technology has been licensed to Alimera Sciences and is in pivotal Phase III clinical trials for the treatment of diabetic macular edema (DME), a potentially blinding disease that affects over 1,000,000 people in the US. The Phase III clinical trials were fully enrolled over a year ago with preliminary efficacy and safety results expected in approximately one year. If approved by the FDA, Alimera will market the product under the name IluvienTM.
The new study is an investigator sponsored pilot study designed to assess the safety and efficacy of Iluvien in patients with bilateral geographic atrophy (GA) secondary to dry-AMD (News/Aktienkurs) and will compare two doses of Iluvien with a sham injection.
”The impetus for this study was the results of experiments conducted in two animal models of retinal degenerations. In both of these models, a miniaturized version of Iluvien demonstrated protective effects on the spontaneous degeneration which occurs in these animals,” said Raymond Iezzi, M.D., of Kresge Eye Institute, Wayne State University School of Medicine. ”These results were considered compelling enough to warrant a human study, especially for a condition for which there is no approved treatment,” added Dr. Iezzi.
Dr Paul Ashton, Managing Director of pSivida Corp. said, ”We are pleased that another application of our Medidur technology has now entered clinical trials.”
pSivida is a drug delivery company committed to the biomedical sector, with a primary focus on ophthalmology and oncology. pSivida has two products approved by the Food and Drug Administration (FDA): Retisert® to treat uveitis and Vitrasert® for treating AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch&Lomb Incorporated. pSivida has one product in fully recruited Phase III clinical trials: Iluvien™, which delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME), formerly known as Medidur FA for DME. pSivida has licensed certain drug delivery technology to Alimera Sciences, Inc. for the development of Iluvien and certain other ophthalmic products. pSivida has a worldwide collaborative research and license agreement with Pfizer Inc. under which Pfizer may develop additional ophthalmic products.
pSivida owns the rights to develop and commercialize a modified form of silicon known as BioSilicon™, which has potential therapeutic applications. The most advanced BioSilicon product candidate, BrachySil™, delivers a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors. pSivida recently completed an initial safety and efficacy clinical trial of BrachySil for the treatment of pancreatic cancer and has commenced a dose-ranging clinical trial.
pSivida's intellectual property portfolio consists of 64 patent families, 122 granted patents, including patents accepted for issuance, and 282 patent applications. pSivida conducts its operations from Boston in the United States and Malvern in the United Kingdom.
Jun 20, 2008 - Informations - Reincorporation of pSivida to US
pSivida Ltd. (NASDAQ:PSDVV, ASX:PVA, FSE:PSI) has implemented the Scheme of Arrangement for pSivida’s reincorporation in the US, which was approved by shareholders on June 6, 2008 and the Australian Federal Court on June 12, 2008... SI*-LINK: ...MD Paul Ashton with shareholder information
Aug 08, 2007 - pSivida generates A$82m from licensing amendment with Alimera
Global drug delivery company, pSivida Limited and development partner, Alimera Sciences today announced that they have amended their license and collaboration agreement relating to Medidur™ FA, the Companies’ Phase III investigative treatment for diabetic macular edema (DME), and other Medidur products. Alimera is increasing its equity in the future profits of Medidur FA from 50 to 80 percent in exchange for consideration of up to approximately A$82m (US$78m) to pSivida. Cnsideration to pSivida includes an up-front payment of A$13m (US$12m), a A$26m (US$25m) milestone payment upon FDA approval of Medidur™ FA (expected to be submitted in 2010), other payments of up to approximately A$22m (US$21m) by September 30, 2012, and assumption of pSivida's research and development funding obligations estimated at approximately A$21m (US$20m). This agreement gives the pSivida a significant financial interest in exciting late stage products whilst eliminating our need for equity financing for the foreseeable future by significantly reducing the Company's burn rate going forward. Company’s two lead ophthalmology programs in development are now funded by our partners, Alimera Sciences and Pfizer. The Company will now focus its resources on exciting products in development including other ophthalmic products and BrachySilTM for pancreatic cancer, which is expected to commence Phase IIb clinical trials in the near future. In the United States, as many as 200,000 people are diagnosed with DME each year and an estimated 1,000,000 people suffer from DME. Currently there are no FDA approved drug treatments for DME.
Aug 08, 2007 - pSivida completes recruitment of European Pancreatic Cancer Study and releases preliminary findings
pSivida Limited is pleased to announce the completion of the recruitment stage of the 17 persons Phase IIa clinical study of BrachySilTM for the treatment of inoperable pancreatic cancer at three leading hospitals in the United Kingdom and Singapore. All are major centers for cancer therapy. Pancreatic cancer has one of the lowest cancer survival rates (five year relative survival rate of approximately 5%) with 85-90% of patients being diagnosed with the inoperable form of the disease and is the fourth largest cause of death by cancer in the United States.
