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pSivida Announces Tech Evaluation Agreement With Leading Global Pharmaceutical Company

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By Business Wirevia The Motley Fool

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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™ and Tethadur™ technologies 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. Tethadur is pSivida’s proprietary technology for the delivery of proteins, peptides and antibodies.

“We are extremely pleased to be working with another global pharmaceutical company to apply our unique technologies to develop transformational products in ophthalmology,” said Dr. Paul Ashton, pSivida president and CEO.

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.

About pSivida Corp.

pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic Diabetic Macula Edema (DME), licensed to Alimera Sciences, Inc., has received marketing authorization in Austria, France, Germany, Portugal, the U.K. and Spain and is awaiting authorization in Italy. ILUVIEN® for DME has not been approved in the US. pSivida plans to institute pivotal Phase III clinical trials for the treatment of posterior uveitis with the same micro-insert as ILUVIEN® for DME. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible micro-insert to treat glaucoma and ocular hypertension. pSivida’s two FDA-approved products, Retisert® and Vitrasert®, are implants that provide long-term, sustained drug delivery to treat two other chronic diseases of the retina.

SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, …read more

Source: FULL ARTICLE at DailyFinance

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pSivida Reports on Resubmission to FDA of NDA for ILUVIEN® for Chronic Diabetic Macular Edema

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pSivida Reports on Resubmission to FDA of NDA for ILUVIEN® for Chronic Diabetic Macular Edema

WATERTOWN, Mass.–(BUSINESS WIRE)– pSivida Corp. (NAS: PSDV) (ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported the submission of its response to the second Complete Response Letter from the U.S. Food and Drug Administration (FDA) with respect to ILUVIEN® for chronic diabetic macular edema (DME).

Alimera reported in its 10-K filing that it submitted the response, which includes additional analyses of the risks and benefits of ILUVIEN based on the clinical data available from the previously completed Phase III studies (FAME), following a meeting with the FDA in the second quarter 2012. Alimera said that the resubmission focuses on the safety aspects of ILUVIEN and the population of patients with chronic DME. This is the same group for which marketing approval of ILUVIEN has been granted in six EU countries thus far. Alimera reported that it will communicate the Prescription Drug User Fee Act (PDUFA) date once it is known from the FDA and that Alimera does not plan to conduct additional trials for ILUVIEN for DME at this time.

“We are pleased to see the resubmission of the NDA to the FDA,” said Dr. Paul Ashton, president and CEO of pSivida Corp. “To date, we have received over $30m from Alimera from its license of ILUVIEN for DME, and if the FDA approves ILUVIEN, we would be entitled to an additional $25 million milestone payment as well as 20% of net profits, as defined, on any sales in the U.S. by Alimera.”

pSivida is entitled to the same net profit share on sales of ILUVIEN for DME by Alimera in the EU. Alimera has announced its intent to commercially launch ILUVIEN in Germany and for private patients in the UK in the second quarter of 2013, upon approval of the commercial batch size.

About pSivida Corp.

pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic Diabetic Macula Edema (DME), licensed to Alimera Sciences, Inc., has received marketing …read more
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pSivida Reports Updates on ILUVIEN® for Planned Resubmission to FDA and European Launch

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By Business Wirevia The Motley Fool

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pSivida Reports Updates on ILUVIEN® for Planned Resubmission to FDA and European Launch

WATERTOWN, Mass.–(BUSINESS WIRE)– pSivida Corp. (NAS: PSDV) (ASX:PVA), a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported a number of updates with respect to ILUVIEN® for chronic diabetic macular edema (DME).

Alimera announced that it intends to resubmit its New Drug Application for ILUVIEN for DME to the U.S. Food and Drug Administration (FDA) by the end of March 2013. Using data from Alimera’s two previously completed pivotal Phase III clinical trials (FAME™ Study), the resubmission will focus on the safety aspects of ILUVIEN and the population of patients with chronic DME considered insufficiently responsive to available therapies, the same group for which marketing approval for ILUVIEN has been granted in various EU countries, according to Alimera. Approval in the U.S. would entitle pSivida to a $25 million milestone payment from Alimera and 20% of net profits, as defined, from U.S. sales of ILUVIEN by Alimera.

Alimera also announced that shipments of ILUVIEN to the German market are expected to begin in the second quarter of 2013 upon acceptance from the Medicine and Health products Regulatory Agency of the intended commercial batch size, a delay from Alimera’s previous expectation that this would occur in the first quarter of 2013. Alimera further reported that it also expects to begin shipments to the U.K. in the second quarter of 2013 for treatment of privately insured patients.

Alimera reported the submission of a patient access scheme (PAS) for ILUVIEN for DME has been agreed to by the UK’s Department of Health and is now under consideration by NICE for inclusion in its rapid review facility. NICE had previously issued final guidance that ILUVIEN is not a cost-effective treatment for chronic DME considered insufficiently responsive to available therapies. Alimera reported that under the review facility, NICE is expected to assess the impact of the PAS on ILUVIEN‘s cost effectiveness and determine whether an update to the final guidance is warranted.

About pSivida Corp.

pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of …read more
Source: FULL ARTICLE at DailyFinance

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pSivida VP of Research to Discuss Company's Protein and Antibody Sustained Delivery System at 5th Oc

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pSivida VP of Research to Discuss Company’s Protein and Antibody Sustained Delivery System at 5 th Ocular Diseases and Drug Development Conference

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 the Company’s Vice President of Research, Dr. Hong Guo, will present a paper at the 5th Ocular Diseases and Drug Development Conference in San Francisco on March 21. Dr. Guo’s presentation will take place at 10:30 a.m.

Dr. Guo’s presentation entitled “Sustained delivery of proteins and anti-bodies” is expected to discuss recent developments in pSivida’s Tethadur technology.

“One of the many challenges to the pharmaceutical industry is to develop effective delivery systems for protein and antibody drugs,” said Dr. Paul Ashton, President and CEO of pSivida. “Dr. Guo will describe results we have had with our proprietary Tethadur system, which is based on bioerodible, nanostructured, porous silicon. With the large number of biologic patents expiring and the development of the Bio-similar field, improved protein delivery will become increasingly important.”

pSivida has previously announced a technology evaluation agreement with a leading global biopharmaceutical company investigating the use of this technology in ophthalmology.

The Ocular Diseases and Drug Development Conference promotes the discovery of ocular disease development by bringing together leading scientists, researchers and experts to discuss and collaborate on the latest research and development, safety assessment, regulatory issues and drugs in development for combating and curing age-related macular degeneration (AMD), diabetic retinopathy, glaucoma, DME, uveitis and other ocular diseases. Among those participating are representatives from most of the pharmaceutical companies that are involved in the development of treatments for these conditions.

About pSivida Corp.

pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drugs delivery products designed to release drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technology systems, Durasert™ and BioSilicon™. Two FDA-approved products, Vitrasert™ and Retisert™ are licensed to Bausch & Lomb. The company has licensed ILUVIEN® for DME to Alimera Sciences and that product has received marketing authorization in Austria, France, Germany, Portugal, Spain and the UK. pSivida has clinical trials ongoing for the treatment of posterior uveitis and glaucoma and ocular hypertension. Other technologies under development by pSivida include protein and antibody delivery systems in early clinical stages.

SAFE HARBOR STATEMENTS …read more
Source: FULL ARTICLE at DailyFinance