SI*-LINK:
pSivida_BrachySil Recruitment and Prelim Results.pdf
04.04.2007 - pSivida signs A$203 million (US$165 million) Collaborative Research and Licensing Agreement
with Pfizer
pSivida Limited (NASDAQ:PSDV, ASX:PSD, Xetra:PSI), today announced it has signed an exclusive worldwide Collaborative
Research and License Agreement with Pfizer Inc. (PFE: NYSE) for pSivida’s controlled drug delivery technologies, including
the Medidur TM technology, in ophthalmic applications
Under the terms of the agreement, pSivida will receive up to A$191m (US$155m) in development and sales related milestones.
The two companies will work together on a joint research program aimed at developing ophthalmic products using pSivida’s
sustained drug delivery technology. In addition to milestone payments, Pfizer will fund the cost of the joint research
program. Pfizer will have an exclusive license to market all products developed as part of this research collaboration in
ophthalmic applications and will pay pSivida a royalty on net sales of those products. Pfizer may terminate the agreement on 60 days notice without cause.
In addition to the development and sales milestones and payment of the cost of the joint research program, Pfizer has agreed to invest A$6.1m (US$5m) in ordinary shares of pSivida upon entering into the License Agreement, the proceeds of which will
be held in escrow until such proceeds can be used (together with other cash available to pSivida) to redeem an outstanding
convertible note. If pSivida does not repay the full amount outstanding under the convertible note prior to June 4, 2007,
Pfizer may elect during the 90 day period following June 9, 2007 to cause pSivida to return the A$6.1m (US$5m) held in
escrow, in which case the license agreement would terminate. Pfizer has also agreed to invest an additional A$6.1m (US$5m)
in pSivida common equity in the future, subject to certain conditions.
“We believe this collaboration is another significant validation of the drug delivery systems that pSivida has been
developing since its founding,” said Dr. Paul Ashton, Managing Director, pSivida Limited. “pSivida plans to pursue
development and additional collaborations exploiting our innovative drug delivery technologies in other parts of the body.”
Medidur™ is a tiny, injectable device designed for the sustained release of drugs and is currently being studied for the
treatment of Diabetic Macular Edema (DME), the leading cause of blindness for Americans under the age of 65. Medidur TM in
combination with Fluocinolone Acetonide is in Phase III clinical trials in DME in collaboration with Alimera Sciences Inc.,
a specialty pharmaceutical company focused on the ophthalmic industry.
30.01.2007 - RetisertTM Drug Implant Receives Product Specific Bill Code
and Medicare Reimbursement Rate
Streamlines Process for RetisertTM Reimbursement
BOSTON & PERTH, Australia -Global bio-nanotech company pSivida Limited (NASDAQ:PSDV)(ASX:PSD)(Xetra:PSI) today announced
that RetisertTM, developed jointly by pSivida and Bausch & Lomb, has been allocated a product specific J-Code by the Centers for Medicare and Medicaid Services (CMS) in the United States.
The RetisertTM implant was approved as a single indication orphan drug by the United States Food and Drug Administration for the treatment of chronic noninfectious posterior segment uveitis, a sight threatening inflammatory disease and a major cause of blindness. RetisertTM is surgically placed into the back of the eye and releases the steroid, fluocinolone acetonide at a constant rate over a period of up to 30 months. Marketed in the United States by Bausch & Lomb, pSivida receives royalties
on sales.
The new J-Code, J7311 replaces the Medicare hospital outpatient code, C9225, which had been available to hospitals for
billing Medicare when the RetisertTM implant is implanted in a hospital outpatient setting. The J7311 code should be
recognized by all health care insurers as they add this code to their respective billing systems. CMS also has published a
payment rate for J7311 of $19,345, or 106% of the average sales price for the product.
In a recent press release, Michael O'Rourke, General Manager of the U.S. Pharmaceutical business for Bausch & Lomb said,
"This is an important milestone, which recognizes the national utilization of the RetisertTM implant and the critical and
unique role it may play in preventing cumulative damage to the visual system caused by recurrent episodes of inflammation.
Importantly, the establishment of a product-specific J-Code should help patients get timely access to this innovative
therapy. It will also help hospitals and physicians bill accurately and uniformly for the product across the country."
Dr Paul Ashton, Managing Director of pSivida Limited said, "The actions taken by the CMS should make it easier for the
thousands of sufferers of this dehabilitating and chronic disease to find relief with this novel and innovative therapy."
The J-Code and Medicare payment rate are effective as of January 1, 2007. Private insurers may pay at different rates than
Medicare.
